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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]

Background: BERT models have seen widespread use on unstructured text within the clinical domain. However, little to no research has been conducted into classifying unstructured clinical notes on the basis of patient lifestyle indicators, especially in Dutch. This article aims to test the feasibility of deep BERT models on the task of patient lifestyle classification, as well as introducing an experimental framework that is easily reproducible in future research. Methods: This study makes use of unstructured general patient text data from HagaZiekenhuis, a large hospital in The Netherlands. Over 148 000 notes were provided to us, which were each automatically labelled on the basis of the respective patients' smoking, alcohol usage and drug usage statuses. In this paper we test feasibility of automatically assigning labels, and justify it using hand-labelled input. Ultimately, we compare macro F1-scores of string matching, SGD and several BERT models on the task of classifying smoking, alcohol and drug usage. We test Dutch BERT models and English models with translated input. Results: We find that our further pre-trained MedRoBERTa.nl-HAGA model outperformed every other model on smoking (0.93) and drug usage (0.77). Interestingly, our ClinicalBERT model that was merely fine-tuned on translated text performed best on the alcohol task (0.80). In t-SNE visualisations, we show our MedRoBERTa.nl-HAGA model is the best model to differentiate between classes in the embedding space, explaining its superior classification performance. Conclusions: We suggest MedRoBERTa.nl-HAGA to be used as a baseline in future research on Dutch free text patient lifestyle classification. We furthermore strongly suggest further exploring the application of translation to input text in non-English clinical BERT research, as we only translated a subset of the full set and yet achieved very promising results. [ABSTRACT FROM AUTHOR]

Background: This study takes on the challenge of quantifying a complex causal loop diagram describing how poverty and health affect each other, and does so using longitudinal data from The Netherlands. Furthermore, this paper elaborates on its methodological approach in order to facilitate replication and methodological advancement. Methods: After adapting a causal loop diagram that was built by stakeholders, a longitudinal structural equation modelling approach was used. A cross-lagged panel model with nine endogenous variables, of which two latent variables, and three time-invariant exogenous variables was constructed. With this model, directional effects are estimated in a Granger-causal manner, using data from 2015 to 2019. Both the direct effects (with a one-year lag) and total effects over multiple (up to eight) years were calculated. Five sensitivity analyses were conducted. Two of these focus on lower-income and lower-wealth individuals. The other three each added one exogenous variable: work status, level of education, and home ownership. Results: The effects of income and financial wealth on health are present, but are relatively weak for the overall population. Sensitivity analyses show that these effects are stronger for those with lower incomes or wealth. Physical capability does seem to have strong positive effects on both income and financial wealth. There are a number of other results as well, as the estimated models are extensive. Many of the estimated effects only become substantial after several years. Conclusions: Income and financial wealth appear to have limited effects on the health of the overall population of The Netherlands. However, there are indications that these effects may be stronger for individuals who are closer to the poverty threshold. Since the estimated effects of physical capability on income and financial wealth are more substantial, a broad recommendation would be that including physical capability in efforts that are aimed at improving income and financial wealth could be useful and effective. The methodological approach described in this paper could also be applied to other research settings or topics. [ABSTRACT FROM AUTHOR]

Background: The effects of many treatments in healthcare are determined by factors other than the treatment itself. Patients' expectations and the relationship with their healthcare provider can significantly affect treatment outcomes and thereby play a major role in eliciting placebo and nocebo effects. We aim to develop and evaluate an innovative communication training, consisting of an e-learning and virtual reality (VR) training, for healthcare providers across all disciplines, to optimize placebo and minimize nocebo effects through healthcare provider-patient communication. The current paper describes the development, mid-term evaluation, optimization, and final evaluation of the communication training, conducted in The Netherlands. Methods: The development of both the e-learning and the VR training consisted of four phases: 1) content and technical development, 2) mid-term evaluation by healthcare providers and placebo/communication researchers, 3) optimization of the training, and 4) final evaluation by healthcare providers. To ensure the success, applicability, authenticity, and user-friendliness of the communication training, there was ongoing structural collaboration with healthcare providers as future end users, experts in the field of placebo/communication research, and educational experts in all phases. Results: Placebo/communication researchers and healthcare providers evaluated the e-learning positively (overall 7.9 on 0–10 scale) and the content was perceived as useful, accessible, and interesting. The VR training was assessed with an overall 6.9 (0–10 scale) and was evaluated as user-friendly and a safe method for practicing communication skills. Although there were some concerns regarding the authenticity of the VR training (i.e. to what extent the virtual patient reacts like a real patient), placebo and communication researchers, as well as healthcare providers, recognized the significant potential of the VR training for the future. Conclusions: We have developed an innovative and user-friendly communication training, consisting of an e-learning and VR training (2D and 3D), that can be used to teach healthcare providers how to optimize placebo effects and minimize nocebo effects through healthcare provider-patient communication. Future studies can work on improved authenticity, translate the training into other languages and cultures, expand with additional VR cases, and measure the expected effects on providers communication skills and subsequently patient outcomes. [ABSTRACT FROM AUTHOR]

Objective: Hospitals and healthcare providers should assess and compare the quality of care given to patients and based on this improve the care. In the Netherlands, hospitals provide data to national quality registries, which in return provide annual quality indicators. However, this process is time-consuming, resource intensive and risks patient privacy and confidentiality. In this paper, we presented a multicentric 'Proof of Principle' study for federated calculation of quality indicators in patients with colorectal cancer. The findings suggest that the proposed approach is highly time-efficient and consume significantly lesser resources. Materials and methods: Two quality indicators are calculated in an efficient and privacy presevering federated manner, by i) applying the Findable Accessible Interoperable and Reusable (FAIR) data principles and ii) using the Personal Health Train (PHT) infrastructure. Instead of sharing data to a centralized registry, PHT enables analysis by sending algorithms and sharing only insights from the data. Results: ETL process extracted data from the Electronic Health Record systems of the hospitals, converted them to FAIR data and hosted in RDF endpoints within each hospital. Finally, quality indicators from each center are calculated using PHT and the mean result along with the individual results plotted. Discussion and conclusion: PHT and FAIR data principles can efficiently calculate quality indicators in a privacy-preserving federated approach and the work can be scaled up both nationally and internationally. Despite this, application of the methodology was largely hampered by ELSI issues. However, the lessons learned from this study can provide other hospitals and researchers to adapt to the process easily and take effective measures in building quality of care infrastructures. [ABSTRACT FROM AUTHOR]

Background: Holistic housing renovations combine physical housing improvements with social and socioeconomic interventions (e.g. referral to social services, debt counselling, involvement in decision-making, promoting social cohesion). In a deprived neighbourhood in Utrecht, the Netherlands, this paper examined residents' and professionals' experiences, ideas, and perceptions regarding holistic housing renovation, its health effects, and underlying mechanisms explaining those effects. Methods: Semi-structured in-depth interviews were conducted with 21 social housing residents exposed to holistic housing renovation, and 12 professionals involved in either the physical renovation or social interventions implemented. Residents were interviewed in various renovation stages (before, during, after renovation). Transcripts were deductively and inductively coded using qualitative software. Results: Residents experienced and professionals acknowledged renovation stress caused by nuisance from construction work (noise, dust), having to move stuff around, and temporary moving; lack of information and control; and perceived violation of privacy. Involvement in design choices was appreciated, and mental health improvement was expected on the long term due to improved housing quality and visual amenity benefits. Social contact between residents increased as the renovation became topic for small talk. Few comments were made regarding physical health effects. The interviews revealed a certain amount of distrust in and dissatisfaction with the housing corporation, construction company, and other authorities. Conclusions: Renovation stress, aggravated by lack of information and poor accessibility of housing corporation and construction company, negatively affects mental health and sense of control. Potential stress relievers are practical help with packing and moving furniture, and increased predictability by good and targeted communication. Social interventions can best be offered after renovation, when residents live in their renovated apartment and the nuisance and stress from the renovation is behind them. Social partners can use the period leading up to the renovation to show their faces, offer practical help to reduce renovation stress, and increase residents' trust in their organization and authorities in general. This might also contribute to residents' willingness to accept help with problems in the social domain after renovation. [ABSTRACT FROM AUTHOR]

System dynamics approaches are increasingly addressing the complexity of public health problems such as childhood overweight and obesity. These approaches often use system mapping methods, such as the construction of causal loop diagrams, to gain an understanding of the system of interest. However, there is limited practical guidance on how such a system understanding can inform the development of an action programme that can facilitate systems changes. The Lifestyle Innovations Based on Youth Knowledge and Experience (LIKE) programme combines system dynamics and participatory action research to improve obesity-related behaviours, including diet, physical activity, sleep and sedentary behaviour, in 10–14-year-old adolescents in Amsterdam, the Netherlands. This paper illustrates how we used a previously obtained understanding of the system of obesity-related behaviours in adolescents to develop an action programme to facilitate systems changes. A team of evaluation researchers guided interdisciplinary action-groups throughout the process of identifying mechanisms, applying the Intervention Level Framework to identify leverage points and arriving at action ideas with aligning theories of change. The LIKE action programme consisted of 8 mechanisms, 9 leverage points and 14 action ideas which targeted the system's structure and function within multiple subsystems. This illustrates the feasibility of developing actions targeting higher system levels within the confines of a research project timeframe when sufficient and dedicated effort in this process is invested. Furthermore, the system dynamics action programme presented in this study contributes towards the development and implementation of public health programmes that aim to facilitate systems changes in practice. [ABSTRACT FROM AUTHOR]

