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  1. Validation of a consensus-based minimal clinically important difference (MCID) threshold using an objective functional external anchor.

    Science.gov (United States)

    Gatchel, Robert J; Mayer, Tom G; Choi, Yunhee; Chou, Roger

    2013-08-01

    The minimal clinically important difference (MCID) is defined as the smallest change in an outcome that a patient would perceive as meaningful. The Initiative on Methods, Measurement and Assessment in Clinical Trials (IMMPACT) group proposed defining the MCID as a 30% improvement in self-reported pain or function. However, this MCID threshold has not been validated against an objective physical measure. To test the validity of the IMMPACT-based MCID threshold, using an objective physical measure as an external anchor. Prospective study of chronic disabling occupational lumbar disorder (CDOLD) patients completing a functional restoration program. A consecutive cohort of 743 CDOLD patients. Self-report measures of pain-related function were compared with an objective lifting measure, the progressive isoinertial lifting evaluation (PILE), obtained after treatment. The association between reporting 30% or greater improvement (the IMMPACT's MCID key criterion) and the PILE score after treatment was assessed. A 30% or greater improvement on the self-report measures was significantly associated with improvement in physical function on the PILE task. Despite extensive use of the MCID to evaluate effects of treatment in spinal disorders, this is the first empirical documentation of the validity of the IMMPACT's 30% change criterion compared with an objective physical anchor. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation.

    Science.gov (United States)

    Chen, Poyu; Lin, Keh-Chung; Liing, Rong-Jiuan; Wu, Ching-Yi; Chen, Chia-Ling; Chang, Ku-Chou

    2016-06-01

    To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke. The EQ-5D-5L, along with four criterion measures-the Medical Research Council scales for muscle strength, the Fugl-Meyer assessment, the functional independence measure, and the Stroke Impact Scale-was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported. Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %). The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

  3. THE 6-MINUTE WALK TEST AND OTHER CLINICAL ENDPOINTS IN DUCHENNE MUSCULAR DYSTROPHY: RELIABILITY, CONCURRENT VALIDITY, AND MINIMAL CLINICALLY IMPORTANT DIFFERENCES FROM A MULTICENTER STUDY

    Science.gov (United States)

    McDonald, Craig M; Henricson, Erik K; Abresch, R Ted; Florence, Julaine; Eagle, Michelle; Gappmaier, Eduard; Glanzman, Allan M; Spiegel, Robert; Barth, Jay; Elfring, Gary; Reha, Allen; Peltz, Stuart W

    2013-01-01

    Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6-minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6-minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013 PMID:23674289

  4. The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study.

    Science.gov (United States)

    McDonald, Craig M; Henricson, Erik K; Abresch, R Ted; Florence, Julaine; Eagle, Michelle; Gappmaier, Eduard; Glanzman, Allan M; Spiegel, Robert; Barth, Jay; Elfring, Gary; Reha, Allen; Peltz, Stuart W

    2013-09-01

    An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6-minute walk test (6MWT) and other endpoints. Screening and baseline evaluations included the 6-minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate-determined energy expenditure index, and other exploratory endpoints. The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Copyright © 2013 Wiley Periodicals, Inc.

  5. Validity, Responsiveness, Minimal Detectable Change, and Minimal Clinically Important Change of "Pediatric Balance Scale" in Children with Cerebral Palsy

    Science.gov (United States)

    Chen, Chia-ling; Shen, I-hsuan; Chen, Chung-yao; Wu, Ching-yi; Liu, Wen-Yu; Chung, Chia-ying

    2013-01-01

    This study examined criterion-related validity and clinimetric properties of the pediatric balance scale ("PBS") in children with cerebral palsy (CP). Forty-five children with CP (age range: 19-77 months) and their parents participated in this study. At baseline and at follow up, Pearson correlation coefficients were used to determine…

  6. Validity, responsiveness and the minimal clinically important difference for the de Morton Mobility Index (DEMMI in an older acute medical population

    Directory of Open Access Journals (Sweden)

    Davidson Megan

    2010-09-01

    Full Text Available Abstract Background The de Morton Mobility Index (DEMMI is a new mobility instrument that overcomes the limitations of existing instruments. It is the first mobility instrument that accurately measures the mobility of all older adults. The aim of this study was to provide a detailed report of investigations of the validity, responsiveness to change and minimal clinically important difference (MCID of the DEMMI during its development in an older acute medical population. Methods This study was conducted using a head to head comparison design in two independent samples of older acute medical patients (development sample, n = 86; validation sample, n = 106. Consecutive patients (≥ 65 years were assessed using the DEMMI, Barthel Index (BI and Hierarchical Assessment of Balance and Mobility (HABAM within 48 hours of hospital admission and discharge. Convergent and discriminant validity were investigated using Spearman's rho and known groups validity was investigated using a independent t test to compare DEMMI scores for patients who were discharged to home compared to inpatient rehabilitation. Criterion and distribution based methods were employed for estimating instrument responsiveness to change and the MCID. Results Significant moderate to high correlations were identified between DEMMI and BI scores (r = 0.76 and r = 0.68 and DEMMI and HABAM scores (r = 0.91 and r = 0.92 in both samples. In both samples, DEMMI scores for patients who were discharged to home were significantly higher than for patients discharged to inpatient rehabilitation and provided evidence of known groups validity. Patients who were discharged to inpatient rehabilitation (n = 8 had a mean DEMMI score of 50.75 (sd = 11.29 at acute hospital discharge compared to patients who were discharged to home (n = 70 with a mean DEMMI score of 62.14 (sd = 18.41. MCID estimates were similar across samples using distribution and criterion based methods. The MCID for the DEMMI was 10

  7. Clinical validity: defining biomarker performance

    NARCIS (Netherlands)

    Bossuyt, Patrick M. M.

    2010-01-01

    A central phase in the evaluation of a biomarker is the assessment of its clinical validity. In most cases, clinical validity will be expressed in terms of the marker's diagnostic accuracy: the degree to which it can be used to identify diseased patients or, more generally, patients with the target

  8. Assessment of Mobility in Older People Hospitalized for Medical Illness Using de Morton Mobility Index and Cumulated Ambulation Score-Validity and Minimal Clinical Important Difference.

    Science.gov (United States)

    Trøstrup, Jeanette; Andersen, Helle; Kam, Charlotte Agger Meiner; Magnusson, S Peter; Beyer, Nina

    2017-12-15

    Older adults acutely hospitalized for medical illness typically have comorbidity and disability, and inhospital physical inactivity greatly increases the likelihood of developing new disability. Thus, assessment of the patients' mobility status is crucial for planning and carrying out targeted interventions that ensure mobilization during hospital admission. The aim of this study was to determine convergent validity, known group validity, floor and ceiling effects, and anchor-based minimal clinically important difference (MCID) of the more time-consuming de Morton Mobility Index (DEMMI) and the less time-consuming Cumulated Ambulation Score (CAS) in older adults acutely hospitalized for medical illness. In this multicenter cohort study, 235 older hospitalized adults, with a mean (standard deviation) age of 84.8 (7.1) years, were consecutively included. Assessments of mobility using the DEMMI (score range 0-100), the CAS (score range 0-6), and the Barthel Index (BI, score range 0-100) were performed by physical or occupational therapists at hospital admission and discharge. In addition, at discharge patients and therapists were independently asked to assess the patients' current mobility status compared with their mobility status at hospital admission using the Global Rating of Change scale. Complete data sets were obtained for 155 patients. Baseline characteristics of those with complete data sets did not differ from those with incomplete data sets, except for the number of secondary diagnoses, which was lower in the latter. Significant and moderate relationships existed both at admission and at discharge between scores in the DEMMI and the BI (rs = 0.68, P mobility and can be considered to have the required properties for measuring mobility in older adults who are hospitalized in medical and geriatric wards. In contrast, the CAS appears to be appropriate to identify whether a patient is independently mobile or needs assistance, while the measure is less suitable

  9. The minimal clinically important difference of the control of allergic rhinitis and asthma test (CARAT): Cross-cultural validation and relation with pollen counts

    NARCIS (Netherlands)

    S. Van Der Leeuw (Sander); T. van der Molen (Thys); P.N.R. Dekhuijzen (Richard); J.A. Fonseca (J.); F.A. Van Gemert (Frederik A); R. Gerth van Wijk (Roy); J.W. Kocks (Janwillem Wh); H. Oosterom (Helma); R.A. Riemersma (Roland); I.G. Tsiligianni (Ioanna G); L.A. De Weger (Letty A); J.N.G. Oude Elberink; B.M.J. Flokstra-De Blok

    2015-01-01

    textabstractBackground:The Control of Allergic Rhinitis and Asthma Test (CARAT) monitors control of asthma and allergic rhinitis.Aims:To determine the CARATs minimal clinically important difference (MCID) and to evaluate the psychometric properties of the Dutch CARAT.Methods:CARAT was applied in

  10. The minimal clinically important difference of the control of allergic rhinitis and asthma test (CARAT) : cross-cultural validation and relation with pollen counts

    NARCIS (Netherlands)

    van der Leeuw, Sander; van der Molen, Thys; Dekhuijzen, P. N. Richard; Fonseca, Joao A.; van Gemert, Frederik A.; van Wijk, Roy Gerth; Kocks, Janwillem W. H.; Oosterom, Helma; Riemersma, Roland A.; Tsiligianni, Ioanna G.; de Weger, Letty A.; Oude Elberink, Joanne N. G.; Flokstra-de Blok, Bertine M. J.

    2015-01-01

    BACKGROUND: The Control of Allergic Rhinitis and Asthma Test (CARAT) monitors control of asthma and allergic rhinitis. AIMS: To determine the CARAT's minimal clinically important difference (MCID) and to evaluate the psychometric properties of the Dutch CARAT. METHODS: CARAT was applied in three

  11. The minimal clinically important difference of the control of allergic rhinitis and asthma test (CARAT): cross-cultural validation and relation with pollen counts

    NARCIS (Netherlands)

    Leeuw, S. van der; Molen, T. van der; Dekhuijzen, P.N.R.; Fonseca, J.A.; Gemert, F.A. van; Wijk, R. Gerth van; Kocks, J.W.; Oosterom, H.; Riemersma, R.A.; Tsiligianni, I.G.; Weger, L.A. de; Oude Elberink, J.N.; Flokstra-de Blok, B.M.

    2015-01-01

    BACKGROUND: The Control of Allergic Rhinitis and Asthma Test (CARAT) monitors control of asthma and allergic rhinitis. AIMS: To determine the CARAT's minimal clinically important difference (MCID) and to evaluate the psychometric properties of the Dutch CARAT. METHODS: CARAT was applied in three

  12. Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation.

    Science.gov (United States)

    Völler, Swantje; Flint, Robert B; Stolk, Leo M; Degraeuwe, Pieter L J; Simons, Sinno H P; Pokorna, Paula; Burger, David M; de Groot, Ronald; Tibboel, Dick; Knibbe, Catherijne A J

    2017-11-15

    Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population pharmacokinetic model for phenobarbital. We externally validate the model using prospective phenobarbital data from an ongoing pharmacokinetic study in preterm neonates. TDM data from 53 neonates (gestational age (GA): 37 (24-42) weeks, bodyweight: 2.7 (0.45-4.5) kg; postnatal age (PNA): 4.5 (0-22) days) contained information on dosage histories, concentration and covariate data (including birth weight, actual weight, post-natal age (PNA), postmenstrual age, GA, sex, liver and kidney function, APGAR-score). Model development was carried out using NONMEM(®) 7.3. After assessment of model fit, the model was validated using data of 17 neonates included in the DINO (Drug dosage Improvement in NeOnates)-study. Modelling of 229 plasma concentrations, ranging from 3.2 to 75.2mg/L, resulted in a one compartment model for phenobarbital. Clearance (CL) and volume (Vd) for a child with a birthweight of 2.6kg at PNA day 4.5 was 0.0091L/h (9%) and 2.38L (5%), respectively. Birthweight and PNA were the best predictors for CL maturation, increasing CL by 36.7% per kg birthweight and 5.3% per postnatal day of living, respectively. The best predictor for the increase in Vd was actual bodyweight (0.31L/kg). External validation showed that the model can adequately predict the pharmacokinetics in a prospective study. Data-sharing can help to successfully develop and validate population pharmacokinetic models in neonates. From the results it seems that both PNA and bodyweight are required to guide dosing of phenobarbital in term and preterm neonates. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Loneliness: Clinical Import and Interventions

    Science.gov (United States)

    Cacioppo, Stephanie; Grippo, Angela J.; London, Sarah; Goossens, Luc; Cacioppo, John T.

    2014-01-01

    In 1978, when the Task Panel report to the US President’s Commission on Mental Health emphasized the importance of improving health care and easing the pain of those suffering from emotional distress syndromes including loneliness, few anticipated that this issue would still need to be addressed 40 years later. A meta-analysis (Masi et al., 2011) on the efficacy of treatments to reduce loneliness identified a need for well-controlled randomized clinical trials focusing on the rehabilitation of maladaptive social cognition. We review assessments of loneliness and build on this meta-analysis to discuss the efficacy of various treatments for loneliness. With the advances made over the past 5 years in the identification of the psychobiological and pharmaceutical mechanisms associated with loneliness and maladaptive social cognition, there is increasing evidence for the potential efficacy of integrated interventions that combine (social) cognitive behavioral therapy with short-term adjunctive pharmacological treatments. PMID:25866548

  14. Validity, Responsiveness, Minimal Detectable Change, and Minimal Clinically Important Change of the Pediatric Motor Activity Log in Children with Cerebral Palsy

    Science.gov (United States)

    Lin, Keh-chung; Chen, Hui-fang; Chen, Chia-ling; Wang, Tien-ni; Wu, Ching-yi; Hsieh, Yu-wei; Wu, Li-ling

    2012-01-01

    This study examined criterion-related validity and clinimetric properties of the Pediatric Motor Activity Log (PMAL) in children with cerebral palsy. Study participants were 41 children (age range: 28-113 months) and their parents. Criterion-related validity was evaluated by the associations between the PMAL and criterion measures at baseline and…

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  18. DEFINING BIOMARKER PERFORMANCE AND CLINICAL VALIDITY

    NARCIS (Netherlands)

    Bossuyt, P.M.M.

    2011-01-01

    In the evaluation of biomarkers three questions can be answered: what is the analytical validity of the marker, what is its clinical validity, and does the marker have clinical utility? In most cases, clinical validity will be expressed in terms of the marker's accuracy: the degree to which it can

  19. [Clinical approach to imported eosinophilia].

    Science.gov (United States)

    Cañas García-Otero, Elías; Praena-Segovia, Julia; Ruiz-Pérez de Pipaón, Maite; Bosh-Guerra, Xerach; Sánchez-Agüera, Magdalena; Álvarez-Martínez, Daniel; Cisneros-Herreros, José Miguel

    2016-12-01

    Eosinophilia is a common finding in international travelers and immigrants, being an helmintic infection its main etiology. The positive predictive value of eosinophilia for an helmintosis is low in travellers. Eosinophilia may be an incidental finding, or symptomatic, and it represents a clinical challenge due to the low sensitivity and specificity of direct and indirect parasitological diagnostic tests, respectively. It requires a structured approach based on geographical areas, environmental exposures and behavioral risks, and associated symptoms. The initial assessment should include a comprehensive and tailored anamnesis and physical examination, basic laboratory tests, a complete parasitological examination of stool samples and a Strongyloides stercoralis serology, supplemented with other explorations guided by epidemiological and clinical suspicion. Empiric treatment with albendazole and/or ivermectin (plus praziquantel if risk of schistosomiasis) is an option for unidentified persistent eosinophilia after study, and in persons in whom a proper assessment or follow-up can not be assured. In patients at risk for estrongiloidosis who are candidates for immunosuppressive therapies, it is indicated a prior screening and treatment to prevent a future hyperinfestation syndrome. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  20. Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation

    NARCIS (Netherlands)

    Völler, S. (Swantje); R. Flint (Robert); L. Stolk (Lisette); Degraeuwe, P.L.J. (Pieter L.J.); S.H. Simons (Sinno); P. Pokorna (Pavla); D.M. Burger (David); de Groot, R. (Ronald); D. Tibboel (Dick); C.A.J. Knibbe (Catherijne)

    2017-01-01

    textabstractBackground: Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... In the past, clinical trial participants often were White men. Researchers assumed that trial results were valid ... in different ethnic groups sometimes respond differently than White men to the same medical approach. As a ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient care. ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These ... Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  9. IMPORTANCE AND CLINICAL SIGNIFICANCE OF SERUM SIALIC ...

    African Journals Online (AJOL)

    Open Access DOWNLOAD FULL TEXT Subscription or Fee Access. IMPORTANCE AND CLINICAL SIGNIFICANCE OF SERUM SIALIC ACID AND LACTATE DEHYDROGENASE DETERMINATION IN CERVICAL CANCER PATIENTS. Farouk H. Saber, Essam F. Hammouda, Mohamed Khaled M, Essam A. Afifi. Abstract.

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... treatments, drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... screening tests to see which test produces the best results. Some companies and ... Clinical Trials Are Important Clinical trials are ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  13. The generation and validation of white matter connectivity importance maps.

    Science.gov (United States)

    Kuceyeski, Amy; Maruta, Jun; Niogi, Sumit N; Ghajar, Jamshid; Raj, Ashish

    2011-09-01

    Both the size and location of injury in the brain influences the type and severity of cognitive or sensorimotor dysfunction. However, even with advances in MR imaging and analysis, the correspondence between lesion location and clinical deficit remains poorly understood. Here, structural and diffusion images from 14 healthy subjects are used to create spatially unbiased white matter connectivity importance maps that quantify the amount of disruption to the overall brain network that would be incurred if that region were compromised. Some regions in the white matter that were identified as highly important by such maps have been implicated in strategic infarct dementia and linked to various attention tasks in previous studies. Validation of the maps is performed by investigating the correlations of the importance maps' predicted cognitive deficits in a group of 15 traumatic brain injury patients with their cognitive test scores measuring attention and memory. While no correlation was found between amount of white matter injury and cognitive test scores, significant correlations (r>0.68, pimprove surgical planning, diagnosis, and assessment of disease severity in a variety of pathologies like multiple sclerosis, trauma, and stroke. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: validity, responsiveness, and identification of the minimally important difference in a phase 2 clinical trial.

    Science.gov (United States)

    Anderson, Roger T; Baran, Robert W; Erickson, Pennifer; Revicki, Dennis A; Dietz, Birgitta; Gooch, Katherine

    2014-04-01

    To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being. In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR24). Convergent validity of the HCV-PRO was assessed by Pearson's correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds). In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64-0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT -0.76; EOT -0.93). ES and ROC curve analyses indicated an MID of -10 points. The HCV-PRO was valid and responsive in the population studied. An MID of -10 points represented a threshold of clinical significance for the HCV-PRO.

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... These phases have different purposes and help researchers answer different questions. For example, phase I clinical trials test new ... importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... and Clinical Studies Learn about the importance of children in clinical ... America's research hospital, located on the NIH campus in Bethesda, Maryland. ...

  17. Listeriosis in Mexico: Clinical and epidemiological importance

    Directory of Open Access Journals (Sweden)

    Gloria Castañeda-Ruelas

    2014-11-01

    Full Text Available Listeriosis is caused by Listeria monocytogenes, an important food-borne disease due to its clinical forms, high mortality rate, and the economic impact in both clinical and food production industries. In Mexico, the lack of epidemiological surveillance systems leads to the need of accurate data on the incidence of listeriosis and its association with food-borne disease. In this paper, we present data about the presence of this bacterium in food, reports related to clinical cases of listeriosis, and information of diseases in which L. monocytogenes may be involved. However, in most of these cases the etiology was not established. Given this, there´s a need to inform and warn the appropriate entities, to define strategies for the mandatory search of L. monocytogenes through the whole food production chain and clinical suspects, for the epidemiological importance and control of listeriosis in Mexico.

  18. Minimal clinically important difference in radiological progression of joint damage. A definition based on patient perspective.

    NARCIS (Netherlands)

    Welsing, P.M.J.; Borm, G.F.; Riel, P.L.C.M. van

    2006-01-01

    OBJECTIVE: To estimate a threshold for minimal clinically important radiological progression of joint damage using its longitudinal relation with functional disability in patients with rheumatoid arthritis (RA). To validate existing estimates of minimal clinically important difference (MCID) using

  19. Validating EHR clinical models using ontology patterns.

    Science.gov (United States)

    Martínez-Costa, Catalina; Schulz, Stefan

    2017-11-04

    Clinical models are artefacts that specify how information is structured in electronic health records (EHRs). However, the makeup of clinical models is not guided by any formal constraint beyond a semantically vague information model. We address this gap by advocating ontology design patterns as a mechanism that makes the semantics of clinical models explicit. This paper demonstrates how ontology design patterns can validate existing clinical models using SHACL. Based on the Clinical Information Modelling Initiative (CIMI), we show how ontology patterns detect both modeling and terminology binding errors in CIMI models. SHACL, a W3C constraint language for the validation of RDF graphs, builds on the concept of "Shape", a description of data in terms of expected cardinalities, datatypes and other restrictions. SHACL, as opposed to OWL, subscribes to the Closed World Assumption (CWA) and is therefore more suitable for the validation of clinical models. We have demonstrated the feasibility of the approach by manually describing the correspondences between six CIMI clinical models represented in RDF and two SHACL ontology design patterns. Using a Java-based SHACL implementation, we found at least eleven modeling and binding errors within these CIMI models. This demonstrates the usefulness of ontology design patterns not only as a modeling tool but also as a tool for validation. Copyright © 2017. Published by Elsevier Inc.

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn ... patient outcomes; offers no benefit; or causes unexpected harm All of these results are important because they ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Health Topics Education & Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  5. Responsiveness and minimal clinically important change

    DEFF Research Database (Denmark)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah

    2015-01-01

    to assess shoulder outcomes. However, few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinically important change. Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after......Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used....... The change scores of the CS and the OSS were more strongly correlated with the external anchor (PGIC scale) than the change score of the EQ-5D-3L index. The areas under the ROC curves exceeded 0.80 for both shoulder scores, with no significant differences between them, and comparable effect-size estimates...

  6. Abnormal bone scan : Importance of clinical correlation

    Directory of Open Access Journals (Sweden)

    Dharm Raj Singh

    2002-01-01

    Full Text Available A case of renal cell carcinoma which was diagnosed to have metastatic disease on the basis of two hot spots in ribs on bone scan, is presented. After careful and thor-ough history, it turned out to be fracture ribs which oc-curred due to bad positioning during radical nephrectoiny. This case highlights the importance of clinical judgement especially in the modern era of sophisticated investiga-tions.

  7. The Importance of Calibration in Clinical Psychology.

    Science.gov (United States)

    Lindhiem, Oliver; Petersen, Isaac T; Mentch, Lucas K; Youngstrom, Eric A

    2018-02-01

    Accuracy has several elements, not all of which have received equal attention in the field of clinical psychology. Calibration, the degree to which a probabilistic estimate of an event reflects the true underlying probability of the event, has largely been neglected in the field of clinical psychology in favor of other components of accuracy such as discrimination (e.g., sensitivity, specificity, area under the receiver operating characteristic curve). Although it is frequently overlooked, calibration is a critical component of accuracy with particular relevance for prognostic models and risk-assessment tools. With advances in personalized medicine and the increasing use of probabilistic (0% to 100%) estimates and predictions in mental health research, the need for careful attention to calibration has become increasingly important.

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & Resources Press Releases Spotlight On Research NHLBI ... Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children ...

  13. Validation, updating and impact of clinical prediction rules: a review.

    Science.gov (United States)

    Toll, D B; Janssen, K J M; Vergouwe, Y; Moons, K G M

    2008-11-01

    To provide an overview of the research steps that need to follow the development of diagnostic or prognostic prediction rules. These steps include validity assessment, updating (if necessary), and impact assessment of clinical prediction rules. Narrative review covering methodological and empirical prediction studies from primary and secondary care. In general, three types of validation of previously developed prediction rules can be distinguished: temporal, geographical, and domain validations. In case of poor validation, the validation data can be used to update or adjust the previously developed prediction rule to the new circumstances. These update methods differ in extensiveness, with the easiest method a change in model intercept to the outcome occurrence at hand. Prediction rules -- with or without updating -- showing good performance in (various) validation studies may subsequently be subjected to an impact study, to demonstrate whether they change physicians' decisions, improve clinically relevant process parameters, patient outcome, or reduce costs. Finally, whether a prediction rule is implemented successfully in clinical practice depends on several potential barriers to the use of the rule. The development of a diagnostic or prognostic prediction rule is just a first step. We reviewed important aspects of the subsequent steps in prediction research.

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or device is ... Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or device is ...

  16. VALIDATION OF JOKO TINGKIR SOFTWARE USING TSUNAMI IMPORTANCE

    Directory of Open Access Journals (Sweden)

    Madlazim

    2015-07-01

    Full Text Available Joko Tingkir program, an application for tsunami early warning, has been utilised using real-time data processing at the Research and Development Centre, Indonesian Agency for Geophysics, Climatology and Meteorology since 2013. The program can also be used to analyse earthquake events before 2013. The aim of this study is thus to validate Joko Tingkir program for an improved performance of the Indonesian tsunami early warning system using the data recorded by at least 6 seismic stations managed by BMKG-Net where data collecting for each event is limited to only 3 minutes after origin time. The data were used to determine new tsunami parameters: the duration of rupture (Tdur, the 50 second exceed duration (T50Ex, and the dominant period (Td. Hierarchical Product Platform Realisation Method (HPPRM, which had three different phases: defining phase, modeling phase and solving phase, was used to validate the program. This study exercises records before 2014 and during 2014-2015 available at the intranet 172.19.0.13/litbang/www. For earthquakes that occurred before 2008, we make use of IRIS DMC seismic stations at http://ww.iris.edu since BMKG-Net has not yet operated. All of the data in the present study were events having magnitudes of greater than 6.5. After a conversion of quantitative data into qualitative data, the results are compared to those of tsunami importance provided by NOAA database. It was found that there is no significant differences between the results derived from the current study and the NOAA database, leading to a conclusion that the software developed is valid.

  17. Statistics in clinical research: Important considerations

    Directory of Open Access Journals (Sweden)

    Howard Barkan

    2015-01-01

    Full Text Available Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies.

  18. Statistics in clinical research: Important considerations

    Science.gov (United States)

    Barkan, Howard

    2015-01-01

    Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies. PMID:25566715

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... criteria). For more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people ... clinical trials for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Home / Health Topics / < Back To About Clinical Trials / NHLBI Clinical Trials NHLBI Clinical Trials These NHLBI-sponsored research studies are for patients who have heart, lung, ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical Trials Protect Participants?" ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  12. Importance of considering injured microorganisms in sterilization validation.

    Science.gov (United States)

    Shintani, Hideharu

    2006-09-01

    Disinfection or sterilization treatment by heating, irradiation, or chemicals can cause injury to microorganisms at sublethal levels. Microbial injury is the inability to grow under conditions suitable for the uninjured microorganisms. This inability of injured microorganisms to grow is explained in terms of more complex or different nutritional requirements or in terms of increased sensitivity to environmental conditions such as incubation conditions (time or temperature) or to chemical agents such as halogen compounds. Injured microorganisms can be distinguished from those that are dead or mutated by their ability to regain normal physiological activity when placed in appropriate conditions for cultivation. The return to normal physiological function has been termed repair. The extent and severity of sublethal injury, the mechanisms of injury, and the mechanisms and degree of recovery vary with the sterilization procedures, the species, the strains, the condition of the microorganism, and the methods of repair. Injury to spore formers has been detected at different stages of the spore cycle. The sites of injury include damage to enzymes, membrane disruption, and/or damage to DNA or RNA. Information on the sublethal injury and recovery of microorganisms is very important in evaluating sterilization/disinfection procedures. This paper supplies academic as well as practical information dealing with the repair, and detection of injured microorganisms for performing reproducible sterilization validation.

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Entire Site Health Topics News & Resources Intramural ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help ... clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... it clear to whom a clinical trial's results apply. These criteria also are a safety measure. They ... a scientific and responsible way. The IRB also checks on results during the trial. All U.S. clinical ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take ... clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  13. Perioperative thermal insulation: minimal clinically important differences?

    Science.gov (United States)

    Bräuer, A; Perl, T; Uyanik, Z; English, M J M; Weyland, W; Braun, U

    2004-06-01

    Reduction of heat losses from the skin by thermal insulation is used to avoid perioperative hypothermia. However, there is little information about the physical properties of various insulating materials used in the operating room. The following insulation materials were tested using a validated manikin: cotton surgical drape tested in two and four layers; Allegiance drape; 3M Steri-Drape; metallized plastic sheet; Thermadrape Barkey thermcare 1 tested in one and two layers; hospital duvet tested in one and two layers. Heat loss from the surface of the manikin can be described as: Q(*);= h.DeltaT.A where Q(*); is heat flux, h is the heat exchange coefficient, DeltaT is the temperature gradient between the environment and surface and A is the area covered. The heat flux per unit area (Q(*); A(-1)) and surface temperature were measured with nine calibrated heat-flux transducers. The environmental temperature was measured using a thermoanemometer. DeltaT was varied and h was determined by linear regression analysis as the slope of DeltaT vs Qdot; A(-1). The reciprocal of h defines the insulation. The insulation value of air was 0.61 Clo. The insulation values of the materials varied between 0.17 Clo (two layers of cotton surgical drapes) to 2.79 Clo (two layers of hospital duvet). There are relevant differences between various insulating materials. The best commercially available material designed for use in the operating room (Barkey thermcare 1) can reduce heat loss from the covered area by 45% when used in two layers. Given the range of insulating materials available for outdoor activities, significant improvement in insulation of patients in the operating room is both possible and desirable.

  14. Portal ductopathy: Clinical importance and nomenclature

    Science.gov (United States)

    Bayraktar, Yusuf

    2011-01-01

    Non-cirrhotic portal hypertension (PHT) accounts for about 20% of all PHT cases, portal vein thrombosis (PVT) resulting in cavernous transformation being the most common cause. All known complications of PHT may be encountered in patients with chronic PVT. However, the effect of this entity on the biliary tree and pancreatic duct has not yet been fully established. Additionally, a dispute remains regarding the nomenclature of common bile duct abnormalities which occur as a result of chronic PVT. Although many clinical reports have focused on biliary abnormalities, only a few have evaluated both the biliary and pancreatic ductal systems. In this review the relevant literature evaluating the effect of PVT on both ductal systems is discussed, and findings are considered with reference to results of a prominent center in Turkey, from which the term “portal ductopathy” has been put forth to replace “portal biliopathy”. PMID:21472098

  15. Fluorescence characterization of clinically-important bacteria.

    Science.gov (United States)

    Dartnell, Lewis R; Roberts, Tom A; Moore, Ginny; Ward, John M; Muller, Jan-Peter

    2013-01-01

    Healthcare-associated infections (HCAI/HAI) represent a substantial threat to patient health during hospitalization and incur billions of dollars additional cost for subsequent treatment. One promising method for the detection of bacterial contamination in a clinical setting before an HAI outbreak occurs is to exploit native fluorescence of cellular molecules for a hand-held, rapid-sweep surveillance instrument. Previous studies have shown fluorescence-based detection to be sensitive and effective for food-borne and environmental microorganisms, and even to be able to distinguish between cell types, but this powerful technique has not yet been deployed on the macroscale for the primary surveillance of contamination in healthcare facilities to prevent HAI. Here we report experimental data for the specification and design of such a fluorescence-based detection instrument. We have characterized the complete fluorescence response of eleven clinically-relevant bacteria by generating excitation-emission matrices (EEMs) over broad wavelength ranges. Furthermore, a number of surfaces and items of equipment commonly present on a ward, and potentially responsible for pathogen transfer, have been analyzed for potential issues of background fluorescence masking the signal from contaminant bacteria. These include bedside handrails, nurse call button, blood pressure cuff and ward computer keyboard, as well as disinfectant cleaning products and microfiber cloth. All examined bacterial strains exhibited a distinctive double-peak fluorescence feature associated with tryptophan with no other cellular fluorophore detected. Thus, this fluorescence survey found that an emission peak of 340nm, from an excitation source at 280nm, was the cellular fluorescence signal to target for detection of bacterial contamination. The majority of materials analysed offer a spectral window through which bacterial contamination could indeed be detected. A few instances were found of potential problems

  16. Fluorescence characterization of clinically-important bacteria.

    Directory of Open Access Journals (Sweden)

    Lewis R Dartnell

    Full Text Available Healthcare-associated infections (HCAI/HAI represent a substantial threat to patient health during hospitalization and incur billions of dollars additional cost for subsequent treatment. One promising method for the detection of bacterial contamination in a clinical setting before an HAI outbreak occurs is to exploit native fluorescence of cellular molecules for a hand-held, rapid-sweep surveillance instrument. Previous studies have shown fluorescence-based detection to be sensitive and effective for food-borne and environmental microorganisms, and even to be able to distinguish between cell types, but this powerful technique has not yet been deployed on the macroscale for the primary surveillance of contamination in healthcare facilities to prevent HAI. Here we report experimental data for the specification and design of such a fluorescence-based detection instrument. We have characterized the complete fluorescence response of eleven clinically-relevant bacteria by generating excitation-emission matrices (EEMs over broad wavelength ranges. Furthermore, a number of surfaces and items of equipment commonly present on a ward, and potentially responsible for pathogen transfer, have been analyzed for potential issues of background fluorescence masking the signal from contaminant bacteria. These include bedside handrails, nurse call button, blood pressure cuff and ward computer keyboard, as well as disinfectant cleaning products and microfiber cloth. All examined bacterial strains exhibited a distinctive double-peak fluorescence feature associated with tryptophan with no other cellular fluorophore detected. Thus, this fluorescence survey found that an emission peak of 340nm, from an excitation source at 280nm, was the cellular fluorescence signal to target for detection of bacterial contamination. The majority of materials analysed offer a spectral window through which bacterial contamination could indeed be detected. A few instances were found of

  17. The Importance of Magnesium in Clinical Healthcare.

    Science.gov (United States)

    Schwalfenberg, Gerry K; Genuis, Stephen J

    2017-01-01

    The scientific literature provides extensive evidence of widespread magnesium deficiency and the potential need for magnesium repletion in diverse medical conditions. Magnesium is an essential element required as a cofactor for over 300 enzymatic reactions and is thus necessary for the biochemical functioning of numerous metabolic pathways. Inadequate magnesium status may impair biochemical processes dependent on sufficiency of this element. Emerging evidence confirms that nearly two-thirds of the population in the western world is not achieving the recommended daily allowance for magnesium, a deficiency problem contributing to various health conditions. This review assesses available medical and scientific literature on health issues related to magnesium. A traditional integrated review format was utilized for this study. Level I evidence supports the use of magnesium in the prevention and treatment of many common health conditions including migraine headache, metabolic syndrome, diabetes, hyperlipidemia, asthma, premenstrual syndrome, preeclampsia, and various cardiac arrhythmias. Magnesium may also be considered for prevention of renal calculi and cataract formation, as an adjunct or treatment for depression, and as a therapeutic intervention for many other health-related disorders. In clinical practice, optimizing magnesium status through diet and supplementation appears to be a safe, useful, and well-documented therapy for several medical conditions.

  18. The Importance of Magnesium in Clinical Healthcare

    Directory of Open Access Journals (Sweden)

    Gerry K. Schwalfenberg

    2017-01-01

    Full Text Available The scientific literature provides extensive evidence of widespread magnesium deficiency and the potential need for magnesium repletion in diverse medical conditions. Magnesium is an essential element required as a cofactor for over 300 enzymatic reactions and is thus necessary for the biochemical functioning of numerous metabolic pathways. Inadequate magnesium status may impair biochemical processes dependent on sufficiency of this element. Emerging evidence confirms that nearly two-thirds of the population in the western world is not achieving the recommended daily allowance for magnesium, a deficiency problem contributing to various health conditions. This review assesses available medical and scientific literature on health issues related to magnesium. A traditional integrated review format was utilized for this study. Level I evidence supports the use of magnesium in the prevention and treatment of many common health conditions including migraine headache, metabolic syndrome, diabetes, hyperlipidemia, asthma, premenstrual syndrome, preeclampsia, and various cardiac arrhythmias. Magnesium may also be considered for prevention of renal calculi and cataract formation, as an adjunct or treatment for depression, and as a therapeutic intervention for many other health-related disorders. In clinical practice, optimizing magnesium status through diet and supplementation appears to be a safe, useful, and well-documented therapy for several medical conditions.

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting ...

  20. [Clinical importance and diagnosis of halitosis].

    Science.gov (United States)

    Nagy, Akos; Brugoviczky, Zsolt; Novák, Péter; Nagy, Gábor

    2012-09-01

    The origin of halitosis comes from the Latin word "halitus" meaning 'breath, exhaled air', and in the Hungarian terminology it means bad and smelly breath. The human body emits a number of volatile molecules, which have a peculiar odour. Their presence is influenced by several factors, such as genetic, nutritional and psychological factors. Since bad breath belongs to taboo subjects, halitosis can often lead to social isolation. To determine the incidence of halitosis, an exact diagnosis is needed which sometimes predestinates the possible treatment as well. Investigators estimate the incidence about 50% in the whole population. The male/female ratio is the same and the incidence is growing with age. The diagnosis can be genuine halitosis, pseudo halitosis and halitophobia. We can divide the genuine type into physiological and pathophysiological subtypes. The cause of the halitosis usually can be found in the oral cavity. The volatile sulfur compounds (VSC) produced by some of the oral bacteria are responsible for its development. Only 10% of the causes are extraoral, mostly inflammation of airways or gastrointestinal disorders. The judgment of halitosis is based on three objective methods: the organoleptic, the sulphide monitoring and the gas cromatography methods. Since the origin of the halitosis is mainly the oral cavity, dentists should treat them. Beyond the dental treatments the enhancement of the oral hygiene, the continuous motivation and monitoring are also very important, such as the use of tongue cleansing and special anti-malodour rinses.

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that ... trials is a high priority for clinical researchers. Each trial has scientific ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... or they may even answer the NIH study's research question. Scientific oversight informs decisions about a trial while ... in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... these studies should be done. Patient Rights Informed Consent Informed consent is the process of giving clinical trial participants ... part and during the course of the trial. Informed consent includes details about the treatments and tests you ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... define health across the lifespan and will be part of a control group in future studies of ... boys and girls. Visit the Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial ( ...

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... look at the best age and frequency for doing screening tests, such as mammography; and compare two ... available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... boys and girls. Visit the Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial ( ... financial incentives for healthy food purchases can help employees at Massachusetts General Hospital (MGH) prevent weight gain, ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education ... Funding Training & Career Development Division of Intramural ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... works well in the lab or animals doesn't always work well in people. Thus, research in ... Clinical research is done only if doctors don't know whether a new approach works well in ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to the protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. ... Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs and ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ... Privacy Policy Freedom of Information Act (FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trial. IRB members are doctors, statisticians, and community members. The IRB's purpose is to ensure that ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical ... Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols for ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The ... Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical ...

  2. Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

    Science.gov (United States)

    2012-01-01

    Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ) is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID) for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI) scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC) curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p MCID for improvement was −5 points and for deterioration +1 points. Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects. PMID:22781703

  3. Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

    Directory of Open Access Journals (Sweden)

    Adamchic Ilya

    2012-07-01

    Full Text Available Abstract Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p  Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects.

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health ... list to select: the entire site, the Health Topics section only, or the News and Resources section. ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Comparison Groups In most clinical trials, researchers use comparison groups. This means that the patients taking part in a trial are assigned to one of two or more similar groups. Each group will receive different medical strategies. For example, one group may get the current ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... purpose is to ensure that clinical trials are ethical and that the participants' rights are ... Safety Monitoring Board Every National Institutes of ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... children, more studies are needed focusing on children's health with the goal to ... education for parents, clinicians, researchers, children, and the general ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trial and don't get the new strategy being tested, you may receive the current standard care for your condition. This treatment might be ... some downsides, such as the following. The new strategies and treatments ... better than current standard care. Even if a new approach benefits some ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... known to work in adults. To improve clinical care of children, more studies are needed focusing on children's health with the goal to develop treatments, drugs, ... National Institutes of Health Department of Health and Human Services USA.gov

  13. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... research process. The process often begins in a laboratory (lab), where scientists first develop and test new ... of these results are important because they advance medical knowledge and help improve patient care. Sponsorship and ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... find that a new strategy, treatment, or device improves patient outcomes; offers no benefit; or causes unexpected ... important because they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... All of these results are important because they advance medical knowledge and help improve patient care. Sponsorship ... like the two described above, help improve and advance medical care. They also can help health care ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Operations and Administration Advisory Committees Budget and Legislative Information Jobs and Working at the NHLBI Contact and ... moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. Last Updated: August 3, 2015 Resources Educational Website - English / Spanish Paper Kingdom Video Game National Broadcast Film ( ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. Last Updated: August 3, 2015 ... Twitter Facebook YouTube Google+ SITE INDEX ACCESSIBILITY ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. Last Updated: August 3, 2015 Resources Educational Website - English / Spanish Paper Kingdom Video Game National Broadcast Film (Under Development) Posters and Postcards ...

  2. Important clinical advances in the understanding of Clostridium difficile infection.

    Science.gov (United States)

    Pacheco, Susan M; Johnson, Stuart

    2013-01-01

    Clostridium difficile remains an important cause of infectious colitis, particularly in healthcare facilities. This review summarizes recent advances in the epidemiology, diagnosis, and treatment of this endemic pathogen. C. difficile infection (CDI) hospitalizations and mortality rates have increased over the last decade. The BI/NAP1/027 strain has been responsible for epidemics with increased severity and mortality and is now endemic in many settings, particularly North America. Concurrent antibiotics have now been shown to decrease the cure rates for anti-C. difficile therapy and increase the risk of recurrence. Although studies implicate proton pump inhibitors as a risk for CDI, the magnitude of and the biological basis for that risk remain unclear. Molecular diagnostic techniques are rapid and sensitive but highlight the importance of using appropriate clinical testing criteria. Fidaxomicin is a promising new therapy associated with decreased recurrence; infections due to BI strains, however, are associated with inferior outcomes regardless of the treatment agent. Fecal transplantation continues to have impressive success rates for patients with recurrent CDI, and a new colon-sparing surgical procedure presents an intriguing suggested alternative to total colectomy in severe, complicated cases. Elucidating CDI risk factors, identifying rapid, accurate diagnostic tools, and validating new treatment approaches remains an urgent priority.

  3. Preanalytical management: serum vacuum tubes validation for routine clinical chemistry.

    Science.gov (United States)

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

    2012-01-01

    The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE, Tube II: LABOR IMPORT, Tube III: S-Monovette, Tube IV: SST and Tube V: SST II) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas 6000 module. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

  4. Preclinical and clinical validation of a novel oxygenation imaging system

    Science.gov (United States)

    Gioux, Sylvain; Mazhar, Amaan; Lee, Bernard T.; Cuccia, David J.; Stockdale, Alan; Oketokoun, Rafiou; Ashitate, Yoshitomo; Durr, Nicholas; Durkin, Anthony J.; Tromberg, Bruce J.; Frangioni, John V.

    2011-02-01

    Introduction: Two major disadvantages of currently available oxygenation probes are the need for contact with the skin and long measurement stabilization times. A novel oxygenation imaging device based on spatial frequency domain and spectral principles has been designed, validated preclinically on pigs, and validated clinically on humans. Importantly, this imaging system has been designed to operate under the rigorous conditions of an operating room. Materials and Methods: Optical properties reconstruction and wavelength selection have been optimized to allow fast and reliable oxyhemoglobin and deoxyhemoglobin imaging under realistic conditions. In vivo preclinical validation against commercially available contact oxygenation probes was performed on pigs undergoing arterial and venous occlusions. Finally, the device was used clinically to image skin flap oxygenation during a pilot study on women undergoing breast reconstruction after mastectomy. Results: A novel illumination head containing a spatial light modulator (SLM) and a novel fiber-coupled high power light source were constructed. Preclinical experiments showed similar values between local probes and the oxygenation imaging system, with measurement times of the new system being 300 cm2). Conclusion: A novel optical-based oxygenation imaging system has the potential to replace contact probes during human surgery and to provide quantitative, wide-field measurements in near real-time.

  5. Importance of Statistical Evidence in Estimating Valid DEA Scores.

    Science.gov (United States)

    Barnum, Darold T; Johnson, Matthew; Gleason, John M

    2016-03-01

    Data Envelopment Analysis (DEA) allows healthcare scholars to measure productivity in a holistic manner. It combines a production unit's multiple outputs and multiple inputs into a single measure of its overall performance relative to other units in the sample being analyzed. It accomplishes this task by aggregating a unit's weighted outputs and dividing the output sum by the unit's aggregated weighted inputs, choosing output and input weights that maximize its output/input ratio when the same weights are applied to other units in the sample. Conventional DEA assumes that inputs and outputs are used in different proportions by the units in the sample. So, for the sample as a whole, inputs have been substituted for each other and outputs have been transformed into each other. Variables are assigned different weights based on their marginal rates of substitution and marginal rates of transformation. If in truth inputs have not been substituted nor outputs transformed, then there will be no marginal rates and therefore no valid basis for differential weights. This paper explains how to statistically test for the presence of substitutions among inputs and transformations among outputs. Then, it applies these tests to the input and output data from three healthcare DEA articles, in order to identify the effects on DEA scores when input substitutions and output transformations are absent in the sample data. It finds that DEA scores are badly biased when substitution and transformation are absent and conventional DEA models are used.

  6. Validating an instrument for clinical supervision using an expert panel.

    Science.gov (United States)

    Hyrkäs, Kristiina; Appelqvist-Schmidlechner, Kaija; Oksa, Lea

    2003-08-01

    Use of research instruments standardised in English-speaking countries is commonplace in non-English speaking countries. This article describes technical, linguistic and conceptual issued raised in the translation and validation of an acceptable country-specific instrument. The Manchester Clinical Supervision Scale was validated for use in clinical supervision in Finland using quantitative and qualitative methods. The approach applied was triangulation. The focus of this paper, is to describe the item validation process of the scale using an expert panel (n=11) by means of the content validity index and panel interview. The process resulted in a country-specific 33-item instrument. The study indicated that content validity index and panel discussion are easy, but reliable ways of demonstrating the instrument's content validity.

  7. Development and Validation of Standardized Clinical Summary ...

    African Journals Online (AJOL)

    There were 83 students in Paediatrics [SP] and 86 students in Obstetrics and Gynaecology [SOG] postings. The students had video recorded presentation of three clinical cases comprising of two paediatrics [PC1&PC2] and one surgical case [SC3]. The summary for the first case [PC1] was done using an unstructured format ...

  8. Clinical and diagnostic importance of proteinuria: A review

    African Journals Online (AJOL)

    STORAGESEVER

    2008-09-17

    Sep 17, 2008 ... ISSN 1684–5315 © 2008 Academic Journals. Review ... This review examines the clinical and diagnostic importance of proteinuria and available ..... hypertensive pregnant women and suspected nephrotic syndrome cases in ...

  9. Important clinical and laboratory correlates of glomerular filtration ...

    African Journals Online (AJOL)

    Background: Renal impairment is routinely assessed using the estimated glomerular filtration rate (eGFR) and it may be helpful to obtain certain clinical or laboratory markers, which show relationship with glomerular filtration rate (GFR) in sickle cell disease (SCD). Aim: To assess the relationship between important clinical ...

  10. The Importance of Early Experiences: Clinical, Research, and Policy Perspectives

    Science.gov (United States)

    Zeanah, Charles H.

    2009-01-01

    The degree to which early adverse experiences exert long term effects on development and how much early adversity may be overcome through subsequent experiences are important mental health questions. The clinical, research and policy perspectives on these questions lead to different answers. From a clinical perspective, change is always possible,…

  11. Transition questions in clinical practice - validity and reproducibility

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    2008-01-01

    Transition questions in CLINICAL practice - validity and reproducibility Lauridsen HH1, Manniche C3, Grunnet-Nilsson N1, Hartvigsen J1,2 1   Clinical Locomotion Science, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. e-mail: hlauridsen......@health.sdu.dk 2   Nordic Institute of Chiropractic and Clinical Biomechanics, Part of Clinical Locomotion Science, Odense, Denmark 3   Backcenter Funen, Part of Clinical Locomotion Science, Ringe, Denmark   Abstract  Understanding a change score is indispensable for interpretation of results from clinical studies...

