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Background: Physical activity surveillance systems are important for public health monitoring but rely mostly on self-report measurement of physical activity. Integration of device-based measurements in such systems can improve population estimates, however this is still relatively uncommon in existing surveillance systems. This systematic review aims to create an overview of the methodology used in existing device-based national PA surveillance systems. Methods: Four literature databases (PubMed, Embase.com, SPORTDiscus and Web of Science) were searched, supplemented with backward tracking. Articles were included if they reported on population-based (inter)national surveillance systems measuring PA, sedentary time and/or adherence to PA guidelines. When available and in English, the methodological reports of the identified surveillance studies were also included for data extraction. Results: This systematic literature search followed the PRISMA guidelines and yielded 34 articles and an additional 18 methodological reports, reporting on 28 studies, which in turn reported on one or multiple waves of 15 different national and 1 international surveillance system. The included studies showed substantial variation between (waves of) systems in number of participants, response rates, population representativeness and recruitment. In contrast, the methods were similar on data reduction definitions (e.g. minimal number of valid days, non-wear time and necessary wear time for a valid day). Conclusions: The results of this review indicate that few countries use device-based PA measurement in their surveillance system. The employed methodology is diverse, which hampers comparability between countries and calls for more standardized methods as well as standardized reporting on these methods. The results from this review can help inform the integration of device-based PA measurement in (inter)national surveillance systems. [ABSTRACT FROM AUTHOR]

Introduction: This study presents a global research scenario in the broad domain of osteoarthritis (OA) research, using quantitative and qualitative publication and citation indicators. Methods: The study is based on 45,368 global publications, sourced from the Scopus bibliographical database, covering three decades (1994–2023). We studied the performance of the top 12 developed and top 12 developing countries. The key countries, organizations and authors at national and international levels were identified. The broad subject areas and key journals contributing to global OA research were delineated, besides identifying the broad characteristics of highly cited papers in the field. Results: The United States and China were the most productive countries, while the Netherlands and Canada made the largest citation impact. Harvard Medical School and the University of Sydney made the most contribution, while Boston University and Pfizer Inc., USA registered the highest citation impact. Hunter DJ and Guermazi A were the most productive authors, while Lohmander LS, and Hochberg MC registered the highest citation impact. Osteoarthritis and Cartilage (n = 4879) and Annals of the Rheumatic Diseases (n = 786) published the maximum papers, while Arthritis and Rheumatism and Nature Reviews Rheumatology registered the largest citation impact. The highly cited papers with 100 or more citations constituted 6.25% of the total publications. Conclusions: There has been a systematic growth of publications on OA. The research on OA was mainly done in developed countries, with the maximum publications coming from the United States of America, China and Canada. The most impactful publications on OA were from the Netherlands, Canada and the United States of America. [ABSTRACT FROM AUTHOR]

Simple Summary: Recently, nivolumab, pembrolizumab, both immune-checkpoint inhibitors (ICIs) and the combination of dabrafenib plus trametinib (D + T) were registered as adjuvant melanoma treatments, to prevent recurrence. The aim of this paper was to retrospectively review the benefits and risks of these treatments in clinical practice, by extracting data from electronic health records with a text-mining tool. In a population of 122 patients, 55 used nivolumab, 48 used pembrolizumab and 20 used D + T, and we found that the ICIs were better tolerated than D + T. However, the frequent adverse events of D + T are reversible and include pyrexia and fatigue. ICIs show immune-related chronic adverse events, and chronic thyroid-related adverse events occurred frequently. The efficacy results, including the recurrence-free survival, are promising; however, the follow-up was too short for conclusions. This study furthermore showed that the application of text-mining is a valuable method to collect data for the evaluation of adjuvant melanoma treatments. Introduction: Nivolumab (N), pembrolizumab (P), and dabrafenib plus trametinib (D + T) have been registered as adjuvant treatments for resected stage III and IV melanoma since 2018. Electronic health records (EHRs) are a real-world data source that can be used to review treatments in clinical practice. In this study, we applied EHR text-mining software to evaluate the real-world tolerability, safety, and efficacy of adjuvant melanoma treatments. Methods: Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 at the Leiden University Medical Center, the Netherlands, were included. CTcue text-mining software (v3.1.0, CTcue B.V., Amsterdam, The Netherlands) was used to construct rule-based queries and perform context analysis for patient inclusion and data collection from structured and unstructured EHR data. Results: In total, 122 patients were included: 54 patients treated with nivolumab, 48 with pembrolizumab, and 20 with D + T. Significantly more patients discontinued treatment due to toxicity on D + T (N: 16%, P: 6%, D + T: 40%), and X2 (6, n = 122) = 14.6 and p = 0.024. Immune checkpoint inhibitors (ICIs) mainly showed immune-related treatment-limiting adverse events (AEs), and chronic thyroid-related AE occurred frequently (hyperthyroidism: N: 15%, P: 13%, hypothyroidism: N: 20%, P: 19%). Treatment-limiting toxicity from D + T was primarily a combination of reversible AEs, including pyrexia and fatigue. The 1-year recurrence-free survival was 70.3% after nivolumab, 72.4% after pembrolizumab, and 83.0% after D + T. Conclusions: Text-mining EHR is a valuable method to collect real-world data to evaluate adjuvant melanoma treatments. ICIs were better tolerated than D + T, in line with RCT results. For BRAF+ patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D + T against the risk of long-term immune-related AEs. [ABSTRACT FROM AUTHOR]

Purpose: Self-reliance and social participation are strongly promoted by social policy. Both concepts are linked to the concept of vulnerability, for people who do not meet these standards are labelled "vulnerable people". In this paper, the insider's perspective takes central stage by seeking to explore what it means to be labelled a "vulnerable person", and through this to further our insight into the meaning of the concept of vulnerability. Method: Thirty-three in-depth interviews were conducted with 16 allegedly vulnerable people. The data were subjected to thematic content analysis. Results: Our analysis revealed three main dimensions and eight sub-dimensions of perceived vulnerability, outlining an insider's concept of vulnerability. This concept includes manifestations of vulnerability, feelings coexisting with vulnerability, and the image of vulnerable people. Conclusion: The perception of vulnerability changes when interacting with others in society, especially with social policy implementers. In this interaction, the perceived vulnerability increases and becomes societal vulnerability. It concerns a dependency situation in which one's strength and self-determination are not recognized, and the help needed is not provided. By acknowledging the insider's perspective, social policy can fulfil a more empowering role towards "vulnerable people" and contribute to people's well-being. [ABSTRACT FROM AUTHOR]

Aim: To determine neurocognitive performance and behavioural problems in children with Panayiotopoulos syndrome.Method: All 18 children (10 females, 8 males; mean age 4y 7mo; SD 1y 10mo) diagnosed with Panayiotopoulos syndrome at the Kempenhaeghe Epilepsy Center in the Netherlands between 2010 and 2017 were analysed retrospectively. All underwent a neuropsychological/behavioural assessment, an academic assessment, and a 24-hour electroencephalogram.Results: Mean full-scale IQ (93.5; range 76-123; p=0.04) and performance IQ (93.2; range 76-126; p=0.04) were within the normal range, although significantly lower compared to the normative mean. Verbal IQ (96.3; range 76-118) and processing speed (96.1; range 74-114) were not significantly lower. Simple auditory/visual reaction times, visual attention, visual-motor integration, and verbal memory were significantly lower compared to normative values. On average, patients with Panayiotopoulos syndrome were 8 months behind in arithmetic speed and 11 months behind in reading speed for the number of months in school. Behavioural questionnaires revealed significantly higher scores on reported internalizing behavioural problems.Interpretation: Children with Panayiotopoulos syndrome demonstrated diffuse cognitive dysfunction in full-scale IQ, performance IQ, visual attention, visual-motor integration, and verbal memory. A high incidence of internalizing behavioural problems was reported. This strongly suggests neuropsychological and behavioural comorbidity in children with Panayiotopoulos syndrome.What This Paper Adds: Children with Panayiotopoulos syndrome are at risk for cognitive deficits in various cognitive domains. Children with Panayiotopoulos syndrome are also prone to internalizing behavioural problems. Mild-to-severe academic underachievement was present in more than half of the children with Panayiotopoulos syndrome. [ABSTRACT FROM AUTHOR]

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Background: Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries.Method: The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors.Results: A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation.Conclusion: This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care. [ABSTRACT FROM AUTHOR]