Background: Osteogenesis Imperfecta (OI) is characterised by bone fragility. Among several features, easy bruising and multiple case reports on haemorrhagic events have been reported. This paper describes the diverse manifestations of bleeding and bruising in a large cohort of 328 OI patients. The aim of this study is to provide insight in the diverse aspects and therapeutic considerations of bleedings in OI. Methods: This descriptive cohort study was conducted at the National Expert Center for adults with OI in the Netherlands. Bleeding was assessed by the validated self-bleeding assessment tool (Self-BAT) The tool was distributed among 328 adults with different clinically confirmed types of OI. Results: 195 of 328 invited patients (completion rate 60%) with OI type 1 (n = 144), OI type 3 (n = 17) and OI type 4 (n = 34), aged between 18 and 82 years, completed the tool. Self-BAT scores were above the normal range in 42% of all patients. For males Self-BAT scores were increased in 37% with a mean score of 3.7, ranged between 0 and 18. For females the Self-BAT scores were increased in 44% with a mean of 5.4 and a range of 0–24. No statistical differences in OI subtypes were found. Conclusions: Bleeding tendency appears to be a relevant complication in OI patients as this study confirms the presumption of bleeding tendency. There are specific recommendations to clinicians who treat OI patients to consider an assessment of bleeding tendency and use potential interventions to reduce haemorrhagic complications and improve quality of life. [ABSTRACT FROM AUTHOR]

Background: User involvement and participation in the supervision of the quality of care is an important topic for many healthcare inspectorates. It offers regulators an additional view on quality, increases the legitimacy and accountability of the inspectorate, empowers users and enhancing the public's trust in the inspectorate. To assess the accessibility of the local governmental social domain services the Joint Inspectorate Social Domain in the Netherlands worked together with people with intellectual disabilities performing as 'mystery guests' in an innovative project. This paper describes the findings of the evaluation of this project. Methods: People with intellectual disabilities living at home on their own may need some help with daily activities such as administrative tasks, raising children, household tasks, managing debts or finding work. In the Netherlands they have to arrange this help at their municipality. The goal of this project was to find out how easily people with intellectual disabilities could get help from their municipality. The participants were equal partners with the JISD inspectors from the beginning: in constructing an inspection framework, in acting as mystery guest with a fictive support request, reported back the results by storytelling. Results: The evaluation of the project showed that the JISD succeeded in their key aspect of the project: the goal to involve people with intellectual disabilities in a leading role from the beginning until the end. Their perspectives and preferences were the starting point of supervision. Pain points in accessibility became clear straight away and gave important insights for both inspectors as municipality professionals. Municipalities started to improve their services and evaluated the improvements with the clients. Furthermore, the impact on the participants themselves was also huge: they felt being taken seriously, valued and empowered. Conclusion: Involving people with intellectual disabilities as participants in all phases of supervision processes contributes to more relevant and useful outcomes, creates mutual understanding of perspectives, as affirmed by both municipalities and inspectors, and creates empowerment of the participants. Furthermore, it fits perfectly within the United Nation Convention on the rights of persons with disabilities and the current development of 'value driven regulation'. [ABSTRACT FROM AUTHOR]

Introduction: This study characterized the extent to which (1) financial barriers and (2) abortion care-seeking within a person's country of residence were associated with delays in abortion access among those travelling to England and the Netherlands for abortion care from European countries where abortion is legal on broad grounds in the first trimester but where access past the first trimester is limited to specific circumstances. Methodology: We drew on cross-sectional survey data collected at five abortion clinics in England and the Netherlands from 2017 to 2019 (n = 164). We assessed the relationship between difficulty paying for the abortion/travel, acute financial insecurity, and in-country care seeking on delays to abortion using multivariable discrete-time hazards models. Results: Participants who reported facing both difficulty paying for the abortion procedure and/or travel and difficulty covering basic living costs in the last month reported longer delays in accessing care than those who had no financial difficulty (adjusted hazard odds ratio: 0.39 95% CI 0.21–0.74). This group delayed paying other expenses (39%) or sold something of value (13%) to fund their abortion, resulting in ~ 60% of those with financial difficulty reporting it took them over a week to raise the funds needed for their abortion. Having contacted or visited an abortion provider in the country of residence was associated with delays in presenting abroad for an abortion. Discussion: These findings point to inequities in access to timely abortion care based on socioeconomic status. Legal time limits on abortion may intersect with individuals' interactions with the health care system to delay care. Plain Language Summary: This paper explores delays in accessing abortion care associated with financial and medical system barriers. We focus on residents of countries in Europe where abortion is available on broad grounds in the first trimester seeking abortion care outside of their country of residence. This study demonstrates an association between difficulty covering abortion costs for people facing financial insecurity and in-country care seeking and delays in accessing abortion abroad. Policy barriers, medical system barriers, as well as financial barriers may interact to delay access to care for people in European countries with broad grounds for abortion access in the first trimester but restrictions thereafter, especially for people later in pregnancy. [ABSTRACT FROM AUTHOR]

Background: Virtual care centres (VCCs) are novel wards of hospitals and facilitate the provision of remote monitoring and home-based patient care. Whereas since the COVID-19 pandemic VCCs have rapidly emerged, there is no standardised framework for the development and implementation of VCCs. To develop such a framework, insight in current experiences of employment in VCCs is needed. Therefore, the aim of this study was to explore nurses' perceptions and experiences of working in VCCs. Results: Between February and July 2023, semi-structured online interviews were conducted with thirteen nurses (age 45 ± 8 years) from four VCCs in the Netherlands. Interviews were thematically analysed using a six-stage approach, yielding six themes of nurses' perceptions and experiences of working in VCCs: 1)' Changing role of nurses', especially in the patient-professional relationship, transformation of care and communication; 2)'Clinical perspective of nurses', need for general medical knowledge and use of data in relation to nurses' clinical perspective, 3)'Education and training', need to keep nurses' knowledge up-to-date and create time for education; 4)'Organisation of care', nurses' role in the development of protocols and need for sufficient technological preconditions; 5)'Cooperation with other healthcare professionals', consisted of the collaboration with and needed support by other healthcare professionals to organize and provide care to VCC patients; 6)'Experienced effects of VCCs' included advantages and disadvantages of VCCs for the nurses, patients and the hospital. Themes were mapped onto the Capability, Opportunity and Motivation of Behaviour (COM-B) model where all themes included components of capability, opportunity and motivation. Conclusions: Our findings highlight the importance of considering COM-B components of nurses' work in VCCs. Due to the changing roles of nurses in VCCs, there are evolving educational needs in to communicate with patients and colleagues, and the use of data to support their clinical view, as well as providing technological optimisations to further support nurses' work and the VCCs. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to describe salivary flow rate, subjective oral dryness and dental caries 5 years post haematopoietic cell transplantation (HCT). Methods: HCT survivors of a previous longitudinal observational cohort study in the Netherlands (the H-OME study) were invited to participate in this additional follow-up after 5 years (the HOME2 study). During the additional follow-up appointment, stimulated (SWS) and unstimulated whole saliva (UWS) was collected, participants rated subjective oral dryness on a 0 – 10 scale, and caries lesions were assessed. Furthermore, dental records, including treatments and radiographs, were requested for the 5 years preceding and the 5 years following transplantation. Paired t-tests were performed to determine changes in UWS and SWS flow rates and subjective oral dryness from pre-HCT, and to compare the number of caries-related dental treatments (restorations, endodontic treatments or extractions) before and after HCT. Hyposalivation of UWS (< 0.2 mL/min) and SWS (< 0.7 mL/min) at 3 and 12 months, was used to explore the predictive potential of hyposalivation on a high dental treatment need (> 3 treatments) over the 5 years post-HCT. Results: Five years post-HCT, 39 HCT survivors were included. The mean UWS flow rate was 0.36 mL/min (SD 0.26) and the mean SWS flow rate 1.02 (SD 0.57); survivors were diagnosed with a median of 0 dentine lesions (range 0 – 12) and 73% reported a subjective oral dryness score ≥ 1. Survivors underwent a median of 3 (range 0 – 20) dental treatments during the 5 years following transplantation. The mean difference in UWS 5 years post-HCT compared to pre-HCT was 0.03 (95% CI: -0.07 – 10.12), the mean difference for SWS was -0.18 (95% CI: -0.45 – 0.08) and for subjective oral dryness 1.2 (95% CI: 0.2 – 2.1). In the 5 years post-HCT, non-significantly more treatments were performed compared to the 5 years pre-HCT (mean difference: 0.5, 95%CI: -1.2 – 2.2). Seventy eight percent of patients with hyposalivation of SWS at 12 months had a high dental treatment need, compared with 38% with no hyposalivation. Conclusions: Five years post-HCT, mean UWS and SWS flow rates were not significantly different from pre-HCT levels but subjective oral dryness scores were elevated. [ABSTRACT FROM AUTHOR]

Background: While evidence-based interventions are effective for children with post-traumatic stress disorder (PTSD), some adolescents may not respond sufficiently. Intensive trauma treatment (ITT) has shown promise for adults, but research on its efficacy for adolescents is limited. This study therefore aimed to explore the efficacy and subjective experience of change in adolescents participating in ITT. Methods: The present study employed a mixed-methods approach among a sample of adolescents with PTSD (N = 22; 90.1% female, age M = 17.0, SD = 1.72) who participated in an ITT program. Clinical data and narratives were combined to assess treatment efficacy and subjective experiences of change. Results: Quantitative analysis revealed a significant reduction in PTSD symptoms post-ITT, aligning with prior research. Qualitative analysis highlighted themes such as negative thoughts impacting treatment success, the importance of social support, and identity-related struggles. Conclusions: The study contributes to understanding ITT efficacy and emphasizes the need for developmental sensitivity, systemic interventions, and continued research to enhance PTSD treatment for adolescents. [ABSTRACT FROM AUTHOR]

Background: Older patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients. Methods: We will perform a 1:1 cluster randomised controlled trial in 86 general practices in the Netherlands. The DPP will consist of education sessions with general practitioners and practice nurses about reducing glucose-lowering medication in older patients (≥ 70 years). Topics of the sessions include the necessity of deprescribing, tools to initiate deprescribing and strategies to discuss deprescribing with patients (shared decision making). The DPP further includes a support programme with practice visits. The study will employ a selection tool to identify possibly overtreated older patients from the electronic medical records of the general practitioner. Eligibility for enrolment in the study will be based on HbA1c targets indicated by the Dutch guidelines, which depend on age, diabetes duration, presence of frailty, and life expectancy. The control group will provide usual care. We aim to include 406 patients. The follow-up period will be 2 years. For the primary outcome, the effect of the DPP on T2D-complications will be assessed by counting the cumulative incidence of events related to under- and overtreatment in T2D as registered in the electronic medical records. We shall perform an intention-to-treat analysis and an analysis including only patients for whom deprescribing was initiated. The implementation of the DPP in general practice will be evaluated quantitatively and qualitatively using the Extended Normalisation Process Theory (ENPT) and the Reach, Efficacy – Adoption, Implementation and Maintenance (RE-AIM) model. Other secondary outcomes include quality of life, cognitive functioning, events related to overtreatment or undertreatment, biomarkers of health, amount of blood glucose-lowering medication prescriptions, and cost-effectiveness. Discussion: This study will provide insight into the safety and feasibility of a programme aimed at deprescribing sulphonylureas/insulin in older people with T2D who are treated in general practice. Trial registration: ISRCTN Registry, ISRCTN50008265, registered 09 March, 2023. [ABSTRACT FROM AUTHOR]

