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This paper examines the uptake of Rasch measurement in language testing through a consideration of research published in language testing research journals in the period 1984 to 2009. Following the publication of the first papers on this topic, exploring the potential of the simple Rasch model for the analysis of dichotomous language test data, a debate ensued as to the assumptions of the theory, and the place of the model both within Item Response Theory (IRT) more generally and as appropriate for the analysis of language test data in particular. It seemed for some time that the reservations expressed about the use of the Rasch model might prevail. Gradually, however, the relevance of the analyses made possible by multi-faceted Rasch measurement to address validity issues within performance-based communicative language assessments overcame language testing researchers' initial resistance. The paper outlines three periods in the uptake of Rasch measurement in the field, and discusses the research which characterized each period. (Contains 4 tables and 12 notes.)

The Happiness Scale Interval Study deals with survey questions on happiness, using verbal response options, such as "very happy" and "pretty happy". The aim is to estimate what degrees of happiness are denoted by such terms in different questions and languages. These degrees are expressed in numerical values on a continuous [0,10] scale, which are then used to compute "transformed" means and standard deviations. Transforming scores on different questions to the same scale allows to broadening the World Database of Happiness considerably. The central purpose of the Happiness Scale Interval Study is to identify the happiness values at which respondents change their judgment from e.g. "very happy" to "pretty happy" or the reverse. This paper deals with the methodological/statistical aspects of this approach. The central question is always how to convert the frequencies at which the different possible responses to the same question given by a sample into information on the happiness distribution in the relevant population. The primary (cl)aim of this approach is to achieve this in a (more) valid way. To this end, a model is introduced that allows for dealing with happiness as a latent continuous random variable, in spite of the fact that it is measured as a discrete one. The [0,10] scale is partitioned in as many contiguous parts as the number of possible ratings in the primary scale sums up to. Any subject with a (self-perceived) happiness in the same subinterval is assumed to select the same response. For the probability density function of this happiness random variable, two options are discussed. The first one postulates a uniform distribution within each of the different subintervals of the [0,10] scale. On the basis of these results, the mean value and variance of the complete distribution can be estimated. The method is described, including the precision of the estimates obtained in this way. The second option assumes the happiness distribution to be described as a beta distribution on the interval [0,10] with two shape parameters ([alpha] and [beta]). From their estimates on the basis of the primary information, the mean value and the variance of the happiness distribution in the population can be estimated. An illustration is given in which the method is applied to existing measurement results of 20 surveys in The Netherlands in the period 1990-2008. The results clarify our recommendation to apply the model with a uniform distribution within each of the category intervals, in spite of a better validity of the alternative on the basis of a beta distribution. The reason is that the recommended model allows to construct a confidence interval for the true but unknown population happiness distribution. The paper ends with a listing of actual and potential merits of this approach, which has been described here for verbal happiness questions, but which is also applicable to phenomena which are measured along similar lines. (Contains 1 table and 3 figures.)

Background: Current evidence suggests that chlamydia screening programmes can be cost-effective, conditional on assumptions within mathematical models. We explored differences in cost estimates used in published economic evaluations of chlamydia screening from seven countries (four papers each from UK and the Netherlands, two each from Sweden and Australia, and one each from Ireland, Canada and Denmark).Methods: From these studies, we extracted management cost estimates for seven major chlamydia sequelae. In order to compare the influence of different sequelae considered in each paper and their corresponding management costs on the total cost per case of untreated chlamydia, we applied reported unit sequelae management costs considered in each paper to a set of untreated infection to sequela progression probabilities. All costs were adjusted to 2013/2014 Great British Pound (GBP) values.Results: Sequelae management costs ranged from £171 to £3635 (pelvic inflammatory disease); £953 to £3615 (ectopic pregnancy); £546 to £6752 (tubal factor infertility); £159 to £3341 (chronic pelvic pain); £22 to £1008 (epididymitis); £11 to £1459 (neonatal conjunctivitis) and £433 to £3992 (neonatal pneumonia). Total cost of sequelae per case of untreated chlamydia ranged from £37 to £412.Conclusions: There was substantial variation in cost per case of chlamydia sequelae used in published chlamydia screening economic evaluations, which likely arose from different assumptions about disease management pathways and the country perspectives taken. In light of this, when interpreting these studies, the reader should be satisfied that the cost estimates used sufficiently reflect the perspective taken and current disease management for their respective context. [ABSTRACT FROM AUTHOR]

Self-evaluation is supposed to be a valid, reliable and easy-to-use instrument to commit professionals to external quality assurance. The writing of a self-evaluation report is the first step in most higher education accreditation systems all over the world. Research on accreditation in the Netherlands and Flanders shows that professionals consider the writing of a self-evaluation report to be a very complex and time-consuming activity. Furthermore, there is a serious risk of "dramaturgical compliance". The research suggests that writing a self-evaluation report should not be part of a compulsory external quality assurance system. It is not a reliable instrument for control. Self-evaluation can be used for internal quality management, where it can be a powerful instrument for improvement. (Contains 1 figure and 6 tables.)

