58 results on '"reclassification"'
Search Results
2. Does Protocol Make a Difference? Comparison of Two Prostate Cancer Active Surveillance Cohorts: A Non–protocol-based Follow-up and a Protocol-based Contemporary Follow-up
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Kari A.O. Tikkinen, Antti Rannikko, Arttu Siipola, Inari Kalalahti, Hanna Vasarainen, Andrew Erickson, HUS Abdominal Center, Urologian yksikkö, Research Program in Systems Oncology, Department of Surgery, South Carelia Social and Health care District Eksote, HYKS erva, and Clinicum
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Oncology ,medicine.medical_specialty ,Urology ,3122 Cancers ,030232 urology & nephrology ,Active surveillance ,law.invention ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Randomized controlled trial ,law ,Prostate ,Internal medicine ,medicine ,MANAGEMENT ,Treatment of prostate cancer ,RC254-282 ,Protocol (science) ,OUTCOMES ,COMPLICATIONS ,RECLASSIFICATION ,business.industry ,Prostate Cancer ,RADICAL PROSTATECTOMY ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Regression analysis ,Retrospective cohort study ,MEN ,Prostate cancer survival ,PRIAS ,medicine.disease ,3126 Surgery, anesthesiology, intensive care, radiology ,Regression ,Diseases of the genitourinary system. Urology ,3. Good health ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Cohort ,BIOPSIES ,TRIAL ,RC870-923 ,business - Abstract
Take Home Message In terms of clinically relevant outcomes, such as overall survival, prostate cancer–specific survival, metastasis-free survival, and treatment-free survival, a strict follow-up protocol does not provide benefit for men with low-risk prostate cancer on active surveillance., Background Active surveillance (AS) is the preferred option for initial management for low-risk prostate cancer (PC). Although many AS protocols exist, there is little evidence to support one over another. Objective To assess whether there is difference in overall (OS), prostate cancer–specific (CSS), metastasis-free (MFS), or treatment-free (TFS) survival between a strict (Prostate cancer Research International: Active Surveillance [PRIAS]) and a loose (European Randomized study of Screening for Prostate Cancer [ERSPC]) AS protocol. Design, setting, and participants This study included two cohorts of men (n = 518) with low-risk, localized, Gleason score ≤7 PC. The ERSPC cohort included 241 men followed for 9.5 yr (median) with a non–protocol-based follow-up. The PRIAS cohort included 277 men followed for 5 yr (median) with a strict protocol. Outcome measurements and statistical analysis OS, CSS, MFS, and TFS were compared by the Kaplan-Meier method, competing risk analysis, and Cox proportional hazard regression. Results and limitations As expected, due to the difference in median follow-up time between the cohorts, a difference in the absolute number of events was seen. However, no difference in any of the survival outcomes was evident in the Kaplan-Meier or competing risks analysis. Furthermore, in Cox proportional hazard regression analysis, cohort (ERSPC vs PRIAS) was not associated with any of the outcomes. Results are limited by the retrospective study design, limited statistical power, and inability to match the cohorts for predictive factors. Conclusions There was no difference in survival outcomes between a non–protocol-based follow-up and a protocol-based contemporary AS follow-up of patients with low-risk PC. However, a longer follow-up is needed. Patient summary We compared survival outcomes of two cohorts of patients with low-risk prostate cancer: a strict and a loose follow-up protocol. We found no differences in survival measures between the cohorts.
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- 2021
3. Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial
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Martin Burmester, Roswitha Bussar-Maatz, Peter Albers, Michael Stöckle, Heinz Schmidberger, Fried Schneider, Peter Renner, Stefan Wellek, Thomas Wiegel, Christoph Meisner, Klaus Grozinger, Glen Kristiansen, Martin Härter, and Peter Martus
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Adult ,Male ,Nephrology ,medicine.medical_specialty ,Time Factors ,Adolescent ,Urology ,medicine.medical_treatment ,Brachytherapy ,030232 urology & nephrology ,Active surveillance ,Risk Assessment ,law.invention ,Young Adult ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Humans ,Medicine ,Prospective Studies ,External beam radiotherapy ,Watchful Waiting ,Aged ,business.industry ,Prostatectomy ,Reclassifcation ,Prostatic Neoplasms ,Reclassification ,Middle Aged ,medicine.disease ,Clinical trial ,030220 oncology & carcinogenesis ,Early Termination of Clinical Trials ,Original Article ,business ,Intermediate risk - Abstract
Purpose Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups. Methods A randomized trial comparing radical prostatectomy, active surveillance, external beam radiotherapy and brachytherapy was performed from 2013 to 2016 and included 345 patients with low- and early intermediate-risk prostate cancer (ISUP grade groups 1 and 2). The trial was prematurely stopped due to slow accrual. A total of 130 patients were treated with active surveillance. Among them, 42 patients were diagnosed with intermediate-risk PCA. Reference pathology and AS quality control were performed throughout. Results After a median follow-up time of 18.8 months, 73 out of the 130 patients (56%) terminated active surveillance. Of these, 56 (77%) patients were histologically reclassified at the time of rebiopsy, including 35% and 60% of the grade group 1 and 2 patients, respectively. No patients who underwent radical prostatectomy at the time of reclassification had radical prostatectomy specimens ≥ grade group 3. Conclusion In this prospectively analyzed subcohort of patients with AS and conventional staging within a randomized trial, the 2-year histological reclassification rates were higher than those previously reported. Active surveillance may not be based on conventional staging alone, and patients with grade group 2 cancers may be recommended for active surveillance in carefully controlled trials only.
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- 2020
4. Fragmented responsibility: views of Israeli HCPs regarding patient recontact following variant reclassification
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Aviad E. Raz, Shiri Shkedi-Rafid, Stefan Timmermans, and Alma Levin Fridman
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medicine.medical_specialty ,Health professionals ,Patient recontact ,Responsibility ,Epidemiology ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,Reclassification ,Automated database ,Individual health ,VUSs ,Family medicine ,Laboratory Scientists ,medicine ,Genomic medicine ,Genomic information ,Original Article ,business ,Genetics (clinical) ,WGS - Abstract
While genomic medicine is becoming an important part of patient care with an ever-increasing diagnostic yield, recontacting patients after reclassification of variants of uncertain clinical significance (VUSs) remains a major challenge. Although periodical reinterpretation of VUSs is highly desired, recontacting former patients with new classifications is commonly not fulfilled in practice. We draw on semi-structured interviews with 20 Israeli healthcare professionals and stakeholders involved in communicating the results of genome-wide sequencing to patients. Findings show agreement that an individual health care professional cannot address the task of recontacting patients after re-classification, and that responsibility should be shared among the medical specialties, laboratory scientists, as well as patients. In the absence of established guidelines, many respondents suggested that the patient should be informed about reclassification during a follow-up contact but they disagreed who should be responsible for informing the patient. HCPs agreed that the solution to this challenge involves a centralized automated database that is accessible, continuously updated, and facilitates retrospective as well as prospective flagging of reclassification for patients who can benefit from this information. National and international policies providing concrete guidelines on the optimal way to recontact patients with new valuable genomic information are needed.
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- 2021
5. Finding very high lipoprotein(a): the need for routine assessment
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Paul Knaapen, Erik S.G. Stroes, Pauline C E Schuitema, Nick S. Nurmohamed, Shirin Ibrahim, Steven A J Chamuleau, Melchior C. Nierman, Johan Fischer, Yannick Kaiser, Graduate School, Vascular Medicine, Laboratory for General Clinical Chemistry, ACS - Heart failure & arrhythmias, ACS - Amsterdam Cardiovascular Sciences, Cardiology, Experimental Vascular Medicine, and ACS - Atherosclerosis & ischemic syndromes
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Adult ,Male ,Percentile ,medicine.medical_specialty ,Epidemiology ,Arterial disease ,Myocardial Infarction ,Logistic regression ,Risk Assessment ,Risk Factors ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Aged ,biology ,business.industry ,Reclassification ,Lipoprotein(a) ,Odds ratio ,Middle Aged ,medicine.disease ,Cardiovascular risk ,Atherosclerosis ,Confidence interval ,Blood pressure ,Cross-Sectional Studies ,Case-Control Studies ,biology.protein ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims To validate the reported increased atherosclerotic cardiovascular disease (ASCVD) risk associated with very high lipoprotein(a) [Lp(a)] and to investigate the impact of routine Lp(a) assessment on risk reclassification. Methods and results We performed a cross-sectional case-control study in the Amsterdam UMC, a tertiary hospital in The Netherlands. All patients in whom a lipid blood test was ordered between October 2018 and October 2019 were included. Individuals with Lp(a) >99th percentile were age and sex matched to individuals with Lp(a) ≤20th percentile. We computed odds ratios (ORs) for myocardial infarction (MI) and ASCVD using multivariable logistic regression adjusted for age, sex, and systolic blood pressure. Furthermore, we assessed the additive value of Lp(a) to established ASCVD risk algorithms. Lipoprotein(a) levels were determined in 12 437 individuals, out of whom 119 cases [Lp(a) >99th percentile; >387.8 nmol/L] and 119 matched controls [Lp(a) ≤20th percentile; ≤7 nmol/L] were included. Mean age was 58 ± 15 years, 56.7% were female, and 30.7% had a history of ASCVD. Individuals with Lp(a) levels >99th percentile had an OR of 2.64 for ASCVD [95% confidence interval (CI) 1.45–4.89] and 3.39 for MI (95% CI 1.56–7.94). Addition of Lp(a) to ASCVD risk algorithms led to 31% and 63% being reclassified into a higher risk category for Systematic Coronary Risk Evaluation (SCORE) and Second Manifestations of ARTerial disease (SMART), respectively. Conclusion The prevalence of ASCVD is nearly three-fold higher in adults with Lp(a) >99th percentile compared with matched subjects with Lp(a) ≤20th percentile. In individuals with very high Lp(a), addition of Lp(a) resulted in one-third of patients being reclassified in primary prevention, and over half being reclassified in secondary prevention.
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- 2021
6. Analysing the landscape for prescription to non-prescription reclassification (switch) in Germany: an interview study of committee members and stakeholders
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Natalie Gauld
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medicine.medical_specialty ,Prescription Drugs ,Self medication ,Medicines regulation ,Pharmacy ,Health informatics ,Health administration ,03 medical and health sciences ,0302 clinical medicine ,Stakeholder Participation ,Germany ,medicine ,Humans ,030212 general & internal medicine ,Medical prescription ,Health policy ,Qualitative Research ,business.industry ,030503 health policy & services ,Public health ,Nursing research ,lcsh:Public aspects of medicine ,Reclassification ,Access to medicines ,lcsh:RA1-1270 ,Nonprescription drugs ,Public relations ,Committee Membership ,Pharmacy practice ,0305 other medical science ,business ,Research Article - Abstract
Background Non-prescription medicines are increasingly used in Germany, aided by prescription-to-non-prescription reclassification (or switch). This study aimed to examine the barriers and enablers to reclassification of medicines in Germany and provide recommendations for change. Methods Face-to-face conversational interviews with purposively selected key informants in Germany were conducted in 2017 by a researcher informed in the area. Interviews were transcribed, coded in NVIVO and systematically analysed using a framework approach. Results Twenty-four interviews were conducted with 32 participants including members of the committee considering reclassifications, and representatives from government, industry, health insurance, academia, and pharmacy, medical, and patients’ organisations. A range of enablers and barriers emerged that influence reclassification including effects on the committee and process, or the desire of pharmaceutical companies to pursue reclassifications. Enabling market factors included the large population and a culture of self-medication. Enabling health system factors include the pharmacy-only category. Some pharmacy factors appeared enabling (e.g. a positive experience after reclassifying emergency contraception) while others appeared to hinder reclassification (e.g. insufficient pharmacy practice research). Some medical factors were enabling (e.g. reported waiting times) and others limited reclassification (e.g. opposition to some reclassifications). Some committee and government openness to reclassification and self-medication reportedly enabled reclassification, while conservatism was considered a barrier, particularly for classifications with special conditions for supply such as initial doctor diagnosis or other complexities. Some improvements to the committee constitution and considerations were recommended. Some participants found the reclassification process after the committee recommendation opaque, with opportunity for delays and political interference. Industry factors included both enablers such as capability in reclassification, and barriers, such as a perceived low market potential of some reclassifications, and doubt that some candidates would be approved. A need for more data emerged strongly, both pre-reclassification in applications, and post-reclassification. Many participants saw merit with reclassification in non-traditional areas such as hypertension, diabetes and oral contraception. Conclusions Many factors influence reclassification in Germany. Recommended improvements included aspects of the process and committee consideration, and more data collection. Sufficient market exclusivity linked to data collection could aid the generation of evidence to aid committee considerations and encourage more applications of high quality.
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- 2019
7. Utility of Stimulated Thyroglobulin in Reclassifying Low Risk Thyroid Cancer Patients’ Following Thyroidectomy and Radioactive Iodine Ablation: A 7-Year Prospective Trial
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Anwar A. Jammah, Maath A. Alhaddad, Shaimaa Alhaddad, Saad Alzahrani, Afshan Masood, Layan Akkielah, Abdullah M. Alguwaihes, and Mariam S. Alharbi
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Male ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,DTC recurrence ,non-stimulated thyroglobulin ,lcsh:Diseases of the endocrine glands. Clinical endocrinology ,Iodine Radioisotopes ,Endocrinology ,0302 clinical medicine ,Adenocarcinoma, Follicular ,Medicine ,Prospective Studies ,Thyrotropin Alfa ,Thyroid cancer ,Original Research ,Total thyroidectomy ,Middle Aged ,Prognosis ,Ablation ,Combined Modality Therapy ,030220 oncology & carcinogenesis ,Thyroidectomy ,Female ,Radioactive iodine ,Adult ,medicine.medical_specialty ,Adolescent ,reclassification ,Urology ,differentiated thyroid cancer ,030209 endocrinology & metabolism ,Context (language use) ,Thyroglobulin ,stimulated thyroglobulin ,Young Adult ,03 medical and health sciences ,Biomarkers, Tumor ,Humans ,Thyroid Neoplasms ,Aged ,lcsh:RC648-665 ,business.industry ,medicine.disease ,dynamic risk assessment ,highly sensitive thyroglobulin ,Prospective trial ,Neoplasm Recurrence, Local ,business - Abstract
ContextFollowing total thyroidectomy and radioactive iodine (RAI) ablation, serum thyroglobulin levels should be undetectable to assure that patients are excellent responders and at very low risk of recurrence.ObjectiveTo assess the utility of stimulated (sTg) and non-stimulated (nsTg) thyroglobulin levels in prediction of patients outcomes with differentiated thyroid cancer (DTC) following total thyroidectomy and RAI ablation.MethodA prospective observational study conducted at a University Hospital in Saudi Arabia. Patients diagnosed with differentiated thyroid cancer and were post total thyroidectomy and RAI ablation. Thyroglobulin levels (nsTg and sTg) were estimated 3–6 months post-RAI. Patients with nsTg ResultsOf 196 patients, nsTg levels were 1 occurred in 26 (35%) of patients with nsTg 0.1–2.0 ng/ml, 11 (15%) had structural incomplete response. None of the patients with sTg levels ConclusionSuppressed thyroglobulin (nsTg < 0.1 ng/ml) indicates a very low risk of recurrence that does not require stimulation. Stimulated thyroglobulin is beneficial with nsTg 0.1–2 ng/ml for re-classifying patients and estimating their risk for incomplete responses over a 7 years follow-up period.
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- 2021
8. Targeted next-generation sequencing of adult gliomas for retrospective prognostic evaluation and up-front diagnostics
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Mads Thomassen, Rikke Hedegaard Dahlrot, Henning B. Boldt, Slavka Lukacova, Mia D. Sørensen, Lotte Andreasen, Jeanette Krogh Petersen, Guido Reifenberger, Benedicte Parm Ulhøi, Frantz Rom Poulsen, B. W. Kristensen, S. Blach, Henrik Hager, Mark Burton, Torben A Kruse, and Steinbjørn Hansen
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0301 basic medicine ,Oncology ,Male ,Diffuse Glioma ,0302 clinical medicine ,targeted next-generation sequencing (NGS) ,Medicine ,Gliomas ,Prospective cohort study ,Telomerase ,mutational profiles ,Aged, 80 and over ,education.field_of_study ,medicine.diagnostic_test ,Brain Neoplasms ,Astrocytoma ,High-Throughput Nucleotide Sequencing ,Glioma ,Middle Aged ,Prognosis ,TUMORS ,Isocitrate Dehydrogenase ,Neurology ,Cohort ,IDH1 ,Female ,Adult ,medicine.medical_specialty ,Histology ,Adolescent ,reclassification ,Population ,ORGANIZATION ,CLASSIFICATION ,Pathology and Forensic Medicine ,03 medical and health sciences ,Young Adult ,Physiology (medical) ,Internal medicine ,Biomarkers, Tumor ,Humans ,IMMUNOHISTOCHEMISTRY ,education ,neoplasms ,GRADE II ,Aged ,cIMPACT-NOW ,MUTATIONS ,business.industry ,DIFFUSE GLIOMAS ,CENTRAL-NERVOUS-SYSTEM ,Retrospective cohort study ,prognostic evaluation ,medicine.disease ,ANAPLASTIC OLIGODENDROGLIOMA ,nervous system diseases ,030104 developmental biology ,Mutation ,Neurology (clinical) ,business ,Glioblastoma ,030217 neurology & neurosurgery ,Fluorescence in situ hybridization - Abstract
Aims: We aimed to reclassify a population-based cohort of 529 adult glioma patients to evaluate the prognostic impact of the 2016 World Health Organization (WHO) central nervous system tumour classification. Moreover, we evaluated the feasibility of gene panel next-generation sequencing (NGS) in daily diagnostics of 225 prospective glioma patients. Methods: The retrospective cohort was reclassified according to WHO 2016 criteria by immunohistochemistry for IDH-R132H, fluorescence in situ hybridization for 1p/19q-codeletion and gene panel NGS. All tumours of the prospective cohort were subjected to NGS analysis up-front. Results: The entire population-based cohort was successfully reclassified according to WHO 2016 criteria. NGS results were obtained for 98% of the prospective patients. Survival analyses in the population-based cohort confirmed three major prognostic subgroups, that is, isocitrate dehydrogenase (IDH)-mutant and 1p/19q-codeleted oligodendrogliomas, IDH-mutant astrocytomas and IDH-wildtype glioblastomas. The distinction between WHO grade II and III was prognostic in patients with IDH-mutant astrocytoma. The survival of patients with IDH-wildtype diffuse astrocytomas carrying TERT promoter mutation and/or EGFR amplification overlapped with the poor survival of IDH-wildtype glioblastoma patients. Conclusions: Gene panel NGS proved feasible in daily diagnostics. In addition, our study confirms the prognostic role of glioma classification according to WHO 2016 in a large population-based cohort. Molecular features of glioblastoma in IDH-wildtype diffuse glioma were linked to poor survival corresponding to IDH-wildtype glioblastoma patients. The distinction between WHO grade II and III retained prognostic significance in patients with IDH-mutant diffuse astrocytic gliomas.