Background: Sleep problems are common among infants and can have a serious impact on the health and wellbeing of both child and parents. To sustainably promote infant sleep on a population level, it is necessary to develop evidence-based programs that can be implemented on a large scale. The Youth Health Care setting, with its focus on prevention, child health promotion and services widely available for parents, can be a suitable setting to do so. Currently however, sleep health promotion in this setting seems to be suboptimal. To promote healthy infant sleep on a population level, programs need to be accessible and comprehensible for all parents, including parents with limited (health) literacy. Therefore, this study aims to develop, implement and evaluate a program called 'Sleep on number 1', that is tailored to Dutch Youth Health Care, to sustainably promote healthy sleep in 0-2-year-old infants. Methods: The program was developed based on co-creation with parents and Youth Health Care professionals, evidence-based behaviour change theories and sleep health promotion methods. Program effectiveness is investigated with a quasi-experimental study design comparing the program group with the care as usual control group. Participants consist of parents of 0-2-year-old children. Primary outcome is infant sleep quality at the age of 10 weeks and 6, 9, 14 and 24 months, measured with a sleep diary. The primary data analysis focuses on night awakenings at 9 months. Secondary outcomes focus on parental behaviour regarding infant sleep, related behavioural determinants and parental satisfaction with Youth Health Care sleep advice. Program effectiveness is analysed using a linear mixed-model in case of data clustering, and an independent samples T-test or linear regression in case no substantial clustering effects are found. A mixed methods process evaluation is performed with parents and Youth Health Care professionals, assessing program reach, adoption, implementation, maintenance and working mechanisms. Discussion: The 'Sleep on number 1' program is an evidence-based sleep health program for 0-2-year-old children, tailored to Dutch Youth Health Care. If effective, this program has the potential to improve infant sleep on a population level. Trial registration: ISRCTN, ISRCTN27246394, registered on 10/03/2023. https://www.isrctn.com/ISRCTN27246394. [ABSTRACT FROM AUTHOR]

Background: Cancer patients report that they lack support from healthcare providers when it comes to returning to or maintaining employment. In the education of general practitioners (GPs) in the Netherlands, there is little attention given to discussing work participation with patients. The aim of this pilot study was to evaluate a newly developed education program for GPs in training that focuses on discussing work participation with cancer patients. Methods: Two groups of in total twenty-one GPs in training participated in the education program. GPs were educated about the importance of discussing work participation with patients, work-related problems cancer patients can experience, and advice they can give to support cancer patients regarding work issues. In this pilot study using a mixed-method design, participants evaluated the program in two self-developed questionnaires and in a focus group discussion. Results: Seventeen participating GPs (81%) indicated that the education program was suitable for implementation in the education curriculum. Eleven participants (52%) reported that they had never discussed work participation with cancer patients before. Directly after the education program, eighteen participants (86%) reported that they planned to discuss work participation more often with their patients. Four months after the program, 67% indicated they had applied their new knowledge and skills in practice by discussing work participation and by referring cancer patients to occupational health professionals or online resources. According to the GPs in training, integrating the topic of work participation into other education for GPs in training and focusing on a broader group of patients could improve the impact of the education program. Conclusions: According to the results of this pilot study, the newly developed education program increased the awareness of GPs in training on the importance of discussing work participation with cancer patients. Future studies should focus on whether cancer patients experience more support from their GPs for maintaining and returning to employment after their GP has participated in the training program. [ABSTRACT FROM AUTHOR]

Introduction: The aim of our study was to validate the original Charlson Comorbidity Index (1987) (CCI) and adjusted CCI (2011) as a prediction model for 30-day and 1-year mortality after hip fracture surgery. The secondary aim of this study was to verify each variable of the CCI as a factor associated with 30-day and 1-year mortality. Methods: A prospective database of two-level II trauma teaching hospitals in the Netherlands was used. The original CCI from 1987 and the adjusted CCI were calculated based on medical history. To validate the original CCI and the adjusted CCI, the CCI was plotted against the observed 30-day and 1-year mortality, and the area under the curve (AUC) was calculated. Results: A total of 3523 patients were included in this cohort study. The mean of the original CCI in this cohort was 5.1 (SD ± 2.0) and 4.6 (SD ± 1.9) for the adjusted CCI. The AUCs of the prediction models were 0.674 and 0.696 for 30-day mortality for the original and adjusted CCIs, respectively. The AUCs for 1-year mortality were 0.705 and 0.717 for the original and adjusted CCIs, respectively. Conclusions: A higher original and adjusted CCI is associated with a higher mortality rate. The AUC was relatively low for 30-day and 1-year mortality for both the original and adjusted CCIs compared to other prediction models for hip fracture patients in our cohort. The CCI is not recommended for the prediction of 30-day and 1-year mortality in hip fracture patients. [ABSTRACT FROM AUTHOR]

Background: Recent studies revealed an elevated likelihood of unintended pregnancies among women with psychiatric disorders compared to their counterparts without such vulnerability. Despite the importance of understanding family planning decision-making in this group, qualitative inquiries are lacking. This study explored family planning decisions among women with psychiatric disorders. Methods: Utilizing a qualitative approach, three focus group discussions were conducted with purposive sampling: women with a history of unintended pregnancies (N = 3), women without children (N = 5), and women with a history of intended pregnancies (N = 9), all of whom had self-reported psychiatric disorders. Using thematic framework analysis, we investigated the themes "Shadow of the past," reflecting past experiences, and "Shadow of the future," reflecting future imaginaries, building upon the existing "Narrative Framework." Results: The Narrative Framework formed the foundation for understanding family planning among women with psychiatric disorders. The retrospective dimension of focus group discussions provided opportunities for reflective narratives on sensitive topics, revealing emotions of regret, grief and relief. Childhood trauma, adverse events, and inadequate parenting enriched the "Shadow of the past". The "Shadow of the present" was identified as a novel theme, addressing awareness of psychiatric disorders and emotions toward psychiatric stability. Social influences, stigma, and concerns about transmitting psychiatric disorders shaped future imaginaries in the shadow of the future. Conclusions: This study enlightens how family planning decision-making in women with psychiatric disorders might be complex, as marked by the enduring impact of past experiences and societal influences in this sample. These nuanced insights underscore the necessity for tailored support for women with psychiatric disorders. Plain English Summary: Recent studies show that women with psychiatric disorders are more likely to experience unintended pregnancies. However, the underlying reasons are not fully understood. Understanding those reasons is important to provide better healthcare. Our study explored how women with psychiatric disorders make decisions about family planning. We had conversations with different groups of women—women with unintended pregnancies, women without children, and women with intended pregnancies—through focus group discussions. We partnered with the Dutch mental health organization MIND to capture diverse opinions. Key themes and categories in the discussions were identified and organized. We found four main themes: "Shadow of the past" showed how past events, trauma, and lack of knowledge about parenting affect family planning. "Shadow of the present" revealed different feelings about family planning, the importance of the awareness of psychiatric disorders, and uncertainty about decisions. "Shadow of the future" included thoughts about becoming a mother, the impact of social influences, and concerns about passing on psychiatric disorders. "Reflections on the decision" showed how psychiatric disorders, experiences with motherhood, and feelings of regret, grief and relief had an influence on family planning decisions. In conclusion, our study highlighted the complexity of family planning decisions for women with psychiatric disorders. Past experiences and societal influences, like stigma, play a big role. These insights show the need for personalized family planning support for women with psychiatric disorders. [ABSTRACT FROM AUTHOR]