This paper presents the methods and the main results of the 6 studies which were conducted in order to test the validity of the comprehensive model of educational effectiveness. The synthesis of these studies reveals that some support to the model has been provided. It is also demonstrated that 2 characteristics of the comprehensive model concerned with its multilevel nature can be seen as starting points for the development of the dynamic model of effectiveness, which is able to establish strong links between effectiveness research and improvement of practice. Finally, the results of these studies reveal the importance of 4 elements of the dynamic model concerned with its attempt to (a) use a framework to measure the functioning of effectiveness factors, (b) take into account new theories of learning in defining classroom-level factors, (c) incorporate results of differential effectiveness research, and (d) illustrate the dynamic perspective of effectiveness. (Contains 1 table.)

The evaluation of government-financed research has become increasingly important in the last few decades in terms of increasing the quality of, and payoff from, the research that is done, reducing the cost of doing it, and lending public credibility to the manner in which research is funded. But there are very large differences throughout the world in the extent to which systems used promote these results. This paper briefly presents the dimensional results of a study designed to comparatively evaluate the national-level research evaluation models in sixteen countries on five merit-defining dimensions. (Contains 6 figures.)

Introduction: The Netherlands Study of Depression and Anxiety (NESDA, www.nesda.nl) is a longitudinal, multi-site, naturalistic, case-control cohort study set up to examine the etiology, course and consequences of depressive and anxiety disorders. This paper presents a cohort profile of NESDA.Methods and Results: The NESDA sample recruited initially 2329 persons with a remitted or current DSM-IV based depressive (major depressive disorder, dysthymia) and/or anxiety disorder (panic disorder, social phobia, agoraphobia, generalized anxiety disorder), 367 of their siblings and 652 healthy controls, yielding a total of 3348 participants. Half-day face-to-face assessments of participants started in 2004 and since then have been repeated six times over a period of 9 years. A 13-year follow-up assessment is ongoing, at what time we also recruit offspring of participants. Retention rates are generally high, ranging from 87.1% (after 2 years) to 69.4% (after 9 years). Psychiatric diagnostic interviews have been administered at all face-to-face assessments, as was monitoring of clinical characteristics, psychosocial functioning and somatic health. Assessed etiological factors include e.g. early and current environmental risk factors, psychological vulnerability and resilience factors as well as (neuro)biology through hypothesis-driven biomarker assessments, genome-wide and large-scale '-omics' assessments, and neuroimaging assessments.Limitations: The naturalistic design allows research into course and consequences of affective disorders but is limited in treatment response interpretation.Conclusions: NESDA provides a strong research infrastructure for research into depressive and/or anxiety disorders. Its data have been used for many scientific papers describing either NESDA-based analyses or joint collaborative consortia-projects, and are in principle available to researchers outside the NESDA consortium. [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]

Background: Clinical Ethics Support (CES) services are offered to support healthcare professionals in dealing with ethically difficult situations. Evaluation of CES is important to understand if it is indeed a supportive service in order to inform and improve future implementation of CES. Yet, methods to measure outcomes of CES are scarce. In 2014, the European Moral Case Deliberation Outcomes Instrument (Euro-MCD) was developed to measure outcomes of Moral Case Deliberation (MCD). To further validate the instrument, we tested it in field studies and revised it. This paper presents the Euro-MCD 2.0 and describes the revision process.Methods: The revision process comprised an iterative dialogue among the authors as Euro-MCD-project team, including empirical findings from six Euro-MCD field-studies and input from European experts in CES and theory. Empirical findings contained perceptions and experiences of MCD outcomes among healthcare professionals who participated in MCDs in various settings in Norway, Sweden and the Netherlands. Theoretical viewpoints on CES, literature on goals of CES and MCD and ethics theory guided the interpretation of the empirical findings and final selection of MCD outcomes.Results: The Euro-MCD 2.0 Instrument includes three domains: Moral Competence, Moral Teamwork and Moral Action. Moral Competence consists of items about moral sensitivity, analytical skills and virtuous attitude. Moral Teamwork includes open dialogue and supportive relationships and Moral Action refers to moral decision-making and responsible care. During the revision process, we made decisions about adding and reformulating items as well as decreasing the number from 26 to 15 items. We also altered the sentence structure of items to assess the current status of outcomes (e.g. 'now') instead of an assumed improvement over time (e.g. 'better') and we omitted the question about perceived importance.Conclusions: The Euro-MCD 2.0 is shorter, less complex and more strongly substantiated by an integration of empirical findings, theoretical reflections and dialogues with participants and experts. Use of the Euro-MCD 2.0 will facilitate evaluation of MCD and can thereby monitor and foster implementation and quality of MCD. The Euro-MCD 2.0 will strengthen future research on evaluation of outcomes of MCD. [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]

