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Article ; Online: The European Medicines Agency assessment of mavacamten as treatment of symptomatic obstructive hypertrophic cardiomyopathy in adult patients.

DeVries, J Hans / Irs, Alar / Hillege, Hans L

2023 Volume 44, Issue 37, Page(s) 3492–3494

MeSH term(s)	Humans ; Adult ; Cardiomyopathy, Hypertrophic ; Benzylamines ; Uracil
Chemical Substances	MYK-461 ; Benzylamines ; Uracil (56HH86ZVCT)
Language	English
Publishing date	2023-07-24
Publishing country	England
Document type	Journal Article
ZDB-ID	603098-1
ISSN	1522-9645 ; 0195-668X
ISSN (online)	1522-9645
ISSN	0195-668X
DOI	10.1093/eurheartj/ehad429
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Zs.A 1563: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: A simulated maximum likelihood procedure for analyzing imprecise trade-off thresholds between the benefits and harms of medicines.

Postmus, Douwe / Pignatti, Francesco / Hillege, Hans L / Tervonen, Tommi

Statistics in medicine

2022 Volume 41, Issue 29, Page(s) 5612–5621

Abstract: Stated preference studies in which information on the willingness to trade-off between the benefits and harms of medicines is elicited from patients or other stakeholders are becoming increasingly mainstream. Such trade-offs can mathematically be ... ...

Abstract	Stated preference studies in which information on the willingness to trade-off between the benefits and harms of medicines is elicited from patients or other stakeholders are becoming increasingly mainstream. Such trade-offs can mathematically be represented by a weighted additive function, with the weights, whose ratios determine how much an individual is willing to trade-off between the treatment attributes, being the response vector for the statistical analysis. One way of eliciting trade-off information is through multi-dimensional thresholding (MDT), which is a bisection-based approach that results in increasingly tight bounds on the values of the weights ratios. While MDT is cognitively less demanding than other, more direct elicitation methods, its use complicates the statistical analysis as it results in weights data that are region censored. In this article, we present a simulated maximum likelihood (SML) procedure for fitting a Dirichlet population model directly to the region-censored weights data and perform a series of computational experiments to compare the proposed SML procedure to a naive approach in which a Dirichlet distribution is fitted to the centroids of the weights boundaries obtained with MDT. The results indicate that the SML procedure consistently outperformed the centroid-based approach, with the centroid-based approach requiring three bisection steps per trade-off to achieve a similar precision as the SML procedure with one bisection step per trade-off. Using the newly proposed SML procedure, MDT can be applied with smaller sample sizes or with fewer questions compared to the more naïve centroid-based approach that was applied in previous applications of MDT.
MeSH term(s)	Humans ; Patient Preference ; Data Collection
Language	English
Publishing date	2022-09-26
Publishing country	England
Document type	Journal Article
ZDB-ID	843037-8
ISSN	1097-0258 ; 0277-6715
ISSN (online)	1097-0258
ISSN	0277-6715
DOI	10.1002/sim.9583
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Zs.A 1756: Show issues

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Article: Cardiac Magnetic Resonance Derived Left Ventricular Eccentricity Index and Right Ventricular Mass Measurements Predict Outcome in Children with Pulmonary Arterial Hypertension.

Haarman, Meindina G / Coenraad, Iris / Hagdorn, Quint A J / Hillege, Hans L / Willems, Tineke P / Berger, Rolf M F / Douwes, Johannes M

Children (Basel, Switzerland)

2023 Volume 10, Issue 4

Abstract: Pulmonary arterial hypertension (PAH) is associated with increased right ventricular (RV) afterload, affecting RV remodeling and RV performance, a major determinant of outcome in PAH-patients. In children with PAH, treatment strategy is guided by risk ... ...