Simple Summary: This nationwide cohort study evaluated the incidence and severity of immune-related adverse events (irAEs) in melanoma patients receiving adjuvant versus advanced anti-PD-1 therapy. A total of 1465 advanced melanoma patients and 908 adjuvant-treated patients were included. Patients in the adjuvant group were younger, had superior ECOG performance status, and had fewer comorbidities compared to those in the advanced group. No significant difference was observed in the incidence of grade III-IV irAEs between the two groups. However, higher ECOG status (>1) and the presence of any comorbidities were independently associated with an increased risk of irAE development across both treatment settings. Although adjuvant therapy was not linked to a heightened risk of severe irAEs compared to advanced therapy, it was more frequently discontinued due to toxicity in the adjuvant group. These findings provide critical insights for informing patient consultations regarding adjuvant anti-PD-1 treatment. Introduction: The difference in incidence and severity of anti-PD-1 therapy-related adverse events (irAEs) between adjuvant and advanced treated melanoma patients remains unclear, as no head-to-head studies have compared these groups. Methods: This multi-center cohort study analyzed melanoma patients treated with anti-PD-1 in adjuvant or advanced settings between 2015 and 2021. Comorbidities and ECOG performance status were assessed before treatment, and grade III-IV irAEs were monitored during treatment. Univariate and multivariate regression analyses were conducted to identify factors associated with irAE development. Results: A total of 1465 advanced melanoma patients and 908 resected melanoma patients received anti-PD-1 therapy. Adjuvant-treated patients were younger, with a median age of 63 years compared to 69 years in the advanced group (p < 0.01), and had a better ECOG performance status (p < 0.01). Comorbidities were seen more frequently in advanced melanoma patients than in those receiving adjuvant treatment, 76% versus 68% (p < 0.01). Grade III-IV irAEs occurred in 214 (15%) advanced treated patients and in 119 (13%) adjuvant-treated patients. Multivariate analysis showed an increased risk of severe irAE development with the presence of any comorbidity (adjusted OR 1.22, 95% CI 1.02–1.44) and ECOG status greater than 1 (adjusted OR 2.00, 95% CI 1.20–3.32). Adjuvant therapy was not associated with an increased risk of irAE development compared to advanced treatment (adjusted OR 0.95, 95% CI 0.74–1.21) after correcting for comorbidities and ECOG performance score. Anti-PD-1 therapy was halted due to toxicity (any grade irAE) more often in the adjuvant setting than in the advanced setting, 20% versus 15% (p < 0.01). Conclusions: Higher ECOG performance status and presence of any comorbidity were independently associated with an increased risk of Grade III-IV irAE in adjuvant and advanced treated melanoma patients. Patients treated in the adjuvant setting did not have an increased risk of developing severe irAEs compared to advanced melanoma patients. These findings are of clinical significance in consulting patients for adjuvant anti-PD-1 treatment. [ABSTRACT FROM AUTHOR]

Abstract In 2015, Radboud University (Nijmegen, the Netherlands) started a project to extend its CRIS (Metis) with functionalities that allow researchers to register (metadata) and archive (uploading files) their research data, while at the same time making the data available for reuse in a FAIR way (via national Dutch data archive DANS). The new functionality was integrated with already existing functions in the CRIS, thus offering a one-stop-shop interface to researchers in which registration and archiving of data is combined with registration of publications, the uploading of full text to the university's repository, the linking of datasets and publications and the creation of researcher's profile (CV) pages. Next to the functional extension of the CRIS, the project also included an organizational element: the establishment of support and management structures and workflows, including data curation processes, in order to assure the quality of the data registration process and to foster the FAIRness of the research data. In the period up to now, we continued to transform the university's CRIS, by bringing it in line with the research life cycle perspective and policy changes in Research Data Management (RDM), including a Data Management Plan (DMP) module and FAIR data. In this paper, it will be argued and demonstrated that both for researchers and research institutes, a CRIS oriented approach to RDM brings added value. We also point to future use cases that put a central role for CRIS's even earlier within the research life cycle, e.g. at pre-registration of research questions and informed consent/ethics approval procedures. We further envision our CRIS to play a linking pin function between storage and service locations of data during research and at publication. The paper will use Radboud University as a good practice of past, present and future use of CRIS's in the research life cycle that universities and research institutes as well as researchers and research support desks are currently dealing with in the FAIR data era. [ABSTRACT FROM AUTHOR]

Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium.Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges.Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses.Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.Trial Registration: Netherlands Trial Register, identifier: NTR3842 . Registered on 24 January 2013. [ABSTRACT FROM AUTHOR]

Background: Disability Adjusted Life Years (DALYs) quantify the loss of healthy years of life due to dying prematurely and due to living with diseases and injuries. Current methods of attributing DALYs to underlying risk factors fall short on two main points. First, risk factor attribution methods often unjustly apply incidence-based population attributable fractions (PAFs) to prevalence-based data. Second, it mixes two conceptually distinct approaches targeting different goals, namely an attribution method aiming to attribute uniquely to a single cause, and an elimination method aiming to describe a counterfactual situation without exposure. In this paper we describe dynamic modeling as an alternative, completely counterfactual approach and compare this to the approach used in the Global Burden of Disease 2010 study (GBD2010).Methods: Using data on smoking in the Netherlands in 2011, we demonstrate how an alternative method of risk factor attribution using a pure counterfactual approach results in different estimates for DALYs. This alternative method is carried out using the dynamic multistate disease table model DYNAMO-HIA. We investigate the differences between our alternative method and the method used by the GBD2010 by doing additional analyses using data from a synthetic population in steady state.Results: We observed important differences between the outcomes of the two methods: in an artificial situation where dynamics play a limited role, DALYs are a third lower as compared to those calculated with the GBD2010 method (398,000 versus 607,000 DALYs). The most important factor is newly occurring morbidity in life years gained that is ignored in the GBD2010 approach. Age-dependent relative risks and exposures lead to additional differences between methods as they distort the results of prevalence-based DALY calculations, but the direction and magnitude of the distortions depend on the particular situation.Conclusions: We argue that the GBD2010 approach is a hybrid of an attributional and counterfactual approach, making the end result hard to understand, while dynamic modelling uses a purely counterfactual approach and thus yields better interpretable results. [ABSTRACT FROM AUTHOR]

Background: Medication non-adherence is a complex health care problem. Due to non-adherence, substantial numbers of cardiovascular patients benefit from their medication to only a limited extent. In order to improve adherence, a variety of pharmacist-led interventions have been developed. However, even the most effective interventions achieved only a modest positive effect. To be effective, interventions should be targeted at underlying barriers to adherence, developed in a systematic manner and tailored to specific features of a target group and setting. The current paper describes the design of the Cardiovascular medication non-Adherence Tailored Intervention (CATI) study aimed to evaluate the (cost-)effectiveness of a patient-tailored intervention programme in patients using antihypertensive medication.Methods: The CATI study is a randomised controlled trial that will be performed in 13 community pharmacies. Patients aged 45-75 years using antihypertensive medication and considered non-adherent according to pharmacy dispensing data, as well according to a self-report questionnaire, are eligible to participate. Patients in the intervention condition will receive a patient-tailored, pharmacist-led intervention programme. This programme consists of a structured interview at the pharmacy to identify patients' barriers to adherence and to counsel patients in order to overcome these barriers. The primary outcome is self-reported medication adherence measured with the MARS-5 questionnaire. Secondary outcome measures are blood pressure, illness perceptions, quality of life and societal costs. A cost-effectiveness analysis and process evaluation will also be performed.Discussion: This study will provide insight into the (cost-)effectiveness of a patient-tailored, pharmacist-led intervention programme in non-adherent patients using antihypertensive medication. This intervention programme allows community pharmacists to support their patients in overcoming barriers to adherence and improving medication adherence in a structured and patient-tailored manner. An effective intervention will not only enhance medication adherence, but may also improve health outcomes and decrease health care utilisation and costs.Trial Registration: Netherlands Trial Register (identifier: NTR5017), registered on 2 February 2015. [ABSTRACT FROM AUTHOR]

Background: The worksite cafeteria is a suitable setting for interventions focusing on changing eating behavior, because a lot of employees visit the worksite cafeteria regularly and a variety of interventions could be implemented there. The aim of this paper is to describe the intervention development and design of the evaluation of an intervention to make the purchase behavior of employees in the worksite cafeteria healthier. The developed intervention called "the worksite cafeteria 2.0" consists of a set of 19 strategies based on theory of nudging and social marketing (marketing mix). The intervention will be evaluated in a real-life setting, that is Dutch worksite cafeterias of different companies and with a number of contract catering organizations.Methods/design: The study is a randomized controlled trial (RCT), with 34 Dutch worksite cafeterias randomly allocated to the 12-week intervention or to the control group. Primary outcomes are sales data of selected products groups like sandwiches, salads, snacks and bread topping. Secondary outcomes are satisfaction of employees with the cafeteria and vitality.Discussion: When executed, the described RCT will provide better knowledge in the effect of the intervention "the worksite cafeteria 2.0" on the purchasing behavior of Dutch employees in worksite cafeterias.Trial Registration: Dutch Trial register: NTR5372 . [ABSTRACT FROM AUTHOR]

