Publications by authors named "Jonker C"

Aim of the study To assess the incidence and types of complications and patient-reported outcomes in pediatric patients with therapy-resistant constipation or fecal incontinence (FI) without constipation who underwent Chait TrapdoorTM cecostomy (CTC). The findings contribute to the discussion on selecting the optimal antegrade continence (ACE) procedure for this population. Materials and Methods A retrospective review was conducted on all pediatric patients with therapy-resistant constipation or FI without constipation who underwent a CTC procedure at our tertiary referral center between 2009 and 2023.

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Article Synopsis
  • - There’s a rising trend in drug development to incorporate real-world evidence (RWE) during the pre-marketing phase, influenced by initiatives like DARWIN EU® and regulator-initiated observational studies.
  • - An expert meeting held by the Regulatory Science Network Netherlands in 2022 addressed key aspects of these studies, including transparency, independence, and engagement with stakeholders.
  • - The authors stress the significance of reproducibility and collaborative efforts among stakeholders to effectively implement regulator-initiated studies for a better European RWE framework in regulatory decisions.
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Background: Despite optimal conservative and medical treatment, some children with functional constipation (FC) continue to experience symptoms. Antegrade continence enema (ACE) surgery has been suggested as the primary surgical option after less invasive pharmacological and non-pharmacological interventions have not been effective. The purpose of this systematic review was to assess the outcomes of ACE for children with FC.

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Purpose: The aim of this study was to investigate the accessory root canal morphology of maxillary first molars in a Black South African subpopulation.

Methods: Micro-computed tomography was used to investigate 101 maxillary first molars (from 50 male and 51 female teeth, right 53 teeth, left 48 teeth). The prevalence of chamber canals, and the number, type and location (root third) of accessory canals were recorded.

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Article Synopsis
  • Progress in genetic diagnosis and orphan drug legislation has led to new therapies for rare neurogenetic diseases (RNDs), but challenges remain in academia, regulation, and finances.
  • The study aims to create a practical framework for developing patient registries that address these challenges and enhance outcomes in care, research, and drug development for RNDs.
  • A comprehensive approach combining literature review, interviews with existing registries, and feedback from various stakeholders was used to ensure the framework meets diverse needs and emphasizes key principles like accessible, independent, and trustworthy data governance.
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Transition services-programs that support adolescents and young adults (AYAs) as they move from a child-centered to a more autonomous, adult-orientated healthcare system-have been associated with improved short- and long-term healthcare outcomes. Unfortunately, there is a paucity of evidence exploring transition services within the neurogastroenterology and motility (NGM) field. The overall aim of this article, endorsed by the American Neurogastroenterology and Motility Society and European Society of Neurogastroenterology and Motility, is to promote a discussion about the role of transition services for patients with NGM disorders.

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Purpose: This study was conducted to investigate the root canal anatomy of maxillary first molars in Black South Africans.

Methods: Micro-computed tomography was used to investigate 101 maxillary first molars (53 teeth from the right, 48 from the left; 50 male and 51 female teeth). The number of root canals in each tooth was determined, and the relationship between side, sex and age was analyzed using chi-squared test.

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Many technological systems these days interact with their environment with increasingly little human intervention. This situation comes with higher stakes and consequences that society needs to manage. No longer are we dealing with 404 pages: AI systems today may cause serious harm.

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Background: The distinction between where the pulp chamber ends and the root canal system begins is poorly defined within the existing literature.

Methods: This paper aimed to describe a range of accurate methods to define the transition from pulp chamber to root canal in different first molar root morphologies using micro-focus computed tomography (micro-CT).

Methods: The sample consisted of 86 mandibular and 101 maxillary first molars from the skeletal collections housed in the Department of Anatomy and Histology of the Sefako Makgatho Health Sciences University and the Pretoria Bone Collection.

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In situ cryo-electron tomography (cryo-ET) is the most current, state-of-the-art technique to study cell machinery in its hydrated near-native state. The method provides ultrastructural details at sub-nanometer resolution for many components within the cellular context. Making use of recent advances in sample preparation techniques and combining this method with correlative light and electron microscopy (CLEM) approaches have enabled targeted molecular visualization.