  12. Determining relative importance of variables in developing and validating predictive models

    Directory of Open Access Journals (Sweden)

    Atenafu Eshetu G

    2009-09-01

    Full Text Available Abstract Background Multiple regression models are used in a wide range of scientific disciplines and automated model selection procedures are frequently used to identify independent predictors. However, determination of relative importance of potential predictors and validating the fitted models for their stability, predictive accuracy and generalizability are often overlooked or not done thoroughly. Methods Using a case study aimed at predicting children with acute lymphoblastic leukemia (ALL who are at low risk of Tumor Lysis Syndrome (TLS, we propose and compare two strategies, bootstrapping and random split of data, for ordering potential predictors according to their relative importance with respect to model stability and generalizability. We also propose an approach based on relative increase in percentage of explained variation and area under the Receiver Operating Characteristic (ROC curve for developing models where variables from our ordered list enter the model according to their importance. An additional data set aimed at identifying predictors of prostate cancer penetration is also used for illustrative purposes. Results Age is chosen to be the most important predictor of TLS. It is selected 100% of the time using the bootstrapping approach. Using the random split method, it is selected 99% of the time in the training data and is significant (at 5% level 98% of the time in the validation data set. This indicates that age is a stable predictor of TLS with good generalizability. The second most important variable is white blood cell count (WBC. Our methods also identified an important predictor of TLS that was otherwise omitted if relying on any of the automated model selection procedures alone. A group at low risk of TLS consists of children younger than 10 years of age, without T-cell immunophenotype, whose baseline WBC is 9/L and palpable spleen is Conclusion Our model selection procedures based on bootstrap re-sampling and

  13. Using Chinese Version of MYMOP in Chinese Medicine Evaluation: Validity, Responsiveness and Minimally Important Change

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2010-09-01

    Full Text Available Abstract Background Measure Yourself Medical Outcome Profile (MYMOP is a patient generated outcome instrument applicable in the evaluation of both allopathic and complementary medicine treatment. This study aims to adapt MYMOP into Chinese, and to assess its validity, responsiveness and minimally important change values in a sample of patients using Chinese medicine (CM services. Methods A Chinese version of MYMOP (CMYMOP is developed by forward-backward-forward translation strategy, expert panel assessment and pilot testing amongst patients. 272 patients aged 18 or above with subjective symptoms in the past 2 weeks were recruited at a CM clinic, and were invited to complete a set of questionnaire containing CMYMOP and SF-36. Follow ups were performed at 2nd and 4th week after consultation, using the same set of questionnaire plus a global rating of change question. Criterion validity of CMYMOP was assessed by its correlation with SF-36 at baseline, and responsiveness was evaluated by calculating the Cohen effect size (ES of change at two follow ups. Minimally important difference (MID values were estimated via anchor based method, while minimally detectable difference (MDC figures were calculated by distribution based method. Results Criterion validity of CMYMOP was demonstrated by negative correlation between CMYMOP Profile scores and all SF-36 domain and summary scores at baseline. For responsiveness between baseline and 4th week follow up, ES of CMYMOP Symptom 1, Activity and Profile reached the moderate change threshold (ES>0.5, while Symptom 2 and Wellbeing reached the weak change threshold (ES>0.2. None of the SF-36 scores reached the moderate change threshold, implying CMYMOP's stronger responsiveness in CM setting. At 2nd week follow up, MID values for Symptom 1, Symptom 2, Wellbeing and Profile items were 0.894, 0.580, 0.263 and 0.516 respectively. For Activity item, MDC figure of 0.808 was adopted to estimate MID. Conclusions The

  14. Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories

    NARCIS (Netherlands)

    Torlakovic, E.E.; Cheung, C.C.; D'Arrigo, C.; Dietel, M.; Francis, G.D.; Gilks, C.B.; Hall, J.A.; Hornick, J.L.; IBRAHIM, M.; Marchetti, A.; Miller, K.; Krieken, J.H.J.M. van; Nielsen, S.; Swanson, P.E.; Vyberg, M.; Zhou, X.; Taylor, C.R.

    2017-01-01

    Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for

  15. Importance Of Logotherapy In Clinical Practice | Asagba | IFE ...

    African Journals Online (AJOL)

    The importance of logotherapy has been neglected in the clinical practice in Nigeria. This paper raises some important aspects of logotherapy, which have not been taken in to consideration. For instance, there is the issue of using knowledge and wisdom in logotherapy. Other issues are the great emphasis of responsibility ...

  16. Interprofessional clinical education: clinicians' views on the importance of leadership.

    Science.gov (United States)

    Missen, Karen; Jacob, Elisabeth R; Barnett, Tony; Walker, Lorraine; Cross, Merylin

    2012-01-01

    The current shortage of health professionals necessitates new approaches to clinical education that can expand the number of undergraduate students undertaking clinical placements without increasing the burden on clinical staff or placing patients at risk. Interprofessional education has the potential to help increase clinical capacity whilst enriching students' clinical experience. This paper reports on a project which investigated the potential for interprofessional education to increase undergraduate clinical placement capacity in clinical settings. The project utilised an exploratory descriptive methodology to obtain the views of health care professionals about the use of interprofessional education in clinical education at three rural health facilities in Victoria, Australia. Participants (n = 57) had a key role with each health care facility in coordinating and facilitating undergraduate clinical placements. This paper examines the clinicians' views about the central role that leadership plays in actioning interprofessional education in the clinical setting. Whilst interprofessional education was regarded favourably by the majority of participants, data indicated that leadership from education providers, health services, and regulatory authorities was crucial to enable interprofessional education to be implemented and sustained within the clinical learning environment. Without leadership from each of these three spheres of influence, interprofessional education will continue to be difficult to implement for undergraduate students and compromise their exposure to an important aspect of the working life of health care professionals. Such a failure will limit graduates' readiness for collaborative and cross-disciplinary practice.

  17. Brief pain inventory--facial minimum clinically important difference.

    Science.gov (United States)

    Sandhu, Sukhmeet K; Halpern, Casey H; Vakhshori, Venus; Mirsaeedi-Farahani, Keyvan; Farrar, John T; Lee, John Y K

    2015-01-01

    Neurosurgeons are frequently the primary physicians measuring pain relief in patients with trigeminal neuralgia (TN). Unfortunately, the measurement of pain can be complex. The Brief Pain Inventory-Facial (BPI-Facial) is a reliable and validated multidimensional tool that consists of 18 questions. It measures 3 domains of pain: 1) pain intensity (worst and average pain intensity), 2) interference with general activities of daily living (ADL), and 3) face-specific pain interference. The objective of this paper is to determine the patient-reported minimum clinically important difference (MCID) using the BPI-Facial. The authors conducted a retrospective study of 234 patients with TN seen in a single neurosurgeon's office. Patients completed baseline and 1-month follow-up BPI-Facial questionnaires. The MCID was calculated using an anchor-based approach in which the defined anchor was the 7-point patient global impression of change (PGIC). Two statistical methods were employed: mean change score and optimal cutoff point. Using the mean change score method, the investigators calculated the MCID for the 3 domains of the BPIFacial: 44% and 30% improvement in pain intensity at its worst and average, respectively, 54% improvement in interference with general ADL, and 63% improvement in interference with facial ADL. Using the optimal cutoff point method, they also calculated the MCID for the 3 domains of the BPI-Facial: 57% and 28% improvement in pain intensity at its worst and average, respectively, 75% improvement in interference with general ADL, and 62% improvement in interference with facial ADL. The BPI-Facial is a multidimensional pain scale that measures 3 domains of pain. Although 2 statistical methods were used to calculate the MCID, the optimal cutoff point method was the superior one because it used data from the majority of subjects included in this study. A 57% improvement in pain intensity at its worst and a 28% improvement in pain intensity at its average were

  18. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID)

    OpenAIRE

    Wright, Alexis; Hannon, Joseph; Hegedus, Eric J.; Kavchak, Alicia Emerson

    2012-01-01

    Minimal clinically important difference (MCID) scores are commonly used by clinicians when determining patient response to treatment and to guide clinical decision-making during the course of treatment. For research purposes, the MCID score is often used in sample size calculations for adequate powering of a study to minimize the false-positives (type 1 errors) and the false-negatives (type 2 errors). For clinicians and researchers alike, it is critical that the MCID score is a valid and stab...

  19. Learning in clinical practice: the importance of peers.

    Science.gov (United States)

    Roberts, Deborah

    To explore whether nursing students learn from each other and, if so, how, when and where this learning takes place. An interpretive ethnographic qualitative research study of a group of pre-registration nursing students (n = 15). Participant observation was the primary tool of data collection. Students gave their consent to be observed in classroom and clinical environments throughout the three years of the pre-registration programme. Data took the form of audio-taped conversations with and between students together with field notes. A thematic analysis was undertaken to reveal the student experience of peer learning. The importance of friendships to clinical learning for students was apparent in three respects: friendships and learning in clinical practice, survival skills and developing clinical skills. The students talked about their friendships being strong and enduring and enabling learning to take place. The students used their peers as a resource to pass on survival skills and help each other to learn how to be a nurse. Students also taught each other a variety of clinical skills. Traditional notions of seniority were challenged because the students appeared more concerned with what their peers had experienced. Friendships were an important aspect of peer learning for the students in this study and, more importantly, friendship fostered learning. Peer learning in clinical practice is an informal and underestimated aspect of clinical learning and is valued by students.

  20. The Reliability and Validity of the Clinical Competence Evaluation Scale in Physical Therapy

    National Research Council Canada - National Science Library

    Yoshino, Jun; Usuda, Shigeru

    2013-01-01

    [Purpose] To examine the internal consistency, criterion-related validity, factorial validity, and content validity of the Clinical Competence Evaluation Scale in Physical Therapy (CEPT). [Subjects...

  1. The Validation of Quantitative Mass Spectrometry Assays for Clinical Chemistry Assessments in Animal Models.

    Science.gov (United States)

    Colangelo, Jennifer L

    2017-10-01

    Mass spectrometry (MS) has become a key platform in the clinical pathology laboratory and is being used more frequently for clinical pathology assessments in preclinical species for drug development studies. MS assays are being utilized for some traditional clinical pathology end points as well as novel biomarker analyses. For effective deployment in drug development toxicology studies, assays must be validated for use, and these validations are not very different from other bioanalytical platforms commonly found in the clinical pathology laboratory. Validations for MS assays include accuracy and precision assessments, analyte stability evaluations, carryover determinations, and recovery measures. The MS platform does present some unique challenges that should be considered, including ion suppression and availability of reference standards with MS data. Understanding the caveats of the MS platform is important for thorough validations and effective deployment.

  2. Embedded performance validity testing in neuropsychological assessment: Potential clinical tools.

    Science.gov (United States)

    Rickards, Tyler A; Cranston, Christopher C; Touradji, Pegah; Bechtold, Kathleen T

    2017-01-31

    The article aims to suggest clinically-useful tools in neuropsychological assessment for efficient use of embedded measures of performance validity. To accomplish this, we integrated available validity-related and statistical research from the literature, consensus statements, and survey-based data from practicing neuropsychologists. We provide recommendations for use of 1) Cutoffs for embedded performance validity tests including Reliable Digit Span, California Verbal Learning Test (Second Edition) Forced Choice Recognition, Rey-Osterrieth Complex Figure Test Combination Score, Wisconsin Card Sorting Test Failure to Maintain Set, and the Finger Tapping Test; 2) Selecting number of performance validity measures to administer in an assessment; and 3) Hypothetical clinical decision-making models for use of performance validity testing in a neuropsychological assessment collectively considering behavior, patient reporting, and data indicating invalid or noncredible performance. Performance validity testing helps inform the clinician about an individual's general approach to tasks: response to failure, task engagement and persistence, compliance with task demands. Data-driven clinical suggestions provide a resource to clinicians and to instigate conversation within the field to make more uniform, testable decisions to further the discussion, and guide future research in this area.

  3. Public health importance of lassa fever epidemiology, clinical ...

    African Journals Online (AJOL)

    The public health importance of Lassa fever can not be over emphasized if one considers the high infectivity and mortality rates associated with the disease. This study dealt extensively on the epidemiology, clinical features and current management of Lassa fever through literature review. The aim of this study is to sensitise ...

  4. The clinical importance of erythrocyte deformability, a hemorrheological parameter

    NARCIS (Netherlands)

    Mokken, F. C.; Kedaria, M.; Henny, C. P.; Hardeman, M. R.; Gelb, A. W.

    1992-01-01

    Hemorheology, the science of the flow behavior of blood, has become increasingly important in clinical situations. The rheology of blood is dependent on its viscosity, which in turn is influenced by plasma viscosity, hematocrit, erythrocyte aggregation, and erythrocyte deformability. In recent years

  5. Graduate admissions in clinical neuropsychology: the importance of undergraduate training.

    Science.gov (United States)

    Karazsia, Bryan T; Stavnezer, Amy Jo; Reeves, Jonathan W

    2013-11-01

    Discussions of and recommendations for the training of clinical neuropsychologists exist at the doctoral, internship, and post-doctoral level. With few exceptions, the literature on undergraduate preparations in clinical neuropsychology is sparse and lacks empirical evidence. In the present study, graduate-level faculty and current trainees completed surveys about graduate school preparations. Faculty expectations of minimum and ideal undergraduate training were highest for research methods, statistics, and assessment. Preferences for "goodness of fit" also emerged as important admissions factors. These results offer evidence for desirable undergraduate preparations for advanced study in clinical neuropsychology. Although undergraduate training in psychology is intentionally broad, results from this study suggest that students who desire advanced study in clinical neuropsychology need to tailor their experiences to be competitive in the application process. The findings have implications for prospective graduate students, faculty who train and mentor undergraduates, and faculty who serve on admissions committees.

  6. Clinical validation of robot simulation of toothbrushing - comparative plaque removal efficacy

    OpenAIRE

    Lang, Tomas; Staufer, Sebastian; Jennes, Barbara; Gaengler, Peter

    2014-01-01

    Background Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Methods Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33–47 with three techniques (hori...

  7. Development, Validation, and Implementation of a Clinic Nurse Staffing Guideline.

    Science.gov (United States)

    Deeken, Debra Jean; Wakefield, Douglas; Kite, Cora; Linebaugh, Jeanette; Mitchell, Blair; Parkinson, Deidre; Misra, Madhukar

    2017-10-01

    Ensuring that the level of nurse staffing used to care for patients is appropriate to the setting and service intensity is essential for high-quality and cost-effective care. This article describes the development, validation, and implementation of the clinic technical skills permission list developed specifically to guide nurse staffing decisions in physician clinics of an academic medical center. Results and lessons learned in using this staffing guideline are presented.

  8. Reliability and validation of a behavioral model of clinical behavioral formulation

    Directory of Open Access Journals (Sweden)

    Amanda M Muñoz-Martínez

    2011-05-01

    Full Text Available The aim of this study was to determine the reliability and content and predictive validity of a clinical case formulation, developed from a behavioral perspective. A mixed design integrating levels of descriptive analysis and A-B case study with follow-up was used. The study established the reliability of the following descriptive and explanatory categories: (a problem description, (b predisposing factors, (c precipitating factors, (d acquisition and (e inferred mechanism (maintenance. The analysis was performed on cases from 2005 to 2008 formulated with the model derived from the current study. With regards to validity, expert judges considered that the model had content validity. The predictive validity was established across application of model to three case studies. Discussion shows the importance of extending the investigation with the model in other populations and to establish the clinical and concurrent validity of the model.

  9. 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.

  10. The Clinical Importance of the Heterogeneity of HER2 neu

    Directory of Open Access Journals (Sweden)

    Enrique Davila

    2010-07-01

    Full Text Available We report on a patient with breast cancer in whom there were areas of the tumor that were 3+ positive and negative for HER2 neu by immunohistochemistry, adjacent to each other. Depending on the area tested the results were completely different. The clinical implications are important. We recommend retesting a large portion of the tumor in all cases of initially negative test results.

  11. A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.

    LENUS (Irish Health Repository)

    Na, Xi

    2015-04-23

    Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI.

  12. Validity of ABCD Rule of Dermoscopy in Clinical Practice.

    Science.gov (United States)

    Ahnlide, Ingela; Bjellerup, Mats; Nilsson, Fredrik; Nielsen, Kari

    2016-03-01

    The ABCD rule of dermoscopy was developed to facilitate the dermoscopic differentiation between benign and malignant melanocytic lesions. However, there is a lack of studies on its validity in clinical practice. The aim of this study was to evaluate the accuracy of the algorithm used bedside, compared with the accuracy of the preliminary preoperative diagnosis, and to rate physicians' level of confidence in the diagnosis. Melanocytic tumours were preoperatively scored bedside, according to the ABCD algorithm; 309 cases (46 melanomas and 263 naevi) were included. A sensitivity of 83% and specificity of 45% were found for the ABCD algorithm. A comparable sensitivity (74%), but a significantly higher specificity (91%), was found for the preliminary diagnosis. Interestingly, there was a considerable percentage (19.6%) of early melanomas for which a malignant diagnosis was not preoperatively expected, indicating that it is important to maintain generous indications for excision or to practise short-term follow-up of ambiguous lesions in order to detect early melanomas.

  13. Validity of routine clinical diagnoses in acute psychiatric inpatients.

    Science.gov (United States)

    Zander, Eduard; Wyder, Lea; Holtforth, Martin Grosse; Schnyder, Ulrich; Hepp, Urs; Stulz, Niklaus

    2018-01-01

    To examine the validity of diagnoses obtained by clinicians during routine clinical examination on acute psychiatric inpatient wards. N=100 inpatients with a broad spectrum of major mental disorders were randomly selected in a mental hospital's department of general psychiatry. Patients were diagnosed by independent assessors within Md = 5 (Range: 1-18) days of admission using the SCID I in order to examine the validity of the diagnoses given by the clinical staff based on routine assessments. The commonly used clinical examination technique had good overall agreement with the SCID I assessments regarding primary diagnoses at the level of ICD-10 main categories (F2, F30-31, F32-F33, F4; κ = 0.65). However, agreement between routine clinical diagnoses and the SCID I diagnoses tended to be low for some specific mental disorders (e.g., depressive disorders) and for secondary diagnoses. The validity of routine clinical diagnoses established in acute inpatient settings is limited and should be improved. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Completeness and validity in a national clinical thyroid cancer database

    DEFF Research Database (Denmark)

    Londero, Stefano Christian; Mathiesen, Jes Sloth; Krogdahl, Annelise

    2014-01-01

    BACKGROUND: Although a prospective national clinical thyroid cancer database (DATHYRCA) has been active in Denmark since January 1, 1996, no assessment of data quality has been performed. The purpose of the study was to evaluate completeness and data validity in the Danish national clinical thyroid...... and extended governmental databases, it is possible to establish national clinical cancer databases with a satisfactory completeness and validity. The DATHYRCA database is considered reliable in terms of describing thyroid carcinoma at a national level....... cancer database: DATHYRCA. STUDY DESIGN AND SETTING: National prospective cohort. Denmark; population 5.5 million. Completeness of case ascertainment was estimated by the independent case ascertainment method using three governmental registries as a reference. The reabstracted record method was used...

  15. Validation of the tool assessment of clinical education (AssCE): A study using Delphi method and clinical experts.

    Science.gov (United States)

    Löfmark, Anna; Mårtensson, Gunilla

    2017-03-01

    The aim of the present study was to establish the validity of the tool Assessment of Clinical Education (AssCE). The tool is widely used in Sweden and some Nordic countries for assessing nursing students' performance in clinical education. It is important that the tools in use be subjected to regular audit and critical reviews. The validation process, performed in two stages, was concluded with a high level of congruence. In the first stage, Delphi technique was used to elaborate the AssCE tool using a group of 35 clinical nurse lecturers. After three rounds, we reached consensus. In the second stage, a group of 46 clinical nurse lecturers representing 12 universities in Sweden and Norway audited the revised version of the AssCE in relation to learning outcomes from the last clinical course at their respective institutions. Validation of the revised AssCE was established with high congruence between the factors in the AssCE and examined learning outcomes. The revised AssCE tool seems to meet its objective to be a validated assessment tool for use in clinical nursing education. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Perceived job importance and job performance satisfaction of selected clinical nutrition management responsibilities.

    Science.gov (United States)

    Pratt, Peggy E; Kwon, Junehee; Rew, Martha L

    2005-07-01

    A nationwide survey of clinical nutrition managers was conducted to assess perceived importance of selected job responsibilities and perceived performance satisfaction of those job responsibilities. A questionnaire was developed to achieve the study objectives, validated by an expert panel, and pilot-tested prior to data collection. All members of the American Dietetic Association's Clinical Nutrition Management dietetic practice group (N=1,668) were asked to rate the importance of selected job responsibilities and their satisfaction with those responsibilities using Likert-type scales with descriptions. Results revealed that clinical nutrition managers perceived all job responsibilities listed in the questionnaire to be important (ie, the mean score of each responsibility was >3.0 of a 4.0 scale). Respondents rated regulatory-related job responsibilities as most important and were most satisfied with their performance of these responsibilities. Following regulatory-related responsibilities, clinical nutrition managers perceived patient satisfaction and staff retention to be more important than other responsibilities. In general, clinical nutrition managers were more satisfied with their job performance for job responsibilities that they ranked as more important.

  17. [Current dental implant design and its clinical importance].

    Science.gov (United States)

    Ye, Lin

    2017-02-01

    The development of clinical implant dentistry was intensively affected by dental implant design improvement and innovation, which brought about new concept, even milestone-like changes of clinical protocol. The current improvements of dental implant design and their clinical importance could be highlighted as followings: 1) The implant apical design influences the implant preliminary stability in immediate implant. The apical 3-5 mm design of implant makes implant stable in immediate implant, because this part would be screwed into alveolar bone through fresh socket, the other part of implant could not be tightly screwed in the socket because of smaller implant diameter. Implant apical form, screw design, self-taping of apical part would be essential for immediate implant. 2) The enough preliminary stability of implant makes immediate prosthesis possible. When osseointegration does not occur, the implant stability comes from a mechanical anchorage, which depends on implant form, screw thread and self-taping design. 3) Implant neck design may have influence for soft tissue recession in esthetic zone. The implant with large shoulder would not be selected for the esthetic area. The platform design may be more favorable in the area. 4) The connection design between implant and abutment is thought a very important structure in implant long-term stability. Moose taper and "tube in tube" were well documented structure design in 20-year clinical practice in Peking University. 5) In last 15 years, the plenty studies showed the platform design of implant had positive influence in implant marginal bone level. Whatever in single implant restoration or multi-implant prosthesis. 6) The digital technology makes clinical work more precise and high-tech. This would be a trend in implant dentistry. New generation of chair-side digital computer-aided design/computer-aided manufacturing makes immediate prosthesis without conventional impression possible. 7) New abutment design have

  18. Validation of Immunohistochemical Assays for Integral Biomarkers in the NCI-MATCH EAY131 Clinical Trial.

    Science.gov (United States)

    Khoury, Joseph D; Wang, Wei-Lien; Prieto, Victor G; Medeiros, L Jeffrey; Kalhor, Neda; Hameed, Meera; Broaddus, Russell; Hamilton, Stanley R

    2017-08-24

    Biomarkers that guide therapy selection are gaining unprecedented importance as targeted therapy options increase in scope and complexity. In conjunction with high-throughput molecular techniques, therapy-guiding biomarker assays based upon immunohistochemistry (IHC) have a critical role in cancer care in that they inform about the presence of a protein target. Here, we describe the validation procedures for four clinically available IHC biomarker assays - PTEN, RB, MLH1 and MSH2 - for use as integral biomarkers in the nationwide NCI-MATCH (Molecular Analysis for Therapy Choice) EAY131 clinical trial. Validation procedures were developed through an iterative process based on collective experience and adaptation of broad guidelines from the United State Food and Drug Administration (FDA). The steps included primary antibody selection, assay optimization, development of assay interpretation criteria incorporating biological considerations and expected staining patterns, including indeterminate results, orthogonal validation, and tissue validation. Following assay lockdown, patient samples and cell lines were used for analytical and clinical validation. The assays were then approved as laboratory developed tests and used for clinical trial decisions for treatment selection. Calculations of sensitivity and specificity were undertaken using various definitions of gold standard references, and external validation was required for the PTEN IHC assay. In conclusion, validation of IHC biomarker assays critical for guiding therapy in clinical trials is feasible using comprehensive pre-analytical, analytical and post-analytical steps. Implementation of standardized guidelines provides a useful framework for validating IHC biomarker assays that allow for reproducibility across institutions for routine clinical use. Copyright ©2017, American Association for Cancer Research.

  19. Validation of a new clinical scoring system for acute bronchitis.

    Science.gov (United States)

    Mwachari, C; Nduba, V; Nguti, R; Park, D R; Sanguli, L; Cohen, C R

    2007-11-01

    Although several clinical prediction rules exist for lower respiratory tract infection (LRTI), few are for acute bronchitis (acute bronchitis) and most have not been validated in high human immunodeficiency virus (HIV) prevalence settings. An Acute Bronchitis Severity Score (ABSS) was developed and validated during a randomized trial of antibiotic treatment for acute bronchitis. Ambulatory adults with productive cough of acute bronchitis; 129 (20%) were HIV-seropositive. The ABSS had small floor and ceiling effects (1.8/0.2) and demonstrated high internal consistency (alpha-coefficient of 0.66) and internal validity, with a mean inter item total correlation of > or =0.25. Effect sizes from baseline to subsequent follow-up visits were large (>0.5). Wheezing and chest pain were associated with higher ABSS values, whereas irrelevant clinical variables were not. The ABSS demonstrated good responsiveness, high internal consistency, good correlation with common respiratory signs and symptoms and high discriminatory validity among patients with acute bronchitis in a high HIV-seroprevalence setting.

  20. Validation and verification of measurement methods in clinical chemistry.

    Science.gov (United States)

    Theodorsson, Elvar

    2012-02-01

    The present overview of validation and verification procedures in clinical chemistry focuses on the use of harmonized concepts and nomenclature, fitness-for-purpose evaluations and procedures for minimizing overall measurement and diagnostic uncertainty. The need for mutually accepted validation procedures in all fields of bioanalysis becomes obvious when they implement international accreditation and certification standards or their equivalents. The guide on bioanalytical method validation published by the US FDA in 2001 represents a sensible compromise between thoroughness and cost-effectiveness. Lacking comprehensive international agreements in the field, this document has also been successfully adapted in other fields of bioanalysis. European and international efforts aiming for consensus in the entire field of bioanalysis are currently being made. Manufacturers of highly automated in vitro diagnostic methods provide the majority of measurement methods used in unmodified in clinical chemistry. Validated by the manufacturers for their intended use and fitness-for-purpose, they need to be verified in the circumstances of the end-users. As yet, there is unfortunately no general agreement on the extent of the verification procedures needed.

  1. Basic overview of method validation in the clinical virology laboratory.

    Science.gov (United States)

    Newman, Howard; Maritz, Jean

    2017-08-30

    Diagnostic virology laboratories are an essential part of the health system and are often relied upon to provide information to clinicians that will inform clinical decision making. It is therefore imperative that diagnostic results produced in the laboratory are reliable. One way of ensuring quality results is by ensuring that all tests are either validated (for tests developed in-house) or verified (for commercial assays that are FDA-approved or CE-labeled). In the diagnostic virology laboratory, these processes can be complex as both qualitative and quantitative measurements for serological and molecular tests are routinely offered. While there are numerous guidelines governing quality assurance in the virology laboratory, all accrediting agencies would insist on tests being validated or verified prior to implementation without providing explicit guidance to the process. As there is no universal guideline on the optimal way to perform validation/verification experiments, this review will provide a basic overview of method validation/verification, specific for clinical virology laboratories, and includes explanation of statistical analysis and acceptance/rejection criteria. Copyright © 2017 John Wiley & Sons, Ltd.

  2. Validation of a clinical critical thinking skills test in nursing

    Directory of Open Access Journals (Sweden)

    Sujin Shin

    2015-01-01

    Full Text Available Purpose: The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS and to subsequently validate its performance. Methods: This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Results: Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. Conclusion: From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability.

  3. Validation of a clinical critical thinking skills test in nursing.

    Science.gov (United States)

    Shin, Sujin; Jung, Dukyoo; Kim, Sungeun

    2015-01-27

    The purpose of this study was to develop a revised version of the clinical critical thinking skills test (CCTS) and to subsequently validate its performance. This study is a secondary analysis of the CCTS. Data were obtained from a convenience sample of 284 college students in June 2011. Thirty items were analyzed using item response theory and test reliability was assessed. Test-retest reliability was measured using the results of 20 nursing college and graduate school students in July 2013. The content validity of the revised items was analyzed by calculating the degree of agreement between instrument developer intention in item development and the judgments of six experts. To analyze response process validity, qualitative data related to the response processes of nine nursing college students obtained through cognitive interviews were analyzed. Out of initial 30 items, 11 items were excluded after the analysis of difficulty and discrimination parameter. When the 19 items of the revised version of the CCTS were analyzed, levels of item difficulty were found to be relatively low and levels of discrimination were found to be appropriate or high. The degree of agreement between item developer intention and expert judgments equaled or exceeded 50%. From above results, evidence of the response process validity was demonstrated, indicating that subjects respondeds as intended by the test developer. The revised 19-item CCTS was found to have sufficient reliability and validity and will therefore represents a more convenient measurement of critical thinking ability.

  4. Data from clinical database on septic shock are valid

    DEFF Research Database (Denmark)

    Grønlykke, Lars; Brandstrup, Sofie Louise Rygaard; Perner, Anders

    2012-01-01

    Clinical databases have become important tools in intensive care. Disease severity and organ dysfunction scoring systems are registered in the databases, including the Simplified Acute Physiology Score II (SAPS II) and the Sequential Organ Failure Assessment (SOFA) score. The purpose of this study...... was to evaluate the reliability and accuracy of a clinical database on intensive care unit (ICU) patients....

  5. The Importance of Prediction Model Validation and Assessment in Obesity and Nutrition Research

    Science.gov (United States)

    Ivanescu, Andrada E.; Li, Peng; George, Brandon; Brown, Andrew W.; Keith, Scott W.; Raju, Dheeraj; Allison, David B.

    2015-01-01

    Deriving statistical models to predict one variable from one or more other variables, or predictive modeling, is an important activity in obesity and nutrition research. To determine the quality of the model, it is necessary to quantify and report the predictive validity of the derived models. Conducting validation of the predictive measures provides essential information to the research community about the model. Unfortunately, many articles fail to account for the nearly inevitable reduction in predictive ability that occurs when a model derived on one dataset is applied to a new dataset. Under some circumstances, the predictive validity can be reduced to nearly zero. In this overview, we explain why reductions in predictive validity occur, define the metrics commonly used to estimate the predictive validity of a model (e.g., R2, mean squared error, sensitivity, specificity, receiver operating characteristic, concordance index), and describe methods to estimate the predictive validity (e.g., cross-validation, bootstrap, adjusted and shrunken R2). We emphasize that methods for estimating the expected reduction in predictive ability of a model in new samples are available and this expected reduction should always be reported when new predictive models are introduced. PMID:26449421

  6. Free testosterone: clinical utility and important analytical aspects of measurement.

    Science.gov (United States)

    Shea, Jennifer L; Wong, Pui-Yuen; Chen, Yu

    2014-01-01

    Testosterone, the most abundant androgen in men, is a steroid hormone that is synthesized predominantly by the testes. In women, minor amounts are synthesized in the ovaries. Androgen precursors are also produced and secreted from the adrenal glands in both sexes, where they undergo peripheral conversion to testosterone. Circulating concentrations are approximately 15-25 times higher in adult men compared to women. Maintenance of these levels is necessary for development and maintenance of secondary sexual characteristics, libido, growth, prevention of osteoporosis, and most importantly in men, spermatogenesis. Most testosterone circulates tightly bound to sex hormone-binding globulin (SHBG) or weakly bound to albumin. A minor amount circulates as free testosterone, and it is believed that this is the metabolically active fraction. Measurement of free testosterone is important in the diagnosis of many diseases, most importantly disorders of androgen deficiency in men (i.e., hypogonadism) and androgen excess in women (i.e., polycystic ovary syndrome and hirsutism). Many methodologies are available for free testosterone measurement including the reference methods (equilibrium dialysis and ultrafiltration), analog immunoassay, and calculated free testosterone based on measurement of total testosterone, SHBG, and albumin. Moreover, measurement of bioavailable testosterone, a combination of albumin-bound and free testosterone, also has clinical utility and can be measured by selective protein precipitation or calculation. In this review, the advantages and limitations of each of these methods will be discussed in the context of clinical utility and implementation into a routine hospital laboratory. Furthermore, up and coming methodologies for free testosterone measurement, including liquid chromatography-tandem mass spectrometry, will also be discussed.

  7. Health status measurement in COPD : the minimal clinically important difference of the clinical COPD questionnaire

    NARCIS (Netherlands)

    Kocks, J. W. H.; Tuinenga, M. G.; Uil, S. M.; van den Berg, J. W. K.; Stahl, E.; van der Molen, T.

    2006-01-01

    Background: Patient-reported outcomes ( PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for

  8. A clinical importance of natriuretic peptides in pediatric practice

    Directory of Open Access Journals (Sweden)

    Е. В. Саперова

    2017-04-01

    Full Text Available Natriuretic peptides (NUP are peptide hormones secreted by cardiomyocytes in response to a volume overload of the heart. Emphasis in the article is placed on the history of NUP discovery, their chemical structure and pathophysiological mechanisms of action. The data on determination of NUP reference values in children with cardiac pathologies are analyzed. A NUP clinical significance in early diagnosis of heart failure in children, including those with congenital heart defects is shown. Also considered is NUP dynamics after surgical correction of congenital heart defects. A conclusion is drawn that NUP play an important prognostic role in evaluating early and late postoperative periods and disease outcomes on a whole.Received 11 October 2016. Accepted 22 December 2016.Funding: The study had no sponsorship.Conflict of interest: The authors declare no conflict of interest.Author contributionsAll authors contributed equally at all stages of the research.

  9. Minimum Clinically Important Difference: Current Trends in the Spine Literature.

    Science.gov (United States)

    Chung, Andrew S; Copay, Anne G; Olmscheid, Neil; Campbell, David; Walker, J Brock; Chutkan, Norman

    2017-07-15

    Review of the 2011 to 2015 minimum clinically important difference (MCID)-related publications in Spine, Spine Journal, Journal of Neurosurgery-Spine, and European Spine Journal. To summarize the various determinations of MCID and to analyze its usage in the spine literature of the past 5 years in order to develop a basic reference to help practitioners interpret or utilize MCID. MCID represents the smallest change in a domain of interest that is considered beneficial to a patient or clinician. The many sources of variation in calculated MCID values and inconsistency in its utilization have resulted in confusion in the interpretation and use of MCID. All articles from 2011 to 2015 were reviewed. Only clinical science articles utilizing patient reported outcome scores (PROs) were included in the analysis. A keyword search was then performed to identify articles that used MCID. MCID utilization in the selected papers was characterized and recorded. MCID was referenced in 264/1591 (16.6%) clinical science articles that utilized PROs: 22/264 (8.3%) independently calculated MCID values and 156/264 (59.1%) used previously published MCID values as a gauge of their own results. Despite similar calculation methods, there was a two- or three-fold range in the recommended MCID values for the same instrument. Half the studies recommended MCID values within the measurement error. Most studies (97.2%) using MCID to evaluate their own results relied on generic MCID. The few studies using specific MCID (MCID calculated for narrowly defined indications or treatments) did not consistently match the characteristics of their sample to the specificity of the MCID. About 48% of the studies compared group averages instead of individual scores to the MCID threshold. Despite a clear interest in MCID as a measure of patient improvement, its current developments and uses have been inconsistent. N/A.

  10. Friendship fosters learning: The importance of friendships in clinical practice.

    Science.gov (United States)

    Roberts, Debbie

    2009-11-01

    This paper reports on one of the key findings from a recent ethnographic study (Roberts, D., 2007. Friendships and the community of students: peer learning amongst a group of pre-registration student nurses. Unpublished PhD Thesis, University of Salford, UK) and aims to highlight the importance of friendships for student nurses in clinical practice. An interpretive ethnographic approach was taken in order to reveal the student experience during their pre registration programme. Data was collected using ethnographic interviewing (Sorrell, J.M., Redmond, G.M., 1995. Interviews in qualitative nursing research: differing approaches for ethnographic and phenomenological studies. Journal of Advanced Nursing 21, 1117-1122.) and participant observation. Within this paper I argue that student nurses exist on the edge of the community of practice (of the qualified staff) and therefore form their own parallel community where students are all seen as being in the same boat. In particular students use the friendships they develop in clinical practice to enable them to learn; developing an 'ask anything' culture where all students are perceived as valuable sources of knowledge. Furthermore, it appears that knowledge is contextually bound and not therefore linked to seniority, or length of time served on the course.

  11. Radiological findings and the clinical importance of megacalycosis

    Science.gov (United States)

    Kalaitzis, Christos; Patris, Emmanuel; Deligeorgiou, Evangelia; Sountoulides, Petros; Bantis, Athanasios; Giannakopoulos, Stilianos; Touloupidis, Stavros

    2015-01-01

    Objective To describe the radiological findings and the clinical importance of megacalycosis. Materials and methods On the basis of a case report and literature review, diagnostic criteria and clinical significance of megacalycosis are presented. Result Megacalycosis is mostly asymptomatic and is usually discovered either accidentally or as a result of its complications, such as stone formation, flank pain, hematuria, infection, and fever. The renal pelvis, infundibulum, and ureter are not dilated. Calyces have a semilunar configuration rather than the conventional triangular or conical form. The tip of each pyramid is flat, and the calyces possess neither fornix nor papillae impressions. The number of calyces is increased compared to the healthy condition, typically from 20–25. The renal parenchyma has a normal width but with a slight narrowing of the renal medulla. The kidney exhibits normal function, in particular with respect to its ability to concentrate the urine. Conclusion Megacalycosis is a rare, usually unilateral dilatation of the kidney calyces in the presence of a normal, undilated renal pelvis and ureter. Its pathological significance lies in the occurrence of complications. PMID:26528455

  12. Toward a more clinically valid approach to therapy research.

    Science.gov (United States)

    Goldfried, M R; Wolfe, B E

    1998-02-01

    Despite the advances in psychotherapy outcome research, findings are limited because they do not fully generalize to the way therapy is conducted in the real world. Research's clinical validity has been compromised by the medicalization of outcome research, use of random assignment of clients without regard to appropriateness of treatment, fixed number of therapy sessions, nature of the therapy manuals, and use of theoretically pure therapies. The field needs to foster a more productive collaboration between clinician and researcher; study theoretically integrated interventions; use process research findings to improve therapy manuals; make greater use of replicated clinical case studies; focus on less heterogeneous, dimensionalized clinical problems; and find a better way of disseminating research findings to the practicing clinician.

  13. Clinical gait and balance scale (GABS): validation and utilization.

    Science.gov (United States)

    Thomas, Madhavi; Jankovic, Joseph; Suteerawattananon, Monthaporn; Wankadia, Sharmin; Caroline, Kavitha Salomi; Vuong, Kevin Dat; Protas, Elizabeth

    2004-01-15

    Gait and Balance Scale (GABS) consists of historical information and examination of 14 different gait and balance parameters designed to assess the severity of these functional domains. Thirty-five patients with Parkinson's disease (PD), Hoehn and Yahr stages 1-3, were tested during their "off" period. GABS items were compared to quantitative data from two computerized gait analysis instruments, GAITRite and Pro Balance Master. Intra-class correlation coefficients were calculated to establish reliability. Intra-rater test-retest reliability was determined using Cohen's Kappa statistic. Concurrent validity was derived using the Spearman's rho test with the items from GABS, GAITRite and Balance Master. Intra-rater reliability was high with k>0.41 (k=kappa statistic) for 17 items, 6 had k>0.61. When performing validity measurements, a number of items on the GABS had a correlation coefficient significant at pscale and provocative testing had significant correlation with the GAITRite items (R=0.51-0.83). GABS is an easy-to-use comprehensive clinical scale with high intra-rater and internal item reliability. We have shown concurrent validity with two computerized gait analysis instruments. We expect GABS to have a particular utility in clinical trials designed to modify functional impairment associated with abnormalities in gait and balance.

  14. Reliability, validity, and clinical usability of a digital goniometer.

    Science.gov (United States)

    Carey, Mark A; Laird, Daniel E; Murray, Keith A; Stevenson, John R

    2010-01-01

    The purposes of this study were to establish the validity of a digital goniometer (DG) prototype, determine the inter- and intra-rater reliability of the DG as compared to the universal goniometer (UG), and evaluate and describe the clinical usability of the DG as a measurement tool. Eighteen healthy patient models and 5 physical therapists volunteered to participate. Reliability testing of both the UG and DG was determined from the measurements of 5 therapists who performed 2 randomized, repeated measures of 5 joint motions on each of 6 patient models during 3 data collection sessions. To determine the validity of the DG, the investigators measured 8 randomly selected, computer-aided design (CAD) angles during each of the 3 data collection sessions. Physical therapist participants completed pre-/post-surveys to assess perceptions of clinical usability of the DG. No statistically significant differences were found between devices. Comparison of the DG and UG demonstrated no difference for intra- or inter-rater reliability, with the DG yielding higher inter-rater ICC values for each of the 5 motions measured. The DG has adequate concurrent criterion-related validity as a tool for assessment of joint ROM and equivalent inter- and intra-rater reliability to the UG. User surveys indicated that several of the novel features of the DG contributed to a higher likelihood that the device would be utilized by clinicians.

  15. Variations in Transverse Foramina of Cervical Vertebrae: Morphology & Clinical Importance

    Directory of Open Access Journals (Sweden)

    Vaishakhi Gonsai

    2015-12-01

    Full Text Available Background: The purpose of this study is to investigate variations in transverse foramina in the cervical vertebrae and its morphological and clinical importance. Materials and Method : The variations in the number and size of transverse foramina was studied in total 200 human dried cervical vertebrae, which were taken from the Department of Anatomy, B.J.Medical College, Ahmedabad. All the vertebrae were observed for variation in number and size of transverse foramina. Results: Out of 200 cervical vertebrae, complete double transverse foramina were observed in 40 vertebrae (20%, among them unilateral double foramina were found in 31 vertebrae (15.5% and the bilateral double foramina were found in 9 vertebrae (4.5%. Incomplete double transverse foramina were observed in 22 vertebrae (11%, among them unilateral double foramina were found in 16 vertebrae (8% and bilateral double foramina were observed in 6 vertebrae (3%. Conclusion: Complete unilateral double transverse foramina of cervical vertebrae were more common than bilateral. Also unilateral small size transverse foramina of cervical vertebrae were also common. This variation is important for the neurosurgeon during cervical surgery. Under such condition the course of the vertebral artery may be distorted. It is also useful for Radiologist during CT and MRI scan.

  16. Reliable and Valid Assessment of Clinical Bronchoscopy Performance

    DEFF Research Database (Denmark)

    Konge, Lars; Larsen, Klaus Richter; Clementsen, Paul

    2012-01-01

    Background: There have been several attempts to systematically assess performance in bronchoscopy. Earlier validation studies have used bronchoscopy simulators, not real-life performance in patients. Objectives: The aim of this study was to explore the reliability and validity of an assessment tool...... aimed for the use in a clinical setting. Methods: Five junior residents, 5 senior residents and 9 consultants performed 3 bronchoscopies each. All 57 bronchoscopies were video-recorded and assessed blindly and independently by two bronchoscopy experts using the new assessment tool. Results......: The interrater reliability was high, with Cronbach's a = 0.86. Assessment of 3 bronchoscopies by a single rater had a generalizability coefficient of 0.84. The correlation between experience and performance was good (Pearson correlation = 0.76). There were significant differences between the groups for all...

  17. Validation of Clinical Observations of Mastication in Persons with ALS.

    Science.gov (United States)

    Simione, Meg; Wilson, Erin M; Yunusova, Yana; Green, Jordan R

    2016-06-01

    Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

  18. Predictive validity of measurements of clinical competence using the team objective structured bedside assessment (TOSBA): assessing the clinical competence of final year medical students.

    LENUS (Irish Health Repository)

    Meagher, Frances M

    2009-11-01

    The importance of valid and reliable assessment of student competence and performance is gaining increased recognition. Provision of valid patient-based formative assessment is an increasing challenge for clinical teachers in a busy hospital setting. A formative assessment tool that reliably predicts performance in the summative setting would be of value to both students and teachers.

  19. Assessing task importance and anxiety in medical school: an instrument development and initial validation study.

    Science.gov (United States)

    Phillips, Henry L; Dong, Ting; Durning, Steven J; Artino, Anthony R

    2015-04-01

    Recent research in medical education suggests that students' motivational beliefs, such as their beliefs about the importance of a task, and their emotions are meaningful predictors of learning and performance. The primary purpose of this study was to develop a self-report measure of "task importance" and "anxiety" in relation to several medical education competencies and to collect validity evidence for the new measures. The secondary purpose was to evaluate differences in these measures by year of medical school. Exploratory factor analysis of scores from 368 medical school students suggested two task importance factors and three anxiety factors. The task importance and anxiety subscales were weakly related to each other and exhibited consistently negative and positive correlations, respectively, with three self-efficacy subscales. The task importance subscales were positively related to "metacognition," whereas "interpersonal skills anxiety" and "health knowledge anxiety" were positively related to "procrastination." All three anxiety factors were positively related to "avoidance of help seeking," whereas "interpersonal skills and professionalism importance" was negatively related to help avoidance behaviors. Finally, comparisons across the 4 years of medical school indicated that some aspects of task importance and anxiety varied significantly. Overall, findings from this study provide validity evidence for the psychometric quality of these scales, which capture task importance and anxiety in medical students. Limitations and implications for medical education research are discussed. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

  20. Clinical and psychometric validation of the psychotic depression assessment scale

    DEFF Research Database (Denmark)

    Østergaard, Søren D; Pedersen, Christina H; Uggerby, Peter

    2015-01-01

    of the PDAS and its subscales was investigated by Spearman correlation analysis of the global severity ratings and the PDAS, HAM-D6, and BPRS5 total scores. The unidimensionality of the scales was tested by item response theory analysis (Mokken). RESULTS: Ratings from 39 participants with unipolar psychotic...... depression and nine participants with bipolar psychotic depression were included in the analysis. The Spearman correlation analysis indicated that the PDAS, HAM-D6 and BPRS5 were clinically valid (correlation coefficients from 0.78 to 0.85, p

  1. Longitudinal predictive validity of the DSM-5 anxious distress specifier for clinical outcomes in a large cohort of patients with major depressive disorder

    NARCIS (Netherlands)

    Gaspersz, Roxanne; Lamers, Femke; Kent, Justine M.; Beekman, Aartjan T. F.; Smit, Johannes H.; van Hemert, Albert M.; Schoevers, Robert A.; Penninx, Brenda W. J. H.

    OBJECTIVE: While the new DSM-5 anxious distress specifier is of great clinical importance, no evidence exists for its longitudinal predictive validity for clinical outcomes in patients with major depressive disorder (MDD). We examined the longitudinal validity of this specifier and validated it

  2. Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.

    Science.gov (United States)

    Torlakovic, Emina E; Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Vyberg, Mogens; Zhou, Xiaoge; Taylor, Clive R

    2017-03-01

    Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are "fit-for-purpose." Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

  3. Total knee replacement; minimal clinically important differences and responders.

    Science.gov (United States)

    Escobar, A; García Pérez, L; Herrera-Espiñeira, C; Aizpuru, F; Sarasqueta, C; Gonzalez Sáenz de Tejada, M; Quintana, J M; Bilbao, A

    2013-12-01

    To provide new data on minimally clinical important difference (MCID) and percentages of responders on pain and functional dimensions of Western Ontario and McMaster Osteoarthritis Index (WOMAC) in patients who have undergone total knee replacement (TKR). 1-year prospective multicentre study with two different cohorts. Consecutive patients on the waiting list were recruited. There were 415 and 497 patients included. Pain and function were collected by the reverse scoring option of the WOMAC (0-100, worst to best). Transition items (five point scale) were collected at 1-year and MCID was calculated through mean change in patients somewhat better, Receiver Operating Characteristic (ROC) and two other questions about satisfaction. Analysis was performed in the whole sample and by tertiles of baseline severity. Likewise were calculated the percentages of patients who attained cut-off values. Global MCID for pain were about 30 in both cohorts and 32 for. By ROC these values were about 20 and 24 respectively. According to the other two transitional questions these values were for pain 27 and 20 for function. By tertiles the worst the baseline score the higher the cut-off values. Percentage of responders does not change when comparing responders to the global MCID with their own tertile MCID and were about 61% for pain and 50% for function. Due to the wide variations, MCID estimates should be calculated and used according to the baseline severity score. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  4. PET: the importance of physicists for the clinical arena

    CERN Multimedia

    2005-01-01

    David Townsend giving a seminar at CERN on 9 February. The past few years have seen significant advances in the development of instrumentation for Positron Emission Tomography (PET). The recent appearance of combined PET and Computed Tomography (CT) scanners that can simultaneously image both anatomy and function is of particular importance. This was the main subject of "Advances in PET imaging: from physics to physician", a seminar presented at CERN by David Townsend on Wednesday 9 February  and organized by the TT and PH groups. David Townsend, who started his career at CERN in the 1970s, is now Professor at the Department of Medicine, University of Tennessee Medical Center (Knoxville, TN). Recipient of the 2004 Clinical Scientist of the Year Award, he is an internationally renowned researcher and PET physicist, with over 25 years of experience in the field. His 1999 image of the year, an award from the Society of Nuclear Medicine in the US, was produced using a combined state-of-the art PET and a true d...

  5. Validation of a global measure of faculty's clinical teaching performance.

    Science.gov (United States)

    Williams, Brent C; Litzelman, Debra K; Babbott, Stewart F; Lubitz, Robert M; Hofer, Tim P

    2002-02-01

    To validate the University of Michigan Global Rating Scale (GRS), a single-item, five-point global measure of faculty members' clinical teaching performances previously shown to be reliable. In June 1998, 98 senior medical residents (98% of seniors) from four academic institutions completed the GRS for all teaching faculty at their institutions. Each resident also completed the 26-item Stanford Faculty Development questionnaire (SFDP26) for ten faculty with whom he or she had had teaching contact during residency. The SFDP26 is a validated instrument that measures seven specific aspects of clinical teaching (e.g., communication of goals, feedback). The mean GRS score (SE) was 3.83 (.07). There was no difference in mean GRS or SFDP26 subscale scores across institutions. In a random-effects model that controlled for interrater reliability, correlation coefficients comparing the mean GRS scores and the mean scores for the individual SFDP26 subscales ranged from.86 to.98. The GRS correlates highly with measures of seven specific aspects of teaching effectiveness among senior medical residents. The GRS is a simple, readily administered measure of faculty's teaching performances that can be used by residency programs as part of an incentive or reward program, to identify teachers as potential candidates for faculty development, or for consideration in promotion decisions.