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- 2021
9. Prevalence and reclassification of BRCA1 and BRCA2 variants in a large, unselected Chinese Han breast cancer cohort
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Yun Liu, Zhigang Bai, Yi Shen, Yun Zhang, Olivier Gires, Ying Wu, Xin Wang, Jiaqi Liu, Xiaoling Weng, Honglian Wang, Jiancheng Guo, Lijun Di, Yiding Chen, Fatao Liu, Xiang Wang, Junjian Li, Qinghua Zhou, Zhongtao Zhang, and Hongxia Wang
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Adult ,0301 basic medicine ,Oncology ,China ,Cancer Research ,medicine.medical_specialty ,Breast Neoplasms ,lcsh:RC254-282 ,Cohort Studies ,03 medical and health sciences ,Breast cancer ,0302 clinical medicine ,Asian People ,BRCA1/2 ,Internal medicine ,Prevalence ,Humans ,Medicine ,Genetic Predisposition to Disease ,In patient ,Chinese han ,Family history ,Letter to the Editor ,Molecular Biology ,BRCA2 Protein ,Hematology ,lcsh:RC633-647.5 ,BRCA1 Protein ,business.industry ,Cohort ,Reclassification ,Genetic Variation ,lcsh:Diseases of the blood and blood-forming organs ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,VUS ,030104 developmental biology ,030220 oncology & carcinogenesis ,Female ,business ,Risk assessment ,Cohort study - Abstract
Accurate interpretation of BRCA1/2 variants is critical for risk assessment and precise treatment of breast cancer (BC). Hence, the establishment of an ethnicity-based BRCA1/2 variant database of the Chinese population is of paramount importance. In this study, panel-based sequencing served to detect BRCA1/2 variants in a Chinese multicenter cohort of 21,216 BC patients and 6434 healthy controls. Overall, the percentage of subjects carrying pathogenic variants was 5.5% (1174/21,216) in BC patients and 1.1% (71/6434) in healthy controls. We identified 13 pathogenic variants as high-frequency variants that had a frequency of > 0.45‰ in BC patients (≥ 10 in 21,216 patients), none of which has been reported in Caucasians. Pathogenic BRCA1/2 variants correlated with younger onset age, higher frequencies of bilateral and triple-negative BC (TNBC), invasive carcinomas, high histological grades, and family history of BC and other cancers. Furthermore, the percentage of the subjects carrying VUS was 9.8% (2071/21,216) in BC patients and 6.9% (446/6434) in healthy controls. Based on our cohort study, we unambiguously reclassified 7 out of the 858 VUS resulting in lower VUS ratio in patients (from 9.8 to 7.9%) as well as in healthy control (from 6.9 to 5.3%). We also re-analyzed the 100 variants in 13 exons (2–5 and 15–23) of the BRCA1 genes using a functional assay (saturation genome editing; SGE). 55 of the 59 VUS had distinct status in the SGE study: 24 (43.6%) were pathogenic, and 31 (56.4%) were benign. Strong ethnicity-specific occurrences of pathogenic BRCA1/2 variants were identified in the Chinese population. Hence, the findings provide rationale and sequencing information for the implementation of BRCA1/2 variants tailored to the Chinese population into clinical risk assessment.
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- 2021
10. The role of multiparametric MRI in active surveillance for low-risk prostate cancer: The ROMAS randomized controlled trial
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Michelangelo Fiorentino, Riccardo Schiavina, Marco Borghesi, Pietro Piazza, Eugenio Brunocilla, Rita Golfieri, Francesca Giunchi, Valeria Panebianco, Angelo Porreca, Paolo Verze, Cristian Vincenzo Pultrone, Beniamino Corcioni, M. Guerra, Lorenzo Bianchi, Matteo Droghetti, Federico Mineo Bianchi, Vincenzo Mirone, Caterina Gaudiano, Giacomo Novara, Schiavina, Riccardo, Droghetti, Matteo, Novara, Giacomo, Bianchi, Lorenzo, Gaudiano, Caterina, Panebianco, Valeria, Borghesi, Marco, Piazza, Pietro, Mineo Bianchi, Federico, Guerra, Marco, Corcioni, Beniamino, Fiorentino, Michelangelo, Giunchi, Francesca, Verze, Paolo, Pultrone, Cristian, Golfieri, Rita, Porreca, Angelo, Mirone, Vincenzo, Brunocilla, Eugenio, Schiavina, R., Droghetti, M., Novara, G., Bianchi, L., Gaudiano, C., Panebianco, V., Borghesi, M., Piazza, P., Mineo Bianchi, F., Guerra, M., Corcioni, B., Fiorentino, M., Giunchi, F., Verze, P., Pultrone, C., Golfieri, R., Porreca, A., Mirone, V., and Brunocilla, E.
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Male ,medicine.medical_specialty ,Urology ,Population ,030232 urology & nephrology ,Random biopsy ,Active surveillance ,Risk Assessment ,law.invention ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Randomized controlled trial ,law ,Multiparametric magnetic resonance imaging ,Biopsy ,medicine ,Clinical endpoint ,Humans ,Prospective Studies ,education ,Watchful Waiting ,Multiparametric Magnetic Resonance Imaging ,Fusion biopsy ,Indolent prostate cancer ,Reclassification ,Aged ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Multiparametric MRI ,Prostatic Neoplasms ,Middle Aged ,medicine.disease ,Oncology ,030220 oncology & carcinogenesis ,Radiology ,business - Abstract
Background: We aim to evaluate the impact of multiparametric magnetic resonance imaging and fusion-target biopsy for early reclassification of patients with low-risk Prostate Cancer in a randomized trial. Materials and methods: Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria were enrolled and centrally randomized (1:1 ratio) to study group or control group. Patients randomized to study group underwent multiparametric magnetic resonance imaging at 3 months from enrollment: patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy was performed at 12 months. Patients in control group underwent PRIAS protocol, including a confirmatory 12-core random biopsy at 12 months. Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls. Reclassification was defined as biopsy ISUP Grade Group 1 in >2 biopsy cores or disease upgrading. Results: A total of 124 patients were randomized to study group (n = 62) or control group (n = 62). Around 21 of 62 patients (34%) in study group had a positive multiparametric magnetic resonance imaging, and underwent fusion-target biopsy, with 11 (17.7%) reclassifications. Considering the intention-to-treat population, reclassification rate at 12-month random biopsy was 6.5% for study group and 29% for control group, respectively (P < 0.001). Conclusions: The early employment of multiparametric magnetic resonance imaging for active surveillance patients enrolled after random biopsy consents to significantly reduce reclassifications at 12-month random biopsy.
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- 2021
11. Non-invasive determination of pressure recovery by cardiac MRI and echocardiography in patients with severe aortic stenosis: short and long-term outcome prediction
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Sebastian Herrmann, Andreas Liebold, Frank Weidemann, Horst Brunner, Volker Rasche, Meinrad Beer, Florian Sagmeister, Peter Bernhardt, and Tobias Gassenmaier
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medicine.medical_specialty ,Medicine (General) ,reclassification ,cardiac MR ,Hemodynamics ,030204 cardiovascular system & hematology ,Biochemistry ,Severity of Illness Index ,outcome prediction ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,R5-920 ,Internal medicine ,pressure recovery ,medicine ,Humans ,In patient ,Aged ,business.industry ,Biochemistry (medical) ,Non invasive ,Cell Biology ,General Medicine ,Aortic Valve Stenosis ,Middle Aged ,medicine.disease ,Magnetic Resonance Imaging ,Term (time) ,Stenosis ,Echocardiography ,Aortic valve stenosis ,Aortic Valve ,Cardiology ,Outcome prediction ,business ,Retrospective Clinical Research Report - Abstract
Objective To assess the influence of pressure recovery (PR)-corrected haemodynamic parameters on outcome in patients with aortic stenosis. Methods Aortic stenosis severity parameters were corrected for PR (increase in static pressure due to decreasing dynamic pressure), assessed using transthoracic echocardiography (TTE) or cardiac magnetic resonance imaging (CMR), in patients with aortic stenosis. PR, indexed PR (iPR) and energy loss index (ELI) were determined. Factors that predicted all-cause mortality, and 9-month or 10-year New York Heart Association classification ≥2 were assessed using Cox proportional hazards regression. Results A total of 25 patients, aged 68 ± 10 years, were included. PR was 17 ± 6 mmHg using CMR, and CMR correlated with TTE measurements. PR correction using CMR data reduced the AS-severity classification in 12–20% of patients, and correction using TTE data reduced the AS-severity classification in 16% of patients. Age (Wald 4.774) was a statistically significant predictor of all-cause mortality; effective orifice area (Wald 3.753) and ELI (Wald 3.772) almost reached significance. Conclusions PR determination may result in significant reclassification of aortic stenosis severity and may hold value in predicting all-cause mortality.
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- 2020
12. The Association and Predictive Ability of ECG Abnormalities with Cardiovascular Diseases: A Prospective Analysis
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Meng Dai, Mian Li, Weiqing Wang, Guang Ning, Shuangyuan Wang, Jieli Lu, Yuhong Chen, Min Xu, Yu Xu, Yufang Bi, Zhiyun Zhao, Chanjuan Deng, Tiange Wang, Ruizhi Zheng, and Jingya Niu
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Male ,lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,China ,Time Factors ,Epidemiology ,Disease ,030204 cardiovascular system & hematology ,Risk Assessment ,Electrocardiography ,Cardiovascular disease risk prediction ,Reclassification ,Discrimination ,Calibration ,03 medical and health sciences ,Prospective analysis ,0302 clinical medicine ,Heart Rate ,Risk Factors ,Internal medicine ,Medicine ,Humans ,Mass Screening ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,cardiovascular diseases ,Stroke ,Original Research ,Community and Home Care ,medicine.diagnostic_test ,business.industry ,Proportional hazards model ,lcsh:Public aspects of medicine ,Hazard ratio ,lcsh:RA1-1270 ,Middle Aged ,medicine.disease ,Confidence interval ,Survival Rate ,lcsh:RC666-701 ,Cardiovascular Diseases ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Aims: To examine whether electrocardiography (ECG) could provide additional values to the traditional risk factors for cardiovascular disease (CVD) risk prediction among different cardiovascular risk subgroups. Methods: A total of 7,872 community residents aged ≥40 years were followed up for a median of 4.5 years. A 12-lead resting ECG was examined for participants at baseline. CVD events including myocardial infarction, stroke and cardiovascular mortality were collected. Cox proportional hazards models were used and models of traditional risk factors with and without ECG were compared. Results: At baseline, 2,470 participants (31.3%) had ECG abnormalities. During follow-up, 464 participants developed CVD events. ECG abnormalities were associated with an increased risk of CVD after adjustment for the traditional risk factors in participants with a 10-year atherosclerotic CVD (ASCVD) risk ≥10% (hazard ratio, HR: 1.45; 95% confidence interval, CI: 1.11, 1.91). Adding ECG abnormalities to the traditional CVD risk factors improved reclassification for those who did not experience events [net reclassification index: 8.0% (95% CI: 2%, 19.5%)], discrimination (integrated discrimination improvement: 0.7% (95% CI: 0.1%, 1.9%), and calibration (goodness of fit P value from 0.600 to 0.873) in participants with a 10-year ASCVD risk ≥10%. However, no significant association and improvement were found in participants with a 10-year ASCVD risk
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- 2020
13. Computed tomography calcium scoring association and reclassification of clinical cardiovascular risk in asymptomatic Mexican patients
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Rafael Choza Chenhalls, Michelle C. Williams, María Nayeli Vázquez Sánchez, Maria José Acosta Falomir, Ana Patricia Chischistz Condey, Marco Antonio Téliz Meneses, Aldo Javier Vázquez Mézquita, and Nancy Berenice Guzmán Martínez
- Subjects
coronary calcium scoring ,medicine.medical_specialty ,reclassification ,Computed tomography ,030204 cardiovascular system & hematology ,Asymptomatic ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,030212 general & internal medicine ,Framingham ,lcsh:R5-920 ,Framingham Risk Score ,medicine.diagnostic_test ,business.industry ,cardiovascular ,Mexican ,General Medicine ,Calcium scoring ,Cardiology ,Original Article ,medicine.symptom ,business ,lcsh:Medicine (General) ,ASCVD ,Coronary Artery Calcium Scoring - Abstract
Objectives: To establish tailored preventive treatment, we studied the ability of coronary artery calcium scoring to reclassify patients with intermediate cardiovascular risk and its association with additional risk factors in our Mexican preventive care center. Materials and methods: In this retrospective cohort study, we analyzed 520 asymptomatic patients from a Mexican primary prevention population between 2014 and 2018. Coronary artery calcium scoring, laboratory results, and anthropometric measurements (abdominal circumference and body mass index) were assessed. The Framingham risk score and American Heart Association/American College of Cardiology (AHA/ACC) atherosclerotic cardiovascular disease risk algorithm were calculated. Correlations between coronary artery calcium scoring, anthropometric measurements, and clinical cardiovascular risk scores were assessed. We assessed the ability of coronary artery calcium scoring to reclassify patients recommended for statin therapy compared with the cardiovascular risk scores. Results: Patients had a mean age of 67.5 years ( SD ± 9.8) and 294 subjects (56.5%) were male. Coronary artery calcium scoring has a positive correlation with age, AHA/ACC atherosclerotic cardiovascular disease risk algorithm, and Framingham risk score ( p Conclusion: Coronary artery calcium scoring is prevalent in this Mexican primary prevention cohort and has the ability to reclassify a significant percentage of intermediate cardiovascular risk patients.
- Published
- 2020
14. Patient perspectives on variant reclassification after cancer susceptibility testing
- Author
-
Bronson C. Wessinger, Colin M.E. Halverson, Georgia L. Wiesner, Ellen Wright Clayton, and Laurie M. Connors
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Patients ,lcsh:QH426-470 ,reclassification ,media_common.quotation_subject ,Genetic counseling ,Genetic Counseling ,030105 genetics & heredity ,03 medical and health sciences ,Neoplasms ,Surveys and Questionnaires ,Health care ,Genetics ,medicine ,Humans ,Genetic Predisposition to Disease ,Genetic Testing ,uncertainty ,Molecular Biology ,recontact ,Genetics (clinical) ,Aged ,media_common ,business.industry ,Cancer ,Original Articles ,Middle Aged ,medicine.disease ,ethics ,Test (assessment) ,Comprehension ,lcsh:Genetics ,Distress ,030104 developmental biology ,Attitude ,Feeling ,Family medicine ,Medical genetics ,Original Article ,Female ,business - Abstract
Background Little is known about the impact of reclassification on patients’ perception of medical uncertainty or trust in genetics‐based clinical care. Methods Semistructured telephone interviews were conducted with 20 patients who had received a reclassified genetic test result related to hereditary cancer. All participants had undergone genetic counseling and testing for cancer susceptibility at Vanderbilt‐Ingram Cancer Center Hereditary Cancer Clinic within the last six years. Results Most of the participants did not express distress related to the variant reclassification and only a minority expressed a decrease in trust in medical genetics. However, recall of the new interpretation was limited, even though all participants were recontacted by letter, phone, or clinic visit. Conclusion Reclassification of genetic tests is an important issue in modern healthcare because changes in interpretation have the potential to alter previously recommended management. Participants in this study did not express strong feelings of mistrust or doubt about their genetic evaluation. However, there was a low level of comprehension and information retention related to the updated report. Future research can build on this study to improve communication with patients about their reclassified results., Little is known about the impact of reclassification on patients’ perception of medical uncertainty or trust in genetics‐based clinical care. Participants in this study did not express strong feelings of mistrust or doubt about their genetic evaluation. However, there was a low level of comprehension and information retention related to the updated report.
