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Article ; Online: Evaluating a shrinkage estimator for the treatment effect in clinical trials.

van Zwet, Erik W / Tian, Lu / Tibshirani, Robert

2023 Volume 43, Issue 5, Page(s) 855–868

Abstract: The main objective of most clinical trials is to estimate the effect of some treatment compared to a control condition. We define the signal-to-noise ratio (SNR) as the ratio of the true treatment effect to the SE of its estimate. In a previous ... ...

Abstract	The main objective of most clinical trials is to estimate the effect of some treatment compared to a control condition. We define the signal-to-noise ratio (SNR) as the ratio of the true treatment effect to the SE of its estimate. In a previous publication in this journal, we estimated the distribution of the SNR among the clinical trials in the Cochrane Database of Systematic Reviews (CDSR). We found that the SNR is often low, which implies that the power against the true effect is also low in many trials. Here we use the fact that the CDSR is a collection of meta-analyses to quantitatively assess the consequences. Among trials that have reached statistical significance we find considerable overoptimism of the usual unbiased estimator and under-coverage of the associated confidence interval. Previously, we have proposed a novel shrinkage estimator to address this "winner's curse." We compare the performance of our shrinkage estimator to the usual unbiased estimator in terms of the root mean squared error, the coverage and the bias of the magnitude. We find superior performance of the shrinkage estimator both conditionally and unconditionally on statistical significance.
MeSH term(s)	Humans ; Bias ; Clinical Trials as Topic ; Systematic Reviews as Topic ; Meta-Analysis as Topic
Language	English
Publishing date	2023-12-19
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.9992
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Article ; Online: How large should the next study be? Predictive power and sample size requirements for replication studies.

van Zwet, Erik W / Goodman, Steven N

Statistics in medicine

2022 Volume 41, Issue 16, Page(s) 3090–3101

Abstract: We use information derived from over 40K trials in the Cochrane Collaboration database of systematic reviews (CDSR) to compute the replication probability, or predictive power of an experiment given its observed (two-sided) ...

Abstract	We use information derived from over 40K trials in the Cochrane Collaboration database of systematic reviews (CDSR) to compute the replication probability, or predictive power of an experiment given its observed (two-sided)
MeSH term(s)	Humans ; Probability ; Research Design ; Sample Size ; Statistics as Topic ; Systematic Reviews as Topic
Language	English
Publishing date	2022-04-08
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.9406
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Article ; Online: Is hospital volume related to quality of hip fracture care? Analysis of 43,538 patients and 68 hospitals from the Dutch Hip Fracture Audit.

Würdemann, Franka S / van Zwet, Erik W / Krijnen, Pieta / Hegeman, Johannes H / Schipper, Inger B

European journal of trauma and emergency surgery : official publication of the European Trauma Society

2023 Volume 49, Issue 3, Page(s) 1525–1534

Abstract: Purpose: Evidence for a hospital volume-outcome relationship in hip fracture surgery is inconclusive. This study aimed to analyze the association between hospital volume as a continuous parameter and several processes and outcomes of hip fracture care.!# ...

Abstract	Purpose: Evidence for a hospital volume-outcome relationship in hip fracture surgery is inconclusive. This study aimed to analyze the association between hospital volume as a continuous parameter and several processes and outcomes of hip fracture care. Methods: Adult patients registered in the nationwide Dutch Hip Fracture Audit (DHFA) between 2018 and 2020 were included. The association between annual hospital volume and turnaround times (time on the emergency ward, surgery < 48 h and length of stay), orthogeriatric co-treatment and case-mix adjusted in-hospital and 30 days mortality was evaluated with generalized linear mixed models with random effects for hospital and treatment year. We used a fifth-degree polynomial to allow for nonlinear effects of hospital volume. P-values were adjusted for multiple comparisons using the Bonferoni method. Results: In total, 43,258 patients from 68 hospitals were included. The median annual hospital volume was 202 patients [range 1-546]. Baseline characteristics did not differ with hospital volume. Provision of orthogeriatric co-treatment improved with higher volumes but decreased at > 367 patients per year (p < 0.01). Hospital volume was not significantly associated with mortality outcomes. No evident clinical relation between hospital volume and turnaround times was found. Conclusion: This is the first study analyzing the effect of hospital volume on hip fracture care, treating volume as a continuous parameter. Mortality and turnaround times showed no clinically relevant association with hospital volume. The provision of orthogeriatric co-treatment, however, increased with increasing volumes up to 367 patients per year, but decreased above this threshold. Future research on the effect of volume on complications and functional outcomes is indicated.
MeSH term(s)	Humans ; Hip Fractures/surgery ; Hospitals ; Length of Stay
Language	English
Publishing date	2023-01-21
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2275480-5
ISSN	1863-9941 ; 1863-9933
ISSN (online)	1863-9941
ISSN	1863-9933
DOI	10.1007/s00068-022-02205-5
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Zs.A 1221: 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: Prevalence and burden of pain across the entire spectrum of Huntington's disease.