Abstract	Pulmonary arterial hypertension (PAH) is associated with increased right ventricular (RV) afterload, affecting RV remodeling and RV performance, a major determinant of outcome in PAH-patients. In children with PAH, treatment strategy is guided by risk stratification where noninvasive prognosticators are highly needed. The prognostic value of RV characteristics derived by cardiac magnetic resonance (CMR) has been scarcely studied in pediatric PAH. We aimed to identify CMR-derived morphometric and functional RV characteristics prognostic for outcome in children with PAH. From the Dutch National cohort, thirty-eight children with either idiopathic/heritable PAH (IPAH/HPAH) or PAH associated with congenital heart disease (PAH-CHD), who underwent CMR, were included (median (interquartile range) [IQR] age 13.0 years (10.8-15.0), 66% females). Patients had severe PAH, characterized by their World Health Organization Functional Class, increased N-terminal pro-B-type natriuretic peptide and high pulmonary arterial pressure and pulmonary vascular resistance index at time of CMR. RV-ejection fraction (RVEF), indexed RV-mass (RVMi), the ratio between RV and LV mass (RVM/LVM-ratio) and left ventricular eccentricity index (LVEI) all correlated with transplant-free survival from time of CMR. These correlations could not be confirmed in the PAH-CHD group. This study shows that CMR-derived measures reflecting RV function and remodeling (LVEI, RVMi, RVM/LVM-ratio, RVEF) predict transplant-free survival in children with IPAH/HPAH and may be included in risk stratification scores in pediatric PAH.
Language	English
Publishing date	2023-04-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2732685-8
ISSN	2227-9067
ISSN	2227-9067
DOI	10.3390/children10040756
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Article ; Online: Trajectories of renal biomarkers and new-onset heart failure in the general population: Findings from the PREVEND study.

Sakaniwa, Ryoto / Tromp, Jasper / Streng, Koen W / Suthahar, Navin / Kieneker, Lyanne M / Postmus, Douwe / Iso, Hiroyasu / Gansevoort, Ron T / Bakker, Stephan J L / Hillege, Hans L / de Boer, Rudolf A / Demissei, Biniyam G

European journal of heart failure

2023 Volume 25, Issue 7, Page(s) 1072–1079

Abstract: Aims: Renal dysfunction is one of the most critical risk factors for developing heart failure (HF). However, the association between repeated measures of renal function and incident HF remains unclear. Therefore, this study investigated the longitudinal ...

Abstract	Aims: Renal dysfunction is one of the most critical risk factors for developing heart failure (HF). However, the association between repeated measures of renal function and incident HF remains unclear. Therefore, this study investigated the longitudinal trajectories of urinary albumin excretion (UAE) and serum creatinine and their association with new-onset HF and all-cause mortality. Methods and results: Using group-based trajectory analysis, we estimated trajectories of UAE and serum creatinine in 6881 participants from the Prevention of Renal and Vascular End-stage Disease (PREVEND) study and their association with new-onset HF and all-cause death during the 11-years of follow-up. Most participants had stable low UAE or serum creatinine. Participants with persistently higher UAE or serum creatinine were older, more often men, and more often had comorbidities, such as diabetes, a previous myocardial infarction or dyslipidaemia. Participants with persistently high UAE had a higher risk of new-onset HF or all-cause mortality, whereas stable serum creatinine trajectories showed a linear association for new-onset HF and no association with all-cause mortality. Conclusion: Our population-based study identified different but often stable longitudinal patterns of UAE and serum creatinine. Patients with persistently worse renal function, such as higher UAE or serum creatinine, were at a higher risk of HF or mortality.
MeSH term(s)	Male ; Humans ; Heart Failure/epidemiology ; Creatinine ; Kidney/physiology ; Biomarkers ; Myocardial Infarction ; Risk Factors ; Albuminuria/epidemiology
Chemical Substances	Creatinine (AYI8EX34EU) ; Biomarkers
Language	English
Publishing date	2023-07-04
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1483672-5
ISSN	1879-0844 ; 1388-9842
ISSN (online)	1879-0844
ISSN	1388-9842
DOI	10.1002/ejhf.2925
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Zs.A 5299: Show issues

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Article ; Online: Tools and Techniques - Statistical. Estimating cumulative incidences in the presence of right-censoring and competing risks: an introduction with illustrations from the COACH study.

