Search

Word problems are often used to assess numeracy, despite the growing number of reports on difficulties students encounter with this genre of mathematical problems. These reports contend that a large number of difficulties are influenced by the way the problems are presented, that is, with verbal representations of the problem situations. These difficulties are said to be associated with a form of suspension of sensemaking. In this study, conducted in the Netherlands, we investigated the effect on adult participants' performances of changing the representation of the problem situation, from verbal to image-rich. A controlled randomised trial was the main part of this investigation. Furthermore, we compared the results of adult participants with the results of a similar trial which was held with students from primary and secondary education. The study showed that adult participants' performances improved slightly with the change in representation, particularly on tasks in the content domain of measurement & geometry. These results were comparable with the results found of students from primary and secondary education, indicating that the effect is not related to age. The results could be of interest, however, for all practitioners involved in the work of numeracy task design.

Introduction: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch investigator-initiated randomized controlled clinical trials (RCTs). Methods: All Dutch investigator-initiated RCTs with a completion date between December 31, 2010, and January 1, 2012, and registered in the Trial Register of The Netherlands database were included. PubMed was searched for the publication of these RCT results until September 2016, and the time to the publication date was calculated. Consistency in hypothesis, sample size, and primary endpoint compared with the registry data were assessed. Results: The search resulted in a total of 168 Dutch investigator-initiated RCTs. In September 2016, the results of 129 (77%) trials had been published, of which 50 (39%) within 2 years after completion of accrual. Consistency in hypothesis with the original protocol was observed in 108 (84%) RCTs; in 71 trials (55%), the planned sample size was reached; and 103 trials (80%) presented the original primary endpoint. Consistency in all three parameters was observed in 50 studies (39%). Conclusion: This study shows that approximately one out of four Dutch investigator-initiated RCTs remains unpublished 5 years after initiation. The observed low overall consistency with the initial study outline is a matter of concern and warrants improvements in trial design and assessment of trial feasibility.

Inclusive education has brought new challenges for teachers, including the search for a suitable place in the classroom for children with externalizing problems. In the current study, we examined whether a careful rearrangement of the classroom seats could promote social acceptance and more prosocial behaviors for children with externalizing problems, and limit the potential negative consequences for classmates sitting next to them. The sample of this randomized controlled trial consisted of 64 classrooms with 221 fourth- to sixth-grade children selected by their teachers because of elevated levels of externalizing behavior. Results showed that over time children with externalizing behavior were better liked by their seatmates and showed fewer externalizing problems according to the teacher. This was particularly the case when students sat next to a well-liked and prosocial buddy, or when they were initially disliked. Classmates who sat next to a child with externalizing problems did not become more aggressive or less prosocial over time. Yet their social status did decrease slightly over time as a result of the rearrangement. We discuss implications and future directions for research on classroom seating arrangements to support children with externalizing problems.

In this digital era, a fundamental challenge is to design digital reading materials in such a way that they improve children's reading skills. Since reading books is challenging for many fifth graders--particularly for those genetically susceptible to attention problems--the researchers hypothesized that guidance from a digital Pedagogical Agent (PA) could improve students' reading motivation and incidental vocabulary learning. Using a sample of 147 fifth-grade students, the researchers carried out a randomized control trial with three groups of students reading: (a) hardcopy (print) books, (b) digital books, and (c) digital books with a PA. For students with a genetic predisposition to attention problems, carriers of the DRD4 seven-repeat allele, the PA supported their incidental vocabulary learning. For noncarriers, there were no effects of the digital reading materials or the PA.

This study tested effects of a program that offers teachers universal classroom management strategies, on teachers' burnout symptoms and self-efficacy, and their teaching behaviors. Data were collected from 147 teachers (mean age = 38.4 years, SD = 10.8) in 15 special secondary education schools for students with emotional and behavioral problems, at the start and end of the school year. Schools were randomly assigned to the experimental condition or a care-as-usual condition. Results show that the program impacted beneficially on self-reported levels of emotional exhaustion, and self-efficacy in engaging students and in classroom management, but not on teaching behaviors. Implications of this study for the professional development of teachers in special education and research are discussed.