Background: In the Netherlands, university medical centres (UMCs) bear primary responsibility for conducting medical research and delivering highly specialized care. The TopCare program was a policy experiment lasting 4 years in which three non-academic hospitals received funding from the Dutch Ministry of Health to also conduct medical research and deliver highly specialized care in specific domains. This study investigates research collaboration outcomes for all Dutch UMCs and non-academic hospitals in general and, more specifically, for the domains in the non-academic hospitals participating in the TopCare program. Additionally, it explores the organizational boundary work employed by these hospitals to foster productive research collaborations. Methods: A mixed method research design was employed combining quantitative bibliometric analysis of publications and citations across all Dutch UMCs and non-academic hospitals and the TopCare domains with geographical distances, document analysis and ethnographic interviews with actors in the TopCare program. Results: Quantitative analysis shows that, over the period of study, international collaboration increased among all hospitals while national collaboration and single institution research declined slightly. Collaborative efforts correlated with higher impact scores, and international collaboration scored higher than national collaboration. A total of 60% of all non-academic hospitals' publications were produced in collaboration with UMCs, whereas almost 30% of the UMCs' publications were the result of such collaboration. Non-academic hospitals showed a higher rate of collaboration with the UMC that was nearest geographically, whereas TopCare hospitals prioritized expertise over geographical proximity within their specialized domains. Boundary work mechanisms adopted by TopCare hospitals included aligning research activities with organizational mindset (identity), bolstering research infrastructure (competence) and finding and mobilizing strategic partnerships with academic partners (power). These efforts aimed to establish credibility and attractiveness as collaboration partners. Conclusions: Research collaboration between non-academic hospitals and UMCs, particularly where this also involves international collaboration, pays off in terms of publications and impact. The TopCare hospitals used the program's resources to perform boundary work aimed at becoming an attractive and credible collaboration partner for academia. Local factors such as research history, strategic domain focus, in-house expertise, patient flows, infrastructure and network relationships influenced collaboration dynamics within TopCare hospitals and between them and UMCs. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial resistance (AMR) has become one of the major public health threats worldwide, emphasizing the necessity of preventing the development and transmission of drug resistant microorganisms. This is particularly important for people with vulnerable health conditions, such as people with intellectual disabilities (ID) and long-term care residents. This study aimed to assess the current status of AMR, antimicrobial stewardship (AMS) and infection prevention and control (IPC) in Dutch long-term care facilities for people with intellectual disabilities (ID-LTCFs). Methods: A web-based cross-sectional survey distributed between July and November 2023, targeting (both nonmedically and medically trained) healthcare professionals working in ID-LTCFs in The Netherlands, to study knowledge, attitudes and perceptions regarding AMR, AMS and IPC. Results: In total, 109 participants working in 37 long-term care organizations for people with intellectual disabilities throughout the Netherlands completed the questionnaire. The knowledge levels of AMR and IPC among nonmedically trained professionals (e.g., social care professionals) were lower than those among medically trained professionals (p = 0.026). In particular regarding the perceived protective value of glove use, insufficient knowledge levels were found. Furthermore, there was a lack of easy-read resources and useful information regarding IPC and AMR, for both healthcare professionals as well as people with disabilities. The majority of the participants (> 90%) reported that AMR and IPC need more attention within the disability care sector, but paradoxically, only 38.5% mentioned that they would like to receive additional information and training about IPC, and 72.5% would like to receive additional information and training about AMR. Conclusion: Although the importance of AMR and IPC is acknowledged by professionals working in ID-LTCFs, there is room for improvement in regards to appropriate glove use and setting-specific IPC and hygiene policies. As nonmedically trained professionals comprise most of the workforce within ID-LTCFs, it is also important to evaluate their needs. This can have a substantial impact on developing and implementing AMR, AMS and/or IPC guidelines and policies in ID-LTCFs. [ABSTRACT FROM AUTHOR]

Background: Good preoperative conditions help patients to counteract surgical injury. Prehabilitation is a multimodal preoperative management strategy, including physical, nutritional, psychological, and other interventions, which can improve the functional reserve of patients and enhance postoperative recovery. The purpose of this study is to show the evolution trend and future directions of research related to the prehabilitation of surgical patients. Methods: The global literature regarding prehabilitation was identified from The Web of Science Core Collection database. Bibliometric methods of the Bibliometrix package of R (version 4.2.1) and VOSviewer were used to analyze publication trends, cooperative networks, study themes, and co-citation relationships in the field. Results: A total of 638 publications were included and the number of publications increased rapidly since 2016, with an average annual growth rate of 41.0%. "Annals of Surgery", "British Journal of Surgery" and "British Journal of Anesthesia" were the most cited journals. Experts from the USA, Canada, the UK, and the Netherlands contributed the most in this field, and an initial cooperative network among different countries and clinical teams was formed. Malnutrition, older patients, frailty, and high-risk patients were the hotspots of recent studies. However, among the top 10 cited articles, the clinical effects of prehabilitation were conflicting. Conclusion: This bibliometric review summarized the most influential publications as well as the publication trends and clarified the progress and future directions of prehabilitation, which could serve as a guide for developing evidence-based practices. [ABSTRACT FROM AUTHOR]

Background: Patients with irresectable stage III or metastatic melanoma presenting with poor prognostic factors are usually treated with a combination of immune checkpoint inhibitors (ICIs), consisting of ipilimumab and nivolumab. This combination therapy is associated with severe immune related adverse events (irAEs) in about 60% of patients. In current clinical practice, patients are usually treated with ICIs for up to two years or until disease progression or the occurrence of unacceptable AEs. The incidence of irAEs gradually increases with duration of treatment. While durable tumour responses have been observed after early discontinuation of treatment, no consensus has been reached on optimal treatment duration. The objective of the Safe Stop IPI-NIVO trial is to evaluate whether early discontinuation of ICIs is safe in patients with irresectable stage III or metastatic melanoma who are treated with combination therapy. Methods: The Safe Stop IPI-NIVO trial is a nationwide, multicentre, prospective, single-arm, interventional study in the Netherlands. A total of 80 patients with irresectable stage III or metastatic melanoma who are treated with combination therapy of ipilimumab-nivolumab and have a complete or partial response (CR/PR) according to RECIST v1.1 will be included to early discontinue maintenance therapy with anti-PD-1. The primary endpoint is the rate of ongoing response at 12 months after start of ICI. Secondary endpoints include ongoing response at 24 months, disease control at different time points, melanoma specific and overall survival, the incidence of irAEs and health-related quality of life. Discussion: From a medical, healthcare and economic perspective, overtreatment should be prevented and shorter treatment duration of ICIs is preferred. If early discontinuation of ICIs is safe for patients who are treated with the combination of ipilimumab-nivolumab, the treatment duration of nivolumab could be shortened in patients with a favourable tumour response. Trial registration: ClinicalTrials.gov ID NCT05652673, registration date: 08–12-2022. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity (PA) is a key factor of lifestyle behavior enhancing general health and fitness, especially in people after total hip or knee replacement (THR and TKR). Orthopaedic surgeons can play a primary role in advocating the benefits of an active lifestyle. Aim of the study was 1) to assess the attitude of orthopaedic surgeons towards PA for people after THR/TKR and 2) to compare the attitude between a Northern European (the Netherlands) and a Southern European (Italy) country and analyze which factors influence the attitude towards PA. Methods: A cross-cultural study. An (online) survey was distributed among orthopaedic surgeons in Italy and the Netherlands. Chi-square and Mann–Whitney tests were used to compare surgeons' and clinics' characteristics, and questionnaires' scores, respectively. A linear regression analysis was conducted to assess which surgeon characteristics influence attitude towards PA. Results: A cohort of 159 surgeons (103 Italians and 56 Dutch) was analyzed. The median score of overall orthopaedic surgeons' attitude towards PA was positive (57 out of 72). Dutch surgeons showed a more positive attitude compared to Italian surgeons (p < 0.01). Main difference was found in the "Physical activity concern" factor, where Italian surgeons showed more concern about the negative effects of PA on the survival of the prosthesis. The regression analyses showed that "Country" and "Type of clinic" were associated with the surgeons' attitude. Conclusions: Overall, the orthopaedic surgeons' attitude towards PA for people with THR and TKR was positive. However, Dutch surgeons seem to be more positive compared to the Italian. The country of residence was the item that most influenced attitude. Further investigations are needed to untangle specific factors, such as cultural, socioeconomic, or contextual differences within the variable "country" that may influence orthopaedic surgeons' attitudes towards PA. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy is common in chronic medication users, which increases the risk of drug related problems. A suitable intervention is the clinical medication review (CMR) that was introduced in the Netherlands in 2012, but the effectiveness might be hindered by limited implementation in community pharmacies. Therefore our aim was to describe the current implementation of CMRs in Dutch community pharmacies and to identify barriers to the implementation. Methods: An online questionnaire was developed based on the Consolidated Framework for Implementation Research (CFIR) and consisted of 58 questions with open ended, multiple choice or Likert-scale answering options. It was sent out to all Dutch community pharmacies (n = 1,953) in January 2021. Descriptive statistics were used. Results: A total of 289 (14.8%) community pharmacies filled out the questionnaire. Most of the pharmacists agreed that a CMR has a positive effect on the quality of pharmacotherapy (91.3%) and on medication adherence (64.3%). Pharmacists structured CMRs according to available selection criteria or guidelines (92%). Pharmacists (90%) believed that jointly conducting a CMR with a general practitioner (GP) improved their mutual relationship, whereas 21% believed it improved the relationship with a medical specialist. Lack of time was reported by 43% of pharmacists and 80% (fully) agreed conducting CMRs with a medical specialist was complicated. Most pharmacists indicated that pharmacy technicians can assist in performing CMRs, but they rarely do in practice. Conclusions: Lack of time and suboptimal collaboration with medical specialists are the most important barriers to the implementation of CMRs. [ABSTRACT FROM AUTHOR]

Background: Modern medicine becomes more dependent on radiologic imaging techniques. Over the past decade, radiology has also gained more attention in the medical curricula. However, little is known with regard to students' perspectives on this subject. Therefore, this study aims to gain insight into the thoughts and ideas of medical students and junior doctors on radiology education in medical curricula. Methods: A qualitative, descriptive study was carried out at one medical university in the Netherlands. Participants were recruited on social media and were interviewed following a predefined topic list. The constant comparative method was applied in order to include new questions when unexpected topics arose during the interviews. All interviews were transcribed verbatim and coded. Codes were organized into categories and themes by discussion between researchers. Results: Fifteen participants (nine junior doctors and six students) agreed to join. From the coded interviews, four themes derived from fifteen categories arose: (1) The added value of radiology education in medical curricula, (2) Indispensable knowledge on radiology, (3) Organization of radiology education and (4) Promising educational innovations for the radiology curriculum. Conclusion: This study suggests that medical students and junior doctors value radiology education. It provides insights in educational topics and forms for educational improvement for radiology educators. Key points: • Ultrasound was suggested to integrate within radiology education in medical curricula. • Integration of applied radiology in a longitudinal learning community could be explored. • Regardless of their personal interests, participants valued radiology education in medical curricula. [ABSTRACT FROM AUTHOR]