A literature review was carried out to identify pre and perinatal characteristics associated with variation in Apgar scores in population-based studies. The parameters identified in the literature search were included in the classical twin design study to estimate effects of pre and perinatal factors shared and nonshared by twins and to test for a contribution of genetic factors in 1- and 5-min Apgar scores in a large sample of Dutch monozygotic (MZ) and dizygotic (DZ) twins. The sample included MZ and DZ twins (N = 5181 pairs) recruited by the Netherlands Twin Register shortly after birth, with data on prenatal characteristics and Apgar scores at first and/or fifth minutes. The ordinal regression and structural equation modeling were used to analyze the effects of characteristics identified in the literature review and to estimate genetic and nongenetic variance components. The literature review identified 63 papers. Consistent with the review, we observed statistically significant effects of birth order, zygosity and gestational age (GA) for 1- and 5-min Apgar scores of both twins. Apgar scores are higher in first-born versus second-born twins and DZ first-born versus MZ first-born twins. Birth weight had an effect on the 5-min Apgar of the first born. Fetal presentation and mode of delivery had different effects on Apgar scores of first- and second-born twins. Parental characteristics and chorionicity did not have significant main effects on Apgar scores. The MZ twins' Apgar correlations equaled the DZ Apgar correlations. Our analyses suggest that individual differences in 1- and 5-min Apgar scores are attributable to shared and nonshared pre and perinatal factors, but not to genotypic factors of the newborns. The main predictors of Apgar scores are birth order, zygosity, GA, birth weight, mode of delivery and fetal presentation. [ABSTRACT FROM AUTHOR]

The objective of the paper is to assess the cost-effectiveness of targeted respiratory syncytial virus (RSV) prophylaxis based on a validated prediction rule with 1-year time horizon in moderately preterm infants compared to no prophylaxis. Data on health care consumption were derived from a randomised clinical trial on wheeze reduction following RSV prophylaxis and a large birth cohort study on risk prediction of RSV hospitalisation. We calculated the incremental cost-effectiveness ratio (ICER) of targeted RSV prophylaxis vs. no prophylaxis per quality-adjusted life year (QALYs) using a societal perspective, including medical and parental costs and effects. Costs and health outcomes were modelled in a decision tree analysis with sensitivity analyses. Targeted RSV prophylaxis in infants with a first-year RSV hospitalisation risk of > 10% resulted in a QALY gain of 0.02 (0.931 vs. 0.929) per patient against additional cost of €472 compared to no prophylaxis (ICER €214,748/QALY). The ICER falls below a threshold of €80,000 per QALY when RSV prophylaxis cost would be lowered from €928 (baseline) to €406 per unit. At a unit cost of €97, RSV prophylaxis would be cost saving.Conclusions: Targeted RSV prophylaxis is not cost-effective in reducing RSV burden of disease in moderately preterm infants, but it can become cost-effective if lower priced biosimilar palivizumab or a vaccine would be available. [ABSTRACT FROM AUTHOR]

This paper estimates the impact of early retirement on mortality using Dutch administrative micro panel data. An unexpected temporary decrease in the eligibility age for retirement benefits for civil servants is used to instrument the retirement choice. We find that induced early retirement decreased the probability that a man dies within 5 years by 2.6 percentage points. The result is robust to alternative specifications and data selection criteria. [ABSTRACT FROM AUTHOR]