Simple Summary: Transoral Robotic Surgery (TORS) is increasingly used for various conditions, yet its success and failure remain underexplored. In this multicenter study, we assessed 220 TORS interventions across 211 patients. Success criteria differed by condition, including tumor identification for CUP, resection margins for malignancies, and symptom improvement for benign cases like OSA and chronic lingual tonsillitis. Predictors of success varied, with factors such as patient comorbidity, tumor characteristics, and demographics playing roles. Conversely, failure predictors encompassed postoperative complications and pain, linked to patient health and demographics. These insights into TORS outcomes may aid in patient selection and counseling across different conditions, informing clinical practice and enhancing patient care. Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and chronic lingual tonsillitis. However, the success and failure of TORS have not been analyzed to date. In this retrospective observational multicenter cohort study, we evaluated patients treated with TORS using the da Vinci surgical system. Success criteria were defined as identification of the primary tumor for CUP, >2 mm resection margin for malignant conditions, and improvement on respiratory polygraphy and tonsillitis complaints for benign conditions. A total of 220 interventions in 211 patients were included. We identified predictors of success, such as low comorbidity status ACE-27, positive P16 status, and lower age for CUP, and female gender and OSA severity for benign conditions. For other malignancies, no predictors for success were found. Predictors of failure based on postoperative complications included high comorbidity scores (ASA) and anticoagulant use, and for postoperative pain, younger age and female gender were identified. This study provides valuable insights into the outcomes and predictors of success and failure in TORS procedures across various conditions and may also help in patient selection and counseling. [ABSTRACT FROM AUTHOR]

A child's disability, long-term illness, or mental ill-health is known to affect siblings' health, social life, school engagement, and quality of life. This article addresses a research gap by its focus on young sibling carers and the impact of providing care to a sibling. A cross-national survey study was conducted in 2018–2019 (Italy, the Netherlands, Slovenia, Sweden, Switzerland, the UK) to examine the incidence of adolescent sibling carers, the extent of care they provide, and their self-reported health, well-being, and school situation. The survey was completed by 7146 adolescents, aged 15–17, and 1444 of them provided care to family members with health-related conditions. Out of these, 286 were identified as Sibling Carers and 668 as Parent Carers, while 181 had both sibling(s) and parent(s) with health-related conditions, and thus were identified as Sibling–Parent Carers. Sibling Carers and Sibling–Parent Carers carried out higher levels of caring activities compared to Parent Carers. They reported both positive aspects of caring, such as increased maturity, and negative aspects, such as mental ill-health, impact on schooling and a lack of support. To reduce the negative aspects of a sibling carer role, it is important to recognise them and to implement early preventive measures and formal support. [ABSTRACT FROM AUTHOR]

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months.Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change.Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial Registration: Isrctn: 81935608 . Registered 16 June 2015. [ABSTRACT FROM AUTHOR]

Background: Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care.Methods/design: This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury.Discussion: The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention.Trial Registration: Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015. [ABSTRACT FROM AUTHOR]

Background: A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. This paper presents the study protocol.Methods/design: The effects of implementing a PHR in maternity care on patients and professionals will be identified in a stepped-wedge, cluster-randomised, controlled trial. The study will be performed in the region of Nijmegen, a Dutch area with an average of 4,500 births a year and more than 230 healthcare professionals involved in maternity care. Data analyses will describe the effects of MyPregn@ncy on health outcomes in maternity care, quality of care from the patients' perspectives, and collaboration among healthcare professionals. Additionally, a process evaluation of the implementation of MyPregn@ncy will be performed. Data will be collected using data from the Dutch perinatal registry, questionnaires, interviews, and log data.Discussion: The study is expected to yield new information about the effects, strengths, possibilities, and challenges to the implementation and usage of a PHR in routine maternal care settings. Results may lead to new insights and improvements in the quality of maternal and perinatal care.Trial Registration: Netherlands Trial Register: NTR4063. [ABSTRACT FROM AUTHOR]

Background: Over 30 % of older patients experience hospitalization-associated disability (HAD) (i.e., loss of independence in Activities of Daily Living (ADLs)) after an acute hospitalization. Despite its high prevalence, the mechanisms that underlie HAD remain elusive. This paper describes the protocol for the Hospital-Associated Disability and impact on daily Life (Hospital-ADL) study, which aims to unravel the potential mechanisms behind HAD from admission to three months post-discharge.Methods/design: The Hospital-ADL study is a multicenter, observational, prospective cohort study aiming to recruit 400 patients aged ≥70 years that are acutely hospitalized at departments of Internal Medicine, Cardiology or Geriatrics, involving six hospitals in the Netherlands. Eligible are patients hospitalized for at least 48 h, without major cognitive impairment (Mini Mental State Examination score ≥15), who have a life expectancy of more than three months, and without disablement in all six ADLs. The study will assess possible cognitive, behavioral, psychosocial, physical, and biological factors of HAD. Data will be collected through: 1] medical and demographical data; 2] personal interviews, which includes assessment of cognitive impairment, behavioral and psychosocial functioning, physical functioning, and health care utilization; 3] physical performance tests, which includes gait speed, hand grip strength, balance, bioelectrical impedance analysis (BIA), and an activity tracker (Fitbit Flex), and; 4] analyses of blood samples to assess inflammatory and metabolic markers. The primary endpoint is additional disabilities in ADLs three months post-hospital discharge compared to ADL function two weeks prior to hospital admission. Secondary outcomes are health care utilization, health-related quality of life (HRQoL), physical performance tests, and mortality. There will be at least five data collection points; within 48 h after admission (H1), at discharge (H3), and at one (P1; home visit), two (P2; by telephone) and three months (P3; home visit) post-discharge. If the patient is admitted for more than five days, additional measurements will be planned during hospitalization on Monday, Wednesday, and Friday (H2).Discussion: The Hospital-ADL study will provide information on cognitive, behavioral, psychosocial, physical, and biological factors associated with HAD and will be collected during and following hospitalization. These data may inform new interventions to prevent or restore hospitalization-associated disability. [ABSTRACT FROM AUTHOR]

Clinical and research staff who work around magnetic resonance imaging (MRI) scanners are exposed to the static magnetic stray fields of these scanners. Although the past decade has seen strong developments in the assessment of occupational exposure to electromagnetic fields from MRI scanners, there is insufficient insight into the exposure variability that characterizes routine MRI work practice. However, this is an essential component of risk assessment and epidemiological studies. This paper describes the results of a measurement survey of shift-based personal exposure to static magnetic fields (SMF) (B) and motion-induced time-varying magnetic fields (dB/dt) among workers at 15 MRI facilities in the Netherlands. With the use of portable magnetic field dosimeters, >400 full-shift and partial shift exposure measurements were collected among various jobs involved in clinical and research MRI. Various full-shift exposure metrics for B and motion-induced dB/dt exposure were calculated from the measurements, including instantaneous peak exposure and time-weighted average (TWA) exposures. We found strong correlations between levels of static (B) and time-varying (dB/dt) exposure (r = 0.88–0.92) and between different metrics (i.e. peak exposure, TWA exposure) to express full-shift exposure (r = 0.69–0.78). On average, participants were exposed to MRI-related SMFs during only 3.7% of their work shift. Average and peak B and dB/dt exposure levels during the work inside the MRI scanner room were highest among technical staff, research staff, and radiographers. Average and peak B exposure levels were lowest among cleaners, while dB/dt levels were lowest among anaesthesiology staff. Although modest exposure variability between workplaces and occupations was observed, variation between individuals of the same occupation was substantial, especially among research staff. This relatively large variability between workers with the same job suggests that exposure classification based solely on job title may not be an optimal grouping strategy for epidemiological purposes. [ABSTRACT FROM AUTHOR]

Resistance exercise training is effective to counteract the adverse effects of androgen deprivation therapy (ADT) on body composition, muscle mass and leg strength in prostate cancer patients (PCa). However, it is unknown whether these effects can be autonomously maintained after cessation of the supervised program. Sixty‐eight PCa patients on ADT were included. The exercise intervention group (EX, n = 37) performed 20 weeks of supervised resistance exercise training. Thereafter, patients were advised to autonomously continue exercise training. The control group (CON, n = 31) only received usual care. Outcome measures were compared between baseline and after 1 year. Changes during the intervention (baseline vs. 20 weeks) and follow‐up period (20 weeks vs. 1 year) were descriptively explored. In EX, 83% reported to have continued exercise training themselves. After 1 year, fat mass gains were attenuated in EX compared to CON (1.2 ± 2.6 and 2.8 ± 1.9 kg, respectively; time × treatment effect p = 0.032). The fat percentage increased, and lean mass and quadriceps muscle cross‐sectional area decreased over time, with no differences between groups (overall 1.6 ± 2.1%, −0.7 ± 2.3 kg and −2.2 ± 2.9 cm2, respectively; time effects, all p < 0.05). For muscle strength, an increase of ∼5% in EX was observed, significantly different from the ∼10% decrease in CON (p < 0.001). Subsequent analyses showed that the initial exercise training‐obtained gains in lean mass, muscle mass and strength in EX compared to CON, declined during the follow‐up period. In conclusion, PCa patients on ADT are not capable to autonomously maintain the exercise‐obtained gains of a 20‐week supervised training program over a subsequent 1‐year period. Highlights: ADT for prostate cancer results in many side effects, including muscle mass lossA supervised resistance exercise training program can counteract many side effectsAfter cessation of the supervised program, exercise benefits are not effectively preservedMore focus on sustainability of exercise programs during ADT is required [ABSTRACT FROM AUTHOR]

