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Background: The Patient Reported Outcome Measurement Information System profile instruments include "high information" items drawn from large item banks following the application of modern psychometric criteria. The shortest adult profile, PROMIS-29, looks set to replace existing short-form instruments in research and clinical practice. The objective of this study was to undertake the first psychometric evaluation of the Norwegian PROMIS-29, following a postal survey of a random sample of 12,790 Norwegians identified through the National Registry of the Norwegian Tax Administration. Confirmatory factor analysis was used to assess structural validity. Fit to the Rasch partial credit model and differential item functioning (DIF) were assessed in relation to age, gender, and education. PROMIS-29 scores were compared to those for the EQ-5D-5L and the Self-assessed Comorbidity Questionnaire (SCQ), for purposes of assessing validity based on a priori hypotheses. Results: There were 3200 (25.9%) respondents with a mean age (SD) of 51 (20.7, range 18 to 97 years) and 55% were female. The PROMIS-29 showed satisfactory structural validity and acceptable fit to Rasch model including unidimensionality, and measurement invariance across age and education levels. One pain interference item had uniform DIF for gender but splitting gave satisfactory fit. Domain reliability estimates ranged from 0.85 to 0.95. Correlations between PROMIS-29 domain, SCQ and EQ-5D scores were largely as expected, the largest being for scores assessing very similar aspects of health. Conclusions: The Norwegian version of the PROMIS-29 is a reliable and valid generic self-reported measure of health in the Norwegian general population. The instrument is recommended for further application, but the analysis should be replicated and responsiveness to change assessed in future studies before it can be recommended for clinical and health services evaluation in Norway. [ABSTRACT FROM AUTHOR]

Background: Among patients successfully resuscitated after an out-of-hospital cardiac arrest (OHCA), 10% to 15% evolve toward brain death (BD), thus becoming potential organ donors.Research Question: Is it possible to establish a score for early estimation of BD risk after OHCA?Study Design and Methods: The BD after cardiac arrest (BDCA) score was developed from data available within 24 hours after OHCA from two OHCA trials: Cyclosporine in Cardiac Arrest Resuscitation and Erythropoietin After OHCA. The BDCA score was then validated in another large prospective multicenter data set. The main outcome was the occurrence of BD. Independent prognostic covariates for BD were identified using a binomial two-stage adaptive least absolute shrinkage and selection operator procedure.Results: The development cohort included 569 patients alive 24 hours after OHCA, among whom 84 (14.8%) experienced BD. Independent predictors of BD used to build the BDCA score were being female (4 points), nonshockable rhythm (24 points), cardiac cause of OHCA (-6 points), neurological cause of OHCA (45 points), natremia at 24 hours (natremia in millimoles per liter minus 140 points), and vasoactive drug at admission (4 points) and at 24 hours (6 points). The area under the curve (AUC) of the BDCA score was 0.82 (95% CI, 0.77-0.86), and the discrimination value in the validation cohort (n = 487) was consistent (AUC, 0.81; 95% CI, 0.76-0.86). In the validation cohort, BD occurred in 4.0%, 20.4%, and 67.7% of patients with scores of < 20, 20 to 50, and > 50, respectively.Interpretation: The BDCA score allows early detection of patients with a high probability of experiencing BD, which may help increase organ donation after OHCA.Clinical Trial Registration: ClinicalTrials.gov; No.: NCT01595958, and ClinicalTrials.gov; No.: NCT00999583; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Purpose: Fractures are common events, but the exact incidence and severity of fractures have not been clearly determined for most anatomical sites. We estimated the incidence and severity of fractures in France regardless of the anatomical site.Methods: Observational cross-sectional study in France in 2016 based on the national health data system. All incident fractures in patients 20 years and older were included. We determined the anatomical fracture site (12 sites) and the severity using a 4-point scale (outpatient care, hospitalization, surgery, and in-hospital death).Results: We identified 562,094 incident fractures, predominantly occurring in women (319,858: 56.9%); with a mean age of 63.6 years, and an exponential increase after the age of 70 years. Distal upper limb (172,591: 30.7%), distal lower limb (84,602: 15.1%), and femoral neck (78,766: 14.0%) accounted for more than one-half of all fractures. Sex and age of onset distributions varied widely according to fracture sites, with earlier onset for distal lower limb fractures (mean age: 54.2 years) and distal upper limb fractures (mean age: 55.2 years) with a men predominance for skull fractures. Only 105,165 (18.7%) fractures were treated on an outpatient basis; 11,913 (2.1%) in-hospital deaths occurred in patients with a mean age of 79.5 years. High mortality was observed for skull (12.9%), rib (4.9%), and femoral fractures (femoral neck 4.3% and proximal lower limb 4.2%).Conclusion: We estimated the incidence of fractures in France by sex and anatomical site. We also showed that fractures remain common and serious life events, especially in older people. [ABSTRACT FROM AUTHOR]