Health state valuations of patients and non-patients are not the same, whereas health state values obtained from general population samples are a weighted average of both. The latter constitutes an often-overlooked source of bias. This study investigates the resulting bias and tests for the impact of reference dependency on health state valuations using an efficient discrete choice experiment administered to a Dutch nationally representative sample of 788 respondents. A Bayesian discrete choice experiment design consisting of eight sets of 24 (matched pairwise) choice tasks was developed, with each set providing full identification of the included parameters. Mixed logit models were used to estimate health state preferences with respondents' own health included as an additional predictor. Our results indicate that respondents with impaired health worse than or equal to the health state levels under evaluation have approximately 30% smaller health state decrements. This confirms that reference dependency can be observed in general population samples and affirms the relevance of prospect theory in health state valuations. At the same time, the limited number of respondents with severe health impairments does not appear to bias social tariffs as obtained from general population samples. Copyright © 2016 John Wiley & Sons, Ltd. [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]

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]

Purpose -- The purpose of this paper is to describe the development and application of the KIPP-list of care activities. The acronym KIPP stands for Knowledge and Insight into Primary Processes. The instrument is intended as a tool for family coaches to systematically report care activities conducted in the Dutch family support programme Ten for the Future (in Dutch: Tien voor Toekomst). Design/methodology/approach -- The design of the instrument was based on the components of the programme and a literature search for similar instruments used in the Netherlands, complemented by a staff survey. A series of three studies was carried out to test the instrument's validity and user-friendliness, and to assess its potential for programme evaluation. Findings -- The majority of care activities were performed in cooperation with one or both parents alone, and less frequently with children or external professionals. Although the main focus of the work of the family coaches fell into the categories of "collecting information" and "working towards (behavioural) change" with families, the relatively high frequency of all the types of care contacts emphasises the intensity of this family support programme with a complex target group. Originality/value -- Data gathered with the instrument provided meaningful information by descriptive analysis. KIPP thereby proved its general feasibility in increasing insight into service provision. The instrument can be useful in several stages and on several levels of quality assurance and service optimisation, including reflective practice, supervision, team management and research. [ABSTRACT FROM AUTHOR]

In the late 1980s The Netherlands Twin Register (NTR) was established by recruiting young twins and multiples at birth and by approaching adolescent and young adult twins through city councils. The Adult NTR (ANTR) includes twins, their parents, siblings, spouses and their adult offspring. The number of participants in the ANTR who take part in survey and / or laboratory studies is over 22,000 subjects. A special group of participants consists of sisters who are mothers of twins. In the Young NTR (YNTR), data on more than 50,000 young twins have been collected. Currently we are extending the YNTR by including siblings of twins. Participants in YNTR and ANTR have been phenotyped every 2 to 3 years in longitudinal survey studies, since 1986 and 1991 for the YNTR and ANTR, respectively. The resulting large population-based datasets are used for genetic epidemiological studies and also, for example, to advance phenotyping through the development of new syndrome scales based on existing items from other inventories. New research developments further include brain imaging studies in selected and unselected groups, clinical assessment of psychopathology through interviews, and cross-referencing the NTR database to other national databases. A large biobank enterprise is ongoing in the ANTR in which blood and urine samples are collected for genotyping, expression analysis, and metabolomics studies. In this paper we give an update on the YNTR and ANTR phenotyping and on the ongoing ANTR biobank studies. [ABSTRACT FROM AUTHOR]

Objectives: Demand-oriented care has recently become a key topic in the area of care provision, fitting into the modern pursuit for patient autonomy. This paper introduces a measuring instrument to assess demand-orientation in mental health care.Method: A concept mapping procedure was used to understand the concept of demand-orientation. The resulting items were introduced to a validating sample of 204 patients of three mental health facilities. After factor analysis, a 19-item General-Demand Orientated Care Questionnaire (DOC-G), and a supplementary questionnaire (DOC-S) containing 6 sections remained. This questionnaire was submitted to confirmatory analysis in a random sample (n = 304) of psychiatric patients.Results: Respondents were predominantly female (57.6%), of Dutch ethnic origin (84.1%), and outpatients (71.4%). The analyses confirmed the 4-factor structure of the questionnaire. Both internal and external validity of the instrument proved to be sufficient. The questionnaire discriminated in the experience of demand-orientation of care between patients who did and those who did not have a treatment plan put up; between those who did and those who did not have a crisis plan, and between those who had a lifetime prevalence of undergoing compulsory treatment, and those who had not.Conclusions: We conclude that the DOC is a useful instrument to measure demand-orientation in a population of psychiatric patients. It is useful to measure changes in care quality. The supplementary questionnaires make it possible to evaluate chosen projects or subprojects quickly. [ABSTRACT FROM AUTHOR]