- Published
- 2020
15. Usefulness of Routine Fractional Flow Reserve for Clinical Management of Coronary Artery Disease in Patients With Diabetes
- Author
-
Didier Barreau, Marco Costa, Michel Hanssen, Ruben Ramos, Patrick Dupouy, Eric Van Belle, Emmanuel Teiger, F Vincent, Eduardo Oliveira, Lino Santos, Alberto Rodrigues, Bruno da Silva, Christophe Pouillot, Pierre Barnay, Luís Nunes, Luís Raposo, Nuno Fonseca, Renato Fernandes, Maria-João Sousa, Elisabete Jorge, Luís Seca, J. Guardado, Cyril Besnard, Christophe Bretelle, John Henderson, João Costa, Alessandro Cosenza, Sina Porouchani, Rita Calé, Nicolas Lhoest, João Carlos Silva, Sérgio Bravo Baptista, Thomas Cuisset, Jean Dallongeville, Laurent Leborgne, Carina Machado, Loic Belle, Georgios Sideris, Institut Coeur Poumon [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Département de Cardiologie [Hôpital de la Timone - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM), Abbott (St. Jude Medical) Biotronik, and Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)
- Subjects
Male ,IMPACT ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Myocardial Infarction ,Fractional flow reserve ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,HSM CAR ,ANGIOGRAPHY ,Coronary artery disease ,0302 clinical medicine ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,Coronary Artery Bypass ,Original Investigation ,education.field_of_study ,RECLASSIFICATION ,Diabetes ,3. Good health ,TIME ,Fractional Flow Reserve, Myocardial ,Cardiology ,Female ,REVASCULARIZATION ,GUIDED PCI ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,WAVE-FREE RATIO ,Population ,Clinical Decision-Making ,Revascularization ,STENOSIS ,03 medical and health sciences ,Percutaneous Coronary Intervention ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Internal medicine ,medicine ,Diabetes Mellitus ,Humans ,STRATEGY ,education ,Aged ,business.industry ,Myocardial fractional flow reserve ,Coronary Stenosis ,Percutaneous coronary intervention ,Cardiovascular Agents ,medicine.disease ,Cross-Sectional Studies ,Cardiovascular agent ,business ,Mace ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; This cross-sectional study evaluates the association of major adverse cardiac events (MACE) integrated with fractional flow reserve as the management strategy for diabetes with outcomes in patients with ambiguous lesions who undergo angiography.Key PointsQuestionWhat are the usefulness, rate of major adverse cardiovascular events (MACE), and clinical outcomes of routinely integrating fractional flow reserve in the management strategy for patients with diabetes who undergo coronary angiography? FindingsIn this cross-sectional study of 1983 patients, overall reclassification by fractional flow rate was high and similar in patients with diabetes (41.2%) and patients without diabetes (37.5%); however, reclassification from medical treatment to revascularization was more frequent among patients with diabetes. The rate of 1-year MACE was similar in reclassified (9.7%) and nonreclassified (12.0%) patients with diabetes, and the rate of MACE of patients deferred based on fractional flow reserve was similar among those with and without diabetes. MeaningThe findings suggest that management strategies guided by fractional flow reserve, including revascularization deferral, may be useful for patients with diabetes.ImportanceApproximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned. ObjectiveTo evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography. Design, Setting, and ParticipantsThis cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018. Main Outcomes and MeasuresDeath from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year. ResultsAmong 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P=.13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P=.001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P=.37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P=.04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P=.87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status. Conclusions and RelevanceRoutine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.
- Published
- 2020
16. Should We Continue Assessing Glomerular Filtration Rate with the Cockroft-Gault Formula in NOAC-Treated Patients? The Magnitude of the Problem
- Author
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Roberto Cemin, Luisa Foco, Raffaele De Caterina, and Carmine Zoccali
- Subjects
medicine.medical_specialty ,non-vitamin K antagonist oral anticoagulants ,reclassification ,lcsh:Medicine ,Renal function ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,Article ,City hospital ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,parasitic diseases ,Epidemiology ,medicine ,atrial fibrillation ,In patient ,030212 general & internal medicine ,reproductive and urinary physiology ,business.industry ,lcsh:R ,renal function ,Atrial fibrillation ,General Medicine ,medicine.disease ,female genital diseases and pregnancy complications ,Cohort ,Cardiology ,business ,Kidney disease - Abstract
Despite the proven superiority of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over the Cockcroft&ndash, Gault (CG) formula, current guidelines recommend the latter to assess renal function in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). To assess the relationship between the CG and the recommended CKD-EPI formulas, in a cohort of atrial fibrillation (AF) patients treated with NOACs, and the misclassifications introduced by the CG formula for renal function levels, we estimated renal function with three equations: CG, CKD-EPI with body surface adjustment (1.73 mL/m2, CKD-EPI) and without such adjustment (CKD-EPI_noBSA), in all consecutive AF patients discharged from NOACs from the Cardiology Division of a main city hospital between February 1st and May 31st 2018. We compared the different estimates of glomerular filtration rate and potential renal function class misclassifications. We reclassified 37/115 patients (32.1%) when switching from the CG to the CKD-EPI, and 24/115 (20.8%) switching from the CG to the CKD-EPI_noBSA formulas. Class reallocation was distributed across all levels of renal function, but mostly affected the &ldquo, hyper-normal&rdquo, function. In estimating consequences of such reallocation, a change in NOAC dosages would have occurred in 10/115 patients (8.7%) when switching from the CG to the CKD-EPI formula and in 10/115 patients when switching from the CG to the CKD-EPI_noBSA formula. Although the CG method has been traditionally used to calculate renal function in all NOAC studies, a renal dysfunction class reallocation occurs in a substantial fraction of hospital-admitted AF patients with the use of better estimates of renal function.
- Published
- 2020
17. Coronary artery disease risk reclassification using an acoustic-based score in view of the new European Society of Cardiology 2019 guidelines on Chronic Coronary Syndromes
- Author
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Simon Winther, Samuel Emil Schmidt, and Morten Boettcher
- Subjects
medicine.medical_specialty ,Letter to the editor ,Consensus ,Cost effectiveness ,Societies, Medical/standards ,Coronary Artery Disease Risk ,Coronary Artery Disease ,Non-invasive testing ,030204 cardiovascular system & hematology ,Risk Assessment ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,Cardiac imaging ,Societies, Medical ,Original Paper ,business.industry ,Reproducibility of Results ,Reclassification ,030229 sport sciences ,Acoustics ,medicine.disease ,Prognosis ,Heart sounds ,Practice Guidelines as Topic ,Cardiology ,Cost-effectiveness ,Stable coronary artery disease ,Coronary Artery Disease/classification ,Practice Guidelines as Topic/standards ,Cardiology and Cardiovascular Medicine ,Risk assessment ,business - Abstract
In August 2019, ESC published new guidelines on Chronic Coronary Syndromes including a new risk assessment paradigm for estimation of pre-test-probability. The CAD-score is an acoustic-based score for ruling-out of coronary artery disease (CAD). In the current letter to the editor we re-evaluate the re-classification potential the CAD-score in the view of the new guidelines.
- Published
- 2020
18. Ultrasound risk marker variability in symptomatic carotid plaque : impact on risk reclassification and association with temporal variation pattern
- Author
-
Per Wester, Christer Grönlund, Elias Sjödin, Isak Stenudd, Elias Johansson, and Emma Nyman
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Vulnerability ,030204 cardiovascular system & hematology ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,Humans ,Medicine ,Carotid Stenosis ,Radiology, Nuclear Medicine and imaging ,Variability ,Cardiac imaging ,Aged ,Retrospective Studies ,Ultrasonography ,Plaque ,Aged, 80 and over ,Observer Variation ,Original Paper ,Rupture, Spontaneous ,business.industry ,Risk marker ,Ultrasound ,Reproducibility of Results ,Reclassification ,Middle Aged ,Prognosis ,Atherosclerosis ,Plaque, Atherosclerotic ,Carotid Arteries ,Variation (linguistics) ,Cardiology ,Female ,Radiologi och bildbehandling ,Cardiology and Cardiovascular Medicine ,business ,030217 neurology & neurosurgery ,Radiology, Nuclear Medicine and Medical Imaging - Abstract
Purpose Ultrasound examinations of atherosclerotic carotid plaques can be used to calculate risk markers associated with plaque vulnerability. Recent studies demonstrate significant inter-frame variability in risk markers. Here, we investigate risk marker variability in symptomatic plaques and its impact on reclassification of plaque vulnerability, as well as its association with the shape of the temporal variation over the cardiac cycle. Methods 56 patients with symptomatic carotid stenosis were included in this study. 88 plaques were identified and the plaque risk markers size (area), echogenicity (gray scale median, GSM) and heterogeneity (coarseness) were measured in all frames of ultrasound B-mode image sequences. Inter-frame variability was quantified using the coefficient of variation (CV). Results Inter-frame variabilities of the risk markers were area CV 5–8%; GSM CV 4–7%; coarseness CV 8–15% and was in general significantly lower in large as compared to smaller plaques. The variability in GSM risk marker caused a reclassification of vulnerability in 30 to 38% of the plaques. Temporal variations in GSM with a heart rate periodic or drift/trending pattern were found in smaller plaques (2), whereas random pattern was found in larger plaques. In addition, hypoechoic plaques (GSM Conclusions Risk marker variability causes substantial reclassification of plaque vulnerability in symptomatic patients. Inter-frame variation and its temporal pattern should be considered in the design of future studies related to risk markers.
- Published
- 2020
19. Proposed Imprecision Quality Goals for Urinary Albumin/Creatinine Ratio
- Author
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Sung Woo Lee, Hyun Soo Kim, Min Jeong Park, Dong-Hoon Shin, Jungwon Hyun, and Dae Hyun Ko
- Subjects
Adult ,Male ,musculoskeletal diseases ,Urinary albumin ,media_common.quotation_subject ,Clinical Biochemistry ,030232 urology & nephrology ,030204 cardiovascular system & hematology ,Albumin/creatinine ratio ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,immune system diseases ,Albumins ,Biological variation ,Statistics ,Albuminuria ,Humans ,Medicine ,Quality (business) ,Child ,skin and connective tissue diseases ,Retrospective Studies ,media_common ,Clinical Chemistry ,Quality goal ,Creatinine ,business.industry ,Biochemistry (medical) ,Uncertainty ,Reclassification ,General Medicine ,Confidence interval ,chemistry ,Female ,Original Article ,medicine.symptom ,business - Abstract
Background The urinary albumin/creatinine ratio (ACR) is an important indicator of albuminuria. We aimed to estimate ACR uncertainty and its impact on test results and proposed imprecision quality goals based on the estimated uncertainty. Methods The combined ACR uncertainty was calculated using the individual uncertainties of urinary albumin and creatinine. ACR confidence intervals (CIs) were estimated based on the expanded uncertainty. When the CI contained the ACR category boundary (30 or 300 mg/g), the cases were considered ambiguous. Quality goals for ACR were suggested using the number of ambiguous cases among actual patient results. Results The number of ambiguous cases resulting from the combined ACR uncertainty was higher than expected based on biological variation (BV) quality goals. When the ACR met BV quality specifications, we estimated that 4.8-15.5% of the results may have been misclassified. To minimize the number of ambiguous results, the minimum, desirable, and optimum quality goals were set at 34.0%, 18.0%, and 4.5%, respectively. Conclusions We expressed ACR uncertainty using the uncertainties of urinary albumin and creatinine and assessed the impact of this combined uncertainty on the test results. Subsequently, we proposed imprecision quality goals for ACR based on ambiguous results.
- Published
- 2018
20. EAU-EANM-ESTRO-ESUR-SIOG Prostate Cancer Guideline Panel Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer from an International Collaborative Study (DETECTIVE Study)
- Author
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Niall F. Davis, Muhammad Imran Omar, Alberto Briganti, Olivier Rouvière, James N'Dow, Ann Henry, Brett Cox, James W.F. Catto, Derya Tilki, Christopher J.D. Wallis, Maurizio Colecchia, Silke Gillessen, Steven MacLennan, Murali Varma, Thomas Van den Broeck, Philip Cornford, Susanne Vahr Lauridsen, J.P. Michiel Sedelaar, Nicola Fossati, Michael Lardas, Gemma Sancho Pardo, Paolo Dell'Oglio, André Deschamps, Nicolas Mottet, Lisa Moris, Marcus G. Cumberbatch, Thomas Wiegel, Raphaële Renard-Penna, Fabio Zattoni, James Donaldson, Phillip D. Stricker, Matthew Liew, Ivo G. Schoots, Stefano Fanti, Theodorus H. van der Kwast, Geert J.L.H. van Leenders, Nikolaos Grivas, Monique J. Roobol, Erik Briers, Hendrik Van Poppel, Karin Plass, Jeff Davies, Jonathan Richenberg, Maria De Santis, Jacques Irani, Daniel W. Lin, Shin Egawa, Tobias Gross, Peter Paul M. Willemse, Roderick C.N. van den Bergh, Alberto Bossi, Henk G. van der Poel, Chris H. Bangma, Maria J. Ribal, Giorgio Gandaglia, Alexandre Ingels, Karl H. Pang, Morgan Rouprêt, Robert Shepherd, Jeremy Grummet, Thomas B. Lam, Malcolm David Mason, Catherine Paterson, Karel Tim Buddingh, Christian D. Fankhauser, Ruud Baanders, Anders Bjartell, Philippe D. Violette, Karen Wilkinson, Lam, T. B. L., Maclennan, S., Willemse, P. -P. M., Mason, M. D., Plass, K., Shepherd, R., Baanders, R., Bangma, C. H., Bjartell, A., Bossi, A., Briers, E., Briganti, A., Buddingh, K. T., Catto, J. W. F., Colecchia, M., Cox, B. W., Cumberbatch, M. G., Davies, J., Davis, N. F., De Santis, M., Dell'Oglio, P., Deschamps, A., Donaldson, J. F., Egawa, S., Fankhauser, C. D., Fanti, S., Fossati, N., Gandaglia, G., Gillessen, S., Grivas, N., Gross, T., Grummet, J. P., Henry, A. M., Ingels, A., Irani, J., Lardas, M., Liew, M., Lin, D. W., Moris, L., Omar, M. I., Pang, K. H., Paterson, C. C., Renard-Penna, R., Ribal, M. J., Roobol, M. J., Roupret, M., Rouviere, O., Sancho Pardo, G., Richenberg, J., Schoots, I. G., Sedelaar, J. P. M., Stricker, P., Tilki, D., Vahr Lauridsen, S., van den Bergh, R. C. N., Van den Broeck, T., van der Kwast, T. H., van der Poel, H. G., van Leenders, G. J. L. H., Varma, M., Violette, P. D., Wallis, C. J. D., Wiegel, T., Wilkinson, K., Zattoni, F., N'Dow, J. M. O., Van Poppel, H., Cornford, P., Mottet, N., Urology, Radiology & Nuclear Medicine, Pathology, and Lam TBL, MacLennan S, Willemse PM, Mason MD, Plass K, Shepherd R, Baanders R, Bangma CH, Bjartell A, Bossi A, Briers E, Briganti A, Buddingh KT, Catto JWF, Colecchia M, Cox BW, Cumberbatch MG, Davies J, Davis NF, De Santis M, Dell'Oglio P, Deschamps A, Donaldson JF, Egawa S, Fankhauser CD, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Gross T, Grummet JP, Henry AM, Ingels A, Irani J, Lardas M, Liew M, Lin DW, Moris L, Omar MI, Pang KH, Paterson CC, Renard-Penna R, Ribal MJ, Roobol MJ, Rouprêt M, Rouvière O, Sancho Pardo G, Richenberg J, Schoots IG, Sedelaar JPM, Stricker P, Tilki D, Vahr Lauridsen S, van den Bergh RCN, Van den Broeck T, van der Kwast TH, van der Poel HG, van Leenders GJLH, Varma M, Violette PD, Wallis CJD, Wiegel T, Wilkinson K, Zattoni F, N'Dow JMO, Van Poppel H, Cornford P, Mottet N.
- Subjects
Male ,medicine.medical_specialty ,Localised prostate cancer ,Urology ,education ,030232 urology & nephrology ,Delphi method ,Reclassification ,Outcome measures ,Time-to-Treatment ,Outcome measure ,03 medical and health sciences ,Prostate cancer ,Active surveillance and monitoring ,0302 clinical medicine ,SDG 3 - Good Health and Well-being ,Consensus group meeting ,Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15] ,medicine ,Humans ,610 Medicine & health ,Clinical practice guideline ,Curative intent ,Clinical Oncology ,Eligibility ,business.industry ,Follow-up ,Prostatic Neoplasms ,Consensus statements ,Guideline ,Deferred treatment with curative intent ,medicine.disease ,Clinical practice guidelines ,Delphi survey ,Deferred treatment ,Consensus statement ,030220 oncology & carcinogenesis ,Family medicine ,business - Abstract
Background: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised. Objective: To develop consensus statements for all domains of DAT. Design, setting, and participants: A protocol-driven, three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed. Results and limitations: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion. Conclusions: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials. Patient summary: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers. (C) 2019 Published by Elsevier B.V. on behalf of European Association of Urology.
- Published
- 2019
21. Development of a reference data set for assigning Streptococcus and Enterococcus species based on next generation sequencing of the 16S-23S rRNA region
- Author
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Anna M D Mirjam Kooistra-Smid, Alexander W. Friedrich, Artur J. Sabat, Jacek Miedzobrodzki, Maja Kosecka-Strojek, Viktoria Akkerboom, and Microbes in Health and Disease (MHD)
- Subjects
0301 basic medicine ,genetic identification ,REEVALUATION ,MITIS GROUP ,NOV ,RNA, Ribosomal, 16S ,diagnostics ,Medicine ,GRAM-POSITIVE COCCI ,Pharmacology (medical) ,Diagnostics ,Sanger sequencing ,biology ,RECLASSIFICATION ,High-Throughput Nucleotide Sequencing ,16S-23S rRNA region ,Bacterial Typing Techniques ,RNA, Ribosomal, 23S ,Infectious Diseases ,NGS ,symbols ,Microbiology (medical) ,Sequence analysis ,030106 microbiology ,Computational biology ,DNA sequencing ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,symbols.namesake ,23S ribosomal RNA ,DNA, Ribosomal Spacer ,Humans ,lcsh:RC109-216 ,Genetic identification ,Gram-Positive Bacterial Infections ,IDENTIFICATION ,business.industry ,Research ,Public Health, Environmental and Occupational Health ,COAGULASE-NEGATIVE STAPHYLOCOCCUS ,Streptococcus ,Sequence Analysis, DNA ,Ribosomal RNA ,TAXONOMY ,biology.organism_classification ,rpoB ,16S ribosomal RNA ,GENE ,GALLOLYTICUS ,030104 developmental biology ,Enterococcus ,Genes, Bacterial ,16S–23S rRNA region ,business - Abstract
Background Many members of Streptococcus and Enterococcus genera are clinically relevant opportunistic pathogens warranting accurate and rapid identification for targeted therapy. Currently, the developed method based on next generation sequencing (NGS) of the 16S–23S rRNA region proved to be a rapid, reliable and precise approach for species identification directly from polymicrobial and challenging clinical samples. The introduction of this new method to routine diagnostics is hindered by a lack of the reference sequences for the 16S–23S rRNA region for many bacterial species. The aim of this study was to develop a careful assignment for streptococcal and enterococcal species based on NGS of the 16S–23S rRNA region. Methods Thirty two strains recovered from clinical samples and 19 reference strains representing 42 streptococcal species and nine enterococcal species were subjected to bacterial identification by four Sanger-based sequencing methods targeting the genes encoding (i) 16S rRNA, (ii) sodA, (iii) tuf and (iv) rpoB; and NGS of the 16S–23S rRNA region. Results This study allowed obtainment and deposition of reference sequences of the 16S–23S rRNA region for 15 streptococcal and 3 enterococcal species followed by enrichment for 27 and 6 species, respectively, for which reference sequences were available in the databases. For Streptococcus, NGS of the 16S–23S rRNA region was as discriminative as Sanger sequencing of the tuf and rpoB genes allowing for an unambiguous identification of 93% of analyzed species. For Enterococcus, sodA, tuf and rpoB genes sequencing allowed for identification of all species, while the NGS-based method did not allow for identification of only one enterococcal species. For both genera, the sequence analysis of the 16S rRNA gene was endowed with a low identification potential and was inferior to that of other tested identification methods. Moreover, in case of phylogenetically related species the sequence analysis of only the intergenic spacer region was not sufficient enough to precisely identify Streptococcus strains at the species level. Conclusions Based on the developed reference dataset, clinically relevant streptococcal and enterococcal species can now be reliably identified by 16S–23S rRNA sequences in samples. This study will be useful for introduction of a novel diagnostic tool, NGS of the 16S–23S rRNA region, which undoubtedly is an improvement for reliable culture-independent species identification directly from polymicrobially constituted clinical samples.
