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Article ; Online: Potential impact of unblinding on observed treatment effects in Alzheimer's disease trials.

Wolters, Frank J / Labrecque, Jeremy A

Alzheimer's & dementia : the journal of the Alzheimer's Association

2024 Volume 20, Issue 4, Page(s) 3119–3125

Abstract: Introduction: Adverse effects of monoclonal antibodies against amyloid beta are common, and may affect validity of randomized controlled trials (RCTs) through unblinding of participants.: Methods: We used observations from published phase 3 RCTs in ... ...

Abstract	Introduction: Adverse effects of monoclonal antibodies against amyloid beta are common, and may affect validity of randomized controlled trials (RCTs) through unblinding of participants. Methods: We used observations from published phase 3 RCTs in Alzheimer's disease to calculate the magnitude of unblinding effects on cognition that would be required to explain observed cognitive benefits in RCTs. Results: In trials of lecanemab, aducanumab, and donanemab, incidence of amyloid-related imaging abnormalities with active treatment ranged from 22% to 44%, the vast majority of which presumably led to unblinding. Effects of unblinding on the Clinical Dementia Rating Sum of Boxes required to fully explain observed drug effects ranged from 1.1 point (95% confidence interval: 0.2-2.0) with aducanumab, to 3.3 points (2.1-4.4) with donanemab and 3.7 points (2.0-5.6) with lecanemab. Infusion-related reactions were common, with potential unblinding effects particularly for lecanemab. Similar patterns were observed for the Alzheimer's Disease Assessment Scale Cognitive subscale. Discussion: Psychological treatment effects due to unblinding may explain a substantial share of observed treatment effects in RCTs.
MeSH term(s)	Humans ; Alzheimer Disease/drug therapy ; Amyloid beta-Peptides ; Amyloidogenic Proteins ; Cognition ; Drug-Related Side Effects and Adverse Reactions ; Antibodies, Monoclonal, Humanized
Chemical Substances	donanemab ; Amyloid beta-Peptides ; Amyloidogenic Proteins ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2024-02-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2211627-8
ISSN	1552-5279 ; 1552-5260
ISSN (online)	1552-5279
ISSN	1552-5260
DOI	10.1002/alz.13690
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Article ; Online: Academische carrièreperspectieven van gepromoveerde dokters.

Wolters, Frank J

Nederlands tijdschrift voor geneeskunde

2020 Volume 164

Abstract: Objective: To determine secular trends in the number of doctoral degrees among medical doctors in the Netherlands, and assess their future career perspectives.: Design: Retrospective cohort study.: Method: Data on awarded doctoral degrees in the ... ...

Title translation	Time trends in doctorates and academic career perspectives among Dutch medical doctors: a nationwide cohort study.
Abstract	Objective: To determine secular trends in the number of doctoral degrees among medical doctors in the Netherlands, and assess their future career perspectives. Design: Retrospective cohort study. Method: Data on awarded doctoral degrees in the period 1992-2018 were acquired from all medical faculties in the Netherlands. For the 2008 cohort of graduates, I assessed 10-year career perspectives by determining their job affiliation and number of scientific publications in PubMed as of 2019. Results: The average number of doctorate degrees awarded per medical faculty increased from 64 in 1992 to 198 in 2018, largely due to an increase in the number of female graduates, who comprised 60-65% of graduates in recent years. Nearly half of all PhD graduates were medical doctors. Of 368 medical doctors in the year 2008, 43% had an academic affiliation 10 years after graduation, similar for men and women (odds ratio [95% CI] for women: 1.40 [0.92-2.14]). During the intermediate 10 years, they published a median 7 scientific papers (interquartile range: 2-20), of which 1 (0-3) were written as lead author and 0 (0-2) as senior author. Men published more often than women (9 [3-27] vs. 6 [2-15] papers, P=0.03), in particular when situated in an academic work environment (23 [11-47] vs. 12 [5-25], P=0.005). Conclusion: The number of doctoral degrees awarded at medical faculties in the Netherlands has increased threefold over the past 30 years. While 10-year career perspectives after their viva were similar across gender, scientific output of men during this period exceeded that of women.
MeSH term(s)	Adult ; Career Mobility ; Education, Medical, Graduate ; Faculty, Medical/trends ; Female ; Humans ; Male ; Middle Aged ; Netherlands ; Physicians/trends ; Physicians, Women/trends ; Publishing/trends ; Retrospective Studies
Language	Dutch
Publishing date	2020-10-05
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	82073-8
ISSN	1876-8784 ; 0028-2162
ISSN (online)	1876-8784
ISSN	0028-2162
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Article ; Online: An AI-ECG algorithm for atrial fibrillation risk: steps towards clinical implementation.

Wolters, Frank J

Lancet (London, England)

2020 Volume 396, Issue 10246, Page(s) 235–236

MeSH term(s)	Algorithms ; Artificial Intelligence ; Atrial Fibrillation ; Electrocardiography ; Humans ; Retrospective Studies
Language	English
Publishing date	2020-05-27
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(20)31062-X
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Article ; Online: Improving Clinical Applicability of Mortality Prediction Models Among Persons With Dementia.

