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Mokkink L.B.,VU University Amsterdam | Terwee C.B.,VU University Amsterdam | Gibbons E.,University of Oxford | Stratford P.W.,McMaster University | And 6 more authors.
BMC Medical Research Methodology | Year: 2010

Background. The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114). Methods. 75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item. Results. 88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions. Conclusions. Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved. © 2010 Mokkink et al; licensee BioMed Central Ltd.

Rajmil L.,Imim Institute Of Recerca Hospital Del Mar | Rajmil L.,Catalan Agency for Health Information | Rajmil L.,CIBER ISCIII | Roizen M.,Committee of Quality of Life | And 4 more authors.
Value in Health | Year: 2012

Objectives: To analyze the characteristics of instruments designed to assess the health-related quality of life (HRQOL) in children, developed or adapted from 2000 to 2010 in Argentina, Chile, Mexico, Spain, and Uruguay. Methods: The protocol-led literature review included database searching (e.g., Medline, ISI Science Citation Index) and manual searching to retrieve studies focused on measures of HRQOL, health status, or well-being addressed to children and adolescents. Country-specific filters were applied to identify studies carried out in the participating countries. The characteristics of the instruments and type of studies were analyzed. Descriptive characteristics and psychometric properties were analyzed following the guidelines of the Scientific Advisory Committee of the Medical Outcomes Trust. Results: Ninety-nine documents were included. Thirty-one questionnaires were identified, 24 instruments were adapted, and the psychometric properties of 20 HRQOL instruments were reported in the study period. There was substantial variability in the number and characteristics of the dimensions included. Reliability was generally acceptable, and the majority of instruments provided data on internal consistency (n = 18) and, to a lesser extent, on test-retest reliability (n = 12). Nearly all studies reported construct validity, but only four analyzed sensitivity to change. Conclusions: There is a scarcity of instruments to measure HRQOL of children and adolescents in the countries analyzed. Certain psychometric characteristics have been reasonably well tested, but others, most notably sensitivity to change, have not been tested in most instruments. Extension of this study to other Latin American countries would help to further identify gaps in this area and promote the use of HRQOL measurement in children and adolescents in Spanish-speaking cultures. Copyright © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

Allory Y.,Epithelial Carcinogenesis Group | Allory Y.,University Paris Est Creteil | Beukers W.,Erasmus University Rotterdam | Sagrera A.,Epithelial Carcinogenesis Group | And 25 more authors.
European Urology | Year: 2014

Background Hotspot mutations in the promoter of the gene coding for telomerase reverse transcriptase (TERT) have been described and proposed to activate gene expression. Objectives To investigate TERT mutation frequency, spectrum, association with expression and clinical outcome, and potential for detection of recurrences in urine in patients with urothelial bladder cancer (UBC). Design, setting, and participants A set of 111 UBCs of different stages was used to assess TERT promoter mutations by Sanger sequencing and TERT messenger RNA (mRNA) expression by reverse transcription-quantitative polymerase chain reaction. The two most frequent mutations were investigated, using a SNaPshot assay, in an independent set of 184 non-muscle-invasive and 173 muscle-invasive UBC (median follow-up: 53 mo and 21 mo, respectively). Voided urine from patients with suspicion of incident UBC (n = 174), or under surveillance after diagnosis of non-muscle-invasive UBC (n = 194), was tested using a SNaPshot assay. Outcome measurements and statistical analysis Association of mutation status with age, sex, tobacco, stage, grade, fibroblast growth factor receptor 3 (FGFR3) mutation, progression-free survival, disease-specific survival, and overall survival. Results and limitations In the two series, 78 of 111 (70%) and 283 of 357 (79%) tumors harbored TERT mutations, C228T being the most frequent substitution (83% for both series). TERT mutations were not associated with clinical or pathologic parameters, but were more frequent among FGFR3 mutant tumors (p = 0.0002). There was no association between TERT mutations and mRNA expression (p = 0.3). Mutations were not associated with clinical outcome. In urine, TERT mutations had 90% specificity in subjects with hematuria but no bladder tumor, and 73% in recurrence-free UBC patients. The sensitivity was 62% in incident and 42% in recurrent UBC. A limitation of the study is its retrospective nature. Conclusions Somatic TERT promoter mutations are an early, highly prevalent genetic event in UBC and are not associated with TERT mRNA levels or disease outcomes. A SNaPshot assay in urine may help to detect UBC recurrences. © 2013 European Association of Urology.

Rubio L.,University of Lleida | Valls R.-M.,Rovira i Virgili University | MacIa A.,University of Lleida | Pedret A.,Rovira i Virgili University | And 9 more authors.
Food Chemistry | Year: 2012

Three different functional phenol-enriched virgin olive oils (FVOO) were prepared with a phenolic content of 250 (L-FVOO), 500 (M-FVOO), and 750 mg (H-FVOO) total phenols/kg. In a randomised, cross-over study with 12 healthy volunteers, the pharmacokinetics of phenolic biological metabolites was assessed. An increasing linear trend was observed for hydroxytyrosol sulfate, the main phenolic metabolite quantified in plasma, with Cmax values of 1.35, 3.32, and 4.09 μmol/l, and AUC mean values of 263.7, 581.4, and 724.4 μmol/min for L-FVOO, M-FVOO, and H-FVOO, respectively. From our data an acute intake of phenol-enriched olive oils promotes a dose-dependent response of phenol conjugate metabolites in human plasma. Also, we point out for the first time hydroxytyrosol acetate sulfate as a main biological metabolite of hydroxytyrosol from olive oil ingestion. © 2012 Elsevier Ltd. All rights reserved.

Verdejo-Garcia A.,University of Granada | Verdejo-Garcia A.,Monash University | Albein-Urios N.,University of Granada | Martinez-Gonzalez J.M.,University of Granada | And 7 more authors.
Psychopharmacology | Year: 2014

Rationale: One of the key outstanding challenges in cocaine dependence research is determining who is at risk of relapsing during treatment.Objectives: We examined whether cognitive decision-making profiles predict objectively (hair) indexed cocaine relapse at 3-month follow-up.Methods: Thirty-three cocaine-dependent patients commencing outpatient treatment in a public clinic performed baseline decision-making assessments with the original and variant versions of the Iowa Gambling Task, and provided a 3-cm hair sample 3 months afterwards. Based on Iowa Gambling Tasks' performance cut-offs, 5 patients had intact decision-making skills, 17 patients showed impaired sensitivity to reward or punishment (impairment in one of the tasks), and 9 patients showed insensitivity to future consequences (impairment in both tasks). Based on a 0.3 ng/mg cocaine cut-off, 23 patients were classified as relapsers and 10 as non-relapsers at the 3-month follow-up.Results: Eighty percent of patients with intact decision-making were abstinent at follow-up, whereas 90 % of patients with insensitivity to future consequences had relapsed. The two subgroups (relapsers and non-relapsers) showed no significant differences on drug use, comorbidities, or psychosocial function, and significantly differed on verbal but not performance IQ. A regression model including decision-making scores and verbal IQ predicted abstinence status with high sensitivity (95 %) and moderately high specificity (81 %).Conclusion: These preliminary findings demonstrate that decision-making profiles are associated with cocaine relapse. Moreover, combined decision-making and IQ assessments provide optimal predictive values over stimulant relapse, yielding significant opportunities for clinical translation. © 2014 Springer-Verlag Berlin Heidelberg.

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