Purpose: Achieving greater health and social care integration is a policy priority in many countries, but challenges remain. We focused on governance and accountability for integrated care and explored arrangements that shape more integrated delivery models or systems in Italy, the Netherlands and Scotland. We also examined how the COVID-19 pandemic affected existing governance arrangements. Design/methodology/approach: A case study approach involving document review and semi-structured interviews with 35 stakeholders in 10 study sites between February 2021 and April 2022. We used the Transparency, Accountability, Participation, Integrity and Capability (TAPIC) framework to guide our analytical enquiry. Findings: Study sites ranged from bottom-up voluntary agreements in the Netherlands to top-down mandated integration in Scotland. Interviews identified seven themes that were seen to have helped or hindered integration efforts locally. Participants described a disconnect between what national or regional governments aspire to achieve and their own efforts to implement this vision. This resulted in blurred, and sometimes contradictory, lines of accountability between the centre and local sites. Flexibility and time to allow for national policies to be adapted to local contexts, and engaged local leaders, were seen to be key to delivering the integration agenda. Health care, and in particular acute hospital care, was reported to dominate social care in terms of policies, resource allocation and national monitoring systems, thereby undermining better collaboration locally. The pandemic highlighted and exacerbated existing strengths and weaknesses but was not seen as a major disruptor to the overall vision for the health and social care system. Research limitations: We included a relatively small number of interviews per study site, limiting our ability to explore complexities within sites. Originality: This study highlights that governance is relatively neglected as a focus of attention in this context but addressing governance challenges is key for successful collaboration. [ABSTRACT FROM AUTHOR]

Internet usage is a salient developmental factor in adolescents' lives. Although relevant correlates of Internet use have been documented earlier, there is a lack of information on lower socioeconomic status groups. This is important, as these adolescents have increased risk of negative online experiences. The current survey aimed to explore Internet use and parental involvement amongst adolescents from areas of socio-economic disadvantage in 30 urban schools across five European countries. A total of 2594 students participated, of whom 90% were 14–16 years. Virtually all adolescents of socioeconomic disadvantage had Internet access, with 88.5% reporting spending more than two hours per day online, often on apps such as Instagram, Snapchat, and YouTube. Almost one-third of adolescents did not talk with their parents about their Internet use and almost two-thirds indicated that their parents were only a little or not interested in their Internet use. A consistent finding across countries was that girls more often talked with their parents about their Internet use and more often reported that their parents were interested in their Internet use than boys. The results suggest that parents have an important task in explicitly showing interest in their adolescents' Internet use, with special attention needed for boys. [ABSTRACT FROM AUTHOR]

Simple Summary: CAR T-cell therapy has emerged as the new standard of care for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), but real-world outcomes differ across countries. Additionally, real-world data on health-related quality of life (HR-QoL) are scarce but important, as they reflect the direct experience of patients. In the Netherlands, patients can be referred to the CAR-T tumorboard, a national CAR-T expert panel, who decide whether CAR-T is a feasible treatment option. This multicenter study reports on the favorable outcomes, including the HR-QoL, of axicabtagene ciloleucel (axi-cel) for patients with R/R LBCL after ≥2 lines of systemic therapy in the Netherlands. On the other hand, we show that a substantial proportion of patients are still in need of alternative treatments, including improved CAR-T strategies, as they are unfit for or do not respond to axi-cel. Comparing real-world outcomes between cohorts could help to select best practices and further optimize CAR-T treatment. The real-world results of chimeric antigen receptor T-cell (CAR-T) therapy for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) substantially differ across countries. In the Netherlands, the CAR-T tumorboard facilitates a unique nationwide infrastructure for referral, eligibility assessment and data collection. The aim of this study was to evaluate real-world outcomes of axicabtagene ciloleucel (axi-cel) in the Dutch population, including the thus-far underreported effects on health-related quality of life (HR-QoL). All patients with R/R LBCL after ≥2 lines of systemic therapy referred for axi-cel treatment between May 2020–May 2022 were included (N = 250). Of the 160 apheresed patients, 145 patients received an axi-cel infusion. The main reason for ineligibility was rapidly progressive disease. The outcomes are better or at least comparable to other studies (best overall response rate: 84% (complete response: 66%); 12-month progression-free-survival rate and overall survival rate: 48% and 62%, respectively). The 12-month NRM was 5%, mainly caused by infections. Clinically meaningful improvement in several HR-QoL domains was observed from Month 9 onwards. Expert-directed patient selection can support effective and sustainable application of CAR-T treatment. Matched comparisons between cohorts will help to understand the differences in outcomes across countries and select best practices. Despite the favorable results, for a considerable proportion of patients with R/R LBCL there still is an unmet medical need. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to gain insight into nurses' perspectives on the shift‐to‐shift handover in relation to providing Person‐centred care (PCC) in nursing homes. Background: PCC is perceived as the gold standard for nursing home care. To preserve the continuity of PCC, an adequate handover during the nurses' shift change is essential. There is, however, little empirical evidence for what constitutes best shift‐to‐shift nursing handover practices in nursing homes. Design: An exploratory qualitative descriptive study. Methods: Nine nurses were selected purposively and through snowball sampling from five Dutch nursing homes. Semi‐structured face‐to‐face and telephone interviews were conducted. Analysis relied on Braun and Clarke's thematic analysis. Results: Four main themes were identified related to enabling PCC informed handovers: (1) knowing the resident to be enable to provide PCC was key, (2) the actual handover, (3) additional ways of information transfer and (4) nurses' knowledge of the resident prior to start shift. Conclusion: The shift‐to‐shift handover is one way that nurses become informed about residents. Knowing the resident is essential to enable PCC. The fundamental underlying question is to what extent nurses have to know the resident in order to enable PCC. Once that level of detail has been established, in‐depth research is needed to determine the best method for conveying this information to all nurses. Only then can we start to rethink the role of the shift‐to‐shift handover in conveying PCC‐driven information. No Patient or Public Contribution. [ABSTRACT FROM AUTHOR]

Purpose: This paper examines the flow of thoughts on Business Ethics research lines from experts of European countries.Design/methodology/approach: A Delphi method was used to achieve consensuses among the perceptions and opinions of experts about Business Ethics matters. Moreover, the research agenda is investigated using a Delphi process developed with the participation of 12 experts from eight countries (France, Spain, the UK, the Netherlands, Sweden, Switzerland, Germany, and Hungary) from March to September 2015.Findings: The state of the art based on the expert panel’s consensuses on the emerging issues in Business Ethics permits the early detection of emerging lines, thus narrowing the research line and decreasing subject selection time. Additionally, an active research map has been constructed based on researchers, countries, and lines of investigation.Originality/value: There is a gap in the representation of the research on certain management topics in Business Ethics, so this research will constitute a significant and valuable tool for novel researchers. It is useful for creating a research agenda. [ABSTRACT FROM AUTHOR]

Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of "poor", "moderate", and "good" knowledge, as well as "positive" and "negative" attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting. [ABSTRACT FROM AUTHOR]

Background: The preconception period provides a window of opportunity for interventions aiming to reduce unhealthy lifestyle behaviours and their negative effect on pregnancy outcomes. This study aimed to assess the effectiveness of a locally tailored preconception care (PCC) intervention in a hybrid-II effectiveness implementation design.Methods: A stepped-wedge cluster randomized controlled trial was performed in four Dutch municipalities. The intervention contained a social marketing strategy aiming to improve the uptake (prospective parents) and the provision (healthcare providers) of PCC. Prospective parents participated by administering a questionnaire in early pregnancy recalling their preconceptional behaviours. Experiences of healthcare providers were also evaluated through questionnaires. The composite primary outcome was adherence to at least three out of four preconceptional lifestyle recommendations (early initiation of folic acid supplements, healthy nutrition, no smoking or alcohol use). Secondary outcomes were preconceptional lifestyle behaviour change, (online) reach of the intervention and improved knowledge among healthcare providers.Results: A total of 850 women and 154 men participated in the control phase and 213 women and 39 men in the intervention phase. The composite primary outcome significantly improved among women participating in the municipality where the reach of the intervention was highest (Relative Risk (RR) 1.57 (95% Confidence Interval (CI) 1.11-2.22). Among women, vegetable intake had significantly improved in the intervention phase (RR 1.82 (95%CI 1.14-2.91)). The aimed online reach- and engagement rate of the intervention was achieved most of the time. Also, after the intervention, more healthcare providers were aware of PCC-risk factors (54.5% vs. 47.7%; p = 0.040) and more healthcare providers considered it easier to start a conversation about PCC (75.0% vs. 47.9%; p = 0.030).Conclusion: The intervention showed some tentative positive effects on lifestyle behaviours among prospective parents. Primarily on vegetable intake and the knowledge and competence of healthcare providers. The results of this study contribute to the evidence regarding successfully implementing PCC-interventions to optimize the health of prospective parents and future generations.Trial Registration: Dutch Trial Register: NL7784 (Registered 06/06/2019). [ABSTRACT FROM AUTHOR]

Twenty-five years after its inception, we present new analyses and reference data for the DUX-25, a questionnaire on health-related quality of life for children 8–17 years old and their parents as proxy. Data from 774 healthy children and their caregivers were collected through web-based data collection. Participants were recruited via primary and secondary schools in the Netherlands. The DUX-25 showed adequate psychometric qualities. Using exploratory and confirmatory factor analyses, we were able to support the theorized four-factor model. In addition, a model with five factors emerged in which the factor 'Social' was divided into 'Social Close' and 'Social Far'. A comparison of the outcomes of the PedsQL with those of the DUX-25 provides evidence for a high construct validity of the DUX-25. With the new updated reference data, the DUX-25 can still be used in inpatient and outpatient settings to measure health-related quality of life of children with chronic conditions. [ABSTRACT FROM AUTHOR]