- Published
- 2019
22. Coronary artery disease risk reclassification by a new acoustic-based score
- Author
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Simon Winther, Louise Nissen, Flemming Hald Steffensen, Jelmer Westra, M.H. Groenhoej, Jess Lambrechtsen, Morten Boettcher, Bjarke Skogstad Larsen, M S Nørskov, Samuel Emil Schmidt, Niels Ramsing Holm, Axel Cosmus Pyndt Diederichsen, L Frost, Hans Mickley, and Johannes J. Struijk
- Subjects
Male ,Cost effectiveness ,Cost-Benefit Analysis ,Coronary Artery Disease Risk ,CAD ,Coronary Artery Disease ,Non-invasive testing ,030204 cardiovascular system & hematology ,Coronary Angiography ,Severity of Illness Index ,Coronary artery disease ,0302 clinical medicine ,030212 general & internal medicine ,Cardiac imaging ,Aged, 80 and over ,Reclassification ,Health Care Costs ,Middle Aged ,Prognosis ,Heart sounds ,Diameter stenosis ,Cardiology ,Female ,Stable coronary artery disease ,Cardiology and Cardiovascular Medicine ,Algorithms ,Adult ,medicine.medical_specialty ,Decision Support Techniques ,03 medical and health sciences ,Young Adult ,Cost Savings ,Predictive Value of Tests ,Internal medicine ,Stable cad ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Ultrasensitive phonocardiography ,Aged ,Retrospective Studies ,Original Paper ,business.industry ,Coronary Stenosis ,Phonocardiography ,Reproducibility of Results ,Acoustics ,medicine.disease ,Exercise Test ,Cost-effectiveness ,business - Abstract
To determine the potential of a non-invasive acoustic device (CADScor®System) to reclassify patients with intermediate pre-test probability (PTP) and clinically suspected stable coronary artery disease (CAD) into a low probability group thereby ruling out significant CAD. Audio recordings and clinical data from three studies were collected in a single database. In all studies, patients with a coronary CT angiography indicating CAD were referred to coronary angiography. Audio recordings of heart sounds were processed to construct a CAD-score. PTP was calculated using the updated Diamond-Forrester score and patients were classified according to the current ESC guidelines for stable CAD: low 85% PTP. Intermediate PTP patients were re-classified to low probability if the CAD-score was ≤ 20. Of 2245 patients, 212 (9.4%) had significant CAD confirmed by coronary angiography ( ≥ 50% diameter stenosis). The average CAD-score was higher in patients with significant CAD (38.4 ± 13.9) compared to the remaining patients (25.1 ± 13.8; p
- Published
- 2019
23. The Diagnostic and Prognostic Value of Neuropsychological Assessment in Memory Clinic Patients
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Philip Scheltens, Frans R.J. Verhey, Willemijn J. Jansen, Ron Handels, Pauline Aalten, Ania M. Oleksik, Inez H.G.B. Ramakers, Albert F.G. Leentjens, Marcel G. M. Olde Rikkert, Femke H. Bouwman, Machiel Smid, Claire A. G. Wolfs, Peter van Domburg, Jan Hoogmoed, Pieter Jelle Visser, Erik Hoff, Jurgen A.H.R. Claassen, Neurology, Amsterdam Neuroscience - Neurodegeneration, Psychiatrie & Neuropsychologie, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Hersenen & Gedrag, and MUMC+: MA Med Staf Spec Psychiatrie (9)
- Subjects
Male ,neuropsychological tests ,050103 clinical psychology ,Pediatrics ,medicine.medical_specialty ,diagnosis ,reclassification ,Disease ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,mild cognitive impairment ,Alzheimer Disease ,Image Processing, Computer-Assisted ,Humans ,Medicine ,Dementia ,Outpatient clinic ,0501 psychology and cognitive sciences ,Neuropsychological assessment ,Medical diagnosis ,Psychiatry ,Prospective cohort study ,Memory Disorders ,medicine.diagnostic_test ,outpatient clinic ,business.industry ,General Neuroscience ,05 social sciences ,Memory clinic ,General Medicine ,Alzheimer's disease ,medicine.disease ,Magnetic Resonance Imaging ,Psychiatry and Mental health ,Clinical Psychology ,consensus ,Etiology ,cognitive disorders ,Female ,prognosis ,Geriatrics and Gerontology ,Cognition Disorders ,Mental Status Schedule ,business ,030217 neurology & neurosurgery - Abstract
Background Neuropsychological testing has long been embedded in daily clinical practice at memory clinics but the added value of a complete neuropsychological assessment (NPA) to standard clinical evaluation is unknown. Objective To evaluate the added diagnostic and prognostic value of NPA to clinical evaluation only in memory clinic patients. Methods In 221 memory clinic patients of a prospective cohort study, clinical experts diagnosed clinical syndrome (subjective cognitive impairment (SCI), mild cognitive impairment (MCI), or dementia) and etiology (Alzheimer's disease (AD) or no AD), and provided a prognosis of disease course (decline or no decline) before and after results of NPA were made available. The reference standard was a panel consensus based on all clinical information at baseline and up to 2 follow-up assessments. Results With NPA data available, clinicians changed their initial syndromal diagnosis in 22% of patients, and the etiological diagnosis as well as the prognosis in 15%. This led to an increase in correctly classified cases of 18% for syndromal diagnosis, 5% for etiological diagnosis, and 1% for prognosis. NPA data resulted in the largest improvement in patients initially classified as SCI (syndrome: 93.3% (n = 14) correctly reclassified, etiology: net reclassification improvement [NRI] = 0.61, prognosis: NRI = 0.13) or MCI (syndrome: 89.3% (n = 23) correctly reclassified, etiology: NRI = 0.17, prognosis: NRI = 0.14), while there was no improvement in patients with dementia (syndrome: 100% (n = 1) correctly reclassified, etiology: NRI = -0.05, prognosis: NRI = -0.06). Overall, inclusion of NPA in the diagnostic process increased confidence in all diagnoses with 6-7%. Conclusion Administration of a complete NPA after standard clinical evaluation has added value for diagnosing cognitive syndrome and its underlying etiology in patients regarded as non-demented based on the first clinical impression.
- Published
- 2017
24. Essential role of small bowel capsule endoscopy in reclassification of colonic inflammatory bowel disease type unclassified
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Maria João Moreira, José Cotter, Bruno Rosa, Pedro Boal Carvalho, Miguel Mascarenhas Saraiva, Sara Monteiro, Francisca Dias de Castro, Rolando Pinho, and Universidade do Minho
- Subjects
Crohn’s disease ,medicine.medical_specialty ,Pathology ,Inflammatory bowel disease type unclassified ,Gastroenterology ,Inflammatory bowel disease ,Medicina Clínica [Ciências Médicas] ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Capsule endoscopy ,law ,Retrospective Study ,Internal medicine ,medicine ,Ciências Médicas::Medicina Clínica ,Crohn's disease ,Science & Technology ,business.industry ,digestive, oral, and skin physiology ,Reclassification ,medicine.disease ,digestive system diseases ,3. Good health ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Lewis score ,business - Abstract
AIM To evaluate the role of small bowel capsule endoscopy (SBCE) on the reclassification of colonic inflammatory bowel disease type unclassified (IBDU). METHODS We performed a multicenter, retrospective study including patients with IBDU undergoing SBCE, between 2002 and 2014. SBCE studies were reviewed and the inflammatory activity was evaluated by determining the Lewis score (LS). Inflammatory activity was considered significant and consistent with Crohn's disease (CD) when the LS >= 135. The definitive diagnosis during follow-up (minimum 12 mo following SBCE) was based on the combination of clinical, analytical, imaging, endoscopic and histological elements. RESULTS Thirty-six patients were included, 21 females (58%) with mean age at diagnosis of 33 +/- 13 (15-64) years. The mean follow-up time after the SBCE was 52 +/- 41 (12-156) mo. The SBCE revealed findings consistent with significant inflammatory activity in the small bowel (LS >= 135) in 9 patients (25%); in all of them the diagnosis of CD was confirmed during follow-up. In 27 patients (75%), the SBCE revealed no significant inflammatory activity (LS < 135); among these patients, the diagnosis of Ulcerative Colitis (UC) was established in 16 cases (59.3%), CD in 1 case (3.7%) and 10 patients (37%) maintained a diagnosis of IBDU during follow-up. A LS >= 135 at SBCE had a sensitivity = 90%, specificity = 100%, positive predictive value = 100% and negative predictive value = 94% for the diagnosis of CD. CONCLUSION SBCE proved to be fundamental in the reclassification of patients with IBDU. Absence of significant inflammatory activity in the small intestine allowed exclusion of CD in 94% of cases., info:eu-repo/semantics/publishedVersion
- Published
- 2017
25. Does recycling contribute to accounting quality?
- Author
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Ali Coskun, Melik Ertugrul, İstinye Üniversitesi, İktisadi, İdari ve Sosyal Bilimler Fakültesi, Ekonomi Bölümü, and Ertugrul, Melik
- Subjects
Predictive Power ,IAS 1 ,business.industry ,media_common.quotation_subject ,Geography, Planning and Development ,General Social Sciences ,Reclassification ,Accounting ,Predictive power ,Economics ,Other Comprehensive Income ,Quality (business) ,Recycling ,Value Relevance ,business ,media_common - Abstract
As a result of amendments in existing financial reporting standards, certain items have been transferred (or recycled) from other comprehensive income to income statement since 2013. Based on a sample of Turkish listed firms over 2013-2018, we document the following outcomes for accounting quality, measured by value relevance and predictive power, of recycling. First, recycling is not value relevant, and net income with recycling and net income are equally value relevant. In other words, recycling does not provide useful information for valuation purposes. Second, net income with recycling and net income have statistically indifferent predictive powers
- Published
- 2019
26. Rare Variants Associated with Arrhythmogenic Cardiomyopathy: Reclassification Five Years Later
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Victoria Fiol, Josep Brugada, Ana García-Álvarez, Paloma Jordà, Ferran Picó, Anna Iglesias, Georgia Sarquella-Brugada, Mireia Alcalde, Rocío Toro, Marta Puigmulé, Monica Coll, Carles Ferrer-Costa, Anna Fernandez-Falgueras, Alexandra Pérez-Serra, Ramon Brugada, Bernat del Olmo, Antonio Oliva, Oscar Campuzano, Coloma Tiron de Llano, Elena Arbelo, Marta Vallverdú-Prats, Simone Grassi, Sergi Cesar, and Laura Lopez
- Subjects
medicine.medical_specialty ,reclassification ,Cardiomyopathy ,Arrítmia ,lcsh:Medicine ,Medicine (miscellaneous) ,Reclas-sification ,Genomics ,030204 cardiovascular system & hematology ,Bioinformatics ,Sudden death ,Article ,sudden cardiac death ,Sudden cardiac death ,03 medical and health sciences ,0302 clinical medicine ,Cor -- Malalties -- Aspectes genètics ,Medicine ,genetics ,In patient ,Likely pathogenic ,030304 developmental biology ,0303 health sciences ,Myocardium -- Diseases ,business.industry ,Mort sobtada ,lcsh:R ,rare variants ,Heart -- Diseases -- Genetic aspects ,Settore MED/43 - MEDICINA LEGALE ,arrhythmogenic cardiomyopathy ,medicine.disease ,Miocardi -- Malalties ,Medical genetics ,business ,Arrhythmia - Abstract
Genetic interpretation of rare variants associated with arrhythmogenic cardiomyopathy (ACM) is essential due to their diagnostic implications. New data may relabel previous variant classifications, but how often reanalysis is necessary remains undefined. Five years ago, 39 rare ACM-related variants were identified in patients with features of cardiomyopathy. These variants were classified following the American College of Medical Genetics and Genomics' guidelines. In the present study, we reevaluated these rare variants including novel available data. All cases carried one rare variant classified as being of ambiguous significance (82.05%) or likely pathogenic (17.95%) in 2016. In our comprehensive reanalysis, the classification of 30.77% of these variants changed, mainly due to updated global frequencies. As in 2016, nowadays most variants were classified as having an uncertain role (64.1%), but the proportion of variants with an uncertain role was significantly decreased (17.95%). The percentage of rare variants classified as potentially deleterious increased from 17.95% to 23.07%. Moreover, 83.33% of reclassified variants gained certainty. We propose that periodic genetic reanalysis of all rare variants associated with arrhythmogenic cardiomyopathy should be undertaken at least once every five years. Defining the roles of rare variants may help clinicians obtain a definite diagnosis This work was supported by Obra Social “La Caixa Foundation” (LCF/PR/GN16/50290001 and LCF/PR/GN19/50320002), La Marató de TV3 (400/U/2015) and Sociedad Española Cardiología, Proyecto Investigación Básica Cardiología 2020
- Published
- 2021
27. Accidents and undetermined deaths: re-evaluation of nationwide samples from the Scandinavian countries
- Author
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Gunvor Furu Østevold, Øivind Ekeberg, Ingvild Maria Tøllefsen, Karin Helweg-Larsen, Erlend Hem, Marianne Kastrup, Ullakarin Nyberg, Ingemar Thiblin, Sidsel Rogde, and Per Henrik Zahl
- Subjects
Adult ,Male ,medicine.medical_specialty ,Forensic Science ,Adolescent ,Poison control ,Datasets as Topic ,Norwegian ,Scandinavian and Nordic Countries ,Occupational safety and health ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Environmental health ,Cause of Death ,Epidemiology ,Injury prevention ,Medicine ,Humans ,030212 general & internal medicine ,Cause of death ,Aged ,Undetermined deaths ,business.industry ,Public health ,lcsh:Public aspects of medicine ,Public Health, Environmental and Occupational Health ,Reproducibility of Results ,Reclassification ,Public Health, Global Health, Social Medicine and Epidemiology ,lcsh:RA1-1270 ,Middle Aged ,medicine.disease ,language.human_language ,030227 psychiatry ,Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi ,Suicide ,Accidents ,language ,Female ,Suicide statistics ,Medical emergency ,Autopsy ,Biostatistics ,business ,Rättsmedicin ,Research Article - Abstract
Background National mortality statistics should be comparable between countries that use the World Health Organization’s International Classification of Diseases. Distinguishing between manners of death, especially suicides and accidents, is a challenge. Knowledge about accidents is important in prevention of both accidents and suicides. The aim of the present study was to assess the reliability of classifying deaths as accidents and undetermined manner of deaths in the three Scandinavian countries and to compare cross-national differences. Methods The cause of death registers in Norway, Sweden and Denmark provided data from 2008 for samples of 600 deaths from each country, of which 200 were registered as suicides, 200 as accidents or undetermined manner of deaths and 200 as natural deaths. The information given to the eight experts was identical to the information used by the Cause of Death Register. This included death certificates, and if available external post-mortem examinations, forensic autopsy reports and police reports. Results In total, 69 % (Sweden and Norway) and 78 % (Denmark) of deaths registered in the official mortality statistics as accidents were confirmed by the experts. In the majority of the cases where disagreement was seen, the experts reclassified accidents to undetermined manner of death, in 26, 25 and 19 % of cases, respectively. Few cases were reclassified as suicides or natural deaths. Among the extracted accidents, the experts agreed least with the official mortality statistics concerning drowning and poisoning accidents. They also reported most uncertainty in these categories of accidents. In a second re-evaluation, where more information was made available, the Norwegian psychiatrist and forensic pathologist increased their agreement with the official mortality statistics from 76 to 87 %, and from 85 to 88 %, respectively, regarding the Norwegian and Swedish datasets. Among the extracted undetermined deaths in the Swedish dataset, the two experts reclassified 22 and 51 %, respectively, to accidents. Conclusion There was moderate agreement in reclassification of accidents between the official mortality statistics and the experts. In the majority of cases where there was disagreement, accidents were reclassified as undetermined manner of death, and only a small proportion as suicides.