Postmus, Douwe / Demissei, Biniyam G / Hillege, Hans L

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

2016 Volume 11, Issue 11, Page(s) e1322–4

MeSH term(s)	Clinical Studies as Topic ; Humans ; Incidence ; Models, Statistical ; Risk ; Statistics as Topic/methods
Language	English
Publishing date	2016-02
Publishing country	France
Document type	Journal Article ; Review
ZDB-ID	2457174-X
ISSN	1969-6213 ; 1774-024X
ISSN (online)	1969-6213
ISSN	1774-024X
DOI	10.4244/EIJV11I11A256
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Zs.A 6680: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 571: Show issues

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Article: Pragmatic rules for comparability of biological medicinal products

van der Plas, R. Martijn / Hoefnagel, Marcel H.N / Hillege, Hans L / Roes, Kit C.B

Biologicals. 2020 Jan., v. 63

2020

Abstract: Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are ...

Abstract	Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial.
Keywords	biomedical research ; drugs ; manufacturing ; research methods
Language	English
Dates of publication	2020-01
Size	p. 97-100.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2019.11.002
Database	NAL-Catalogue (AGRICOLA)

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Zs.A 879: Show issues

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Article: Can an algorithm based on dipstick urine protein and urine specific gravity accurately predict proteinuria?

Hillege, Hans L

Nature clinical practice. Nephrology

2006 Volume 2, Issue 2, Page(s) 68–69

MeSH term(s)	Algorithms ; Humans ; Predictive Value of Tests ; Proteinuria/diagnosis ; Proteinuria/urine ; Reagent Strips ; Reproducibility of Results ; Specific Gravity
Chemical Substances	Reagent Strips
Language	English
Publishing date	2006-02
Publishing country	England
Document type	Journal Article
ZDB-ID	2228557-X
ISSN	1745-8331 ; 1745-8323
ISSN (online)	1745-8331
ISSN	1745-8323
DOI	10.1038/ncpneph0099
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Article ; Online: Pragmatic rules for comparability of biological medicinal products.

van der Plas, R Martijn / Hoefnagel, Marcel H N / Hillege, Hans L / Roes, Kit C B

Biologicals : journal of the International Association of Biological Standardization

2019 Volume 63, Page(s) 97–100

Abstract	Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial.
MeSH term(s)	Biosimilar Pharmaceuticals/standards ; Drug Industry/standards
Chemical Substances	Biosimilar Pharmaceuticals
Language	English
Publishing date	2019-12-11
Publishing country	England
Document type	Journal Article
ZDB-ID	1017370-5
ISSN	1095-8320 ; 1045-1056
ISSN (online)	1095-8320
ISSN	1045-1056
DOI	10.1016/j.biologicals.2019.11.002
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Article ; Online: Urinary Marker Profiles in Heart Failure with Reduced Versus Preserved Ejection Fraction.

Streng, Koen W / Hillege, Hans L / Ter Maaten, Jozine M / van Veldhuisen, Dirk J / Dickstein, Kenneth / Samani, Nilesh J / Ng, Leong L / Metra, Marco / Filippatos, Gerasimos S / Ponikowski, Piotr / Zannad, Faiez / Anker, Stefan D / van der Meer, Peter / Lang, Chim C / Voors, Adriaan A / Damman, Kevin

Journal of cardiovascular translational research

2023 Volume 17, Issue 1, Page(s) 3–12

Abstract: Background: Recent data suggest different causes of renal dysfunction between heart failure with reduced (HFrEF) versus preserved ejection fraction (HFpEF). We therefore studied a wide range of urinary markers reflecting different nephron segments in ... ...