Background: In primary care, a shift from a disease‐oriented approach for patients with multimorbidity towards a more person‐centred approach is needed. Aim: To transform a self‐report questionnaire for patients with chronic conditions in primary care, the Primary Care Functioning Scale (PCFS), into an understandable, visually attractive and feasible consultation tool for patients and health care providers. The consultation tool consists of a web‐based version of the PCFS, which is filled in by the patient and is processed to a feedback report that summarizes and visualizes the main findings. The feedback report can be discussed with the patient to facilitate a more person‐centred conversation for patients with chronic conditions and multimorbidity in general practice. Design and Setting: In this qualitative study, we developed the consultation tool by using design thinking in a participatory developmental process. Methods: In the first phase, we constructed five different feedback report templates to summarize and display the results of a completed PCFS questionnaire in a series of two expert meetings with patients and general practitioners (GPs). In the second phase, we performed an exploratory qualitative interview study involving dyads of patients with chronic conditions and their practice nurses. In an iterative process, we explored their experiences with the consultation tool. Results: Patients, as well as GPs, preferred a clear manner of presenting the results of the questionnaire in a feedback report. In 18 interviews with patients and practice nurses during three different interview rounds, we adjusted the feedback report and consultation tool based on the input from patients and practice nurses. After the final interview round, patients and practice nurses consented that the consultation tool was useful for having a more in‐depth consultation about functioning and patients' preferences when integrated into the regularly scheduled consultations. Conclusion: We were able to develop an understandable and feasible consultation tool that is applicable in already existing chronic disease management programmes in general practice in the Netherlands. Patient or Public Contribution: To increase the understandability and feasibility of the consultation tool, we collaborated with end‐users and actively involved patients, GPs and practice nurses in a participatory development process. [ABSTRACT FROM AUTHOR]

Background: MPS IIIA is a rare, degenerative pediatric genetic disease characterized by symptoms impacting cognition, mobility and behavior; the mean age of death is around 15 years of age. Currently, there are no approved therapies for MPS IIIA.Methods: A two-year, multi-center, prospective, descriptive cohort study was conducted to document the natural history course of MPS IIIA. In the context of this study, semi-structured interviews were performed with parents of children at study entry and one year later. Interview transcripts were analyzed using thematic analysis methods to identity concepts of interest to children and parents, identify what factors impacted parents' burden the most, and develop qualitatively-derived disease severity stages. Children were sorted into these stages according to the symptoms their parents described at the entry interview. This sorting was compared quantitatively to the sorting of children at baseline according to the child's calendar age and their BSID development quotient (DQ).Results: 22 parents in France, Germany, the Netherlands and the UK were interviewed. Children ranged in age from 28 to 105 months (mean 61.4 months). The conceptual models for children's symptoms and impacts and parents' impacts provided a detailed and comprehensive picture of what it is like for children of various ages and their parents to live with MPS IIIA. Four factors were identified as mediating the burden perceived by parents: state support, family support, time since diagnosis, and parent coping strategy. Four disease stages were developed, accounting for both the presence and the severity of MPS IIIA symptoms. The comparison of children's sorting into these stages with the BSID DQ and the child's calendar age showed strong statistical associations.Conclusions: The findings of this qualitative research embedded in a natural history study add to the current understanding of MPS IIIA as a complex disease that impacts every aspect of the lives of children and their families. This study demonstrates the unique potential of mixed methods research in rare diseases to address some of the current limitations of more traditional quantitative approaches by providing an individualized, detailed understanding of the patient experience. [ABSTRACT FROM AUTHOR]

Background: Preterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high, and additional preventive measures are required. Our objective was to assess the effectiveness of low-dose aspirin compared to placebo in the prevention of preterm birth in women with a previous spontaneous preterm birth.Methods and Findings: We performed a parallel multicentre, randomised, double-blinded, placebo-controlled trial (the APRIL study). The study was performed in 8 tertiary and 26 secondary care hospitals in the Netherlands. We included women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks. Participants were randomly assigned to aspirin 80 mg daily or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. Randomisation was computer generated, with allocation concealment by using sequentially numbered medication containers. Participants, their healthcare providers, and researchers were blinded for treatment allocation. The primary outcome was preterm birth <37 weeks of gestation. Secondary outcomes included a composite of poor neonatal outcome (bronchopulmonary dysplasia, periventricular leukomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotising enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis, or perinatal death). Analyses were performed by intention to treat. From May 31, 2016 to June 13, 2019, 406 women were randomised to aspirin (n = 204) or placebo (n = 202). A total of 387 women (81.1% of white ethnic origin, mean age 32.5 ± SD 3.8) were included in the final analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth <37 weeks occurred in 41 (21.2%) women in the aspirin group and 49 (25.4%) in the placebo group (relative risk (RR) 0.83, 95% confidence interval (CI) 0.58 to 1.20, p = 0.32). In women with ≥80% medication adherence, preterm birth occurred in 24 (19.2%) versus 30 (24.8%) women (RR 0.77, 95% CI 0.48 to 1.25, p = 0.29). The rate of the composite of poor neonatal outcome was 4.6% (n = 9) versus 2.6% (n = 5) (RR 1.79, 95% CI 0.61 to 5.25, p = 0.29). Among all randomised women, serious adverse events occurred in 11 out of 204 (5.4%) women allocated to aspirin and 11 out of 202 (5.4%) women allocated to placebo. None of these serious adverse events was considered to be associated with treatment allocation. The main study limitation is the underpowered sample size due to the lower than expected preterm birth rates.Conclusions: In this study, we observed that low-dose aspirin did not significantly reduce the preterm birth rate in women with a previous spontaneous preterm birth. However, a modest reduction of preterm birth with aspirin cannot be ruled out. Further research is required to determine a possible beneficial effect of low-dose aspirin for women with a previous spontaneous preterm birth.Trial Registration: Dutch Trial Register (NL5553, NTR5675) https://www.trialregister.nl/trial/5553. [ABSTRACT FROM AUTHOR]

Study Question: Is there an association between maternal occupational exposure to endocrine-disrupting chemicals (EDCs) early in pregnancy and subgroups of congenital anomalies of kidney and urinary tract (CAKUT), and hypospadias?Summary Answer: Exposure to specific EDCs can increase the risk of CAKUT and no association with hypospadias was observed.What Is Known Already: Previous studies showed an association between maternal occupational exposure to EDCs and hypospadias. However, little is known about the effect of these chemicals on the development of CAKUT, especially subgroups of urinary tract anomalies.Study Design, Size, Duration: For this case-control study, cases with urogenital anomalies from the European Concerted Action on Congenital Anomalies and Twins Northern Netherlands (Eurocat NNL) registry and non-malformed controls from the Lifelines children cohort (living in the same catchment region as Eurocat NNL) born between 1997 and 2013 were selected. This study included 530 cases with CAKUT, 364 cases with hypospadias, 7 cases with both a urinary tract anomaly and hypospadias and 5602 non-malformed controls. Cases with a genetic or chromosomal anomaly were excluded, and to avoid genetic correlation, we also excluded cases in which a sibling with the same defect was included.Participants/materials, Setting, Methods: Information on maternal occupation held early in pregnancy was collected via self-administered questionnaires. Job titles were translated into occupational exposure to EDCs using a job-exposure matrix (JEM). Adjusted odds ratios (aORs) and 95% CIs were estimated to assess the association between maternal occupational exposure to EDCs (and to specific types of EDCs) and CAKUT and hypospadias.Main Results and the Role Of Chance: For CAKUT and hypospadias, 23.1% and 22.9% of the cases were exposed to EDCs, respectively, whereas 19.8% of the controls were exposed. We found an association between maternal occupational exposure to organic solvents/alkylphenolic compounds and CAKUT (aOR 1.41, 95% CI 1.01-1.97) that became stronger when combinations of urinary tract anomalies co-occurred with other defects (aOR 7.51, 95% CI 2.41-23.43). An association was also observed for exposure to phthalates/benzophenones/parabens/siloxanes and CAKUT (aOR 1.56, 95% CI 1.06-2.29), specifically urinary collecting system anomalies (aOR 1.62, 95% CI 1.03-2.54) and combinations of urinary tract anomalies (aOR 2.90, 95% CI 1.09-7.71). We observed no association between EDC exposure and hypospadias.Limitations, Reasons For Caution: The different study designs of Eurocat NNL and Lifelines could have introduced differential information bias. Also, exposure misclassification could be an issue: it is possible that the actual exposure differed from the exposure estimated by the JEM. In addition, women could also have been exposed to other exposures not included in the analysis, which could have resulted in residual confounding by co-exposures.Wider Implications Of the Findings: Women, their healthcare providers, and their employers need to be aware that occupational exposure to specific EDCs early in pregnancy may be associated with CAKUT in their offspring. An occupational hygienist should be consulted in order to take exposure to those specific EDCs into consideration when risk assessments are carried out at the workplace.Study Funding/competing Interest(s): N.S. was paid by the Graduate School of Medical Sciences (MD/PhD programme), University Medical Center Groningen (UMCG), Groningen, the Netherlands. Eurocat Northern Netherlands is funded by the Dutch Ministry of Health, Welfare and Sports. The Lifelines Biobank initiative has been made possible by subsidy from the Dutch Ministry of Health, Welfare and Sport, the Dutch Ministry of Economic Affairs, the University Medical Center Groningen (UMCG the Netherlands), University Groningen and the Northern Provinces of the Netherlands. The authors report no conflict of interest.Trial Registration No: N/A. [ABSTRACT FROM AUTHOR]