- Published
- 2016
28. Prognostic Value of Baseline and Changes in Circulating Soluble ST2 Levels and the Effects of Nesiritide in Acute Decompensated Heart Failure
- Author
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Roger M. Mills, Richard W. Troughton, Adrian F. Hernandez, Randall C. Starling, Justin L. Grodin, Marco Metra, W.H. Wilson Tang, Amy Hsu, Adriaan A. Voors, G. Michael Felker, Javed Butler, Paul W. Armstrong, Christopher M. O'Connor, John J.V. McMurray, Yuping Wu, and Cardiovascular Centre (CVC)
- Subjects
Male ,Acute decompensated heart failure ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,RISK STRATIFICATION ,0302 clinical medicine ,Natriuretic Peptide, Brain ,Natriuretic peptide ,TROPONIN-T ,Prospective Studies ,030212 general & internal medicine ,Myocardial infarction ,RECLASSIFICATION ,Troponin T ,Hazard ratio ,acute decompensated heart failure ,nesiritide ,prognosis ,soluble ST2 ,SERUM-LEVELS ,CARDIAC STRUCTURE ,Treatment Outcome ,Acute Disease ,Cardiology ,Biomarker (medicine) ,Female ,Natriuretic Agents ,Cardiology and Cardiovascular Medicine ,FAMILY-MEMBER ST2 ,medicine.drug ,ACUTE MYOCARDIAL-INFARCTION ,medicine.medical_specialty ,medicine.drug_class ,Receptors, Cell Surface ,ACUTE DYSPNEA ,Risk Assessment ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Aged ,Heart Failure ,Nesiritide ,business.industry ,MORTALITY ,medicine.disease ,Interleukin-1 Receptor-Like 1 Protein ,Peptide Fragments ,Heart failure ,business ,Biomarkers - Abstract
OBJECTIVES The study sought to investigate the association between soluble growth stimulation expressed gene 2 (sST2) Level and adverse outcomes in acute heart failure (HF).BACKGROUND Several studies have demonstrated the prognostic utility of sST2 Levels in HF.METHODS sST2 levels were measured in sequential baseline and follow-up (48 to 72 h and 30 days) plasma samples from 858 acute HF subjects enrolled in the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial biomarker substudy and were related to in-hospital and post-discharge clinical outcomes.RESULTS Higher sST2 levels were associated with increased death risk at 180 days (baseline hazard ratio [FIR]: 2.21; follow-up HR: 2.64; both p 60 ng/ml) sST2 Levels at follow-up had higher 180-day death rates than those with lower follow-up sST2 Levels (adjusted HR: 2.91, p = 0.004). Neither baseline nor follow-up sST2 levels were associated with dyspnea improvement. Changes in sST2 from baseline were less in the nesiritide versus placebo group at follow-up, but were similar at 30 days.CONCLUSIONS Elevated levels of sST2 were associated with an increased risk of adverse clinical events in acute HF, but prognostic value of baseline sST2 diminished after adjusting for clinical covariates and aminoterminal pro-B-type natriuretic peptide. In those with elevated baseline sST2 Levels, persistently elevated sST2 levels at follow-up were associated with increased mortality risk. In addition, nesiritide did not demonstrate an incremental impact on sST2 Levels over standard therapy. (C) 2016 by the American College of Cardiology Foundation.
- Published
- 2016
29. Reclassifying severity after 48 hours could better predict mortality in acute respiratory distress syndrome
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Chen-Yiu Hung, Pi-Hua Liu, Chung-Shu Lee, Han-Chung Hu, Shih-Hong Li, Huang-Pin Wu, Li-Chung Chiu, Li-Pang Chuang, Hsin-Hsien Li, Chung-Chi Huang, Shih-Wei Lin, Kuo-Chin Kao, and Chih-Hao Chang
- Subjects
Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,ARDS ,Time Factors ,reclassification ,Taiwan ,macromolecular substances ,Disease ,Acute respiratory distress ,Risk Assessment ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Disease severity ,Predictive Value of Tests ,Risk Factors ,medicine ,Humans ,Pharmacology (medical) ,Hospital Mortality ,Aged ,Retrospective Studies ,Original Research ,lcsh:RC705-779 ,Aged, 80 and over ,Respiratory Distress Syndrome ,business.industry ,030208 emergency & critical care medicine ,lcsh:Diseases of the respiratory system ,prediction ,Middle Aged ,acute respiratory distress syndrome ,Prognosis ,medicine.disease ,mortality ,030228 respiratory system ,Emergency medicine ,outcome ,Female ,business - Abstract
Background: Disease severity may change in the first week after acute respiratory distress syndrome (ARDS) onset. The aim of this study was to evaluate whether the reclassification of disease severity after 48 h (i.e. day 3) of ARDS onset could help in predicting mortality and determine factors associated with ARDS persistence and mortality. Methods: We performed a secondary analysis of a 3-year prospective, observational cohort study of ARDS in a tertiary care referral center. Disease severity was reclassified after 48 h of enrollment, and cases that still fulfilled the Berlin criteria were regarded as nonresolving ARDS. Results: A total of 1034 ARDS patients were analyzed. Overall hospital mortality was 57.7% (56.7%, 57.5%, and 58.6% for patients with initial mild, moderate, and severe ARDS, respectively, p = 0.189). On day 3 reclassification, the hospital mortality rates were as follows: resolved (42.1%), mild (47.9%), moderate (62.4%), and severe ARDS (76.1%) ( p 2/FiO2, or higher positive end-expiratory pressure on day 1 were significantly associated with nonresolving ARDS on day 3. A Cox regression model with ARDS severity as a time-dependent covariate and competing risk analysis demonstrated that ARDS severity was independently associated with hospital mortality, and nonresolving ARDS had significantly increased hazard of death than resolved ARDS ( p Conclusions: Reclassification of disease severity after 48 h of ARDS onset could help to divide patients into subgroups with greater separation in terms of mortality. The reviews of this paper are available via the supplemental material section.
- Published
- 2020
30. Double-Dosing and Other Dangers with Non-Prescription Medicines: Pharmacists' Views and Experiences
- Author
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Natalie Gauld and Tracey Sullivan
- Subjects
medicine.medical_specialty ,Consumer confusion ,reclassification ,health care facilities, manpower, and services ,education ,Psychological intervention ,lcsh:RS1-441 ,Pharmacy ,030226 pharmacology & pharmacy ,Article ,lcsh:Pharmacy and materia medica ,03 medical and health sciences ,0302 clinical medicine ,Intervention (counseling) ,health services administration ,medicine ,community pharmacy ,Pharmacology (medical) ,030212 general & internal medicine ,Dosing ,General Pharmacology, Toxicology and Pharmaceutics ,Medical prescription ,health care economics and organizations ,non-prescription drugs ,Descriptive statistics ,business.industry ,pharmacist intervention ,self-medication ,Family medicine ,business ,Self-medication - Abstract
The aim of this paper was to explore pharmacists&rsquo, views on reclassifications from pharmacy-only to general sales and their experiences with the supply of these medicines, in addition to pharmacists&rsquo, views on the reclassification of the shingles vaccine and sildenafil to be available through &lsquo, accredited&rsquo, pharmacists. New Zealand community pharmacists were surveyed in 2013 with a written questionnaire of six Likert-style or open-ended questions sent to Pharmacy Guild member pharmacies. The analysis involved descriptive statistics. Responses were received from 246 pharmacies. Two thirds of pharmacists supported the reclassification of the shingles vaccine and sildenafil, although 14% disagreed with the sildenafil reclassification. Over 90% of pharmacists disagreed with the reclassification of paracetamol and ibuprofen liquids, omeprazole, naproxen, and oxymetazoline from pharmacy-only medicine to general sales. This opinion was strongest for omeprazole. With liquid paracetamol and ibuprofen, pharmacists described consumer confusion with dosing, and particularly potentially doubling-up on liquid analgesics/antipyretics including using both prescription and non-prescription variants. Many reported giving safety advice frequently. Anti-inflammatories and omeprazole were also subject to potential double-dosing, as well as requests by consumers with contraindications, precautions, and drug interactions, and for inappropriate indications. Pharmacists described various interventions, including some that were potentially life-saving. Pharmacy availability of medicines provides the potential for intervention that would not happen in a general sales environment.
- Published
- 2018
31. Lack of genotype-phenotype correlation in Brugada Syndrome and Sudden Arrhythmic Death Syndrome families with reported pathogenic SCN1B variants
- Author
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Takeshi Aiba, Raymond W. Sy, Jodie Ingles, Belinda Gray, Christopher Semsarian, Vincent Probst, Can Hasdemir, Mary N. Sheppard, Elijah R. Behr, Naomasa Makita, Arthur A.M. Wilde, Ruth Newbury-Ecob, Ege Üniversitesi, Cardiology, and ACS - Heart failure & arrhythmias
- Subjects
Adult ,Male ,0301 basic medicine ,Proband ,medicine.medical_specialty ,Genotype-phenotype correlation ,Adolescent ,Genotype ,DNA Mutational Analysis ,030204 cardiovascular system & hematology ,Sudden cardiac death ,Electrocardiography ,Young Adult ,03 medical and health sciences ,QRS complex ,0302 clinical medicine ,SCN1B ,Physiology (medical) ,Internal medicine ,Humans ,Medicine ,Family ,Genetic Testing ,PR interval ,Child ,Genetic Association Studies ,SADS ,Aged ,Genetic testing ,Brugada syndrome ,Brugada Syndrome ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Reclassification ,DNA ,Middle Aged ,Voltage-Gated Sodium Channel beta-1 Subunit ,medicine.disease ,Death, Sudden, Cardiac ,030104 developmental biology ,Mutation ,Cardiology ,Medical genetics ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
WOS: 000436479200017, PubMed ID: 29758173, BACKGROUND There is limited evidence that Brugada Syndrome (BrS) is due to SCN1B variants (BrS5). This gene may be inappropriately included in routine genetic testing panels for BrS or Sudden Arrhythmic Death Syndrome (SADS). OBJECTIVE We sought to characterize the genotype-phenotype correlation in families who had BrS and SADS with reportedly pathogenic SCN1B variants and to review their pathogenicity. METHODS Families with BrS and SADS were assessed from 6 inherited arrhythmia centers worldwide, and a comprehensive literature review was performed. Clinical characteristics including relevant history, electrocardiographic parameters and drug provocation testing results were studied. SCN1B genetic testing results were reclassified using American College of Medical Genetics criteria. RESULTS A total of 23 SCN1B genotype-positive individuals were identified from 8 families. Four probands (17%) experienced ventricular fibrillation or sudden cardiac death at the time of presentation. All family members were free from syncope or ventricular arrhythmias. Only 2 of 23 genotype-positive individuals (9%) demonstrated a spontaneous BrS electrocardiographic pattern. Drug challenge testing for BrS in 87% (13 of 15) was negative. There was no difference in PR interval (161 +/- 7 ms vs 165 +/- 9 ms; P = .83), QRS duration (101 +/- 6 ms vs 89 +/- 5 ms; P = .35), or corrected QT interval (414 +/- 35 ms vs 405 +/- 8 ms; P = .7) between genotype-positive and genotype-negative family members. The overall frequency of previously implicated SCN1B variants in the Genome Aggregation Database browser is 0.004%, exceeding the estimated prevalence of BrS owing to SCN1B (0.0005%), including 15 of 23 individuals (65%) who had the p.Trp179X variant. CONCLUSION The lack of genotype-phenotype concordance among families, combined with the high frequency of previously reported mutations in the Genome Aggregation Database browser, suggests that SCN1B is not a monogenic cause of BrS or SADS., National Health and Medical Research Council Early Career FellowshipNational Health and Medical Research Council of Australia [1122330]; National Heart Foundation of Australia Future Leader FellowshipNational Heart Foundation of Australia [100833]; National Health and Medical Research Council Practitioner FellowshipNational Health and Medical Research Council of Australia [1059156]; Robert Lancaster Memorial Fund - McColl's Retail Group Ltd., Dr Gray is the recipient of a National Health and Medical Research Council Early Career Fellowship (Fellowship no # 1122330). Dr Ingles is the recipient of a National Heart Foundation of Australia Future Leader Fellowship (Fellowship no # 100833). Dr Semsarian is the recipient of a National Health and Medical Research Council Practitioner Fellowship (Fellowship no # 1059156). Dr Behr receives research funding from the Robert Lancaster Memorial Fund sponsored by McColl's Retail Group Ltd.
- Published
- 2018
32. The management of active surveillance in prostate cancer: validation of the Canary Prostate Active Surveillance Study risk calculator with the Spanish Urological Association Registry
- Author
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Borque-Fernando, Angel, Rubio-Briones, Jose, Mariano Esteban, Luis, Collado-Serra, Argimiro, Pallas-Costa, Yoni, Angel Lopez-Gonzalez, Pedro, Huguet-Perez, Jorge, Ignacio Sanz-Velez, Jose, Manuel Gil-Fabra, Jesus, Gomez-Gomez, Enrique, Quicios-Dorado, Cristina, Fumado, Lluis, Martinez-Breijo, Sara, Soto-Villalba, Juan, PIEM Active Surveillance Study Grp, [Borque-Fernando, Angel] Hosp Univ Miguel Servet, IIS Aragon, Dept Urol, Zaragoza, Spain, [Manuel Gil-Fabra, Jesus] Hosp Univ Miguel Servet, IIS Aragon, Dept Urol, Zaragoza, Spain, [Rubio-Briones, Jose] Inst Valenciano Oncol, Dept Urol, Valencia, Spain, [Collado-Serra, Argimiro] Inst Valenciano Oncol, Dept Urol, Valencia, Spain, [Mariano Esteban, Luis] Univ Zaragoza, Escuela Univ Politecn La Almunia, Zaragoza, Spain, [Pallas-Costa, Yoni] Hosp Manises, Dept Urol, Valencia, Spain, [Angel Lopez-Gonzalez, Pedro] Hosp Clin Univ Virgen de la Arrixaca, Dept Urol, Murcia, Spain, [Huguet-Perez, Jorge] Hosp Clin Barcelona, Dept Urol, Barcelona, Spain, [Ignacio Sanz-Velez, Jose] Hosp Gen San Jorge, Dept Urol, Huesca, Spain, [Gomez-Gomez, Enrique] Hosp Univ Reina Sofia, Dept Urol, IMIBIC, Cordoba, Spain, [Quicios-Dorado, Cristina] Fdn Jimenez Diaz, Dept Urol, Madrid, Spain, [Fumado, Lluis] Hosp del Mar, Dept Urol, Barcelona, Spain, [Martinez-Breijo, Sara] Complexo Hosp Univ A Coruna, Dept Urol, La Coruna, Spain, and [Soto-Villalba, Juan] Hosp Univ Puerta del Mar, Dept Urol, Cadiz, Spain
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medicine.medical_specialty ,Pròstata -- Càncer -- Espanya ,Surveillance study ,reclassification ,Biopsy ,030232 urology & nephrology ,Outcomes ,Nomogram ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,external validation ,Medicine ,Disease ,Gynecology ,Program ,business.industry ,General surgery ,Follow-up ,active surveillance ,External validation ,Men ,medicine.disease ,prostate cancer ,Clinical Practice ,Oncology ,030220 oncology & carcinogenesis ,Cohort ,risk calculator ,business ,Validation cohort ,Research Paper - Abstract
// Angel Borque-Fernando 1, * , Jose Rubio-Briones 2, * , Luis Mariano Esteban 3 , Argimiro Collado-Serra 2 , Yoni Pallas-Costa 4 , Pedro Angel Lopez-Gonzalez 5 , Jorge Huguet-Perez 6 , Jose Ignacio Sanz-Velez 7 , Jesus Manuel Gil-Fabra 1 , Enrique Gomez-Gomez 8 , Cristina Quicios-Dorado 9 , Lluis Fumado 10 , Sara Martinez-Breijo 11 and Juan Soto-Villalba 12 , on behalf of the PIEM Active Surveillance Study Group 1 Department of Urology, Hospital Universitario Miguel Servet, IIS-Aragon, Zaragoza, Spain 2 Department of Urology, Instituto Valenciano de Oncologia, Valencia, Spain 3 Escuela Universitaria Politecnica de La Almunia, Universidad de Zaragoza, Zaragoza, Spain 4 Department of Urology, Hospital de Manises, Valencia, Spain 5 Department of Urology, Hospital Clinico Universitario Virgen de la Arrixaca, Murcia, Spain 6 Department of Urology, Hospital Clinic de Barcelona, Barcelona, Spain 7 Department of Urology, Hospital General San Jorge, Huesca, Spain 8 Department of Urology, Hospital Universitario Reina Sofia, IMIBIC, Cordoba, Spain 9 Department of Urology, Fundacion Jimenez Diaz, Madrid, Spain 10 Department of Urology, Hospital del Mar, Barcelona, Spain 11 Department of Urology, Complexo Hospitalario Universitario A Coruna, A Coruna, Spain 12 Department of Urology, Hospital Universitario Puerta del Mar, Cadiz, Spain * These authors have contributed equally to this work Correspondence to: Luis Mariano Esteban, email: lmeste@unizar.es Keywords: active surveillance; prostate cancer; reclassification; risk calculator; external validation Received: August 10, 2017 Accepted: October 03, 2017 Published: October 24, 2017 ABSTRACT The follow up of patients on active surveillance requires to repeat prostate biopsies. Predictive models that identify patients at low risk of progression or reclassification are essential to reduce the number of unnecessary biopsies. The aim of this study is to validate the Prostate Active Surveillance Study risk calculator (PASS-RC) in the multicentric Spanish Urological Association Registry of patients on active surveillance (AS), from common clinical practice. Results: We find significant differences in age, PSA and clinical stage between our validation cohort and the PASS-RC generation cohort ( p < .0001), with a reclassification rate of 10–22% on the follow-up Bx, no cancer was found in 43% of the first follow-up Bx. The calibration curve shows underestimation of real appearance of reclassification. The AUC is 0.65 (C.I.95%: 0.60–0.71). PDF and CUC do not suggest a specific cut-off point of clinical use. Methods: We select 498 patients on AS with a minimum of one follow-up biopsy (Bx) from the 1,024 males registered by 36 Spanish centers recruiting patients on the Spanish Urological Association Registry on AS. PASS-RC external validation is carried by means of calibration curve and area under de ROC-curve (AUC), identifying cut-offs of clinical utility by probability density functions (PDF) and clinical utility curves (CUC). Conclusions: In our first external validation of the PASS-RC we have obtained a moderate discrimination ability, although we cannot recommend cut-off points of clinical use. We suggest the exploration of new biomarkers and/or morpho-functional parameters from multiparametric magnetic resonance image, to improve those necessary tools on AS.