Sprenger, Gregory P / van Zwet, Erik W / Bakels, Hannah S / Achterberg, Wilco P / Roos, Raymund A / de Bot, Susanne T

Journal of neurology, neurosurgery, and psychiatry

2024

Abstract: Background: Pain is an important symptom in Huntington's disease (HD), however, not systematically studied and understood. The objective of the current study is to assess the prevalence of pain, pain interference in daily activities, painful conditions, ...

Abstract	Background: Pain is an important symptom in Huntington's disease (HD), however, not systematically studied and understood. The objective of the current study is to assess the prevalence of pain, pain interference in daily activities, painful conditions, analgesic use and the severity of the pain burden across different disease stages and 'Age at symptom Onset' groups. Additionally, the association between pain and disease burden was investigated. Methods: A cross-sectional analysis was conducted within two large data sets, which included different types of pain scales. Multivariable logistic regression analyses and analyses of variance were performed to compare the pain levels with those in the general population. The analyses were adjusted for sex and age. Locally Estimated Scatterplot Smoothing was used to test the association between pain and the HD pathology score: a measure of disease burden. Results: The mean prevalence of pain in the HD population was 40% and for pain interference around 35% in both data sets. Patients in the early, middle and late stage of HD experience more pain burden compared with what is reported in patients with chronic pain (p<0.01). A positive and significant association was demonstrated between pain and disease burden. Patients in late stage HD with pain use significantly less analgesics compared with the general population (5% vs 13%, respectively (p<0.01)). Conclusions: Pain is a prevalent and important symptom in HD. Severe pain burden in the HD population is present and positively associated with disease burden. Risk for undertreatment with analgesics is nevertheless present. Awareness of pain in HD needs to be increased, both clinically and scientifically.
Language	English
Publishing date	2024-01-30
Publishing country	England
Document type	Journal Article
ZDB-ID	3087-9
ISSN	1468-330X ; 0022-3050
ISSN (online)	1468-330X
ISSN	0022-3050
DOI	10.1136/jnnp-2023-332992
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Article ; Online: Cutaneous allodynia as predictor for treatment response in chronic migraine: a cohort study.

Pijpers, Judith A / Kies, Dennis A / van Zwet, Erik W / de Boer, Irene / Terwindt, Gisela M

The journal of headache and pain

2023 Volume 24, Issue 1, Page(s) 118

Abstract: Background: Central sensitisation is an important mechanism in migraine chronification. It is presumed to occur in second and third order neurons sequentially, resulting in an analogous spatial distribution of cutaneous allodynia with cephalic and ... ...