Background While advances in the field of functional magnetic resonance imaging (fMRI) provide new opportunities to study brain networks underlying the experience of hallucinations in psychosis, there are methodological challenges unique to symptom-capture studies. Study Design We extracted brain networks activated during hallucination-capture for schizophrenia patients when fMRI data collected from two sites was merged (combined N = 27). A multidimensional analysis technique was applied, which would allow separation of brain networks involved in the hallucinatory experience itself from those involved in the motor response of indicating the beginning and end of the perceived hallucinatory experience. To avoid reverse inference when attributing a function (e.g. a hallucination) to anatomical regions, it was required that longer hallucinatory experiences produce extended brain responses relative to shorter. Study Results For radio-speech sound files, an auditory perception brain network emerged, and displayed speech-duration-dependent hemodynamic responses (HDRs). However, in the hallucination-capture blocks, no network showed hallucination-duration-dependent HDRs, but a retrieved network that was anatomically classified as motor response emerged. Conclusions During symptom capture of hallucinations during fMRI, no HDR showed duration dependence, but a brain network anatomically matching the motor response network was retrieved. Previous reports on brain networks detected by fMRI during hallucination capture are reviewed in this context; namely, that the brain networks interpreted as involved in hallucinations may in fact be involved only in the motor response indicating the onset of the hallucination. [ABSTRACT FROM AUTHOR]

Background: Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study's aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated.Methods: The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains.Discussion: This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome.Trial Registration: Netherlands Trial Register NL6965, registered 25/04/2018. [ABSTRACT FROM AUTHOR]

Objective: The aim of the current study was to establish whether the neighbourhood food environment, characterised by the healthiness of food outlets, the diversity of food outlets and fast-food outlet density within a 500 m or 1000 m street network buffer around the home address, contributed to ethnic differences in diet quality.Design: Cross-sectional cohort study.Setting: Amsterdam, the Netherlands.Participants: Data on adult participants of Dutch, South-Asian Surinamese, African Surinamese, Turkish and Moroccan descent (n total 4728) in the HELIUS study were analysed.Results: The neighbourhood food environment of ethnic minority groups living in Amsterdam is less supportive of a healthy diet and of less diversity than that of participants of Dutch origin. For example, participants of Turkish, Moroccan and South-Asian Surinamese descent reside in a neighbourhood with a significantly higher fast-food outlet density (≤1000 m) than participants of Dutch descent. However, we found no evidence that neighbourhood food environment characteristics directly contributed to ethnic differences in diet quality.Conclusion: Although ethnic minority groups lived in less healthy food environments than participants of ethnic Dutch origin, this did not contribute to ethnic differences in diet quality. Future research should investigate other direct or indirect consequences of residing in less supportive food environments and gain a better understanding of how different ethnic groups make use of their neighbourhood food environment. [ABSTRACT FROM AUTHOR]

Background: Activity pacing is a behavioral strategy for coping with fatigue, optimizing physical activity (PA) levels, and achieving a paced approach to lifestyle and sustainable self-regulated exercise practice to optimize health and well-being. Yet little is known about how activity pacing affects PA and health-related quality of life (HRQOL) while controlling for fatigue and demographic characteristics over time in adults with multiple sclerosis (MS). This study examined the natural use of activity pacing and how it is associated with PA and HRQOL over time in adults with MS. Methods: Sixty-eight adults with MS (mean ± SD age, 45.2 ± 10.9 years) completed questionnaires on their activity pacing, fatigue, PA, and HRQOL 14, 33, and 52 weeks after rehabilitation. Associations between the variables were examined using multilevel models. Results: No associations were found between activity pacing and PA ( β = -0.01, P = .89) or between activity pacing and HRQOL ( β = -0.15, P = .09). Conclusions: This study provides an initial understanding of how activity pacing relates to PA and HRQOL in people with MS over time and indicates that there is no clear strategy among adults with MS that is successful in improving PA and HRQOL in the short or long term. Persons with MS may benefit from goal-directed activity pacing interventions to improve longitudinal engagement in PA, and the present study provides a foundation for further intervention development. [ABSTRACT FROM AUTHOR]

Background: Telemonitoring could offer solutions to the mounting challenges for health care and could improve patient self-management. Studies have addressed the benefits and challenges of telemonitoring for certain patient groups.Objective: This paper will examine the nationwide uptake of telemonitoring in chronic care in the Netherlands from 2014 to 2019 by means of an annual representative survey among patients and health care professionals.Methods: Between 2014 and 2019, approximately 2900 patients with chronic diseases, 700 nurses, and 500 general practitioners (GPs) and medical specialists received a questionnaire. About 30 questions addressed topics about the use of eHealth and experiences with it, including data about telemonitoring.Results: Between 2014 and 2019, the use of telemonitoring remained stable for all groups except medical specialists. In medical specialist departments, the use of telemonitoring increased from 11.2% (18/161) in 2014 to 19.6% (36/184) in 2019 (χ24=12.3; P=.02). In 2019, telemonitoring was used by 5.8% (28/485) of people with chronic disease. This was 18.2% (41/225) in GP organizations and 40.4% (44/109), 38.0% (78/205), and 8.9% (29/325) in the organizations of nurses working in primary, secondary, and elderly care, respectively. Up to 10% of the targeted patient group such as diabetics were regarded by health care professionals as suitable for using telemonitoring. The main benefits mentioned by the patients were "comfort" (421/1043, 40.4%) and "living at home for longer/more comfortably" (334/1047, 31.9%). Health care professionals added "improvement of self-management" (63/176, 35.8% to 57/71, 80.3%), "better understanding of the patient's condition" (47/176, 26.7% to 42/71, 59.2%), "reduction of workload" (53/134, 39.6% of nurses in elderly care), "better tailoring of care plan to the patient's situation" (95/225, 42.2% of GPs), and "saves time for patients/caregivers" (61/176, 34.7% of medical specialists). Disadvantages mentioned by professionals were that "it takes time to monitor data" (13/130, 10% to 108/225, 48.0%), "it takes time to follow up alerts" (15/130, 11.5% to 117/225, 52.0%), and "it is difficult to estimate which patients can work with telemonitoring" (22/113, 19.5% to 94/225, 41.8%).Conclusions: The uptake of telemonitoring in Dutch chronic care remained stable during 2014-2019 but increased among medical specialists. According to both patients and professionals, telemonitoring improves the quality of life and quality of care. Skills for suitably including eligible patients and for allocating the tasks of data monitoring and follow-up care within the team would help to further increase the use of telemonitoring. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the feasibility of obtaining nasal and rectal swabs from general practice patients for measuring carriage of antibiotic resistant microorganisms in an area in Rotterdam (the Netherlands) with low socioeconomic status and a large immigrant population.Methods: Data collection was from May to December 2017, in one general practice in Rotterdam. We asked adults (≥18 years) visiting the general practitioner (GP) with complaints not related to infections for one nasal and two rectal swabs and tested these for highly resistant microorganisms (HRMOs). Indicators for feasibility were recruitment rate, implementation and acceptation of data collection procedures by the participants.Results: We obtained a nasal swab from all included 234 patients and 164 (70%) also gave rectal swabs. On average, 3 out of 30 invited patients (10%) were recruited per day. The GPs considered the workload high to inform and refer to eligible patients for the study and did this inconsistently. Most participants experienced the rectal swab procedure as burdensome and preferred assistance of a medical assistant above self-swabbing. A monetary incentive increased the willingness to provide rectal swabs.Conclusions: Obtaining (nasal and) rectal swabs from general practice patients for study purposes proved difficult. Lessons learnt from this feasibility study will help increase participation in HRMO prevalence studies among asymptomatic general practice patients. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of a social network intervention (SNI) to improve children's healthy drinking behaviours.Design: A three-arm cluster randomised control trial design was used. In the SNI, a subset of children were selected and trained as 'influence agents' to promote water consumption-as an alternative to sugar-sweetened beverages (SSB)-among their peers. In the active control condition, all children were simultaneously exposed to the benefits of water consumption. The control condition received no intervention.Setting: Eleven schools in the Netherlands.Participants: Four hundred and fifty-one children (Mage = 10·74, SDage = 0·97; 50·8 % girls).Results: Structural path models showed that children exposed to the SNI consumed 0·20 less SSB per day compared to those in the control condition (β = 0·25, P = 0·035). There was a trend showing that children exposed to the SNI consumed 0·17 less SSB per day than those in the active control condition (β = 0·20, P = 0·061). No differences were found between conditions for water consumption. However, the moderation effects of descriptive norms (β = -0·12, P = 0·028) and injunctive norms (β = 0·11-0·14, both P = 0·050) indicated that norms are more strongly linked to water consumption in the SNI condition compared to the active control and control conditions.Conclusions: These findings suggest that a SNI promoting healthy drinking behaviours may prevent children from consuming more SSB. Moreover, for water consumption, the prevailing social norms in the context play an important role in mitigating the effectiveness of the SNI. [ABSTRACT FROM AUTHOR]