  6. Data from clinical database on septic shock are valid

    DEFF Research Database (Denmark)

    Grønlykke, Lars; Brandstrup, Sofie Louise Rygaard; Perner, Anders

    2012-01-01

    Clinical databases have become important tools in intensive care. Disease severity and organ dysfunction scoring systems are registered in the databases, including the Simplified Acute Physiology Score II (SAPS II) and the Sequential Organ Failure Assessment (SOFA) score. The purpose of this stud...

  7. External validation and comparison of three pediatric clinical dehydration scales.

    Science.gov (United States)

    Jauregui, Joshua; Nelson, Daniel; Choo, Esther; Stearns, Branden; Levine, Adam C; Liebmann, Otto; Shah, Sachita P

    2014-01-01

    To prospectively validate three popular clinical dehydration scales and overall physician gestalt in children with vomiting or diarrhea relative to the criterion standard of percent weight change with rehydration. We prospectively enrolled a non-consecutive cohort of children ≤ 18 years of age with an acute episode of diarrhea or vomiting. Patient weight, clinical scale variables and physician clinical impression, or gestalt, were recorded before and after fluid resuscitation in the emergency department and upon hospital discharge. The percent weight change from presentation to discharge was used to calculate the degree of dehydration, with a weight change of ≥ 5% considered significant dehydration. Receiver operating characteristics (ROC) curves were constructed for each of the three clinical scales and physician gestalt. Sensitivity and specificity were calculated based on the best cut-points of the ROC curve. We approached 209 patients, and of those, 148 were enrolled and 113 patients had complete data for analysis. Of these, 10.6% had significant dehydration based on our criterion standard. The Clinical Dehydration Scale (CDS) and Gorelick scales both had an area under the ROC curve (AUC) statistically different from the reference line with AUCs of 0.72 (95% CI 0.60, 0.84) and 0.71 (95% CI 0.57, 0.85) respectively. The World Health Organization (WHO) scale and physician gestalt had AUCs of 0.61 (95% CI 0.45, 0.77) and 0.61 (0.44, 0.78) respectively, which were not statistically significant. The Gorelick scale and Clinical Dehydration Scale were fair predictors of dehydration in children with diarrhea or vomiting. The World Health Organization scale and physician gestalt were not helpful predictors of dehydration in our cohort.

  8. Copy number variation plays an important role in clinical epilepsy

    Science.gov (United States)

    Olson, Heather; Shen, Yiping; Avallone, Jennifer; Sheidley, Beth R.; Pinsky, Rebecca; Bergin, Ann M.; Berry, Gerard T.; Duffy, Frank H.; Eksioglu, Yaman; Harris, David J.; Hisama, Fuki M.; Ho, Eugenia; Irons, Mira; Jacobsen, Christina M.; James, Philip; Kothare, Sanjeev; Khwaja, Omar; Lipton, Jonathan; Loddenkemper, Tobias; Markowitz, Jennifer; Maski, Kiran; Megerian, J. Thomas; Neilan, Edward; Raffalli, Peter C.; Robbins, Michael; Roberts, Amy; Roe, Eugene; Rollins, Caitlin; Sahin, Mustafa; Sarco, Dean; Schonwald, Alison; Smith, Sharon E.; Soul, Janet; Stoler, Joan M.; Takeoka, Masanori; Tan, Wen-Han; Torres, Alcy R.; Tsai, Peter; Urion, David K.; Weissman, Laura; Wolff, Robert; Wu, Bai-Lin; Miller, David T.; Poduri, Annapurna

    2015-01-01

    Objective To evaluate the role of copy number abnormalities detectable by chromosomal microarray (CMA) testing in patients with epilepsy at a tertiary care center. Methods We identified patients with ICD-9 codes for epilepsy or seizures and clinical CMA testing performed between October 2006 and February 2011 at Boston Children’s Hospital. We reviewed medical records and included patients meeting criteria for epilepsy. We phenotypically characterized patients with epilepsy-associated abnormalities on CMA. Results Of 973 patients who had CMA and ICD-9 codes for epilepsy or seizures, 805 patients satisfied criteria for epilepsy. We observed 437 copy number variants (CNVs) in 323 patients (1–4 per patient), including 185 (42%) deletions and 252 (58%) duplications. Forty (9%) were confirmed de novo, 186 (43%) were inherited, and parental data were unavailable for 211 (48%). Excluding full chromosome trisomies, CNV size ranged from 18 kb to 142 Mb, and 34% were over 500 kb. In at least 40 cases (5%), the epilepsy phenotype was explained by a CNV, including 29 patients with epilepsy-associated syndromes and 11 with likely disease-associated CNVs involving epilepsy genes or “hotspots.” We observed numerous recurrent CNVs including 10 involving loss or gain of Xp22.31, a region described in patients with and without epilepsy. Interpretation Copy number abnormalities play an important role in patients with epilepsy. Given that the diagnostic yield of CMA for epilepsy patients is similar to the yield in autism spectrum disorders and in prenatal diagnosis, for which published guidelines recommend testing with CMA, we recommend the implementation of CMA in the evaluation of unexplained epilepsy. PMID:24811917

  9. Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

    Science.gov (United States)

    Wu, R Ryanne; Kinsinger, Linda S; Provenzale, Dawn; King, Heather A; Akerly, Patricia; Barnes, Lottie K; Datta, Santanu K; Grubber, Janet M; Katich, Nicholas; McNeil, Rebecca B; Monte, Robert; Sperber, Nina R; Atkins, David; Jackson, George L

    2014-12-01

    Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

  10. Minimal Clinically Important Differences of Disease Activity Indices in Childhood-onset Systemic Lupus Erythematosus

    Science.gov (United States)

    Brunner, Hermine I.; Higgins, Gloria C.; Klein-Gitelman, Marisa S.; Lapidus, Sivia K.; Olson, Judyann C.; Onel, Karen; Punaro, Marilynn; Ying, Jun; Giannini, Edward H.

    2010-01-01

    Objective To determine the minimal clinically important differences (MCID) of validated measures of SLE disease activity in childhood-onset systemic lupus erythematosus (cSLE). Methods cSLE patients (n=98) were followed every 3 months for up to 7 visits (total number of visits 623). Disease activity measures (ECLAM, SLEDAI, SLAM, BILAG, RIFLE) were completed at the time of each visit. Physician-rated changes in the disease course (clinically relevant improvement, no change, clinically relevant worsening) between visits served as the criterion standard. Results MCID defined by mean change scores with improvement and worsening, or those based on the standard error of measurement with stable disease were both small and did not discriminate well between disease courses (detection rates for improvement or worsening were all MCID based on discriminant and classification analyses yielded similar results. Alternative MCID, defined by a 70% predicted probability of improvement or worsening as per discrimination analysis, were larger but underestimated the proportion of patients with change. The RIFLE only correctly identified 26% and 8% episodes of clinically important worsening and improvement of cSLE, respectively. Conclusions The MCID of cSLE disease activity measures are often small but similar to those reported for adults with SLE. Thus even small changes in disease activity scores can be clinically relevant. Low correct detection rates of these MCID thresholds for changes in disease course support the notion that worsening and improvement with cSLE, or its response to therapy, is unlikely to be captured adequately by validated measures of disease activity alone. PMID:20589695

  11. Clinical importance of toxin concentration in Amanita verna mushroom.

    Science.gov (United States)

    Yilmaz, Ismail; Kaya, Ertugrul; Sinirlioglu, Zeynep Aydin; Bayram, Recep; Surmen, Mustafa Gani; Colakoglu, Serdar

    2014-09-01

    Poisoning from Amanita group of mushrooms comprises approximately 3% of all poisonings in our country and their being responsible for nearly the entire fatal mushroom poisonings makes them important. These mushrooms contain primarily two types of toxins, amatoxins and phallotoxins. Phallotoxins have a more limited toxicity potential and they primarily consist of phalloidin (PHN) and phallacidin (PCN). Amatoxins, on the other hand, are very toxic and they primarily consist of alpha-amanitin (AA), beta-amanitin (BA) and gamma-amanitin (GA). Toxin levels can vary among various species, even among varieties of the same species, of Amanita mushroom family. Revealing the differences between the toxin compositions of the Amanita species that grow in our region may contribute to the clinics of poisonings. Our study aims at showing in detail the toxin levels in various parts of Amanita verna mushroom. A. verna mushrooms needed for toxin analysis were collected from Kozak Plateau near Ayvalik county of Balıkesir, Turkey in April 2013. The mushrooms were divided into their parts as pileus, gills, stripe and volva. Following the procedures required before the analysis, the AA, BA, GA, PHN and PCN levels were measured using the RP-HPLC method. While the lowest level of amatoxin was in the volva of the mushroom, the highest was measured in the gills. This was followed by pileus and stripe where the levels were close to each other. Similarly, the highest level of phallotoxin was measured in the gills. Gamma toxin and phalloidin were at lower amounts than the other toxins. A. verna is frequently confused with edible mushrooms with white caps due to its macroscopic similarity. If just one of them is eaten by mistake by an adult person with no mushroom experience, it can easily poison them. The amount of amatoxin is more as compared to Amanita phalloides and A. phalloides var. alba. Particularly, the AA and BA levels are approximately three times higher, whereas GA levels are lower

  12. Clinical and Business Intelligence: Why It's Important to Your Pharmacy.

    Science.gov (United States)

    Pinto, Brian; Fox, Brent I

    2016-07-01

    According to the Healthcare Information Management and Systems Society, "Clinical & Business Intelligence (C&BI) is the use and analysis of data captured in the healthcare setting to directly inform decision-making" (http://www.himss.org/library/clinical-business-intelligence). Some say that it is the right information given to the right person at the right time in the right way. No matter how you define it, the fact remains that timely access, synthesis, and visualization of clinical data have become key to how health professionals make patient care decisions and improve care delivery.

  13. A critical evaluation of the validity of episodic future thinking: A clinical neuropsychology perspective.

    Science.gov (United States)

    Ward, Amanda M

    2016-11-01

    Episodic future thinking is defined as the ability to mentally simulate a future event. Although episodic future thinking has been studied extensively in neuroscience, this construct has not been explored in depth from the perspective of clinical neuropsychology. The aim of this critical narrative review is to assess the validity and clinical implications of episodic future thinking. A systematic review of episodic future thinking literature was conducted. PubMed and PsycInfo were searched through July 2015 for review and empirical articles with the following search terms: "episodic future thinking," "future mental simulation," "imagining the future," "imagining new experiences," "future mental time travel," "future autobiographical experience," and "prospection." The review discusses evidence that episodic future thinking is important for adaptive functioning, which has implications for neurological populations. To determine the validity of episodic future thinking, the construct is evaluated with respect to related constructs, such as imagination, episodic memory, autobiographical memory, prospective memory, narrative construction, and working memory. Although it has been minimally investigated, there is evidence of convergent and discriminant validity for episodic future thinking. Research has not addressed the incremental validity of episodic future thinking. Practical considerations of episodic future thinking tasks and related constructs in a clinical neuropsychological setting are considered. The utility of episodic future thinking is currently unknown due to the lack of research investigating the validity of episodic future thinking. Future work is discussed, which could determine whether episodic future thinking is an important missing piece in standard clinical neuropsychological assessment. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  14. VALIDATION OF TWO CLINICAL MEASURES OF CORE STABILITY.

    Science.gov (United States)

    Butowicz, Courtney M; Ebaugh, D David; Noehren, Brian; Silfies, Sheri P

    2016-02-01

    Emerging evidence suggests poor core stability is a risk factor for low back and lower extremity injuries in athletes. Recently the trunk stability test (TST) and unilateral hip bridge endurance test (UHBE) were developed to clinically assess core stability. Although these and other clinical tests of core stability exist, how well they assess core stability when compared to biomechanical measures of isolated core stability has not been thoroughly evaluated. The purposes of this study were to 1) determine concurrent validity of two novel clinical core stability assessments (TST and UHBE), and 2) assess relationships between these assessments and the trunk endurance and Y-Balance tests. The authors' hypothesized that the TST and UHBE would be highly correlated to the lab-based biomechanical measure of isolated core stability. Also, the TST and UHBE would be moderately correlated with each other, but not with the trunk extensor endurance and Y-Balance. Cross-Sectional design. Twenty healthy active individuals completed the TST (recorded number of errors), UHBE (s), trunk extensor endurance (s), Y-Balance (% leg length) test (YBT), and biomechanical test of core stability. Correlational analyses revealed a small, non-significant association between TST and biomechanical measures (rs = 0.2 - 0.22), while a moderate, significant relationship existed between UHBE and biomechanical measures (rs = -0.49 to -0.56, p core stability. The poor relationship between the TST and biomechanical measures, combined with observation of most control faults occurring in the lower extremity (LE) suggest the TST may not be an appropriate clinical test of core stability. Level 3.

  15. Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management.

    Science.gov (United States)

    Gaddale, Jagadeeswara Rao

    2015-01-01

    In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.

  16. Clinical data acquisition standards harmonization importance and benefits in clinical data management

    Directory of Open Access Journals (Sweden)

    Jagadeeswara Rao Gaddale

    2015-01-01

    Full Text Available In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH provides guidance to develop the case report form (CRF for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.

  17. International Transporter Consortium commentary on clinically important transporter polymorphisms.

    Science.gov (United States)

    Giacomini, K M; Balimane, P V; Cho, S K; Eadon, M; Edeki, T; Hillgren, K M; Huang, S-M; Sugiyama, Y; Weitz, D; Wen, Y; Xia, C Q; Yee, S W; Zimdahl, H; Niemi, M

    2013-07-01

    This Commentary focuses on genetic polymorphisms in membrane transporters. We present two polymorphisms for which there is a compelling body of literature supporting their clinical relevance: OATP1B1 (c.521T>C, p.V174A, rs4149056) and BCRP (c.421C>A, p.Q141K, rs2231142). The clinical evidence demonstrating their role in variation in pharmacokinetics and pharmacodynamics is described along with their allele frequencies in ethnic populations. Recommendations for incorporating studies of transporter polymorphisms in drug development are provided, along with the regulatory implications.

  18. Secondary Hemophagocytic Syndrome: The Importance of Clinical Suspicion

    Directory of Open Access Journals (Sweden)

    Cristina Oliveira

    2014-01-01

    Full Text Available Hemophagocytic syndrome is a rare and potentially fatal disorder characterized by pathological immune activation associated with a primary familial disorder, genetic mutations, or occurring as a sporadic condition. The latter can be secondary to infections, malignancies, or autoimmune diseases. Clinically, patients present signs of severe inflammation, with unremitting fever, cytopenias, spleen enlargement, phagocytosis of bone marrow elements, hypertriglyceridemia, and hypofibrinogenemia. Increased suspicion is determinant to timely initiate treatment in an attempt to alter the natural history. The authors present three clinical cases of this syndrome, with a brief review of the diagnostic criteria and treatment.

  19. Sitosterolemia: A multifaceted metabolic disorder with important clinical consequences.

    Science.gov (United States)

    Tzavella, Eleftheria; Hatzimichael, Eleftheria; Kostara, Christina; Bairaktari, Eleni; Elisaf, Moses; Tsimihodimos, Vasilis

    Sitosterolemia is a metabolic disorder characterized by increased intestinal absorption and tissue accumulation of phytosterols. Although sitosterolemia is considered a rare disease, its prevalence may be significantly higher than initially thought. Indeed, accumulating evidence suggests that patients with unexplained hematologic abnormalities or premature cardiovascular disease in the absence of classic risk factors may exhibit disordered phytosterol metabolism. In this review, we present a patient with sitosterolemia, describe the pathophysiology and the clinical picture of this disorder, and discuss the clinical value of phytosterol supplementation in patients with primary dyslipidemias. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  20. From items to syndromes in the Hypomania Checklist (HCL-32): Psychometric validation and clinical validity analysis

    DEFF Research Database (Denmark)

    Bech, P; Christensen, E M; Vinberg, M

    2011-01-01

    -taking/irritable behaviour in the HCL-32. Using the Bech-Rafaelsen Mania Scale as index of clinical validity a shorter version was developed. Item response theory analysis was used to evaluate whether the total score of the HCL-32 was sufficient to measure subthreshold bipolarity. The short 13-item Mood Disorder......BACKGROUND: The Hypomania Checklist (HCL-32) was developed to identify subthreshold bipolarity in patients with major depression. An HCL-32 version with fewer items has been suggested. METHODS: Principal component analysis (PCA) without rotation was used to identify active/elevated mood versus risk...... Questionnaire (MDQ) was used for comparison. RESULTS: In accordance with the SCID-II criteria, we included 59 bipolar I and 63 unipolar (depressed) outpatients who had recently been discharged from inpatient treatment. In the HCL-32, PCA identified the two contrasting factors: active/elevated mood versus risk...

  1. Psychometric validation and clinical validity of the Minor Melancholia Mood Checklist (MMCL-32)

    DEFF Research Database (Denmark)

    Bech, Per; Christensen, Ellen Margrethe; Vinberg, Maj

    2012-01-01

    a bidirectorial principal component. To evaluate the clinical validity of the bidirectorial factors, with reference to brief recurrent depression, the Bech-Rafaelsen Melancholia Scale was used. RESULTS: We included 59 patients with bipolar I disorder (SCID criteria) and 57 patients with unipolar depression (more......BACKGROUND: The Minor Melancholia Mood Checklist (MMCL-32) was developed to identify sub-threshold states of major depression. The MMCL-32 can be considered as the counterpole to the Hypomanic Check List (HCL-32). METHODS: Principal component analysis (PCA) without rotation was used to identify...... than one major depressive episode without hypomanic or manic episodes). They were all outpatients, but had recently been discharged from inpatient treatment. The PCA identified two contrasting factors: 17 items with negative loadings (psychasthenic depression factor) and 15 items with positive loadings...

  2. Validation of survey information on smoking and alcohol consumption against import statistics, Greenland 1993–2010

    Directory of Open Access Journals (Sweden)

    Peter Bjerregaard

    2013-03-01

    Full Text Available Background. Questionnaires are widely used to obtain information on health-related behaviour, and they are more often than not the only method that can be used to assess the distribution of behaviour in subgroups of the population. No validation studies of reported consumption of tobacco or alcohol have been published from circumpolar indigenous communities. Objective. The purpose of the study is to compare information on the consumption of tobacco and alcohol obtained from 3 population surveys in Greenland with import statistics. Design. Estimates of consumption of cigarettes and alcohol using several different survey instruments in cross-sectional population studies from 1993–1994, 1999–2001 and 2005–2010 were compared with import statistics from the same years. Results. For cigarettes, survey results accounted for virtually the total import. Alcohol consumption was significantly under-reported with reporting completeness ranging from 40% to 51% for different estimates of habitual weekly consumption in the 3 study periods. Including an estimate of binge drinking increased the estimated total consumption to 78% of the import. Conclusion. Compared with import statistics, questionnaire-based population surveys capture the consumption of cigarettes well in Greenland. Consumption of alcohol is under-reported, but asking about binge episodes in addition to the usual intake considerably increased the reported intake in this population and made it more in agreement with import statistics. It is unknown to what extent these findings at the population level can be inferred to population subgroups.

  3. Sleep syncope: Important clinical associations with phobia and vagotonia

    NARCIS (Netherlands)

    Busweiler, L.; Jardine, D. L.; Frampton, C. M.; Wieling, W.

    2010-01-01

    Objectives: To compare demographic and clinical data from patients with sleep syncope to those of patients with "classical" vasovagal syncope [VVS] collected over the last 8 years. Design: Retrospective case-controlled study. Setting: Syncope unit. Patients and methods: Fifty-four patients with a

  4. Minimal Clinically Important Differences of Three Patient-Rated Outcomes Instruments

    Science.gov (United States)

    Sorensen, Amelia; Howard, Daniel; Hui Tan, Wen; Ketchersid, Jeffrey; Calfee, Ryan P.

    2013-01-01

    Purpose Patient-rated instruments are increasingly used to measure orthopaedic outcomes. However, the clinical relevance of modest score changes on such instruments is often unclear. This study was designed to define the minimal clinically important differences (MCID) of the Disabilities of the Arm, Shoulder, and Hand (DASH), QuickDASH, and Patient Rated Wrist Evaluation (PRWE) for atraumatic conditions of the hand, wrist, and forearm. Methods One hundred two patients undergoing nonoperative treatment for isolated tendonitis, arthritis, or nerve compression syndromes from the forearm to the hand were analyzed prospectively. Patients completed the DASH, Quick DASH (subset of DASH), and PRWE at enrollment, 2 weeks (n=78 used in analysis), and 4 weeks (n=24 used in analysis) after initiating treatment by telephone. Patients reporting clinical improvement each contributed a single data point categorized as no change (n=41), minimal improvement (n=30), or marked improvement (n=31) via a validated anchor-based approach. The minimal clinically important difference was calculated as the mean change score for each outcome measure in the minimal improvement group. Results The MCID (95%CI) for the DASH was 10 (5-15). The MCID for the Quick DASH was 14 (9-20). The MCID was 14 (8-20) for the PRWE. MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement. MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores. Discussion Longitudinal changes on the DASH of 10 points, the Quick DASH of 14 points, and the PRWE of 14 points represent minimal clinically important changes. We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients. These MCID values may provide a basis for sample size calculations for future

  5. [Medication and bone metabolism: Clinical importance for fracture treatment].

    Science.gov (United States)

    Barvencik, F

    2015-12-01

    The improvement and acceleration of fracture healing has been a component of medical practice since fractures have been treated. The aim is not only to fulfill the basic principles of fracture healing, such as reduction, retention, soft tissue coverage and infection prevention but also to reduce negative influences on fracture healing and promote positive factors. Nicotine, alcohol, diabetes and malnutrition can negatively affect fracture healing and should be appropriately controlled during fracture treatment; however, it is far more difficult to develop medicinal treatment strategies that lead to improvement and acceleration of fracture healing. This article provides an overview of pharmacological factors influencing fracture healing. In addition, substances frequently used in clinical practice will be evaluated in terms of the effects on fracture healing processes. An extensive literature search was conducted in PubMed based on thematic keywords. The selection of studies and scientific publications focused mainly on results from clinical trials in order to provide practically relevant information. In this context, preclinical studies have identified several drugs that lead to the acceleration of fracture healing; however, only a very limited number of clinical trials have confirmed this positive effect. Most of these studies dealt with drugs developed for the treatment of osteoporosis, as osteoporotic fractures are common and a positive or negative influence of such drugs are of particular interest in this field. In the field of osteoporosis medication a certain degree of positive effect of parathyroid hormone 1-34 (PTH) on fracture healing has been shown in clinical trials. For other osteoporosis medications no negative influence on fracture healing in clinical settings has been reported; however, there seems to be a positive effect in terms of better implant fixation for patients receiving oral bisphosphonate therapy. Systemic medication to improve fracture

  6. [Recurrent clinical mastitis in dairy cattle - importance and causes].

    Science.gov (United States)

    Grieger, A-S; Zoche-Golob, V; Paduch, J-H; Hoedemaker, M; Krömker, V

    2014-01-01

    Clinical mastitis as a frequently recurrent event can cause substantive economic loss on dairy farms. The reason for recurrent mastitis can be either a persistent infection of the bovine mammary gland by a mastitis pathogen or a reinfection of a quarter or udder after bacteriological cure. The virulence properties of a mastitis pathogen and the cure odds of an individual cow determine the development of persistent infections. Clinical episodes may alternate with periods without symptoms in the course of persistent infections. Strategies to reduce cases of recurrent mastitis have to include improved treatment concepts and measures to decrease new infection rates. The present literature review summarises the knowledge of definitions, frequencies, causes and effects of recurrent mastitis.

  7. Clinical validation of simultaneous dual-isotope myocardial scintigraphy

    Energy Technology Data Exchange (ETDEWEB)

    Weinmann, Pierre; Moretti, Jean Luc [Department of Nuclear Medicine, Avicenne Hospital, Paris XIII University, 125, Rue de Stalingrad, 93 009 Bobigny Cedex (France); Faraggi, Marc [Department of Nuclear Medicine, Bichat Hospital, Paris VII University (France); Hannequin, Pascal [Centre d' Imagerie Nucleaire, Annecy (France)

    2003-01-01

    Simultaneous dual-isotope (rest thallium-201/stress technetium-99m sestamibi) myocardial single-photon emission tomography (SPET) would be an ideal procedure; however, {sup 99m}Tc cross-talk on the {sup 201}Tl window hampers its routine use. Photon energy recovery (PER) is a spectral deconvolution technique validated for scatter and cross-talk removal in phantom studies and a limited series of patients. In this study we aimed to validate the technique in 295 patients within a context of clinical routine practice. Conventional separate rest {sup 201}Tl myocardial SPET data sets were visually compared with simultaneous dual-isotope data sets corrected by PER. Conventional separate rest {sup 201}Tl data sets were identical to dual PER-corrected {sup 201}Tl data sets in 173 (58.6%) patients. As dual PER {sup 201}Tl data sets are corrected for {sup 99m}Tc cross-talk but also for {sup 201}Tl scatter, they were compared with separate rest {sup 201}Tl data sets corrected by PER in the 122 discordant patients. No difference was found in 77 (26.1%) patients. In 26 (8.8%) patients, the difference consisted in the presence of a defect on dual PER {sup 201}Tl data sets only, mirroring an ischaemic defect on {sup 99m}Tc-sestamibi data sets. This difference can be attributed to the influence of stress on the kinetics of {sup 201}Tl injected at rest. In the remaining 19 (6.4%) patients, the difference between separate and simultaneous PER-corrected data sets was scored as mild in 11 and moderate in eight patients and seemed to be related to multiple methodological factors. It is concluded that PER correctly removes {sup 99m}Tc cross-talk. With the addition of an appropriate attenuation correction, the PER technique may allow the routine use of simultaneous dual-isotope myocardial scintigraphy in the near future. (orig.)

  8. Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

    Directory of Open Access Journals (Sweden)

    van den Berg JWK

    2006-04-01

    Full Text Available Abstract Background Patient-reported outcomes (PRO questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID. This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM. Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4.

  9. Clinical and diagnostic importance of proteinuria: A review | Oni ...

    African Journals Online (AJOL)

    A continual function of the kidney is essential to good health playing active roles in urine formation. Under normal physiological state urine is expected to be protein free. The production of protein free urine is exclusively carried out by the kidney nephrons. Nephrons are structured to perform an important role of filtration and ...

  10. Clinical importance of Demodex folliculorum in patients receiving phototherapy.

    Science.gov (United States)

    Kulac, Mustafa; Ciftci, Ihsan Hakki; Karaca, Semsettin; Cetinkaya, Zafer

    2008-01-01

    Patients with immunodeficiency are prone to infestation with Demodex folliculorum mites. Ultraviolet (UV) radiation can lead to immunosuppression and sebaceous gland hyperplasia. Although some cases of demodicidosis related to UV radiation exposure have been reported, no studies have been performed on the incidence of D. folliculorum and its clinical characteristics in patients receiving phototherapy. Objective To investigate the effects of phototherapy on the density of D. folliculorum infestation and its clinical characteristics. This was a cross-sectional study. Forty-five patients receiving phototherapy and 43 age- and sex-matched healthy controls were enrolled to the study. The sociodemographic characteristics, occupational information, and skin types (2, 3, 4, or 5) of both patients and controls were carefully recorded. The dermatologic diseases requiring phototherapy, type and number of phototherapy treatments, and cumulative UV doses of all patients were noted. The clinical findings that may relate to demodicidosis were recorded. Standardized skin surface biopsies were taken from three anatomic regions (forehead, cheek, and nasal dorsum) and suspected lesions; five or more D. folliculorum mites per square centimeter of skin was defined as demodicidosis. Twelve (26.7%) patients received psoralen plus UV-A (PUVA) and 33 (73.3%) received narrow-band UV-B. Demodicidosis was detected in 13 (28.9%) patients and three (7%) controls. The difference in the demodicidosis rate between patients and controls was statistically significant (P = 0.01). In eight of the 13 patients (61.5%) with demodicidosis, clinical demodicidosis was present. Demodicidosis was present in seven of the 12 patients (58.3%) receiving PUVA and in six of the 33 patients (18.2%) receiving narrow-band UV-B. The difference in demodicidosis rates between patients receiving PUVA and those receiving narrow-band UV-B was statistically significant (P = 0.02). A statistically significant difference was

  11. Clinical validation and calibration of in vitro peroxide tooth whitening.

    Science.gov (United States)

    Putt, Mark S; Moore, Michael H; Milleman, Jeffery L; Milleman, Kimberly R; Thong, Stephen H; Vorwerk, Linda M; Charig, Andrew J; Nelson, Bruce J; Winston, Anthony E

    2009-01-01

    The purpose of this study was to validate and calibrate an in vitro test method for screening the performance of peroxide-containing toothpastes against actual clinical whitening performance. An additional objective was to estimate the whitening performance of a new peroxide-additive gel using the in vitro methodology. A one-month longitudinal clinical study was performed to provide a benchmark for the in vivo intrinsic whitening performance of a peroxide-containing fluoride toothpaste. An in vitro study was then conducted, using freshly prepared slurries of the same peroxide-containing toothpaste in artificial saliva, to repeatedly treat extracted human teeth with natural intrinsic stain. The effect of cumulative treatment time on whiteness was determined using objective chromometer whiteness measurements (L*, a*, and b*), and more subjective Vita Shade guide (Vitapan) comparisons, and the results were correlated. A non-peroxide fluoride toothpaste was used as a negative control. The peroxide gel additive, combined in a 1:1 ratio with each of two non-peroxide toothpastes and diluted in artificial saliva, was evaluated using the same instrumental and subjective measures for in vitro whitening efficacy. The previously evaluated peroxide toothpaste and one of the non-peroxide toothpastes were used as positive and negative controls, respectively. In the clinical study, the peroxide-containing toothpaste produced a linear increase in tooth whiteness with time, achieving an approximately two Vita Shade guide improvement in whiteness at the end of four weeks. The same peroxide toothpaste in vitro produced a curvilinear increase in tooth whiteness versus cumulative treatment time, with a two-shade increase being achieved in 116 minutes. The non-peroxide control toothpaste produced less than half a shade guide increase in whiteness within the first 30 minutes, and none thereafter. Both the clinical and in vitro studies indicated that further whitening can be obtained with

  12. Examples for the importance of radiophysical measurements in clinical phototherapy.

    Science.gov (United States)

    Schneider, Lars Alexander; Wlaschek, Meinhard; Dissemond, Joachim; Scharffetter-Kochanek, Karin

    2007-05-01

    Optimal UV therapy requires regular surveillance of the variables that influence therapeutic success. In daily practice, phototherapy equipment is often operated with an attitude of "autocontrol." This implies that thorough control measurements of the emission spectra and calibration of UV fluences are not routinely performed. For both quality control and patient safety, it is essential to regularly check whether a UV source is providing the right target spectrum with the correct dose to the skin. We have exemplarily taken three UV sources currently used in clinical practice and performed radiophysical measurements, i. e. determined emission spectra, radiation output and correctness of dose calculation. All three sources revealed either a largely inhomogeneous distribution pattern of radiation intensity, variation of radiation intensity over time or insufficient filtering of the UV lamp emission spectrum. Furthermore the dose calculation procedures had to be revised because of significant differences between the estimated and the administered UV doses. Radiophysical measurement of all UV-equipment in clinical use is a simple and effective way to improve the safety and reliability of phototherapy. Such measurements help to uncover technical flaws in radiation sources and prevent unnecessary side effects and UV exposure risks for the patient.

  13. Mammary field cancerization: molecular evidence and clinical importance.

    Science.gov (United States)

    Heaphy, Christopher M; Griffith, Jeffrey K; Bisoffi, Marco

    2009-11-01

    The term "field cancerization" originally denoted the presence of histologically abnormal tissue/cells surrounding primary tumors of the head and neck. Similar concepts with different and continuously changing definitions have been used for other types of tumors including breast adenocarcinoma, where field cancerization presently denotes the occurrence of molecular alterations in histologically normal tissues surrounding areas of overt cancer. Human mammary tissue morphology lends itself to the proposed concepts of field cancerization, which may include the gradual accumulation of genetic and other aberrations in stationary epithelial cells with intact morphology, or the spread of histologically normal yet genetically aberrant epithelial cells within mammary tissue. In this report, we review published molecular genetic, epigenetic, and gene expressional data in support of field cancerization in human mammary tissues. We then discuss the clinical implications of mammary field cancerization, including its source for potential biomarkers with diagnostic/prognostic potential, and its relationship to surgical margins and disease recurrence. We conclude with a future outlook on further research on mammary field cancerization addressing experimental methods, as well as the development of possible models and integrated approaches to gain a better understanding of the underlying mechanisms with the ultimate goal of developing clinical applications.

  14. [Imported malaria: a clinical and epidemiological description of 49 cases].

    Science.gov (United States)

    Tomás, S; Torne, J; García-Conesa, J; Garcés, J M

    1989-10-01

    Malaria is the most common protozoan infection in the world. In 1964, it was considered eradicated in our country, all the new cases being declared as imported, the present migratory and tourism factors obviously having increased the incidence. We analyzed 49 cases of imported malaria diagnosed at "Hospital de Mar" in Barcelona between 1976 and 1987. 14 patients were emigrants from endemic areas. Africa as the continent (73.4%), and equatorial Guinea as the country (44.8%) being the geographical areas most frequently found as sources of the cases. Only 40% of tourists took chemoprophylaxis measures and only half of them did it correctly. The most usual plasmodium found was the P. Falciparum (21 cases). The conclusion is evident, it is necessary to create a greater awareness in our area, improving the information for travellers to tropical countries applying sanitary controls to immigrants who come from endemic areas.

  15. Methods for Cultivation of Luminal Parasitic Protists of Clinical Importance

    Science.gov (United States)

    Clark, C. Graham; Diamond, Louis S.

    2002-01-01

    Cultivation of luminal protistan parasites has a long history. In this review we discuss the methods and media that are most widely used for the establishment and maintenance of the following organisms in culture: Entamoeba histolytica, Giardia intestinalis, Trichomonas vaginalis, Dientamoeba fragilis, Blastocystis hominis, and Balantidium coli. While cultivation is of limited importance in the diagnostic laboratory, it is essential to most research laboratories, and it is toward the latter that this review is primarily aimed. PMID:12097242

  16. Assessing Aggressive Behavior in Forensic Psychiatric Patients: Validity and Clinical Utility of Combining Two Instruments

    NARCIS (Netherlands)

    Kobes, M.H.B.M.; Nijman, H.L.I.; Bulten, B.H.

    2012-01-01

    Objectives Accurate observation of aggressive behavior among forensic psychiatric patients requires valid instruments. This study examines the validity and clinical utility of combining the social dysfunction and aggression scale (SDAS) and staff observation aggression scale revised

  17. CLINICAL IMPORTANCE OF INTERLEUKIN-4 IN SYSTEMIC SCLERODERMA

    Directory of Open Access Journals (Sweden)

    T A Nevskaya

    2002-01-01

    Full Text Available The aim of the study was to investigate whether serum levels of interleukin-4 ( IL-4 reflects the clinical disease status and laboratory features of systemic sclerosis (SSc. IL-4 was measured by ELISA in forty patients wilh SSc. We revealed IL-4 (Ю-lOOOpg/ml in sera from 12 of 40 pts (30%. These pts had significantly less duration of disease, the progression of skin and visceral involvement by the time of investigation and a trend lo the greater frequency of lung fibrosis. There was no correlation of IL-4 level with type of SSc. The pts with increased scrum levels of IL-4 had higher levels of circulated immune complexes, y-globulins, but the levels of acute phase reactants (CRP, fibrinogen were lower compared with the of others. We suggest that serum IL-4 may serve a biologic marker for the progression of skin and lung fibrosis, but the results require confirmation in longitudinal study.

  18. The increasing clinical importance of alloantibodies in kidney transplantation.

    Science.gov (United States)

    Pankewycz, Oleh; Soliman, Karim; Laftavi, Mark R

    2014-01-01

    Historically, cellular rather than humoral immunity has gathered the most attention in kidney transplantation. As the specter of cellular acute rejection and early graft loss has faded due to the availability of highly effective immunosuppressive therapy, scientific and clinical studies now focus on improving long-term graft survival. It is increasingly appreciated that alloantibodies directed against HLA and non-HLA antigens are key factors in determining graft longevity. Significant efforts are now being made to better understand the critical impact that B cells and alloantibodies make on organ allocation and graft survival. Future therapies directed specific for the humoral alloresponse will undoubtedly lead to improved outcomes after kidney transplantation. This review will cover some of the advances in the understanding and management of the continuum of humoral immunity in renal transplantation in the pre, peri and post-transplant periods.

  19. What is clinical leadership…and why is it important?

    Science.gov (United States)

    Swanwick, Tim; McKimm, Judy

    2011-03-01

    The 'invitation' for clinicians to participate in leadership practices, previously considered the province of the professional health service manager, is driven by a number of international policy and professional agendas. This article, the first in a short series, considers definitions and theories of clinical leadership and management, and explores leadership roles and responsibilities of the clinician in terms of levels of engagement. Recent developments in the UK's National Health Service (NHS), the largest health care organisation in the world, are used as illustrations of how theory has informed clinical leadership development. Narrative review and discussion. The tensions arising from the situation of health care professionals within managed health care are described. Leadership is defined alongside its relationship to management. Key theories of leadership are considered and applications of theory to practice explored. The role and usefulness of the 'competency framework' in leadership development is debated. Health care is delivered by complex systems often involving large numbers of individuals and organisations. The effective clinician needs to understand these pathways and systems of care if they are to be able to function effectively, and must be comfortable working both within, and with, these systems for the benefit of their patients. Engaging in leading and managing systems of health care, on whatever scale - team, department, unit, hospital or health authority - is therefore a professional obligation of all clinicians. Just as leadership is argued to be necessary 'at all levels', so 'leadership development', assessment and feedback must be provided throughout the education and training of health professionals. © Blackwell Publishing Ltd 2011.

  20. Big Data Clinical Research: Validity, Ethics, and Regulation.

    Science.gov (United States)

    Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne

    2015-01-01

    Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

  1. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference

    NARCIS (Netherlands)

    Schram, M. E.; Spuls, Ph I.; Leeflang, M. M. G.; Lindeboom, R.; Bos, J. D.; Schmitt, J.

    2012-01-01

    Background: Demonstration of adequate reliability and validity is sufficient for concluding that an instrument is applicable for descriptive and predictive purposes, but before we can confidently use an outcome measure in clinical trials, the responsiveness (synonymous with sensitivity to change)

  2. Clinical Importance of the Heel Drop Test and a New Clinical Score for Adult Appendicitis

    Science.gov (United States)

    Ahn, Shin; Lee, Hyeji; Choi, Wookjin; Ahn, Ryeok; Hong, Jung-Suk; Sohn, Chang Hwan; Seo, Dong Woo; Lee, Yoon-Seon; Lim, Kyung Soo; Kim, Won Young

    2016-01-01

    Objective We tried to evaluate the accuracy of the heel drop test in patients with suspected appendicitis and tried to develop a new clinical score, which incorporates the heel drop test and other parameters, for the diagnosis of this condition. Methods We performed a prospective observational study on adult patients with suspected appendicitis at two academic urban emergency departments between January and August 2015. The predictive characteristics of each parameter, along with heel drop test results were calculated. A composite score was generated by logistic regression analysis. The performance of the generated score was compared to that of the Alvarado score. Results Of the 292 enrolled patients, 165 (56.5%) had acute appendicitis. The heel drop test had a higher predictive value than rebound tenderness. Variables and their points included in the new (MESH) score were pain migration (2), elevated white blood cell (WBC) >10,000/μL (3), shift to left (2), and positive heel drop test (3). The MESH score had a higher AUC than the Alvarado score (0.805 vs. 0.701). Scores of 5 and 11 were chosen as cut-off values; a MESH score ≥5 compared to an Alvarado score ≥5, and a MESH score ≥8 compared to an Alvarado score ≥7 showed better performance in diagnosing appendicitis. Conclusion MESH (migration, elevated WBC, shift to left, and heel drop test) is a simple clinical scoring system for assessing patients with suspected appendicitis and is more accurate than the Alvarado score. Further validation studies are needed. PMID:27723842

  3. Local anesthetics: dentistry's most important drugs, clinical update 2006.

    Science.gov (United States)

    Malamed, Stanley F

    2006-12-01

    Local anesthetics are the safest most effective drugs in medicine for the control and management of pain. They also represent the most important drugs in dentistry. Today, dentistry has a spectrum of local anesthetics that permit pain control to be tailored to the specific needs of the patient: short-, intermediate-, and long-acting drugs. Bupivacaine has become a standard part of the armamentarium for postsurgical pain control while articaine has become the second-most used local anesthetic in the United States since its introduction in 2000. Despite an increase in anecdotal reports of paresthesia since articaine's introduction there is yet, no supporting scientific evidence.

  4. Bone biology in the elderly: clinical importance for fracture treatment

    Directory of Open Access Journals (Sweden)

    Rolvien Tim

    2016-12-01

    Full Text Available Age-related bone impairment often leads to fragility fractures in the elderly. Although excellent surgical care is widely provided, diagnosis and treatment of the underlying bone disorder are often not kept in mind. The interplay of the three major bone cells – osteoblasts, osteoclasts, and osteocytes – is normally well regulated via the secretion of messengers to control bone remodeling. Possible imbalances that might occur in the elderly are partly due to age, genetic risk factors, and adverse lifestyle factors but importantly also due to imbalances in calcium homeostasis (mostly due to vitamin D deficiency or hypochlorhydria, which have to be eliminated. Therefore, the cooperation between the trauma surgeon and the osteologist is of major importance to diagnose and treat the respective patients at risk. We propose that any patient suffering from fragility fractures is rigorously screened for osteoporosis and metabolic bone diseases. This includes bone density measurement by dual-energy X-ray absorptiometry, laboratory tests for calcium, phosphate, vitamin D, and bone turnover markers, as well as additional diagnostic modalities if needed. Thereby, most risk factors, including vitamin D deficiency, can be identified and treated while patients who meet the criteria for a specific therapy (i.e. antiresorptive and osteoanabolic receive such. If local health systems succeed to manage this process of secondary fracture prevention, morbidity and mortality of fragility fractures will decline to a minimum level.

  5. Perceived Importance of Marijuana to the College Experience Scale (PIMCES): Initial Development and Validation.

    Science.gov (United States)

    Pearson, Matthew R; Kholodkov, Tatyana; Gray, Matt J

    2017-03-01

    Internalization of college substance use culture refers to the degree to which an individual perceives the use of that substance to be an integral part of the college experience. Although there is a growing literature characterizing this construct for alcohol, the present study describes the development and validation of a new measure to assess the internalization of the college marijuana use culture, the Perceived Importance of Marijuana to the College Experience Scale (PIMCES). We recruited a large, diverse sample (N = 8,141) of college students from 11 participating universities. We examined the psychometric properties of the PIMCES and evaluated its concurrent validity by examining its associations with marijuana-related outcomes. A single-factor, eight-item PIMCES demonstrated good model fit and high internal consistency (Cronbach's α = .89) and was correlated with marijuana user status, frequency of marijuana use, marijuana consequences, and injunctive norms. Overall, the PIMCES exhibits sound psychometric properties. The PIMCES can serve as a possible mediator of the effects of personality and other factors on marijuana-related outcomes and may be a promising target for marijuana interventions.

  6. Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

    Directory of Open Access Journals (Sweden)

    Vollmar Horst C

    2006-12-01

    Full Text Available Abstract Background It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. Methods The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. Results A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemised and transformed into a questionnaire format. Conclusion The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

  7. Clinical importance of cystic fibrosis-related diabetes.

    Science.gov (United States)

    Brennan, Amanda L; Geddes, Duncan M; Gyi, Khin M; Baker, Emma H

    2004-12-01

    The prevalence of cystic fibrosis-related diabetes (CFRD) and glucose intolerance (IGT) has risen dramatically over the past 20 years as survival has increased for people with cystic fibrosis (CF). Diabetes is primarily caused by pancreatic damage, which reduces insulin secretion, but glucose tolerance is also modified by factors that alter insulin resistance, such as intercurrent illness and infection. CFRD not only causes the symptoms and micro and macrovascular complications seen in type 1 and type 2 diabetes in the general population, but also is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD, implying that impaired glucose tolerance may be detrimental. Current practice is to screen for changes in glucose tolerance by regular measurement of fasting blood glucose, by oral glucose tolerance test or a combination of these approaches with symptom review and measurement of HbA1C. Treatment is clearly indicated for those with CFRD and fasting hyperglycaemia to control symptoms and reduce complications. As nutrition is critical in people with CF to maintain body mass and lung function, blood glucose should be controlled in CFRD by adjusting insulin doses to the requirements of adequate food intake and not by calorie restriction. It is less clear whether blood glucose control will have clinical benefits in the management of patients with CFRD without fasting hyperglycaemia or with impaired glucose tolerance and further studies are required to establish the best treatment for this patient group.

  8. Polymorphism of human haptoglobin and its clinical importance

    Directory of Open Access Journals (Sweden)

    Vânia Peretti de Albuquerque Wobeto

    2008-01-01

    Full Text Available Haptoglobin (Hp is a plasma glycoprotein, the main biological function of which is to bind free hemoglobin (Hb and prevent the loss of iron and subsequent kidney damage following intravascular hemolysis. Haptoglobin is also a positive acute-phase protein with immunomodulatory properties. In humans, the HP locus is polymorphic, with two codominant alleles (HP1 and HP2 that yield three distinct genotypes/phenotypes (Hp1-1, Hp2-1 and Hp2-2. The corresponding proteins have structural and functional differences that may influence the susceptibility and/or outcome in several diseases. This article summarizes the available data on the structure and functions of Hp and the possible effects of Hp polymorphism in a number of important human disorders.

  9. Are gender differences important for the clinical effects of antidepressants?

    DEFF Research Database (Denmark)

    Hildebrandt, Malene Grubbe; Steyerberg, Ewout Willem; Stage, Kurt Bjerregaard

    2003-01-01

    /day), and moclobemide (400 mg/day). Assessments were performed by using the 17-item Hamilton Depression Rating Scale and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. In a subgroup of 110 patients, weekly measurements of clomipramine plasma concentrations were obtained. Nonparametric statistical tests....... The plasma concentrations of clomipramine were significantly higher for female than for male patients. No gender differences were found in posttreatment Hamilton depression scale scores, nor did the therapeutic effects of treatment depend on gender. Rates of dropout and side effects were similar for men...... and women. No relationship between plasma concentrations, gender, and therapeutic outcome was found. CONCLUSIONS: In a group of patients with major and predominantly melancholic depression, differentiation according to gender was not important in treatment with common antidepressants. Women appeared to have...

  10. Importance of using basic statistics adequately in clinical research

    Directory of Open Access Journals (Sweden)

    Célio Fernando de Sousa Rodrigues

    Full Text Available Abstract Background and objective The inadequate use of basic statistics is the main responsible for scientific article misinterpretation. The purpose of this review article was to review some basic statistical topics to alert authors and readers about the importance of basic statistics proper reporting. Content A bibliographical and cross-sectional study was carried out, which analyzed publications in books and articles in the following databases: SciELO (Scientific Electronic Library Online and PubMed (Available from the National Center for Biotechnology Information. Medical research is not free from the risk of false positive and false negative results due to the choice of statistical tests and presence of small sample sizes. Conclusion Understanding the correct use of basic statistics leads to fewer errors in reporting the results of studies performed and in the interpretation of their conclusions.

  11. Identification and validation of Ifit1 as an important innate immune bottleneck.

    Directory of Open Access Journals (Sweden)

    Jason E McDermott

    Full Text Available The innate immune system plays important roles in a number of disparate processes. Foremost, innate immunity is a first responder to invasion by pathogens and triggers early defensive responses and recruits the adaptive immune system. The innate immune system also responds to endogenous damage signals that arise from tissue injury. Recently it has been found that innate immunity plays an important role in neuroprotection against ischemic stroke through the activation of the primary innate immune receptors, Toll-like receptors (TLRs. Using several large-scale transcriptomic data sets from mouse and mouse macrophage studies we identified targets predicted to be important in controlling innate immune processes initiated by TLR activation. Targets were identified as genes with high betweenness centrality, so-called bottlenecks, in networks inferred from statistical associations between gene expression patterns. A small set of putative bottlenecks were identified in each of the data sets investigated including interferon-stimulated genes (Ifit1, Ifi47, Tgtp and Oasl2 as well as genes uncharacterized in immune responses (Axud1 and Ppp1r15a. We further validated one of these targets, Ifit1, in mouse macrophages by showing that silencing it suppresses induction of predicted downstream genes by lipopolysaccharide (LPS-mediated TLR4 activation through an unknown direct or indirect mechanism. Our study demonstrates the utility of network analysis for identification of interesting targets related to innate immune function, and highlights that Ifit1 can exert a positive regulatory effect on downstream genes.