Background: CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD.Objective: To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD.Design: Comparative equivalence cohort study.Setting: Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017).Patients: 5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab.Measurements: The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25).Results: Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]).Limitation: The SNDS does not contain all relevant clinical data (for example, disease activity).Conclusion: This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes.Primary Funding Source: Caisse Nationale de l'Assurance Maladie. [ABSTRACT FROM AUTHOR]

A systematic review of articles using qualitative methods to generate questionnaire items identified in MEDLINE and PsycINFO from 2000 to 2014 was carried out. Articles were analyzed for (a) year of publication and journal domain, (b) qualitative data collection methods, (c) method of data content analysis, (d) professional experts' input in item generation, and (e) debriefing of the newly developed items. In total, 371 articles were included and results showed (a) an acceleration of published articles, (b) individual interviews and focus groups were common ways of generating items and no emergent approach was identified, (c) the content analysis was usually not described (43% of articles), (d) experts were involved in eliciting concepts in less than a third of articles, (e) 61% of articles involved a step of further submission of newly developed items to the population of interest. This review showed an insufficient reporting of qualitative methods used to generate new questionnaires despite previous recommendations. [ABSTRACT FROM AUTHOR]

Objective: Molecular defects of hepatocyte nuclear factor 1B (HNF1B) are associated with a multiorgan disease, including diabetes (maturity-onset diabetes of the young 5) and kidney abnormalities. The HNF1B syndrome is related to HNF1B mutations or to a 17q12 deletion spanning 15 genes, including HNF1B. Here, we described HNF1B-related diabetes and associated phenotypes and assessed genotype/phenotype correlations at diagnosis and in the long-term.Research Design and Methods: This multicenter retrospective cohort study included 201 patients, aged 18 years or older at follow-up, with HNF1B mutations (n = 101) or deletion (n = 100).Results: Diabetes was present in 159 patients. At diagnosis, clinical symptoms of diabetes were present in 67 of 144 patients and HNF1B renal disease in 64 of 102. Although responsiveness to sulfonylureas/repaglinide was observed in 29 of the 51 tested, 111 of 140 patients (79%) were treated with insulin at follow-up. Diabetic retinopathy and/or neuropathy were present in 46 of 114 patients. Renal cysts were present in 122 of 166 patients, chronic kidney disease stages 3-4 (CKD3-4) in 75 of 169 (44%), and end-stage renal disease (ESRD) in 36 of 169 (21%). Compared with the patients with mutations, those with HNF1B deletion less often had CKD3-4/ESRD at diagnosis (11 of 43 vs. 27 of 35, P < 10-4) and in the long term (40 of 78 vs. 71 of 91, P = 0.0003). They were leaner and more frequently treated with insulin.Conclusions: In patients with HNF1B syndrome, diabetes complications, cardiovascular risk factors, CKD3-4, and ESRD are highly prevalent. At diabetes diagnosis, the presence of morphological and/or functional kidney disease may help etiological diagnosis. Genotype/phenotype correlations may have implications for the care and the prognosis of these patients. [ABSTRACT FROM AUTHOR]