Abstract	Background: Recent data suggest different causes of renal dysfunction between heart failure with reduced (HFrEF) versus preserved ejection fraction (HFpEF). We therefore studied a wide range of urinary markers reflecting different nephron segments in heart failure patients. Methods: In 2070, in chronic heart failure patients, we measured several established and upcoming urinary markers reflecting different nephron segments. Results: Mean age was 70 ± 12 years, 74% was male and 81% (n = 1677) had HFrEF. Mean estimated glomerular filtration rate (eGFR) was lower in patients with HFpEF (56 ± 23 versus 63 ± 23 ml/min/1.73 m Conclusions: HFpEF patients showed more evidence of tubular damage and/or dysfunction compared with HFrEF patients, in particular when glomerular function was preserved.
MeSH term(s)	Humans ; Male ; Middle Aged ; Aged ; Aged, 80 and over ; Heart Failure/diagnosis ; Stroke Volume ; Chronic Disease ; Glomerular Filtration Rate ; Prognosis
Language	English
Publishing date	2023-02-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2422411-X
ISSN	1937-5395 ; 1937-5387
ISSN (online)	1937-5395
ISSN	1937-5387
DOI	10.1007/s12265-023-10356-y
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Article ; Online: Serial Measurements of N-Terminal Pro-B-Type Natriuretic Peptide Serum Level for Monitoring Pulmonary Arterial Hypertension in Children.

Said, Fatema / Haarman, Meindina G / Roofthooft, Marcus T R / Hillege, Hans L / Ploegstra, Mark-Jan / Berger, Rolf M F

The Journal of pediatrics

2020 Volume 220, Page(s) 139–145

Abstract: Objective: To assess the association between serially measured N-terminal pro-B-type natriuretic peptide (NT-proBNP) serum levels and disease severity in children with pulmonary arterial hypertension (PAH), and to assess its predictive value for death ... ...

Abstract	Objective: To assess the association between serially measured N-terminal pro-B-type natriuretic peptide (NT-proBNP) serum levels and disease severity in children with pulmonary arterial hypertension (PAH), and to assess its predictive value for death or (heart-)lung transplantation. Study design: This was a longitudinal cohort study of the Dutch National Network for Pediatric Pulmonary Hypertension conducted between 2003 and 2017. Data on NT-proBNP and disease severity markers (World Health Organization Functional Class [WHO-FC], 6-minute walking distance [6MWD], and tricuspid annular plane systolic excursion [TAPSE]) were collected every 3 to 6 months from 82 children with PAH. The outcome measure was death or (heart-)lung transplantation. Also, NT-proBNP levels over time were compared between survivors and nonsurvivors. Results: The median patient age was 8.8 years (IQR, 4.6-13.5 years), and 61% were female. The median duration of follow-up was 4.8 years (IQR, 1.9-10.0 years). At all times during the course of disease, higher NT-proBNP levels were associated with higher WHO-FC (β = 0.526; 95% CI, 0.451-0.600), lower 6MWD z-score (β = -0.587; 95% CI, -0.828 to -0.346), lower TAPSE z-score (β = -0.783; 95% CI, -1.016 to -0.549), and elevated risk of death or (heart-)lung transplantation (hazard ratio 16.61; 95% CI, 7.81-35.33). Compared with survivors, nonsurvivors had NT-proBNP levels that were higher at first measurement and increased exponentially over time (P = .005). Changes in NT-proBNP serum level over time were predictive of outcome. Conclusions: Throughout the disease course of pediatric PAH, serial measurements of NT-proBNP are associated with disease severity and transplant-free survival. Monitoring NT-proBNP levels over time provides important prognostic information that can support clinical decision making in combination with other established prognostic markers.
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Cohort Studies ; Female ; Hematologic Tests/methods ; Humans ; Longitudinal Studies ; Male ; Monitoring, Physiologic ; Natriuretic Peptide, Brain/blood ; Peptide Fragments/blood ; Predictive Value of Tests ; Pulmonary Arterial Hypertension/blood ; Severity of Illness Index
Chemical Substances	Peptide Fragments ; pro-brain natriuretic peptide (1-76) ; Natriuretic Peptide, Brain (114471-18-0)
Language	English
Publishing date	2020-02-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3102-1
ISSN	1097-6833 ; 0022-3476
ISSN (online)	1097-6833
ISSN	0022-3476
DOI	10.1016/j.jpeds.2020.01.001
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