  12. Identification and Validation of Ifit1 as an Important Innate Immune Bottleneck

    Energy Technology Data Exchange (ETDEWEB)

    McDermott, Jason E.; Vartanian, Keri B.; Mitchell, Hugh D.; Stevens, S.L.; Sanfilippo, Antonio P.; Stenzel-Poore, Mary

    2012-06-20

    The innate immune system plays important roles in a number of disparate processes. Foremost, innate immunity is a first responder to invasion by pathogens and triggers early defensive responses and recruits the adaptive immune system. The innate immune system also responds to endogenous damage signals that arise from tissue injury. Recently it has been found that innate immunity plays an important role in neuroprotection against ischemic stroke through the activation of the primary innate immune receptors, Toll-like receptors (TLRs). Using several large-scale transcriptomic data sets from mouse and mouse macrophage studies we identified targets predicted to be important in controlling innate immune processes initiated by TLR activation. Targets were identified as genes with high betweenness centrality, so-called bottlenecks, in networks inferred from statistical associations between gene expression patterns. A small set of putative bottlenecks were identified in each of the data sets investigated including interferon-stimulated genes (Ifit1, Ifi47, Tgtp and Oasl2) as well as genes uncharacterized in immune responses (Axud1 and Ppp1r15a). We further validated one of these targets, Ifit1, in mouse macrophages by showing that silencing it suppresses induction of predicted downstream genes by lipopolysaccharide (LPS)-mediated TLR4 activation through an unknown direct or indirect mechanism. Our study demonstrates the utility of network analysis for identification of interesting targets related to innate immune function, and highlights that Ifit1 can exert a positive regulatory effect on downstream genes.

  13. Clinical validation of robot simulation of toothbrushing--comparative plaque removal efficacy.

    Science.gov (United States)

    Lang, Tomas; Staufer, Sebastian; Jennes, Barbara; Gaengler, Peter

    2014-07-04

    Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33-47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33-47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing.This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning.

  14. Clinical validation of robot simulation of toothbrushing - comparative plaque removal efficacy

    Science.gov (United States)

    2014-01-01

    Background Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Methods Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33–47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33–47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. Results The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. Conclusions The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing. This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning. PMID:24996973

  15. Cerebellum of the Premature Infant: Rapidly Developing, Vulnerable, Clinically Important

    Science.gov (United States)

    Volpe, Joseph J.

    2009-01-01

    Brain abnormality in surviving premature infants is associated with an enormous amount of neurodevelopmental disability, manifested principally by cognitive, behavioral, attentional, and socialization deficits, most commonly with only relatively modest motor deficits. The most recognized contributing neuropathology is cerebral white matter injury. The thesis of this review is that acquired cerebellar abnormality is a relatively less recognized but likely important cause of neurodevelopmental disability in small premature infants. The cerebellar disease may be primarily destructive (eg, hemorrhage, infarction) or primarily underdevelopment. The latter appears to be especially common and relates to a particular vulnerability of the cerebellum of the small premature infant. Central to this vulnerability are the extraordinarily rapid and complex developmental events occurring in the cerebellum. The disturbance of development can be caused either by direct adverse effects on the cerebellum, especially the distinctive transient external granular layer, or by indirect remote trans-synaptic effects. This review describes the fascinating details of cerebellar development, with an emphasis on events in the premature period, the major types of cerebellar abnormality acquired during the premature period, their likely mechanisms of occurrence, and new insights into the relation of cerebellar disease in early life to subsequent cognitive/behavioral/attentional/socialization deficits. PMID:19745085

  16. The human coronary collateral circulation: development and clinical importance.

    Science.gov (United States)

    Seiler, Christian; Stoller, Michael; Pitt, Bertram; Meier, Pascal

    2013-09-01

    Coronary collaterals are an alternative source of blood supply to myocardium jeopardized by ischaemia. In comparison with other species, the human coronary collateral circulation is very well developed. Among individuals without coronary artery disease (CAD), there are preformed collateral arteries preventing myocardial ischaemia during a brief vascular occlusion in 20-25%. Determinants of such anastomoses are low heart rate and the absence of systemic arterial hypertension. In patients with CAD, collateral arteries preventing myocardial ischaemia during a brief occlusion are present in every third individual. Collateral flow sufficient to prevent myocardial ischaemia during coronary occlusion amounts to one-fifth to one-fourth the normal flow through the open vessel. Myocardial infarct size, the most important prognostic determinant after such an event, is the product of coronary artery occlusion time, area at risk for infarction, and the inverse of collateral supply. Well-developed coronary collateral arteries in patients with CAD mitigate myocardial infarcts and improve survival. Approximately one-fifth of patients with CAD cannot be revascularized by percutaneous coronary intervention or coronary artery bypass grafting. Therapeutic promotion of collateral growth is a valuable treatment strategy in those patients. It should aim at growth of large conductive collateral arteries (arteriogenesis). Potential arteriogenic approaches include the treatment with granulocyte colony-stimulating factor, physical exercise training, and external counterpulsation.

  17. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID).

    Science.gov (United States)

    Wright, Alexis; Hannon, Joseph; Hegedus, Eric J; Kavchak, Alicia Emerson

    2012-08-01

    Minimal clinically important difference (MCID) scores are commonly used by clinicians when determining patient response to treatment and to guide clinical decision-making during the course of treatment. For research purposes, the MCID score is often used in sample size calculations for adequate powering of a study to minimize the false-positives (type 1 errors) and the false-negatives (type 2 errors). For clinicians and researchers alike, it is critical that the MCID score is a valid and stable measure. A low MCID value may result in overestimating the positive effects of treatment, whereas a high MCID value may incorrectly classify patients as failing to respond to treatment when in fact the treatment was beneficial. The wide range of methodologies for calculating the MCID score results in varied outcomes, which leads to difficulties with interpretation and application. This clinimetrics corner outlines key factors influencing MCID estimates and discusses limitations with the use of the MCID in both clinical and research practice settings.

  18. Validation of biomarkers to predict response to immunotherapy in cancer: Volume II - clinical validation and regulatory considerations.

    Science.gov (United States)

    Dobbin, Kevin K; Cesano, Alessandra; Alvarez, John; Hawtin, Rachael; Janetzki, Sylvia; Kirsch, Ilan; Masucci, Giuseppe V; Robbins, Paul B; Selvan, Senthamil R; Streicher, Howard Z; Zhang, Jenny; Butterfield, Lisa H; Thurin, Magdalena

    2016-01-01

    There is growing recognition that immunotherapy is likely to significantly improve health outcomes for cancer patients in the coming years. Currently, while a subset of patients experience substantial clinical benefit in response to different immunotherapeutic approaches, the majority of patients do not but are still exposed to the significant drug toxicities. Therefore, a growing need for the development and clinical use of predictive biomarkers exists in the field of cancer immunotherapy. Predictive cancer biomarkers can be used to identify the patients who are or who are not likely to derive benefit from specific therapeutic approaches. In order to be applicable in a clinical setting, predictive biomarkers must be carefully shepherded through a step-wise, highly regulated developmental process. Volume I of this two-volume document focused on the pre-analytical and analytical phases of the biomarker development process, by providing background, examples and "good practice" recommendations. In the current Volume II, the focus is on the clinical validation, validation of clinical utility and regulatory considerations for biomarker development. Together, this two volume series is meant to provide guidance on the entire biomarker development process, with a particular focus on the unique aspects of developing immune-based biomarkers. Specifically, knowledge about the challenges to clinical validation of predictive biomarkers, which has been gained from numerous successes and failures in other contexts, will be reviewed together with statistical methodological issues related to bias and overfitting. The different trial designs used for the clinical validation of biomarkers will also be discussed, as the selection of clinical metrics and endpoints becomes critical to establish the clinical utility of the biomarker during the clinical validation phase of the biomarker development. Finally, the regulatory aspects of submission of biomarker assays to the U.S. Food and

  19. Clinically important ocular reactions to systemic drug therapy.

    Science.gov (United States)

    Rennie, I G

    1993-09-01

    Many systemically administered drugs produce ocular adverse effects. Fortunately, relatively few are capable of causing significant, irreversible visual impairment. It is the responsibility of every clinician when prescribing systemic therapeutic agents to be aware of potential adverse ocular reactions, to appreciate their significance, and to inform the patient of the potential risks of treatment. In instances where serious adverse reactions relate to the cumulative effects of prolonged treatment, it is the responsibility of the prescribing physician to institute appropriate methods of visual screening. In this respect, it is most important to obtain the necessary individual baseline measurements before treatment is commenced. Chloroquine retinopathy is probably the most feared of all adverse ocular reactions to systemic drug therapy. However, it occurs only rarely if the daily dosage of chloroquine does not exceed 250mg. Regular screening using automated perimetry is mandatory if prolonged therapy is contemplated. Amiodarone almost inevitably produces corneal deposits. These rarely produce symptoms, and resolve upon withdrawal of the drug. Optic neuropathy has recently been described with amiodarone. Systemic anticoagulant therapy may be associated with intraocular hemorrhage in patients with pre-existing disciform macular degeneration, and such agents should be used with caution in affected individuals. Systemic corticosteroids produce posterior subcapsular cataracts in susceptible individuals which may profoundly affect visual acuity. Although elevated intraocular pressure may also result from systemic therapy, the relationship between the pressure rise and development of glaucomatous changes remains unclear. Ethambutol may produce optic neuropathy if the daily dosage exceeds 15 mg/kg. The changes are usually reversible within a few weeks of stopping treatment. High doses of tamoxifen may produce a maculopathy with loss of visual acuity, if given for prolonged

  20. Validation of a clinical leadership qualities framework for managers in aged care: a Delphi study.

    Science.gov (United States)

    Jeon, Yun-Hee; Conway, Jane; Chenoweth, Lynn; Weise, Janelle; Thomas, Tamsin Ht; Williams, Anna

    2015-04-01

    To establish validity of a clinical leadership framework for aged care middle managers (The Aged care Clinical Leadership Qualities Framework). Middle managers in aged care have responsibility not only for organisational governance also and operational management but also quality service delivery. There is a need to better define clinical leadership abilities in aged care middle managers, in order to optimise their positional authority to lead others to achieve quality outcomes. A Delphi method. Sixty-nine experts in aged care were recruited, representing rural, remote and metropolitan community and residential aged care settings. Panellists were asked to rate the proposed framework in terms of the relevance and importance of each leadership quality using four-point Likert scales, and to provide comments. Three rounds of consultation were conducted. The number and corresponding percentage of the relevance and importance rating for each quality was calculated for each consultation round, as well as mean scores. Consensus was determined to be reached when a percentage score reached 70% or greater. Twenty-three panellists completed all three rounds of consultation. Following the three rounds of consultation, the acceptability and face validity of the framework was confirmed. The study confirmed the framework as useful in identifying leadership requirements for middle managers in Australian aged care settings. The framework is the first validated framework of clinical leadership attributes for middle managers in aged care and offers an initial step forward in clarifying the aged care middle manager role. The framework provides clarity in the breadth of role expectations for the middle managers and can be used to inform an aged care specific leadership program development, individuals' and organisations' performance and development processes; and policy and guidelines about the types of activities required of middle managers in aged care. © 2014 John Wiley & Sons Ltd.

  1. Clinical importance of steps taken per day among persons with multiple sclerosis.

    Directory of Open Access Journals (Sweden)

    Robert W Motl

    Full Text Available BACKGROUND: The number of steps taken per day (steps/day provides a reliable and valid outcome of free-living walking behavior in persons with multiple sclerosis (MS. OBJECTIVE: This study examined the clinical meaningfulness of steps/day using the minimal clinically important difference (MCID value across stages representing the developing impact of MS. METHODS: This study was a secondary analysis of de-identified data from 15 investigations totaling 786 persons with MS and 157 healthy controls. All participants provided demographic information and wore an accelerometer or pedometer during the waking hours of a 7-day period. Those with MS further provided real-life, health, and clinical information and completed the Multiple Sclerosis Walking Scale-12 (MSWS-12 and Patient Determined Disease Steps (PDDS scale. MCID estimates were based on regression analyses and analysis of variance for between group differences. RESULTS: The mean MCID from self-report scales that capture subtle changes in ambulation (1-point change in PDSS scores and 10-point change in MSWS-12 scores was 779 steps/day (14% of mean score for MS sample; the mean MCID for clinical/health outcomes (MS type, duration, weight status was 1,455 steps/day (26% of mean score for MS sample; real-life anchors (unemployment, divorce, assistive device use resulted in a mean MCID of 2,580 steps/day (45% of mean score for MS sample; and the MCID for the cumulative impact of MS (MS vs. control was 2,747 steps/day (48% of mean score for MS sample. CONCLUSION: The change in motion sensor output of ~800 steps/day appears to represent a lower-bound estimate of clinically meaningful change in free-living walking behavior in interventions of MS.

  2. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus

    DEFF Research Database (Denmark)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S

    2012-01-01

    The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new...

  3. Construct validity of adolescents' self-reported big five personality traits: importance of conceptual breadth and initial validation of a short measure.

    Science.gov (United States)

    Morizot, Julien

    2014-10-01

    While there are a number of short personality trait measures that have been validated for use with adults, few are specifically validated for use with adolescents. To trust such measures, it must be demonstrated that they have adequate construct validity. According to the view of construct validity as a unifying form of validity requiring the integration of different complementary sources of information, this article reports the evaluation of content, factor, convergent, and criterion validities as well as reliability of adolescents' self-reported personality traits. Moreover, this study sought to address an inherent potential limitation of short personality trait measures, namely their limited conceptual breadth. In this study, starting with items from a known measure, after the language-level was adjusted for use with adolescents, items tapping fundamental primary traits were added to determine the impact of added conceptual breadth on the psychometric properties of the scales. The resulting new measure was named the Big Five Personality Trait Short Questionnaire (BFPTSQ). A group of expert judges considered the items to have adequate content validity. Using data from a community sample of early adolescents, the results confirmed the factor validity of the Big Five structure in adolescence as well as its measurement invariance across genders. More important, the added items did improve the convergent and criterion validities of the scales, but did not negatively affect their reliability. This study supports the construct validity of adolescents' self-reported personality traits and points to the importance of conceptual breadth in short personality measures. © The Author(s) 2014.

  4. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  5. Predictive Validity of DSM-IV Oppositional Defiant and Conduct Disorders in Clinically Referred Preschoolers

    Science.gov (United States)

    Keenan, Kate; Boeldt, Debra; Chen, Diane; Coyne, Claire; Donald, Radiah; Duax, Jeanne; Hart, Katherine; Perrott, Jennifer; Strickland, Jennifer; Danis, Barbara; Hill, Carri; Davis, Shante; Kampani, Smita; Humphries, Marisha

    2011-01-01

    Background: Diagnostic validity of oppositional defiant and conduct disorders (ODD and CD) for preschoolers has been questioned based on concerns regarding the ability to differentiate normative, transient disruptive behavior from clinical symptoms. Data on concurrent validity have accumulated, but predictive validity is limited. Predictive…

  6. The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference.

    Science.gov (United States)

    Nolan, Claire M; Longworth, Louise; Lord, Joanne; Canavan, Jane L; Jones, Sarah E; Kon, Samantha S C; Man, William D-C

    2016-06-01

    The EQ-5D, a generic health status questionnaire that is widely used in health economic evaluation, was recently expanded to the EQ-5D-5L to address criticisms of unresponsiveness and ceiling effect. To describe the validity, responsiveness and minimum important difference of the EQ-5D-5L in COPD. Study 1: The validity of the EQ-5D-5L utility index and visual analogue scale (EQ-VAS) was compared with four established disease-specific health status questionnaires and other measures of disease severity in 616 stable outpatients with COPD. Study 2: The EQ-5D-5L utility index and EQ-VAS were measured in 324 patients with COPD before and after 8 weeks of pulmonary rehabilitation. Distribution and anchor-based approaches were used to estimate the minimum important difference. There were moderate-to-strong correlations between utility index and EQ-VAS with disease-specific questionnaires (Pearson's r=0.47-0.72). A ceiling effect was seen in 7% and 2.6% of utility index and EQ-VAS. Utility index decreased (worsening health status) with indices of worsening disease severity. With rehabilitation, mean (95% CI) changes in utility index and EQ-VAS were 0.065 (0.047 to 0.083) and 8.6 (6.5 to 10.7), respectively, with standardised response means of 0.39 and 0.44. The mean (range) anchor estimates of the minimum important difference for utility index and EQ-VAS were 0.051 (0.037 to 0.063) and 6.9 (6.5 to 8.0), respectively. The EQ-5D-5L is a valid and responsive measure of health status in COPD and may provide useful additional cost-effectiveness data in clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. What should we mean by empirical validation in hypnotherapy: evidence-based practice in clinical hypnosis.

    Science.gov (United States)

    Alladin, Assen; Sabatini, Linda; Amundson, Jon K

    2007-04-01

    This paper briefly surveys the trend of and controversy surrounding empirical validation in psychotherapy. Empirical validation of hypnotherapy has paralleled the practice of validation in psychotherapy and the professionalization of clinical psychology, in general. This evolution in determining what counts as evidence for bona fide clinical practice has gone from theory-driven clinical approaches in the 1960s and 1970s through critical attempts at categorization of empirically supported therapies in the 1990s on to the concept of evidence-based practice in 2006. Implications of this progression in professional psychology are discussed in the light of hypnosis's current quest for validation and empirical accreditation.

  8. Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation

    Directory of Open Access Journals (Sweden)

    Muhammad Miftahussurur

    2016-01-01

    Full Text Available Among the methods developed to detect H. pylori infection, determining the gold standard remains debatable, especially for epidemiological studies. Due to the decreasing sensitivity of direct diagnostic tests (histopathology and/or immunohistochemistry [IHC], rapid urease test [RUT], and culture, several indirect tests, including antibody-based tests (serology and urine test, urea breath test (UBT, and stool antigen test (SAT have been developed to diagnose H. pylori infection. Among the indirect tests, UBT and SAT became the best methods to determine active infection. While antibody-based tests, especially serology, are widely available and relatively sensitive, their specificity is low. Guidelines indicated that no single test can be considered as the gold standard for the diagnosis of H. pylori infection and that one should consider the method’s advantages and disadvantages. Based on four epidemiological studies, culture and RUT present a sensitivity of 74.2–90.8% and 83.3–86.9% and a specificity of 97.7–98.8% and 95.1–97.2%, respectively, when using IHC as a gold standard. The sensitivity of serology is quite high, but that of the urine test was lower compared with that of the other methods. Thus, indirect test validation is important although some commercial kits propose universal cut-off values.

  9. A standardized framework for the validation and verification of clinical molecular genetic tests.

    NARCIS (Netherlands)

    Mattocks, C.J.; Morris, M.A.; Matthijs, G.; Swinnen, E.; Corveleyn, A.; Dequeker, E.; Muller, C.R.; Pratt, V.; Wallace, A.

    2010-01-01

    The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular

  10. External validation of clinical decision rules for children with wrist trauma

    NARCIS (Netherlands)

    Mulders, Marjolein A. M.; Walenkamp, Monique M. J.; Dubois, Bente F. H.; Slaar, Annelie; Goslings, J. Carel; Schep, Niels W. L.

    2017-01-01

    Clinical decision rules help to avoid potentially unnecessary radiographs of the wrist, reduce waiting times and save costs. The primary aim of this study was to provide an overview of all existing non-validated clinical decision rules for wrist trauma in children and to externally validate these

  11. A standardized framework for the validation and verification of clinical molecular genetic tests.

    Science.gov (United States)

    Mattocks, Christopher J; Morris, Michael A; Matthijs, Gert; Swinnen, Elfriede; Corveleyn, Anniek; Dequeker, Els; Müller, Clemens R; Pratt, Victoria; Wallace, Andrew

    2010-12-01

    The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards.

  12. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID)

    National Research Council Canada - National Science Library

    Wright, Alexis; Hannon, Joseph; Hegedus, Eric J; Kavchak, Alicia Emerson

    2012-01-01

    Minimal clinically important difference (MCID) scores are commonly used by clinicians when determining patient response to treatment and to guide clinical decision-making during the course of treatment...

  13. The Importance of Children in Clinical Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... please turn Javascript on. Feature: Medicines for Children The Importance of Children in Clinical Trials Past Issues / ... rare event. Can you point to some of the successes with children from clinical trials research in ...

  14. Differential predictive validity of the Historical, Clinical and Risk Management Scales (HCR-20) for inpatient aggression.

    Science.gov (United States)

    O'Shea, Laura E; Picchioni, Marco M; Mason, Fiona L; Sugarman, Philip A; Dickens, Geoffrey L

    2014-12-15

    The Historical, Clinical and Risk Management Scales (HCR-20) may be a better predictor of inpatient aggression for selected demographic and clinical groups but homogeneity of study samples has prevented definitive conclusions. The aim of this study, therefore, was to test the predictive validity of the HCR-20 as a function of gender, diagnosis, age, and ethnicity while controlling for potential covariates. A pseudo-prospective cohort study (n=505) was conducted in a UK secure/forensic mental health setting using routinely collected data. The HCR-20 predicted aggression better for women than men, and for people with schizophrenia and/or personality disorder than for other diagnostic groups. In women, the presence of the risk management items (R5) was important while men׳s aggression was best predicted solely by current clinical features from the C5 scale. R5 items were better than C5 items for predicting aggression in people with organic and developmental diagnoses. Our data provide additional information on which HCR-20 raters can formulate overall summary judgements about risk for inpatient aggression based on important demographic and clinical characteristics. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. SRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery.

    Science.gov (United States)

    Carreon, Leah Y; Kelly, Michael P; Crawford, Charles H; Baldus, Christine R; Glassman, Steven D; Shaffrey, Christopher I; Bridwell, Keith H

    2018-01-01

    Longitudinal cohort. To determine if the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for the Scoliosis Research Society-22R (SRS22R) domains in patients with degenerative lumbar scoliosis are similar to those in patients with adult spinal deformity (ASD) with fusions extending into the thoracic spine. The MCID and SCB thresholds for the SRS22R domains in patients with ASD and adolescent idiopathic scoliosis have been reported. Patients enrolled in the NIH-sponsored Adult Symptomatic Lumbar Scoliosis (ASLS) trial who underwent surgery and completed the SRS22R preoperative and the SRS30 one-year postoperative were identified. One-year postoperative answers to the last eight questions of the SRS30 were used as anchors to determine the MCID and SCB for the Pain, Appearance, and Activity domains, and the Subscore and Total score using receiver operating characteristic (ROC) curve analysis. The sample population consisted of 147 patients. A total of 132 (89%) were females with a mean age of 59.4 years. There was a statistically significant improvement in all SRS22R scores from preoperative to one-year postoperative. There was also a statistically significant difference in domain scores among the different responses to the anchors. According to the ROC analysis, MCID was 1.17 for Appearance, 0.40 for Activity, 0.60 for Pain, 0.53 for Subscore, and 0.77 for Total; and SCB was 1.67 for Appearance, 0.60 for Activity, 0.62 for Subscore, and 1.11 for Total score. These are similar to previous reports of MCID and SCB thresholds for ASD patients who underwent fusion to the thoracic spine. The MCID and SCB thresholds for the SRS22R domains in patients with adult symptomatic lumbar scoliosis are very similar to the threshold values previously reported for adult deformity patients. Level II. Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

  16. Self-operated endovaginal telemonitoring: a prospective, clinical validation study.

    Science.gov (United States)

    Pereira, Isabel; von Horn, Kyra; Depenbusch, Marion; Schultze-Mosgau, Askan; Griesinger, Georg

    2016-08-01

    To study the comparability of self-operated endovaginal telemonitoring (SOET) with conventional two-dimensional transvaginal sonography (2D-TVS) monitoring during assisted reproductive technology (ART) cycles. Single center, observational, single-blinded cohort study. University-affiliated in vitro fertilization center. A total of 60 women undergoing ART cycles. Explanation, training, and use of SOET system, and measurements of follicular and endometrial diameter with SOET and 2D-TVS. Correlation of the total number of follicles >10 mm measured by SOET versus conventional 2D-TVS. In 16 cases (26.7%) the images were judged unsuitable for analysis. In these excluded cases the body mass index (BMI) was statistically significantly higher (29.3 vs. 24.4 kg/m(2)). The total number of follicles >10 mm was highly similar comparing SOET with conventional 2D-TVS (r = 0.91). For the concordance of whether more than 19 follicles or more than 25 follicles >10 mm were present, we found agreement between the methods in 43 of 44 cases (κ = 0.88) and 43 of 44 cases (κ = 0.85), respectively. For concordance on predefined human chorionic gonadotropin administration criteria, agreement was found in 39 of 44 cases (κ = 0.734). The incidence of SOET videos not suitable for analysis seems to be associated with higher BMI. Otherwise, SOET showed good agreement with conventional 2D-TVS both for follicles and endometrium measurements. More importantly we also found good concordance regarding the cutoffs relevant for clinical decisions. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  17. Measuring perceptions related to e-cigarettes: Important principles and next steps to enhance study validity.

    Science.gov (United States)

    Gibson, Laura A; Creamer, MeLisa R; Breland, Alison B; Giachello, Aida Luz; Kaufman, Annette; Kong, Grace; Pechacek, Terry F; Pepper, Jessica K; Soule, Eric K; Halpern-Felsher, Bonnie

    2018-04-01

    Measuring perceptions associated with e-cigarette use can provide valuable information to help explain why youth and adults initiate and continue to use e-cigarettes. However, given the complexity of e-cigarette devices and their continuing evolution, measures of perceptions of this product have varied greatly. Our goal, as members of the working group on e-cigarette measurement within the Tobacco Centers of Regulatory Science (TCORS) network, is to provide guidance to researchers developing surveys concerning e-cigarette perceptions. We surveyed the 14 TCORS sites and received and reviewed 371 e-cigarette perception items from seven sites. We categorized the items based on types of perceptions asked, and identified measurement approaches that could enhance data validity and approaches that researchers may consider avoiding. The committee provides suggestions in four areas: (1) perceptions of benefits, (2) harm perceptions, (3) addiction perceptions, and (4) perceptions of social norms. Across these 4 areas, the most appropriate way to assess e-cigarette perceptions depends largely on study aims. The type and number of items used to examine e-cigarette perceptions will also vary depending on respondents' e-cigarette experience (i.e., user vs. non-user), level of experience (e.g., experimental vs. established), type of e-cigarette device (e.g., cig-a-like, mod), and age. Continuous formative work is critical to adequately capture perceptions in response to the rapidly changing e-cigarette landscape. Most important, it is imperative to consider the unique perceptual aspects of e-cigarettes, building on the conventional cigarette literature as appropriate, but not relying on existing conventional cigarette perception items without adjustment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference.

    Science.gov (United States)

    Schram, M E; Spuls, Ph I; Leeflang, M M G; Lindeboom, R; Bos, J D; Schmitt, J

    2012-01-01

      Demonstration of adequate reliability and validity is sufficient for concluding that an instrument is applicable for descriptive and predictive purposes, but before we can confidently use an outcome measure in clinical trials, the responsiveness (synonymous with sensitivity to change) and minimal clinically important difference (MCID) should be known. With this study, we aimed to assess responsiveness and MCID of four outcome measures used in atopic eczema: the Severity Scoring of Atopic Dermatitis (SCORAD), the objective SCORAD, Eczema Area and Severity Index (EASI), and the Patient-Oriented Eczema Measure (POEM).   Data of three randomized controlled trials were used. To demonstrate responsiveness, we plotted receiver operating characteristic (ROC) curves. MCID was estimated using mean change scores of patients that showed a relevant improvement. Bland and Altman methods were used to quantify the limits of agreement.   Area under the ROC curve for the SCORAD was 0.70 [95% confidence interval (CI): 0.61-0.78], for the objective SCORAD, 0.73 (95% CI: 0.70-0.77), for the EASI, 0.67 (95% CI: 0.60-0.76), and for the POEM, 0.67 (95% CI: 0.59-0.75). Scores above 0.70 represent a fair responsiveness. The MCID was 8.7 points for the SCORAD, 8.2 for the objective SCORAD, 6.6 for the EASI, and 3.4 for the POEM.   The objective SCORAD and SCORAD showed a fair responsiveness. The MCIDs are an important prerequisite for the interpretation of published eczema trials and for the planning/sample size estimation of future trials. © 2011 John Wiley & Sons A/S.

  19. How are we measuring clinically important outcome for operative treatments in sports medicine?

    Science.gov (United States)

    Nwachukwu, Benedict U; Runyon, R Scott; Kahlenberg, Cynthia A; Gausden, Elizabeth B; Schairer, William W; Allen, Answorth A

    2017-05-01

    Minimal clinically important difference (MCID) and other measures of minimum clinical importance are increasingly recognized as important clinical considerations for evaluating the efficacy of an intervention. As our interpretation of clinical outcome evolves beyond statistical significance, psychometric properties such as MCID will be increasingly important to various stakeholders in the orthopaedic community. The purpose of this study was to: 1) describe the state of clinically important outcome reporting and 2) describe the methods used to derive these psychometric values for sports medicine patients undergoing operative treatments. A review of the MEDLINE database was performed. Studies primarily deriving and reporting clinically important outcome measures for operative interventions in sports medicine were included. Demographic, methodological and psychometric properties of included studies were extracted. Level of Evidence and the Newcastle Ottawa Scale (NOS) were used to assess study quality. Statistical analysis was primarily descriptive. Fifteen studies met inclusion criteria; 10 of the 15 studies were Level II evidence and mean NOS score was 5.3/9. Minimal detectable change (MDC) was the most commonly derived measure of clinical importance, calculated in 53.3% of studies, followed by MCID, calculated in 40.0% of studies. A combination of distribution and anchor-based methods was the most commonly used method to determine clinical importance (N = 7, 46.7%) followed by distribution only (N = 5, 33.3%). Predictors of clinically important change were reported in four studies and were most commonly related to pre-operative functional score. MDC and the MCID are the most commonly reported measures of clinically important outcome after operative treatment in sports medicine. A combination of both distribution and anchor-based methods is commonly used to derive these values. More attention should be paid to reporting outcomes that are clinically important and

  20. Minimal important change and other measurement properties of the Oxford Elbow Score and the Quick Disabilities of the Arm, Shoulder, and Hand in patients with a simple elbow dislocation : Validation study alongside the multicenter FuncSiE trial

    NARCIS (Netherlands)

    G.I.T. Iordens (Gijs); D. den Hartog (Dennis); W.E. Tuinebreijer (Wim); D. Eygendaal (Denise); N.W.L. Schep (Niels); M.H.J. Verhofstad (Michiel); E.M.M. van Lieshout (Esther)

    2017-01-01

    textabstractStudy design: Validation study using data from a multicenter, randomized, clinical trial (RCT). Objectives: To evaluate the reliability, validity, responsiveness, and minimal important change (MIC) of the Dutch version of the Oxford Elbow Score (OES) and the Quick Disabilities of the

  1. Minimal clinically important differences of 3 patient-rated outcomes instruments.

    Science.gov (United States)

    Sorensen, Amelia A; Howard, Daniel; Tan, Wen Hui; Ketchersid, Jeffrey; Calfee, Ryan P

    2013-04-01

    Patient-rated instruments are increasingly used to measure orthopedic outcomes. However, the clinical relevance of modest score changes on such instruments is often unclear. This study was designed to define the minimal clinically important differences (MCIDs) of the Disabilities of the Arm, Shoulder, and Hand (DASH), QuickDASH (subset of DASH), and Patient-Rated Wrist Evaluation (PRWE) questionnaires for atraumatic conditions of the hand, wrist, and forearm. We prospectively analyzed 102 patients undergoing nonoperative treatment for isolated tendinitis, arthritis, or nerve compression syndromes from the forearm to the hand. By phone, patients completed the DASH, QuickDASH, and PRWE at enrollment and at 2 weeks (n = 78 used in the analysis) and 4 weeks (n = 24 used in the analysis) after initiating treatment. Patients reporting clinical improvement each contributed a single data point categorized as no change (n = 41), minimal improvement (n = 30), or marked improvement (n = 31) via a validated anchor-based approach. We calculated the MCID as the mean change score for each outcome measure in the minimal improvement group. The MCID (95% confidence interval) for the DASH was 10 (5-15). The MCID for the QuickDASH was 14 (9-20). The MCID was 14 (8-20) for the PRWE. The MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement. The MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores. Longitudinal changes on the DASH of 10 points, on the QuickDASH of 14 points, and on the PRWE of 14 points represent minimal clinically important changes. We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients. These MCID values may provide a basis for sample size calculations for future investigation using these

  2. Strengthening Clinical Skills Using Peer-Student Validation.

    Science.gov (United States)

    O'Brien, Tara; Talbot, Laura; Santevecchi, Eileen

    2015-01-01

    This study compared nursing students' satisfaction with the peer-student validation (PSV) method for learning basic skills and the traditional method. Students in the PSV group (n = 41) were compared with students in the traditional method group (n = 46) using a posttest survey. The PSV group reported significantly greater improvements in communication with their patients (P skills (P skills laboratory content (P < .04) than the traditional group.

  3. Further validation of the visual analogue scale for irritable bowel syndrome after use in clinical practice.

    Science.gov (United States)

    Bengtsson, Mariette; Persson, Jesper; Sjölund, Kristina; Ohlsson, Bodil

    2013-01-01

    The Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS), a self-rating questionnaire, was designed to measure symptoms and the effect of treatment in patients suffering from irritable bowel syndrome. The aim of this descriptive correlational study was to conduct further psychometric validation after the VAS-IBS had been used in clinical practice, translate it into English, and compare the results with controls. Forty-nine patients with irritable bowel syndrome (median age = 38 years old [range, 18-69 years]) were compared with 90 healthy persons (median age = 44 years old [range, 21-77 years]) who served as controls. The patients with irritable bowel syndrome completed 3 questionnaires: the VAS-IBS, the Gastrointestinal Symptom Rating Scale, and the Perception of Change of Symptoms. Controls completed only the VAS-IBS. Results showed that the VAS-IBS is a valid questionnaire that measures the degree of change of symptoms and discriminates between patients who have irritable bowel syndrome from those who do not. It is important to compare the VAS-IBS among different cultural populations so we suggest that the English version of the VAS-IBS should now be used in English-speaking countries and be further tested for validity and reliability with English-speaking patients.

  4. Health status instruments for patients with COPD in pulmonary rehabilitation : defining a minimal clinically important difference

    NARCIS (Netherlands)

    Alma, Harma; de Jong, Corina; Jelusic, Danijel; Wittmann, Michael; Schuler, Michael; Flokstra-de Blok, Bertine; Kocks, Janwillem; Schultz, Konrad; van der Molen, Thys

    2016-01-01

    The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive

  5. 78 FR 23958 - Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-04-23

    ...), a basic class of controlled substance in schedule II. The company plans to import the listed... Clinical Services, Inc., to import the basic class of controlled substance is consistent with the public... effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure that the company's...

  6. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Science.gov (United States)

    2012-12-21

    ... noroxymorphone (9668), a basic class of controlled substance in schedule II. The company plans to import the... registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance is consistent..., or protocols in effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure...

  7. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-01-25

    ...), a basic class of controlled substance listed in schedule II. The company plans to import the listed... Clinical Services, Inc., to import the basic class of controlled substance is consistent with the public... effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure that the company's...

  8. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Science.gov (United States)

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Minimum Clinically Important Difference: An Outcome Metric... the following public workshop entitled ``Minimum Clinically Important Difference: An Outcome Metric in... number of participants from each organization. If time and space permits, onsite registration on Day 1 of...

  9. A validated gene expression profile for detecting clinical outcome in breast cancer using artificial neural networks.

    Science.gov (United States)

    Lancashire, L J; Powe, D G; Reis-Filho, J S; Rakha, E; Lemetre, C; Weigelt, B; Abdel-Fatah, T M; Green, A R; Mukta, R; Blamey, R; Paish, E C; Rees, R C; Ellis, I O; Ball, G R

    2010-02-01

    Gene expression microarrays allow for the high throughput analysis of huge numbers of gene transcripts and this technology has been widely applied to the molecular and biological classification of cancer patients and in predicting clinical outcome. A potential handicap of such data intensive molecular technologies is the translation to clinical application in routine practice. In using an artificial neural network bioinformatic approach, we have reduced a 70 gene signature to just 9 genes capable of accurately predicting distant metastases in the original dataset. Upon validation in a follow-up cohort, this signature was an independent predictor of metastases free and overall survival in the presence of the 70 gene signature and other factors. Interestingly, the ANN signature and CA9 expression also split the groups defined by the 70 gene signature into prognostically distinct groups. Subsequently, the presence of protein for the principal prognosticator gene was categorically assessed in breast cancer tissue of an experimental and independent validation patient cohort, using immunohistochemistry. Importantly our principal prognosticator, CA9, showed that it is capable of selecting an aggressive subgroup of patients who are known to have poor prognosis.

  10. Construction and Validation of the Clinical Judgment Skill Inventory: Clinical Judgment Skill Competencies That Measure Counselor Debiasing Techniques

    Science.gov (United States)

    Austin, Bryan S.; Leahy, Michael J.

    2015-01-01

    Purpose: To construct and validate a new self-report instrument, the Clinical Judgment Skill Inventory (CJSI), inclusive of clinical judgment skill competencies that address counselor biases and evidence-based strategies. Method: An Internet-based survey design was used and an exploratory factor analysis was performed on a sample of rehabilitation…

  11. Concurrent and predictive validity of physical activity measurement items commonly used in clinical settings--data from SCAPIS pilot study.

    Science.gov (United States)

    Ekblom, Örjan; Ekblom-Bak, Elin; Bolam, Kate A; Ekblom, Björn; Schmidt, Caroline; Söderberg, Stefan; Bergström, Göran; Börjesson, Mats

    2015-09-28

    As the understanding of how different aspects of the physical activity (PA) pattern relate to health and disease, proper assessment is increasingly important. In clinical care, self-reports are the most commonly used assessment technique. However, systematic comparisons between questions regarding concurrent or criterion validity are rare, as are measures of predictive validity. The aim of the study was to examine the concurrent (using accelerometry as reference) and predictive validity (for metabolic syndrome) of five PA questions. A sample of 948 middle-aged Swedish men and women reported their PA patterns via five different questions and wore an accelerometer (Actigraph GT3X) for a minimum of 4 days. Concurrent validity was assessed as correlations and ROC-analyses. Predictive validity was assessed using logistic regression, controlling for potential confounders. Concurrent validity was low-to-moderate (r physical activity pattern. The PHAS and WALK items are proposed for assessment of adherence to PA recommendations. Assessing PA patterns using self-report measures results in methodological problems when trying to predict individual risk for the metabolic syndrome, as the concurrent validity generally was low. However, several of the investigated questions may be useful for assessing risk at a group level, showing better predictive validity.

  12. Recurrent miscarriage is a useful and valid clinical concept

    DEFF Research Database (Denmark)

    Christiansen, Ole B

    2014-01-01

    favorable. Believers of the latter hypothesis think that treatments aimed at the woman may improve pregnancy outcome, but that testing of such treatments in randomized controlled trials is needed. In this article in favor of RM being a specific and useful clinical concept, arguments are advanced......Although epidemiological, clinical and biochemical risk factors are known for recurrent miscarriage (RM), the etiology is mainly unknown. Two main hypotheses dominate: that RM is mainly caused by aneuploid conceptions and other conception errors and that the recurrence rate is explained...

  13. Individualism: a valid and important dimension of cultural differences between nations.

    Science.gov (United States)

    Schimmack, Ulrich; Oishi, Shigehiro; Diener, Ed

    2005-01-01

    Oyserman, Coon, and Kemmelmeier's (2002) meta-analysis suggested problems in the measurement of individualism and collectivism. Studies using Hofstede's individualism scores show little convergent validity with more recent measures of individualism and collectivism. We propose that the lack of convergent validity is due to national differences in response styles. Whereas Hofstede statistically controlled for response styles, Oyserman et al.'s meta-analysis relied on uncorrected ratings. Data from an international student survey demonstrated convergent validity between Hofstede's individualism dimension and horizontal individualism when response styles were statistically controlled, whereas uncorrected scores correlated highly with the individualism scores in Oyserman et al.'s meta-analysis. Uncorrected horizontal individualism scores and meta-analytic individualism scores did not correlate significantly with nations' development, whereas corrected horizontal individualism scores and Hofstede's individualism dimension were significantly correlated with development. This pattern of results suggests that individualism is a valid construct for cross-cultural comparisons, but that the measurement of this construct needs improvement.

  14. Validation of survey information on smoking and alcohol consumption against import statistics, Greenland 1993-2010

    DEFF Research Database (Denmark)

    Bjerregaard, Peter; Becker, Ulrik

    2013-01-01

    Questionnaires are widely used to obtain information on health-related behaviour, and they are more often than not the only method that can be used to assess the distribution of behaviour in subgroups of the population. No validation studies of reported consumption of tobacco or alcohol have been...

  15. Preliminary psychometric validation data for a non-clinical South ...

    African Journals Online (AJOL)

    Normative psychometric test data for computerized neuro-cognitive batteries are scarce in the South African testing literature. The research explores the psychometric test properties of a computerized neuropsychological test battery in a non-clinical South African sample. A non-experimental correlational design was ...

  16. Clinical validation of synthetic brain MRI in children: initial experience

    Energy Technology Data Exchange (ETDEWEB)

    West, Hollie; Leach, James L.; Jones, Blaise V.; Care, Marguerite; Radhakrishnan, Rupa; Merrow, Arnold C.; Alvarado, Enrique; Serai, Suraj D. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States)

    2017-01-15

    The purpose of this study was to determine the diagnostic accuracy of synthetic MR sequences generated through post-acquisition processing of a single sequence measuring inherent R1, R2, and PD tissue properties compared with sequences acquired conventionally as part of a routine clinical pediatric brain MR exam. Thirty-two patients underwent routine clinical brain MRI with conventional and synthetic sequences acquired (22 abnormal). Synthetic axial T1, T2, and T2 fluid attenuation inversion recovery or proton density-weighted sequences were made to match the comparable clinical sequences. Two exams for each patient were de-identified. Four blinded reviewers reviewed eight patients and were asked to generate clinical reports on each exam (synthetic or conventional) at two different time points separated by a mean of 33 days. Exams were rated for overall and specific finding agreement (synthetic/conventional and compared to gold standard consensus review by two senior reviewers with knowledge of clinical report), quality, and diagnostic confidence. Overall agreement between conventional and synthetic exams was 97%. Agreement with consensus readings was 84% (conventional) and 81% (synthetic), p = 0.61. There were no significant differences in sensitivity, specificity, or accuracy for specific imaging findings involving the ventricles, CSF, brain parenchyma, or vasculature between synthetic or conventional exams (p > 0.05). No significant difference in exam quality, diagnostic confidence, or noise/artifacts was noted comparing studies with synthetic or conventional sequences. Diagnostic accuracy and quality of synthetically generated sequences are comparable to conventionally acquired sequences as part of a standard pediatric brain exam. Further confirmation in a larger study is warranted. (orig.)

  17. Clinical reliability and validity of elbow functional assessment in rheumatoid arthritis.

    NARCIS (Netherlands)

    Boer, Y.A. de; Ende, C.H.M. van den; Eygendaal, D.; Jolie, I.M.M.; Hazes, J.M.W.; Rozing, P.M.

    1999-01-01

    OBJECTIVES: (1) To investigate the measurement characteristics of the Hospital for Special Surgery (HSS) and Mayo Clinic elbow assessment instruments, utilizing methodological criteria including feasibility, reliability, validity, and discriminative ability; and (2) to develop an efficient and

  18. Validity, reliability, and feasibility of clinical staging scales in dementia: a systematic review

    DEFF Research Database (Denmark)

    Rikkert, Marcel G M Olde; Tona, Klodiana Daphne; Janssen, Lieneke

    2011-01-01

    New staging systems of dementia require adaptation of disease management programs and adequate staging instruments. Therefore, we systematically reviewed the literature on validity and reliability of clinically applicable, multidomain, and dementia staging instruments. A total of 23 articles desc...

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

    Science.gov (United States)

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

    2012-01-01

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

  20. External validation of a clinical scoring system for the risk of gestational diabetes mellitus

    NARCIS (Netherlands)

    van Leeuwen, M.; Opmeer, B. C.; Zweers, E. J. K.; van Ballegooie, E.; ter Brugge, H. G.; de Valk, H. W.; Visser, G. H. A.; Mol, B. W. J.

    Aim: A prediction rule for gestational diabetes mellitus (GDM) could be helpful in early detection and increased efficiency of screening. A prediction rule by means of a clinical scoring system is available, but has never been validated externally. The aim of this study was to validate the scoring

  1. Rotating-crystal Malaria Diagnosis: Pre-clinical validation

    CERN Document Server

    Orban, Agnes; Prohle, Zsofia; Fulop, Gergely; Zelles, Tivadar; Forsyth, Wasan; Hill, Danika; Schofield, Louis; Mueller, Ivo; Karl, Stephan; Kezsmarki, Istvan

    2013-01-01

    Improving the efficiency of malaria diagnosis is one of the main goals of current malaria research. We have recently developed a magneto-optical (MO) method which allows high-sensitivity detection of malaria pigment (hemozoin) crystals via their magnetically induced rotation in blood. Here, we validate this technique on laboratory derived blood samples infected with \\textit{Plasmodium falciparum}. Using two parasite cultures, the first containing mostly ring stages and the second corresponding to the end of the parasite life cycle, we demonstrate that our novel method can detect parasite densities as low as $\\sim$40 and $\\sim$10\\,parasites per microliter of blood for ring and schizont stage parasites, respectively. This detection limit exceeds the performance of rapid diagnostic tests and competes with the threshold achievable by light microscopic observation of blood smears. Our method can be performed with as little as 50\\,microliter of capillary blood and is sensitive to the presence of hemozoin micro-crys...

  2. An instrument for evaluating clinical teaching in Japan: content validity and cultural sensitivity.

    Science.gov (United States)

    Kikukawa, Makoto; Stalmeijer, Renee E; Emura, Sei; Roff, Sue; Scherpbier, Albert J J A

    2014-08-28

    Many instruments for evaluating clinical teaching have been developed but almost all in Western countries. None of these instruments have been validated for the Asian culture, and a literature search yielded no instruments that were developed specifically for that culture. A key element that influences content validity in developing instruments for evaluating the quality of teaching is culture. The aim of this study was to develop a culture-specific instrument with strong content validity for evaluating clinical teaching in initial medical postgraduate training in Japan. Based on data from a literature search and an earlier study we prepared a draft evaluation instrument. To ensure a good cultural fit of the instrument with the Asian context we conducted a modified Delphi procedure among three groups of stakeholders (five education experts, twelve clinical teachers and ten residents) to establish content validity, as this factor is particularly susceptible to cultural factors. Two rounds of Delphi were conducted. Through the procedure, 52 prospective items were reworded, combined or eliminated, resulting in a 25-item instrument validated for the Japanese setting. This is the first study describing the development and content validation of an instrument for evaluating clinical teaching specifically tailored to an East Asian setting. The instrument has similarities and differences compared with instruments of Western origin. Our findings suggest that designers of evaluation instruments should consider the probability that the content validity of instruments for evaluating clinical teachers can be influenced by cultural aspects.

  3. The Utrecht questionnaire (U-CEP) measuring knowledge on clinical epidemiology proved to be valid.

    Science.gov (United States)

    Kortekaas, Marlous F; Bartelink, Marie-Louise E L; de Groot, Esther; Korving, Helen; de Wit, Niek J; Grobbee, Diederick E; Hoes, Arno W

    2017-02-01

    Knowledge on clinical epidemiology is crucial to practice evidence-based medicine. We describe the development and validation of the Utrecht questionnaire on knowledge on Clinical epidemiology for Evidence-based Practice (U-CEP); an assessment tool to be used in the training of clinicians. The U-CEP was developed in two formats: two sets of 25 questions and a combined set of 50. The validation was performed among postgraduate general practice (GP) trainees, hospital trainees, GP supervisors, and experts. Internal consistency, internal reliability (item-total correlation), item discrimination index, item difficulty, content validity, construct validity, responsiveness, test-retest reliability, and feasibility were assessed. The questionnaire was externally validated. Internal consistency was good with a Cronbach alpha of 0.8. The median item-total correlation and mean item discrimination index were satisfactory. Both sets were perceived as relevant to clinical practice. Construct validity was good. Both sets were responsive but failed on test-retest reliability. One set took 24 minutes and the other 33 minutes to complete, on average. External GP trainees had comparable results. The U-CEP is a valid questionnaire to assess knowledge on clinical epidemiology, which is a prerequisite for practicing evidence-based medicine in daily clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

    Science.gov (United States)

    2015-10-01

    AWARD NUMBER: W81XWH-14-1-0595 TITLE: Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi- Institutional Validation... Institutional Validation Trial 5b. GRANT NUMBER W81XWH-14-1-0595 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Daniel Lin, MD 5d. PROJECT NUMBER 5e. TASK...to report. Other Products As part of this project we continue to maintain a large biospecimen repository with associated clinical and demographic

  5. Danish clinical quality databases – an important and untapped resource for clinical research

    Directory of Open Access Journals (Sweden)

    Sørensen HT

    2016-10-01

    Full Text Available Henrik Toft Sørensen,1 Lars Pedersen,1 Jørgen Jørgensen,2 Vera Ehrenstein11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, 2Danish Regions, Copenhagen, DenmarkThe health care systems in many countries are facing several challenges: the aging population,the need for personalized medicine, evolving treatment modalities, quality andsafety imperatives, and unsustainable costs, to mention only a few. Population aging in the face of significant pressure to contain costs is perhaps the most immediate challenge. The proportion of people aged 65 years or older in Western Europe and North America is expected to increase to 26% in 2025. Furthermore, clinical medicine in the Western world is confronting an evolving set of diseases, as smoking becomes less prevalent and obesity more common. Diagnostics and treatment of chronic disease have improved, while the threshold for initiating preventive treatment of asymptomatic conditions has been lowered. Consequently, the number of patients with multimorbidity, that is, the coexistence of several chronic diseases, will increase dramatically.1 To treat a disease or prevent its progression, patients with several chronic diseases often take multiple drugs, each with potentially severe side effects. In patients with multiple morbidities, “polypharmacy” is a challenging clinical issue, often associated with iatrogenic harm.2 A call for innovative approaches to polypharmacy has been the focus of recent editorials in high-impact medical journals.3–5 Randomized trials rarely address multimorbidity, adherence to treatments, co-intervention (polypharmacy, or their long-term risks.6 These challenges underscore the need for population-based long-term longitudinal clinical data available for clinical care and research.