: ObjectiveTo investigate stressful maternal life events as candidate risk factors for ectopic pregnancy.: DesignPopulation-based registry study.: SettingAuvergne ectopic pregnancy registry (France).: Patient(s)Women (n = 641) registered between 1997 and 2000.: Intervention(s)Standard treatment of ectopic pregnancy.: Main outcome measure(s)Based on the Psychiatric Epidemiology Life Events Scale, we analyzed the nonresponse bias, the confounding effects of sociobehavioral factors associated with both life events and ectopic pregnancy, and the potential buffering effects of socio-cultural variables. A multivariate model was constructed to test the association between life events and ectopic pregnancy, adjusting for identified confounders and testing interactions.: Result(s)The primary hypothesis that life events might be independent risk factors for ectopic pregnancy was not confirmed in this study, which nevertheless illustrated the numerous biases and measurement problems confronting association studies of life events with adverse pregnancy outcomes.: Conclusion(s)Recommendations are made for future studies on life events and adverse pregnancy outcomes to avoid most selection, information, and confounding biases. Methodological improvements are needed for measurement of life events to develop measures that more closely consider the consequences of stress and the mechanisms of buffering. [Copyright &y& Elsevier]

Purpose: To evaluate magnetic resonance imaging (MRI) for diaphragmatic endometriosis diagnosis.Materials and Methods: Over a 2-year period, all diaphragmatic MRI performed in the context of diaphragmatic endometriosis were reviewed. Axial and coronal fat-suppressed T1- and T2-weighted sequences were analyzed by two independent readers for the presence of nodules, plaque lesions, micronodule clustering, or focal liver herniation. MR abnormalities were correlated to surgical findings in women surgically treated. Interobserver agreement was assessed by κ statistics.Results: Twenty-three women with diaphragmatic endometriosis criteria comprised the population; 14 had surgical confirmation and nine had symptoms relief with hormonal treatment. MRI sensitivity was 83 % (19/23; 95 % confidence interval [CI]: 68, 98) for reader 1 and 78 % (18/23; 95 % CI: 61, 95) for reader 2. Kappa value was 0.86 (95 % CI: 0.47, 1.00). Readers 1 and 2 detected 35 and 36 lesions, respectively, all right-sided and agreed for 32 lesions on the type, location, and signal. Lesions were mostly nodules (23/32, 72 %), predominantly posterior (28/32, 87.5 %) and hyperintense on T1 (20/32, 63 %). MRI was negative for both readers in 2 surgically treated patients with small nodules or isolated diaphragmatic holes.Conclusion: MRI allows diaphragmatic endometriosis diagnosis with 78 to 83 % sensitivity and excellent interobserver agreement.Key Points: • MRI allows the diagnosis of diaphragmatic endometriosis with up to 83 % sensitivity. • Diaphragmatic endometriosis lesions are better depicted on fat-suppressed T1-weighted sequences. • Diaphragmatic lesions, mostly hyperintense nodules, are right-sided and predominantly posterior. • MRI can help in timely diagnosis of diaphragmatic endometriosis. [ABSTRACT FROM AUTHOR]