Background: Optimizing transitional care by practicing family-centered care might reduce unplanned events for patients who undergo major abdominal cancer surgery. However, it remains unknown whether involving family caregivers in patients' healthcare also has negative consequences for patient safety. This study assessed the safety of family involvement in patients' healthcare by examining the cause of unplanned events in patients who participated in a family involvement program (FIP) after major abdominal cancer surgery. Methods: This is a secondary analysis focusing on the intervention group of a prospective cohort study conducted in the Netherlands. Data were collected from April 2019 to May 2022. Participants in the intervention group were patients who engaged in a FIP. Unplanned events were analyzed, and root causes were identified using the medical version of a prevention- and recovery-information system for monitoring and analysis (PRISMA) that analyses unintended events in healthcare. Unplanned events were compared between patients who received care from family caregivers and patients who received professional at-home care after discharge. A Mann-Whitney U test was used to analyze data. Results: Of the 152 FIP participants, 68 experienced an unplanned event and were included. 112 unplanned events occurred with 145 root causes since some unplanned events had several root causes. Most root causes of unplanned events were patient-related factors (n = 109, 75%), such as patient characteristics and disease-related factors. No root causes due to inadequate healthcare from the family caregiver were identified. Unplanned events did not differ statistically (interquartile range 1–2) (p = 0.35) between patients who received care from trained family caregivers and those who received professional at-home care after discharge. Conclusion: Based on the insights from the root-cause analysis in this prospective multicenter study, it appears that unplanned emergency room visits and hospital readmissions are not related to the active involvement of family caregivers in surgical follow-up care. Moreover, surgical follow-up care by trained family caregivers during hospitalization was not associated with increased rates of unplanned adverse events. Hence, the concept of active family involvement by proficiently trained family caregivers in postoperative care appears safe and feasible for patients undergoing major abdominal surgery. [ABSTRACT FROM AUTHOR]

Background: In the Netherlands, population-based cancer screening programmes (CSPs) are organized aiming at cervical, breast and colorectal cancer. For a CSP to be effective, high participation rates are essential; however, there is an alarming downward trend, including wide regional variation in screening uptake. General practitioner (GP) involvement can have a stimulating effect on screening participation. Current GP involvement is however, limited, varies between the programmes and has changed over time. Unexplored is what GPs think of their role(s) in the CSPs. The aim of this study was therefore to map the perceptions and beliefs of GPs regarding their current and future role in the Dutch CSPs. Methods: A mixed-methods sequential explanatory study was conducted in the Leiden/The Hague area of the Netherlands, between the end of 2021 and 2022. A questionnaire was developed and distributed among 110 GPs. The aggregated results obtained from the questionnaires served as starting points for conducting semi-structured interviews, with purposefully selected GPs. With this sequential approach we aimed to further enhance the understanding of the questionnaire data, and delved into the topics that emerged from the questionnaire responses. Results: In total, 46 GPs completed the online questionnaire (response rate 42%). Subsequent five semi-structured comprehensive interviews were conducted. GPs indicated that they frequently encounter the CSP in their daily practice and consider it important. They also emphasised it is important that GPs remain closely involved with the CSPs in the future. Nevertheless, GPs also repeatedly mentioned that they are not eager to take on more logistical/organizational tasks. They are however willing to empower CSPs in a positive manner. Conclusion: GPs were generally positive about the CSPs and their current role within these programmes. Nevertheless, several options have been proposed to improve the CSPs, especially to increase screening uptake for populations in a socioeconomically disadvantaged position. Since it is of utmost importance to screen those who are most at risk of developing the screening-specific tumours, efforts should be made to achieve this goal. [ABSTRACT FROM AUTHOR]

Background: While remote patient management (RPM) has the potential to assist in achieving treatment targets for cardiovascular risk factors in primary care, its effectiveness may vary among different patient subgroups. Panel management, which involves proactive care for specific patient risk groups, could offer a promising approach to tailor RPM to these groups. This study aims to (i) assess the perception of healthcare professionals and other stakeholders regarding the adoption and (ii) identify the barriers and facilitators for successfully implementing such a panel management approach. Methods: In total, nineteen semi-structured interviews and two focus groups were conducted in the Netherlands. Three authors reviewed the audited transcripts. The Consolidated Framework for Implementation Strategies (CFIR) domains were used for the thematic analysis. Results: A total of 24 participants (GPs, nurses, health insurers, project managers, and IT consultants) participated. Overall, a panel management approach to RPM in primary care was considered valuable by various stakeholders. Implementation barriers encompassed concerns about missing necessary risk factors for patient stratification, additional clinical and technical tasks for nurses, and reimbursement agreements. Facilitators included tailoring consultation frequency and early detection of at-risk patients, an implementation manager accountable for supervising project procedures and establishing agreements on assessing implementation metrics, and ambassador roles. Conclusion: Panel management could enhance proactive care and accurately identify which patients could benefit most from RPM to mitigate CVD risk. For successful implementation, we recommend having clear agreements on technical support, financial infrastructure and the criteria for measuring evaluation outcomes. [ABSTRACT FROM AUTHOR]

Background: Worldwide, recommendations for fruit and vegetable consumption are not met, which can cause chronic diseases. Especially adolescence is an important phase for the development of health behaviours. Therefore, in the Netherlands, the Healthy School program was established to aid schools in promoting healthy lifestyles among their students. We examined to what extent the variation between secondary schools regarding students' fruit and vegetable consumption could be explained by differences between schools regarding Healthy School certification, general school characteristics, and the school population. Additionally, we examined whether Healthy School certification was related to the outcomes, and whether the association differed for subgroups. Methods: We performed a repeated cross-sectional multilevel study. We used data from multiple school years from the national Youth Health Monitor on secondary schools (grades 2 and 4, age ranged from approximately 12 to 18 years) of seven Public Health Services, and added data with regard to Healthy School certification, general school characteristics and school population characteristics. We included two outcomes: the number of days a student consumed fruit and vegetables per week. In total, we analysed data on 168,127 students from 256 secondary schools in the Netherlands. Results: Results indicated that 2.87% of the variation in fruit consumption and 5.57% of the variation in vegetable consumption could be attributed to differences at the school-level. Characteristics related to high parental educational attainment, household income, and educational track of the students explained most of the variance between schools. Additionally, we found a small favourable association between Healthy School certification and the number of days secondary school students consumed fruit and vegetables. Conclusions: School population characteristics explained more variation between schools than Healthy School certification and general school characteristics, especially indicators of parental socioeconomic status. Nevertheless, Healthy School certification seemed to be slightly related to fruit and vegetable consumption, and might contribute to healthier dietary intake. We found small differences for some subgroups, but future research should focus on the impact in different school contexts, since we were restricted in the characteristics that could be included in this study. [ABSTRACT FROM AUTHOR]

Background: The emergence of artificial intelligence (AI) in medicine has prompted the development of numerous ethical guidelines, while the involvement of patients in the creation of these documents lags behind. As part of the European PROFID project we explore patient perspectives on the ethical implications of AI in care for patients at increased risk of sudden cardiac death (SCD). Aim: Explore perspectives of patients on the ethical use of AI, particularly in clinical decision-making regarding the implantation of an implantable cardioverter-defibrillator (ICD). Methods: Semi-structured, future scenario-based interviews were conducted among patients who had either an ICD and/or a heart condition with increased risk of SCD in Germany (n = 9) and the Netherlands (n = 15). We used the principles of the European Commission's Ethics Guidelines for Trustworthy AI to structure the interviews. Results: Six themes arose from the interviews: the ability of AI to rectify human doctors' limitations; the objectivity of data; whether AI can serve as second opinion; AI explainability and patient trust; the importance of the 'human touch'; and the personalization of care. Overall, our results reveal a strong desire among patients for more personalized and patient-centered care in the context of ICD implantation. Participants in our study express significant concerns about the further loss of the 'human touch' in healthcare when AI is introduced in clinical settings. They believe that this aspect of care is currently inadequately recognized in clinical practice. Participants attribute to doctors the responsibility of evaluating AI recommendations for clinical relevance and aligning them with patients' individual contexts and values, in consultation with the patient. Conclusion: The 'human touch' patients exclusively ascribe to human medical practitioners extends beyond sympathy and kindness, and has clinical relevance in medical decision-making. Because this cannot be replaced by AI, we suggest that normative research into the 'right to a human doctor' is needed. Furthermore, policies on patient-centered AI integration in clinical practice should encompass the ethics of everyday practice rather than only principle-based ethics. We suggest that an empirical ethics approach grounded in ethnographic research is exceptionally well-suited to pave the way forward. [ABSTRACT FROM AUTHOR]

Background: Relatives have no formal position in the practice of euthanasia and physician-assisted suicide (EAS) according to Dutch legislation. However, research shows that physicians often involve relatives in EAS decision-making. It remains unclear why physicians do (not) want to involve relatives. Therefore, we examined how many physicians in the Netherlands involve relatives in EAS decision-making and explored reasons for (not) involving relatives and what involvement entails. Methods: In a mixed-methods study, 746 physicians (33% response rate) completed a questionnaire, and 20 were interviewed. The questionnaire included two statements on relatives' involvement in EAS decision-making. Descriptive statistics were used, and multivariable logistic regression analyses to explore characteristics associated with involving relatives. In subsequent interviews, we explored physicians' views on involving relatives in EAS decision-making. Interviews were thematically analysed. Results: The majority of physicians want to know relatives' opinions about an EAS request (80%); a smaller group also takes these opinions into account in EAS decision-making (35%). Physicians who had ever received an explicit EAS request were more likely to want to know opinions and clinical specialists and elderly care physicians were more likely to take these opinions into account. In interviews, physicians mentioned several reasons for involving relatives: e.g. to give relatives space and help them in their acceptance, to tailor support, to be able to perform EAS in harmony, and to mediate in case of conflicting views. Furthermore, physicians explained that relatives' opinions can influence the decision-making process but cannot be a decisive factor. If relatives oppose the EAS request, physicians find the process more difficult and try to mediate between patients and relatives by investigating relatives' objections and providing appropriate information. Reasons for not taking relatives' opinions into account include not wanting to undermine patient autonomy and protecting relatives from a potential burdensome decision. Conclusions: Although physicians know that relatives have no formal role, involving relatives in EAS decision-making is common practice in the Netherlands. Physicians consider this important as relatives need to continue with their lives and may need bereavement support. Additionally, physicians want to perform EAS in harmony with everyone involved. However, relatives' opinions are not decisive. [ABSTRACT FROM AUTHOR]