  6. Assessing clinical probability of pulmonary embolism: prospective validation of the simplified Geneva score.

    Science.gov (United States)

    Robert-Ebadi, H; Mostaguir, K; Hovens, M M; Kare, M; Verschuren, F; Girard, P; Huisman, M V; Moustafa, F; Kamphuisen, P W; Buller, H R; Righini, M; Le Gal, G

    2017-09-01

    Essentials The simplified Geneva score allows easier pretest probability assessment of pulmonary embolism (PE). We prospectively validated this score in the ADJUST-PE management outcome study. The study shows that it is safe to manage patients with suspected PE according to this score. The simplified Geneva score is now ready for use in routine clinical practice. Background Pretest probability assessment by a clinical prediction rule (CPR) is an important step in the management of patients with suspected pulmonary embolism (PE). A limitation to the use of CPRs is that their constitutive variables and corresponding number of points are difficult to memorize. A simplified version of the Geneva score (i.e. attributing one point to each variable) has been proposed but never been prospectively validated. Aims Prospective validation of the simplified Geneva score (SGS) and comparison with the previous version of the Geneva score (GS). Methods In the ADJUST-PE study, which had the primary aim of validating the age-adjusted D-dimer cut-off, the SGS was prospectively used to determine the pretest probability in a subsample of 1621 study patients. Results Overall, PE was confirmed in 294 (18.1%) patients. Using the SGS, 608 (37.5%), 980 (60.5%) and 33 (2%) were classified as having a low, intermediate and high clinical probability. Corresponding prevalences of PE were 9.7%, 22.4% and 45.5%; 490 (30.1%) patients with low or intermediate probability had a D-dimer level below 500 μg L-1 and 653 (41.1%) had a negative D-dimer test according to the age-adjusted cut-off. Using the GS, the figures were 491(30.9%) and 650 (40.9%). None of the patients considered as not having PE based on a low or intermediate SGS and negative D-dimer had a recurrent thromboembolic event during the 3-month follow-up. Conclusions The use of SGS has similar efficiency and safety to the GS in excluding PE in association with the D-dimer test. © 2017 International Society on Thrombosis and

  7. Which clinical signs are valid indicators for speech language disorder?

    OpenAIRE

    Visser-Bochane, Margot I.; Luinge, Margreet R.; Reijneveld, Sijmen A.; Krijnen, W.P.; Schans, van der, C.P.

    2016-01-01

    Speech language disorders, which include speech sound disorders and language disorders, are common in early childhood. These problems, and in particular language problems, frequently go under diagnosed, because current screening instruments have no satisfying psychometric properties. Recent research describes consensus among healthcare professionals on clinical signs of atypical speech language development. The aim of this study is to construct a scale with characteristics from different doma...

  8. What's the DIF? Why Differential Item Functioning Analyses Are an Important Part of Instrument Development and Validation

    Science.gov (United States)

    Walker, Cindy M.

    2011-01-01

    The purpose of this manuscript was to help researchers better understand the causes and implications of differential item functioning (DIF), as well as the importance of testing for DIF in the process of test development and validation. The underlying theoretical reason for the presence of DIF is explicated, followed by a discussion of how to test…

  9. Exploring the clinical validity of predicted TRE in navigation

    Science.gov (United States)

    Bickel, M.; Güler, Ö.; Kral, F.; Schwarm, F.; Freysinger, W.

    2010-02-01

    In a detailed laboratory investigation we performed a series of experiments in order to assess the validity of the widely used TRE concept to predict the application accuracy. On base of 1mm CT scan a plastic skull, a cadaver head and a volunteer were registered to an in house navigation system. We stored the position data of an optical camera (NDI Polaris) for registration with pre-defined CT coordinates. For every specimen we choose 3, 5, 7 and 9 registration and 10 evaluation points, respectively, performing 10 registrations. The data were evaluated both with the Arun and the Horn approaches. The vectorial difference between actual and predefined position in the CT data set was stored and evaluated for FRE and TRE. Evaluation and visualization was implemented in Matlab. The data were analyzed, specifically for normal distribution, with MS Excel and SPSS Version 15.0. For the plastic skull and the anatomic specimen submillimetric application accuracy was found experimentally and confirmed by the calculated TRE. Since for the volunteer no Titanium screws were implanted anatomic landmarks had to be used for registration and evaluation; an application accuracy in the low millimeter regime was found in all approaches. However, the detailed statistical analysis of the data revealed that the model predictions and the actual measurements do not exhibit a strong statistical correlation (p data suggest that the TRE predictions are too optimistic and should be used with caution intraoperatively.

  10. External validation of clinical decision rules for children with wrist trauma.

    Science.gov (United States)

    Mulders, Marjolein A M; Walenkamp, Monique M J; Dubois, Bente F H; Slaar, Annelie; Goslings, J Carel; Schep, Niels W L

    2017-05-01

    Clinical decision rules help to avoid potentially unnecessary radiographs of the wrist, reduce waiting times and save costs. The primary aim of this study was to provide an overview of all existing non-validated clinical decision rules for wrist trauma in children and to externally validate these rules in a different cohort of patients. Secondarily, we aimed to compare the performance of these rules with the validated Amsterdam Pediatric Wrist Rules. We included all studies that proposed a clinical prediction or decision rule in children presenting at the emergency department with acute wrist trauma. We performed external validation within a cohort of 379 children. We also calculated the sensitivity, specificity, negative predictive value and positive predictive value of each decision rule. We included three clinical decision rules. The sensitivity and specificity of all clinical decision rules after external validation were between 94% and 99%, and 11% and 26%, respectively. After external validation 7% to 17% less radiographs would be ordered and 1.4% to 5.7% of all fractures would be missed. Compared to the Amsterdam Pediatric Wrist Rules only one of the three other rules had a higher sensitivity; however both the specificity and the reduction in requested radiographs were lower in the other three rules. The sensitivity of the three non-validated clinical decision rules is high. However the specificity and the reduction in number of requested radiographs are low. In contrast, the validated Amsterdam Pediatric Wrist Rules has an acceptable sensitivity and the greatest reduction in radiographs, at 22%, without missing any clinically relevant fractures.

  11. Clinical importance of personality difficulties: diagnostically sub-threshold personality disorders.

    Science.gov (United States)

    Karukivi, Max; Vahlberg, Tero; Horjamo, Kalle; Nevalainen, Minna; Korkeila, Jyrki

    2017-01-14

    Current categorical classification of personality disorders has been criticized for overlooking the dimensional nature of personality and that it may miss some sub-threshold personality disturbances of clinical significance. We aimed to evaluate the clinical importance of these conditions. For this, we used a simple four-level dimensional categorization based on the severity of personality disturbance. The sample consisted of 352 patients admitted to mental health services. All underwent diagnostic assessments (SCID-I and SCID-II) and filled in questionnaires concerning their social situation and childhood adversities, and other validated tools, including the Beck Depression Inventory (BDI), Alcohol Use Disorders Identification Test (AUDIT), health-related quality of life (15D), and the five-item Mental Health Index (MHI-5). The patients were categorized into four groups according to the level of personality disturbance: 0 = No personality disturbance, 1 = Personality difficulty (one criterion less than threshold for one or more personality disorders), 2 = Simple personality disorder (one personality disorder), and 3 = Complex/Severe personality disorder (two or more personality disorders or any borderline and antisocial personality disorder). The proportions of the groups were as follows: no personality disturbance 38.4% (n = 135), personality difficulty 14.5% (n = 51), simple personality disorder 19.9% (n = 70), and complex/severe personality disorder 24.4% (n = 86). Patients with no personality disturbance were significantly differentiated (p personality disorders stood out as being worst off. Social dysfunction was related to the severity of the personality disturbance. Patients with a personality difficulty or a simple personality disorder had prominent symptoms and difficulties, but the differences between these groups were mostly non-significant. An elevated severity level of personality disturbance is associated with an

  12. Pitfalls in efficacy testing – how important is the validation of neutralization of chlorhexidine digluconate?

    Directory of Open Access Journals (Sweden)

    Heisig Peter

    2008-12-01

    Full Text Available Abstract Background Effective neutralization of active agents is essential to obtain valid efficacy results, especially when non-volatile active agents like chlorhexidine digluconate (CHG are tested. The aim of this study was to determine an effective and non-toxic neutralizing mixture for a propan-1-ol solution containing 2% CHG. Methods Experiments were carried out according to ASTM E 1054-02. The neutralization capacity was tested separately with five challenge microorganisms in suspension, and with a rayon swab carrier. Either 0.5 mL of the antiseptic solution (suspension test or a saturated swab with the antiseptic solution (carrier test was added to tryptic soy broth containing neutralizing agents. After the samples were mixed, aliquots were spread immediately and after 3 h of storage at 2 – 8°C onto tryptic soy agar containing a neutralizing mixture. Results The neutralizer was, however, not consistently effective in the suspension test. Immediate spread yielded a valid neutralization with Staphylococcus aureus, Staphylococcus epidermidis and Corynebacterium jeikeium but not with Micrococcus luteus (p Candida albicans (p Staphylococcus epidermidis (p Corynebacterium jeikeium (p = 0.044. In the carrier test, the neutralizing mixture was found to be effective and non toxic to all challenge microorganisms when spread immediately. However, after 3 h storage of the neutralized active agents significant carry-over activity of CHG against Micrococcus luteus (p = 0.004; Tukey HSD was observed. Conclusion Without effective neutralization in the sampling fluid, non-volatile active ingredients will continue to reduce the number of surviving microorganisms after antiseptic treatment even if the sampling fluid is kept cold straight after testing. This can result in false-positive antiseptic efficacy data. Attention should be paid during the neutralization validation process to the amount of antiseptic solution, the storage time and to the choice of

  13. Clinical Validation of the Nursing Diagnosis Spiritual Distress in Cancer Patients Undergoing Chemotherapy.

    Science.gov (United States)

    Caldeira, Sílvia; Timmins, Fiona; de Carvalho, Emília Campos; Vieira, Margarida

    2017-01-01

    Validate the nursing diagnosis spiritual distress in cancer patients. Cross-sectional approach using Richard Fehring's Clinical Diagnostic Validity Model. The prevalence of diagnosis was 40.8% in a sample of 170 patients. A total of 16 defining characteristics were validated. Expresses suffering had the highest sensitivity value and lack of meaning in life had the highest specificity value. The diagnosis was validated. Cancer patients in spiritual distress are in a state of suffering related to lack of meaning in life. Sensitive diagnosis tools and language are required for nurses to make accurate judgments in situations of spiritual distress. Validation in different contexts would increase the clinical evidence of this diagnosis. © 2015 NANDA International, Inc.

  14. [Validation of the Italian Clinical Learning Environment Instrument (SVIAT):study protocol].

    Science.gov (United States)

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

    2016-01-01

    . Validation of the Italian Clinical Learning Environment Instrument (SVIAT): study protocol. Nursing students obtain most of their university credits in internship environments whose quality can affect their clinical learning. Several tools are available to measure the quality of the clinical learning environment (CLE) as perceived by students: these instruments developed in other countries, were validated in Italian but do not discriminate those CLEs capable (or not) to promote significant clinical learning. To validate an instrument to measure the capability of the CLE to generate clinical learning; the secondary aim is to describe the learning environments as perceived by nursing students according to individual course site and tutorial models adopted. The study will be developed in three phases: a) instrument development and pilot phase, b) validation of the psychometric properties of the instrument and c) description of the CLEs as perceived by the students including factors/item confirmed in the validation process. Expected outcomes. A large validation, with more than 8,000 participating students is expected; the construct under lying will be confirmed through exploratory and confirmatory factor analysis and will report high internal consistency; the instrument will report also a high test-retest and inter-rater reliability; in addition, the instrument will demonstrate predictive ability by discriminating those units able (or not) to activate effective learning processes.

  15. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

    Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

  16. Minimal clinically important difference (MCID)--adding meaning to statistical inference

    National Research Council Canada - National Science Library

    Chan, Linda S

    2013-01-01

    ... A. If the sample size were larger, the width of the CI would be narrower. [...]the width of the confidence interval and its location with respect to the MCID are important considerations in making clinical conclusions...

  17. 78 FR 54913 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Science.gov (United States)

    2013-09-06

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on July 22, 2013, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made...

  18. More than a (negative feeling: Validity of the perceived stress scale in Serbian clinical and non-clinical samples

    Directory of Open Access Journals (Sweden)

    Jovanović Veljko

    2015-01-01

    Full Text Available The goal of the present study was to test the validity of a Serbian version of the Perceived Stress Scale. The PSS was administered to 157 psychiatric outpatients, 165 adults from the non-clinical population, and 283 university students. The results of the confirmatory factor analysis supported a bifactor model of the PSS with one general factor and two specific factors reflecting perceived distress and perceived self-efficacy. Internal consistencies of the scale and its two subscales were adequate across clinical and non-clinical samples. Results supported the ability of the scale to discriminate between clinical and non-clinical samples. The PSS evidenced good convergent validity, showing moderate to high positive correlations with measures of unpleasant emotional states and moderate negative correlations with positive affect and life satisfaction. All but one correlation remained significant after controlling for the measures of emotional distress. The results of the present research support validity of the PSS and its use in both clinical and non-clinical samples. [Projekat Ministarstva nauke Republike Srbije, br. 179006

  19. Validation of the Mayo Clinic Staging System in Determining Prognoses of Patients With Perihilar Cholangiocarcinoma

    NARCIS (Netherlands)

    Coelen, Robert J. S.; Gaspersz, Marcia P.; Labeur, Tim A.; van Vugt, Jeroen L. A.; van Dieren, Susan; Willemssen, François E. J. A.; Nio, Chung Y.; Ijzermans, Jan N. M.; Klümpen, Heinz-Josef; Groot Koerkamp, Bas; van Gulik, Thomas M.

    2017-01-01

    BACKGROUND & AIMS: Most systems for staging perihilar cholangiocarcinoma (PHC) have been developed for the minority of patients with resectable disease. The recently developed Mayo Clinic system for staging PHC requires only clinical and radiologic variables, but has not yet been validated. We

  20. Clinical Scores for Dyspnoea Severity in Children : A Prospective Validation Study

    NARCIS (Netherlands)

    Eggink, Hendriekje; Brand, Paulus; Reimink, Roelien; Bekhof, Jolita

    2016-01-01

    Background In acute dyspnoeic children, assessment of dyspnoea severity and treatment response is frequently based on clinical dyspnoea scores. Our study aim was to validate five commonly used paediatric dyspnoea scores. Methods Fifty children aged 0-8 years with acute dyspnoea were clinically

  1. External validation of clinical decision rules for children with wrist trauma

    NARCIS (Netherlands)

    M.A.M. Mulders (Marjolein A. M.); M.M.J. Walenkamp (Monique); B.F.H. Dubois (Bente F. H.); A. Slaar (Annelie); J.C. Goslings (Carel); N.W.L. Schep (Niels)

    2017-01-01

    textabstractBackground: Clinical decision rules help to avoid potentially unnecessary radiographs of the wrist, reduce waiting times and save costs. Objective: The primary aim of this study was to provide an overview of all existing non-validated clinical decision rules for wrist trauma in children

  2. The Reliability, Validity, and Usefulness of the Objective Structured Clinical Examination (OSCE) in Dental Education

    Science.gov (United States)

    Graham, Roseanna

    2010-01-01

    This study evaluated the reliability, validity, and educational usefulness of a comprehensive, multidisciplinary Objective Structured Clinical Examination (OSCE) in dental education. The OSCE was administered to dental students at the Columbia University College of Dental Medicine (CDM) before they entered clinical training. Participants in this…

  3. Controlling Rater Stringency Error in Clinical Performance Rating: Further Validation of a Performance Rating Theory.

    Science.gov (United States)

    Cason, Gerald J.; And Others

    Prior research in a single clinical training setting has shown Cason and Cason's (1981) simplified model of their performance rating theory can improve rating reliability and validity through statistical control of rater stringency error. Here, the model was applied to clinical performance ratings of 14 cohorts (about 250 students and 200 raters)…

  4. The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

    Science.gov (United States)

    Woodburn, Jim; Sutcliffe, Nick

    1996-01-01

    The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

  5. The subtalar joint axis palpation technique-part 1: validating a clinical mechanical model.

    Science.gov (United States)

    Van Alsenoy, Ken K; De Schepper, Joris; Santos, Derek; Vereecke, Evie E; D'Août, Kristiaan

    2014-05-01

    Locating the position of the subtalar joint axis can be a predictive clinical variable in biomechanical analysis and a valuable tool in the design of functional foot orthoses. Before testing Kirby's palpation technique to locate the subtalar joint axis in cadavers, it was important to develop and test the experimental methods in a mechanical model in which the exact location of the hinge joint can be controlled. Four testers determined the hinge joint location and moved it through its range of motion, capturing the movement of the joint axis using a kinematic model. The joint axis location was determined and validated by comparing the actual hinge joint location on the mechanical model with the location determined by the palpation technique described by Kirby in 1987 and the location determined by the helical joint axis method using three-dimensional kinematic data. The overall angles result in mean slopes and intersections of 87° and 92 mm, 86° and 97 mm, 85° and 92 mm, and 88° and 91 mm for testers 1, 2, 3, and 4, respectively. Testers 1 and 3 were able to determine the location to 1° and 1 mm accuracy, tester 2 to 0° and 4 mm, and tester 4 to 2° and 2 mm compared with the kinematic data. The technique of determining the points of no rotation as described by Kirby could be validated by using a three-dimensional kinematic model to determine the helical axis.

  6. Virtual Reality for Enhanced Ecological Validity and Experimental Control in the Clinical, Affective and Social Neurosciences

    Science.gov (United States)

    Parsons, Thomas D.

    2015-01-01

    An essential tension can be found between researchers interested in ecological validity and those concerned with maintaining experimental control. Research in the human neurosciences often involves the use of simple and static stimuli lacking many of the potentially important aspects of real world activities and interactions. While this research is valuable, there is a growing interest in the human neurosciences to use cues about target states in the real world via multimodal scenarios that involve visual, semantic, and prosodic information. These scenarios should include dynamic stimuli presented concurrently or serially in a manner that allows researchers to assess the integrative processes carried out by perceivers over time. Furthermore, there is growing interest in contextually embedded stimuli that can constrain participant interpretations of cues about a target’s internal states. Virtual reality environments proffer assessment paradigms that combine the experimental control of laboratory measures with emotionally engaging background narratives to enhance affective experience and social interactions. The present review highlights the potential of virtual reality environments for enhanced ecological validity in the clinical, affective, and social neurosciences. PMID:26696869

  7. Clinical Validation of a Test for the Diagnosis of Vaginitis.

    Science.gov (United States)

    Gaydos, Charlotte A; Beqaj, Sajo; Schwebke, Jane R; Lebed, Joel; Smith, Bonnie; Davis, Thomas E; Fife, Kenneth H; Nyirjesy, Paul; Spurrell, Timothy; Furgerson, Dorothy; Coleman, Jenell; Paradis, Sonia; Cooper, Charles K

    2017-07-01

    Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs. We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture. For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3-92.2%) and specificity was 85.8% (95% CI 83.0-88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1-93.1%) and specificity was 94

  8. Initial Validation of the Sexual Pleasure Scale in Clinical and Non-Clinical Samples of Partnered Heterosexual People.

    Science.gov (United States)

    Pascoal, Patrícia M; Sanchez, Diana T; Raposo, Catarina Fonseca; Pechorro, Pedro

    2016-09-01

    Sexual pleasure is a central aspect of human sexuality; however, no validated measurements exist that assess sexual pleasure. We present a preliminary validation study of the psychometric properties of a Sexual Pleasure Scale (SPS), based on the three items developed by Sanchez, Crocker and Boike to measure sexual pleasure. The SPS is a brief and easy-to-implement instrument that assesses the extent of sexual pleasure experienced from sexual relationships, sexual activities, and sexual intimacy. To assess the validity of the SPS in a subgroup of patients diagnosed with sexual dysfunction (n = 89) and a non-clinical community sample (n = 188) of Portuguese men and women. We provide an initial examination of the reliability (eg, Cronbach α), convergent validity (eg, with measurements of sexual satisfaction), and divergent validity (eg, with measurements of body satisfaction) of the SPS. The survey included a sociodemographic questionnaire and a set of questionnaires to test the psychometric properties of the SPS. The reliability study showed a high Cronbach value (α = 0.94). Convergent validity of the SPS with the measurements described showed mostly moderate to high statistically significant positive correlations, whereas the criterion-related validity showed the expected low non-significant correlation. The results also showed that the SPS shows strong sensitivity to discriminate people with from those without sexual problems. Results from the clinical population indicate that the SPS has good psychometric qualities and is a reliable measurement of sexual pleasure with applicability in clinical practice and clinical research but shows little variability within the community sample. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  9. Important options available--from start to finish--for translating proteomics results to clinical chemistry.

    Science.gov (United States)

    Heegaard, Niels H H; Østergaard, Ole; Bahl, Justyna M C; Overgaard, Martin; Beck, Hans C; Rasmussen, Lars Melholt; Larsen, Martin R

    2015-02-01

    In the realm of clinical chemistry, the field of clinical proteomics, that is, the application of proteomic methods for understanding mechanisms and enabling diagnosis, prediction, measurement of activity, and treatment response in disease, is first and foremost a discovery and research tool that feeds assay development downstream. Putative new assay candidates generated by proteomics discovery projects compete with well-established assays with known indications, well-described performance, and of known value in specific clinical settings. Careful attention to the many options available in the design, execution, and interpretation of clinical proteomics studies is thus necessary for translation into clinical practice. We here review and discuss important options associated with clinical proteomics endeavors stretching from the planning phases to the final use in clinical chemistry. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Important options available - from start to finish -for translating proteomics results to clinical chemistry

    DEFF Research Database (Denmark)

    Heegaard, Niels H H; Ostergaard, Ole; Bahl, Justyna M C

    2015-01-01

    In the realm of clinical chemistry the field of clinical proteomics, i.e., the application of proteomic methods for understanding mechanisms and enabling diagnosis, prediction, measurement of activity, and treatment response in disease, is first and foremost a discovery and research tool that feed......, execution, and interpretation of clinical proteomics studies is thus necessary for translation into clinical practice. We here review and discuss important options associated with clinical proteomics endeavors stretching from the planning phases to the final use in clinical chemistry. This article...... assay development downstream. Putative new assay candidates generated by proteomics discovery projects compete with well-established assays with known indications, well-described performance, and of known value in specific clinical settings. Careful attention to the many options available in the design...

  11. Development and validation of a clinical prediction rule for chest wall syndrome in primary care

    Directory of Open Access Journals (Sweden)

    Ronga Alexandre

    2012-08-01

    Full Text Available Abstract Background Chest wall syndrome (CWS, the main cause of chest pain in primary care practice, is most often an exclusion diagnosis. We developed and evaluated a clinical prediction rule for CWS. Methods Data from a multicenter clinical cohort of consecutive primary care patients with chest pain were used (59 general practitioners, 672 patients. A final diagnosis was determined after 12 months of follow-up. We used the literature and bivariate analyses to identify candidate predictors, and multivariate logistic regression was used to develop a clinical prediction rule for CWS. We used data from a German cohort (n = 1212 for external validation. Results From bivariate analyses, we identified six variables characterizing CWS: thoracic pain (neither retrosternal nor oppressive, stabbing, well localized pain, no history of coronary heart disease, absence of general practitioner’s concern, and pain reproducible by palpation. This last variable accounted for 2 points in the clinical prediction rule, the others for 1 point each; the total score ranged from 0 to 7 points. The area under the receiver operating characteristic (ROC curve was 0.80 (95% confidence interval 0.76-0.83 in the derivation cohort (specificity: 89%; sensitivity: 45%; cut-off set at 6 points. Among all patients presenting CWS (n = 284, 71% (n = 201 had a pain reproducible by palpation and 45% (n = 127 were correctly diagnosed. For a subset (n = 43 of these correctly classified CWS patients, 65 additional investigations (30 electrocardiograms, 16 thoracic radiographies, 10 laboratory tests, eight specialist referrals, one thoracic computed tomography had been performed to achieve diagnosis. False positives (n = 41 included three patients with stable angina (1.8% of all positives. External validation revealed the ROC curve to be 0.76 (95% confidence interval 0.73-0.79 with a sensitivity of 22% and a specificity of 93%. Conclusions This CWS score offers

  12. Greek pre-service physical education teachers’ beliefs about curricular orientations: Instrument validation and examination of four important goals

    Directory of Open Access Journals (Sweden)

    Manolis Adamakis

    2013-12-01

    Full Text Available BACKGROUND: The way people interpret reality is influenced by their mental constructions, their cognitive abilities and their beliefs. Physical Education (PE students have a wide range of formed beliefs concerning the purposes of PE, which cannot be easily modified, even during undergraduate studies. OBJECTIVE: This study validated the scores from a previously constructed questionnaire and investigated the Physical Education students’ belief systems toward the Greek curricular outcome goals. METHODS: Students (N = 483; males = 259, females = 224 from a Greek Faculty of Physical Education and Sport Science shared their beliefs about curricular outcomes. They completed the Greek version of the four factor instrument “Attitudes/beliefs toward curriculum in physical education”. A confirmatory factor analysis was conducted for the validation of the instrument and MANOVAs followed in order to control for group differences. Finally, a profile analysis was run in order to determine if PE students considered each goal to be equally important. RESULTS: The validation of the instrument confirmed the proposed four factors dependant model. Both internal consistency and the confirmatory factor analysis fit indices produced valid and reliable scores. The profile analysis was significant, indicating that students did not view the outcome goals as equally important. The leading goal was physical activity and fitness, followed by self-actualization, social development and motor skill development. MANOVA results for comparisons between sub-groups revealed significant differences only between genders. CONCLUSIONS: Between groups similarities and differences are discussed, focusing on the classification of the four important outcome goals. Currently, Greek Physical Education students consider physical activity and fitness outcome goal as the most important, while motor skill development is considered the least important one.

  13. Validity of clinical and patient ratings of tremor disability among older adults.

    Science.gov (United States)

    Lundervold, Duane A; Pahwa, Rajesh; Ament, Patrick A; Corbin, D Edward

    2003-10-01

    To evaluate the validity of the clinical tremor disability interview using a performance-based measure, patient ratings of tremor disability, and bedside tremor severity ratings of upper extremity (UE) action/intention (A/I) and postural (P) tremor. Sixteen older adult essential tremor patients (mean age=75.4 years, sd=5.7 years) took part in a study evaluating the validity of clinical and self-rating scales of tremor disability. A neurologist obtained bedside clinical ratings of UE A/I and P tremor of each limb and completed a clinical tremor disability rating. A second investigator, blind to neurological exam results obtained a clinical disability rating using the same measure, patient rated tremor disability ratings and conducted a performance-based disability assessment. Clinical tremor disability ratings were not significantly related to functional performance-based or patient ratings of tremor disability. Bedside clinical ratings of tremor severity also were not associated with clinical or patient-rated tremor disability. Patient ratings were significantly correlated with performance-based ratings. Further research is needed to validate a brief, sensitive clinical rating scale of tremor disability among older adults. Use of bedside ratings of tremor severity may be problematic and possibly estimate tremor disability. Empirical evaluation of differences in rating methods needs to be directly addressed.

  14. Clinical Scores for Dyspnoea Severity in Children: A Prospective Validation Study.

    Directory of Open Access Journals (Sweden)

    Hendriekje Eggink

    Full Text Available In acute dyspnoeic children, assessment of dyspnoea severity and treatment response is frequently based on clinical dyspnoea scores. Our study aim was to validate five commonly used paediatric dyspnoea scores.Fifty children aged 0-8 years with acute dyspnoea were clinically assessed before and after bronchodilator treatment, a subset of 27 children were videotaped and assessed twice by nine observers. The observers scored clinical signs necessary to calculate the Asthma Score (AS, Asthma Severity Score (ASS, Clinical Asthma Evaluation Score 2 (CAES-2, Pediatric Respiratory Assessment Measure (PRAM and respiratory rate, accessory muscle use, decreased breath sounds (RAD.A total of 1120 observations were used to assess fourteen measurement properties within domains of validity, reliability and utility. All five dyspnoea scores showed overall poor results, scoring insufficiently on more than half of the quality criteria for measurement properties. The AS and PRAM were the most valid with good values on six and moderate values on three properties. Poor results were mainly due to insufficient measurement properties in the validity and reliability domains whereas utility properties were moderate to good in all scores.This study shows that commonly used dyspnoea scores show insufficient validity and reliability to allow for clinical use without caution.

  15. Determination of the minimal clinically important difference on the Australian therapy outcome measures for occupational therapy (AusTOMs-OT).

    Science.gov (United States)

    Unsworth, Carolyn Anne; Coulson, Melissa; Swinton, Luchie; Cole, Helen; Sarigiannis, Mary

    2015-01-01

    Outcome measures must be responsive to change (able to show statistically significant change) and must also produce information on the degree of change that is clinically significant, or the minimal clinically important difference (MCID). This research sought to establish the MCID for four domains of the Australian Therapy Outcome Measures for Occupational Therapy (AusTOMs-OT). Using a criterion approach, 30 international clinicians were surveyed about their perceptions of the MCID for AusTOMs-OT. Second, using a distribution-based approach, the MCID was calculated as half of the standard deviation (SD) of the AusTOMs-OT raw scores for a sample of 787 clients. Just over half the clinicians surveyed indicated that a one-point change represented the MCID for AusTOMs-OT for three domains, and 0.5-point change showed MCID for the final domain. The data analysed for the distribution-based calculation indicated that the half SD ranged from 0.51 to 0.61. Using both criterion and distribution-based approaches, this research empirically demonstrated that a change on the four domains of the AusTOMs-OT of between 0.51 and 1 point shows MCID. Considering these findings, and for ease of clinical interpretation, it is recommended that a one-point shift be adopted as the MCID across all domains. The AusTOMs-OT have been previously shown to be valid and reliable outcome measures for use with all client groups across all settings including rehabilitation. So that rehabilitation professionals can interpret outcomes data from AusTOMs-OT, information must be available on the degree of change that is clinically significant (also referred to as the minimal clinically important difference or MCID). Using empirical calculations as well as clinician opinion, it is recommended that a one-point shift be used as the minimal clinically important difference for the AusTOMs-OT.

  16. Defining the minimal clinically important difference (MCID) of the Heinrichs-carpenter quality of life scale (QLS).

    Science.gov (United States)

    Falissard, Bruno; Sapin, Christophe; Loze, Jean-Yves; Landsberg, Wally; Hansen, Karina

    2016-06-01

    To determine the Minimal Clinically Important Difference (MCID) of the Heinrichs-Carpenter Quality of Life Scale (QLS). Data from the "Schizophrenia Trial of Aripiprazole" (STAR) study were used in this analysis. The MCID value of the QLS total score was estimated using the anchor-based method. These findings were substantiated/validated by comparing the MCID estimate to other measurements collected in the study. Half of the patients (49%) showed improvement in Clinical Global Impressions of Severity (CGI-S) during the trial. The estimated MCID of the QLS total score was 5.30 (standard error: 2.60; 95% confidence interval: [0.16; 10.43]; p MCID for the QLS and may be a useful tool in evaluating antipsychotic treatment effects and improving long-term patient outcomes in schizophrenia. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  17. Automated EEG detection algorithms and clinical semiology in epilepsy: importance of correlations.

    Science.gov (United States)

    Hogan, R Edward

    2011-12-01

    With advances in technological innovation, electroencephalography has remained the gold standard for classification and localization of epileptic seizures. Like other diagnostic modalities, technological advances have opened new avenues for assessment of data, and hold great promise to improve interpretive capabilities. However, proper overall interpretation and application of electroencephalographic findings relies on valid correlations of associated clinical semiology. This article addresses interpretation of clinical signs and symptoms in the context of the diagnostic predictive value of electroencephalographic, clinical, and electrographic definitions of seizures, and upcoming challenges of interpreting intracranial high-frequency electroencephalographic data. This article is part of a Supplemental Special Issue entitled The Future of Automated Seizure Detection and Prediction. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology

    DEFF Research Database (Denmark)

    Andersson, Lars; Andreasen, Jens O

    2011-01-01

    The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology. Exam....... Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized....

  19. Refining and validating a conceptual model of Clinical Nurse Leader integrated care delivery.

    Science.gov (United States)

    Bender, Miriam; Williams, Marjory; Su, Wei; Hites, Lisle

    2017-02-01

    To empirically validate a conceptual model of Clinical Nurse Leader integrated care delivery. There is limited evidence of frontline care delivery models that consistently achieve quality patient outcomes. Clinical Nurse Leader integrated care delivery is a promising nursing model with a growing record of success. However, theoretical clarity is necessary to generate causal evidence of effectiveness. Sequential mixed methods. A preliminary Clinical Nurse Leader practice model was refined and survey items developed to correspond with model domains, using focus groups and a Delphi process with a multi-professional expert panel. The survey was administered in 2015 to clinicians and administrators involved in Clinical Nurse Leader initiatives. Confirmatory factor analysis and structural equation modelling were used to validate the measurement and model structure. Final sample n = 518. The model incorporates 13 components organized into five conceptual domains: 'Readiness for Clinical Nurse Leader integrated care delivery'; 'Structuring Clinical Nurse Leader integrated care delivery'; 'Clinical Nurse Leader Practice: Continuous Clinical Leadership'; 'Outcomes of Clinical Nurse Leader integrated care delivery'; and 'Value'. Sample data had good fit with specified model and two-level measurement structure. All hypothesized pathways were significant, with strong coefficients suggesting good fit between theorized and observed path relationships. The validated model articulates an explanatory pathway of Clinical Nurse Leader integrated care delivery, including Clinical Nurse Leader practices that result in improved care dynamics and patient outcomes. The validated model provides a basis for testing in practice to generate evidence that can be deployed across the healthcare spectrum. © 2016 John Wiley & Sons Ltd.

  20. Time-dependent prediction and evaluation of variable importance using superlearning in high-dimensional clinical data.

    Science.gov (United States)

    Hubbard, Alan; Munoz, Ivan Diaz; Decker, Anna; Holcomb, John B; Schreiber, Martin A; Bulger, Eileen M; Brasel, Karen J; Fox, Erin E; del Junco, Deborah J; Wade, Charles E; Rahbar, Mohammad H; Cotton, Bryan A; Phelan, Herb A; Myers, John G; Alarcon, Louis H; Muskat, Peter; Cohen, Mitchell J

    2013-07-01

    Prediction of outcome after injury is fraught with uncertainty and statistically beset by misspecified models. Single-time point regression only gives prediction and inference at one time, of dubious value for continuous prediction of ongoing bleeding. New statistical machine learning techniques such as SuperLearner (SL) exist to make superior prediction at iterative time points while evaluating the changing relative importance of each measured variable on an outcome. This then can provide continuously changing prediction of outcome and evaluation of which clinical variables likely drive a particular outcome. PROMMTT data were evaluated using both naive (standard stepwise logistic regression) and SL techniques to develop a time-dependent prediction of future mortality within discrete time intervals. We avoided both underfitting and overfitting using cross validation to select an optimal combination of predictors among candidate predictors/machine learning algorithms. SL was also used to produce interval-specific robust measures of variable importance measures (VIM resulting in an ordered list of variables, by time point) that have the strongest impact on future mortality. Nine hundred eighty patients had complete clinical and outcome data and were included in the analysis. The prediction of ongoing transfusion with SL was superior to the naive approach for all time intervals (correlations of cross-validated predictions with the outcome were 0.819, 0.789, 0.792 for time intervals 30-90, 90-180, 180-360, >360 minutes). The estimated VIM of mortality also changed significantly at each time point. The SL technique for prediction of outcome from a complex dynamic multivariate data set is superior at each time interval to standard models. In addition, the SL VIM at each time point provides insight into the time-specific drivers of future outcome, patient trajectory, and targets for clinical intervention. Thus, this automated approach mimics clinical practice, changing

  1. Nursing outcomes content validation according to Nursing Outcomes Classification (NOC) for clinical, surgical and critical patients.

    Science.gov (United States)

    Seganfredo, Deborah Hein; Almeida, Miriam de Abreu

    2011-01-01

    The objective of this study was to validate the Nursing Outcomes (NO) from the Nursing Outcomes Classification (NOC) for the two Nursing Diagnoses (ND) most frequent in hospitalized surgical, clinical and critical patients. The content validation of the REs was performed adapting the Fehring Model. The sample consisted of 12 expert nurses. The instrument for data collection consisted of the NOs proposed by NOC for the two NDs in the study, its definition and a five-point Likert scale. The data were analyzed using descriptive statistics. The NOs that obtained averages of 0.80 or higher were validated. The ND Risk for Infection was the most frequent, being validated eight (38.1%) of 21 NOs proposed by the NOC. The ND Self-Care Deficit: Bathing/Hygiene was the second most frequent and five (14.28%) out of 35 NOs were validated.

  2. Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

    Science.gov (United States)

    Flatman, Robert; Férard, Georges; Dybkaer, René

    2017-04-01

    Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences. These recommendations are founded on and in agreement with the principles and work of the International Organization for Standardization (ISO), Bureau International des Poids et Mesures (BIPM), IUPAC, and the IFCC. Practical applications described are based on those scientific principles. The SB recommendations apply to all types of examination, not only to measurement of quantities but also examination of nominal properties where no magnitude is involved. The SB is applicable not only to clinical chemistry, but to many other clinical laboratory disciplines. For examples, reports regarding haemostasis, toxicology, clinical microbiology, reproduction and fertility, clinical pharmacology, clinical allergology, clinical molecular biology, and clinical immunohaematology have been published by the IUPAC and the IFCC. Peak scientific bodies such as the IUPAC and the IFCC have important roles in the development of sound international standards for nomenclature of examinations. Such standards support safe and effective representation of patient health information, foster portability, and empower future decision support systems. Copyright © 2016. Published by Elsevier B.V.

  3. Minimal clinically important difference of the L Test for individuals with lower limb amputation: A pilot study.

    Science.gov (United States)

    Rushton, Paula W; Miller, William C; Deathe, A Barry

    2015-12-01

    The L Test is a reliable/valid clinical evaluation of mobility that measures walking speed in seconds. It can be used with individuals with lower limb amputation. Responsiveness of the L Test is not yet determined. The purpose of this pilot study was to determine how well the L Test identified individuals with a lower limb amputation who have/have not undergone a minimal clinically important difference. Prospective follow-up study. In total, 33 individuals with lower limb amputation, deemed to require a major intervention, were recruited consecutively from a follow-up clinic. Participants completed the L Test at baseline and follow-up. A Global Rating Change scale was also completed at follow-up. The participants had a mean age ± standard deviation of 60 ± 13.0 years, and 81.8% had a transtibial amputation. The mean ± standard deviation for the L Test change scores was 6.0 ± 13.9. The area under the curve was 0.67, and the minimal clinically important difference was 4.5 s. The L Test identified individuals as having an important clinical change. Results must be interpreted with caution, as the accuracy, based on the Global Rating Change scale, is low. Further inquiry into the L Test is encouraged. The L Test can guide the clinical management of individuals with lower limb amputation. Results from this pilot study indicate that individuals with a lower limb amputation who improve by at least 4.5 s on the L Test after an intervention have likely undergone an important change. This result must be interpreted with caution given that the ability of the L Test to correctly identify individuals, who have and have not undergone an important change, using the Global Rating Change scale as the gold standard, is limited because this is a pilot study. It is plausible that the precision of the cut-point threshold could increase or decrease given a larger sample or when using a different method of identifying important clinical change. © The International Society for

  4. Measuring the statistical validity of summary meta-analysis and meta-regression results for use in clinical practice.

    Science.gov (United States)

    Willis, Brian H; Riley, Richard D

    2017-09-20

    An important question for clinicians appraising a meta-analysis is: are the findings likely to be valid in their own practice-does the reported effect accurately represent the effect that would occur in their own clinical population? To this end we advance the concept of statistical validity-where the parameter being estimated equals the corresponding parameter for a new independent study. Using a simple ('leave-one-out') cross-validation technique, we demonstrate how we may test meta-analysis estimates for statistical validity using a new validation statistic, Vn, and derive its distribution. We compare this with the usual approach of investigating heterogeneity in meta-analyses and demonstrate the link between statistical validity and homogeneity. Using a simulation study, the properties of Vn and the Q statistic are compared for univariate random effects meta-analysis and a tailored meta-regression model, where information from the setting (included as model covariates) is used to calibrate the summary estimate to the setting of application. Their properties are found to be similar when there are 50 studies or more, but for fewer studies Vn has greater power but a higher type 1 error rate than Q. The power and type 1 error rate of Vn are also shown to depend on the within-study variance, between-study variance, study sample size, and the number of studies in the meta-analysis. Finally, we apply Vn to two published meta-analyses and conclude that it usefully augments standard methods when deciding upon the likely validity of summary meta-analysis estimates in clinical practice. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

  5. Performance Validity Testing in Neuropsychology: Scientific Basis and Clinical Application-A Brief Review.

    Science.gov (United States)

    Greher, Michael R; Wodushek, Thomas R

    2017-03-01

    Performance validity testing refers to neuropsychologists' methodology for determining whether neuropsychological test performances completed in the course of an evaluation are valid (ie, the results of true neurocognitive function) or invalid (ie, overly impacted by the patient's effort/engagement in testing). This determination relies upon the use of either standalone tests designed for this sole purpose, or specific scores/indicators embedded within traditional neuropsychological measures that have demonstrated this utility. In response to a greater appreciation for the critical role that performance validity issues play in neuropsychological testing and the need to measure this variable to the best of our ability, the scientific base for performance validity testing has expanded greatly over the last 20 to 30 years. As such, the majority of current day neuropsychologists in the United States use a variety of measures for the purpose of performance validity testing as part of everyday forensic and clinical practice and address this issue directly in their evaluations. The following is the first article of a 2-part series that will address the evolution of performance validity testing in the field of neuropsychology, both in terms of the science as well as the clinical application of this measurement technique. The second article of this series will review performance validity tests in terms of methods for development of these measures, and maximizing of diagnostic accuracy.

  6. The Korean version of the Lasater Clinical Judgment Rubric: a validation study.

    Science.gov (United States)

    Shin, Hyunsook; Park, Chang Gi; Shim, Kaka

    2015-01-01

    The scarcity of reliable and valid evaluation tools targeting nursing students' learning outcomes including clinical judgment was identified as one of the barriers in advancing nursing knowledge and skills. However, few studies have assessed the validity and reliability of these tools. Therefore, this study aimed to validate the Korean language version of the Lasater Clinical Judgment Rubric (LCJR), a clinical judgment tool currently used in nursing simulation research and English speaking nursing societies. This was an observational study in which a cross-sectional designed survey was used to validate the Korean version of the LCJR (K-LCJR) in three universities in Seoul, South Korea with one hundred fifty two senior nursing students. All participants completed the established simulation coursework as well as the regular clinical rotation on pediatric nursing along with their assigned team. Students evaluated their clinical judgment from their simulation performance using the K-LCJR after completing a simulation session using high-fidelity simulators and standardized patients (SP). Audio-video enhancing equipment for the student's individual and group reflection was used. Item analysis of K-LCJR results showed a Cronbach's alpha coefficient of between .897 and .909 and the overall internal consistency reliability coefficient was .910. In the confirmatory factor analysis, the four-factor K-LCJR composed by noticing, interpreting, responding, and reflecting was confirmed with a very good model fit to data, which demonstrated good construct validity. The K-LCJR is a reliable and valid instrument for measuring clinical judgment in nursing students in Korea. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Development and Validation of the Amphetamine-Type Stimulants Motive Questionnaire in a Clinical Population

    Directory of Open Access Journals (Sweden)

    Daniela Thurn

    2017-09-01

    conclude, the AMQ is a valid and reliable instrument for assessing motives of ATS use in a clinical population. It can provide important insights into the motivational structure of the first and latest months of ATS use which are useful for preventive and therapeutic treatments as well as the development of abstinence skills.

  8. How to develop, validate, and compare clinical prediction models involving radiological parameters: Study design and statistical methods

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kyung Hwa; Choi, Byoung Wook [Dept. of Radiology, and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Song, Ki Jun [Dept. of Biostatistics and Medical Informatics, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2016-06-15

    Clinical prediction models are developed to calculate estimates of the probability of the presence/occurrence or future course of a particular prognostic or diagnostic outcome from multiple clinical or non-clinical parameters. Radiologic imaging techniques are being developed for accurate detection and early diagnosis of disease, which will eventually affect patient outcomes. Hence, results obtained by radiological means, especially diagnostic imaging, are frequently incorporated into a clinical prediction model as important predictive parameters, and the performance of the prediction model may improve in both diagnostic and prognostic settings. This article explains in a conceptual manner the overall process of developing and validating a clinical prediction model involving radiological parameters in relation to the study design and statistical methods. Collection of a raw dataset; selection of an appropriate statistical model; predictor selection; evaluation of model performance using a calibration plot, Hosmer-Lemeshow test and c-index; internal and external validation; comparison of different models using c-index, net reclassification improvement, and integrated discrimination improvement; and a method to create an easy-to-use prediction score system will be addressed. This article may serve as a practical methodological reference for clinical researchers.

  9. [Clinical analysis of 91 cases of imported falciparum malaria from Africa].

    Science.gov (United States)

    Wang, Zhong-Lei; Wang, Yu-Ru; Fu, Ting-Xia; Mao, De-Hua

    2013-06-01

    To explore the clinical characteristics, early diagnosis, and treatment of patients with imported falciparum malaria from Africa. The clinical data of 91 imported falciparum malaria cases were analyzed by retrospective study. All the 91 cases had the history of mosquito bites. The clinical manifestation of these cases varied, including fever, headache, chill, diarrhea, anemia, thrombocytopenia, proteinuria, damage of liver function, abdominal ultrasonographic presentations (enlarged liver and spleen). All the patients were successfully treated with the combination therapy of artemether and primaquine. The key procedures for treating imported falciparum malaria are earlier diagnosis and effective therapy. The combination therapy with artemether and primaquine shows a high efficacy and low side effect and low relapsed rate.

  10. Clinimetrics Corner: The Minimal Clinically Important Change Score (MCID): A Necessary Pretense.

    Science.gov (United States)

    Cook, Chad E

    2008-01-01

    Minimal clinically important differences (MCID) are patient derived scores that reflect changes in a clinical intervention that are meaningful for the patient. At present, there are a number of different methods to obtain an MCID, as there a number of different factors that can influence the MCID value. This clinimetric corner outlines the hidden challenges associated with identifying a viable MCID and possible suggestions to improve the future development of these single scores.

  11. Clinimetrics Corner: The Minimal Clinically Important Change Score (MCID): A Necessary Pretense

    OpenAIRE

    Cook, Chad E.

    2008-01-01

    Minimal clinically important differences (MCID) are patient derived scores that reflect changes in a clinical intervention that are meaningful for the patient. At present, there are a number of different methods to obtain an MCID, as there a number of different factors that can influence the MCID value. This clinimetric corner outlines the hidden challenges associated with identifying a viable MCID and possible suggestions to improve the future development of these single scores.

  12. Importance of Hepatic Transporters in Clinical Disposition of Drugs and Their Metabolites.

    Science.gov (United States)

    Patel, Mitesh; Taskar, Kunal S; Zamek-Gliszczynski, Maciej J

    2016-07-01

    This review provides a practical clinical perspective on the relevance of hepatic transporters in pharmacokinetics and drug-drug interactions (DDIs). Special emphasis is placed on transporters with clear relevance to clinical DDIs, efficacy, and safety. Basolateral OATP1B1 and 1B3 emerged as important hepatic drug uptake pathways, sites for systemic DDIs, and sources of pharmacogenetic variability. As the first step in hepatic drug removal from the circulation, OATPs are an important determinant of systemic pharmacokinetics, specifically influencing systemic absorption, clearance, and hepatic distribution for subsequent metabolism and/or excretion. Biliary excretion of parent drugs is a less prevalent clearance pathway than metabolism or urinary excretion, but BCRP and MRP2 are critically important to biliary/fecal elimination of drug metabolites. Inhibition of biliary excretion is typically not apparent at the level of systemic pharmacokinetics but can markedly increase liver exposure. Basolateral efflux transporters MRP3 and MRP4 mediate excretion of parent drugs and, more commonly, polar metabolites from hepatocytes into blood. Basolateral excretion is an area in need of further clinical investigation, which will necessitate studies more complex than just systemic pharmacokinetics. Clinical relevance of hepatic uptake is relatively well appreciated, and clinical consequences of hepatic excretion (biliary and basolateral) modulation remain an active research area. © 2016, The American College of Clinical Pharmacology.

  13. The psychological importance of collective assembly: Development and validation of the Tendency for Effervescent Assembly Measure (TEAM).