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Collaboration in teams composed of both humans and automation has an interdependent nature, which demands calibrated trust among all the team members. For building suitable autonomous teammates, we need to study how trust and trustworthiness function in such teams. In particular, automation occasionally fails to do its job, which leads to a decrease in a human's trust.

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Behavioral changes are commonly observed in patients with dementia and can lead to criminal offenses, even without a history of criminal or antisocial behavior. Due to the growth of the aging population, this poses a rising problem to deal with for the criminal justice system and in general for society. Criminal behavior may include minor crimes such as theft or traffic violations, but also serious crimes such as physical abuse, sexual offense, or murder.

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Background: The chest X-ray (CXR) remains a widely used examination in the evaluation of patients with fever, to diagnose or rule out pneumonia. Recently, a study by our group suggested that it has no diagnostic value in patients with fever without respiratory signs and/or symptoms.

Objective: The objective of this study is to validate the results of our previous study.

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Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). Real world data has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines.

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Cryogenic electron tomography (cryo-ET) combined with subtomogram averaging, allows in situ visualization and structure determination of macromolecular complexes at subnanometre resolution. Cryogenic focused ion beam (cryo-FIB) micromachining is used to prepare a thin lamella-shaped sample out of a frozen-hydrated cell for cryo-ET imaging, but standard cryo-FIB fabrication is blind to the precise location of the structure or proteins of interest. Fluorescence-guided focused ion beam (FIB) milling at target locations requires multiple sample transfers prone to contamination, and relocation and registration accuracy is often insufficient for 3D targeting.

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Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE to demonstrate efficacy requires further evaluation. This study aimed to (i) characterize RWD/RWE presented by applicants to support claims on medicines' efficacy within initial marketing authorization applications (MAAs) and extension of indication applications (EoIs), and (ii) analyze the contribution of RWD/RWE to regulatory decisions on medicines' benefit-risk profile.

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People seem to hold the human driver to be primarily responsible when their partially automated vehicle crashes, yet is this reasonable? While the driver is often required to immediately take over from the automation when it fails, placing such high expectations on the driver to remain vigilant in partially automated driving is unreasonable. Drivers show difficulties in taking over control when needed immediately, potentially resulting in dangerous situations. From a normative perspective, it would be reasonable to consider the impact of automation on the driver's ability to take over control when attributing responsibility for a crash.

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Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment, study design and little knowledge on the natural history of the disease, the overall clinical evidence submitted at the time of marketing authorisation application for these medicines is often limited. Patient registries have been recognised as important sources of data on healthcare practices, drug utilisation and clinical outcomes.

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Sequential decision making, commonly formalized as optimization of a Markov Decision Process, is a key challenge in artificial intelligence. Two successful approaches to MDP optimization are and , which both largely have their own research communities. However, if both research fields solve the same problem, then we might be able to disentangle the common factors in their solution approaches.

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Introduction: As patient registries are not subject to regulatory requirements on the collection of adverse events (AEs) related to medicinal products, they may not have foreseen the collection of such information on a routine basis or as part of specific data collection schemes.

Objective: The European Medicines Agency conducted a survey among registries to better understand their approach towards the collection, management and reporting of AEs related to medicines.

Method: An online survey composed of 15 questions was distributed in May 2020 to registries listed in the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) resources database for completion by August 2020.

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Unlabelled: The pursuit of values drives human behavior and promotes cooperation. Existing research is focused on general values (e.g.

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Introduction: Only 6.4-17% of the load is transmitted through the fibula when weight-bearing. Plate fixation of distal fibular fractures using minifragments (≤ 2.

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Introduction: In rare diseases, registry-based studies can be used to provide natural history data pre-approval and complement drug efficacy and/or safety knowledge post-approval.

Objective: The objective of this study was to investigate the opinion of stakeholders about key aspects of rare disease registries that are used to support regulatory decision making and to compare the responses of employees from industry to other stakeholders.

Methods: A web-based survey was used to gauge the importance of (1) common data elements (including safety outcomes), (2) data quality and (3) governance aspects that are generic across different rare diseases.

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