Mooldijk, Sanne S / Licher, Silvan / Wolters, Frank J

JAMA internal medicine

2023 Volume 183, Issue 5, Page(s) 498

MeSH term(s)	Humans ; Dementia/mortality
Language	English
Publishing date	2023-03-27
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2699338-7
ISSN	2168-6114 ; 2168-6106
ISSN (online)	2168-6114
ISSN	2168-6106
DOI	10.1001/jamainternmed.2023.0173
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Article ; Online: Letter by Wolters Regarding Article, "Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial)".

Wolters, Frank J

Stroke

2018 Volume 49, Issue 4, Page(s) e165

MeSH term(s)	Humans ; Sample Size ; Stroke
Language	English
Publishing date	2018-02-22
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	80381-9
ISSN	1524-4628 ; 0039-2499 ; 0749-7954
ISSN (online)	1524-4628
ISSN	0039-2499 ; 0749-7954
DOI	10.1161/STROKEAHA.117.020360
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Article ; Online: The US Preventive Services Task Force Recommendation Statement About Screening Asymptomatic Adults for Carotid Stenosis.

Wolters, Frank J / Volovici, Victor

JAMA

2021 Volume 326, Issue 1, Page(s) 88

Language	English
Publishing date	2021-03-30
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2021.6495
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Article ; Online: Populatie-attributieve fractie.

Yaqub, Amber / Ikram, Mohammad / Wolters, Frank J

Nederlands tijdschrift voor geneeskunde

2022 Volume 166

Abstract: The improvement of public health relies on effective strategies for disease prevention, but the optimal preventive strategy is often difficult to determine. The population attributable fraction is a tool that allows policy makers to prioritise among ... ...

Title translation	Population attributable fraction: a guideline for disease prevention.
Abstract	The improvement of public health relies on effective strategies for disease prevention, but the optimal preventive strategy is often difficult to determine. The population attributable fraction is a tool that allows policy makers to prioritise among different interventions by quantifying the share of disease in the population that is due to one specific risk factor. In this article, we discuss the computation of the population attributable fraction, as well as its advantages, limitations, and challenges for proper interpretation. We further compare the population attributable fraction to the etiologic fraction, which concerns the impact of a risk factor of disease at the individual level. We illustrate the importance of either measure, as well as differences between them, on the basis of scenarios in which community medicine and patient-centred care might not always be in agreement.
MeSH term(s)	Causality ; Humans ; Risk Factors
Language	Dutch
Publishing date	2022-06-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	82073-8
ISSN	1876-8784 ; 0028-2162
ISSN (online)	1876-8784
ISSN	0028-2162
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Article ; Online: Characterizing Demographic, Racial, and Geographic Diversity in Dementia Research: A Systematic Review.

Mooldijk, Sanne S / Licher, Silvan / Wolters, Frank J

JAMA neurology

2021 Volume 78, Issue 10, Page(s) 1255–1261

Abstract: Importance: For informed decision making on diagnosis and treatment of dementia, physicians and their patients rely on the generalizability of evidence from published studies to clinical practice. However, it is uncertain whether everyday care of ... ...

Abstract	Importance: For informed decision making on diagnosis and treatment of dementia, physicians and their patients rely on the generalizability of evidence from published studies to clinical practice. However, it is uncertain whether everyday care of elderly patients with dementia is sufficiently captured in contemporary research. Objective: To systematically review contemporary dementia research in terms of study and patient characteristics in order to assess generalizability of research findings. Evidence review: PubMed was searched for dementia studies published in the top 100 journals in the fields of neurology and neuroscience, geriatrics, psychiatry, and general medicine between September 1, 2018, and August 31, 2019. Two reviewers extracted study characteristics, including setting, number of participants, age at diagnosis, and use of biomarkers. Findings: Among 513 identified studies, 211 (41%) included fewer than 50 individuals with dementia and were excluded. The remaining 302 studies included a median (interquartile range) of 214 patients (98-628) with a mean (SD) age at diagnosis of 74.1 years (8.0). Age at diagnosis differed with study setting. Patients in the 180 clinic-based studies had a mean (SD) age of 71.8 (6.4) years at time of diagnosis compared with 80.6 (4.7) years among patients in the 79 population-based studies (mean difference, 8.8 years; 95% CI, 7.3-10.2). Use of magnetic resonance imaging, positron emission tomography imaging, and cerebrospinal fluid imaging was mostly done in clinic-based studies (80% to 96%) and consequently in relatively young patients (mean [SD] age, 71.6 [5.1] years). A longitudinal design was more common in population-based studies than in clinic-based studies (82 % vs 40%). Most studies originated from North America and Europe (89%), including almost exclusively White participants (among 74 studies [22%] reporting on ethnicity: median [interquartile range], 89% [78-97]). The 3 most studied cohorts represented 21% of all included study populations. Conclusions and relevance: Contemporary dementia research is limited in terms of racial and geographic diversity and draws largely from clinic-based populations with relatively young patients. Greater inclusivity and deeper phenotyping in unselected cohorts could improve generalizability as well as diagnosis and development of effective treatments for all patients with dementia.
MeSH term(s)	Cultural Diversity ; Dementia ; Demography ; Humans ; Racial Groups ; Research
Language	English
Publishing date	2021-09-06
Publishing country	United States
Document type	Journal Article ; Systematic Review
ZDB-ID	2702023-X
ISSN	2168-6157 ; 2168-6149
ISSN (online)	2168-6157
ISSN	2168-6149
DOI	10.1001/jamaneurol.2021.2943
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Article ; Online: Antidepressant use in relation to dementia risk, cognitive decline, and brain atrophy.