Objective: OpenSDE is an application that supports structured recording of narrative patient data to enable use of the data in both clinical practice and clinical research. Reliability and accuracy of collected data are essential for subsequent data use. In this study we analyze the uniformity of data entered with OpenSDE. Our objective is to obtain insight into the consensus and differences of recorded data.Methods: Three pediatricians transcribed 20 paper patient records using OpenSDE. The transcribed records were compared and all recorded findings were classified into one of six categories of difference.Results: Of all findings 22% were recorded identically; 17% of the findings were recorded differently (predominantly as free text); 61% was omitted, inferred, or in conflict with the paper record.Conclusion: The results of this study show that recording patient data using structured data entry does not necessarily lead to uniformly structured data. [ABSTRACT FROM AUTHOR]

Background: Total extraperitoneal (TEP) laparoscopic inguinal hernia repair is preferred to the transabdominal preperitoneal (TAPP) repair since it preserves peritoneal integrity. However, in general it is considered to be more difficult than the latter because of the peculiarity of anatomy and limitation of working space. Therefore it has been assigned with a "steep learning curve" that the surgeon needs to climb steadily and slowly. This paper offers a working protocol, which is aimed at reducing the steep limb of this curve.Methods: A total of 61 patients were studied between April 2000 and September 2002. Of these, five patients had a open unilateral Stoppa's preperitoneal operation to learn the detailed anatomy of the extraperitoneal space. Thereafter, laparoscopic TEP procedure was started in the following 56 cases by P.L. In case of difficulty, the procedure was to be converted to the open preperitoneal operation only. Of the first 10 cases, five were converted to unilateral Stoppa's preperitoneal operation for various reasons, and one case was converted after 30 cases. Thus a total of 11 cases were completed by open unilateral Stoppa's preperitoneal operation and 50 cases were completed laparoscopically. The first 30 cases started initially as laparoscopic operations were analyzed in groups of 10 each and compared to another study from Netherlands (evaluating four surgeons) wherein the initial laparoscopic procedures were started with the assistance of a surgeon well experienced in laparoscopic TEP operation.Results: The comparison of our first 30 cases with the Netherlands group showed that while the conversions (five cases) to open operation were higher in the first 10 cases, there were no conversions in the next 20 cases. Also, there were no complications or recurrences in the present study, in striking contrast to three recurrences and 10 complications in the comparative study. The following 26 cases were associated with no recurrence or major complication.Conclusion: In this study we performed a total of 11 open unilateral Stoppa's preperitoneal procedures in our attempt to learn the anatomy of this extraperitoneal space better, and in the absence of any surgeon experienced in laparoscopic TEP procedure. We were able to place a large mesh in each and every case and also recognize double hernias in six cases, thus preventing recurrences and complications. We strongly recommend a minimum of 10 open Stoppa's preperitoneal procedures, to enable a trained laparoscopic surgeon to start laparoscopic TEP operation independently and in the absence of another trained laparoscopic hernia surgeon, whose presence may not prevent complications and recurrences. [ABSTRACT FROM AUTHOR]

Background: We implemented a comprehensive intervention program targeting general practice staff, that proved successful in optimizing practice organization and clinical decision-making. In this paper, health-related quality of life (HRQL) is investigated as a clinical outcome.Objective: To evaluate the effect of the implementation of an intervention program on the HRQL in patients at high cardiovascular risk.Research Design: Randomized controlled trial. Intervention practices (n = 62) received a comprehensive intervention program (by means of outreach visitors) lasting 21 months. HRQL of patients at high cardiovascular risk was assessed by the MOS 36-Item Short-Form Health Survey (SF-36), at baseline and after intervention. Three patient categories were distinguished: diabetes mellitus, cardiovascular disease and hypertension.Results: HRQL deteriorated in all respondents, but more pronounced in the control group. In diabetes patients the differences between intervention and control group were significant for the Vitality and Mental Health scales, with mean difference in change of 3.93 (95% CI: 1.08-6.78) and 3.71 (95% CI: 0.73-6.68), respectively. Patients with cardiovascular disease had significantly different changes on three scales: physical functioning (3.57, 95% CI: 0.71-6.43), vitality (3.01, 95% CI: 0.72-5.30) and social functioning (3.96, 95% CI: 0.50-7.42). In patients with hypertension, there were no differences between the intervention and control group.Conclusion: Our comprehensive intervention program resulted in changes in HRQL on several domains, particularly in patients with diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