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- 2017
33. Quantifying the impact of using Coronary Artery Calcium Score for risk categorization instead of Framingham Score or European Heart SCORE in lipid lowering algorithms in a Middle Eastern population
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Samir Alam, Mukbil Hourani, Mohamad M. Almedawar, Wissam Alajaji, Laila Al-Shaar, Fadi El-Merhi, Bernard Harbieh, Hussain Isma'eel, and Antoine Abchee
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lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,animal structures ,Population ,Bioinformatics ,Lipid-lowering therapy ,Full Length Article ,Internal medicine ,medicine ,Risk categorization ,cardiovascular diseases ,education ,education.field_of_study ,Coronary Artery Calcium Score ,Framingham Risk Score ,business.industry ,Coronary artery calcium score ,Canadian Cardiology Society guidelines ,Reclassification ,nutritional and metabolic diseases ,lcsh:RC666-701 ,European Society of Cardiology guidelines ,Heart score ,Cardiology ,cardiovascular system ,population characteristics ,Lipid lowering ,business ,Lipid lowering therapy - Abstract
Background: The use of the Coronary Artery Calcium Score (CACS) for risk categorization instead of the Framingham Risk Score (FRS) or European Heart SCORE (EHS) to improve classification of individuals is well documented. However, the impact of reclassifying individuals using CACS on initiating lipid lowering therapy is not well understood. We aimed to determine the percentage of individuals not requiring lipid lowering therapy as per the FRS and EHS models but are found to require it using CACS and vice versa; and to determine the level of agreement between CACS, FRS and EHS based models. Methods: Data was collected for 500 consecutive patients who had already undergone CACS. However, only 242 patients met the inclusion criteria and were included in the analysis. Risk stratification comparisons were conducted according to CACS, FRS, and EHS, and the agreement (Kappa) between them was calculated. Results: In accordance with the models, 79.7% to 81.5% of high-risk individuals were down-classified by CACS, while 6.8% to 7.6% of individuals at intermediate risk were up-classified to high risk by CACS, with slight to moderate agreement. Moreover, CACS recommended treatment to 5.7% and 5.8% of subjects untreated according to European and Canadian guidelines, respectively; whereas 75.2% to 81.2% of those treated in line with the guidelines would not be treated based on CACS. Conclusion: In this simulation, using CACS for risk categorization warrants lipid lowering treatment for 5–6% and spares 70–80% from treatment in accordance with the guidelines. Current strong evidence from double randomized clinical trials is in support of guideline recommendations. Our results call for a prospective trial to explore the benefits/risks of a CACS-based approach before any recommendations can be made.
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- 2015
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34. Will the future lie in multitude? A critical appraisal of biomarker panel studies on prediction of diabetic kidney disease progression
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Jacqueline Benner, Hiddo J.L. Heerspink, Elise Schutte, Ron T. Gansevoort, and Helen L. Lutgers
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medicine.medical_specialty ,Pathology ,NEPHROPATHY ,MODELS ,Renal function ,FROZEN STORAGE ,Disease ,urologic and male genital diseases ,PROTEIN BIOMARKERS ,Nephropathy ,Diabetic nephropathy ,MARKERS ,chronic renal failure ,Diabetes mellitus ,medicine ,Humans ,Diabetic Nephropathies ,Intensive care medicine ,DECLINE ,Transplantation ,RISK PREDICTION ,RECLASSIFICATION ,business.industry ,diabetic nephropathy ,biomarkers ,medicine.disease ,diabetic kidney disease ,Critical appraisal ,Nephrology ,diabetes mellitus ,ENDOTHELIAL DYSFUNCTION ,Disease Progression ,Albuminuria ,Biomarker (medicine) ,medicine.symptom ,business ,INCREMENTAL VALUE - Abstract
Diabetic kidney disease is diagnosed and staged by albuminuria and estimated glomerular filtration rate. Although albuminuria has strong predictive power for renal function decline, there is still variability in the rate of renal disease progression across individuals that are not fully captured by the level of albuminuria. Therefore, research focuses on discovering and validating additional biomarkers that improve risk stratification for future renal function decline and end-stage renal disease in patients with diabetes, on top of established biomarkers. Most studies address the value of single biomarkers to predict progressive renal disease and aim to understand the mechanisms that underlie accelerated renal function decline. Since diabetic kidney disease is a disease encompassing several pathophysiological processes, a combination of biomarkers may be more likely to improve risk prediction than a single biomarker. In this review, we provide an overview of studies on the use of multiple biomarkers and biomarker panels, appraise their study design, discuss methodological pitfalls and make recommendations for future biomarker panel studies.
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- 2015
35. The ratio of the neutrophil leucocytes to the lymphocytes predicts the outcome after cardiac resynchronization therapy
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Zsigmond Jenei, Endre Zima, Dávid Becker, Levente Molnár, Astrid Apor, László Gellér, Gábor Széplaki, Zoltán Prohászka, Zsolt Bagyura, András Mihály Boros, Béla Merkely, and Péter Perge
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Male ,Neutrophils ,medicine.medical_treatment ,Lymphocyte ,Prohormone ,030204 cardiovascular system & hematology ,Cardiac Resynchronization Therapy ,0302 clinical medicine ,Natriuretic Peptide, Brain ,Clinical endpoint ,Prospective Studies ,Outcome ,Hazard ratio ,Neutrophil ,Reclassification ,Middle Aged ,Brain natriuretic peptide ,Pacing and Resynchronization Therapy ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,Cardiac resynchronization therapy ,03 medical and health sciences ,Clinical Research ,Predictive Value of Tests ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,Lymphocyte Count ,Aged ,Proportional Hazards Models ,Heart Failure ,Hungary ,business.industry ,Odds ratio ,medicine.disease ,Chronic heart failure ,Peptide Fragments ,Logistic Models ,Heart failure ,Case-Control Studies ,Chronic Disease ,Multivariate Analysis ,Resynchronization ,business ,Biomarkers ,Follow-Up Studies - Abstract
Aims The low lymphocyte counts and high neutrophil leucocyte fractions have been associated with poor prognosis in chronic heart failure. We hypothesized that the baseline ratio of the neutrophil leucocytes to the lymphocytes (NL ratio) would predict the outcome of chronic heart failure patients undergoing cardiac resynchronization therapy (CRT). Methods and results The qualitative blood counts and the serum levels of N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) of 122 chronic heart failure patients and 122 healthy controls were analysed prospectively in this observational study. The 2-year mortality was considered as primary endpoint and the 6-month reverse remodelling (≥15% decrease in the end-systolic volume) as secondary endpoint. Multivariable regression analyses were applied and net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were calculated. The NL ratio was elevated in chronic heart failure patients when compared with the healthy controls [2.93 (2.12–4.05) vs. 2.21 (1.64–2.81), P < 0.0001]. The baseline NL ratio exceeding 2.95 predicted the lack of the 6-month reverse remodelling [n = 63, odds ratio = 0.38 (0.17–0.85), P = 0.01; NRI = 0.49 (0.14–0.83), P = 0.005; IDI = 0.04 (0.00–0.07), P = 0.02] and the 2-year mortality [n = 29, hazard ratio = 2.44 (1.04–5.71), P = 0.03; NRI = 0.63 (0.24–1.01), P = 0.001; IDI = 0.04 (0.00–0.08), P = 0.02] independently of the NT-proBNP levels or other factors. Conclusion The NL ratio is elevated in chronic heart failure and predicts outcome after CRT. According to the reclassification analysis, 4% of the patients would have been better categorized in the prediction models by combining the NT-proBNP with the NL ratio. Thus, a single blood count measurement could facilitate the optimal patient selection for the CRT.
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- 2015
36. Genetic Association and Risk Scores in a Chronic Obstructive Pulmonary Disease Meta-analysis of 16,707 Subjects
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Robert Busch, Brian D. Hobbs, Jin Zhou, Peter J. Castaldi, Michael J. McGeachie, Megan E. Hardin, Iwona Hawrylkiewicz, Pawel Sliwinski, Jae-Joon Yim, Woo Jin Kim, Deog K. Kim, Alvar Agusti, Barry J. Make, James D. Crapo, Peter M. Calverley, Claudio F. Donner, David A. Lomas, Emiel F. Wouters, Jørgen Vestbo, Ruth Tal-Singer, Per Bakke, Amund Gulsvik, Augusto A. Litonjua, David Sparrow, Peter D. Paré, Robert D. Levy, Stephen I. Rennard, Terri H. Beaty, John Hokanson, Edwin K. Silverman, Michael H. Cho, James Crapo, Edwin Silverman, Barry Make, Elizabeth Regan, Terri Beaty, Nan Laird, Christoph Lange, Michael Cho, Stephanie Santorico, Dawn DeMeo, Nadia Hansel, Craig Hersh, Peter Castaldi, Merry-Lynn McDonald, Emily Wan, Megan Hardin, Jacqueline Hetmanski, Margaret Parker, Marilyn Foreman, Brian Hobbs, Adel El-Bouiez, Dandi Qiao, Eitan Halper-Stromberg, Ferdouse Begum, Sungho Won, Sharon Lutz, David A. Lynch, Harvey O. Coxson, MeiLan K. Han, Eric A. Hoffman, Stephen Humphries, Francine L. Jacobson, Philip F. Judy, Ella A. Kazerooni, John D. Newell, James C. Ross, Raul San Jose Estepar, Berend C. Stoel, Juerg Tschirren, Eva van Rikxoort, Bram van Ginneken, George Washko, Carla G. Wilson, Mustafa Al Qaisi, Teresa Gray, Alex Kluiber, Tanya Mann, Jered Sieren, Douglas Stinson, Joyce Schroeder, Edwin Van Beek, Robert Jensen, Douglas Everett, Anna Faino, Matt Strand, Carla Wilson, John E. Hokanson, Gregory Kinney, Kendra Young, Katherine Pratte, Lindsey Duca, Jeffrey L. Curtis, Carlos H. Martinez, Perry G. Pernicano, Nicola Hanania, Philip Alapat, Venkata Bandi, Mustafa Atik, Aladin Boriek, Kalpatha Guntupalli, Elizabeth Guy, Amit Parulekar, Arun Nachiappan, Francine Jacobson, R. Graham Barr, Byron Thomashow, John Austin, Belinda D'Souza, Gregory D. N. Pearson, Anna Rozenshtein, Neil MacIntyre, Lacey Washington, H. Page McAdams, Charlene McEvoy, Joseph Tashjian, Robert Wise, Robert Brown, Karen Horton, Nirupama Putcha, Richard Casaburi, Alessandra Adami, Janos Porszasz, Hans Fischer, Matthew Budoff, Harry Rossiter, Amir Sharafkhaneh, Charlie Lan, Christine Wendt, Brian Bell, Gloria Westney, Eugene Berkowitz, Russell Bowler, David Lynch, Richard Rosiello, David Pace, Gerard Criner, David Ciccolella, Francis Cordova, Chandra Dass, Gilbert D'Alonzo, Parag Desai, Michael Jacobs, Steven Kelsen, Victor Kim, A. James Mamary, Nathaniel Marchetti, Aditi Satti, Kartik Shenoy, Robert M. Steiner, Alex Swift, Irene Swift, Maria Elena Vega-Sanchez, Mark Dransfield, William Bailey, J. Michael Wells, Surya Bhatt, Hrudaya Nath, Joe Ramsdell, Paul Friedman, Xavier Soler, Andrew Yen, Alejandro Comellas, John Newell, Brad Thompson, MeiLan Han, Ella Kazerooni, Carlos Martinez, Joanne Billings, Tadashi Allen, Frank Sciurba, Divay Chandra, Joel Weissfeld, Carl Fuhrman, Jessica Bon, Antonio Anzueto, Sandra Adams, Diego Maselli-Caceres, Mario E. Ruiz, Jaume Sauleda, Peter M. A. Calverley, Stephen Rennard, Y. Ivanov, K. Kostov, J. Bourbeau, M. Fitzgerald, P. Hernandez, K. Killian, R. Levy, F. Maltais, D. O'Donnell, J. Krepelka, J. Vestbo, E. Wouters, D. Quinn, P. Bakke, M. Kosnik, A. Agusti, J. Sauleda, Y. Feschenko, V. Gavrisyuk, L. Yashina, N. Monogarova, P. Calverley, D. Lomas, W. MacNee, D. Singh, J. Wedzicha, A. Anzueto, S. Braman, R. Casaburi, B. Celli, G. Giessel, M. Gotfried, G. Greenwald, N. Hanania, D. Mahler, B. Make, S. Rennard, C. Rochester, P. Scanlon, D. Schuller, F. Sciurba, A. Sharafkhaneh, T. Siler, E. Silverman, A. Wanner, R. Wise, R. ZuWallack, H. Coxson, C. Crim, L. Edwards, R. Tal Singer, J. Yates, B. Miller, R. Tal-Singer, J. Benditt, G. Criner, M. DeCamp, P. Diaz, M. Ginsburg, L. Kaiser, M. Katz, M. Krasna, N. MacIntyre, R. McKenna, F. Martinez, Z. Mosenifar, J. Reilly, A. Ries, J. Utz, RS: NUTRIM - R3 - Respiratory & Age-related Health, Pulmonologie, MUMC+: MA Longziekten (3), and RS: NUTRIM - R3 - Chronic inflammatory disease and wasting
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0301 basic medicine ,Male ,Clinical Biochemistry ,EMPHYSEMA ,SUSCEPTIBILITY ,AIR-FLOW OBSTRUCTION ,Pulmonary Disease, Chronic Obstructive ,Risk Factors ,Medicine ,EPIDEMIOLOGY ,Genetic epidemiology ,Original Research ,COPD ,COMPLEX DISEASE ,RECLASSIFICATION ,Chronic obstructive pulmonary disease ,Middle Aged ,Genetic risk score ,Respiratory Function Tests ,LUNG-FUNCTION ,Genetic risk factors ,alpha-1 antitrypsin ,Meta-analysis ,Female ,SMOKING ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,genetic epidemiology ,Pulmonary disease ,Single-nucleotide polymorphism ,genetic risk score ,chronic obstructive pulmonary disease ,03 medical and health sciences ,Internal medicine ,Genetic variation ,genetic risk factors ,Humans ,Genetic Predisposition to Disease ,GENOME-WIDE ASSOCIATION ,Molecular Biology ,Genotyping ,Genetic association ,Aged ,business.industry ,Cell Biology ,Heritability ,medicine.disease ,respiratory tract diseases ,030104 developmental biology ,Physical therapy ,business ,Genome-Wide Association Study - Abstract
The heritability of chronic obstructive pulmonary disease (COPD) cannot be fully explained by recognized genetic risk factors identified as achieving genome-wide significance. In addition, the combined contribution of genetic variation to COPD risk has not been fully explored. We sought to determine: (1) whether studies of variants from previous studies of COPD or lung function in a larger sample could identify additional associated variants, particularly for severe COPD; and (2) the impact of genetic risk scores on COPD. We genotyped 3,346 single-nucleotide polymorphisms (SNPs) in 2,588 cases (1,803 severe COPD) and 1,782 control subjects from four cohorts, and performed association testing with COPD, combining these results with existing genotyping data from 6,633 cases (3,497 severe COPD) and 5,704 control subjects. In addition, we developed genetic risk scores from SNPs associated with lung function and COPD and tested their discriminatory power for COPD-related measures. We identified significant associations between SNPs near PPIC (P = 1.28 X 10(-8)) and PPP4R4/SERPINA1 (P = 1.01 X 10(-8)) and severe COPD; the latter association may be driven by recognized variants in SERPINA1. Genetic risk scores based on SNPs previously associated with COPD and lung function had a modest ability to discriminate COPD (area under the curve, similar to 0.6), and accounted for a mean 0.9-1.9% lower forced expiratory volume in 1 second percent predicted for each additional risk allele. In a large genetic association analysis, we identified associations with severe COPD near PPIC and SERPINA1. A risk score based on combining genetic variants had modest, but significant, effects on risk of COPD and lung function.
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- 2017
37. Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry
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Campbell Rogers, Jeroen J. Bax, Tomohiro Kawasaki, Bjarne L. Nørgaard, Yoshihiro Morino, Koen Nieman, Manesh R. Patel, Hitoshi Matsuo, Gianluca Pontone, Mark G. Rabbat, Kavitha Chinnaiyan, Tetsuya Amano, Gilbert L. Raff, Jonathon Leipsic, Neils Peter Sand, Philipp Blanke, Bernard De Bruyne, Takashi Akasaka, and Radiology & Nuclear Medicine
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Canada ,medicine.medical_specialty ,Asia ,Computed Tomography Angiography ,medicine.medical_treatment ,Hemodynamics ,Coronary Artery Disease ,Fractional flow reserve ,030204 cardiovascular system & hematology ,Coronary Angiography ,Revascularization ,Severity of Illness Index ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Ischemia ,Internal medicine ,Journal Article ,medicine ,Clinical endpoint ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Registries ,cardiovascular diseases ,030212 general & internal medicine ,business.industry ,Coronary Stenosis ,Percutaneous coronary intervention ,Reclassification ,Prognosis ,medicine.disease ,United States ,Europe ,Fractional Flow Reserve, Myocardial ,Multicenter Study ,Stenosis ,medicine.anatomical_structure ,FFRct ,Research Design ,Cardiology ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Artery - Abstract
Background Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFR CT ) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFR CT as an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina. Methods The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFR CT -guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFR CT to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFR CT . The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up. Conclusions The ADVANCE registry is designed to assess the real-world impact of FFR CT on the clinical management of stable CAD when used along with coronary CTA.