Abstract	Background: Central sensitisation is an important mechanism in migraine chronification. It is presumed to occur in second and third order neurons sequentially, resulting in an analogous spatial distribution of cutaneous allodynia with cephalic and extracephalic symptoms. We investigated whether allodynia, and its subtypes based on spatial distribution and type of stimulus, predict response to treatment in chronic migraine patients. Methods: This study was conducted as part of the CHARM study (NTR3440), a randomized, double-blind, placebo-controlled trial in chronic migraine patients with medication overuse. We included 173 patients. The presence of cutaneous allodynia at baseline was established with the Allodynia Symptom Checklist. Primary endpoint was reversion from chronic to episodic migraine. Results: Of all patients, 74.6% reported cutaneous allodynia. Absence of allodynia compared to presence of allodynia was predictive for reversion from chronic to episodic migraine, odds ratio (OR): 2.45 (95% CI: 1.03-5.84), p = 0.042. The predictive value was more pronounced when subdivided for spatial distribution, for participants without allodynia versus cephalic (OR: 4.16 (95% CI: 1.21-14.30), p = 0.024) and extracephalic (OR: 7.32 (95% CI: 1.98- 27.11), p = 0.003) allodynia. Mechanical, but not thermal, allodynia, was associated with outcome. Conclusions: Cutaneous allodynia, an important marker for central sensitization, likely has predictive value for treatment response in chronic migraine.
MeSH term(s)	Humans ; Cohort Studies ; Hyperalgesia ; Central Nervous System Sensitization ; Migraine Disorders/complications ; Migraine Disorders/drug therapy ; Neurons
Language	English
Publishing date	2023-08-30
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2036768-5
ISSN	1129-2377 ; 1129-2369
ISSN (online)	1129-2377
ISSN	1129-2369
DOI	10.1186/s10194-023-01651-9
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Zs.A 5464: Show issues

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Article ; Online: Doublecortin-Like Is Implicated in Adult Hippocampal Neurogenesis and in Motivational Aspects to Escape from an Aversive Environment in Male Mice.

Saaltink, Dirk-Jan / van Zwet, Erik W / Vreugdenhil, Erno

eNeuro

2020 Volume 7, Issue 5

Abstract: Doublecortin (DCX)-like (DCL) is a microtubule (MT)-associated protein (MAP) that is highly homologous to DCX and is crucially involved in embryonic neurogenesis. Here, we have investigated ... ...

Abstract	Doublecortin (DCX)-like (DCL) is a microtubule (MT)-associated protein (MAP) that is highly homologous to DCX and is crucially involved in embryonic neurogenesis. Here, we have investigated the
MeSH term(s)	Animals ; Cell Proliferation ; Dentate Gyrus ; Doublecortin Domain Proteins ; Doublecortin Protein ; Escape Reaction ; Hippocampus ; Male ; Mice ; Mice, Transgenic ; Microtubule-Associated Proteins ; Motivation ; Neurogenesis ; Neuropeptides
Chemical Substances	Dcx protein, mouse ; Doublecortin Domain Proteins ; Doublecortin Protein ; Microtubule-Associated Proteins ; Neuropeptides
Language	English
Publishing date	2020-10-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2800598-3
ISSN	2373-2822 ; 2373-2822
ISSN (online)	2373-2822
ISSN	2373-2822
DOI	10.1523/ENEURO.0324-19.2020
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Article ; Online: Simultaneous confidence intervals for ranks with application to ranking institutions.

Al Mohamad, Diaa / Goeman, Jelle J / van Zwet, Erik W

Biometrics

2021 Volume 78, Issue 1, Page(s) 238–247

Abstract: When a ranking of institutions such as medical centers or universities is based on a numerical measure of performance provided with a standard error, confidence intervals (CIs) should be calculated to assess the uncertainty of these ranks. We present a ... ...

Abstract	When a ranking of institutions such as medical centers or universities is based on a numerical measure of performance provided with a standard error, confidence intervals (CIs) should be calculated to assess the uncertainty of these ranks. We present a novel method based on Tukey's honest significant difference test to construct simultaneous CIs for the true ranks. When all the true performances are equal, the probability of coverage of our method attains the nominal level. In case the true performance measures have no exact ties, our method is conservative. For this situation, we propose a rescaling method to the nominal level that results in shorter CIs while keeping control of the simultaneous coverage. We also show that a similar rescaling can be applied to correct a recently proposed Monte-Carlo based method, which is anticonservative. After rescaling, the two methods perform very similarly. However, the rescaling of the Monte-Carlo based method is computationally much more demanding and becomes infeasible when the number of institutions is larger than 30-50. We discuss another recently proposed method similar to ours based on simultaneous CIs for the true performance. We show that our method provides uniformly shorter CIs for the same confidence level. We illustrate the superiority of our new methods with a data analysis for travel time to work in the United States and on rankings of 64 hospitals in the Netherlands.
MeSH term(s)	Confidence Intervals ; Hospitals ; Monte Carlo Method ; Probability ; Research Design ; United States
Language	English
Publishing date	2021-01-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	213543-7
ISSN	1541-0420 ; 0099-4987 ; 0006-341X
ISSN (online)	1541-0420
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13419
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Article ; Online: Behavioural intervention in medication overuse headache: A concealed double-blind randomized controlled trial.