Background: Several countries have reported an increase in life expectancy at advanced ages. This paper analyses recent changes in life expectancy at age 60 and 85 in The Netherlands, a low mortality country with reliable mortality data.Methods: We used data on the population and the number of deaths by age, sex and underlying cause of death for 1970-1994. Life expectancy at age 60 and 85 was estimated using standard life-table techniques. The contribution of different ages and causes of death to the change in life expectancy during the 1970s (1970/74-1980/84) and the 1980s (1980/84-1990/94) were estimated with a decomposition technique developed by Arriaga.Results: Life expectancy at age 60 increased in the 1970s and 1980s, whereas life expectancy at age 85 decreased (men) and stagnated (women) in the 1980s, and has decreased in both sexes since 1985/89. The decomposition by age showed that constant mortality rates in women aged 85-89, and increasing mortality rates at ages 85+ (men) and 90+ (women) have caused this lack of increase in life expectancy. The decomposition by cause of death showed that smaller mortality reductions from other cardiovascular and cerebrovascular diseases, which contributed most to the increase in life expectancy at age 85 in the 1970s, and mortality increases from, amongst others, chronic obstructive pulmonary disease (COPD), mental disorders and diabetes mellitus produced the decrease (men) and plateau (women) in life expectancy at age 85.Conclusions: Life expectancy at advanced ages stopped increasing during the 1980s in The Netherlands due to mortality increases at ages 85+ (men) and 90+ (women). Cause-specific trends suggest that, in addition to (past) smoking behaviour in men, changes in the distribution of morbidity and frailty in the population might have contributed to this stagnation. [ABSTRACT FROM AUTHOR]

Objectives: Little direction exists on how to effectively implement palliative care for patients with COPD. In the COMPASSION study, we developed, executed, and evaluated a multifaceted implementation strategy to improve the uptake of region-tailored palliative care intervention components into routine COPD care. We evaluated the implementation strategy and assessed the implementation process, barriers, and facilitators. Methods: A mixed methods process evaluation was performed. Primary and secondary healthcare providers in four hospital regions in the Netherlands were trained. Patients identified during hospitalisation for an acute exacerbation received palliative care and were followed for a year. Various sources were used: process data, questionnaires including the End-of-life Professional Caregiver Survey (EPCS), medical records, monitoring meetings, and interviews. The Consolidated Framework of Implementation Research (CFIR) was used to categorize implementation determinants. Results: The training sessions with roleplay were positively evaluated and increased professionals' self-efficacy in providing palliative care statistically significantly. Of 98 patients identified, 44 (44.9%) received one or more palliative care conversations at the outpatient clinic. Having those conversations was highly valued by healthcare providers because it led to clarity and peace of mind for the patient and higher job satisfaction. Coordination and continuity remained suboptimal. Most important barriers to implementation were time constraints, the COVID-19 pandemic, and barriers related to transmural and interdisciplinary collaboration. Facilitators were the systematic screening of patients for palliative care needs, adapting to the patient's readiness, conducting palliative care conversations with a pulmonologist and a COPD nurse together, and meeting regularly with a small team led by a dedicated implementation leader. Conclusions: Providing integrated palliative care for patients with COPD is highly valued by healthcare providers but remains challenging. Our findings will guide future implementation efforts. Future research should focus on how to optimize transmural and interdisciplinary collaboration. Trial registration The COMPASSION study is registered in the Netherlands Trial Register (NTR): NL7644. Registration date: 07/04/2019. [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]

Background/aims: Patient-reported outcomes (PROs) are increasingly considered important. We developed a web-based application to electronically assess PROs in routine dermatological practice. We assessed (1) the relevance of PRO measurement according to health care providers and patients, (2) the feasibility of our application in routine practice according to health care providers, supporting staff and patients, and (3) barriers/facilitators for implementation according to health care providers and supporting staff. Methods: Health care providers, supporting staff and patients completed study-specific questionnaires. Also, website statistics were analysed. Results: 3/6 clinics participated, including 9 professionals and 80 patients. Both health care providers and patients rated PRO measurement as relevant. However, implementation was only moderately feasible. Time constraints and logistical problems were mentioned as barriers, and motivated patients and supportive staff as facilitators. Conclusion: Electronic PRO assessment in routine practice is not self-evident. Adjustments in logistics are recommended to optimize implementation, using a plan-do-study-act approach. [ABSTRACT FROM AUTHOR]