    Science.gov (United States)

    Gabriel, Shira; Valenti, Jennifer; Naragon-Gainey, Kristin; Young, Ariana F

    2017-11-01

    Although previous research suggests that connection to large, mostly anonymous groups is important for the fulfillment of psychological needs and a sense of psychological well-being, no measure exists to assess individual differences in this area. In 5 studies, we developed and provided support for the validity of the Tendency for Effervescent Assembly Measure (TEAM). Utilizing data from student and community samples, we conducted exploratory factor analyses to guide item selection for the scale (Study 1), evaluated the structure of the scale in an independent sample (Study 2), examined the convergent, discriminant, and incremental validity of the scale (Study 3), and assessed measurement invariance of the scale across different demographic groups (Study 4). Study 5 explored the role of social needs fulfillment in effervescent assembly, as well as examined the relationship of the scale with recent collective effervescence experiences. Results revealed that our final 11-item scale was unidimensional, with excellent internal consistency and good test-retest reliability over 2 months. Measurement invariance was established across gender, ethnicity, and religion, providing support for the validity of the measure across demographic subgroups. Importantly, the TEAM predicted decreased loneliness, increased positive feelings, a sense of meaning in one's life, self-awareness, and spiritual transcendence, above and beyond the effects of the big 5 factors of personality and collective and relational interdependence. Furthermore, results suggested that positive outcomes associated with the TEAM are because of social need fulfillment. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  14. The reliability, validity, and usefulness of the Objective Structured Clinical Examination (OSCE) in dental education

    Science.gov (United States)

    Graham, Roseanna

    This study evaluated the reliability, validity, and educational usefulness of a comprehensive, multidisciplinary Objective Structured Clinical Examination (OSCE) in dental education. The OSCE was administered to dental students at the Columbia University College of Dental Medicine (CDM) before they entered clinical training. Participants in this study included CDM's class of 2010 which consisted of 78 students. The overall reliability of the examination was measured via calculation of Cronbach's alpha. Content validity was examined through evaluation of the OSCE by three experienced clinical faculty members. Predictive validity was evaluated by correlating student grades on the OSCE to future clinical performance as measured by number of clinical points achieved during the third year of training. Student perceptions regarding the educational usefulness of the examination were evaluated through a 12-question Liken-type survey and focus group interviews analyzed using a phenomenological approach. Findings of the study indicated the OSCE was a highly reliable examination (alpha=0.86) with high content validity and a moderately high correlation to future clinical performance (r=.614, pstudent perceptions of the educational usefulness of the OSCE were positive as based on their responses to a 5-point Likert scale (1=strongly disagree and 5=strongly agree). They reported that the exam required the ability to think critically and problem-solve (4.0 +/- 0.85), assessed clinically relevant skills (4.59 +/- 0.69), helped identify clinical weaknesses (4.16 +/- 0.90), and was a learning experience (4.58 +/- 0.84). Findings from the qualitative portion of the study identified four main themes including the student perception that the OSCE is a unique assessment experience that required integration and application of knowledge. Recommendations for the use of the OSCE to improve clinical teaching and the implications of this study relating to the expanded use of the OSCE in

  15. Clinical validation of the nursing diagnosis of dysfunctional family processes related to alcoholism.

    Science.gov (United States)

    Mangueira, Suzana de Oliveira; Lopes, Marcos Venícios de Oliveira

    2016-10-01

    To evaluate the clinical validity indicators for the nursing diagnosis of dysfunctional family processes related to alcohol abuse. Alcoholism is a chronic disease that negatively affects family relationships. Studies on the nursing diagnosis of dysfunctional family processes are scarce in the literature. This diagnosis is currently composed of 115 defining characteristics, hindering their use in practice and highlighting the need for clinical validation. This was a diagnostic accuracy study. A sample of 110 alcoholics admitted to a reference centre for alcohol treatment was assessed during the second half of 2013 for the presence or absence of the defining characteristics of the diagnosis. Operational definitions were created for each defining characteristic based on concept analysis and experts evaluated the content of these definitions. Diagnostic accuracy measures were calculated from latent class models with random effects. All 89 clinical indicators were found in the sample and a set of 24 clinical indicators was identified as clinically valid for a diagnostic screening for family dysfunction from the report of alcoholics. Main clinical indicators with high specificity included sexual abuse, disturbance in academic performance in children and manipulation. The main indicators that showed high sensitivity values were distress, loss, anxiety, low self-esteem, confusion, embarrassment, insecurity, anger, loneliness, deterioration in family relationships and disturbance in family dynamics. Eighteen clinical indicators showed a high capacity for diagnostic screening for alcoholics (high sensitivity) and six indicators can be used for confirmatory diagnosis (high specificity). © 2016 John Wiley & Sons Ltd.

  16. Estimating minimal clinically important differences of upper extremity measures early after stroke

    Science.gov (United States)

    Lang, Catherine E.; Edwards, Dorothy F.; Birkenmeier, Rebecca L.; Dromerick, Alexander W.

    2010-01-01

    Objective To estimate minimal clinically important difference values of several upper extremity measures early after stroke. Design Data in this report were collected during the VECTORS trial, an acute, single-blind randomized controlled trial of Constraint Induced Movement Therapy. Subjects were tested at the pre-randomization baseline assessment (average of 9.5 days post stroke), and the first post-treatment assessment (25.9 days post stroke). At each time point, the affected upper extremity was evaluated with a battery of 6 tests. At the second assessment, subjects were also asked to provide a global rating of perceived changes in their affected upper extremity. Anchor-based minimal clinically important difference values were calculated separately for the affected dominant upper extremities and the affected non-dominant upper extremities for each of the 6 tests. Setting Inpatient rehabilitation hospital. Participants Fifty-two people with hemiparesis post stroke. Interventions Not applicable. Main Outcome Measures Estimated minimal clinically important difference values for grip strength, composite upper extremity strength, Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and duration of upper extremity use as measured with accelerometry. Results Minimal clinically important difference values for grip strength were 5.0 and 6.2 kg for the affected dominant and non-dominant sides respectively. Minimal clinically important difference values for the ARAT were 12 and 17 points, for the WMFT Function score were 1.0 and 1.2 points, and for the MAL How well score were 1.0 and 1.1 points for the two sides respectively. Minimal clinically important difference values were indeterminate for the dominant (composite strength), the non-dominant (WMFT Time score) or for both affected sides (duration of use) for the other measures. Conclusions Our data provide some of the first estimates of minimal clinically important difference values

  17. Clinical utility and validity of the Functional Disability Inventory (FDI) among a multicenter sample of youth with chronic pain

    Science.gov (United States)

    Kashikar-Zuck, Susmita; Flowers, Stacy R.; Claar, Robyn Lewis; Guite, Jessica W.; Logan, Deirdre E.; Lynch-Jordan, Anne M; Palermo, Tonya M.; Wilson, Anna C.

    2011-01-01

    The Functional Disability Inventory (FDI) is a well-established and commonly used measure of physical functioning and disability in youth with chronic pain. Further validation of the measure has been called for, in particular, examination of the clinical utility and factor structure of the measure. To address this need, we utilized a large multicenter dataset of pediatric patients with chronic pain who had completed the FDI and other measures assessing pain and emotional functioning. Clinical reference points to allow for interpretation of raw scores were developed to enhance clinical utility of the measure and exploratory factor analysis was performed to examine its factor structure. Participants included 1300 youth ages 8 to 18 years (M=14.2 years; 76% female) with chronic pain. Examination of the distribution of FDI scores and validation with measures of depressive symptoms and pain intensity yielded three distinct categories of disability: No/Minimal Disability, Moderate Disability and Severe Disability. Factor analysis of FDI scores revealed a two-factor solution representing vigorous Physical Activities and non-physically strenuous Daily Activities. The three-level classification system and factor structure were further explored via comparison across the four most commonly encountered pain conditions in clinical settings (head, back, abdominal and widespread pain). Our findings provide important new information regarding the clinical utility and validity of the FDI. This will greatly enhance the interpretability of scores for research and clinical use in a wide range of pediatric pain conditions. In particular these findings will facilitate use of the FDI as an outcome measure in future clinical trials. PMID:21458162

  18. [Clinical importance of CMV-infection in German-speaking burn centers].

    Science.gov (United States)

    Pfau, M; Hamprecht, K; Schaller, H-E; Rennekampff, H-O

    2004-12-01

    Due to immunosuppression, burn patients are at risk for CMV-infection. By means of a retrospective questionnaire we evaluated the clinical rating and management of CMV-infection in German-speaking burn centers. 41 % of the participating burn centers considered the role of CMV-infection of overall minor importance, 41 % of importance only in intensive care burn patients, 18 % of overall great importance. 70 % of the participating burn centers do not perform CMV-screening at admission. More than 50 % of the participating burn centers consider application of CMV-negative human blood-derived products in CMV-seronegative individuals as essential. At present clinical importance of CMV-infection in burn patients can not be clearly determined. But further prospective studies utilizing recently developed diagnostics seem warranted to the potential influence of CMV-infection on morbidity and mortality in burn patients.

  19. The clinical importance of air plethysmography in the assessment of chronic venous disease

    Directory of Open Access Journals (Sweden)

    Nei Rodrigues Alves Dezotti

    Full Text Available Abstract Air plethysmography is a non-invasive test that can quantify venous reflux and obstruction by measuring volume changes in the leg. Its findings correlate with clinical and hemodynamic measures. It can quantitatively assess several components of venous hemodynamics: valvular reflux, calf muscle pump function, and venous obstruction. Although clinical uses of air plethysmography have been validated, it is used almost exclusively for medical research. Air plethysmography can be used to assess chronic venous disease, to evaluate improvement after venous surgery, to diagnose acute and past episodes of deep venous thrombosis, to evaluate compression stocking therapy, to study the physiological implications of high-heeled shoes in healthy women, and even to evaluate the probability of ulcer healing.

  20. Advanced Nursing Directives: Integrating Validated Clinical Scoring Systems into Nursing Care in the Pediatric Emergency Department

    Directory of Open Access Journals (Sweden)

    Erin Kate deForest

    2012-01-01

    Full Text Available In an effort to improve the quality and flow of care provided to children presenting to the emergency department the implementation of nurse-initiated protocols is on the rise. We review the current literature on nurse-initiated protocols, validated emergency department clinical scoring systems, and the merging of the two to create Advanced Nursing Directives (ANDs. The process of developing a clinical pathway for children presenting to our pediatric emergency department (PED with suspected appendicitis will be used to demonstrate the successful integration of validated clinical scoring systems into practice through the use of Advanced Nursing Directives. Finally, examples of 2 other Advanced Nursing Directives for common clinical PED presentations will be provided.

  1. Measuring technology self efficacy: reliability and construct validity of a modified computer self efficacy scale in a clinical rehabilitation setting.

    Science.gov (United States)

    Laver, Kate; George, Stacey; Ratcliffe, Julie; Crotty, Maria

    2012-01-01

    To describe a modification of the computer self efficacy scale for use in clinical settings and to report on the modified scale's reliability and construct validity. The computer self efficacy scale was modified to make it applicable for clinical settings (for use with older people or people with disabilities using everyday technologies). The modified scale was piloted, then tested with patients in an Australian inpatient rehabilitation setting (n = 88) to determine the internal consistency using Cronbach's alpha coefficient. Construct validity was assessed by correlation of the scale with age and technology use. Factor analysis using principal components analysis was undertaken to identify important constructs within the scale. The modified computer self efficacy scale demonstrated high internal consistency with a standardised alpha coefficient of 0.94. Two constructs within the scale were apparent; using the technology alone, and using the technology with the support of others. Scores on the scale were correlated with age and frequency of use of some technologies thereby supporting construct validity. The modified computer self efficacy scale has demonstrated reliability and construct validity for measuring the self efficacy of older people or people with disabilities when using everyday technologies. This tool has the potential to assist clinicians in identifying older patients who may be more open to using new technologies to maintain independence.

  2. International Adaptations of the Millon Clinical Multiaxial Inventory: Construct Validity and Clinical Applications

    NARCIS (Netherlands)

    Rossi, G.M.P.; Derksen, J.J.L.

    2015-01-01

    This article examines the influence of the Millon Clinical Multiaxial Inventory (MCMI) as a clinical and research instrument beyond the borders of the United States. The MCMI's theoretical and empirical grounding, its alignment with the Diagnostic and Statistical Manual of Mental Disorders (DSM),

  3. The reliability and validity of the clinical competence evaluation scale in physical therapy.

    Science.gov (United States)

    Yoshino, Jun; Usuda, Shigeru

    2013-12-01

    [Purpose] To examine the internal consistency, criterion-related validity, factorial validity, and content validity of the Clinical Competence Evaluation Scale in Physical Therapy (CEPT). [Subjects] The subjects were 278 novice physical therapy trainees and 119 tutors from 21 medical facilities. [Methods] The trainees self-evaluated their clinical competences and the tutors evaluated trainee competences using the CEPT. Overall trainee autonomy was evaluated using a visual analog scale (VAS) for self-evaluation and the trainees were also evaluated by their tutors. The content validity of the CEPT was examined by asking if the CEPT could evaluate the competence of novice physical therapists on a four-point scale. [Results] Cronbach's alpha of the CEPT was 0.96 for the trainees and 0.97 for the tutors. The correlation coefficient between the total score of the CEPT and whole competence by VAS was 0.83 for the trainees and 0.87 for the tutors. Factor analysis identified two factors, "the specialty of the physical therapist" and "the essential competence of a health professional". Ninety percent or more of the trainees and the tutors answered that the CEPT could sufficiently evaluate the competence of novice physical therapists. [Conclusion] The CEPT is a reliable and valid scale for clinical competence evaluation of novice physical therapists.

  4. Minimal clinically important change on the unified Parkinson's disease rating scale.

    Science.gov (United States)

    Schrag, Anette; Sampaio, Cristina; Counsell, Nicholas; Poewe, Werner

    2006-08-01

    The Unified Parkinson's Disease Rating Scale (UPDRS) is the main outcome measure in clinical trials of Parkinson's disease (PD). The minimal change that represents a clinically meaningful improvement is unknown. The objective of this study was to determine the minimal change on the UPDRS that represents a clinically meaningful improvement in early PD after 6 months of treatment. Data from two independent randomized treatment trials over 6 months involving 603 patients with de novo PD were analyzed to determine the minimal clinically important change (MCIC), referred to the status before treatment, for the UPDRS motor, activities of daily living (ADL), and total scores. An anchor-based method using ratings on a seven-point global clinical improvement was used. A change of five points on the UPDRS motor part was found to be the most appropriate cutoff score for all Hoehn and Yahr stages I to III, and a change of eight points for the UDPRS total score. For the UDPRS ADL score, an MCIC of two points for Hoehn and Yahr stages I/I.5 and II and of three points for Hoehn and Yahr stage II.5/III was the most appropriate cutoff score. These data give the first estimate for cutoffs defining clinically important changes in UPDRS ADL and motor scores. Further studies using larger databases from more diverse study populations are encouraged to better define and solidify the MCIC for the UPDRS. (c) 2006 Movement Disorder Society

  5. Minimal Clinically Important Difference on Parkinson's Disease Sleep Scale 2nd Version.

    Science.gov (United States)

    Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Deli, Gabriella; Janszky, József; Komoly, Sámuel; Karádi, Kázmér; Kovács, Márton; Makkos, Attila; Faludi, Béla; Kovács, Norbert

    2015-01-01

    Background and Aims. The aim of the present study was to determine the estimates of minimal clinically important difference for Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score and dimensions. Methods. The subject population consisted of 413 PD patients. At baseline, MDS-UPDRS, Hoehn-Yahr Scale, Mattis Dementia Rating Scale, and PDSS-2 were assessed. Nine months later the PDSS-2 was reevaluated with the Patient-Reported Global Impression Improvement Scale. Both anchor-based techniques (within patients' score change method and sensitivity- and specificity-based method by receiver operating characteristic analysis) and distribution-based approaches (effect size calculations) were utilized to determine the magnitude of minimal clinically important difference. Results. According to our results, any improvements larger than -3.44 points or worsening larger than 2.07 points can represent clinically important changes for the patients. These thresholds have the effect size of 0.21 and -0.21, respectively. Conclusions. Minimal clinically important differences are the smallest change of scores that are subjectively meaningful to patients. Studies using the PDSS-2 as outcome measure should utilize the threshold of -3.44 points for detecting improvement or the threshold of 2.07 points for observing worsening.

  6. 77 FR 50162 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Science.gov (United States)

    2012-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Correction In notice document 2012-19197 appearing on pages 47109-47110 in the issue of...

  7. 77 FR 24984 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Science.gov (United States)

    2012-04-26

    ... Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration... Management, Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug...

  8. Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example.

    NARCIS (Netherlands)

    van Tulder, M.W.; Malmivaara, A.; Hayden, J.; Koes, B.

    2007-01-01

    STUDY DESIGN. Critical appraisal of the literature. OBJECIVES. The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. SUMMARY OF BACKGROUND DATA. There seems to be a discrepancy between conclusions reported by authors and

  9. The minimal clinical important difference in the World Health Organization Quality of Life instrument-100

    NARCIS (Netherlands)

    den Oudsten, B.L.; Zijlstra, W.P.; de Vries, J.

    2013-01-01

    Purpose The aim of this study was to estimate the minimal clinical important difference (MCID) of the World Health Organization Quality of Life assessment instrument (WHOQOL-100) for women with early-stage breast cancer. If the MCID is known, then the instrument is also useful for individual

  10. The attitudes of medical students in Europe toward the clinical importance of embryology.

    Science.gov (United States)

    Moxham, Bernard John; Emmanouil-Nikoloussi, Elpida; Standley, Henrietta; Brenner, Erich; Plaisant, Odile; Brichova, Hana; Pais, Diogo; Stabile, Isobel; Borg, Jordy; Chirculescu, Andy

    2016-03-01

    Although there have been many studies reporting the attitudes of medical students to the clinical importance of gross anatomy, little is known about their opinions concerning the clinical importance of embryology. Using Thurstone and Chave methods to assess attitudes, nearly 1,600 medical students across Europe in the early stages of their training provided responses to a survey that tested the hypothesis that they do not regard embryology as highly clinically relevant. Indeed, we further proposed that student attitudes to gross anatomy are much more positive than those toward embryology. Our findings show that our hypotheses hold, regardless of the university and country surveyed and regardless of the teaching methods employed for embryology. Clearly, embryology has a significant part to play in medical education in terms of understanding prenatal life, of appreciating how the organization of the mature human body has developed, and of providing essential information for general medical practice, obstetrics and pediatrics, and teratology. However, while newly recruited medical students understand the importance of gross anatomy in the development of professional competence, understanding the importance of embryology requires teachers, medical educationalists, and devisors of medical curricula to pay special attention to informing students of the significant role played by embryology in attaining clinical competence and achieving the knowledge and understanding of the biomedical sciences that underpins becoming a learned member of a health care profession. © 2015 Wiley Periodicals, Inc.

  11. Validation of a Brief Insomnia Severity Measure in Youth Clinically Referred for Sleep Evaluation.

    Science.gov (United States)

    Byars, Kelly C; Simon, Stacey L; Peugh, James; Beebe, Dean W

    2017-05-01

    Evaluate psychometric properties of the Pediatric Insomnia Severity Index (PISI), a brief measure of insomnia severity. Clinically referred youth ( n = 462; 283 males, 179 females, mean age = 7.28 ± 2.05 years) and their caregiver(s) completed sleep evaluation including the PISI, Children's Sleep Habits Questionnaire, and sleep disorders inventory for students. Tests of reliability and validity and confirmatory factor analysis (CFA) were conducted to assess PISI psychometric properties. Exploratory analyses were conducted to examine insomnia severity by insomnia diagnosis. Measures of internal consistency for the PISI factor scores varied. CFA indicated that a two-factor model had optimal fit relative to a single-factor solution. Overall, convergent and discriminant validity of PISI factors were supported. Insomnia severity varied by diagnosis. Findings provide preliminary support for the reliability and validity of the PISI within a large pediatric sample and for its clinical utility as a brief measure of insomnia severity.

  12. Assessing aggressive behavior in forensic psychiatric patients: validity and clinical utility of combining two instruments.

    Science.gov (United States)

    Kobes, Marjolein H B M; Nijman, Henk H L I; Bulten, Erik B H

    2012-12-01

    Accurate observation of aggressive behavior among forensic psychiatric patients requires valid instruments. This study examines the validity and clinical utility of combining the social dysfunction and aggression scale (SDAS) and staff observation aggression scale revised (SOAS-R). Nurses weekly obtained SDAS scores of 127 patients, resulting in 6.124 assessments. Aggressive incidents were documented by the SOAS-R. Internal consistency, subscale structure, interobserver reliability of the SDAS, and convergent validity with SOAS-R were analyzed. A three-factor solution was found. Interobserver reliability was moderate, and good convergent validity was found. The SDAS, in conjunction with the SOAS-R, monitors changes in aggressiveness and may contribute to the prevention of aggressive behavior. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. The Contribution of the Rasch Model to the Clinical Validation of Nursing Diagnoses: Integrative Literature Review.

    Science.gov (United States)

    de Souza Oliveira-Kumakura, Ana Railka; Caldeira, Sílvia; Prado Simão, Talita; Camargo-Figuera, Fabio Alberto; de Almeida Lopes Monteiro da Cruz, Diná; Campos de Carvalho, Emília

    2016-10-26

    To analyze the knowledge related to the use of the Rasch model in validation of nursing diagnoses. Integrative literature review with search in LILACS, PUBMED, CINAHL, and SCOPUS. Five studies comprised the sample, which analyzed unidimensionality, local independence, item calibration, item reliability, separation of items and people, and differential item functioning for analyzing nursing diagnoses. The Rasch model seems to be a useful method to validate nursing diagnoses and probably also for the validation of nursing outcomes in the Nursing Outcomes Classification. The use of this model is promising, considering the advantages that it can be used in studies with several methodological designs. Methods that are able to provide more robust evidence of nursing diagnosis validity are needed to support highly accurate diagnostic findings in clinical practice. © 2016 NANDA International, Inc.

  14. Prediction of higher cost of antiretroviral therapy (ART) according to clinical complexity. A validated clinical index.

    Science.gov (United States)

    Velasco, Cesar; Pérez, Inaki; Podzamczer, Daniel; Llibre, Josep Maria; Domingo, Pere; González-García, Juan; Puig, Inma; Ayala, Pilar; Martín, Mayte; Trilla, Antoni; Lázaro, Pablo; Gatell, Josep Maria

    2016-03-01

    The financing of antiretroviral therapy (ART) is generally determined by the cost incurred in the previous year, the number of patients on treatment, and the evidence-based recommendations, but not the clinical characteristics of the population. To establish a score relating the cost of ART and patient clinical complexity in order to understand the costing differences between hospitals in the region that could be explained by the clinical complexity of their population. Retrospective analysis of patients receiving ART in a tertiary hospital between 2009 and 2011. Factors potentially associated with a higher cost of ART were assessed by bivariate and multivariate analysis. Two predictive models of "high-cost" were developed. The normalized estimated (adjusted for the complexity scores) costs were calculated and compared with the normalized real costs. In the Hospital Index, 631 (16.8%) of the 3758 patients receiving ART were responsible for a "high-cost" subgroup, defined as the highest 25% of spending on ART. Baseline variables that were significant predictors of high cost in the Clinic-B model in the multivariate analysis were: route of transmission of HIV, AIDS criteria, Spanish nationality, year of initiation of ART, CD4+ lymphocyte count nadir, and number of hospital admissions. The Clinic-B score ranged from 0 to 13, and the mean value (5.97) was lower than the overall mean value of the four hospitals (6.16). The clinical complexity of the HIV patient influences the cost of ART. The Clinic-B and Clinic-BF scores predicted patients with high cost of ART and could be used to compare and allocate costs corrected for the patient clinical complexity. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  15. Preliminary Validation of a Screening Tool for Adolescent Panic Disorder in Pediatric Primary Care Clinics

    Science.gov (United States)

    Queen, Alexander H.; Ehrenreich-May, Jill; Hershorin, Eugene R.

    2012-01-01

    This study examines the validity of a brief screening tool for adolescent panic disorder (PD) in a primary care setting. A total of 165 participants (ages 12-17 years) seen in two pediatric primary care clinics completed the Autonomic Nervous System Questionnaire (ANS; Stein et al. in Psychosomatic Med 61:359-364, 40). A subset of those screening…

  16. Identification and validation of clinically meaningful benchmarks in the 12-item Multiple Sclerosis Walking Scale.

    Science.gov (United States)

    Goldman, Myla D; Ward, Melanie D; Motl, Robert W; Jones, David E; Pula, John H; Cadavid, Diego

    2017-09-01

    The 12-item Multiple Sclerosis Walking Scale (12-MSWS) is a validated questionnaire which assessed walking function; it has been widely adopted in multiple sclerosis (MS) clinical research. Identify and validate clinically meaningful 12-MSWS benchmarks in MS. Cross-sectional study of 159 MS patients permitted identification of clinically meaningful 12-MSWS benchmarks based on their relationship to real-life anchors. Identified 12-MSWS benchmarks were then validated in a second population of 96 subjects using measures of ambulation, cognition, and patient-reported outcomes. 12-MSWS score of 0-24.99 was associated with working outside the home and assistance-free mobility; 25-49.99 was associated with gait disability and difficulty doing housework; 50-74.99 was associated with unemployment, government healthcare, cane use, and difficulty performing instrumental activities of daily living (IADLs); and 75-100 was associated with change in occupation due to walking, mobility impairment requiring bilateral assistance, and inability to perform IADLs. During the validation step, strong linear associations were identified between 12-MSWS benchmarks and other MS-related disability outcome measures, including ambulatory and non-ambulatory measures. We have identified clinically meaningful 12-MSWS benchmarks which define four groups differentiated by increasing levels of mobility impairment and associated loss of functional independence. These data provide insight into how 12-MSWS translate to meaningful functional limitations in MS.

  17. Developing Treatment, Treatment Validation & Treatment Scope in the Setting of an Autism Clinical Trial

    Science.gov (United States)

    2011-10-01

    Validation & Treatment Scope in the Setting of an Autism Clinical Trial PRINCIPAL INVESTIGATOR: T. Peter Stein, Ph.D...School of Osteopathic Medicine Piscataway, NJ 08854 REPORT DATE...Unlimited The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official

  18. About article "Construct and predictive validity of clinical caries diagnostic criteria assessing lesion activity."

    NARCIS (Netherlands)

    Bosch, Jaap J. ten; Huysmans, Marie-Charlotte D.N.J.M.

    2003-01-01

    Letter to the editor about article: Nyvad B, Machiulskiene V, Baelum V (2003). Construct and predictive validity of clinical caries diagnostic criteria assessing lesion activity. J Dent Res 82:117-122. Published in: J Dent Res 82(11):862-863, 2003

  19. Validation of Three Dimensions of Childhood Psychopathology in Young Clinic-Referred Boys

    Science.gov (United States)

    Loney, Jan; Carlson, Gabrielle A.; Salisbury, Helen; Volpe, Robert J.

    2005-01-01

    Short measures of child inattention-overactivity (IO), aggression-defiance (AG), and anxiety-depression or emotionality (EM) derived through a double validation procedure are administered to mothers of 243 clinic-referred suburban New York boys between 6 and 10 years of age. Mother-rated IO is uniquely related to poor performance on cognitive and…

  20. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

    Science.gov (United States)

    2016-10-01

    on the commercial use of the molecular diagnostics. What was the impact on society beyond science and technology ? Successful execution of this...clinical practice to predict aggressive disease. The accuracy of each biomarker for predicting short- and long-term progression will be characterized...multiple established and analytically validated quantitative molecular biomarkers to predict PCa progression in a multi- center active surveillance

  1. Clinical Validation of the "Sedentary Lifestyle" Nursing Diagnosis in Secondary School Students

    Science.gov (United States)

    de Oliveira, Marcos Renato; da Silva, Viviane Martins; Guedes, Nirla Gomes; de Oliveira Lopes, Marcos Venícios

    2016-01-01

    This study clinically validated the nursing diagnosis of "sedentary lifestyle" (SL) among 564 Brazilian adolescents. Measures of diagnostic accuracy were calculated for defining characteristics, and Mantel--Haenszel analysis was used to identify related factors. The measures of diagnostic accuracy showed that the following defining…

  2. Planning clinically relevant biomarker validation studies using the "number needed to treat" concept.

    Science.gov (United States)

    Day, Roger S

    2016-05-04

    Despite an explosion of translational research to exploit biomarkers in diagnosis, prediction and prognosis, the impact of biomarkers on clinical practice has been limited. The elusiveness of clinical utility may partly originate when validation studies are planned, from a failure to articulate precisely how the biomarker, if successful, will improve clinical decision-making for patients. Clarifying what performance would suffice if the test is to improve medical care makes it possible to design meaningful validation studies. But methods for tackling this part of validation study design are undeveloped, because it demands uncomfortable judgments about the relative values of good and bad outcomes resulting from a medical decision. An unconventional use of "number needed to treat" (NNT) can structure communication for the trial design team, to elicit purely value-based outcome tradeoffs, conveyed as the endpoints of an NNT "discomfort range". The study biostatistician can convert the endpoints into desired predictive values, providing criteria for designing a prospective validation study. Next, a novel "contra-Bayes" theorem converts those predictive values into target sensitivity and specificity criteria, to guide design of a retrospective validation study. Several examples demonstrate the approach. In practice, NNT-guided dialogues have contributed to validation study planning by tying it closely to specific patient-oriented translational goals. The ultimate payoff comes when the report of the completed study includes motivation in the form of a biomarker test framework directly reflecting the clinical decision challenge to be solved. Then readers will understand better what the biomarker test has to offer patients.

  3. FORENSIC-CLINICAL INTERVIEW: RELIABILITY AND VALIDITY FOR THE EVALUATION OF PSYCHOLOGICAL INJURY

    Directory of Open Access Journals (Sweden)

    Francisca Fariña

    2013-01-01

    Full Text Available Forensic evaluation of psychological injury involves the use of a multimethod approximation i.e., a psychometric instrument, normally the MMPI-2, and a clinical interview. In terms of the clinical interview, the traditional clinical interview (e.g., SCID is not valid for forensic settings as it does not fulfil the triple objective of forensic evaluation: diagnosis of psychological injury in terms of Post Traumatic Stress Disorder (PTSD, a differential diagnosis of feigning, and establishing a causal relationship between allegations of intimate partner violence (IPV and psychological injury. To meet this requirement, Arce and Fariña (2001 created the forensic-clinical interview based on two techniques that do not contaminate the contents i.e., reinstating the contexts and free recall, and a methodic categorical system of contents analysis for the diagnosis of psychological injury and a differential diagnosis of feigning. The reliability and validity of the forensic-clinical interview designed for the forensic evaluation of psychological injury was assessed in 51 genuine cases of (IPV and 54 mock victims of IPV who were evaluated using a forensic-clinical interview and the MMPI-2. The result revealed that the forensic-clinical interview was a reliable instrument (α = .85 for diagnostic criteria of psychological injury, and α = .744 for feigning strategies. Moreover, the results corroborated the predictive validity (the diagnosis of PTSD was similar to the expected rate; the convergence validity (the diagnosis of PTSD in the interview strongly correlated with the Pk Scale of the MMPI-2, and discriminant validity (the diagnosis of PTSD in the interview did not correlate with the Pk Scale in feigners. The feigning strategies (differential diagnosis also showed convergent validity (high correlation with the Scales and indices of the MMPI2 for the measure of feigning and discriminant validity (no genuine victim was classified as a feigner

  4. [Neurotoxicity of penicillin and other beta-lactam antibiotics--importance in clinical practice].

    Science.gov (United States)

    Gralewicz, S; Walusiak-Stankiewicz, J

    1997-01-01

    Epileptogenic properties of penicillin, applied either directly to the brain or systemically, have been known for many years and may be also of clinical importance. In the present work different aspects of this action, including clinical ones, as well as risk factors for the occurrence of epileptic seizures, and mechanism of penicillin action in the central nervous system have been shortly described. Moreover, results of experimental studies confirming epileptogenic properties of many antibiotics, mainly b-lactams, have been mentioned. Data from experimental studies, revealing the possibility of long-term adverse effects of repeated injections of convulsants, have been emphasized, and the absence of relevant clinical studies has been pointed out. Widespread usage of beta-lactam antibiotics should encourage medical personnel to pay more attention to all these problems in everyday clinical practice.

  5. Incidental extracerebral findings on brain nonenhanced magnetic resonance imaging: frequency, nondetection rate, and clinical importance

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Ming-Liang; Wei, Xiao-Er [School of Medicine, Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Shanghai (China); Lu, Li-Yan [Nanjing Medical University, Department of Radiology, Nanjing First Hospital, Nanjing (China); Li, Wen-Bin [School of Medicine, Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Shanghai (China); Kashgar Prefecture Second People' s Hospital, Imaging Center, Kashgar (China)

    2017-03-15

    This study aims to elucidate the frequency, nondetection rate, and clinical importance of incidental extracerebral findings (IECFs) on brain nonenhanced magnetic resonance imaging (MRI). A total of 8284 brain MRIs performed between January 1, 2015 and December 31, 2015 were evaluated for the presence of IECFs and the distribution of IECFs was analyzed. IECFs were categorized as E1 (clinically unimportant, e.g., sinus mucosal thickening); E2 (likely unimportant, e.g., pharyngeal mucosal symmetrical thickening); and E3 (potentially important, e.g., pharyngeal mucosal asymmetrical thickening). The nondetection rate was determined by comparing the results of the structured approach with the initial MRI reports. The medical records were examined for patients with E3 IECFs to assess clinical importance and outcome of these lesions. A total of 5992 IECFs were found in 4469 of the 8284 patients (54.0%). E1 findings constituted 82.2% (4924/5992) of all IECFs; E2 constituted 16.6% (995/5992) and E3 constituted 1.2% (73/5992). Overall IECFs and E1 findings were significantly more common in male patients (P < 0.05). Statistically significant difference was also seen between the different age groups (P < 0.001). The nondetection rate was 56.9% (3409/5992) for overall IECFs and 32.9% (24/73) for E3 IECFs. Of the 73 patients with E3 IECFs, 34 (46.6%) received final diagnosis and appropriate treatment during the study period. IECFs are prevalent in clinical patients on brain MR images with a nondetection rate of 32.9% for potentially important (E3) findings. The reporting of IECFs according to clinical importance is helpful for patients' management. (orig.)

  6. Diagnostic validity of clinical protocols to assess temporomandibular disk displacement disorders: a meta-analysis.

    Science.gov (United States)

    Pupo, Yasmine Mendes; Pantoja, Leticia Lopes Quirino; Veiga, Flavia Fusco; Stechman-Neto, José; Zwir, Liete Figueiredo; Farago, Paulo Vitor; De Luca Canto, Graziela; Porporatti, André Luís

    2016-11-01

    To evaluate the diagnostic validity of clinical examination protocols compared with magnetic resonance imaging (MRI) in adults with temporomandibular joint disk displacement disorders. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review was undertaken using a selection process in 2 phases; 283 different references were identified, and 10 articles were included for qualitative analysis and 7 for meta-analysis. Temporomandibular joint disorders were assessed through clinical diagnosis protocols with the aid of Research Diagnostic Criteria for Temporomandibular Disorders, Diagnostic Criteria for Temporomandibular Disorders, or Clinical Diagnostic Criteria for Temporomandibular Disorders. The authors searched the following electronic databases: Cochrane, LILACS, PubMed, Science Direct, SCOPUS, and Web of Science. Additional search of gray literature was performed. Selected studies were evaluated by using the Quality Assessment Tool for Diagnostic Accuracy Studies-2. Two subgroups were analyzed: Disk displacement with reduction (DDwR) and disk displacement without reduction (DDwoR). The validity of clinical protocols compared with MRI performed in studies evaluating only DDwR presented sensitivity of 44% (39%-49%) and specificity 51% (46%-57%). In studies evaluating only DDwoR, sensitivity was 22% (16%-30%) and specificity 93% (85%-98%). The area under the curve value for validity of clinical protocols in all studies was 0.63, 0.56 for studies evaluating DDwR and 0.64 for studies evaluating DDwoR. Area under the curve values were considered poor. Clinical examination protocols have poor validity to diagnose DDwR and DDwoR compared with MRI. MRI should be used to increase the diagnostic accuracy when the information provided can influence clinical decisions. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Relationships among victoria symptom validity test indices and personality assessment inventory validity scales in a large clinical sample.

    Science.gov (United States)

    Haggerty, Kathryn A; Frazier, Thomas W; Busch, Robyn M; Naugle, Richard I

    2007-12-01

    The purpose of this study was twofold: (1) to examine the relationships among measures of cognitive symptom exaggeration (i.e., response accuracy and response latency) and (2) to examine the relationship between measures of cognitive and psychopathological symptom exaggeration. It was expected that Victoria Symptom Validity Test (VSVT) accuracy and latency measures would be significantly correlated, with invalid responders demonstrating longer response latencies. VSVT scores were also expected to correlate significantly with the Negative Impression Management (NIM) and Infrequency (INF) subscales of the Personality Assessment Inventory (PAI). VSVT and PAI data were collected from 300 patients during routine clinical neuropsychological evaluations. Results indicated that VSVT accuracy and latency measures were significantly and moderately correlated, and both types of VSVT scores were significantly, but modestly, related to NIM, but not INF. These findings suggest that VSVT response latencies may supplement accuracy scores in identifying patients who are exerting suboptimal effort on cognitive measures. These findings further suggest that measures of cognitive symptom validity only partially overlap with measures of psychopathological symptom exaggeration.

  8. Concurrent criterion-related validity and reliability of a clinical test to measure femoral anteversion.

    Science.gov (United States)

    Souza, Richard B; Powers, Christopher M

    2009-08-01

    Clinical measurement, criterion standard. To determine if the clinical measure of femoral anteversion is comparable to measures obtained from magnetic resonance imaging (MRI). An additional purpose of this study was to assess the intertester and intratester reliability of the clinical test. Femoral anteversion is commonly assessed as part of the physical examination; however, limited and inconsistent data exist on the validity and reliability of the clinical test. Eighteen healthy adults (9 males, 9 females; mean +/- SD age, 25.4 +/- 3.3 years; body mass index, 22.9 +/- 3.4 kg/m2) participated. Each underwent 3 data collection sessions: (1) MRI to measure femoral anteversion, (2) clinical testing of femoral anteversion, measured independently by 2 physical therapists, and (3) repeated clinical testing. Validity and reliability were assessed using intraclass correlation coefficient (ICC2,3) and standard error of measurement (SEM). Moderate agreement was found between the clinical test and MRI measures of femoral anteversion (ICCs of 0.69 and 0.67 for examiners 1 and 2, respectively). The SEM was similar for both examiners (5.8 degrees and 6.0 degrees ). Both intra tester (ICCs of 0.88 and 0.90 for examiners 1 and 2, respectively) and intertester (ICC = 0.83) reliability was found to be substantial. In persons with a low body mass index, the clinical test to assess femoral anteversion was shown to exhibit substantial reliability, but only moderate agreement with MRI measurements. When performing the clinical test, one can be 95% confident that the true value of femoral anteversion will fall within 11.8 degrees of the clinically measured value. This relatively wide confidence interval calls into question the clinical utility of the clinical test for assessing femoral anteversion.

  9. Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection

    Science.gov (United States)

    Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection, a 2013 workshop sponsored by the Epidemiology and Genomics Research Program.

  10. Acute viral bronchiolitis: Physician perspectives on definition and clinically important outcomes.

    Science.gov (United States)

    Fernandes, Ricardo M; Andrade, Maria Gabriela; Constant, Carolina; Malveiro, Duarte; Magalhães, Manuel; Abreu, Daisy; Azevedo, Inês; Sousa, Eduarda; Salgado, Rizério; Bandeira, Teresa

    2016-07-01

    Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  11. The attitudes of medical students in Europe toward the clinical importance of histology.

    Science.gov (United States)

    Moxham, Bernard John; Emmanouil-Nikoloussi, Elpida; Brenner, Erich; Plaisant, Odile; Brichova, Hana; Kucera, Tomas; Pais, Diogo; Stabile, Isobel; Borg, Jordy; Scholz, Michael; Paulsen, Friedrich; Luis Bueno-López, José; Alfonso Arraez Aybar, Luis; De Caro, Raffaele; Arsic, Stojanka; Lignier, Baptiste; Chirculescu, Andy

    2017-07-01

    Many studies have been undertaken to assess the attitudes of medical students to the clinical importance of gross anatomy. However, much less is known about their attitudes toward the clinical importance of histology. Using Thurstone and Chave methods to assess attitudes, over 2,000 early stage medical students across Europe provided responses to a survey that tested the hypothesis that the students have a high regard for histology's clinical relevance. Regardless of the university and country surveyed, and of the teaching methods employed for histology, our findings were not consistent with our hypotheses, students providing a more moderate assessment of histology's importance compared to gross anatomy but more positive than their attitudes toward embryology. Histology should play a significant role in medical education in terms of appreciating not just normal structure and function but also pathology. We conclude that teachers of histology should pay special attention to informing newly-recruited medical students of the significant role played by histology in attaining clinical competence and in underpinning their status as being learned members of a healthcare profession. This work was conducted under the auspices of the Trans-European Pedagogic Research Group (TEPARG). Clin. Anat. 30:635-643, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  12. Validity Evidences for the Dimensional Clinical Personality Inventory in Outpatient Psychiatric Sample

    Directory of Open Access Journals (Sweden)

    Roberta Katz Abela

    2015-08-01

    Full Text Available The Dimensional Clinical Personality Inventory (IDCP was developed in Brazil for the assessment of pathological personality traits. This study aimed to seek validity evidence for the dimensions of IDCP based on external criteria, psychiatric diagnosis. We examined the profile in IDCP of 105 psychotherapy outpatients, previously diagnosed with personality disorders. The profiles were compared with the profile of the normative non-clinical sample and we conducted the repeated measures analysis to investigate whether the IDCP is able to discriminate consistent profiles for different diagnoses and compared the general population. The results suggest validity evidence based on external criteria for the IDCP dimensions and points to the clinical effectiveness of the instrument.

  13. Validation of the Novaco Anger Scale-Provocation Inventory (Danish) With Nonclinical, Clinical, and Offender Samples

    DEFF Research Database (Denmark)

    Moeller, Stine Bjerrum; Novaco, Raymond; Heinola-Nielsen, Vivian

    2015-01-01

    . Because the Novaco Anger Scale and Provocation Inventory (NAS-PI) has been extensively validated with different clinical populations and lends itself to clinical case formulation, it was selected for translation and evaluation in the present multistudy project. Psychometric properties of the NAS-PI were...... investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant...... aggressive behavior in hospital. Regression analyses showed that higher scores on NAS increase the risk of having acted aggressively in the past and of acting aggressively in the future....

  14. Clinical characteristics of acute kidney injury in patients with scrub typhus--RIFLE criteria validation.

    Science.gov (United States)

    Sun, In O; Kim, Moon Chul; Park, Jae Woo; Yang, Min A; Lee, Cheon Beom; Yoon, Hyun Ju; Kim, Jeong Gwan; Lee, Kwang Young

    2014-02-01

    There are limited data available on the validity of the RIFLE classification for AKI in patients with scrub typhus. We investigated the incidence and clinical characteristics of scrub typhus associated AKI using the RIFLE criteria. From 2010 to 2012, 238 patients were diagnosed with scrub typhus. Of these, we included 223 patients who were followed up until renal recovery or for at least three months. We evaluated the incidence, clinical characteristics, and severity of AKI based on the RIFLE classification. Of the 223 patients, 47 (21%) had scrub typhus-associated AKI. The incidence of AKI was 21.1%; of which, 10.7%, 9.4% and 1% were classified as Risk, Injury and Failure, respectively. In comparison with patients in the non-AKI group, the patients in the AKI group were older (70 ± 9 vs 61 ± 14 year, P = 0.01) and had one or more comorbidities such as hypertension, diabetes, and chronic kidney disease (77% vs 22%, p = 0.01). In the AKI group, forty-four patients had AKI prior to admission, and three patients experienced AKI during their hospitalization. By multivariate logistic regression analysis, age and comorbidity were significant predictors of AKI. All patients recovered baseline renal function without renal replacement therapy following antibiotics therapy and supportive care. The incidence of AKI in patient with scrub typhus is 21%. Age and co-morbidity are significant predictors of AKI in scrub typhus. In cases of scrub typhus-associated AKI, anti-rickettsia agent and supportive care are very important. Copyright © 2013 Japanese Society of Chemotherapy and The Japanese Association for Infectious Disease. Published by Elsevier Ltd. All rights reserved.

  15. Minimal clinically important difference on the Motor Examination part of MDS-UPDRS.

    Science.gov (United States)

    Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Deli, Gabriella; Janszky, József; Komoly, Sámuel; Balázs, Éva; Takács, Katalin; Karádi, Kázmér; Kovács, Norbert

    2015-12-01

    Recent studies increasingly utilize the Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). However, the minimal clinically important difference (MCID) has not been fully established for MDS-UPDRS yet. To assess the MCID thresholds for MDS-UPDRS Motor Examination (Part III). 728 paired investigations of 260 patients were included. At each visit both MDS-UPDRS and Clinician-reported Global Impression-Improvement (CGI-I) scales were assessed. MDS-UPDRS Motor Examination (ME) score changes associated with CGI-I score 4 (no change) were compared with MDS-UPDRS ME score changes associated with CGI-I score 3 (minimal improvement) and CGI-I score 5 (minimal worsening). Both anchor- and distribution-based techniques were utilized to determine the magnitude of MCID. The MCID estimates for MDS-UPDRS ME were asymmetric: -3.25 points for detecting minimal, but clinically pertinent, improvement and 4.63 points for observing minimal, but clinically pertinent, worsening. MCID is the smallest change of scores that are clinically meaningful to patients. These MCID estimates may allow the judgement of a numeric change in MDS-UPDRS ME on its clinical importance. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

    Science.gov (United States)

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

    2015-04-08

    The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.

  17. Validating and Determining the Weight of Items Used for Evaluating Clinical Governance Implementation Based on Analytic Hierarchy Process Model

    Directory of Open Access Journals (Sweden)

    Elaheh Hooshmand

    2015-10-01

    Full Text Available Background The purpose of implementing a system such as Clinical Governance (CG is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. Methods The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP model. Results The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients’ non-medical needs, complaints and patients’ participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients’ non-medical needs, patients’ participation in the treatment process and research and development. Conclusion The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety.

  18. [Questionnaire to evaluate the importance of the family in nursing care. Validation of the Spanish version (FINC-NA)].

    Science.gov (United States)

    Pascual Fernández, M C; Ignacio Cerro, M C; Cervantes Estévez, L; Jiménez Carrascosa, M A; Medina Torres, M; García Pozo, A M

    2015-01-01

    The nursing profession is focused on patient care, without forgetting that patients are part of a social group, the family. The aim of this study was the adaptation of the "Families' Importance in Nursing Care-Nurses' Attitudes" (FINC-NA) scale to the Spanish language and its validation. A descriptive cross-sectional study was carried out, using the bidirectional translation method for linguistic-cultural adaptation. It was applied to the nursing staff in the Paediatric Department of a University Hospital in Madrid. To evaluate the psychometric properties of the Spanish version, reliability, internal consistence and construct validity were calculated. The sample consisted of 274 professionals. Cronbach´s Alpha coefficient for the total scale was 0.864, oscillating between 0.888 and 0.769 in the subscales. The principal components factor analysis identified 4 factors, which explained 54.22% of total variance. The new instrument makes it possible to determine the importance nurses give to participation by family members and their attitude to involving the latter in patient care, and the possibility of involving them in planning. It has been adapted to the Spanish population with good psychometrics results and enough evidence for its use in this context.

  19. Validity and clinical interpretability of Overall Anxiety Severity And Impairment Scale (OASIS).

    Science.gov (United States)

    Ito, Masaya; Oe, Yuki; Kato, Noriko; Nakajima, Shun; Fujisato, Hiroko; Miyamae, Mitsuhiro; Kanie, Ayako; Horikoshi, Masaru; Norman, Sonya B

    2015-01-01

    The Overall Anxiety Severity and Impairment Scale is a brief generic measure for anxiety that encompasses frequency and intensity as well as behavioral and functional aspects of anxiety. This study was conducted to elucidate aspects of reliability, validity, and interpretability, such as equivalence of factor loadings across non-clinical and clinical populations, convergence and discriminance of related variables, and performance of detecting diagnostic and medical status of anxiety disorders. Non-clinical and clinical Japanese populations were taken from a panelist pool registered with an internet survey company (total n=2830; 619 panic disorder, 576 for social anxiety disorder, 645 for obsessive-compulsive disorder, a 619 for major depressive disorder, and 371 for non-disorder panelists). Conventional measures of anxiety, depression, mental health and measures for discriminant validity were administered in addition to OASIS. Exploratory and confirmatory factor analyses indicated good fit to data for the one-factor model of OASIS. Multi-group confirmatory factor analysis showed the equivalence of the factor loadings between those of non-clinical and clinical subsamples. The OASIS reliability was confirmed by internal consistency and test-retest coefficients. Receiver operating characteristic curve analyses showed that OASIS and conventional anxiety measures have fair performance for detecting diagnostic and medical status as anxiety disorders. Participants were limited to a Japanese population of people who had registered themselves at an internet survey company. Along with useful information to interpret OASIS, the results suggest the reliability and validity of OASIS in Japanese populations. These results also suggest cross-cultural validity. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Clinical drug trials in general practice: how well are external validity issues reported?