Pijpers, Judith A / Kies, Dennis A / van Zwet, Erik W / Rosendaal, Frits R / Terwindt, Gisela M

European journal of neurology

2022 Volume 29, Issue 5, Page(s) 1496–1504

Abstract: Background and purpose: Medication overuse headache is a prevalent disorder, with a strong biobehavioural component. Hence, behavioural interventions might effectuate reduction of the overused medication. We assessed in a double-blind manner the ... ...

Abstract	Background and purpose: Medication overuse headache is a prevalent disorder, with a strong biobehavioural component. Hence, behavioural interventions might effectuate reduction of the overused medication. We assessed in a double-blind manner the efficacy of a behavioural intervention during medication withdrawal therapy. Methods: In this concealed, double-blind, randomized controlled trial in medication overuse headache, conducted at the Leiden University Medical Centre, we compared the effect of maximal versus minimal behavioural intervention by a headache nurse during withdrawal therapy. Maximal intervention consisted of an intensive contact schedule, comprising education, motivational interviewing, and value-based activity planning during 12 weeks of withdrawal therapy. Minimal intervention consisted of a short contact only. Patients were unaware of the existence of these treatment arms, as the trial was concealed in another trial investigating botulinum toxin A. Endpoints were successful withdrawal and monthly days of acute medication use after the withdrawal period. Results: We enrolled 179 patients (90 maximal, 89 minimal intervention). At Week 12, most patients achieved withdrawal in both groups (82/90 [93%] maximal intervention vs. 75/89 [86%] minimal intervention, odds ratio = 2.44, 95% confidence interval [CI] = 0.83-7.23, p = 0.107). At Week 24, patients in the maximal intervention group had fewer medication days (mean difference = -2.23, 95% CI = -3.76 to -0.70, p = 0.005). This difference receded over time. Change in monthly migraine days did not differ between groups (-6.75 vs. -6.22). Conclusions: This trial suggests modest benefit of behavioural intervention by a headache nurse during withdrawal therapy for medication overuse headache, to reduce acute medication use during and shortly after intervention, but extension seems warranted for a prolonged effect.
MeSH term(s)	Botulinum Toxins, Type A/therapeutic use ; Double-Blind Method ; Headache ; Headache Disorders, Secondary/drug therapy ; Humans ; Migraine Disorders/drug therapy
Chemical Substances	Botulinum Toxins, Type A (EC 3.4.24.69)
Language	English
Publishing date	2022-02-10
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1280785-0
ISSN	1468-1331 ; 1351-5101 ; 1471-0552
ISSN (online)	1468-1331
ISSN	1351-5101 ; 1471-0552
DOI	10.1111/ene.15256
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Zs.A 4738: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: The inactive X chromosome accumulates widespread epigenetic variability with age.

Liu, Yunfeng / Sinke, Lucy / Jonkman, Thomas H / Slieker, Roderick C / van Zwet, Erik W / Daxinger, Lucia / Heijmans, Bastiaan T

Clinical epigenetics

2023 Volume 15, Issue 1, Page(s) 135

Abstract: Background: Loss of epigenetic control is a hallmark of aging. Among the most prominent roles of epigenetic mechanisms is the inactivation of one of two copies of the X chromosome in females through DNA methylation. Hence, age-related disruption of X- ... ...