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- 2017
38. External Validation and Update of a Prediction Rule for the Duration of Sickness Absence Due to Common Mental Disorders
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Corne A. M. Roelen, Giny Norder, Karen Nieuwenhuijsen, Judith K. Sluiter, Jac J. L. van der Klink, Ute Bültmann, APH - Societal Participation & Health, APH - Quality of Care, Coronel Institute of Occupational Health, APH - Mental Health, Tranzo, Scientific center for care and wellbeing, and Arbeid & Gezondheid
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Male ,PROGNOSTIC MODELS ,RETURN ,Pediatrics ,Time Factors ,medicine.medical_treatment ,Mental disorders ,Occupational safety and health ,0302 clinical medicine ,Occupational Therapy ,Risk Factors ,Surveys and Questionnaires ,Sick leave ,Prospective Studies ,030212 general & internal medicine ,Prospective cohort study ,POPULATION ,education.field_of_study ,Rehabilitation ,RECLASSIFICATION ,DISABILITY PENSION ,Middle Aged ,SYMPTOM QUESTIONNAIRE 4DSQ ,Prognosis ,030210 environmental & occupational health ,8. Economic growth ,Anxiety ,Female ,HEALTH ,medicine.symptom ,Adult ,Employment ,medicine.medical_specialty ,Return to work ,Population ,Article ,03 medical and health sciences ,medicine ,Humans ,education ,Occupational Health ,WORK ,ENVIRONMENT ,Receiver operating characteristic ,business.industry ,Disability pension ,ROC Curve ,Validation studies ,RISK-FACTORS ,Physical therapy ,business - Abstract
Purpose: The objective of the present study was to validate an existing prediction rule (including age, education, depressive/anxiety symptoms, and recovery expectations) for predictions of the duration of sickness absence due to common mental disorders (CMDs) and investigate the added value of work-related factors. Methods: A prospective cohort study including 596 employees who reported sick with CMDs in the period from September 2013 to April 2014. Work-related factors were measured at baseline with the Questionnaire on the Experience and Evaluation of Work. During 1-year follow-up, sickness absence data were retrieved from an occupational health register. The outcome variables of the study were sickness absence (no = 0, yes = 1) at 3 and 6 months after reporting sick with CMDs. Discrimination between workers with and without sickness absence was investigated at 3 and 6 months with the area under the receiver operating characteristic curve (AUC). Results: A total of 220 (37 %) employees agreed to participate and 211 (35 %) had complete data for analysis. Discrimination was poor with AUC = 0.69 and AUC = 0.55 at 3 and 6 months, respectively. When ‘variety in work’ was added as predictor variable, discrimination between employees with and without CMD sickness absence improved to AUC = 0.74 (at 3 months) and AUC = 0.62 (at 6 months). Conclusions: The original prediction rule poorly predicted CMD sickness absence duration. After adding ‘variety in work’, the prediction rule discriminated between employees with and without CMD sickness absence 3 months after reporting sick. This new prediction rule remains to be validated in other populations.
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- 2017
39. Additive value of the CRUSADE score to the GRACE score for mortality risk prediction in patients with acute coronary syndromes
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Violeta González-Salvado, Moisés Rodríguez-Mañero, Rosa Agra-Bermejo, Alberto Cordero, Belen Cid, Ramón López-Palop, José Ramón González-Juanatey, Vicente Bertomeu-Martínez, Pilar Carrillo, Diego Iglesias-Álvarez, and José María García-Acuña
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Adult ,Male ,medicine.medical_specialty ,Acute coronary syndrome ,Multivariate analysis ,030204 cardiovascular system & hematology ,Risk Assessment ,Severity of Illness Index ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Ischemic risk ,Predictive Value of Tests ,Internal medicine ,Bleeding risk ,medicine ,Humans ,In patient ,Prospective Studies ,030212 general & internal medicine ,Acute Coronary Syndrome ,Mortality ,Prospective cohort study ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Mortality rate ,Reclassification ,Mean age ,Middle Aged ,medicine.disease ,Prognosis ,Predictive value ,Methods observational ,Female ,Medical emergency ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Introduction: Acute coronary syndrome (ACS) treatments increase bleeding complications that also impair prognosis. Bleeding risk scores reclassification of actual mortality risk estimated by the GRACE score might improve overall estimation. Methods: Observational and prospective study of all ACS patients admitted in two hospitals. Mortality risk was assessed by the GRACE score and bleeding risk by the CRUSADE score. We analyzed the net reclassification improvement (NRI) of adding the CRUSADE score to the GRACE score. Results: We included 6997 patients, mean age 67.4 (12.9), 38.0% ST-elevation ACS, mean GRACE score 145.2 (39.9). The percentage of patients with CRUSADE score >20 or >50 increased as the GRACE score was higher. Hospital mortality was 5.3% and the addition of the CRUSADE score reclassified a relevant percentage of patients with GRACE score >109; NRI was 3.80% (1.10-6.10). During follow-up, (median 53.0 months) mortality rate was 22.6% and patients with CRUSADE score >50 had significantly higher mortality rates in all GRACE score categories; NRI was high (46.6%, 95% CI 41.0-53.1). The multivariate analysis outlined the independent predictive value of CRUSADE score >20 or >50 as well as GRACE scores 109-139 and >140. Conclusions: The addition of the CRUSADE score to the GRACE score improved mortality risk estimation. A CRUSADE score >50 identified patients with higher post-discharge mortality and higher hospital mortality if GRACE score was >109. The CRUSADE score improved hospital and long-term mortality prediction in patients with GRACE score >140. Individual mortality risk estimation should integrate the CRUSADE and GRACE scores. (C) 2017 Elsevier B.V. All rights reserved.
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- 2017
40. Prediction of Chronic Kidney Disease Stage 3 by CKD273, a Urinary Proteomic Biomarker
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Adela Ramirez-Torres, Ronald Klein, William Mullen, Raymond Vanholder, Claudia Pontillo, Peter Verhamme, Lutgarde Thijs, Griet Glorieux, Jan A. Staessen, Harald Mischak, Rudolf W. Bilous, Zhenyu Zhang, Antonia Vlahou, Eva Schepers, Hiddo J.L. Heerspink, Lotte Jacobs, Peter Rossing, Petra Zürbig, Joost P. Schanstra, Trevor J. Orchard, Morten Lindhardt, Nishi Charturvedi, Joachim Jankowski, Massimo Porta, Christian Delles, Pathologie, RS: CARIM - R3.06 - The vulnerable plaque: makers and markers, Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
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0301 basic medicine ,medicine.medical_specialty ,Urinary system ,030232 urology & nephrology ,Urology ,Renal function ,PROGRESSION ,RETINOPATHY ,lcsh:RC870-923 ,GLOMERULAR-FILTRATION-RATE ,CANDESARTAN ,03 medical and health sciences ,0302 clinical medicine ,proteomics ,Clinical Research ,Diabetes mellitus ,Internal medicine ,medicine ,Journal Article ,Medicine and Health Sciences ,FIBROSIS ,FIBRINOGEN ,glomerular filtration rate ,RECLASSIFICATION ,business.industry ,MICROALBUMINURIA ,peptidomics ,medicine.disease ,lcsh:Diseases of the genitourinary system. Urology ,PREVENTION ,clinical science ,3. Good health ,030104 developmental biology ,Endocrinology ,Nephrology ,Cohort ,Albuminuria ,Biomarker (medicine) ,biomarker ,Microalbuminuria ,TRIAL ,medicine.symptom ,business ,chronic kidney disease ,Kidney disease - Abstract
INTRODUCTION: CKD273 is a urinary biomarker, which in advanced chronic kidney disease predicts further deterioration. We investigated whether CKD273 can also predict a decline of estimated glomerular filtration rate (eGFR) to
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- 2017
41. Preserving amortized costs within a fair-value-accounting framework: reclassification of gains and losses on available-for-sale securities upon realization
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Xiao-Jun Zhang, Minyue Dong, and Stephen G. Ryan
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business.industry ,Financial economics ,Equity (finance) ,Cost accounting ,Holding gains ,Accounting ,Accumulated other comprehensive income ,Monetary economics ,General Business, Management and Accounting ,Corporate finance ,Earnings management ,Available for sale ,Net income ,Cash flow hedge ,Income statement ,Fair value ,Economics ,Available-for-sale securities ,Reclassification ,Fair value accounting ,Realization ,Business ,Financial accounting ,Market value ,Book value - Abstract
SFAS No. 115 requires firms to recognize available-for-sale (AFS) securities at fair value with accumulated unrealized gains and losses (AUGL) recorded in accumulated other comprehensive income. Firms reclassify AUGL to net income when they realize gains and losses. We refer to the amount reclassified each period by ''RECLASS.'' As of 1998, SFAS No. 130 requires firms to present RECLASS prominently in their financial statements. We investigate the incremental explanatory power of RECLASS for banks' market values and market-adjusted returns. In the market value analysis, we control for AUGL, other components of book value of equity, net income before extraordinary items and RECLASS (NIBEXother), and other components of comprehensive income. In the returns analysis, we control for DAUGL, DNIBEXother, and extraordinary items. We find high positive coefficients on RECLASS in both analyses, consistent with investors pricing RECLASS as a relatively permanent component of net income. Exploring possible explanations for these pricing implications, we find no evidence that they are attributable to RECLASS remedying unreliable fair value measurement of AUGL. We provide three distinct analyses indicating that RECLASS's pricing implications are explained in significant part by it helping investors predict banks' future performance. Our results illustrate that an important type of amortized cost accounting information, realized gains and losses, remains highly useful to investors despite the overall fair-value-accounting framework for AFS securities.
- Published
- 2013
42. Stroke Severity and Comorbidity Index for Prediction of Mortality after Ischemic Stroke from the Virtual International Stroke Trials Archive-Acute Collaboration
- Author
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Phan, Thanh G, Clissold, Benjamin, Ly, John, Ma, Henry, Moran, Chris, Srikanth, Velandai, Lees, K R, Alexandrov, A, Bath, P M, Bluhmki, E, Bornstein, N, Claesson, L, Davis, S M, Donnan, G, Diener, Hans Christoph, Fisher, M, Ginsberg, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, M G, Hommel, M, Kaste, M, Lyden, P, Marler, J, Muir, K, Sacco, R, Shuaib, A, Teal, P, Wahlgren, N G, Warach, S, Weimar, Christian, Neurologian yksikkö, and Clinicum
- Subjects
medicine.medical_specialty ,Databases, Factual ,medicine.medical_treatment ,Medizin ,Severity of Illness Index ,3124 Neurology and psychiatry ,Brain Ischemia ,03 medical and health sciences ,User-Computer Interface ,0302 clinical medicine ,Interquartile range ,Predictive Value of Tests ,Risk Factors ,Severity of illness ,Medicine ,Humans ,030212 general & internal medicine ,cardiovascular diseases ,Cooperative Behavior ,Stroke ,Aged ,Aged, 80 and over ,RISK ,Ischemic stroke ,RECLASSIFICATION ,business.industry ,Rehabilitation ,Regression analysis ,Thrombolysis ,Middle Aged ,Models, Theoretical ,medicine.disease ,mortality ,Confidence interval ,3. Good health ,TISSUE ,Predictive value of tests ,Emergency medicine ,Physical therapy ,Surgery ,Neurology (clinical) ,prognosis ,Cardiology and Cardiovascular Medicine ,business ,Charlson Comorbidity Index ,030217 neurology & neurosurgery - Abstract
M. Kaste on työryhmän VISTA-Acute Collaboration jäsen. Background: There is increasing interest in the use of administrative data (incorporating comorbidity index) and stroke severity score to predict ischemic stroke mortality. The aim of this study was to determine the optimal timing for the collection of stroke severity data and the minimum clinical dataset to be included in models of stroke mortality. To address these issues, we chose the Virtual International Stroke Trials Archive (VISTA), which contains National Institutes of Health Stroke Scale (NIHSS) on admission and at 24 hours, as well as outcome at 90 days. Methods: VISTA was searched for patients who had baseline and 24-hour NIHSS. Improvement in regression models was performed by the net reclassification improvement (NRI) method. Results: The clinical data among 5206 patients were mean age, 69 +/- 13; comorbidity index, 3.3 +/- .9; median NIHSS at baseline, 12 (interquartile range [IQR] 8-17); NIHSS at 24 hours, 9 (IQR 8-15); and death at 90 days in 15%. The baseline model consists of age, gender, and comorbidity index. Adding the baseline NIHSS to model 1 improved the NRI by 0.671 (95% confidence interval [CI] 0.595-0.747) [or 67.1% correct reclassification between model 1 and model 2]. Adding the 24 hour NIHSS term to model 1 (model 3) improved the NRI by 0.929 (95% CI 0.857-1.000) for model 3 versus model 1. Adding the variable thrombolysis to model 3 (model 4) improve NRI by 0.1 (95% CI 0.023-0.178) [model 4 versus model 3]. Conclusion: The optimal model for the prediction of mortality was achieved by adding the 24-hour NIHSS and thrombolysis to the baseline model.
- Published
- 2016
43. Growth-Differentiation Factor 15 Predicts Worsening of Albuminuria in Patients With Type 2 Diabetes
- Author
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Hiddo J. Lambers-Heerspink, Leo E. Deelman, Ron T. Gansevoort, Stephan J. L. Bakker, Merel E. Hellemons, Dick de Zeeuw, Magdalena Mazagova, Robert H. Henning, Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), Cardiovascular Centre (CVC), Groningen Institute for Organ Transplantation (GIOT), Lifestyle Medicine (LM), and Vascular Ageing Programme (VAP)
- Subjects
Male ,medicine.medical_specialty ,Cardiovascular and Metabolic Risk ,Growth Differentiation Factor 15 ,endocrine system diseases ,NEPHROPATHY ,Endocrinology, Diabetes and Metabolism ,Urology ,Renal function ,PROGRESSION ,Type 2 diabetes ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,GLOMERULAR-FILTRATION-RATE ,Nephropathy ,RISK STRATIFICATION ,ACTIVATION ,03 medical and health sciences ,0302 clinical medicine ,Diabetes mellitus ,Internal medicine ,Internal Medicine ,Medicine ,Albuminuria ,Humans ,030304 developmental biology ,ALL-CAUSE MORTALITY ,Original Research ,Aged ,Advanced and Specialized Nursing ,0303 health sciences ,RECLASSIFICATION ,business.industry ,MICROALBUMINURIA ,Type 2 Diabetes Mellitus ,Middle Aged ,medicine.disease ,Endocrinology ,MYOCARDIAL-INFARCTION ,Diabetes Mellitus, Type 2 ,MARKER ,Cohort ,Hypertension ,Microalbuminuria ,Female ,medicine.symptom ,business - Abstract
OBJECTIVE Development of micro- or macroalbuminuria is associated with increased risk of cardiorenal complications, particularly in diabetes. For prevention of transition to micro- or macroalbuminuria, more accurate prediction markers on top of classical risk markers are needed. We studied a promising new marker, growth-differentiation factor (GDF)-15, to predict transition to increasing stage of albuminuria in type 2 diabetes mellitus (T2DM). In addition, we looked at the GDF-15 potential in nondiabetic subjects with hypertension (HT). RESEARCH DESIGN AND METHODS Case and control subjects were selected from the PREVEND cohort, a large (n = 8,592), prospective general population study on the natural course of albuminuria, with >10 years of follow-up and repeated albuminuria measurements. We found 24 T2DM and 50 HT case subjects transitioning from normo- to macroalbuminuria and 9 T2DM and 25 HT case subjects transitioning from micro- to macroalbuminuria (average follow-up 2.8 years). Control subjects with stable albuminuria were pair matched for age, sex, albuminuria status, and diabetes duration. GDF-15 was measured in samples prior to albuminuria transition. RESULTS Prior to transition, GDF-15 was significantly higher in case subjects with T2DM than in control subjects (median [IQR] 1,288 pg/mL [885–1,546] vs. 948 pg/mL [660–1,016], P < 0.001). The odds ratio for transition in albuminuria increased significantly per SD of GDF-15 (2.9 [95% CI 1.1–7.5], P = 0.03). GDF-15 also improved prediction of albuminuria transition, with significant increases in C statistic (from 0.87 to 0.92, P = 0.03) and integrated discrimination improvement (0.148, P = 0.001). In HT, GDF-15 was also independently associated with transition in albuminuria stage (2.0 [1.1–3.5], P = 0.02) and improved prediction significantly. CONCLUSIONS We identified GDF-15 as a clinically valuable marker for predicting transition in albuminuria stage in T2DM beyond conventional risk markers. These findings were confirmed in nondiabetic HT subjects.
- Published
- 2012
44. A method for the early health technology assessment of novel biomarker measurement in primary prevention programs
- Author
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Erik Buskens, Hans L. Hillege, Douwe Postmus, Gimon de Graaf, Ewout W. Steyerberg, Science in Healthy Ageing & healthcaRE (SHARE), Life Course Epidemiology (LCE), Methods in Medicines evaluation & Outcomes research (M2O), Cardiovascular Centre (CVC), Groningen Kidney Center (GKC), General Practice, and Public Health
- Subjects
Statistics and Probability ,early health technology assessment ,medicine.medical_specialty ,Technology Assessment, Biomedical ,MEDICAL DEVICES ,Epidemiology ,Cost effectiveness ,Cost-Benefit Analysis ,primary prevention ,Biomedical Technology ,UNCERTAINTY ,COST-EFFECTIVENESS ,SDG 3 - Good Health and Well-being ,Intervention (counseling) ,Primary prevention ,Health care ,medicine ,Humans ,Intensive care medicine ,CURVE ,RISK ,Models, Statistical ,RECLASSIFICATION ,business.industry ,Management science ,cost-effectiveness analysis ,Health technology ,Cost-effectiveness analysis ,FRAMEWORK ,Models, Economic ,Diabetes Mellitus, Type 2 ,PREDICTION MODELS ,Biomarker (medicine) ,biomarker ,business ,Predictive modelling ,Biomarkers - Abstract
Many promising biomarkers for stratifying individuals at risk of developing a chronic disease or subsequent complications have been identified. Research into the potential cost-effectiveness of applying these biomarkers in actual clinical settings has however been lacking. Investors and analysts may improve their venture decision making should they have indicative estimates of the potential costs and effects associated with a new biomarker technology already at the early stages of its development. To assist in obtaining such estimates, this paper presents a general method for the early health technology assessment of a novel biomarker technology. The setting considered is that of primary prevention programs where initial screening to select high-risk individuals eligible for a subsequent intervention occurs, for example, prevention of type 2 diabetes. The method is based on quantifying the health outcomes and downstream healthcare consumption of all individuals who get reclassified as a result of moving from a screening variant based on traditional risk factors to a screening variant based on traditional risk factors plus a novel biomarker. As these individuals form well-defined subpopulations, a combination of disease progression modeling and sensitivity analysis can be used to perform an initial assessment of the maximum increase in screening cost for which the use of the new biomarker technology is still likely to be cost effective. Copyright (C) 2012 John Wiley & Sons, Ltd.
