903 resultados para validation study


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Background and Objective: Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) is a health-related quality of life (HRQOL) assessment tool for pediatric systemic lupus erythematosus (SLE), which has been translated into Portuguese for Brazil. We are reporting preliminary data on cross-cultural validation and reliability of SMILEY in Portuguese (Brazil). Methods: In this multi-center cross-sectional study, Brazilian children and adolescents 5-18 years of age with SLE and parents participated. Children and parents completed child and parent reports of Portuguese SMILEY and Portuguese Pediatric Quality of Life Inventory (PedsQLTM) Generic and Rheumatology modules. Parents also completed the Childhood Health Assessment Questionnaire (CHAQ). Physicians completed the SLE disease activity index (SLEDAI), Physician's Global Assessment of disease activity (PGA) and Systemic Lupus Erythematosus International Collaborating Clinics ACR Damage Index (SDI). Results: 99 subjects (84 girls) were enrolled; 93 children and 97 parents filled out the SMILEY scale. Subjects found SMILEY relevant and easy to understand and completed SMILEY in 5-15 minutes. Brazilian SMILEY was found to have good psychometric properties (validity and reliability), and the child-parent agreement was moderate. Conclusion: SMILEY may eventually be used routinely as a research/clinical tool in Brazil. It may be also adapted for other Portuguese-speaking nations offering critical information regarding the effect of SLE on HRQOL for children with SLE. © The Author(s), 2012.

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Objectives To consensually validate the operational definitions of the nursing diagnoses activity intolerance, excessive fluid volume, and decreased cardiac output in patients with decompensated heart failure. Method Consensual validation was performed in two stages: analogy by similarity of defining characteristics, and development of operational definitions and validation with experts. Results A total of 38 defining characteristics were found. Operational definitions were developed and content-validated. One hundred percent of agreement was achieved among the seven experts after five rounds. Ascites was added in the nursing diagnosis excessive fluid volume. Conclusion The consensual validation improves interpretation of human response, grounding the selection of nursing interventions and contributing to improved nursing outcomes. Implications for Practice Support the assessment of patients with decompensated heart failure. Objetivos Realizar a validacAo consensual das definicoes operacionais dos diagnosticos de enfermagem Intolerancia a atividade, Volume de liquidos excessivo e Debito cardiaco diminuido em pacientes com insuficiencia cardiaca descompensada. Metodo ValidacAo consensual em duas etapas: Analogia de semelhanca das caracteristicas definidoras e desenvolvimento de definicoes operacionais e validacAo com expertst. Resultados Foram encontradas 38 caracteristicas definidoras para os diagnosticos de enfermagem. Suas definicoes operacionais foram desenvolvidas e seu conteudo validado. Os resultados mostram que houve 100% de concordancia entre os sete experts apos cinco rodada. As definicoes operacionais foram classificadas com base no nivel de concordanica. Ascite foi acrescentada ao diagnostico Volume de liquidos excessivo. ConclusAo A validacAo consensual melhora a interpretacAo das respostas humanas, embasando a selecAo de intervencoes de enfermagem e contribuindo para melhorar os resultados. Implicacoes Para A Pratica Apoio a avaliacAo dos pacientes com insuficiencia cardiaca descompensada.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Whether the use of mobile phones is a risk factor for brain tumors in adolescents is currently being studied. Case--control studies investigating this possible relationship are prone to recall error and selection bias. We assessed the potential impact of random and systematic recall error and selection bias on odds ratios (ORs) by performing simulations based on real data from an ongoing case--control study of mobile phones and brain tumor risk in children and adolescents (CEFALO study). Simulations were conducted for two mobile phone exposure categories: regular and heavy use. Our choice of levels of recall error was guided by a validation study that compared objective network operator data with the self-reported amount of mobile phone use in CEFALO. In our validation study, cases overestimated their number of calls by 9% on average and controls by 34%. Cases also overestimated their duration of calls by 52% on average and controls by 163%. The participation rates in CEFALO were 83% for cases and 71% for controls. In a variety of scenarios, the combined impact of recall error and selection bias on the estimated ORs was complex. These simulations are useful for the interpretation of previous case-control studies on brain tumor and mobile phone use in adults as well as for the interpretation of future studies on adolescents.