This paper is the first to apply prospect theory to societal health-related decision making. In particular, we allow for utility curvature, equity weighting, sign-dependence, and loss aversion in choices concerning quality of life of other people. We find substantial inequity aversion, both for gains and losses, which can be attributed to both diminishing marginal utility and differential weighting of better-off and worse-off. There are also clear framing effects, which violate expected utility. Moreover, we observe loss aversion, indicating that subjects give more weight to one group's loss than another group's gain of the same absolute magnitude. We also elicited some information on the effect of the age of the studied group. The amount of inequity aversion is to some extent influenced by the age of the considered patients. In particular, more inequity aversion is observed for gains of older people than gains of younger people. [ABSTRACT FROM AUTHOR]

Background: CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment.Methods: In this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m2). PROs (calculated from EQ-5D-5L, and EORTC QLQ-C30 and QLQ-CR29) were compared between baseline and 1 and 4 weeks after the first three procedures using linear mixed modeling with determination of clinical relevance (Cohen's D ≥ 0.50) of statistically significant differences.Results: Twenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure.Conclusions: Patients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure.Trial Registration: Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426. [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]

Abstract: Purpose: Providing access to patient information is the key factor in nurses’ adoption of a Nursing Information System (NIS). In this study the requirements for information quality and the perceived quality of information are investigated. A teaching hospital in the Netherlands has developed a NIS as a module of the Hospital Information System. After the NIS was implemented in six wards in March 2009, the NIS was evaluated. Methods: A paper questionnaire was distributed among all 195 nurses, who used the system. Included in the research were 93 (48%) respondents. Also twelve NIS-users were interviewed, using the USE IT-model. Results: Nurses express a broad need for information of each patient. Although the history is essential, the information needs are not very specified. They expect complete, correct, up-to-date and accessible information of each patient. The information quality of the NIS is satisfactory, but needs improvement. Since the achieved quality of information depends largely on the data-entry by the nurses themselves, a controversy exists between the required information quality and the effort needed to accomplish this. Conclusions: The aspect of data-entry by the user of the information is not included in Information Quality-literature. To further increase the quality of information, a redesign of both process and system seems necessary, which reduces the information needs of nurses and rewards the nurse for accurate data-entry. [Copyright &y& Elsevier]

Summary: This paper describes five recent Dutch studies of the effectiveness of physical activity interventions carried out in diverse settings: general practice (GP), aged care facilities, and workplaces. The stage-based physical activity counselling carried out in the GP setting demonstrated a beneficial effect on the determinants of physical activity, but did not show any additional effect on physical activity behaviour, compared with standard physical activity advice. In contrast, the stage-based intervention through the workplace was effective in increasing physical activity, due mostly to an increase in vigorous-intensity activities. In the aged care setting, functional-skills training alone or in combination with resistance training showed functional improvement only in participants with high participation rates. Functional-skills training appeared to be more feasible than resistance training in this population of frail elderly. The two studies which aimed to promote earlier return-to-work among workers with sick leave due to non-specific low back pain also showed promising results. As a result, it was recommended that occupational physicians (OP) should refer workers with low back pain in the subacute phase of their sick leave to a low intensity intervention consisting of short meetings and exercises aimed at changing behaviour, and that the OPs contact other health care providers (GPs and physiotherapists) about the treatment strategy. Together, the results of these five Dutch studies suggest that it is feasible to successfully promote physical activity to groups of people in diverse places, with benefits in terms of both prevention and management of chronic disease and injury. [Copyright &y& Elsevier]

Objective: We developed AsthmaCritic, a non-inquisitive critiquing system integrated with the general practitioners' electronic medical records. The system is based on the guidelines for asthma and chronic obstructive pulmonary disease (COPD) as issued by the Dutch College of General Practitioners. This paper assesses the effect of AsthmaCritic on monitoring and treatment of asthma and COPD by Dutch general practitioners in daily practice.Methods: A randomized clinical trial in 32 practices (40 Dutch general practitioners) using electronic patient records. An intervention group was given the use of AsthmaCritic, a control group continued working in the usual manner. Both groups had the disposal of the asthma and COPD guidelines routinely distributed by the Dutch College of General Practitioners. We measured the average number of contacts, FEV 1 (forced expiratory volume), and peak-flow measurements per asthma/COPD patient per practice; and, the average number of antihistamine, cromoglycate, deptropine, and oral bronchodilator prescriptions per asthma/COPD patient per practice.Results: The number of contacts increased in the age group of 12-39 years. The number of FEV1 , peak-flow measurements, and the ratio of coded measurements increased, whereas the number of cromoglycate prescriptions decreased in the age group of 12-39 years.Conclusions: Our study shows that the guideline-based critiquing system AsthmaCritic changed the manner in which the physicians monitored their patients and, to a lesser extent, their treatment behavior. In addition, the physicians changed their data-recording habits. [ABSTRACT FROM AUTHOR]

Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions. [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: Poor social health is likely associated with cognitive decline and risk of dementia; however, studies show inconsistent results. Additionally, few studies separate social health components or control for mental health.Objective: To investigate whether loneliness and social support are independently associated with cognitive decline and risk of dementia, and whether depressive symptoms confound the association.Methods: We included 4,514 participants from the population-based Rotterdam Study (RS; aged 71±7SD years) followed up to 14 years (median 10.8, interquartile range 7.4-11.6), and 2,112 participants from the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K; aged 72±10SD years) followed up to 10 years (mean 5.9±1.6SD). At baseline, participants were free of major depression and scored on the Mini-Mental State Examination (MMSE) ≥26 for RS and ≥25 for SNAC-K. We investigated loneliness, perceived social support, and structural social support (specifically marital status and number of children). In both cohorts, dementia was diagnosed and cognitive function was repeatedly assessed with MMSE and a global cognitive factor (g-factor).Results: Loneliness was prospectively associated with a decline in the MMSE in both cohorts. Consistently, persons who were lonely had an increased risk of developing dementia (RS: HR 1.34, 95%CI 1.08-1.67; SNAC-K: HR 2.16, 95%CI 1.12-4.17). Adjustment for depressive symptoms and exclusion of the first 5 years of follow-up did not alter results. Neither perceived or structural social support was associated with cognitive decline or dementia risk.Conclusion: Loneliness, not social support, predicted cognitive decline and incident dementia independently of depressive symptoms. [ABSTRACT FROM AUTHOR]

It may seem paradoxical to speak of the 'good life' for demented elderly. Many people consider dementia to be a life-wrecking disease and nursing homes to be terrible places. Still, it is relevant to ask how we can make life as good as possible for demented nursing home residents. This paper explores what three standard philosophical accounts of well-being--subjective preference theory, objectivist theories, and hedonism--have to say about the good life for demented people. It is concluded that the relevant differences between the various philosophical theories manifest themselves not so much in their general account of the substantial content of 'the good life' but in a number of specific controversies. These concern the nature of well-being, the necessity of endorsement by the patient, the value of experience and the need for experiences to be rooted in reality. Moreover, it is argued that further research should pay detailed attention to the process of dementia and to the effects of this process on patients' identities, self-conceptions, capacities, preferences, values and the like, and that a narrative approach which incorporates the factor time may offer a more comprehensive account of the good life for demented elderly. [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]

Objective: To study the effects of a comprehensive secondary prevention programme on weight loss and to identify determinants of weight change in patients with coronary artery disease (CAD).Methods: We performed a secondary analysis focusing on the subgroup of overweight CAD patients (BMI ≥27 kg/m2) in the Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists-2 (RESPONSE-2) multicentre randomised trial. We evaluated weight change from baseline to 12-month follow-up; multivariable logistic regression with backward elimination was used to identify determinants of weight change.Results: Intervention patients (n=280) lost significantly more weight than control patients (n=257) (-2.4±7.1 kg vs -0.2±4.6 kg; p<0.001). Individual weight change varied widely, with weight gain (≥1.0 kg) occurring in 36% of interventions versus 41% controls (p=0.21). In the intervention group, weight loss of ≥5% was associated with higher age (OR 2.94), lower educational level (OR 1.91), non-smoking status (OR 2.92), motivation to start with weight loss directly after the baseline visit (OR 2.31) and weight loss programme participation (OR 3.33), whereas weight gain (≥1 kg) was associated with smoking cessation ≤6 months before or during hospitalisation (OR 3.21), non-Caucasian ethnicity (OR 2.77), smoking at baseline (OR 2.70), lower age (<65 years) (OR 1.47) and weight loss programme participation (OR 0.59).Conclusion: The comprehensive secondary prevention programme was, on average, effective in achieving weight loss. However, wide variation was observed. As weight gain was observed in over one in three participants in both groups, prevention of weight gain may be as important as attempts to lose weight.Trial Registration Number: NTR3937. [ABSTRACT FROM AUTHOR]