Vom Hofe, Ilse / Stricker, Bruno H / Vernooij, Meike W / Ikram, M Kamran / Ikram, M Arfan / Wolters, Frank J

Alzheimer's & dementia : the journal of the Alzheimer's Association

2024

Abstract: Introduction: We aimed to assess the effect of antidepressant use on dementia risk, cognitive decline, and brain atrophy.: Methods: In this prospective cohort study, we included 5511 dementia-free participants (Mini-Mental State Examination [MMSE] > ... ...

Abstract	Introduction: We aimed to assess the effect of antidepressant use on dementia risk, cognitive decline, and brain atrophy. Methods: In this prospective cohort study, we included 5511 dementia-free participants (Mini-Mental State Examination [MMSE] > 25) of the Rotterdam study (57.5% women, mean age 70.6 years). Antidepressant use was extracted from pharmacy records from 1991 until baseline (2002-2008). Incident dementia was monitored from baseline until 2018, with repeated cognitive assessment and magnetic resonance imaging (MRI) every 4 years. Results: Compared to never use, any antidepressant use was not associated with dementia risk (hazard ratio [HR] 1.14, 95% confidence interval [CI] 0.92-1.41), or with accelerated cognitive decline or atrophy of white and gray matter. Compared to never use, dementia risk was somewhat higher with tricyclic antidepressants (HR 1.36, 95% CI 1.01-1.83) than with selective serotonin reuptake inhibitors (HR 1.12, 95% CI 0.81-1.54), but without dose-response relationships, accelerated cognitive decline, or atrophy in either group. Discussion: Antidepressant medication in adults without indication of cognitive impairment was not consistently associated with long-term adverse cognitive effects. Highlights: Antidepressant medications are frequently prescribed, especially among older adults. In this study, antidepressant use was not associated with long-term dementia risk. Antidepressant use was not associated with cognitive decline or brain atrophy. Our results support safe prescription in an older, cognitively healthy population.
Language	English
Publishing date	2024-04-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2211627-8
ISSN	1552-5279 ; 1552-5260
ISSN (online)	1552-5279
ISSN	1552-5260
DOI	10.1002/alz.13807
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Article ; Online: Epidemiology of Vascular Dementia.

Wolters, Frank J / Ikram, M Arfan

Arteriosclerosis, thrombosis, and vascular biology

2019 Volume 39, Issue 8, Page(s) 1542–1549

Abstract: The notion of what qualifies as vascular dementia has varied greatly since the first mention of dementia after apoplexy in ancient literature. Current insight points towards a multifactorial cause of cognitive decline at old age, in which vascular ... ...

Abstract	The notion of what qualifies as vascular dementia has varied greatly since the first mention of dementia after apoplexy in ancient literature. Current insight points towards a multifactorial cause of cognitive decline at old age, in which vascular components like atherosclerosis, arterio(lo)sclerosis, (micro)infarcts, and amyloid angiopathy play an important role alongside other markers of neurodegeneration. Cerebrovascular disease will be present in most individuals with dementia, but-just like other causes-rarely a cause on its own. The consequent limitations of nosology may be alleviated by addition of a vascular component to the recently introduced amyloid/tau/neurodegeneration etiological classification system for dementia. Meanwhile, risk of dementia is increased about 2-fold after stroke, and the prevention of (recurrent) stroke remains a cornerstone in the prevention of vascular dementia. Similarly, control of cardiovascular risk factors from middle age onwards is likely to have contributed to the reported decline in the age-specific incidence of dementia over the past decades. In conjunction with experimental studies, large-scale observational evidence from imaging, genomics, metabolomics, and alike will continue to improve our understanding of the underlying pathophysiological processes. To prevent ecological fallacies, such etiological studies in patients with dementia are best served by inclusion of subjects regardless of the presumed (single) cause of their disease.
MeSH term(s)	Cerebrovascular Disorders/complications ; Dementia, Vascular/epidemiology ; Dementia, Vascular/etiology ; Humans ; Risk Factors ; Stroke/complications
Language	English
Publishing date	2019-07-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1221433-4
ISSN	1524-4636 ; 1079-5642
ISSN (online)	1524-4636
ISSN	1079-5642
DOI	10.1161/ATVBAHA.119.311908
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