Background: Policymakers generally lack sufficiently detailed health information to develop localized health policy plans. Chronic disease prevalence mapping is difficult as accurate direct sources are often lacking. Improvement is possible by adding extra information such as medication use and demographic information to identify disease. The aim of the current study was to obtain small geographic area prevalence estimates for four common chronic diseases by modelling based on medication use and socio-economic variables and next to investigate regional patterns of disease.Methods: Administrative hospital records and general practitioner registry data were linked to medication use and socio-economic characteristics. The training set (n = 707,021) contained GP diagnosis and/or hospital admission diagnosis as the standard for disease prevalence. For the entire Dutch population (n = 16,777,888), all information except GP diagnosis and hospital admission was available. LASSO regression models for binary outcomes were used to select variables strongly associated with disease. Dutch municipality (non-)standardized prevalence estimates for stroke, CHD, COPD and diabetes were then based on averages of predicted probabilities for each individual inhabitant.Results: Adding medication use data as a predictor substantially improved model performance. Estimates at the municipality level performed best for diabetes with a weighted percentage error (WPE) of 6.8%, and worst for COPD (WPE 14.5%)Disease prevalence showed clear regional patterns, also after standardization for age.Conclusion: Adding medication use as an indicator of disease prevalence next to socio-economic variables substantially improved estimates at the municipality level. The resulting individual disease probabilities could be aggregated into any desired regional level and provide a useful tool to identify regional patterns and inform local policy. [ABSTRACT FROM AUTHOR]

Study Question: Does septum resection improve reproductive outcomes in women with a septate uterus?Summary Answer: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus.What Is Known Already: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant.Study Design, Size, Duration: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018.Participants/materials, Setting, Methods: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI.Main Results and the Role Of Chance: We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%).Limitations, Reasons For Caution: Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance.Wider Implications Of the Findings: The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery.Study Funding/competing Interest(s): There was no study funding. M.H.E. reports a patent on a surgical endoscopic cutting device and process for the removal of tissue from a body cavity licensed to Medtronic, outside the scope of the submitted work. H.A.v.V. reports personal fees from Medtronic, outside the submitted work. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. M.G. reports several research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the scope of the submitted work. The remaining authors have nothing to declare.Trial Registration Number: Dutch trial registry: NTR 1676.Trial Registration Date: 18 February 2009.Date Of First Patient’s Enrolment: 20 October 2010. [ABSTRACT FROM AUTHOR]

Background During the first wave of the coronavirus disease 2019 (COVID-19) pandemic, older patients had an increased risk of hospitalisation and death. Reports on the association of frailty with poor outcome have been conflicting. Objective The aim of the present study was to investigate the independent association between frailty and in-hospital mortality in older hospitalised COVID-19 patients in the Netherlands. Methods This was a multicentre retrospective cohort study in 15 hospitals in the Netherlands, including all patients aged ≥70 years, who were hospitalised with clinically confirmed COVID-19 between February and May 2020. Data were collected on demographics, co-morbidity, disease severity and Clinical Frailty Scale (CFS). Primary outcome was in-hospital mortality. Results A total of 1,376 patients were included (median age 78 years (interquartile range 74–84), 60% male). In total, 499 (38%) patients died during hospital admission. Parameters indicating presence of frailty (CFS 6–9) were associated with more co-morbidities, shorter symptom duration upon presentation (median 4 versus 7 days), lower oxygen demand and lower levels of C-reactive protein. In multivariable analyses, the CFS was independently associated with in-hospital mortality: compared with patients with CFS 1–3, patients with CFS 4–5 had a two times higher risk (odds ratio (OR) 2.0 (95% confidence interval (CI) 1.3–3.0)) and patients with CFS 6–9 had a three times higher risk of in-hospital mortality (OR 2.8 (95% CI 1.8–4.3)). Conclusions The in-hospital mortality of older hospitalised COVID-19 patients in the Netherlands was 38%. Frailty was independently associated with higher in-hospital mortality, even though COVID-19 patients with frailty presented earlier to the hospital with less severe symptoms. [ABSTRACT FROM AUTHOR]

Background: Hospital readmission after transplantation is common in kidney transplant recipients (KTRs). In this study, we aim to compare the risk of 3-month hospital readmission after kidney transplantation with different donor types in the overall population and in both young (< 65 years) and elderly (≥65 years) KTRs.Methods: We included all first-time adult KTRs from 2016 to 2018 in the Netherlands Organ Transplant Registry. Multivariable logistic regression models were used to estimate the effect while adjusting for baseline confounders.Results: Among 1917 KTRs, 615 (32.1%) had at least one hospital readmission. Living donor kidney transplantation (LDKT) recipients had an adjusted OR of 0.76 (95%CI, 0.61 to 0.96; p = 0.02) for hospital readmission compared to deceased donor kidney transplantation (DDKT) recipients. In the young and elderly, the adjusted ORs were 0.69 (95%CI, 0.52 to 0.90, p = 0.01) and 0.93 (95%CI, 0.62 to 1.39, p = 0.73) and did not differ significantly from each other (p-value for interaction = 0.38). In DDKT, the risk of hospital readmission is similar between recipients with donation after cardiac death (DCD) or brain death (DBD) and the risk was similar between the young and elderly.Conclusion: A lower risk of post-transplant 3-month hospital readmission was found in recipients after LDKT compared to DDKT, and this benefit of LDKT might be less dominant in elderly patients. In DDKT, having either DCD or DBD donors is not associated with post-transplant 3-month hospital readmission, regardless of age. Tailored patient management is needed for recipients with DDKT and elderly KTRs. [ABSTRACT FROM AUTHOR]

Study Question: Is IVF with frozen-thawed blastocyst transfer (freeze-all strategy) more effective than IVF with fresh and frozen-thawed blastocyst transfer (conventional strategy)?Summary Answer: The freeze-all strategy was inferior to the conventional strategy in terms of cumulative ongoing pregnancy rate per woman.What Is Known Already: IVF without transfer of fresh embryos, thus with frozen-thawed embryo transfer only (freeze-all strategy), is increasingly being used in clinical practice because of a presumed benefit. It is still unknown whether this new IVF strategy increases IVF efficacy.Study Design, Size, Duration: A single-centre, open label, two arm, parallel group, randomised controlled superiority trial was conducted. The trial was conducted between January 2013 and July 2015 in the Netherlands. The intervention was one IVF cycle with frozen-thawed blastocyst transfer(s) versus one IVF cycle with fresh and frozen-thawed blastocyst transfer(s). The primary outcome was cumulative ongoing pregnancy resulting from one IVF cycle within 12 months after randomisation. Couples were allocated in a 1:1 ratio to the freeze-all strategy or the conventional strategy with an online randomisation programme just before the start of down-regulation.Participants/materials, Setting, Methods: Participants were subfertile couples with any indication for IVF undergoing their first IVF cycle, with a female age between 18 and 43 years. Differences in cumulative ongoing pregnancy rates were expressed as relative risks (RR) with 95% CI. All outcomes were analysed following the intention-to-treat principle.Main Results and the Role Of Chance: Two-hundred-and-five couples were randomly assigned to the freeze-all strategy (n = 102) or to the conventional strategy (n = 102). The cumulative ongoing pregnancy rate per woman was significantly lower in women allocated to the freeze-all strategy (19/102 (19%)) compared to women allocated to the conventional strategy (32/102 (31%); RR 0.59; 95% CI 0.36-0.98).Limitations, Reasons For Caution: As this was a single-centre study, we were unable to study differences in study protocols and clinic performance. This, and the limited sample size, should make one cautious in using the results as the basis for definitive policy. All patients undergoing IVF, including those with a poor prognosis, were included; therefore, the outcome could differ in women with a good prognosis of IVF treatment success.Wider Implications Of the Findings: Our results indicate that there might be no benefit of a freeze-all strategy in terms of cumulative ongoing pregnancy rates. The efficacy of the freeze-all strategy in subgroups of patients, different stages of embryo development, and different freezing protocols needs to be further established and balanced against potential benefits and harms for mothers and children.Study Funding/competing Interest(s): The Netherlands Organisation for Health Research and Development (ZonMW grant 171101007). S.M., F.M. and M.v.W. stated they are authors of the Cochrane review 'Fresh versus frozen embryo transfers in assisted reproduction'.Trial Registration Number: Dutch Trial Register, NTR3187.Trial Registration Date: 9 December 2011.Date Of First Patient’s Enrolment: 8 January 2013. [ABSTRACT FROM AUTHOR]