Background and importance: Differences exist between sexes in pain and pain-related outcomes, such as development of chronic pain. Previous studies suggested a higher risk for pain chronification in female patients. Furthermore, pain catastrophizing is an important risk factor for chronification of pain. However, it is unclear whether sex differences in catastrophic thinking could explain the sex differences in pain chronification. Objectives: The aim of this study was to examine sex differences in pain catastrophizing. Additionally, we investigated pain catastrophizing as a potential mediator of sex differences in the transition of acute to chronic pain. Design, settings and participants: Adults visiting one of the 15 participating emergency departments in the Netherlands with acute pain-related complaints. Subjects had to meet inclusion criteria and complete questionnaires about their health and pain. Outcomes measure and analysis: The outcomes in this prospective cohort study were pain catastrophizing (short form pain catastrophizing) and pain chronification at 90 days (Numeric Rating Scale ≥ 1). Data was analysed using univariate and multivariable logistic regression models. Finally, stratified regression analyses were conducted to assess whether differences in pain catastrophizing accounted for observed differences in pain chronification between sexes. Main results: In total 1,906 patients were included. Females catastrophized pain significantly more than males (p < 0.001). Multiple regression analyses suggested that pain catastrophizing is associated with pain chronification in both sexes. Conclusions: This study reported differences between sexes in catastrophic cognitions in the development of chronic pain. This is possibly of clinical importance to identify high-risk patients and ensure an early intervention to prevent the transition from acute to chronic pain. [ABSTRACT FROM AUTHOR]

Background: End-of-life (EoL) care volunteers in hospitals are a novel approach to support patients and their close ones. The iLIVE Volunteer Study supported hospital volunteer coordinators from five European countries to design and implement an EoL care volunteer service on general wards in their hospitals. This study aimed to identify and explore barriers and facilitators to the implementation of EoL care volunteer services in the five hospitals. Methods: Volunteer coordinators (VCs) from the Netherlands (NL), Norway (NO), Slovenia (SI), Spain (ES) and United Kingdom (UK) participated in a focus group interview and subsequent in-depth one-to-one interviews. A theory-inspired framework based on the five domains of the Consolidated Framework for Implementation Research (CFIR) was used for data collection and analysis. Results from the focus group were depicted in radar charts per hospital. Results: Barriers across all hospitals were the COVID-19 pandemic delaying the implementation process, and the lack of recognition of the added value of EoL care volunteers by hospital staff. Site-specific barriers were struggles with promoting the service in a highly structured setting with many stakeholders (NL), negative views among nurses on hospital volunteering (NL, NO), a lack of support from healthcare professionals and the management (SI, ES), and uncertainty about their role in implementation among VCs (ES). Site-specific facilitators were training of volunteers (NO, SI, NL), involving volunteers in promoting the service (NO), and education and awareness for healthcare professionals about the role and boundaries of volunteers (UK). Conclusion: Establishing a comprehensive EoL care volunteer service for patients in non-specialist palliative care wards involves multiple considerations including training, creating awareness and ensuring management support. Implementation requires involvement of stakeholders in a way that enables medical EoL care and volunteering to co-exist. Further research is needed to explore how trust and equal partnerships between volunteers and professional staff can be built and sustained. Trial registration: NCT04678310. Registered 21/12/2020. [ABSTRACT FROM AUTHOR]

Background: Mosquito-borne diseases are on the rise. While climatic factors have been linked to disease occurrences, they do not explain the non-random spatial distribution in disease outbreaks. Landscape-related factors, such as vegetation structure, likely play a crucial but hitherto unquantified role. Methods: We explored how three critically important factors that are associated with mosquito-borne disease outbreaks: microclimate, mosquito abundance and bird communities, vary at the landscape scale. We compared the co-occurrence of these three factors in two contrasting habitat types (forest versus grassland) across five rural locations in the central part of the Netherlands between June and September 2021. Results: Our results show that forest patches provide a more sheltered microclimate, and a higher overall abundance of birds. When accounting for differences in landscape characteristics, we also observed that the number of mosquitoes was higher in isolated forest patches. Conclusions: Our findings indicate that, at the landscape scale, variation in tree cover coincides with suitable microclimate and high Culex pipiens and bird abundance. Overall, these factors can help understand the non-random spatial distribution of mosquito-borne disease outbreaks. [ABSTRACT FROM AUTHOR]

Background: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population. Methods: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses. Results: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses. Conclusions: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population. [ABSTRACT FROM AUTHOR]

Background: Residual neuromuscular blockade (rNMB) remains a persistent and preventable problem, with serious risks. Methods: Our objective was to describe and assess patterns in the use of neuromuscular blocking agents (NMBAs), neuromuscular transmission (NMT) monitoring, and factors associated with the use of sugammadex. We performed a retrospective, observational cohort study based on electronic medical records in a large teaching hospital in the Netherlands that introduced an integrated NMT monitoring module with automatic recording in 2017. A total of 22,000 cases were randomly selected from all surgeries between January 2015 and December 2019 that required endotracheal intubation with the use of an NMBA. A total of 14,592 cases fulfilled all the inclusion criteria for complete analyses. Results: Relative NMBA usage remained the same over time. For rocuronium, spontaneous reversal decreased from 86 to 81%, sugammadex reversal increased from 12 to 18%. There was a decline in patients extubated in the operating room (OR) with neither documented NMT monitoring nor sugammadex-mediated reversal from 46 to 31%. The percentage of patients extubated in the OR without a documented train-of-four ratio ≥ 0.9, decreased from 77 to 56%. Several factors were independently associated with the use of sugammadex, including BMI > 30 kg/m2 (odds ratio: 1.41; 95% CI: 1.24–1.60), ASA class 3 or 4 (1.20; 1.07–1.34), age > 60 years (1.37; 1.23–1.53), duration of surgery < 120 min (3.01; 2.68–3.38), emergency surgery (1.83; 1.60–2.09), laparoscopic surgery (2.01; 1.71–2.36), open abdominal/thoracic surgery (1.56; 1.38–1.78), NMT monitoring used (5.31; 4.63–6.08), total dose of rocuronium (1.99; 1.76–2.25), and (inversely) use of inhalational anaesthetics (0.88; 0.79–0.99). Conclusion: Our data demonstrate that the implementation of NMT monitoring with automatic recording coincides with a gradual increase in the (documented) use of NMT monitoring and an increased use of sugammadex with a more precise dose. Factors associated with sugammadex use include higher age, ASA score, BMI, abdominal and thoracic surgery, higher rocuronium doses, emergency surgery and the use of NMT monitoring. Trial registration N/A. Key points: • Introduction of NMT monitoring with automatic recording coincides with an increase in (documented) use of NMT monitoring. • Sugammadex is more frequently used in patients with a presumed higher a priori risk of pulmonary complications. • Despite increased NMT monitoring and use of sugammadex a significant percentage of patients remain at potential risk of rNMB. [ABSTRACT FROM AUTHOR]

Background: A strong increase in mental health emergency consultations and admissions in youths has been reported in recent years. Although empirical evidence is lacking, gender differences in risk of admission may have contributed to this increase. A clearer understanding of the relationship, if any, between gender and various aspects of (in)voluntary care would help in more evidence-based service planning. Methods: We analysed registry data for 2008–2017 on 3770 outpatient emergencies involving young people aged 12 to 18 years from one urban area in the Netherlands, served by outreaching psychiatric emergency services. These adolescents were seen in multiple locations and received a psychosocial assessment including a questionnaire on the severity of their problems and living conditions. Our aims were to (a) investigate the different locations, previous use of mental health service, DSM classifications, severity items, living conditions and family characteristics involved and (b) identify which of these characteristics in particular contribute to an increased risk of admission. Results: In 3770 consultations (concerning 2670 individuals), more girls (58%) were seen than boys. Boys and girls presented mainly with relationship problems, followed by disruptive disorders and internalizing disorders. Diagnostic differences diminished in hospitalisation. More specifically, disruptive disorders were evenly distributed. Suicide risk was rated significantly higher in girls, danger to others significantly higher in boys. More girls than boys had recently been in mental health care prior to admission. Although boys and girls overall did not differ in the severity of their problems, female gender predicted admission more strongly. In both boys and girls severity of problems and lack of involvement of the family significantly predicted admission. Older age and danger to others significantly predicted admission among boys, whereas psychosis, suicidality and poor motivation for treatment predicted admission among girls. Conclusion: There are different pathways for youth admission, which can partly be explained by different psychiatric classifications as well as gender-specific differences with regard to age, suicide risk, danger to others and the influence of motivation for treatment. Finally, for both genders, family desire for hospitalisation is also an important predictor. [ABSTRACT FROM AUTHOR]

Background: Healthy sleep is crucial for the physical and mental wellbeing of adolescents. However, many adolescents suffer from poor sleep health. Little is known about how to effectively improve adolescent sleep health as it is shaped by a complex adaptive system of many interacting factors. This study aims to provide insights into the system dynamics underlying adolescent sleep health and to identify impactful leverage points for sleep health promotion interventions. Methods: Three rounds of single-actor workshops, applying Group Model Building techniques, were held with adolescents (n = 23, 12–15 years), parents (n = 14) and relevant professionals (n = 26). The workshops resulted in a multi-actor Causal Loop Diagram (CLD) visualizing the system dynamics underlying adolescent sleep health. This CLD was supplemented with evidence from the literature. Subsystems, feedback loops and underlying causal mechanisms were identified to understand overarching system dynamics. Potential leverage points for action were identified applying the Action Scales Model (ASM). Results: The resulting CLD comprised six subsystems around the following themes: (1) School environment; (2) Mental wellbeing; (3) Digital environment; (4) Family & Home environment; (5) Health behaviors & Leisure activities; (6) Personal system. Within and between these subsystems, 16 reinforcing and 7 balancing feedback loops were identified. Approximately 60 potential leverage points on different levels of the system were identified as well. Conclusions: The multi-actor CLD and identified system dynamics illustrate the complexity of adolescent sleep health and supports the need for developing a coherent package of activities targeting different leverage points at all system levels to induce system change. [ABSTRACT FROM AUTHOR]