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The short, portable mental status questionnaire (SPMSQ) developed by Pfeiffer has several advantages over previous short instruments designed to assess the intellectual functioning of older adults. It is based upon data from both institutionalized and community-dwelling elderly. Although Pfeiffer a four-group classification, he used to groups in his initial validation study: (a) intact/mildly impaired, and (b) moderately/severely impaired. The present study compared clinicians' ratings with those based upon the SPMSQ scores, and examined the validity of the four-group classification. The sample included 181 subjects from seven intermediate care facilities and nine home-care agencies. All were assessed by the OARS questionnaire, which includes the SPMSQ Three discriminant analyses were performed with three different criteria, for two-group, three-group, and four-group models. Results indicated that the two-group model (intact/mildly impaired and moderately/severely impaired) permitted significant discrimination. The four-group model, however, gave less distinct results. In particular, patients who were mildly intellectually impaired could not be clearly distinguished from those who were intact and from those who were moderately impaired. The three-group model (minimally, moderately, severely impaired) seemed to offer the best compromise between the gross dichotomy of the original two-model system and the less accurate four category system.

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Trichinellosis is a zoonotic disease in humans caused by Trichinella spp. According to international regulations and guidelines, serological surveillance can be used to demonstrate the absence of Trichinella spp. in a defined domestic pig population. Most enzyme-linked immunosorbent assay (ELISA) tests presently available do not yield 100% specificity, and therefore, a complementary test is needed to confirm the diagnosis of any initial ELISA seropositivity. The goal of the present study was to evaluate the sensitivity and specificity of a Western Blot assay based on somatic Trichinella spiralis muscle stage (L1) antigen using Bayesian modeling techniques. A total of 295 meat juice and serum samples from pigs negative for Trichinella larvae by artificial digestion, including 74 potentially cross-reactive sera of pigs with other nematode infections, and 93 meat juice samples from pigs infected with Trichinella larvae were included in the study. The diagnostic sensitivity and specificity of the Western Blot were ranged from 95.8% to 96.0% and from 99.5% to 99.6%, respectively. A sensitivity analysis showed that the model outcomes were hardly influenced by changes in the prior distributions, providing a high confidence in the outcomes of the models. This validation study demonstrated that the Western Blot is a suitable method to confirm samples that reacted positively in an initial ELISA.

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BACKGROUND & Aims: Standardized instruments are needed to assess the activity of eosinophilic esophagitis (EoE), to provide endpoints for clinical trials and observational studies. We aimed to develop and validate a patient-reported outcome (PRO) instrument and score, based on items that could account for variations in patients' assessments of disease severity. We also evaluated relationships between patients' assessment of disease severity and EoE-associated endoscopic, histologic, and laboratory findings. METHODS We collected information from 186 patients with EoE in Switzerland and the US (69.4% male; median age, 43 years) via surveys (n = 135), focus groups (n = 27), and semi-structured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patients' assessment of EoE severity. The PRO instrument was prospectively used in 153 adult patients with EoE (72.5% male; median age, 38 years), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 years). RESULTS Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patients' assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity and PRO score was 0.13 (on a scale from 0 to 10). CONCLUSIONS We developed and validated an EoE scoring system based on 7 PRO items that assesses symptoms over a 7-day recall period. Clinicaltrials.gov number: NCT00939263.

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Lipid peroxidation products like malondialdehyde, 4-hydroxynonenal and F(2)-isoprostanes are widely used as markers of oxidative stress in vitro and in vivo. This study reports the results of a multi-laboratory validation study by COST Action B35 to assess inter-laboratory and intra-laboratory variation in the measurement of lipid peroxidation. Human plasma samples were exposed to UVA irradiation at different doses (0, 15 J, 20 J), encoded and shipped to 15 laboratories, where analyses of malondialdehyde, 4-hydroxynonenal and isoprostanes were conducted. The results demonstrate a low within-day-variation and a good correlation of results observed on two different days. However, high coefficients of variation were observed between the laboratories. Malondialdehyde determined by HPLC was found to be the most sensitive and reproducible lipid peroxidation product in plasma upon UVA treatment. It is concluded that measurement of malondialdehyde by HPLC has good analytical validity for inter-laboratory studies on lipid peroxidation in human EDTA-plasma samples, although it is acknowledged that this may not translate to biological validity.