    Science.gov (United States)

    Brænd, Anja Maria; Straand, Jørund; Klovning, Atle

    2017-12-29

    When reading a report of a clinical trial, it should be possible to judge whether the results are relevant for your patients. Issues affecting the external validity or generalizability of a trial should therefore be reported. Our aim was to determine whether articles with published results from a complete cohort of drug trials conducted entirely or partly in general practice reported sufficient information about the trials to consider the external validity. A cohort of 196 drug trials in Norwegian general practice was previously identified from the Norwegian Medicines Agency archive with year of application for approval 1998-2007. After comprehensive literature searches, 134 journal articles reporting results published from 2000 to 2015 were identified. In these articles, we considered the reporting of the following issues relevant for external validity: reporting of the clinical setting; selection of patients before inclusion in a trial; reporting of patients' co-morbidity, co-medication or ethnicity; choice of primary outcome; and reporting of adverse events. Of these 134 articles, only 30 (22%) reported the clinical setting of the trial. The number of patients screened before enrolment was reported in 61 articles (46%). The primary outcome of the trial was a surrogate outcome for 60 trials (45%), a clinical outcome for 39 (29%) and a patient-reported outcome for 25 (19%). Clinical details of adverse events were reported in 124 (93%) articles. Co-morbidity of included participants was reported in 54 trials (40%), co-medication in 27 (20%) and race/ethnicity in 78 (58%). The clinical setting of the trials, the selection of patients before enrolment, and co-morbidity or co-medication of participants was most commonly not reported, limiting the possibility to consider the generalizability of a trial. It may therefore be difficult for readers to judge whether drug trial results are applicable to clinical decision-making in general practice or when developing clinical

  1. CT and MR imaging of the liver. Clinical importance of nutritional status

    Energy Technology Data Exchange (ETDEWEB)

    Leander, P.; Sjoeberg, S.; Hoeglund, P. [Malmoe Univ. Hospital (Sweden). Dept. of Diagnostic Radiology

    2000-03-01

    Purpose: In an experimental study in rats a correlation between nutritional status and hepatic attenuation in CT and signal intensities in MR imaging was shown. Is physiological nutritional status of importance in clinical CT and MR imaging? Material and methods: In a cross-over study including 12 healthy volunteers (6 women and 6 men, mean age 34 years), CT and MR imaging of the liver were performed with nutritional status at three different levels, i.e., normal, fasting and after glycogen-rich meals. CT and MR were performed on clinical imaging systems and hepatic attenuation and signal intensity, respectively, were assessed. In MR, T1-weighted, proton density-weighted and T2-weighted pulse-sequences were used. Results: In CT there were significantly (p<0.01) higher liver attenuations in normal nutritional status and after glycogen rich-meals compared to the fasting condition. The difference between fasting and glycogen-rich meals were 10.5 HU for men, 7.4 for women and mean 8.8 HU for all 12 volunteers. In MR imaging the differences were small and non-significant. The results of this study are in accordance with an earlier experimental study in rats. Conclusion: In CT it may be of importance not to have patients in a fasting condition as it lowers the attenuation in normal liver tissue. The findings are important for planning of clinical studies where hepatic attenuation will be assessed and may be of some importance in clinical CT. In MR imaging the results indicate that the nutritional status is of less importance.

  2. Fit for purpose and modern validity theory in clinical outcomes assessment.

    Science.gov (United States)

    Edwards, Michael C; Slagle, Ashley; Rubright, Jonathan D; Wirth, R J

    2017-07-07

    The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is "fit for purpose" when used in clinical trials to support drug approval and product labeling. In this paper, we will provide a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred to broadly as validity and has itself evolved over many years of research and application. After a brief introduction, the first section will review current ideas about "fit for purpose" and how it has been viewed by FDA. This section will also describe some of the unique challenges to COA development/evaluation/use in the clinical trials space. Following this, we provide an overview of modern validity theory as it is currently understood in the psychometric tradition. This overview will focus primarily on the perspective of validity theorists such as Messick and Kane whose work forms the backbone for the bulk of high-stakes assessment in areas such as education, psychology, and health outcomes. We situate the concept of fit for purpose within the broader context of validity. By comparing and contrasting the approaches and the situations where they have traditionally been applied, we identify areas of conceptual overlap as well as areas where more discussion and research are needed.

  3. Cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score to Brazilian Portuguese

    Directory of Open Access Journals (Sweden)

    Juliana Machado Schardosim

    2014-10-01

    Full Text Available OBJECTIVE: to describe the process of cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score.METHODS: this methodological cross-cultural adaptation study included five steps: initial translation, synthesis of the initial translation, back translation, review by an Committee of Specialists and testing of the pre-final version, and an observational cross-sectional study with analysis of the psychometric properties using the Adjusted Kappa, Intraclass Correlation Coefficient, and Bland-Altman Method statistical tests. A total of 38 professionals were randomly recruited to review the clarity of the adapted instrument, and 47 newborns hospitalized in the Neonatology Unit of the Clinical Hospital of Porto Alegre were selected by convenience for the clinical validation of the instrument.RESULTS: the adapted scale showed approximately 85% clarity. The statistical tests showed moderate to strong intra and interobserver item to item reliability and from strong to very strong in the total score, with a variation of less than 2 points among the scores assigned by the nurses to the patients.CONCLUSIONS: the scale was adapted and validated to Brazilian Portuguese. The psychometric properties of the Brazilian version of the Neonatal Skin Condition Score instrument were similar to the validation results of the original scale.

  4. Evidence for the criterion validity and clinical utility of the Pathological Narcissism Inventory

    Science.gov (United States)

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

    2012-01-01

    In this study we evaluated aspects of criterion validity and clinical utility of the grandiosity and vulnerability components of the Pathological Narcissism Inventory (PNI) using two undergraduate samples (Ns = 299, 500). Criterion validity was assessed by evaluating the correlations of narcissistic grandiosity and narcissistic vulnerability with established indices of normal personality traits, psychopathology and clinical concerns, and pathological personality traits. Overall, the pattern of correlations supported the convergent and discriminate validity of grandiose and vulnerable conceptualizations of pathological narcissism as measured by the PNI. Clinical utility was assessed by evaluating the extent to which clinicians without specific training in pathological narcissism as well as clinicians with expertise in pathological narcissism could accurately predict the correlates of PNI grandiosity and vulnerability with normal and pathological personality traits and psychopathology. The rcontrast-cv coefficient (Westen & Rosenthal, 2003) provided a global index of accuracy in clinicians’ predictions that was more fully elaborated by examining systematic discrepancies across groups. Overall, novice and expert clinicians were generally able to predict criterion correlations, with some exceptions (e.g., counter to predictions, pathological narcissism was negatively associated with treatment resistance). These results provide further evidence regarding the validity and utility of the narcissistic grandiosity and narcissistic vulnerability constructs as measured by the PNI. PMID:22315481

  5. Is Doubling of Serum Creatinine a Valid Clinical 'Hard' Endpoint in Clinical Nephrology Trials?

    NARCIS (Netherlands)

    Lambers Heerspink, H. J.; Perkovic, V.; de Zeeuw, D.

    2011-01-01

    The composite of end stage renal disease (ESRD), doubling of serum creatinine and (renal) death, is a frequently used endpoint in randomized clinical trials in nephrology. Doubling of serum creatinine is a well-accepted part of this endpoint because a doubling of serum creatinine reflects a large

  6. Revival, modernization and integration of Indian traditional herbal medicine in clinical practice: Importance, challenges and future.

    Science.gov (United States)

    Sen, Saikat; Chakraborty, Raja

    2017-04-01

    In spite of incredible advances in modern science, technology and allopathic medicine a large we are unable to provide quality healthcare to all. Traditional medicine particularly herbal medicine considered as a major healthcare provider around the globe particularly in rural and remote areas. A large section of people depends on such medicine for their primary healthcare mainly in underdeveloped or developing countries. Indian traditional medicinal system like Ayurveda, Siddha and Unani has a very rich history of their effectiveness; modern research also acknowledged the importance of such medicine. Indian traditional medicine or medicinal plants are also considered as a vital source of new drug. Mainstreaming of such medicine is important for the people. Several steps have been taken in India to promote such medicine and to integrate them into clinical practice. Evidence based incorporation of Indian traditional medicine in clinical practice will help to provide quality healthcare to all.

  7. Association between clinically important depressive symptoms and academic achivement among students in Cartagena, Colombia

    Directory of Open Access Journals (Sweden)

    Zuleima Cogollo

    2007-06-01

    Full Text Available Background: Some studies show a strongassociation between depressive symptoms andacademic achievement in the adolescent population.However, there are few Colombian publicationsabout this topic.Objective: To establish the association betweenclinically important depressive symptoms and academic achievement among low socioeconomicstatus adolescent students.Method: A group of 13 to 17 year-aged adolescentswas studied. Meaningful clinically depressivesymptoms were measured with Zung’self-rating depression scale (40/80. Academicachievement was evaluated according to Colombianqualitative model.Results: A total of 43.5% of students reportedclinically important depressive symptoms and30.7% accomplished a poor academic achievement,according to teacher report. The academicachievement was independent of meaningfulclinically depressive symptoms, after controllingother variables.Conclusion: Meaningful clinically depressivesymptoms are frequent in low socioeconomic statusadolescent students. But, meaningful clinicallydepressive symptoms are not associatedwith academic performance. Further investigationsare needed.

  8. Zika virus and the risk of imported infection in returned travelers: Implications for clinical care.

    Science.gov (United States)

    Goorhuis, Abraham; von Eije, Karin J; Douma, Renée A; Rijnberg, Noor; van Vugt, Michele; Stijnis, Cornelis; Grobusch, Martin P

    2016-01-01

    Since late 2015, an unprecedented outbreak of Zika virus is spreading quickly across Southern America. The large size of the current outbreak in The Americas will also result in an increase in Zika virus infections among travelers returning from endemic areas. We report five cases of imported Zika virus infection to The Netherlands. Although the clinical course is usually mild, establishing the diagnosis is important, mainly because of the association with congenital microcephaly and the possibility of sexual transmission. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Validation of computerized diagnostic information in a clinical database from a national equine clinic network

    Directory of Open Access Journals (Sweden)

    Egenvall Agneta

    2009-12-01

    Full Text Available Abstract Background Computerized diagnostic information offers potential for epidemiological research; however data accuracy must be addressed. The principal aim of this study was to evaluate the completeness and correctness of diagnostic information in a computerized equine clinical database compared to corresponding hand written veterinary clinical records, used as gold standard, and to assess factors related to correctness. Further, the aim was to investigate completeness (epidemiologic sensitivity, correctness (positive predictive value, specificity and prevalence for diagnoses for four body systems and correctness for affected limb information for four joint diseases. Methods A random sample of 450 visits over the year 2002 (nvisits = 49,591 was taken from 18 nation wide clinics headed under one company. Computerized information for the visits selected and copies of the corresponding veterinary clinical records were retrieved. Completeness and correctness were determined using semi-subjective criteria. Logistic regression was used to examine factors associated with correctness for diagnosis. Results Three hundred and ninety six visits had veterinary clinical notes that were retrievable. The overall completeness and correctness were 91% and 92%, respectively; both values considered high. Descriptive analyses showed significantly higher degree of correctness for first visits compared to follow up visits and for cases with a diagnostic code recorded in the veterinary records compared to those with no code noted. The correctness was similar regardless of usage category (leisure/sport horse, racing trotter and racing thoroughbred or gender. For the four body systems selected (joints, skin and hooves, respiratory, skeletal the completeness varied between 71% (respiration and 91% (joints and the correctness ranged from 87% (skin and hooves to 96% (respiration, whereas the specificity was >95% for all systems. Logistic regression showed that

  10. Validation of computerized diagnostic information in a clinical database from a national equine clinic network.

    Science.gov (United States)

    Penell, Johanna C; Bonnett, Brenda N; Pringle, John; Egenvall, Agneta

    2009-12-10

    Computerized diagnostic information offers potential for epidemiological research; however data accuracy must be addressed. The principal aim of this study was to evaluate the completeness and correctness of diagnostic information in a computerized equine clinical database compared to corresponding hand written veterinary clinical records, used as gold standard, and to assess factors related to correctness. Further, the aim was to investigate completeness (epidemiologic sensitivity), correctness (positive predictive value), specificity and prevalence for diagnoses for four body systems and correctness for affected limb information for four joint diseases. A random sample of 450 visits over the year 2002 (nvisits=49,591) was taken from 18 nation wide clinics headed under one company. Computerized information for the visits selected and copies of the corresponding veterinary clinical records were retrieved. Completeness and correctness were determined using semi-subjective criteria. Logistic regression was used to examine factors associated with correctness for diagnosis. Three hundred and ninety six visits had veterinary clinical notes that were retrievable. The overall completeness and correctness were 91% and 92%, respectively; both values considered high. Descriptive analyses showed significantly higher degree of correctness for first visits compared to follow up visits and for cases with a diagnostic code recorded in the veterinary records compared to those with no code noted. The correctness was similar regardless of usage category (leisure/sport horse, racing trotter and racing thoroughbred) or gender.For the four body systems selected (joints, skin and hooves, respiratory, skeletal) the completeness varied between 71% (respiration) and 91% (joints) and the correctness ranged from 87% (skin and hooves) to 96% (respiration), whereas the specificity was >95% for all systems. Logistic regression showed that correctness was associated with type of visit, whether

  11. Standardization, Clinical Validation, and Typicality Norms of a New Test Assessing Semantic Verbal Fluency.

    Science.gov (United States)

    Quaranta, Davide; Caprara, Alessia; Piccininni, Chiara; Vita, Maria G; Gainotti, Guido; Marra, Camillo

    2016-08-01

    Semantic verbal fluency (SVF) tests are widely used in clinical neuropsychology. We propose the standardization and clinical validation of a new SVF test based on the production of names of birds and articles of furniture (Birds and Articles of Furniture test-BAF). A sample of 268 subjects aged 40 years or more underwent the test. The clinical validation was conducted on subjects affected by amnesic Mild Cognitive Impairment (aMCI; N = 106), mild (N = 178), and moderate (N = 114) Alzheimer's disease (AD). The BAF total score was influenced by both age and education, whereas the single scores obtained on BAF were also influenced by gender. The percentage of subjects with pathological score on BAF increased from aMCI (19%) to mild (45.5%) and moderate (71.1%) AD, and receiver operating characteristic curves analysis showed that the BAF may be highly reliable in distinguishing aMCI and AD patients from healthy subjects. We also provide typicality norms for birds and articles of furniture that could be useful in the assessment of qualitative features of words produced in semantic fluency tests. The BAF test could be a valid and reliable tool in both clinical practice and research on subjects affected by cognitive impairment. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Minimal clinically important difference in plain films in RA: Group discussions, conclusions, and recommendations

    OpenAIRE

    van der Heijde, Desiree; Lassere, M.; Edmonds, J.; Kirwan, J; Strand, V.; Boers, M

    2001-01-01

    Analysis of progression of structural damage on an individual patient level in randomized controlled trials provides extra information in addition to the analysis on a group level. A cutoff level is required to define which patients show progression and which patients do not. The objective of the mimimal clinically important difference (MCID) module for plain films was to elaborate the various concepts to determine a MCID for plain films, and if possible, to define a MCID for specific scoring...

  13. Cardiovascular magnetic resonance imaging in hypertrophic cardiomyopathy: the importance of clinical context.

    Science.gov (United States)

    Quarta, Giovanni; Aquaro, Giovanni Donato; Pedrotti, Patrizia; Pontone, Gianluca; Dellegrottaglie, Santo; Iacovoni, Attilio; Brambilla, Paolo; Pradella, Silvia; Todiere, Giancarlo; Rigo, Fausto; Bucciarelli-Ducci, Chiara; Limongelli, Giuseppe; Roghi, Alberto; Olivotto, Iacopo

    2017-12-22

    In patients with suspected or established hypertrophic cardiomyopathy (HCM), cardiovascular magnetic resonance (CMR) is widely employed for clinical management, given its multimodality approach capable of providing unique information on cardiac morphology, function, and tissue characterization. Guidance regarding all aspects of HCM diagnosis and management is provided by the comprehensive 2014 European Society of Cardiology (ESC) guidelines on HCM. CMR should be performed in centres with recognized expertise in heart muscle diseases, by physicians who are familiar with the whole HCM disease spectrum, differential diagnoses, and pitfalls. Because CMR is usually performed and interpreted by physicians not directly involved in patient care, detailed, bidirectional, and standardized communication becomes essential to obtain best results and avoid misinterpretation. In order to maximize the potential of CMR, it is of paramount importance that reporting physicians are provided with the essential clinical information and that, in turn, referring physicians are given a core set of CMR morphological, functional, and tissue characterization results following the test. This article aims to summarize the current knowledge on the role of CMR in managing HCM and, in addition, to review the importance of the clinical context in which the report is provided, in both adult and paediatric population, highlighting implications for clinical research. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  14. Diagnosing migraine in research and clinical settings: The validation of the Structured Migraine Interview (SMI)

    Science.gov (United States)

    2010-01-01

    Background Migraine is a common disorder that is highly co-morbid with psychopathological conditions such as depression and anxiety. Despite the extensive research and availability of treatment, migraine remains under-recognised and undertreated. The aim of this study was to design a short and practical screening tool to identify migraine for clinical and research purposes. Methods The structured migraine interview (SMI) based on the International Classification of Headache Disorders (ICHD) criteria was used in a clinical setting of headache sufferers and compared to clinical diagnosis by headache specialist. In addition to the validating characteristics of the interview different methods of administration were also tested. Results The SMI has high sensitivity (0.87) and modest specificity (0.58) when compared to headache specialist's clinical diagnosis. Conclusions Our study demonstrated that a structured interview based on the ICHD criteria is a useful and valid tool to identify migraine in research settings and to a limited extent in clinical settings, and could be used in studies on large samples where clinical interviews are less practical. PMID:20074361

  15. [The importance of electrocardiography in the clinical course of electric injuries].

    Science.gov (United States)

    Vural, Aslı; Sarak, Taner; Vural, Selahattin; Yastı, Ahmet Çınar

    2015-05-01

    The aim of the present study was to investigate the demographic and clinical characteristics of electrical injuries, type of electrical current and the importance of electrocardiography in clinical course. Fifty-three patients (50 males [94.3%], 3 females [5.7%]; mean age 34.5±9.6; range 19 to 61 years) with electrical injuries treated in the burn center between 2011 and 2012 were retrospectively analyzed. The patients were evaluated for demographic and clinical characteristics, electrocardiographic findings and clinical outcomes. The electrocardiography findings of the patients were as follows: twenty-seven normal, twelve sinus tachycardia, three atrial fibrillation, seven right bundle brunch block, and four ventricular extra-systole. There was no mortality among patients with electrocardiographic findings of normal, right bundle brunch block, and ventricular extra-systole. Four patients with sinus tachycardia and one patient with atrial fibrillation died. Electrocardiographic findings of the patients wounded by high-voltage electricity were: two normal, two sinus tachycardia, and one atrial fibrillation. Mortality was higher in patients with sinus tachycardia and atrial fibrillation in the electrocardiography at the time of admission. These ECG findings were more often in patients wounded by high-voltage electricity. Therefore, electrocardiographic findings and type of the electrical current may provide prognostic value in the clinical course of patients.

  16. ALMA, a new tool for the management of asthma patients in clinical practice: development, validation and initial clinical findings.

    Science.gov (United States)

    Kiotseridis, Hampus; Bjermer, Leif; Pilman, Eva; Ställberg, Björn; Romberg, Kerstin; Tunsäter, Alf

    2012-06-01

    Several instruments have been developed for measuring asthma control, but there is still a need to provide a structure for primary care asthma reviews. The Active Life with Asthma (ALMA) tool was developed with the aim of structuring patient visits and assessing asthma treatment in primary care. The ability of ALMA to map out the care of asthma patients was evaluated and validated. ALMA was developed with patient and clinical expert input. Questions were generated in focus groups and the resulting tool was subsequently validated by factor analysis in 1779 patients (1116 females) of mean age 51 years (range 18-89) in primary care. The ALMA tool includes 19 questions, 14 of which belong to a subset assessing asthma control. In this subset, factor analysis revealed three domains (factors): physical, psychological, and environmental triggers. Correlation with the Asthma Control Questionnaire was 0.72 and the Cronbach's alpha was 0.88. The test-retest reliability was 0.93. Of the 1779 patients tested with ALMA in primary care, 62% reported chest tightness, 30% nightly awakenings and 45% asthma breakthrough despite medication. The ALMA tool is useful as a follow-up instrument in clinical practice to structure patient visits and assess asthma treatment in primary care. The breadth of the questions and the pragmatic use in clinical practice also make it useful as an outcome measure.

  17. Assessing the reliability, validity, and use of the Lasater Clinical Judgment Rubric: three approaches.

    Science.gov (United States)

    Adamson, Katie Anne; Gubrud, Paula; Sideras, Stephanie; Lasater, Kathie

    2012-02-01

    The purpose of this article is to summarize the methods and findings from three different approaches examining the reliability and validity of data from the Lasater Clinical Judgment Rubric (LCJR) using human patient simulation. The first study, by Adamson, assessed the interrater reliability of data produced using the LCJR using intraclass correlation (2,1). Interrater reliability was calculated to be 0.889. The second study, by Gubrud-Howe, used the percent agreement strategy for assessing interrater reliability. Results ranged from 92% to 96%. The third study, by Sideras, used level of agreement for reliability analyses. Results ranged from 57% to 100%. Findings from each of these studies provided evidence supporting the validity of the LCJR for assessing clinical judgment during simulated patient care scenarios. This article provides extensive information about psychometrics and appropriate use of the LCJR and concludes with recommendations for further psychometric assessment and use of the LCJR. Copyright 2012, SLACK Incorporated.

  18. The Victorian Gambling Screen: reliability and validation in a clinical population.

    Science.gov (United States)

    Tolchard, B; Battersby, M W

    2010-12-01

    There is a need to establish reliability and the various forms of validity in all measures in order to feel confident in the use of such tools across a wide diversity of settings. The aim of this study is to describe the reliability and validity of the Victorian Gambling Screen (VGS) and in particular one of the sub-scales (Harm to Self-HS) in a specialist problem gambling treatment service in Adelaide, Australia. Sixty-seven consecutive gamblers were assessed using a previously validated clinical interview and the VGS (Ben-Tovim et al., The Victorian Gambling Screen: project report. Victorian Research Panel, Melbourne, 2001). The internal consistency of the combined VGS scales had a Cronbach's alpha of .85 with the HS scale .89. There was satisfactory evidence of convergent validity which included moderate correlations with another measure of gambling-the South Oaks Gambling Screen. There were also moderate correlations with other measures of psychopathology. Finally, how the VGS may best be used in clinical settings is discussed.

  19. Cultural adaptation and validation of the Portuguese version of the Nursing Clinical Facilitators Questionnaire

    Directory of Open Access Journals (Sweden)

    Maria Manuela Frederico-Ferreira

    Full Text Available ABSTRACT Objective: to perform the cultural adaptation to Portuguese of the Nursing Clinical Facilitators Questionnaire (NCFQ, which was designed by the Centre for Learning and Teaching at the University of Technology of Sydney, and to validate this instrument. Methods: this methodological study involved the cultural adaptation of the questionnaire by using translation, back-translation, semantic comparison, idiomatic and conceptual equivalence, and validation through validity and reliability analyses and used a sample of 767 students in their second year of the Nursing Program. Results: construct validity had a two-factor solution according to the varimax rotation method. In addition, there was a high overall internal consistency for the questionnaire (Cronbach's alpha of 0.977 and for the factors found (0.966 and 0.952, respectively. Conclusion: the Portuguese version has good psychometric characteristics; therefore, it is adequate to obtain reliable information on the perception of nursing students concerning the type of supervision that is provided in clinical practice, and this version is adequate to improve teaching practices.

  20. The feasibility and validity of care mapping in the clinical neurosciences.

    Science.gov (United States)

    O'Hanlon, Katie; Leigh, Andrew; Sheldrick, Russell; Surr, Claire; Hare, Dougal Julian

    2015-01-01

    Dementia Care Mapping (DCM) is an observational tool and process that is widely used in dementia care in measuring and improving person-centred care (PCC). DCM was previously piloted on a neurorehabilitation ward, where it was found to be feasible and acceptable in this setting. Following this, a new modified tool and accompanying manual were developed: Care Mapping - Neurorehabilitation (DCM-NR). The current study aimed to assess the feasibility and validity of DCM-NR by piloting its use in a range of clinical neuroscience settings. A mixed-methods design was used employing both quantitative and qualitative techniques. The new DCM-NR was found to be feasible for use both in terms of the suitability of its coding system and the implementation process. DCM-NR was shown to have a moderate level of concurrent validity with participants' self-report of PCC. Participants' subjective reports on their experiences of care provided validation for the areas of psychological need observed in DCM-NR. The results of this study indicate that DCM-NR is feasible and valid for use in a range of clinical neuroscience settings. Further longitudinal research is required to evaluate the impact of DCM-NR on PCC practices over time.

  1. Valuing structured professional judgment: predictive validity, decision-making, and the clinical-actuarial conflict.

    Science.gov (United States)

    Falzer, Paul R

    2013-01-01

    Structured professional judgment (SPJ) has received considerable attention as an alternative to unstructured clinical judgment and actuarial assessment, and as a means of resolving their ongoing conflict. However, predictive validity studies have typically relied on receiver operating characteristic (ROC) analysis, the same technique commonly used to validate actuarial assessment tools. This paper presents SPJ as distinct from both unstructured clinical judgment and actuarial assessment. A key distinguishing feature of SPJ is the contribution of modifiable factors, either dynamic or protective, to summary risk ratings. With modifiable factors, the summary rating scheme serves as a prognostic model rather than a classification procedure. However, prognostic models require more extensive and thorough predictive validity testing than can be provided by ROC analysis. It is proposed that validation should include calibration and reclassification techniques, as well as additional measures of discrimination. Several techniques and measures are described and illustrated. The paper concludes by tracing the limitations of ROC analysis to its philosophical foundation and its origin as a statistical theory of decision-making. This foundation inhibits the performance of crucial tasks, such as determining the sufficiency of a risk assessment and examining the evidentiary value of statistical findings. The paper closes by noting a current effort to establish a viable and complementary relationship between SPJ and decision-making theory. Copyright © 2013 John Wiley & Sons, Ltd.

  2. Semantic validation of the use of SNOMED CT in HL7 clinical documents

    Directory of Open Access Journals (Sweden)

    Heymans Stijn

    2011-07-01

    Full Text Available Abstract Background The HL7 Clinical Document Architecture (CDA constrains the HL7 Reference Information model (RIM to specify the format of HL7-compliant clinical documents, dubbed CDA documents. The use of clinical terminologies such as SNOMED CT® further improves interoperability as they provide a shared understanding of concepts used in clinical documents. However, despite the use of the RIM and of shared terminologies such as SNOMED CT®, gaps remain as to how to use both the RIM and SNOMED CT® in HL7 clinical documents. The HL7 implementation guide on Using SNOMED CT in HL7 Version 3 is an effort to close this gap. It is, however, a human-readable document that is not suited for automatic processing. As such, health care professionals designing clinical documents need to ensure validity of documents manually. Results We represent the CDA using the Ontology Web Language OWL and further use the OWL version of SNOMED CT® to enable the translation of CDA documents to so-called OWL ontologies. We formalize a subset of the constraints in the implementation guide on Using SNOMED CT in HL7 Version 3 as OWL Integrity Constraints and show that we can automatically validate CDA documents using OWL reasoners such as Pellet. Finally, we evaluate our approach via a prototype implementation that plugs in the Open Health Workbench. Conclusions We present a methodology to automatically check the validity of CDA documents which make reference to SNOMED CT® terminology. The methodology relies on semantic technologies such as OWL. As such it removes the burden from IT health care professionals of having to manually implement such guidelines in systems that use HL7 Version 3 documents.

  3. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  4. Semantic validation of the use of SNOMED CT in HL7 clinical documents.

    Science.gov (United States)

    Heymans, Stijn; McKennirey, Matthew; Phillips, Joshua

    2011-07-15

    The HL7 Clinical Document Architecture (CDA) constrains the HL7 Reference Information model (RIM) to specify the format of HL7-compliant clinical documents, dubbed CDA documents. The use of clinical terminologies such as SNOMED CT® further improves interoperability as they provide a shared understanding of concepts used in clinical documents. However, despite the use of the RIM and of shared terminologies such as SNOMED CT®, gaps remain as to how to use both the RIM and SNOMED CT® in HL7 clinical documents. The HL7 implementation guide on Using SNOMED CT in HL7 Version 3 is an effort to close this gap. It is, however, a human-readable document that is not suited for automatic processing. As such, health care professionals designing clinical documents need to ensure validity of documents manually. We represent the CDA using the Ontology Web Language OWL and further use the OWL version of SNOMED CT® to enable the translation of CDA documents to so-called OWL ontologies. We formalize a subset of the constraints in the implementation guide on Using SNOMED CT in HL7 Version 3 as OWL Integrity Constraints and show that we can automatically validate CDA documents using OWL reasoners such as Pellet. Finally, we evaluate our approach via a prototype implementation that plugs in the Open Health Workbench. We present a methodology to automatically check the validity of CDA documents which make reference to SNOMED CT® terminology. The methodology relies on semantic technologies such as OWL. As such it removes the burden from IT health care professionals of having to manually implement such guidelines in systems that use HL7 Version 3 documents.

  5. Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Gonder-Frederick Linda

    2009-10-01

    Full Text Available Abstract Background To explore the concept of the Minimum Clinically Important Difference (MID of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II and to quantify the clinical importance of different types of patient-reported hypoglycaemia. Methods An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM, and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. Results 112 patients (28.6% reported hypoglycaemic episodes, with 15 patients (3.8% reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6 and without (12.1 need for assistance scored higher on the HFS-II (range 0 to 72 than patients who did not report hypoglycaemia (6.0. Conclusion We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.

  6. Validity, reliability, and feasibility of clinical staging scales in dementia: a systematic review

    DEFF Research Database (Denmark)

    Rikkert, Marcel G M Olde; Tona, Klodiana Daphne; Janssen, Lieneke

    2011-01-01

    in only 25%. The scales can be applied in ±15 minutes. Clinical Dementia Rating (CDR), Global Deterioration scale (GDS), and Functional Assessment Staging (FAST) have been monitored on reliability and validity, and the CDR currently is the best-evidenced scale, also studied in international perspective......, and is available in 14 languages. Taking into account the increasing differentiation of Alzheimer's disease in preclinical and predementia stages, there is an urgent need for global rating scales to be refined as well....

  7. Correction to "Evidence for the Criterion Validity and Clinical Utility of the Pathological Narcissism Inventory".

    Science.gov (United States)

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

    2016-04-01

    In our article "Evidence for the Criterion Validity and Clinical Utility of the Pathological Narcissism Inventory" (2012), we provided incorrect values for the r(contrast-cv) coefficients we presented in Table 1. In the current report, we provide correct r(contrast-cv) values in Table 1 and discuss the implications of our updated results, particularly with respect to how these results differ from our initial report. © The Author(s) 2015.

  8. Validation of the Rowland Universal Dementia Assessment Scale for Multicultural Screening in Danish Memory Clinics

    DEFF Research Database (Denmark)

    Nielsen, Thomas Rune; Andersen, Birgitte Bo; Gottrup, Hanne

    2013-01-01

    Background/Aims: 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. Methods: 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...

  9. Occurrence and Diversity of Clinically Important Vibrio Species in the Aquatic Environment of Georgia.

    Science.gov (United States)

    Kokashvili, Tamar; Whitehouse, Chris A; Tskhvediani, Ana; Grim, Christopher J; Elbakidze, Tinatin; Mitaishvili, Nino; Janelidze, Nino; Jaiani, Ekaterine; Haley, Bradd J; Lashkhi, Nino; Huq, Anwar; Colwell, Rita R; Tediashvili, Marina

    2015-01-01

    Among the more than 70 different Vibrio species inhabiting marine, estuarine, and freshwater ecosystems, 12 are recognized as human pathogens. The warm subtropical climate of the Black Sea coastal area and inland regions of Georgia likely provides a favorable environment for various Vibrio species. From 2006 to 2009, the abundance, ecology, and diversity of clinically important Vibrio species were studied in different locations in Georgia and across seasons. Over a 33-month period, 1,595 presumptive Vibrio isolates were collected from the Black Sea (n = 657) and freshwater lakes around Tbilisi (n = 938). Screening of a subset of 440 concentrated and enriched water samples by PCR-electrospray ionization/mass spectrometry (PCR-ESI/MS) detected the presence of DNA from eight clinically important Vibrio species: V. cholerae, V. parahaemolyticus, V. vulnificus, V. mimicus, V. alginolyticus, V. harveyi, V. metschnikovii, and V. cincinnatiensis. Almost 90% of PCR/ESI-MS samples positive for Vibrio species were collected from June through November. Three important human-pathogenic Vibrio species (V. cholerae, V. parahaemolyticus, and V. vulnificus) were detected in 62.8, 37.8, and 21.4% of samples testing positive for Vibrios, respectively. The results of these activities suggest that natural reservoirs for human-pathogenic Vibrios exist in Georgian aquatic environments. Water temperature at all sampling sites was positively correlated with the abundance of clinically important Vibrio spp. (except V. metschnikovii), and salinity was correlated with species composition at particular Black Sea sites as well as inland reservoirs.

  10. A reliability and validity study of the cornell scale among elderly inpatients, using various clinical criteria.

    Science.gov (United States)

    Barca, Maria Lage; Engedal, Knut; Selbaek, Geir

    2010-01-01

    The validity of the Cornell Scale for Depression in Dementia is seldom studied in institutions. Two reliability studies, with 103 and 32 patients, and a validity study with 231 patients in nursing homes and in hospital were performed. They were assessed by the Cornell Scale, Clinical Dementia Rating scale and Self-Maintenance scale. A psychiatrist 'blind' to the Cornell assessment diagnosed depression according to the ICD-10, DSM-IV-TR and the Provisional Criteria for Depression in Alzheimer's Disease (PCD-dAD). Cronbach's alpha values were 0.81 and 0.95, and the mean kappa for the Cornell items were 0.91 and 0.57, respectively. In the validity study, 164 subjects had dementia; 105 (45.5%) had depression according to the ICD-10, 68 (29.9%) according to the DSM-IV-TR and 88 (53.3%) of the demented patients had depression according to the PCD-dAD. In the receiver operating characteristic analysis, the DSM-IV-TR criteria produced the highest area under the curve, i.e. 0.81 (95% CI: 0.75-0.87). A range of cutoff points for a depressive disorder was found for the various clinical criteria. The Cornell Scale is reliable and a range of cutoff points should be used for various clinical criteria of depression.

  11. Adapting social neuroscience measures for schizophrenia clinical trials, part 3: fathoming external validity.

    Science.gov (United States)

    Olbert, Charles M; Penn, David L; Kern, Robert S; Lee, Junghee; Horan, William P; Reise, Steven P; Ochsner, Kevin N; Marder, Stephen R; Green, Michael F

    2013-11-01

    It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others' mental states (self-referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance.

  12. Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies.

    Science.gov (United States)

    Cranston, Jessica S; Kaplan, Brett D; Saver, Jeffrey L

    2017-11-01

    Determining the minimal clinically important difference (MCID) is essential for evaluating novel therapies. For acute ischemic stroke, expert surveys have yielded MCIDs that are substantially higher than the MCIDs observed in actual expert behavior in guideline writing and clinical practice, potentially because of anchoring bias. We administered a structured, internet-based survey to a cross-section of academic stroke neurologists in the United States. Survey responses assessed demographic and clinical experience, and expert judgment of the MCID of the absolute increase needed in the proportion of patients achieving functional independence at 3 months to consider a novel, safe neuroprotective agent as clinically worthwhile. To mitigate anchoring bias, the survey response framework used a base 1000 rather than base 100 patient framework. Survey responses were received from 122 of 333 academic stroke neurologists, there were 23% women, 72.8% had ≥6 years of practice experience, and neurovascular disease accounted for more than half of practice time in >70%. Responder-nonresponder and continuum of resistance tests indicated that responders were representative of the full expert population. Among respondents, the median MCID was 1.3% (interquartile range, 0.8% to >2%). Stroke expert responses to MCID surveys are affected by anchoring and centrality bias. When survey design takes these into account, the expert-derived MCID for a safe acute ischemic stroke treatment is 1.1% to 1.5%, in accord with actual physician behavior in guideline writing and clinical practice. This revised MCID value can guide clinical trial design and grant-funding and regulatory agency decisions. © 2017 American Heart Association, Inc.

  13. Do we know the minimal clinically important difference (MCID) for COPD exacerbations?

    Science.gov (United States)

    Chapman, Kenneth R; Bergeron, Celine; Bhutani, Mohit; Bourbeau, Jean; Grossman, Ronald F; Hernandez, Paul; McIvor, R Andrew; Mayers, Irvin

    2013-04-01

    Frequent exacerbations of COPD are associated with accelerated loss of lung function, declining health status, increased mortality, and increased health care costs. Thus, a key objective in the management of COPD is preventing exacerbations or at least reducing their number and severity. When new interventions are examined, their value is sometimes assessed in reference to the minimal clinically important difference (MCID), a theoretical construct that may be defined and estimated numerically in several different ways. There have been limited attempts to calculate the MCID for COPD exacerbations but a figure of 20% reduction in exacerbation frequency is occasionally cited as the "established" MCID from a single manuscript reviewing six clinical trials. Our review suggests that defining and calculating the MCID for COPD exacerbations is problematic, not only because the methodology around developing endpoints for MCIDs is inconsistent, but because the impact of exacerbation reduction is likely to be influenced dramatically by the definitions of exacerbation severity used and the population's baseline status. Reference to current literature shows that at least one other estimate for exacerbation MCID as low as 4%. MCID is sometimes estimated by expert consensus; a review of articles used to shape COPD guidelines shows frequent reference to articles in which interventions yielded exacerbation differences as low as 11%. We find no evidence of an established MCID but suggest that interventions reducing exacerbations by as little as 11% appear to be regarded widely as clinically important.

  14. IMPLICATION OF ALTERNATIVE MINIMAL CLINICALLY IMPORTANT DIFFERENCE THRESHOLD ESTIMATION METHODS ON TECHNOLOGY ASSESSMENT.

    Science.gov (United States)

    Brixner, Diana; Meltzer, Eli O; Morland, Kellie; Carroll, Cathryn A; Munzel, Ullrich; Lipworth, Brian J

    2016-01-01

    Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA). Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel. The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point. The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.

  15. Minimal Clinically Important Difference of Patient Reported Outcome Measures of Lower Extremity Injuries in Orthopedics

    Science.gov (United States)

    Çelik, Derya; Çoban, Özge; Kılıçoğlu, Önder

    2017-01-01

    Purpose: MCID scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. To conduct a systematic review of the quality and content of the the minimal clinically important difference (MCID) relating to 16 patient-rated outcome measures (PROM) used in lower extremity. Methods: We conducted a systematic literature review on articles reporting MCID in lower extremity outcome measures and orthopedics from January 1, 1980, to May 10, 2016. We evaluated MCID of the 16 patient reported outcome measures (PROM) which were Harris Hip Score (HHS), Oxford Hip Score (OHS), Hip Outcome Score (HOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), The International Knee Documentation Committee Subjective Knee Form (IKDC), The Lysholm Scale, The Western Ontario Meniscal Evaluation Tool (WOMET), The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL), The Lower Extremity Functional Scale (LEFS), The Western Ontario and Mcmaster Universities Index (WOMAC), Knee İnjury And Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Kujala Anterior Knee Pain Scale, The Victorian Institute of Sports Assessment Patellar Tendinosis (Jumper’s Knee) (VİSA-P), Tegner Activity Rating Scale, Marx Activity Rating Scale, Foot And Ankle Outcome Score (FAOS), The Foot Function Index (FFI), Foot And Ankle Ability Measure (FAAM), The Foot And Ankle Disability Index Score and Sports Module, Achill Tendon Total Rupture Score(ATRS), The Victorian İnstitute Of Sports Assesment Achilles Questionnaire(VİSA-A), American Orthopaedic Foot and Ankle Society (AOFAS). A search of the PubMed/MEDLINE, PEDro and Cochrane Cen¬tral Register of Controlled Trials and Web of Science databases from the date of inception to May 1, 2016 was conducted. The terms “minimal clinically important difference,” “minimal clinically important change”, “minimal clinically important improvement” “were combined with one of the PROM as mentioned above

  16. Not lost in translation: Emerging clinical importance of the G protein-coupled estrogen receptor GPER.

    Science.gov (United States)

    Barton, Matthias

    2016-07-01

    It has been 20years that the G protein-coupled estrogen receptor (GPER) was cloned as the orphan receptor GPR30 from multiple cellular sources, including vascular endothelial cells. Here, I will provide an overview of estrogen biology and the historical background leading to the discovery of rapid vascular estrogen signaling. I will also review the recent advances in the understanding of the mechanisms underlying GPER function, its role in physiology and disease, some of the currently available GPER-targeting drugs approved for clinical use such as SERMs (selective estrogen receptor modulators) and SERDs (selective estrogen receptor downregulators). Many of currently used drugs such as tamoxifen, raloxifene, or faslodex™/fulvestrant were discovered targeting GPER many years after they had been introduced to the clinics for entirely different purposes. This has important implications for the clinical use of these drugs and their modes of action, which I have termed 'reverse translational medicine'. In addition, environmental pollutants known as 'endocrine disruptors' have been found to bind to GPER. This article also discusses recent evidence in these areas as well as opportunities in translational clinical medicine and GPER research, including medical genetics, personalized medicine, prevention, and its theranostic use. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Minimal Clinically Important Differences (MCID) in Assessing Outcomes of Post-Traumatic Stress Disorder.

    Science.gov (United States)

    Stefanovics, Elina A; Rosenheck, Robert A; Jones, Karen M; Huang, Grant; Krystal, John H

    2017-06-21

    This study sought to determine the minimal clinically important difference (MCID) for two frequently used measures of symptom severity in Post-Traumatic Stress Disorder: the Clinician Administered PTSD Scale (CAPS) and the PTSD Symptom Checklist (PCL). Data from a randomized clinical trial of antipsychotic medication in military-related treatment-resistant PTSD (N= 267) included assessments 4 times over 26 weeks. Methods for estimating the MCID were based on both the anchor-based approach, using the Clinical Global Impressions (CGI) severity and improvement scales, rated by both clinicians and patients; and the distribution-based approach (based on standardized z-scores). Severity and change scores on the CAPS and PCL were converted to z-scores and compared across CGI levels using analysis of variance. The average difference in CAPS z-scores between each of three CGI levels between "moderate" to "severe" and from "no change" to "much improved" was 0.758 for clinician CGI ratings and 0.525 for patient CGI ratings and were similar for the PCL (0.483 and 0.471) with all differences significant at pMCID estimates suggested here provide an empirical basis for determining whether statistically significant changes in CAPS and PCL scores are clinically meaningful.

  18. Emphysema and DLCO predict a clinically important difference for 6MWD decline in COPD.

    Science.gov (United States)

    Díaz, Alejandro A; Pinto-Plata, Victor; Hernández, Camila; Peña, Javier; Ramos, Cristóbal; Díaz, Juan C; Klaassen, Julieta; Patino, Cecilia M; Saldías, Fernando; Díaz, Orlando

    2015-07-01

    Exercise impairment is a central feature of chronic obstructive pulmonary disease (COPD), and a minimal clinically important difference (MCID) for 6-min walk distance (6MWD) decline (>30 m) has been associated with increased mortality. The predictors of the MCID are not fully known. We hypothesize that physiological factors and radiographic measures predict the MCID. We assessed 121 COPD subjects during 2 years using clinical variables, computed tomographic (CT) measures of emphysema, and functional measures including diffusion lung capacity for carbon monoxide (DLCO). The association between an MCID for 6MWD and clinical, CT, and physiologic predictors was assessed using logistic analysis. The C-statistic was used to assess the predictive ability of the models. Forty seven (39%) subjects had an MCID. In an imaging-based model, log emphysema and age were the best predictors of MCID (emphysema Odds Ratio [OR] 2.47 95%CI [1.28-4.76]). In a physiologic model, DLCO, age, and male gender were selected the best predictors (DLCO OR 1.19 [1.08-1.31]). The C-statistic for the ability of these models to predict an MCID was 0.71 and 0.75, respectively. In COPD patients the burden of emphysema on CT scan and DLCO predict a clinically meaningful decline in exercise capacity. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Minimal clinically important difference in myasthenia gravis: outcomes from a randomized trial.

    Science.gov (United States)

    Katzberg, Hans D; Barnett, Carolina; Merkies, Ingemar S J; Bril, Vera

    2014-05-01

    The minimal clinically important difference (MCID) is the smallest outcome change that has clinical significance. Its use has not been established in the study of myasthenia gravis (MG). Patients from a published intravenous immunoglobulin (IVIg) vs. placebo study were studied. One anchor-based and 3 distribution-based techniques were used to identify quantitative myasthenia gravis score (QMGS), repetitive nerve stimulation (RNS), and single-fiber electromyography (SFEMG) MCID cut-offs. Patients with a change-score exceeding MCID cut-offs were compared. MCID cut-offs were below a QMGS change of 3.0. Anchor-based and 1 × SEM cut-offs showed 58.3% vs. 30.7% responders (P = 0.017), ½ SD 54.2% vs. 19.2% responders (P = 0.018), and effect size 0.519 vs. 0.164 (P = 0.011) in IVIg vs. placebo. Anchor-based (P = 0.73) and effect-size (P = 0.41) MCID cut-offs did not show a difference between IVIg and placebo. MCID methods did not produce meaningful RNS cut-offs. QMGS MCID values provide clinically relevant information and are recommended in MG trials. MCID analysis shows that improvement in MG patients treated with IVIg reflects clinically meaningful changes. Copyright © 2013 Wiley Periodicals, Inc.

  20. The mollusks in zootherapy: traditional medicine and clinical-pharmacological importance

    Directory of Open Access Journals (Sweden)

    Eraldo Medeiros Costa Neto

    2006-09-01

    Full Text Available The use of animals as sources of medicines is a cross-cultural phenomenon that is historically ancient and geographically widespread. This article reviews the use of mollusks in traditional medicine and discusses the clinical and pharmacological importance of these invertebrates. The roles that mollusks play in folk practices related to the healing and/or prevention of illnesses have been recorded in different social-cultural contexts worldwide. The clinical and therapeutic use of compounds coming from different species of mollusks is recorded in the literature. The chemistry of natural products provided by oysters, mussels, clams, sluggards, and snails has been substantially investigated, but the majority of these studies have focused on the subclasses Opistobranchia and Prosobranchia. Research into the knowledge and practices of folk medicine makes possible a better understanding of the interaction between human beings and the environment, in addition to allowing the elaboration of suitable strategies for the conservation of natural resources.

  1. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II.

    Science.gov (United States)

    Chatham, C H; Taylor, K I; Charman, T; Liogier D'ardhuy, X; Eule, E; Fedele, A; Hardan, A Y; Loth, E; Murtagh, L; Del Valle Rubido, M; San Jose Caceres, A; Sevigny, J; Sikich, L; Snyder, L; Tillmann, J E; Ventola, P E; Walton-Bowen, K L; Wang, P P; Willgoss, T; Bolognani, F

    2017-09-21

    Autism Spectrum Disorder (ASD) is associated with persistent impairments in adaptive abilities across multiple domains. These social, personal, and communicative impairments become increasingly pronounced with development, and are present regardless of IQ. The Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) is the most commonly used instrument for quantifying these impairments, but minimal clinically important differences (MCIDs) on Vineland-II scores have not been rigorously established in ASD. We pooled data from several consortia/registries (EU-AIMS LEAP study, ABIDE-I, ABIDE-II, INFOR, Simons Simplex Collection and Autism Treatment Network [ATN]) and clinical investigations and trials (Stanford, Yale, Roche) resulting in a data set of over 9,000 individuals with ASD. Two approaches were used to estimate MCIDs: distribution-based methods and anchor-based methods. Distribution-based MCID [d-MCID] estimates included the standard error of the measurement, as well as one-fifth and one-half of the covariate-adjusted standard deviation (both cross-sectionally and longitudinally). Anchor-based MCID [a-MCID] estimates include the slope of linear regression of clinician ratings of severity on the Vineland-II score, the slope of linear regression of clinician ratings of longitudinal improvement category on Vineland-II change, the Vineland-II change score maximally differentiating clinical impressions of minimal versus no improvement, and equipercentile equating. Across strata, the Vineland-II Adaptive Behavior Composite standardized score MCID estimates range from 2.01 to 3.2 for distribution-based methods, and from 2.42 to 3.75 for sample-size-weighted anchor-based methods. Lower Vineland-II standardized score MCID estimates were observed for younger and more cognitively impaired populations. These MCID estimates enable users of Vineland-II to assess both the statistical and clinical significance of any observed change. Autism Res 2017. © 2017

  3. Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods

    Directory of Open Access Journals (Sweden)

    Meer van der Jos

    2009-04-01

    Full Text Available Abstract Background Effective treatment of chronic fatigue syndrome (CFS with cognitive behavioural therapy (CBT relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API, the International Physical Activity Questionnaire (IPAQ or the CFS-Activity Questionnaire (CFS-AQ. Methods The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC curves the validity of the three methods were assessed and compared. Results Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71. None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%. Conclusion The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice.

  4. Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods.

    Science.gov (United States)

    Scheeres, Korine; Knoop, Hans; Meer, van der Jos; Bleijenberg, Gijs

    2009-04-01

    Effective treatment of chronic fatigue syndrome (CFS) with cognitive behavioural therapy (CBT) relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API), the International Physical Activity Questionnaire (IPAQ) or the CFS-Activity Questionnaire (CFS-AQ). The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC) curves the validity of the three methods were assessed and compared. Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71). None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%). The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice.