Background: Negative effects of obesity on health-related quality of life (HRQoL) have been reported, especially in women, but the relative contribution of cardiometabolic and other obesity-related comorbidities to such effects remains unclear. Our objective was to model the association by sex between body mass index and HRQoL and to precisely quantify the indirect effects mediated by obesity-related comorbidities.Methods and Results: Data were drawn from the latest French Decennial Health Survey, a nationwide cross-sectional study conducted in 2003 (21 239 adults aged 25-64 years analyzed). HRQoL was measured by the 36-item short-form health survey questionnaire. A mediation analysis based on the counterfactual framework was performed to quantify the proportion of obesity effects on HRQoL mediated by related comorbidities, including cardiometabolic risk factors (diabetes mellitus, hypertension, dyslipidemia) and diseases (ischemic heart disease, cerebrovascular, and peripheral vascular disease), musculoskeletal disorders, and asthma. After multiple linear regression, inverse associations were found between increasing body mass index category and physically oriented and most mentally oriented 36-item short-form health survey dimensions, with evidence of greater effects in women. Mediation analysis revealed that obesity effects were significantly mediated by several comorbidities, more apparently in men (eg, proportion of obesity class II total effect mediated via cardiometabolic factors: general health 27.0% [men] versus 13.6% [women]; proportion of obesity class II total effect mediated via total count of comorbidities: physical functioning 17.8% [men] versus 7.7% [women] and general health 37.1% [men] versus 20.3% [women]).Conclusions: Women have a greater overall impact of obesity on HRQoL, but with proportionally lower effects mediated by cardiometabolic and other obesity-related conditions, suggesting the possible role of other specific psychosocial processes. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the performance of a commercially available CAD system for automated detection and measurement of subsolid nodules.Materials and Methods: The CAD system was tested on 50 pure ground-glass and 50 part-solid nodules (median diameter: 17mm) previously found on standard-dose CT scans in 100 different patients. True nodule detection and the total number of CAD marks were evaluated at different sensitivity settings. The influence of nodule and CT acquisition characteristics was analyzed with logistic regression. Software and manually measured diameters were compared with Spearman and Bland-Altman methods.Results: With sensitivity adjusted for 3-mm nodule detection, 50/100 (50%) subsolid nodules were detected, at the average cost of 17 CAD marks per CT. These figures were respectively 26/100 (26%) and 2 at the 5-mm setting. At the highest sensitivity setting (2-mm nodule detection), the average number of CAD marks per CT was 41 but the nodule detection rate only increased to 54%. Part-solid nodules were better detected than pure ground glass nodules: 36/50 (72%) versus 14/50 (28%) at the 3-mm setting (p<0.0001), with no influence of the solid component size. Except for the type (i.e. part solid or pure ground glass), no other nodule characteristic influenced the detection rate. High-quality segmentation was obtained for 79 nodules, which for automated measurements correlated well with manual measurements (rho=0.90[0.84-0.93]). All part-solid nodules had software-measured attenuation values above -671Hounsfield units (HU).Conclusion: The detection rate of subsolid nodules by this CAD system was insufficient, but high-quality segmentation was obtained in 79% of cases, allowing automated measurement of size and attenuation. [ABSTRACT FROM AUTHOR]

Objective: Our objective was to compare the use of both anteroposterior (AP) extended-knee X-ray and semi-flexed X-ray (current gold standard) versus the use of semi-flexed X-ray alone to detect femoro-tibial osteoarthritis (OA).Methods: Individuals 40 to 75 years of age with symptomatic hip and/or knee OA (Kellgren/Lawrence [KL] score≥2) were recruited using a multiregional prevalence survey in France. Both AP and schuss X-rays were performed and read; two years later, the same examiner, blinded to the results of the first reading, performed a second reading of the schuss X-ray. We compared the KL stages of each knee and analyzed osteophyte detection and localization, joint space narrowing (JSN), and the relationship to obesity.Results: The analysis included 350 participants with OA of various stages. Comparing the two readings showed that a higher proportion of patients had KL≥2 when the two X-ray views were combined (right knee: P<0.0001; left knee: P<0.001). There were no differences when using the schuss X-ray alone versus in combination with an AP X-ray in terms of detecting JSN, osteophytes. A comparison of schuss X-ray alone versus AP X-ray alone demonstrated the superiority of the schuss view for evaluating JSN (P=0.0001 and P=0.0001) and no difference in osteophyte detection.Conclusion: Our study shows that the schuss view alone was sufficient for detecting knee osteophytes and JSN. Using one X-ray rather than two will reduce medical costs and irradiation burden. Using two views seems preferable for epidemiological studies. [ABSTRACT FROM AUTHOR]