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Objective: To examine the effectiveness of an “Enhancing Positive Emotions Procedure” (EPEP) based on positive psychology and cognitive behavioral therapy in relieving distress at the time of adjuvant chemotherapy treatment in colorectal cancer patients (CRC). It is expected that EPEP will increase quality of life and positive affect in CRC patients during chemotherapy treatment intervention and at 1 month follow-up.Method: A group of 24 CRC patients received the EPEP procedure (intervention group), whereas another group of 20 CRC patients did not receive the EPEP (control group). Quality of life (EORTC-QLQC30), and mood (PANAS) were assessed in three moments: prior to enter the study (T1), at the end of the time required to apply the EPEP (T2, 6 weeks after T1), and, at follow-up (T3, one-month after T2). Patient’s assessments of the EPEP (improving in mood states, and significance of the attention received) were assessed with Lickert scales.Results: Insomnia was reduced in the intervention group. Treatment group had better scores on positive affect although there were no significantly differences between groups and over time. There was a trend to better scores at T2 and T3 for the intervention group on global health status, physical, role, and social functioning scales. Patients stated that positive mood was enhanced and that EPEP was an important resource.Conclusions: CRC patients receiving EPEP during chemotherapy believed that this intervention was important. Furthermore, EPEP seems to improve positive affect and quality of life. EPEP has potential benefits, and its implementation to CRC patients should be considered.

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A validation study examined the accuracy of a purpose-built single photon absorptiometry (SPA) instrument for making on-farm in vivo measurements of bone mineral density (BMD) in tail bones of cattle. In vivo measurements were made at the proximal end of the ninth coccygeal vertebra (Cy9) in steers of two age groups (each n = 10) in adequate or low phosphorus status. The tails of the steers were then resected and the BMD of the Cy9 bone was measured in the laboratory with SPA on the resected tails and then with established laboratory procedures on defleshed bone. Specific gravity and ash density were measured on the isolated Cy9 vertebrae and on 5-mm2 dorso-ventral cores of bone cut from each defleshed Cy9. Calculated BMD determined by SPA required a measure of tail bone thickness and this was estimated as a fraction of total tail thickness. Actual tail bone thickness was also measured on the isolated Cy9 vertebrae. The accuracy of measurement of BMD by SPA was evaluated by comparison with the ash density of the bone cores measured in the laboratory. In vivo SPA measurements of BMD were closely correlated with laboratory measurements of core ash density (r = 0.92). Ash density and specific gravity of cores, and all SPA measures of BMD, were affected by phosphorus status of the steers, but the effect of steer age was only significant (P < 0.05) for steers in adequate phosphorus status. The accuracy of SPA to determine BMD of tail bone may be improved by reducing error associated with in vivo estimation of tail bone thickness, and also by adjusting for displacement of soft tissue by bone mineral. In conclusion a purpose-built SPA instrument could be used to make on-farm sequential non-invasive in vivo measurements of the BMD of tailbone in cattle with accuracy acceptable for many animal studies.

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The aim of this paper was to obtain evidence of the validity of the LSB-50 (de Rivera & Abuín, 2012), a screening measure of psychopathology, in Argentinean adolescents. The sample consisted of 1002 individuals (49.7% male; 50.3% female) between 12 and 18 years-old (M = 14.98; SD = 1.99). A cross-validation study and factorial invariance studies were performed in samples divided by sex and age to test if a seven-factor structure that corresponds to seven clinical scales (Hypersensitivity, Obsessive-Compulsive, Anxiety, Hostility, Somatization, Depression, and Sleep disturbance) was adequate for the LSB-50. The seven-factor structure proved to be suitable for all the subsamples. Next, the fit of the seven-factor structure was studied simultaneously? in the aforementioned subsamples through hierarchical models that imposed different constrains of equivalency?. Results indicated the invariance of the seven clinical dimensions of the LSB-50. Ordinal alphas showed good internal consistency for all the scales. Finally, the correlations with a diagnostic measure of psychopathology (PAI-A) indicated moderate convergence. It is concluded that the analyses performed provide robust evidence of construct validity for the LSB-50