Background: Living in a deprived neighborhood is associated with poorer health, due to factors such as lower socio-economic status and an adverse lifestyle. There is little insight into whether living in deprived neighborhood is associated with adverse maternity care outcomes and maternity health care costs. We expect women in a deprived neighborhood to experience a more complicated pregnancy, with more secondary obstetric care (as opposed to primary midwifery care) and higher maternity care costs. This study aimed to answer the following research question: to what extent are moment of referral from primary to secondary care, mode of delivery, (extreme or very) preterm delivery and maternity care costs associated with neighborhood deprivation? Methods: This retrospective cohort study used a national Dutch database with healthcare claims processed by health insurers. All pregnancies that started in 2018 were included. The moment of referral from primary to secondary care, mode of delivery, (extreme or very) preterm delivery and maternity care costs were compared between women in deprived and non-deprived neighborhoods. We reported descriptive statistics, and results of ordinal logistic, multinomial and linear regressions to assess whether differences between the two groups exist. Results: Women in deprived neighborhoods had higher odds of being referred from primary to secondary care during pregnancy (adjusted OR 1.49, 95%CI 1.41–1.57) and to start their pregnancy in secondary care (adjusted OR 1.55, 95%CI 1.44–1.66). Furthermore, women in deprived neighborhoods had lower odds of assisted delivery than women in non-deprived neighborhoods (adjusted OR 0.73, 95%CI 0.66–0.80), and they had higher odds of a cesarean section (adjusted OR 1.19, 95%CI 1.13–1.25). On average, women in a deprived neighborhood had higher maternity care costs worth 156 euros (95%CI 104–208). Conclusion: This study showed that living in a deprived neighborhood is associated with more intensive maternal care and higher maternal care costs in the Netherlands. These findings support the needs for greater attention to socio-economic factors in maternity care in the Netherlands. [ABSTRACT FROM AUTHOR]

Background: Research into the neurobiological underpinnings of learning and memory has demonstrated the cognitive-enhancing effects associated with diverse classes of phosphodiesterase (PDE) inhibitors. Specific PDE inhibitors have been identified to improve neuronal communication through selective inhibition of PDE activity. Roflumilast, a PDE4 inhibitor, has demonstrated efficacy in enhancing episodic memory in healthy adults and elderly participants with pronounced memory impairment, indicative of amnestic mild cognitive impairment (aMCI). In alignment with these findings, the present protocol aims to provide a proof of concept phase II of the potential of roflumilast to aid patients diagnosed with (a)MCI or mild Alzheimer's disease (AD) dementia. Methods: The study will be conducted according to a double-blind, randomized placebo-controlled, between-subjects design. Participants with (a)MCI and mild AD dementia will be recruited through the Memory Clinic at the Maastricht University Medical Centre + (MUMC +) in Maastricht, the Netherlands, alongside outreach through regional hospitals, and social media. The study will have three arms: placebo, 50 μg roflumilast, and 100 μg roflumilast, with a treatment duration of 24 weeks. The primary outcome measure will focus on the assessment of episodic memory, as evaluated through participants' performance on the 15-word Verbal Learning Task (VLT). Our secondary objectives are multifaceted, including an exploration of various cognitive domains. In addition, insights into the well-being and daily functioning of participants will be investigated through interviews with both the participants and their (informal) caregivers, we are interested in the well-being and daily functioning of the participants. Discussion: The outcomes of the present study aim to elucidate the significance of the PDE4 inhibition mechanism as a prospective therapeutic target for enhancing cognitive function in individuals with (a)MCI and mild AD dementia. Identifying positive effects within these patient cohorts could extend the relevance of this treatment to encompass a broader spectrum of neurological disorders. Trial registration: The Medical Ethics Committee of MUMC + granted ethics approval for the 4th version of the protocol on September 10th, 2020. The trial was registered at the European Drug Regulatory Affairs Clinical Trials (EudraCT) registered on the 19th of December 2019 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004959-36/NL) and ClinicalTrial.gov (NCT04658654, https://clinicaltrials.gov/study/NCT04658654?intr=roflumilast&cond=mci&rank=1) on the 8th of December 2020. The Central Committee on Research Involving Human Subjects (CCMO) granted approval on the 30th of September 2020. [ABSTRACT FROM AUTHOR]

Background: PIENTER 3 (P3), conducted in 2016/17, is the most recent of three nationwide serological surveys in the Netherlands. The surveys aim to monitor the effects of the National Immunisation Programme (NIP) by assessing population seroprevalence of included vaccine preventable diseases (VPDs). The response rate to the main sample was 15.7% (n = 4,983), following a decreasing trend in response compared to the previous two PIENTER studies (P1, 55.0%; 1995/1996 [n = 8,356] and P2, 33.0%; 2006/2007 [n = 5,834]). Non-responders to the main P3 survey were followed-up to complete a "non-response" questionnaire, an abridged 9-question version of the main survey covering demographics, health, and vaccination status. We assess P3 representativeness and potential sources of non-response bias, and trends in decreasing participation rates across all PIENTER studies. Methods: P3 invitees were classified into survey response types: Full Participants (FP), Questionnaire Only (QO), Non-Response Questionnaire (NRQ) and Absolute Non-Responders (ANR). FP demographic and health indicator data were compared with Dutch national statistics, and then the response types were compared to each other. Random forest algorithms were used to predict response type. Finally, FPs from all three PIENTERs were compared to investigate the profile of survey participants through time. Results: P3 FPs were in general healthier, younger and higher educated than the Dutch population. Random forest was not able to differentiate between FPs and ANRs, but when predicting FPs from NRQs we found evidence of healthy-responder bias. Participants of the three PIENTERs were found to be similar and are therefore comparable through time, but in line with national trends we found P3 participants were less inclined to vaccinate than previous cohorts. Discussion: The PIENTER biobank is a powerful tool to monitor population-level protection against VPDs across 30 years in The Netherlands. However, future PIENTER studies should continue to focus on improving recruitment from under-represented groups, potentially by considering alternative and mixed survey modes to improve both overall and subgroup-specific response. Whilst non-responder bias is unlikely to affect seroprevalence estimates of high-coverage vaccines, the primary aim of the PIENTER biobank, other studies with varied vaccination/disease exposures should consider the influence of bias carefully. [ABSTRACT FROM AUTHOR]

Background: Care for persistent somatic symptoms and functional disorders (PSS/FD) is often fragmented. Collaborative care networks (CCNs) may improve care quality for PSS/FD. Effectiveness likely depends on their functioning, but we lack a straightforward quality evaluation system. We therefore aimed to develop quality indicators to evaluate CCNs for PSS/FD. Method: Using an online three-round modified Delphi process, an expert panel provided, selected and ranked quality indicators for CCNs in PSS/FD. Recruited experts were diverse healthcare professionals with relevant experience in PSS/FD care in the Netherlands. Results: The expert panel consisted of 86 professionals representing 15 disciplines, most commonly physiotherapists, psychologists and medical specialists. 58% had more than 10 years experience in PSS/FD care. Round one resulted in 994 quotations, which resulted in 46 unique quality indicators. These were prioritised in round two and ranked in round three by the panel, resulting in a final top ten. The top three indicators were: "shared vision of care for PSS/FD", "pathways tailored to the individual patient", and "sufficiently-experienced caregivers for PSS/FD". Conclusions: The identified quality indicators to evaluate CCNs in the field of PSS/FD can be implemented in clinical practice and may be useful in improving services and when assessing effectiveness. [ABSTRACT FROM AUTHOR]

Background: NGAL and Cystatin C (CysC) as biomarkers for the early detection of AKI are subject to both pathophysiological, as well as patient related heterogeneity. The aim of this study was to investigate the timeline of plasma levels of NGAL and CysC during the first seven days of ICU admission in a mixed ICU population and to relate these to AKI severity during ICU stay. Via these means we aimed to bring clarity to the previously reported heterogeneity of these renal biomarkers. Methods: Prospective Observation Cohort. Consecutive patients admitted to adult ICU at an academic hospital in the Netherlands between 18-02-2014 and 31-03-2014 were included. Urine output, serum creatinine, plasma NGAL and CysC were recorded during the first seven days of ICU admission. Biomarker expression was analyzed based on KDIGO score and time of AKI diagnosis. Results: 335 patients were included, 110 met KDIGO criteria for AKI. NGAL and CysC plasma levels were higher in AKI patients compared to non-AKI, high variability in individual values resulted in 56% of AKI patients having a false negative, and 32% of non-AKI patients having a false positive. Individual biomarker levels were variable, and no pattern based on KDIGO score was observed. Conclusions: Plasma NGAL and CysC as biomarkers for the early AKI detection may be subject to pathophysiological, and patient related heterogeneity. Further understanding of individual biomarker profiles may help in their application amongst mixed ICU populations. Trial Registration: The need for informed consent was waived by the Institutional Ethical Review Board of the University Medical Center Groningen (METc 2013 − 174) by Prof. dr. W.A. Kamps on May 17th 2013. [ABSTRACT FROM AUTHOR]

Background: Day care centres (DCCs) are ideal settings for drug-resistant bacteria to emerge. Prevalence numbers of faecal carriage of antimicrobial resistant bacteria in these settings are rare. We aimed to determine the prevalence of faecal antimicrobial resistant bacteria carriage in children attending DCCs and to assess and identify infection risk factors within DCCs in The Netherlands and Belgium. Methods: A point-prevalence study was conducted in 28 Dutch (499 children) and 18 Belgian (448 children) DCCs. Stool samples were taken from the children's diapers and a questionnaire was filled in by their parents. Hygiene related to stool and toilet use, hygiene related to food, environmental contamination, hand hygiene and hygiene guidelines were assessed conform a standardized questionnaire by the infection prevention and control expert visiting the DCC. Multilevel logistical regression analyses were used to define which characteristics predicted the presence of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E), carbapenemase-producing Enterobacterales (CPE), vancomycin-resistant enterococci (VRE), and ciprofloxacin-resistant Enterobacterales (CipR-E). Results: The ESBL-E prevalence was 16% (n = 71) in Belgium and 6% (n = 30) in the Netherlands. The CipR-E prevalence was 17% (n = 78) in Belgium and 8% (n = 38) in the Netherlands. Antimicrobial use (RR: 0.30; 95% CI: 0.33–0.48) and hospital admissions (RR: 0.37; 95% CI: 0.25–0.54) were lower in the Netherlands. Children travelling to Asia were at higher risk of being an ESBL-E carrier. Children using antimicrobials were at higher risk of being a CipR-E carrier. Cleaning the changing mat after each use was found as a protective factor for CipR-E carriage. Conclusions: We established a significant difference in ESBL-E and CipR-E carriage and antimicrobial use and hospital admissions between the Netherlands and Belgium among children attending DCCs. The differences between both countries should be further studied to improve the policy on anti-microbial use and hospital admissions in children. [ABSTRACT FROM AUTHOR]