Abstract	Background: Loss of epigenetic control is a hallmark of aging. Among the most prominent roles of epigenetic mechanisms is the inactivation of one of two copies of the X chromosome in females through DNA methylation. Hence, age-related disruption of X-chromosome inactivation (XCI) may contribute to the aging process in women. Methods: We analyzed 9,777 CpGs on the X chromosome in whole blood samples from 2343 females and 1688 males (Illumina 450k methylation array) and replicated findings in duplicate using one whole blood and one purified monocyte data set (in total, 991/924 females/males). We used double generalized linear models to detect age-related differentially methylated CpGs (aDMCs), whose mean methylation level differs with age, and age-related variably methylated CpGs (aVMCs), whose methylation level becomes more variable with age. Results: In females, aDMCs were relatively uncommon (n = 33) and preferentially occurred in regions known to escape XCI. In contrast, many CpGs (n = 987) were found to display an increased variance with age (aVMCs). Of note, the replication rate of aVMCs was also high in purified monocytes (94%), indicating an independence of cell composition. aVMCs accumulated in CpG islands and regions subject to XCI suggesting that they stemmed from the inactive X. In males, carrying an active copy of the X chromosome only, aDMCs (n = 316) were primarily driven by cell composition, while aVMCs replicated well (95%) but were infrequent (n = 37). Conclusions: Our results imply that age-related DNA methylation differences at the inactive X chromosome are dominated by the accumulation of variability.
MeSH term(s)	Male ; Female ; Humans ; DNA Methylation ; X Chromosome ; X Chromosome Inactivation ; Aging/genetics ; Epigenesis, Genetic
Language	English
Publishing date	2023-08-25
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2553921-8
ISSN	1868-7083 ; 1868-7075
ISSN (online)	1868-7083
ISSN	1868-7075
DOI	10.1186/s13148-023-01549-y
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Article ; Online: Intra- and interindividual attack frequency variability of chronic cluster headache.

Brandt, Roemer B / Mulleners, Wim / Wilbrink, Leopoldine A / Brandt, Paul / van Zwet, Erik W / Huygen, Frank Jpm / Ferrari, Michel D / Fronczek, Rolf

Cephalalgia : an international journal of headache

2023 Volume 43, Issue 2, Page(s) 3331024221139239

Abstract: Background: The lack of knowledge about the intra- and interindividual attack frequency variability in chronic cluster headache complicates power and sample size calculations for baseline periods of trials, and consensus on their most optimal duration.!# ...

Abstract	Background: The lack of knowledge about the intra- and interindividual attack frequency variability in chronic cluster headache complicates power and sample size calculations for baseline periods of trials, and consensus on their most optimal duration. Methods: We analyzed the 12-week baseline of the ICON trial (occipital nerve stimulation in medically intractable chronic cluster headache) for: (i) weekly vs. instantaneous recording of attack frequency; (ii) intra-individual and seasonal variability of attack frequency; and (iii) the smallest number of weeks to obtain a reliable estimate of baseline attack frequency. Results: Weekly median (14.4 [8.2-24.0]) and instantaneous (14.2 [8.0-24.5]) attack frequency recordings were similar (p = 0.20; Bland-Altman plot). Median weekly attack frequency was 15.3 (range 4.2-140) and highest during spring (p = 0.001) compared to the other seasons. Relative attack frequency variability decreased with increasing attack frequency (p = 0.010). We tabulated the weekly attack frequency estimation accuracies compared to, and the associated deviations from, the 12-week gold standard for different lengths of the observation period. Conclusion: Weekly retrospective attack frequency recording is as good as instantaneous recording and more convenient. Attack frequency is highest in spring. Participants with ≥3 daily attacks show less attack frequency variability than those with <3 daily attacks. An optimal balance between 90% accuracy and feasibility is achieved at a baseline period of seven weeks.The ICON trial is registered in ClinicalTrials.gov under number NCT01151631.
MeSH term(s)	Humans ; Cluster Headache/diagnosis ; Cluster Headache/therapy ; Retrospective Studies ; Treatment Outcome
Language	English
Publishing date	2023-02-04
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	604567-4
ISSN	1468-2982 ; 0333-1024
ISSN (online)	1468-2982
ISSN	0333-1024
DOI	10.1177/03331024221139239
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