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The 12-item Partner in Health (PIH) scale was developed in Australia to measure self-management behaviour and knowledge in patients with chronic diseases. The scale has undergone several changes since first published. Our study aim was to validate the latest PIH in Dutch COPD patients.The 12 items of the PIH are scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).We used forward-backward translation of the latest version of the Australian PIH. Dimensionality and reliability analyses were performed to investigate the psychometric properties, and to determine whether the Dutch PIH replicated the same four subscales of self-management as the original PIH.Reanalysis of the original PIH validation study (186 Australian patients with chronic diseases) showed a single scale. Two scales (1. knowledge and coping; 2. recognition and management of symptoms, adherence to treatment) were found for the Dutch PIH (118 Dutch COPD patients). The correlation between the two Dutch scales was 0.43. The lower-bound of the reliability of the total scale was 0.81 (Australian PIH) and 0.84 (Dutch PIH).Different scale structures were found for the original Australian and the Dutch PIH. Our results did not support the 4-scale structure reported previously. To increase comparability and generalisability of our findings, the scale structure of the revised Australian PIH needs to be investigated further. Meanwhile, we advise using the PIH total score or two subscale scores when assessing COPD patients.

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OBJECTIVES: This study aimed to validate SenseWear Mini software algorithm versions 2.2 (SW2.2) and 5.2 (SW5.2) for estimating energy expenditure (EE) in children. DESIGN: Laboratory-based validation study. METHODS: 57 children aged 5-12 y completed a protocol involving 15 semi-structured sedentary (SED), light-intensity (LPA), and moderate- to vigorous-intensity (MVPA) physical activities. EE was estimated using portable indirect calorimetry (IC). The accuracy of EE estimates (kcal·min(-1)) from SW2.2 and SW5.2 were examined at the group level and individual level using the mean absolute percentage error (MAPE), Bland-Altman plots and equivalence testing. RESULTS: MAPE values were lower for SW5.2 (30.1±10.7%) than for SW2.2 (44.0±6.2%). Although mean differences for SW5.2 were smaller than for SW2.2 during SED (-0.23±0.22 vs. -0.61±0.20kcal·min(-1)), LPA (-0.69±0.76 vs. -1.07±0.46kcal·min(-1)) and MVPA (-2.22±1.15 vs. -2.57±1.15kcal·min(-1)), limits of agreement did not decrease for the updated algorithms. For all activities, SW2.2 and SW5.2 were not equivalent to IC (p>0.05). Errors increased with increasing intensity. CONCLUSION: The current SenseWear Mini algorithms SW5.2 underestimated EE. The overall improved accuracy for SW5.2 was not accompanied with improved accuracy at the individual level and EE estimates were not equivalent to IC.

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Advances in the diagnosis of Mycobacterium bovis infection in wildlife hosts may benefit the development of sustainable approaches to the management of bovine tuberculosis in cattle. In the present study, three laboratories from two different countries participated in a validation trial to evaluate the reliability and reproducibility of a real time PCR assay in the detection and quantification of M. bovis from environmental samples. The sample panels consisted of negative badger faeces spiked with a dilution series of M. bovis BCG Pasteur and of field samples of faeces from badgers of unknown infection status taken from badger latrines in areas with high and low incidence of bovine TB (bTB) in cattle. Samples were tested with a previously optimised methodology. The experimental design involved rigorous testing which highlighted a number of potential pitfalls in the analysis of environmental samples using real time PCR. Despite minor variation between operators and laboratories, the validation study demonstrated good concordance between the three laboratories: on the spiked panels, the test showed high levels of agreement in terms of positive/negative detection, with high specificity (100%) and high sensitivity (97%) at levels of 10(5) cells g(-1) and above. Quantitative analysis of the data revealed low variability in recovery of BCG cells between laboratories and operators. On the field samples, the test showed high reproducibility both in terms of positive/negative detection and in the number of cells detected, despite low numbers of samples identified as positive by any laboratory. Use of a parallel PCR inhibition control assay revealed negligible PCR-interfering chemicals co-extracted with the DNA. This is the first example of a multi-laboratory validation of a real time PCR assay for the detection of mycobacteria in environmental samples. Field studies are now required to determine how best to apply the assay for population-level bTB surveillance in wildlife.