Background: Despite therapeutic hypothermia (TH) and neonatal intensive care, 45–50% of children affected by moderate-to-severe neonatal hypoxic-ischemic encephalopathy (HIE) die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective therapies are sought, besides TH, to further improve the outcome of affected infants. Allopurinol — a xanthine oxidase inhibitor — reduced the production of oxygen radicals and subsequent brain damage in pre-clinical and preliminary human studies of cerebral ischemia and reperfusion, if administered before or early after the insult. This ALBINO trial aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to (near-)term infants with early signs of HIE. Methods/design: The ALBINO trial is an investigator-initiated, randomized, placebo-controlled, double-blinded, multi-national parallel group comparison for superiority investigating the effect of allopurinol in (near-)term infants with neonatal HIE. Primary endpoint is long-term outcome determined as survival with neurodevelopmental impairment versus death versus non-impaired survival at 2 years. Results: The primary analysis with three mutually exclusive responses (healthy, death, composite outcome for impairment) will be on the intention-to-treat (ITT) population by a generalized logits model according to Bishop, Fienberg, Holland (Bishop YF, Discrete Multivariate Analysis: Therory and Practice, 1975) and."will be stratified for the two treatment groups. Discussion: The statistical analysis for the ALBINO study was defined in detail in the study protocol and implemented in this statistical analysis plan published prior to any data analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Trial registration: ClinicalTrials.gov NCT03162653. Registered on 22 May 2017. [ABSTRACT FROM AUTHOR]

Background: Autoimmune hepatitis (AIH) is a rare, chronic inflammatory disease of the liver. The treatment goal is reaching complete biochemical response (CR), defined as the normalisation of aspartate and alanine aminotransferases and immunoglobulin gamma. Ongoing AIH activity can lead to fibrosis and (decompensated) cirrhosis. Incomplete biochemical response is the most important risk factor for liver transplantation or liver-related mortality. First-line treatment consists of a combination of azathioprine and prednisolone. If CR is not reached, tacrolimus (TAC) or mycophenolate mofetil (MMF) can be used as second-line therapy. Both products are registered for the prevention of graft rejection in solid organ transplant recipients. The aim of this study is to compare the effectiveness and safety of TAC and MMF as second-line treatment for AIH. Methods: The TAILOR study is a phase IIIB, multicentre, open-label, parallel-group, randomised (1:1) controlled trial performed in large teaching and university hospitals in the Netherlands. We will enrol 86 patients with AIH who have not reached CR after at least 6 months of treatment with first-line therapy. Patients are randomised to TAC (0.07 mg/kg/day initially and adjusted by trough levels) or MMF (max 2000 mg/day), stratified by the presence of cirrhosis at inclusion. The primary endpoint is the difference in the proportion of patients reaching CR after 12 months. Secondary endpoints include the difference in the proportion of patients reaching CR after 6 months, adverse effects, difference in fibrogenesis, quality of life and cost-effectiveness. Discussion: This is the first randomised controlled trial comparing two second-line therapies for AIH. Currently, second-line treatment is based on retrospective cohort studies. The rarity of AIH is the main issue in clinical research for alternative treatment options. The results of this trial can be implemented in existing international clinical guidelines. Trial registration: ClinicalTrials.gov NCT05221411. Retrospectively registered on 3 February 2022; EudraCT number 2021–003420-33. Prospectively registered on 16 June 2021. [ABSTRACT FROM AUTHOR]

Background: Cognitive impairment occurs in up to 65% of people with multiple sclerosis (PwMS), negatively affecting daily functioning and health-related quality of life. In general, neuropsychological testing is not part of standard MS-care due to insufficient time and trained personnel. Consequently, a baseline assessment of cognitive functioning is often lacking, hampering early identification of cognitive decline and change within a person over time. To assess cognitive functioning in PwMS in a time-efficient manner, a BICAMS-based self-explanatory digital screening tool called the Multiple Screener©, has recently been developed. The aim of the current study is to validate the Multiple Screener© in a representative sample of PwMS in the Netherlands. Additionally, we aim to investigate how cognitive functioning is related to psychological factors, and both work and societal participation. Methods: In this cross-sectional multicentre study, 750 PwMS (aged 18–67 years) are included. To obtain a representative sample, PwMS are recruited via 12 hospitals across the Netherlands. They undergo assessment with the Minimal Assessment of Cognitive Functioning in MS (MACFIMS; reference-standard) and the Multiple Screener©. Sensitivity, specificity, and predictive values for identifying (mild) cognitive impairment are determined in a subset of 300 participants. In a second step, the identified cut-off values are tested in an independent subset of at least 150 PwMS. Moreover, test–retest reliability for the Multiple Screener© is determined in 30 PwMS. Information on psychological and work-related factors is assessed with questionnaires. Discussion: Validating the Multiple Screener© in PwMS and investigating cognition and its determinants will further facilitate early identification and adequate monitoring of cognitive decline in PwMS. [ABSTRACT FROM AUTHOR]

Background: Hospitals and long-term care facilities, which are key institutions to serve health and well-being, have an important exemplary role in providing supportive food environments to encourage healthy and sustainable food choices. The objective of this study is to characterize the physical, socio-cultural, political and economic dimensions of the food environment for health care receivers, health workforce and visitors in healthcare settings, and make comparisons between the food environment of hospitals and long-term care facilities. Methods: To characterize the food environment in healthcare settings, two sub-studies were conducted. In sub-study 1, semi-structured interviews were held with staff members (n = 46) representing 11 hospitals and 26 long-term care facilities (rehabilitation centres, nursing homes, institutions for people with intellectual disabilities and mental healthcare institutions). In sub-study 2, staff members audited the food environment in hospitals (n = 28) and long-term care facilities (n = 36) using a predefined checklist. Results: The food environment in Dutch healthcare settings varies substantially between locations although noticeable differences between hospitals and long-term care facilities were identified. Hospitals and larger long-term care facilities featured more often restaurants and utilized central spaces for preparation of meals, while smaller long-term care facilities often operated as household-like settings. Type of healthcare shaped the socio-cultural food environment, with hospitals primarily emphasizing nutrition for fast recovery, while long-term care facilities more often as an instrument (i.e., to structure the day). Participants highlighted the importance of food policies and broad organizational support for realizing and regulating improvement of the food environment. Yet, long-term care facilities were less familiar with national guidelines for food environments compared to hospitals. Several economical aspects, like profit motives, strict budgets and contracts with external parties affected and shaped the food available within all healthcare settings. Conclusions: This study characterized the food environment in Dutch healthcare settings. Disclosed differences between hospitals and long-term care facilities should be incorporated in strategies for a transition of the food environment. Future research should investigate the underlying mechanisms of the healthcare food environment attaining all healthcare stakeholders - health care receivers, staff and visitors - while prioritizing sustainability alongside healthiness. [ABSTRACT FROM AUTHOR]

Background: People with intellectual disability have a poorer health status than the general population. In The Netherlands, support workers play a key role in meeting health support needs of people with intellectual disability. Research on how people with intellectual disability and their support workers experience the support worker's role in preventing, identifying, and following up health needs of people with intellectual disability is scarce. To enhance health support of people with intellectual disability it is crucial that we understand how health support is delivered in everyday practice. Therefore, this study investigated experiences of people with intellectual disability and support workers with the health support of people with intellectual disability. Method: Data collection consisted of six focus group (FG) discussions with between four and six participants (N = 27). The FGs consisted of three groups with support workers (n = 15), two groups with participants with mild to moderate intellectual disability (n = 8), and one group with family members as proxy informants who represented their relative with severe to profound intellectual disability (n = 4). The data was analysed thematically on aspects relating to health support. Results: We identified three main themes relevant to the health support of people with intellectual disability: 1) dependence on health support, 2) communication practices in health support, and 3) organizational context of health support. Dependence on health support adresses the way in which support workers meet a need that people with intellectual disability cannot meet themselves, and communication practices and organizational context are identified as systems in which health support takes place. Conclusion: This study investigated experiences with the health support of people with intellectual disability from the perspectives of people with intellectual disability and support workers. We discuss the dependence of people with intellectual disability and the complexity of health support in everyday practice. We provide practical implications that can strengthen support workers in the provision of health support for people with intellectual disability in everyday practice. The findings of this study emphasize the need for intellectual disability care-provider organizations to establish policies around consistency in support staff to make it easier to identify and follow up health needs, and an environment where support staff can develop their expertise concerning communication practices, lifestyle choices, and identifying and following up health needs. [ABSTRACT FROM AUTHOR]

Objective: Access to family planning services is a human right that plays an essential role in society's health, particularly women's health. The COVID-19 pandemic has affected all aspects of human life including access to family planning services. Accordingly, the main goal of this study was to explore the experiences of women and service providers from the main challenges and obstacles of access to family planning services and abortion services in Bangladesh, Iran, and the Netherlands during the COVID-19 pandemic. Methods: In this qualitative study, the data were collected through online, telephone, or in-person semi-structured interviews with key informants. Participants selected by purposive sampling method. The participants included women aged 15 to 49 (n = 63) and service providers (n = 54) in the 3 abovementioned countries. These individuals were included from October 2020 until December 2020. Conventional thematic analysis was employed to analyze the collected data. Results: The main extracted themes were challenges (reduction of referral; disruption of access to services; insufficient knowledge; worries among staff; rising prices; and unavailability of some contraceptives), measures (time extension and visit scheduling; telephone, online, and door to door services; and support of the media) and recommendations (health facility improvements; free, online, and closer services; and ongoing trainings and awareness campaigns). Conclusion: The COVID-19 pandemic has affected family planning and reproductive health services in different ways and has uncovered existing inequalities in access to these services. However, in Iran, the reported challenges were also rooted in new population policies that have further limited access to family planning and abortion services. [ABSTRACT FROM AUTHOR]