- Published
- 2012
45. Issues surrounding the classification of accounting information
- Author
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Huibrecht Margaretha van der Poll and Daan G. Gouws
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Knowledge management ,lcsh:Management. Industrial management ,reclassification ,Process (engineering) ,Computer science ,Accounting management ,attribute ,lcsh:Business ,computer.software_genre ,Accounting standard ,Income statement ,Balance sheet ,Pace ,business.industry ,lcsh:HB71-74 ,lcsh:Economics as a science ,Public relations ,General Business, Management and Accounting ,classification ,lcsh:HD28-70 ,Accounting information system ,Compiler ,business ,lcsh:HF5001-6182 ,Accounting information ,General Economics, Econometrics and Finance ,computer - Abstract
The act of classifying information created by accounting practices is ubiquitous in the accounting process; from recording to reporting, it has almost become second nature. The classification has to correspond to the requirements and demands of the changing environment in which it is practised. Evidence suggests that the current classification of items in financial statements is not keeping pace with the needs of users and the new financial constructs generated by the industry. This study addresses the issue of classification in two ways: by means of a critical analysis of classification theory and practices and by means of a questionnaire that was developed and sent to compilers and users of financial statements. A new classification framework for accounting information in the balance sheet and income statement is proposed.
- Published
- 2011
46. Risk prediction of incident coronary heart disease in the Netherlands: re-estimation and improvement of the SCORE risk function
- Author
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Edith J. M. Feskens, Leo J. Schouten, Piet A. van den Brandt, Ton Ambergen, W. M. Monique Verschuren, Anton P.M. Gorgels, Ewout W. Steyerberg, Jolanda M. A. Boer, Audrey H H Merry, and Public Health
- Subjects
Male ,Time Factors ,Nutrition and Disease ,Epidemiology ,clinical-practice ,Blood Pressure ,Coronary Disease ,Kaplan-Meier Estimate ,framingham ,Framingham Heart Study ,c-reactive protein ,Risk Factors ,Voeding en Ziekte ,Statistics ,Prospective Studies ,Registries ,Prospective cohort study ,Netherlands ,validation ,education.field_of_study ,Framingham Risk Score ,Incidence ,Discriminant Analysis ,Middle Aged ,myocardial-infarction ,Cholesterol ,Cohort ,Female ,Cardiology and Cardiovascular Medicine ,Risk assessment ,Cohort study ,Adult ,medicine.medical_specialty ,reclassification ,Population ,Risk Assessment ,Young Adult ,models ,Predictive Value of Tests ,Internal medicine ,medicine ,Humans ,global cardiovascular risk ,education ,Life Style ,Proportional Hazards Models ,VLAG ,Proportional hazards model ,business.industry ,Cholesterol, HDL ,mortality ,roc curve ,Linear Models ,business ,Biomarkers - Abstract
Aims: To re-estimate the SCORE risk function using individual data on risk factors and coronary heart disease (CHD) incidence from the Dutch Cardiovascular Registry Maastricht (CAREMA) population-based cohort study; to evaluate changes that may improve risk prediction after re-estimation; and to compare the performance of the resulting CAREMA risk function with that of existing risk scores. Methods and results: The cohort consisted of 21,148 participants, born in 1927–1977 and randomly sampled from the Maastricht region in 1987–1997. After follow-up (median 10.9 years), 783 incident CHD cases occurred. Model performance was assessed by discrimination and calibration. The additional value of including other risk factors or current risk factors in a different manner was evaluated using the net reclassification index (NRI). The c statistic of the re-estimated SCORE model was 0.799 (95% CI 0.782–0.816). Separating the total/high-density lipoprotein (HDL) cholesterol ratio into total and HDL cholesterol levels did not improve the c statistic ( p = 0.22), but reclassified 6.0% of the participants into a more appropriate risk category ( p Conclusion: In this Dutch population, a re-estimated SCORE function with total and HDL cholesterol levels instead of the cholesterol ratio can be used for the risk prediction of CHD incidence.
- Published
- 2011
47. Validation of the 2009 TNM Version in a Large Multi-Institutional Cohort of Patients Treated for Renal Cell Carcinoma: Are Further Improvements Needed?
- Author
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Novara, G, Ficarra, V, Antonelli, A, Artibani, W, Bertini, R, Carini, M, Cosciani Cunico, S, Imbimbo, C, Longo, N, Martignoni, G, Martorana, G, Minervini, A, Mirone, V, Montorsi, F, Schiavina, R, Simeone, C, Serni, S, Simonato, A, Siracusano, S, Volpe, A, Carmignani, G, De Cobelli O, SATURN Project LUNA F. o. u. n. d. a. t. i. o. n., Corti, S, Castelli, M, Cimino, S, Favilla, V, Morgia, G, Billia, M, Terrone, C, Masieri, L, Oneto, F, Varca, V, Rocco, F, Costantini, E, Porena, M, Zucchi, A, Ciciliato, S, Lampropoulou, N, Fontana, D, Gontero, Paolo, Tizzani, Alessandro, Brunelli, M, Valotto, C, Zattoni, F., Novara, G, Ficarra, V, Antonelli, A, Artibani, W, Bertini, R, Carini, M, Cosciani Cunico, S, Imbimbo, Ciro, Longo, Nicola, Martignoni, G, Martorana, G, Minervini, A, Mirone, Vincenzo, Montorsi, F, Schiavina, R, Simeone, C, Serni, S, Simonato, A, Siracusano, S, Volpe, A, Carmignani, G., Novara, Giacomo, Ficarra, Vincenzo, Antonelli, Alessandro, Artibani, Walter, Bertini, Roberto, Carini, Marco, Cunico Sergio, Cosciani, Martignoni, Guido, Martorana, Giuseppe, Minervini, Andrea, Montorsi, Francesco, Schiavina, Roberto, Simeone, Claudio, Serni, Sergio, Simonato, Alchiede, Siracusano, Salvatore, Volpe, Alessandro, Carmignani, Giorgio, G., Novara, V., Ficarra, A., Antonelli, W., Artibani, R., Bertini, M., Carini, S. C., Cunico, N., Longo, G., Martignoni, G., Martorana, A., Minervini, F., Montorsi, R., Schiavina, C., Simeone, S., Serni, A., Simonato, S., Siracusano, A., Volpe, G., Carmignani, Novara G., Ficarra V., Antonelli A., Artibani W., Bertini R., Carini M., Cosciani Cunico S., Imbimbo C., Longo N., Martignoni G., Martorana G., Minervini A., Mirone V., Montorsi F., Schiavina R., Simeone C., Serni S., Simonato A., Siracusano S., Volpe A., Carmignani G., De Cobelli O., Corti S., Castelli M., Cimino S., Favilla V., Morgia G., Billia M., Terrone C., Masieri L., Oneto F., Varca V., Rocco F., Costantini E., Porena M., Zucchi A., Ciciliato S., Lampropoulou N., Fontana D., Gontero P., Tizzani A., Brunelli M., Valotto C., Zattoni F., Petralia G., Roscigno M., Strada E., NOVARA G, FICARRA V, ANTONELLI A, ARTIBANI W, BERTINI R, CARINI M, COSCIANI CUNICO S, IMBIMBO C, LONGO N, MARTIGNONI G, MARTORANA G, MINERVINI A, MIRONE V, MONTORSI F, SCHIAVINA R., SIMEONE C, SERNI S, SIMONATO A, SIRACUSANO S, VOLPE A, CARMIGNANI G, SATURN PROJECT-LUNA FOUNDATION., ERRATUM IN: EUR UROL. 2011 JAN, 59(1):182. SCHIAVINA, ROBERTO [CORRECTED TO SCHIAVINA, RICCARDO]., Imbimbo, C, Longo, N, Mirone, V, Carmignani, G, and SATURN Project LUNA, Foundation
- Subjects
Male ,Nephrology ,Oncology ,IMPACT ,medicine.medical_treatment ,Validation of the 2009 TNM version in a large multi-institutional cohort of patients treated for renal cell carcinoma: are further improvements needed? ,Kidney neoplasm ,Nephrectomy ,Renal cell carcinoma ,TNM ,Urology ,Cohort Studies ,renal cell carcinoma ,staging system ,PROPOSAL ,PRIMARY TUMOR CLASSIFICATION ,NEPHRECTOMY ,RECLASSIFICATION ,kidney cancer ,RADICAL NEPHRECTOMY ,Middle Aged ,Primary tumor ,Kidney Neoplasms ,REVISION ,classification ,Cohort ,CUTOFF ,Aged ,Carcinoma, Renal Cell ,Female ,Humans ,Neoplasm Staging ,Retrospective Studies ,kidney neoplasm ,Human ,medicine.medical_specialty ,TNM staging system ,STRATIFICATION ,Internal medicine ,medicine ,business.industry ,Carcinoma ,Renal Cell ,Retrospective cohort study ,medicine.disease ,Surgery ,SIZE ,Cohort Studie ,business ,Kidney cancer ,Kidney disease - Abstract
Background: A new edition of the TNM was recently released that includes modifications for the staging system of kidney cancers. Specifically, T2 cancers were subclassified into T2a and T2b ( 10 cm), tumors with renal vein involvement or perinephric fat involvement were classified as T3a cancers, and those with adrenal involvement were classified as T4 cancers. Objective: Our aim was to validate the recently released edition of the TNM staging system for primary tumor classification in kidney cancer. Design, setting, and participants: Our multicenter retrospective study consisted of 5339 patients treated in 16 academic Italian centers. Intervention: Patients underwent either radical or partial nephrectomy. Measurements: Univariable and multivariable Cox regression models addressed cancer-specific survival (CSS) after surgery. Results and limitations: In the study, 1897 patients (35.5%) were classified as pT1a, 1453 (27%) as pT1b, 437 (8%) as pT2a, 153 (3%) as pT2b, 1059 (20%) as pT3a, 117 (2%) as pT3b, 26 (0.5%) as pT3c, and 197 (4%) as pT4. At a median follow-up of 42 mo, 786 (15%) had died of disease. In univariable analysis, patients with pT2b and pT3a tumors had similar CSS, as did patients with pT3c and pT4 tumors. Moreover, both pT3a and pT3b stages included patients with heterogeneous outcomes. In multivariable analysis, the novel classification of the primary tumor was a powerful independent predictor of CSS (p for trend < 0.0001). However, the substratification of pT1 tumors did not retain an independent predictive role. The major limitations of the study are retrospective design, lack of central pathologic review, and the small number of patients included in some substages. Conclusions: The recently released seventh edition of the primary tumor staging system for kidney tumors is a powerful predictor of CSS. However, some of the substages identified by the classification have overlapping prognoses, and other substages include patients with heterogeneous outcomes. The few modifications included in this edition may have not resolved the most critical issues in the previous version. (C) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
- Published
- 2010
48. Late Systolic Central Hypertension as a Predictor of Incident Heart Failure: The Multi‐Ethnic Study of Atherosclerosis
- Author
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Lyndia C. Brumback, Patrick Segers, Richard A. Kronmal, Daniel A. Duprez, David A. Bluemke, David R. Jacobs, Pamela Ouyang, Julio A. Chirinos, Raymond R. Townsend, Payman Zamani, and Dhananjay Vaidya
- Subjects
Male ,medicine.medical_specialty ,left ventricular afterload ,Epidemiology ,Population ,Diastole ,heart failure ,late systolic load ,WALL STRESS ,QUALITY-OF-LIFE ,Internal medicine ,medicine.artery ,medicine ,Medicine and Health Sciences ,Humans ,Arterial Pressure ,Systole ,VARYING MYOCARDIAL STRESS ,education ,CARDIOVASCULAR EVENTS ,Aorta ,LOADING SEQUENCE ,Original Research ,Heart Failure ,education.field_of_study ,RECLASSIFICATION ,business.industry ,Hazard ratio ,LEFT-VENTRICULAR RELAXATION ,medicine.disease ,PRESSURE FALL ,Blood pressure ,WAVE REFLECTION MAGNITUDE ,ARTERIAL LOAD ,Heart failure ,Hypertension ,Aortic pressure ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,arterial hemodynamics - Abstract
Background Experimental studies demonstrate that high aortic pressure in late systole relative to early systole causes greater myocardial remodeling and dysfunction, for any given absolute peak systolic pressure. Methods and Results We tested the hypothesis that late systolic hypertension, defined as the ratio of late (last one third of systole) to early (first two thirds of systole) pressure–time integrals ( PTI ) of the aortic pressure waveform, independently predicts incident heart failure ( HF ) in the general population. Aortic pressure waveforms were derived from a generalized transfer function applied to the radial pressure waveform recorded noninvasively from 6124 adults. The late/early systolic PTI ratio (L/ E SPTI ) was assessed as a predictor of incident HF during median 8.5 years of follow‐up. The L/ E SPTI was predictive of incident HF (hazard ratio per 1% increase=1.22; 95% CI =1.15 to 1.29; P HF ( HR =1.23; 95% CI =1.14 to 1.32: P HF , L/ E SPTI was the modifiable factor associated with the greatest improvements in model performance. A high L/ E SPTI (>58.38%) was more predictive of HF than the presence of hypertension. After adjustment for each other and various predictors of HF , the HR associated with hypertension was 1.39 (95% CI =0.86 to 2.23; P =0.18), whereas the HR associated with a high L/E was 2.31 (95% CI =1.52 to 3.49; P Conclusions Independently of the absolute level of peak pressure, late systolic hypertension is strongly associated with incident HF in the general population.
- Published
- 2015
49. A confidence ellipse for the Net Reclassification Improvement
- Author
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Michael J. Pencina, Olga Kuxhaus, Matthias B. Schulze, Heiner Boeing, Kristin Mühlenbruch, and Hannelore Liero
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Male ,Epidemiology ,Risk model ,Confidence intervals ,Ellipse ,Risk Assessment ,Predictive Value of Tests ,Risk Factors ,Statistics ,Methods ,Medicine ,Humans ,Point estimation ,ddc:610 ,Statistical hypothesis testing ,Event (probability theory) ,Aged ,Models, Statistical ,business.industry ,Institut für Mathematik ,Reclassification ,Model comparison ,Middle Aged ,Confidence interval ,Risk assessment ,Data Interpretation, Statistical ,Chronic Disease ,Female ,Metric (unit) ,Mathematisch-Naturwissenschaftliche Fakultät ,business ,Predictive modelling - Abstract
The Net Reclassification Improvement (NRI) has become a popular metric for evaluating improvement in disease prediction models through the past years. The concept is relatively straightforward but usage and interpretation has been different across studies. While no thresholds exist for evaluating the degree of improvement, many studies have relied solely on the significance of the NRI estimate. However, recent studies recommend that statistical testing with the NRI should be avoided. We propose using confidence ellipses around the estimated values of event and non-event NRIs which might provide the best measure of variability around the point estimates. Our developments are illustrated using practical examples from EPIC-Potsdam study.
- Published
- 2015
50. Incremental value of biomarkers to clinical variables for mortality prediction in acutely decompensated heart failure: the Multinational Observational Cohort on Acute Heart Failure (MOCA) study
- Author
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Said Laribi, Christian Mueller, Atul Pathak, Marco Metra, Semir Nouira, Veli-Pekka Harjola, Damien Logeart, Jiri Parenica, Domingo A. Pascual-Figal, Michael Potocki, James L. Januzzi, Alain Cohen-Solal, Jindrich Spinar, Johan Lassus, Roland R.J. van Kimmenade, Etienne Gayat, Thomas Mueller, Corinne Collet, W. Frank Peacock, Salvatore DiSomma, Alexandre Mebazaa, and Naoki Sato
- Subjects
Male ,ADHF, Biomarkers, Mortality, Reclassification, Risk prediction ,medicine.medical_specialty ,medicine.drug_class ,Renal function ,030204 cardiovascular system & hematology ,Global Health ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,Cause of Death ,Heart rate ,Natriuretic peptide ,medicine ,80 and over ,Humans ,030212 general & internal medicine ,ADHF ,Mortality ,Intensive care medicine ,Aged ,Aged, 80 and over ,Heart Failure ,business.industry ,Mortality rate ,Reclassification ,Biomarkers ,Risk prediction ,Acute Disease ,Biological Markers ,Female ,Follow-Up Studies ,Survival Rate ,medicine.disease ,3. Good health ,Blood pressure ,Heart failure ,Cohort ,Cardiology ,Biomarker (medicine) ,Cardiology and Cardiovascular Medicine ,business - Abstract
This study aims to evaluate the incremental value of plasma biomarkers to traditional clinical variables for risk stratification of 30-day and one-year mortality in acutely decompensated heart failure (ADHF).Through an international collaborative network, individual patient data on 5306 patients hospitalized for ADHF were collected. The all-cause mortality rate was 11.7% at 30 days and 32.9% at one year. The clinical prediction model (age, gender, blood pressure on admission, estimated glomerular filtration rate60 mL/min/1.73 m(2), sodium and hemoglobin levels, and heart rate) had a c-statistic of 0.74 for 30-day mortality and 0.73 for one-year mortality. Several biomarkers measured at presentation improved risk stratification when added to the clinical model. At 30 days, the net reclassification improvement (NRI) was 28.7% for mid-regional adrenomedullin (MR-proADM; p0.001) and 25.5% for soluble (s)ST2 (p0.001). At one year, sST2 (NRI 10.3%), MR-proADM (NRI 9.1%), amino-terminal pro-B-type natriuretic peptide (NT-proBNP; NRI 9.1%), mid-regional proatrial natriuretic peptide (MR-proANP; NRI 7.4%), B-type natriuretic peptide (NRI 5.5%) and C-reactive protein (CRP; NRI 5.3%) reclassified patients with ADHF (p0.05 for all). CRP also markedly improved risk stratification of patients with ADHF as a dual biomarker combination with MR-proADM (NRI 36.8% [p0.001] for death at 30 days) or with sST2 (NRI 20.3%; [p0.001] for one-year mortality).In this study, biomarkers provided incremental value for risk stratification of ADHF patients. Biomarkers such as sST2, MR-proADM, natriuretic peptides and CRP, reflecting different pathophysiologic pathways, add prognostic value to clinical risk factors for predicting both short-term and one-year mortality in ADHF.
- Published
- 2014
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