Although numerous studies have examined how children raised in same-sex-parented families fare relative to children in different-sex-parented families, this body of work suffers from major methodological shortcomings. By leveraging linked administrative data from several population registers from the Netherlands covering the 2006-2018 period (n = 1,454,577), we overcome most methodological limitations affecting earlier research. The unique features of the data include complete population coverage, reliable identification of same-sex-parented families, a large number of children in same-sex-parented families (n = 3,006), multiple objective and verifiable educational outcomes, and detailed measures of family dynamics over children's entire life courses. The results indicate that children in same-sex-parented families outperform children in different-sex-parented families on multiple indicators of academic performance, including standardized tests scores, high school graduation rates, and college enrollment. Such advantages extend to both male and female children, and are more pronounced among children in female than male same-sex-parented families. These findings challenge deficit models of same-sex parenting. [ABSTRACT FROM AUTHOR]

Study Question: Does assisted reproduction, such as ovarian stimulation and/or laboratory procedures, have impact on perinatal outcomes of singleton live births compared to natural conception in couples with unexplained subfertility?Summary Answer: Compared to natural conception, singletons born after intrauterine insemination with ovarian stimulation (IUI-OS) had a lower birthweight, while singletons born after IVF had comparable birthweights, in couples with unexplained subfertility.What Is Known Already: Singletons conceived by assisted reproduction have different perinatal outcomes such as low birthweight and a higher risk of premature birth than naturally conceived singletons. This might be due to the assisted reproduction, such as laboratory procedures or the ovarian stimulation, or to an intrinsic factor in couples with subfertility.Study Design, Size, Duration: We performed a prospective cohort study using the follow-up data of two randomized clinical trials performed in couples with unexplained subfertility. We evaluated perinatal outcomes of 472 live birth singletons conceived after assisted reproduction or after natural conception within the time horizon of the studies.Participants/materials, Setting, Methods: To assess the possible impact of ovarian stimulation we compared the singletons conceived after IUI with FSH or clomiphene citrate (CC) and IVF in a modified natural cycle (IVF-MNC) or standard IVF with single embryo transfer (IVF-SET) to naturally conceived singletons in the same cohorts. To further look into the possible effect of the laboratory procedures, we put both IUI and IVF groups together into IUI-OS and IVF and compared both to singletons born after natural conception. We only included singletons conceived after fresh embryo transfers. The main outcome was birthweight presented as absolute weight in grams and gestational age- and gender-adjusted percentiles. We calculated differences in birthweight using regression analyses adjusted for maternal age, BMI, smoking, parity, duration of subfertility and child gender.Main Results and the Role Of Chance: In total, there were 472 live birth singletons. Of the 472 singleton pregnancies, 209 were conceived after IUI-OS (136 with FSH and 73 with CC as ovarian stimulation), 138 after IVF (50 after IVF-MNC and 88 after IVF-SET) and 125 were conceived naturally.Singletons conceived following IUI-FSH and IUI-CC both had lower birthweights compared to naturally conceived singletons (adjusted difference IUI-FSH -156.3 g, 95% CI -287.9 to -24.7; IUI-CC -160.3 g, 95% CI -316.7 to -3.8). When we compared IVF-MNC and IVF-SET to naturally conceived singletons, no significant difference was found (adjusted difference IVF-MNC 75.8 g, 95% CI -102.0 to 253.7; IVF-SET -10.6 g, 95% CI -159.2 to 138.1). The mean birthweight percentile was only significantly lower in the IUI-FSH group (-7.0 percentile, 95% CI -13.9 to -0.2). The IUI-CC and IVF-SET group had a lower mean percentile and the IVF-MNC group a higher mean percentile, but these groups were not significant different compared to the naturally conceived group (IUI-CC -5.1 percentile, 95% CI -13.3 to 3.0; IVF-MNC 4.4 percentile, 95% CI -4.9 to 13.6; IVF-SET -1.3 percentile, 95% CI -9.1 to 6.4).Looking at the laboratory process that took place, singletons conceived following IUI-OS had lower birthweights than naturally conceived singletons (adjusted difference -157.7 g, 95% CI -277.4 to -38.0). The IVF group had comparable birthweights with the naturally conceived group (adjusted difference 20.9 g, 95% CI -110.8 to 152.6). The mean birthweight percentile was significantly lower in the IUI-OS group compared to the natural group (-6.4 percentile, 95% CI -12.6 to -0.1). The IVF group was comparable (0.7 percentile, 95% CI -6.1 to 7.6).Limitations, Reasons For Caution: The results are limited by the number of cases. The data were collected prospectively alongside the randomized controlled trials, but analyzed as treated.Wider Implications Of the Findings: Our data suggest IUI in a stimulated cycle may have a negative impact on the birthweight of the child and possibly on pre-eclampsia. Further research should look into the effect of different methods of ovarian stimulation on placenta pathology and pre-eclampsia in couples with unexplained subfertility using naturally conceived singletons in the unexplained population as a reference.Study Funding/competing Interest(s): Both initial trials were supported by a grant from ZonMW, the Dutch Organization for Health Research and Development (INeS 120620027, SUPER 80-83600-98-10192). The INeS study also had a grant from Zorgverzekeraars Nederland, the Dutch association of healthcare insurers (09-003). B.W.J.M. is supported by an NHMRC investigator Grant (GNT1176437) and reports consultancy for ObsEva, Merck Merck KGaA, Guerbet and iGenomix, outside the submitted work. A.H. reports grants from Ferring Pharmaceutical company (the Netherlands), outside the submitted work. F.J.M.B. receives monetary compensation as a member of the external advisory board for Merck Serono (the Netherlands), Ferring Pharmaceutics BV (the Netherlands) and Gedeon Richter (Belgium), he receives personal fees from educational activities for Ferring BV (the Netherlands) and for advisory and consultancy work for Roche and he receives research support grants from Merck Serono and Ferring Pharmaceutics BV, outside the submitted work. The remaining authors have nothing to disclose.Trial Registration Number: INeS study Trial NL915 (NTR939); SUPER Trial NL3895 (NTR4057). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins.Methods: This was a follow-up study of two large randomized controlled trials (PROBAAT-1 and PROBAAT-2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30-mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT-1 and oral misoprostol in PROBAAT-2). Data on subsequent ongoing pregnancies > 16 weeks' gestation were collected from hospital charts from clinics participating in this follow-up study. The main outcome measure was preterm birth < 37 weeks' gestation in a subsequent pregnancy.Results: Fourteen hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 572 had been allocated to induction of labor using a Foley catheter and 570 to induction of labor using prostaglandins. Of these, 162 (14%) were lost to follow-up. In total, 251 and 258 women had a known subsequent pregnancy > 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38-2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30-3.51).Conclusion: In women with term singleton pregnancy, induction of labor using a 30-mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Background: The objective of this work was to analyse the prevalence trends of multimorbidity among European community-dwelling adults.Methods: A temporal series study based on waves 1, 2, 4, 5, 6 and 7 of the Survey of Health, Ageing and Retirement in Europe (SHARE) was conducted, and community-dwelling participants aged 50+ (n = 274,614) from 15 European countries were selected for the period 2004-2017. Prevalence, adjusted by age, Average Annual Percentage Change (APC) and 95% confidence interval (95% CI) were all calculated. Trend analyses were realised by period, age groups and groups of diseases.Results: The results showed a large variability in the prevalence of multimorbidity in adults aged 50 and over among European countries. Increase in the prevalence of multimorbidity in the countries of central Europe (Austria, Belgium, Czech Republic, France, Germany and Switzerland) and Spain in both sexes, and in the Netherlands among men. Stability was observed in northern and eastern European countries. Musculoskeletal and neurodegenerative groups showed more significant changes in the trend analyses.Conclusions: This information can be useful for policy makers when planning health promotion and prevention policies addressing modifiable risk factors in health. [ABSTRACT FROM AUTHOR]

Background: The aging of migrant populations across Europe challenges researchers in palliative care to produce knowledge that can be used to respond to the needs of the growing group of patients with a migration background and address ethnic disparities in palliative care. The aim of this study was to identify what factors influence researchers' efforts to address responsiveness of palliative care to patients with a migration background and other underserved populations in their projects. Methods: We conducted semi-structured interviews with 11 researchers involved in seven projects under the Dutch national program for palliative care innovation. Results: Researchers' efforts to address responsiveness of palliative care in their projects were influenced by individual factors, i.e. awareness of the need for responsiveness to patients with a migration background; experience with responsiveness; and, differences in perceptions on responsiveness in palliative care. Researchers' efforts were furthermore influenced by institutional factors, i.e. the interaction with healthcare institutions and healthcare professionals as they rely on their ability to identify the palliative patient with a migration background, address the topic of palliative care, and enrol these patients in research; scientific standards that limit the flexibility needed for responsive research; and, the responsiveness requirements set by funding agencies. Conclusion: Researchers play a key role in ensuring research addresses responsiveness to patients with a migration background. Such responsiveness may also benefit other underserved populations. However, at times researchers lack the knowledge and experience needed for responsive research. To address this we recommend training in responsiveness for researchers in the field of palliative care. We also recommend training for healthcare professionals involved in research projects to increase enrolment of patients with a migration background and other underrepresented populations. Lastly, we encourage researchers as well as research institutions and funding agencies to allow flexibility in research practices and set a standard for responsive research practice. [ABSTRACT FROM AUTHOR]