  5. Measuring clinical management by physicians and nurses in European hospitals: development and validation of two scales

    Science.gov (United States)

    Plochg, Thomas; Arah, Onyebuchi A.; Botje, Daan; Thompson, Caroline A.; Klazinga, Niek S.; Wagner, Cordula; Mannion, Russell; Lombarts, Kiki; Klazinga, NS; Kringos, DS; Lombarts, MJMH; Plochg, T; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Bottaro, S; Garel, P; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Lívio, A; Eiras, M; Franca, M; Leite, I; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; DerSarkissian, M; Thompson, CA; Wang, A; Thompson, A

    2014-01-01

    Objective Clinical management is hypothesized to be critical for hospital management and hospital performance. The aims of this study were to develop and validate professional involvement scales for measuring the level of clinical management by physicians and nurses in European hospitals. Design Testing of validity and reliability of scales derived from a questionnaire of 21 items was developed on the basis of a previous study and expert opinion and administered in a cross-sectional seven-country research project ‘Deepening our Understanding of Quality improvement in Europe’ (DUQuE). Setting and Participants A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Main Outcome Measures Validity and reliability of professional involvement scales and subscales. Results Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between ‘Administration and budgeting’ and ‘Managing medical practice’ among physicians, all inter-scale correlations were management roles’ of physicians and nurses. Conclusions The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale ‘Managing medical practice’ for nurses needs further exploration. The measurement instrument can be used for international research on clinical management. PMID:24615595

  6. The importance of inducible clindamycin resistance in enterotoxin positive S. aureus isolated from clinical samples

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    Memariani M

    2009-07-01

    Full Text Available "nBackground: Clindamycin is a suitable antibiotic for treatment of skin and soft tissue infections. Moreover, it can suppress toxin production in many pathogenic bacteria such as S. aureus. There are two mechanisms of resistance in this antibiotic. Constitutive resistance can be detected by standard disk diffusion method but in the case of inducible resistance, D-test should be carried out. The main aim of this study is to determine prevalence of clindamycin inducible resistance among methicillin resistant and susceptible isolates of S. aureus isolated from different clinical samples. "nMethods: A total of 87 clinical isolates from clinical samples were collected. Methicillin resistance was determined using standard disk diffusion method. Subsequently, D-test was carried out according to CLSI guideline. Presence of the sea gene (enterotoxin A was detected by PCR using specific primers. "nResults: Out of 87 isolates, 18(20.7% were clindamycin inducible resistant while constitutive resistance was detected among 21(24.1% isolates. The 95% Confidence intervals for the proportion of inducible clindamycin resistance among clinical isolates of S. aureus was 12.2% to 29.2%. The inducible phenotype in MRSA isolates was more common than that of MSSA isolates (33.3% vs 5.1%.Significant differences were found between prevalence of inducible clindamycin resistance and type of infection (p=0.045. Importantly, there was a significant correlation between sea gene and the constitutive/inducible resistance (p<0.0001. "nConclusions: Due to the high prevalence of clindamycin inducible resistance among clinical isolates of S. aureus, we recommend D-test to avoid treatment failure.

  7. Challenges for defining minimal clinically important difference (MCID) after spinal cord injury.

    Science.gov (United States)

    Wu, X; Liu, J; Tanadini, L G; Lammertse, D P; Blight, A R; Kramer, John L K; Scivoletto, G; Jones, L; Kirshblum, S; Abel, R; Fawcett, J; Field-Fote, E; Guest, J; Levinson, B; Maier, D; Tansey, K; Weidner, N; Tetzlaff, W G; Hothorn, T; Curt, A; Steeves, J D

    2015-02-01

    This is a review article. This study discusses the following: (1) concepts and constraints for the determination of minimal clinically important difference (MCID), (2) the contrasts between MCID and minimal detectable difference (MDD), (3) MCID within the different domains of International Classification of Functioning, disability and health, (4) the roles of clinical investigators and clinical participants in defining MCID and (5) the implementation of MCID in acute versus chronic spinal cord injury (SCI) studies. The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD. The data from SCI study outcomes are dependent on many elements, including the following: the level and severity of SCI, the heterogeneity within each study cohort, the therapeutic target, the nature of the therapy, any confounding influences or comorbidities, the assessment times relative to the date of injury, the outcome measurement instrument and the clinical end-point threshold used to determine a treatment effect. Even if statistically significant differences can be established, this finding does not guarantee that the experimental therapeutic provides a person living with SCI an improved capacity for functional independence and/or an increased quality of life. The MDD statistical concept describes the smallest real change in the specified outcome, beyond measurement error, and it should not be confused with the minimum threshold for demonstrating a clinical benefit or MCID. Unfortunately, MCID and MDD are not uncomplicated estimations; nevertheless, any MCID should exceed the expected MDD plus any probable spontaneous recovery. Estimation of an MCID for SCI remains elusive. In the interim, if the target of a therapeutic is the injured spinal cord, it is most desirable that any improvement in neurological status be correlated with a functional (meaningful) benefit.

  8. Experimental Validation of Depth Cameras for the Parameterization of Functional Balance of Patients in Clinical Tests

    Directory of Open Access Journals (Sweden)

    Francisco-Ángel Moreno

    2017-02-01

    Full Text Available In clinical practice, patients’ balance can be assessed using standard scales. Two of the most validated clinical tests for measuring balance are the Timed Up and Go (TUG test and the MultiDirectional Reach Test (MDRT. Nowadays, inertial sensors (IS are employed for kinematic analysis of functional tests in the clinical setting, and have become an alternative to expensive, 3D optical motion capture systems. In daily clinical practice, however, IS-based setups are yet cumbersome and inconvenient to apply. Current depth cameras have the potential for such application, presenting many advantages as, for instance, being portable, low-cost and minimally-invasive. This paper aims at experimentally validating to what extent this technology can substitute IS for the parameterization and kinematic analysis of the TUG and the MDRT tests. Twenty healthy young adults were recruited as participants to perform five different balance tests while kinematic data from their movements were measured by both a depth camera and an inertial sensor placed on their trunk. The reliability of the camera’s measurements is examined through the Interclass Correlation Coefficient (ICC, whilst the Pearson Correlation Coefficient (r is computed to evaluate the correlation between both sensor’s measurements, revealing excellent reliability and strong correlations in most cases.

  9. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma.

    Science.gov (United States)

    Clarke, Loren E; Warf, M B; Flake, Darl D; Hartman, Anne-Renee; Tahan, Steven; Shea, Christopher R; Gerami, Pedram; Messina, Jane; Florell, Scott R; Wenstrup, Richard J; Rushton, Kristen; Roundy, Kirstin M; Rock, Colleen; Roa, Benjamin; Kolquist, Kathryn A; Gutin, Alexander; Billings, Steven; Leachman, Sancy

    2015-04-01

    Histopathologic examination is sometimes inadequate for accurate and reproducible diagnosis of certain melanocytic neoplasms. As a result, more sophisticated and objective methods have been sought. The goal of this study was to identify a gene expression signature that reliably differentiated benign and malignant melanocytic lesions and evaluate its potential clinical applicability. Herein, we describe the development of a gene expression signature and its clinical validation using multiple independent cohorts of melanocytic lesions representing a broad spectrum of histopathologic subtypes. Using quantitative reverse-transcription polymerase chain reaction (PCR) on a selected set of 23 differentially expressed genes, and by applying a threshold value and weighting algorithm, we developed a gene expression signature that produced a score that differentiated benign nevi from malignant melanomas. The gene expression signature classified melanocytic lesions as benign or malignant with a sensitivity of 89% and a specificity of 93% in a training cohort of 464 samples. The signature was validated in an independent clinical cohort of 437 samples, with a sensitivity of 90% and specificity of 91%. The performance, objectivity, reliability and minimal tissue requirements of this test suggest that it could have clinical application as an adjunct to histopathology in the diagnosis of melanocytic neoplasms. © 2015 The Authors. Journal of Cutaneous Pathology published by John Wiley & Sons Ltd.

  10. Clinic expert information extraction based on domain model and block importance model.

    Science.gov (United States)

    Zhang, Yuanpeng; Wang, Li; Qian, Danmin; Geng, Xingyun; Yao, Dengfu; Dong, Jiancheng

    2015-11-01

    To extract expert clinic information from the Deep Web, there are two challenges to face. The first one is to make a judgment on forms. A novel method based on a domain model, which is a tree structure constructed by the attributes of query interfaces is proposed. With this model, query interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from response Web pages indexed by query interfaces. To filter the noisy information on a Web page, a block importance model is proposed, both content and spatial features are taken into account in this model. The experimental results indicate that the domain model yields a precision 4.89% higher than that of the rule-based method, whereas the block importance model yields an F1 measure 10.5% higher than that of the XPath method. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Discovery and Validation of Biomarkers to Guide Clinical Management of Pneumonia in African Children

    Science.gov (United States)

    Huang, Honglei; Ideh, Readon C.; Gitau, Evelyn; Thézénas, Marie L.; Jallow, Muminatou; Ebruke, Bernard; Chimah, Osaretin; Oluwalana, Claire; Karanja, Henri; Mackenzie, Grant; Adegbola, Richard A.; Kwiatkowski, Dominic; Kessler, Benedikt M.; Berkley, James A.; Howie, Stephen R. C.; Casals-Pascual, Climent

    2014-01-01

    Background. Pneumonia is the leading cause of death in children globally. Clinical algorithms remain suboptimal for distinguishing severe pneumonia from other causes of respiratory distress such as malaria or distinguishing bacterial pneumonia and pneumonia from others causes, such as viruses. Molecular tools could improve diagnosis and management. Methods. We conducted a mass spectrometry–based proteomic study to identify and validate markers of severity in 390 Gambian children with pneumonia (n = 204) and age-, sex-, and neighborhood-matched controls (n = 186). Independent validation was conducted in 293 Kenyan children with respiratory distress (238 with pneumonia, 41 with Plasmodium falciparum malaria, and 14 with both). Predictive value was estimated by the area under the receiver operating characteristic curve (AUC). Results. Lipocalin 2 (Lpc-2) was the best protein biomarker of severe pneumonia (AUC, 0.71 [95% confidence interval, .64–.79]) and highly predictive of bacteremia (78% [64%–92%]), pneumococcal bacteremia (84% [71%–98%]), and “probable bacterial etiology” (91% [84%–98%]). These results were validated in Kenyan children with severe malaria and respiratory distress who also met the World Health Organization definition of pneumonia. The combination of Lpc-2 and haptoglobin distinguished bacterial versus malaria origin of respiratory distress with high sensitivity and specificity in Gambian children (AUC, 99% [95% confidence interval, 99%–100%]) and Kenyan children (82% [74%–91%]). Conclusions. Lpc-2 and haptoglobin can help discriminate the etiology of clinically defined pneumonia and could be used to improve clinical management. These biomarkers should be further evaluated in prospective clinical studies. PMID:24696240

  12. Sleep quality, the neglected outcome variable in clinical studies focusing on locomotor system; a construct validation study

    Directory of Open Access Journals (Sweden)

    Röder Christoph

    2010-09-01

    Full Text Available Abstract Background In addition to general health and pain, sleep is highly relevant to judging the well-being of an individual. Of these three important outcome variables, however, sleep is neglected in most outcome studies. Sleep is a very important resource for recovery from daily stresses and strains, and any alteration of sleep will likely affect mental and physical health, especially during disease. Sleep assessment therefore should be standard in all population-based or clinical studies focusing on the locomotor system. Yet current sleep assessment tools are either too long or too specific for general use. Methods Based on a literature review and subsequent patient-based rating of items, an expert panel designed a four-item questionnaire about sleep. Construct validation of the questionnaire in a random sample of the German-speaking Swiss population was performed in 2003. Reliability, correlation, and tests for internal consistency and validity were analyzed. Results Overall, 16,634 (70% out of 23,763 eligible individuals participated in the study. Test-retest reliability coefficients ranged from 0.72 to 0.87, and a Cronbach's alpha of 0.83 indicates good internal consistency. Results show a moderate to good correlation between sleep disturbances and health perception, and between sleep disturbances and overall pain. Conclusions The Sleep Standard Evaluation Questionnaire (SEQ-Sleep is a reliable and short tool with confirmed construct validity for sleep assessment in population-based observational studies. It is easy to administer and therefore suitable for postal surveys of the general population. Criterion validity remains to be determined.

  13. The minimal clinical important difference in the World Health Organization Quality of Life instrument--100.

    Science.gov (United States)

    Den Oudsten, Brenda L; Zijlstra, Wobbe P; De Vries, Jolanda

    2013-05-01

    The aim of this study was to estimate the minimal clinical important difference (MCID) of the World Health Organization Quality of Life assessment instrument (WHOQOL-100) for women with early-stage breast cancer. If the MCID is known, then the instrument is also useful for individual patients and thus useful in clinical practice. In this study, the MCID is the smallest change in quality of life (QOL) scores considered clinically relevant for patients. Data were derived from a prospective study in which 223 women with early-stage breast cancer and 383 women with benign breast problems completed the WHOQOL-100. MCID values were determined by two distribution-based methods (0.5 standard deviation (SD) and 1 standard error of measurement (SEM)) and an anchor-based method. For 0.5 SD, MCID estimates ranged from 0.64 to 0.94, and for 1 SEM, MCID estimates ranged from 0.69 to 1.18. The anchor-based approach resulted in MCID estimates ranging from -1.56 to -0.71 for decline and from 0.51 to 1.27 for improvement. A change in score of 1 on the WHOQOL-100 is proposed as the MCID for women with early-stage breast cancer.

  14. What is clinical leadership and why might it be important in dentistry?

    Science.gov (United States)

    Brocklehurst, P; Ferguson, J; Taylor, N; Tickle, M

    2013-03-01

    The concept of leadership means different things to different people. At present there is no single definition of leadership nor an established theoretical approach. Despite this, leadership in the clinical environment is becoming increasingly cited as an important component in the transition of the National Health Service (NHS) and in the development of clinician led services. In medicine, clinical commissioning groups (CCGs) will soon be operational and the Department of Health (DH) seeks to establish a similar approach in dentistry, where local clinicians drive forward a quality agenda with a focus on patient outcomes. To facilitate this, the NHS Commissioning Board (NHSCB) are in the process of developing Local Professional Networks (LPNs) for dentistry. Given this shift towards localism and clinician led services it would appear that leadership will have a significant role in both medicine and dentistry. This paper explores what leadership is, before determining why it might be important in providing a clinician-led, patient-based and outcomes-focused service.

  15. Minimal clinically important difference on the Beck Depression Inventory--II according to the patient's perspective.

    Science.gov (United States)

    Button, K S; Kounali, D; Thomas, L; Wiles, N J; Peters, T J; Welton, N J; Ades, A E; Lewis, G

    2015-11-01

    The Beck Depression Inventory, 2nd edition (BDI-II) is widely used in research on depression. However, the minimal clinically important difference (MCID) is unknown. MCID can be estimated in several ways. Here we take a patient-centred approach, anchoring the change on the BDI-II to the patient's global report of improvement. We used data collected (n = 1039) from three randomized controlled trials for the management of depression. Improvement on a 'global rating of change' question was compared with changes in BDI-II scores using general linear modelling to explore baseline dependency, assessing whether MCID is best measured in absolute terms (i.e. difference) or as percent reduction in scores from baseline (i.e. ratio), and receiver operator characteristics (ROC) to estimate MCID according to the optimal threshold above which individuals report feeling 'better'. Improvement in BDI-II scores associated with reporting feeling 'better' depended on initial depression severity, and statistical modelling indicated that MCID is best measured on a ratio scale as a percentage reduction of score. We estimated a MCID of a 17.5% reduction in scores from baseline from ROC analyses. The corresponding estimate for individuals with longer duration depression who had not responded to antidepressants was higher at 32%. MCID on the BDI-II is dependent on baseline severity, is best measured on a ratio scale, and the MCID for treatment-resistant depression is larger than that for more typical depression. This has important implications for clinical trials and practice.

  16. Determining the minimum clinically important differences for outcomes in the DOMINO trial.

    Science.gov (United States)

    Howard, Robert; Phillips, Patrick; Johnson, Tony; O'Brien, John; Sheehan, Bart; Lindesay, James; Bentham, Peter; Burns, Alistair; Ballard, Clive; Holmes, Clive; McKeith, Ian; Barber, Robert; Dening, Tom; Ritchie, Craig; Jones, Rob; Baldwin, Ashley; Passmore, Peter; Findlay, David; Hughes, Alan; Macharouthu, Ajay; Banerjee, Sube; Jones, Roy; Knapp, Martin; Brown, Richard G; Jacoby, Robin; Adams, Jessica; Griffin, Mary; Gray, Richard

    2011-08-01

    Although less likely to be reported in clinical trials than expressions of the statistical significance of differences in outcomes, whether or not a treatment has delivered a specified minimum clinically important difference (MCID) is also relevant to patients and their caregivers and doctors. Many dementia treatment randomised controlled trials (RCTs) have not reported MCIDs and, where they have been done, observed differences have not reached these. As part of the development of the Statistical Analysis Plan for the DOMINO trial, investigators met to consider expert opinion- and distribution-based values for the MCID and triangulated these to provide appropriate values for three outcome measures, the Standardised Mini-mental State Examination (sMMSE), Bristol Activities of Daily Living Scale (BADLS) and Neuropsychiatric Inventory (NPI). Only standard deviations (SD) were presented to investigators who remained blind to treatment allocation. Adoption of values for MCIDs based upon 0.4 of the SD of the change in score from baseline on the sMMSE, BADLS and NPI in the first 127 participants to complete DOMINO yielded MCIDs of 1.4 points for sMMSE, 3.5 for BADLS and 8.0 for NPI. Reference to MCIDs is important for the full interpretation of the results of dementia trials and those conducting such trials should be open about the way in which they have determined and chosen their values for the MCIDs. Copyright © 2010 John Wiley & Sons, Ltd.

  17. Establishing Minimal Clinically Important Difference of Spinal Cord Stimulation Therapy in Post-Laminectomy Syndrome.

    Science.gov (United States)

    Paul, Alexandra R; Kumar, Vignessh; Roth, Steven; Gooch, M Reid; Pilitsis, Julie G

    2017-12-01

    The concept of minimum clinically important difference (MCID) has been shown to be effective in spine surgery to differentiate between clinically insignificant and significant improvements as determined by the patient. The MCID for spinal cord stimulation (SCS) to date has not been established. We sought to determine the MCID for SCS therapy for failed laminectomy syndromes. Preoperative and 6-mo outcomes were assessed prospectively, including the Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), and McGill and Visual Analog Survey questionnaires. Patients were asked: (1) are you satisfied with SCS therapy and (2) would you have the surgery again. Four methods of calculating the MCID were utilized. Forty-eight patients who underwent placement of an SCS between 2012 and 2014 were reviewed. The 4 calculation methods yielded a range of outcome scores (ODI 8.2-13.3, BDI 3.2-7, McGill 0.3-1.3, and Visual Analog Scale [VAS] 1.2-3.7). The maximum area under the curve was observed for the ODI, BDI, and VAS (0.73, 0.81, and 0.89, respectively), which signifies acceptable accuracy in distinguishing responders from nonresponders with the receiver operating characteristic method and suggests that VAS may be the most sensitive in determining meaningful change for the patient. The MCID for SCS placement was calculated using 4 different methods. The results are similar to calculations for the MCID for many lumbar and cervical procedures done for pain. Our results suggest that an improvement of 1.2 to 3.7 points on the VAS scale and 8.2 to 13.3 points on the ODI is clinically meaningful to the patient. Further defining the MCID for SCS therapy will remain of utmost importance in order to justify the cost of the procedure.

  18. MO-B-BRB-03: 3D Dosimetry in the Clinic: Validating Special Techniques

    Energy Technology Data Exchange (ETDEWEB)

    Juang, T. [Stanford Cancer Center (United States)

    2016-06-15

    Full three-dimensional (3D) dosimetry using volumetric chemical dosimeters probed by 3D imaging systems has long been a promising technique for the radiation therapy clinic, since it provides a unique methodology for dose measurements in the volume irradiated using complex conformal delivery techniques such as IMRT and VMAT. To date true 3D dosimetry is still not widely practiced in the community; it has been confined to centres of specialized expertise especially for quality assurance or commissioning roles where other dosimetry techniques are difficult to implement. The potential for improved clinical applicability has been advanced considerably in the last decade by the development of improved 3D dosimeters (e.g., radiochromic plastics, radiochromic gel dosimeters and normoxic polymer gel systems) and by improved readout protocols using optical computed tomography or magnetic resonance imaging. In this session, established users of some current 3D chemical dosimeters will briefly review the current status of 3D dosimetry, describe several dosimeters and their appropriate imaging for dose readout, present workflow procedures required for good dosimetry, and analyze some limitations for applications in select settings. We will review the application of 3D dosimetry to various clinical situations describing how 3D approaches can complement other dose delivery validation approaches already available in the clinic. The applications presented will be selected to inform attendees of the unique features provided by full 3D techniques. Learning Objectives: L. John Schreiner: Background and Motivation Understand recent developments enabling clinically practical 3D dosimetry, Appreciate 3D dosimetry workflow and dosimetry procedures, and Observe select examples from the clinic. Sofie Ceberg: Application to dynamic radiotherapy Observe full dosimetry under dynamic radiotherapy during respiratory motion, and Understand how the measurement of high resolution dose data in an

  19. MO-B-BRB-02: 3D Dosimetry in the Clinic: IMRT Technique Validation in Sweden

    Energy Technology Data Exchange (ETDEWEB)

    Ceberg, S. [Lund University (Sweden)

    2016-06-15

    Full three-dimensional (3D) dosimetry using volumetric chemical dosimeters probed by 3D imaging systems has long been a promising technique for the radiation therapy clinic, since it provides a unique methodology for dose measurements in the volume irradiated using complex conformal delivery techniques such as IMRT and VMAT. To date true 3D dosimetry is still not widely practiced in the community; it has been confined to centres of specialized expertise especially for quality assurance or commissioning roles where other dosimetry techniques are difficult to implement. The potential for improved clinical applicability has been advanced considerably in the last decade by the development of improved 3D dosimeters (e.g., radiochromic plastics, radiochromic gel dosimeters and normoxic polymer gel systems) and by improved readout protocols using optical computed tomography or magnetic resonance imaging. In this session, established users of some current 3D chemical dosimeters will briefly review the current status of 3D dosimetry, describe several dosimeters and their appropriate imaging for dose readout, present workflow procedures required for good dosimetry, and analyze some limitations for applications in select settings. We will review the application of 3D dosimetry to various clinical situations describing how 3D approaches can complement other dose delivery validation approaches already available in the clinic. The applications presented will be selected to inform attendees of the unique features provided by full 3D techniques. Learning Objectives: L. John Schreiner: Background and Motivation Understand recent developments enabling clinically practical 3D dosimetry, Appreciate 3D dosimetry workflow and dosimetry procedures, and Observe select examples from the clinic. Sofie Ceberg: Application to dynamic radiotherapy Observe full dosimetry under dynamic radiotherapy during respiratory motion, and Understand how the measurement of high resolution dose data in an

  20. The clinical importance of neutralizing antibodies in relapsing-remitting multiple sclerosis.

    Science.gov (United States)

    Namaka, Mike; Pollitt-Smith, Merinda; Gupta, Aneri; Klowak, Meghann; Vasconcelos, Marcus; Turcotte, Dana; Gong, Yuewen; Melanson, Maria

    2006-02-01

    Neutralizing antibodies (NAbs) develop in patients receiving interferon beta (IFN-beta) for multiple sclerosis (MS). Debate continues concerning the relevance of NAb development on treatment efficacy. To determine the incidence and clinical importance of NAbs in patients with relapsing-remitting MS (RRMS). A comprehensive literature review was conducted using PubMed (accessed from 1983 to June 2005), Cochrane MS Group trials register (accessed June 2005), MEDLINE (accessed 1983 to June 2005), and Toxnet (accessed June 2005) databases. NAb-induced changes in clinical efficacy and disease progression were evaluated according to the clinical guidelines established by the American Academy of Neurology. Currently, there is no standardized assay to comparatively assess NAbs among different treatments. NAbs develop independent of age, sex, disease duration and progression index at the onset of treatment. The occurrence of NAbs varies from 2-45% depending on the treatment initiated. NAb+ patients demonstrate accelerated disease progression as confirmed by an approximate 1-point increase in the Expanded Disability Status Scale score. The odds of relapse during a NAb+ period are between 1.51 and 1.58 (p < 0.03) with the time to first relapse being shortened by an average of 244 days after 12 months of IFN-beta therapy. NAb+ patients experience an approximately four-fold increase (p = 0.009) in the median number of active T2 magnetic resonance imaging (MRI) lesions compared to NAb-negative patients (1.4 vs. 0.3 respectively, p < 0.01). The induction of NAbs in IFN-beta treated patients reduce clinical effect and accelerate disease progression.

  1. Minimal Clinically Important Difference (MCID) in Allergic Rhinitis: Agency for Healthcare Research and Quality or Anchor-Based Thresholds?

    Science.gov (United States)

    Meltzer, Eli O; Wallace, Dana; Dykewicz, Mark; Shneyer, Lucy

    2016-01-01

    In 2013, the Agency for Healthcare Research and Quality (AHRQ) recommended that allergic rhinitis (AR) studies calculate a minimal clinically important difference (MCID) based on an estimated threshold equal to 30% of the maximum total nasal symptom score. Applying this threshold, their data showed no differences between well-established treatments, and a subsequent analysis using prescribing information found no differences between active treatments and placebo controls. The objective of this study was to demonstrate the application of an evidence-based model to determine MCIDs for AR studies, with an absolute value for an anchor-based threshold and validated methods for calculating distribution-based thresholds. Using the same studies as the AHRQ report, anchor- and distribution-based MCID thresholds were determined for 3 clinical comparisons identified by the AHRQ: (1) oral antihistamine+intranasal corticosteroid (INCS) versus INCS, (2) montelukast versus INCS, and (3) intranasal antihistamine+INCS in a single device versus the monotherapies. The outcomes were compared with those reported using the AHRQ threshold. No treatment comparison met the AHRQ-defined MCID threshold; all treatments were determined to be equivalent for all 3 queries. In contrast, the evidence-based model revealed some differences between treatments: INCS > montelukast; intranasal antihistamine+INCS > either monotherapy. No clinically relevant benefit was observed for adding an oral antihistamine to INCS, but some studies were not optimal choices for quantitative determination of MCIDs. Updating the literature search revealed no additional studies that met the AHRQ inclusion criteria. The evidence-based threshold for MCID determination for AR studies should supersede the threshold recommended in the AHRQ report. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  2. External validation of a simple clinical tool used to predict falls in people with Parkinson disease.

    Science.gov (United States)

    Duncan, Ryan P; Cavanaugh, James T; Earhart, Gammon M; Ellis, Terry D; Ford, Matthew P; Foreman, K Bo; Leddy, Abigail L; Paul, Serene S; Canning, Colleen G; Thackeray, Anne; Dibble, Leland E

    2015-08-01

    Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76-0.89), comparable to the developmental study. The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual's risk of an impending fall. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. [Validity of the ICD-10 Symptom Rating (ISR) in a Non-Clinical Sample].

    Science.gov (United States)

    Braun, Sarah Ruth; Zimmermann, Julia; Söhner, Stephanie; Neidhardt, Sylwia

    2017-11-01

    Introduction The ICD-10 symptom rating (ISR) is a self-rating instrument that is based on ICD-10 syndromes. Can previous findings concerning its validity be replicated in a non-clinical sample? Material & Methods N=428 study participants - mainly students - completed the ISR and the SCL-90-R in an online survey. Results The assumed factorial structure was replicated with a good model fit. The correlations between the content-related scales of the two instruments ranged from r min =0.60 to r max =0.85. Study participants indicated that they did not find completing the ISR stressful. Discussion and Conclusions These results indicate good validity and applicability of the ISR. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity.

    Science.gov (United States)

    Gajdosik, R L; Bohannon, R W

    1987-12-01

    Clinical measurement of range of motion is a fundamental evaluation procedure with ubiquitous application in physical therapy. Objective measurements of ROM and correct interpretation of the measurement results can have a substantial impact on the development of the scientific basis of therapeutic interventions. The purpose of this article is to review the related literature on the reliability and validity of goniometric measurements of the extremities. Special emphasis is placed on how the reliability of goniometry is influenced by instrumentation and procedures, differences among joint actions and body regions, passive versus active measurements, intratester versus intertester measurements, and different patient types. Our discussion of validity encourages objective interpretation of the meaning of ROM measurements in light of the purposes and the limitations of goniometry. We conclude that clinicians should adopt standardized methods of testing and should interpret and report goniometric results as ROM measurements only, not as measurements of factors that may affect ROM.

  5. Validity of a new assessment rubric for a short-answer test of clinical reasoning.

    Science.gov (United States)

    Yeung, Euson; Kulasagarem, Kulamakan; Woods, Nicole; Dubrowski, Adam; Hodges, Brian; Carnahan, Heather

    2016-07-26

    The validity of high-stakes decisions derived from assessment results is of primary concern to candidates and certifying institutions in the health professions. In the field of orthopaedic manual physical therapy (OMPT), there is a dearth of documented validity evidence to support the certification process particularly for short-answer tests. To address this need, we examined the internal structure of the Case History Assessment Tool (CHAT); this is a new assessment rubric developed to appraise written responses to a short-answer test of clinical reasoning in post-graduate OMPT certification in Canada. Fourteen physical therapy students (novices) and 16 physical therapists (PT) with minimal and substantial OMPT training respectively completed a mock examination. Four pairs of examiners (n = 8) participated in appraising written responses using the CHAT. We conducted separate generalizability studies (G studies) for all participants and also by level of OMPT training. Internal consistency was calculated for test questions with more than 2 assessment items. Decision studies were also conducted to determine optimal application of the CHAT for OMPT certification. The overall reliability of CHAT scores was found to be moderate; however, reliability estimates for the novice group suggest that the scale was incapable of accommodating for scores of novices. Internal consistency estimates indicate item redundancies for several test questions which will require further investigation. Future validity studies should consider discriminating the clinical reasoning competence of OMPT trainees strictly at the post-graduate level. Although rater variance was low, the large variance attributed to error sources not incorporated in our G studies warrant further investigations into other threats to validity. Future examination of examiner stringency is also warranted.

  6. Utilisation, Reliability and Validity of Clinical Evaluation Exercise in Otolaryngology Training.

    Science.gov (United States)

    Awad, Z; Hayden, L; Muthuswamy, K; Tolley, N S

    2015-10-01

    To investigate the utilisation, reliability and validity of clinical evaluation exercise (CEX) in otolaryngology training. Retrospective database analysis. Online assessment database. We analysed all CEXs submitted by north London core (CT) and speciality trainees (ST) in otolaryngology from 2010 to 2013. Internal consistency of the 7 CEX items rated as either O: outstanding, S: satisfactory or D: development required. Overall performance rating (pS) of 1-4 assessed against completion of training level. Receiver operating characteristic was used to describe CEX sensitivity and specificity. Overall score (cS), pS and the number of 'D'-rated items were used to investigate construct validity. One thousand one hundred and sixty CEXs from 45 trainees were included. CEX showed good internal consistency (Cronbach's alpha= 0.85). CEX was highly sensitive (99%), yet not specific (6%). cS and pS for ST was higher than CT (99.1% ± 0.4 versus 96.6% ± 0.8 and 3.06 ± 0.05 versus 1.92 ± 0.04, respectively P otolaryngology trainees in clinical examination, but not at higher level. It has the potential to be used in a summative capacity in selecting trainees for ST positions. This would also encourage trainees to master all domains of otolaryngology clinical examination by end of CT. © 2015 John Wiley & Sons Ltd.

  7. Validation of a virtual reality balance module for use in clinical concussion assessment and management.

    Science.gov (United States)

    Teel, Elizabeth F; Slobounov, Semyon M

    2015-03-01

    To determine the criterion and content validity of a virtual reality (VR) balance module for use in clinical practice. Retrospective, VR balance module completed by participants during concussion baseline or assessment testing session. A Pennsylvania State University research laboratory. A total of 60 control and 28 concussed students and athletes from the Pennsylvania State University. None. This study examined: (1) the relationship between VR composite balance scores (final, stationary, yaw, pitch, and roll) and area of the center-of-pressure (eyes open and closed) scores and (2) group differences (normal volunteers and concussed student-athletes) on VR composite balance scores. With the exception of the stationary composite score, all other VR balance composite scores were significantly correlated with the center of pressure data obtained from a force platform. Significant correlations ranged from r = -0.273 to -0.704 for the eyes open conditions and from r = -0.353 to -0.876 for the eyes closed condition. When examining group differences on the VR balance composite modules, the concussed group did significantly (P Virtual reality balance module is a valid tool for concussion assessment in clinical settings. This novel type of balance assessment may be more sensitive to concussion diagnoses, especially later (7-10 days) in the recovery phase than current clinical balance tools.

  8. Validity and reliability of the Structured Clinical Interview for Depersonalization–Derealization Spectrum (SCI-DER)

    Science.gov (United States)

    Mula, Marco; Pini, Stefano; Calugi, Simona; Preve, Matteo; Masini, Matteo; Giovannini, Ilaria; Conversano, Ciro; Rucci, Paola; Cassano, Giovanni B

    2008-01-01

    This study evaluates the validity and reliability of a new instrument developed to assess symptoms of depersonalization: the Structured Clinical Interview for the Depersonalization-Derealization Spectrum (SCI-DER). The instrument is based on a spectrum model that emphasizes soft-signs, sub-threshold syndromes as well as clinical and subsyndromal manifestations. Items of the interview include, in addition to DSM-IV criteria for depersonalization, a number of features derived from clinical experience and from a review of phenomenological descriptions. Study participants included 258 consecutive patients with mood and anxiety disorders, 16.7% bipolar I disorder, 18.6% bipolar II disorder, 32.9% major depression, 22.1% panic disorder, 4.7% obsessive compulsive disorder, and 1.5% generalized anxiety disorder; 2.7% patients were also diagnosed with depersonalization disorder. A comparison group of 42 unselected controls was enrolled at the same site. The SCI-DER showed excellent reliability and good concurrent validity with the Dissociative Experiences Scale. It significantly discriminated subjects with any diagnosis of mood and anxiety disorders from controls and subjects with depersonalization disorder from controls. The hypothesized structure of the instrument was confirmed empirically. PMID:19183789

  9. Validity and reliability of the Structured Clinical Interview for Depersonalization–Derealization Spectrum (SCI-DER

    Directory of Open Access Journals (Sweden)

    Marco Mula

    2008-08-01

    Full Text Available Marco Mula, Stefano Pini, Simona Calugi, Matteo Preve, Matteo Masini, Ilaria Giovannini, Ciro Conversano, Paola Rucci, Giovanni B CassanoDepartment of Psychiatry, Neurobiology, Pharmacology and Biotechnologies, University of Pisa, ItalyAbstract: This study evaluates the validity and reliability of a new instrument developed to assess symptoms of depersonalization: the Structured Clinical Interview for the Depersonalization-Derealization Spectrum (SCI-DER. The instrument is based on a spectrum model that emphasizes soft-signs, sub-threshold syndromes as well as clinical and subsyndromal manifestations. Items of the interview include, in addition to DSM-IV criteria for depersonalization, a number of features derived from clinical experience and from a review of phenomenological descriptions. Study participants included 258 consecutive patients with mood and anxiety disorders, 16.7% bipolar I disorder, 18.6% bipolar II disorder, 32.9% major depression, 22.1% panic disorder, 4.7% obsessive compulsive disorder, and 1.5% generalized anxiety disorder; 2.7% patients were also diagnosed with depersonalization disorder. A comparison group of 42 unselected controls was enrolled at the same site. The SCI-DER showed excellent reliability and good concurrent validity with the Dissociative Experiences Scale. It significantly discriminated subjects with any diagnosis of mood and anxiety disorders from controls and subjects with depersonalization disorder from controls. The hypothesized structure of the instrument was confirmed empirically.Keywords: depersonalization, derealization, mood disorders, anxiety disorders

  10. From JNK to pay dirt: jun kinases, their biochemistry, physiology and clinical importance.

    Science.gov (United States)

    Karin, Michael; Gallagher, Ewen

    2005-01-01

    The c-Jun N-terminal kinases (JNKs) were originally identified by their ability to phosphorylate c-Jun in response to UV-irradiation, but now are recognized as critical regulators of various aspects of mammalian physiology, including: cell proliferation, cell survival, cell death, DNA repair and metabolism. JNK-mediated phosphorylation enhances the ability of c-Jun, a component of the AP-1 transcription factor, to activate transcription, in response to a plethora of extracellular stimuli. The JNK activation leads to induction of AP-1-dependent target genes involved in cell proliferation, cell death, inflammation, and DNA repair. The JNKs, which are encoded by three different Jnk loci, are now known to be regulated by many other stimuli, from pro-inflammatory cytokines to obesity, in addition to UV-irradiation. Targeted disruption of the Jnk loci in mice has proved to be a critical tool in better understanding their physiological functions. Such studies revealed that the JNKs play important roles in numerous cellular processes, including: programmed cell death, T cell differentiation, negative regulation of insulin signaling, control of fat deposition, and epithelial sheet migration. Importantly, the JNKs have become prime targets for drug development in several important clinical areas, including: inflammation, diabetes, and cancer.

  11. A visitor's guide to effect sizes: statistical significance versus practical (clinical) importance of research findings.

    Science.gov (United States)

    Hojat, Mohammadreza; Xu, Gang

    2004-01-01

    Effect Sizes (ES) are an increasingly important index used to quantify the degree of practical significance of study results. This paper gives an introduction to the computation and interpretation of effect sizes from the perspective of the consumer of the research literature. The key points made are: 1. ES is a useful indicator of the practical (clinical) importance of research results that can be operationally defined from being "negligible" to "moderate", to "important". 2. The ES has two advantages over statistical significance testing: (a) it is independent of the size of the sample; (b) it is a scale-free index. Therefore, ES can be uniformly interpreted in different studies regardless of the sample size and the original scales of the variables. 3. Calculations of the ES are illustrated by using examples of comparisons between two means, correlation coefficients, chi-square tests and two proportions, along with appropriate formulas. 4. Operational definitions for the ES s are given, along with numerical examples for the purpose of illustration.

  12. Validation of an IFNγ/IL2 FluoroSpot assay for clinical trial monitoring.

    Science.gov (United States)

    Körber, Nina; Behrends, Uta; Hapfelmeier, Alexander; Protzer, Ulrike; Bauer, Tanja

    2016-06-14

    The FluoroSpot assay, an advancement of the ELISpot assay, enables simultaneous measurement of different analytes secreted at a single-cell level. This allows parallel detection of several cytokines secreted by immune cells upon antigen recognition. Easier standardization, higher sensitivity and reduced labour intensity render FluoroSpot assays an interesting alternative to flow-cytometry based assays for analysis of clinical samples. While the use of immunoassays to study immunological primary and secondary endpoints becomes increasingly attractive, assays used require pre-trial validation. Here we describe the assay validation (precision, specificity and linearity) of a FluoroSpot immunological endpoint assay detecting Interferon γ (IFNγ) and Interleukin 2 (IL2) for use in clinical trial immune monitoring. We validated an IFNγ/IL2 FluoroSpot assay to determine Epstein-Barr virus (EBV)-specific cellular immune responses (IFNγ, IL2 and double positive IFNγ + IL2 responses), using overlapping peptide pools corresponding to EBV-proteins BZLF1 and EBNA3A. Assay validation was performed using cryopreserved PBMC of 16 EBV-seropositive and 6 EBV-seronegative donors. Precision was assessed by (i) testing 16 donors using three replicates per assay (intra-assay precision/repeatability) (ii) using two plates in parallel (intermediate precision/plate-to-plate variability) and (iii) by performing the assays on three different days (inter-assay precision/reproducibility). In addition, we determined specificity, linearity and quantification limits of the assay. Further we tested precision across the two assay systems, IFNγ/IL2 FluoroSpot and the corresponding enzymatic single cytokine ELISpot. The validation revealed: (1) a high intra-assay precision (coefficient of variation (CV) 9.96, 8.85 and 13.05 %), intermediate precision (CV 6.48, 10.20 and 12.97 %) and reproducibility (CV 20.81 %, 12,75 % and 12.07 %) depending on the analyte and antigen used; (2) a

  13. Individual variability in clinical effect and tolerability of opioid analgesics - Importance of drug interactions and pharmacogenetics.

    Science.gov (United States)

    Solhaug, Vigdis; Molden, Espen

    2017-10-17

    As pain is often a comorbid condition, many patients use opioid analgesics in combination with several other drugs. This implies a generally increased risk of drug interactions, which along with inherent pharmacogenetic variability and other factors may cause differences in therapeutic response of opioids. To provide an overview of interactions and pharmacogenetic variability of relevance for individual differences in effect and tolerability of opioid analgesics, which physicians and other healthcare professionals should be aware of in clinical practice. The article was based on unsystematic searches in PubMed to identify literature highlighting the clinical impact of drug interactions and pharmacogenetics as sources of variable response of opioid analgesics. Cytochrome P450 (CYP)-mediated metabolism is an important process for both clinically relevant interactions and pharmacogenetic variability of several opioids. Concomitant use of CYP inhibitors (e.g. paroxetine, fluoxetine and bupropion) or inducers (e.g. carbamazepine, phenobarbital and phenytoin) could counteract the clinical effect or trigger side effects of analgesics in the same manner as genetically determined differences in CYP2D6-mediated metabolism of many opioids. Moreover, combination treatment with drugs that inhibit or induce P-glycoprotein (ABCB1), a blood-brain barrier efflux transporter, may alter the amount ('dose') of opioids distributed to the brain. At the pharmacodynamic level, it is crucial to be aware of the potential risk of interaction causing serotonergic syndrome when combining opioids and serotonergic drugs, in particular antidepressants inhibiting serotonin reuptake (SSRIs and SNRIs). Regarding pharmacogenetics at the receptor level of pain treatment, the knowledge is currently scarce, but an allelic variant of the μ1 opioid receptor (OPRM1) gene has been associated with higher dosage requirement to achieve analgesia. Drug interactions and pharmacogenetic differences may lead to

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

    Directory of Open Access Journals (Sweden)

    Marleen E. Jansen

    2017-08-01

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

  15. The Adequacy of the Q Methodology for Clinical Validation of Nursing Diagnoses Related to Subjective Foci.

    Science.gov (United States)

    Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

    2016-11-17

    This article describes the adequacy of the Q methodology as a new option for the validation of nursing diagnoses related to subjective foci. Discussion paper about the characteristics of the Q methodology. This method has been used in nursing research particularly related to subjective concepts and includes both a quantitative and qualitative dimension. The Q methodology seems to be an adequate and innovative method for the clinical validation of nursing diagnoses. The validation of nursing diagnoses related to subjective foci using the Q methodology could improve the level of evidence and provide nurses with clinical indicators for clinical reasoning and for the planning of effective interventions. Descrever a adequação da metodologia Q como uma nova opção para a validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos. MÉTODOS: Artigo de discussão sobre as características da metodologia Q. Este método tem sido utilizado na pesquisa em enfermagem relacionada com conceitos subjetivos e inclui em simultâneo uma vertente qualitativa e quantitativa. CONCLUSÕES: A metodologia Q parece ser uma opção metodológica adequada para a validação clínica de diagnósticos de enfermagem. IMPLICAÇÕES PARA A PRÁTICA: A utilização da metodologia Q na validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos pode melhorar o nível e evidência e facilitar o raciocínio clínico dos enfermeiros, ao providenciar indicadores clínicos também necessários ao desenvolvimento de intervenções efetivas. © 2016 NANDA International, Inc.

  16. Validation of two depression screening instruments in a sleep disorders clinic.

    Science.gov (United States)

    Law, Mandy; Naughton, Matthew T; Dhar, Arup; Barton, David; Dabscheck, Eli

    2014-06-15

    Depression is a commonly diagnosed comorbidity in sleep disorder clinics. However, screening instruments for major depressive episode (MDE) have not been validated in this setting. We aimed to validate the Hospital Anxiety and Depression Scale (HADS) and the Beck Depression Inventory - Fast Screen (BDI-FS) with the Mini International Neuropsychiatric Interview (MINI) in patients with suspected obstructive sleep apnea (OSA). Cross-sectional study. Academic center. One hundred one new patients with a clinical suspicion of OSA, as assessed by a sleep physician. MDE, generalized anxiety disorder (GAD), and panic disorder (PD) were assessed by (1) a diagnostic interview utilizing the MINI and (2) by two self-report questionnaires: HADS and BDI-FS. A receiver operating characteristic (ROC) analysis was undertaken to assess which HADS and BDI-FS threshold yielded the highest correlation for a diagnosis of MDE and/or GAD/PD as assessed with an interview conducted using the MINI. A HADS-Depression score ≥ 8 gave optimal sensitivity (83.1%) and specificity (83.3%) with an area under the ROC curve (AUC) 0.851 for predicting the diagnosis of MDE. A HADS-Anxiety score ≥ 11 gave an optimal sensitivity (93.1%) and specificity (84.7%) with an AUC 0.911 for predicting the diagnosis of GAD/PD. A BDI-FS threshold ≥ 6 gave optimal sensitivity (86.7%) and specificity (82.9%) with an AUC 0.897 for MDE. The HADS and BDI-FS are accurate screening instruments with high concurrent validity for identifying the probability of a patient having MDE and-in the case of HADS-GAD and PD disorder in a sleep disorders clinic.

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

    Science.gov (United States)

    Signori, Cácia; Collares, Kauê; Cumerlato, Catarina B F; Correa, Marcos B; Opdam, Niek J M; Cenci, Maximiliano S

    2018-02-10

    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.

  18. 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

  19. Assessing decentering: validation, psychometric properties, and clinical usefulness of the Experiences Questionnaire in a Spanish sample.

    Science.gov (United States)

    Soler, Joaquim; Franquesa, Alba; Feliu-Soler, Albert; Cebolla, Ausias; García-Campayo, Javier; Tejedor, Rosa; Demarzo, Marcelo; Baños, Rosa; Pascual, Juan Carlos; Portella, Maria J

    2014-11-01

    Decentering is defined as the ability to observe one's thoughts and feelings in a detached manner. The Experiences Questionnaire (EQ) is a self-report instrument that originally assessed decentering and rumination. The purpose of this study was to evaluate the psychometric properties of the Spanish version of EQ-Decentering and to explore its clinical usefulness. The 11-item EQ-Decentering subscale was translated into Spanish and psychometric properties were examined in a sample of 921 adult individuals, 231 with psychiatric disorders and 690 without. The subsample of nonpsychiatric participants was also split according to their previous meditative experience (meditative participants, n=341; and nonmeditative participants, n=349). Additionally, differences among these three subgroups were explored to determine clinical validity of the scale. Finally, EQ-Decentering was administered twice in a group of borderline personality disorder, before and after a 10-week mindfulness intervention. Confirmatory factor analysis indicated acceptable model fit, sbχ(2)=243.8836 (p.46; and divergent validity: r<-.35). The scale detected changes in decentering after a 10-session intervention in mindfulness (t=-4.692, p<.00001). Differences among groups were significant (F=134.8, p<.000001), where psychiatric participants showed the lowest scores compared to nonpsychiatric meditative and nonmeditative participants. The Spanish version of the EQ-Decentering is a valid and reliable instrument to assess decentering either in clinical and nonclinical samples. In addition, the findings show that EQ-Decentering seems an adequate outcome instrument to detect changes after mindfulness-based interventions. Copyright © 2014. Published by Elsevier Ltd.

  20. Clinical Validation of 4-Dimensional Computed Tomography Ventilation With Pulmonary Function Test Data

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    Brennan, Douglas [University of Colorado School of Medicine, Aurora, Colorado (United States); Schubert, Leah; Diot, Quentin [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Castillo, Richard [Department of Radiation Oncology, The University of Texas Medical Branch, Galveston, Texas (United States); Castillo, Edward; Guerrero, Thomas [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan (United States); Martel, Mary K. [Department of Radiation Physics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Linderman, Derek; Gaspar, Laurie E.; Miften, Moyed; Kavanagh, Brian D. [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States); Vinogradskiy, Yevgeniy, E-mail: yevgeniy.vinogradskiy@ucdenver.edu [Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado (United States)

    2015-06-01

    Purpose: A new form of functional imaging has been proposed in the form of 4-dimensional computed tomography (4DCT) ventilation. Because 4DCTs are acquired as part of routine care for lung cancer patients, calculating ventilation maps from 4DCTs provides spatial lung function information without added dosimetric or monetary cost to the patient. Before 4DCT-ventilation is implemented it needs to be clinically validated. Pulmonary function tests (PFTs) provide a clinically established way of evaluating lung function. The purpose of our work was to perform a clinical validation by comparing 4DCT-ventilation metrics with PFT data. Methods and Materials: Ninety-eight lung cancer patients with pretreatment 4DCT and PFT data were included in the study. Pulmonary function test metrics used to diagnose obstructive lung disease were recorded: forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity. Four-dimensional CT data sets and spatial registration were used to compute 4DCT-ventilation images using a density change–based and a Jacobian-based model. The ventilation maps were reduced to single metrics intended to reflect the degree of ventilation obstruction. Specifically, we computed the coefficient of variation (SD/mean), ventilation V20 (volume of lung ≤20% ventilation), and correlated the ventilation metrics with PFT data. Regression analysis was used to determine whether 4DCT ventilation data could predict for normal versus abnormal lung function using PFT thresholds. Results: Correlation coefficients comparing 4DCT-ventilation with PFT data ranged from 0.63 to 0.72, with the best agreement between FEV1 and coefficient of variation. Four-dimensional CT ventilation metrics were able to significantly delineate between clinically normal versus abnormal PFT results. Conclusions: Validation of 4DCT ventilation with clinically relevant metrics is essential. We demonstrate good global agreement between PFTs and 4DCT-ventilation, indicating that 4DCT