Data-based decision making (DBDM) is an important element of educational policy in many countries, as it is assumed that student achievement will improve if teachers worked in a data-based way. However, studies that evaluate rigorously the effects of DBDM on student achievement are scarce. In this study, the effects of an intensive DBDM-intervention for Grade 4 teachers on students' mathematical achievement were investigated in a randomized controlled trial. Multilevel analyses showed that although no main effect on students' mathematical achievements was found, students who received "extended instruction" benefited significantly from the intervention. Based on the results, recommendations for the design of new DBDM-interventions and for their evaluation are presented.

This article reports on a "post hoc" study using a randomised controlled trial with 31,842 students in the Netherlands and an instrument consisting of 21 paired problems. The trial showed a variability in the differences of students' results in solving contextual mathematical problems with either a descriptive or a depictive representation of the problem situation. In this study the relation between this variability and two task characteristics is investigated: (1) complexity of the task representation; and (2) the content domain of the task. We found indications that differences in performance on descriptive and depictive representations of the problem situation are related to the content domain of the problems. One of the tentative conclusions is that for depicted problems in the domain of measurement and geometry the inferential step from representation of the problem situation to the mathematical problem to be solved is smaller than for word problems.

The current study used a dyadic and coconstructive approach to examine how to embed exercises that support executive functioning into early literacy instruction to empower its effects. Using a randomized controlled trial design with 100 children, we examined the effects of dyadic activities in which children scaffolded each other's learning and behavior through structured questioning procedures. This group was contrasted with a control group whose dyads observed each other while working with the same literacy exercises and with a business-as-usual control group. Research Findings: Results showed that the experimental group showed greater progress in letter knowledge. Further analyses indicated that these results were mainly driven by children with higher levels of executive functions. Practice or Policy: These results suggest that young children are able to regulate each other's learning behavior during preacademic exercises in dyadic contexts but may need more external control from a teacher when their executive function levels are low.

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended. Repeated-measures analyses and logistic regression analyses were conducted by the principle of intention-to-treat framework (N = 251). Results: Improvements were demonstrated on quality of life; satisfaction with family relations, finances, and health; employed or in school; depression; care needs; autonomy; competence, and resilience in both conditions. A higher proportion of homeless young adults who received care according to Houvast were still receiving care at follow-up and successfully completed the trajectory compared to those who received care as usual. Conclusion: Homeless young adults seem to benefit from service provision in general. Further research on the effectiveness of Houvast is needed after sufficient model fidelity has been achieved.

This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment condition had more ToM knowledge, showed fewer autistic features, and more ToM-related behavior than children in the control condition. Children who had one or two parents with at least a college degree, and children with parents not diagnosed with/suspected of having ASD themselves benefitted from the training. These findings provide valuable information about family variables that need to be taken into account in treatment design and implementation.

The aim of this study was to evaluate the effectiveness of a computer-based executive function (EF) training in children with specific language impairment (SLI). Ten children with SLI, ages 8 to 12 years, completed a 25-session training of visuospatial working memory, inhibition and cognitive flexibility over a 6-week period. Treatment outcome was examined directly after training and at 6 months follow-up by tasks of the three trained EF, tasks of untrained neurocognitive functions (verbal working memory, attention, planning and fluency), and ratings of EF and behavioral problems by parents and teachers. Directly after training, results showed significant improvement on cognitive flexibility and a positive trend for visuospatial storage and inhibition. At 6 months follow-up, the children performed significantly better on tasks of all three trained EFs. Furthermore, the results showed significant improvement on sustained attention, attention control, parent- and teacher-rated attention behavior and parent-rated EF and externalizing behavior with medium effect sizes. The results of this pilot study highlight the importance of a large-scale, randomized controlled trial examining the possible effects of EF training in children with SLI.

Persons with mental illness smoke at rates two to four times higher than do persons without mental illness and comprise 30.9% of the U.S. tobacco market. Given the prevalence of mental illness and the known detrimental effects of tobacco, concerted efforts are needed to promote the use of evidence-based treatment options. We conducted a systematic review of studies that examined the impact of tobacco quitline interventions in this population. Results revealed an overall positive impact of cessation services delivered via a tobacco quitline. More research is needed to determine intervention components and patient characteristics that are associated with cessation success.

Background: The link between disorders of attachment and psychopathology is well documented. Consequently, a person's attachment style has a profound effect on his or her development and psychological well-being. At-risk populations such as adopted children are more prone to developing pervasive patterns of attachment, given the maternal disruptions they experience early in life. Objective: The aim of this review was to identify and systematically appraise the current literature addressing a range of attachment-based interventions for adopted chidren. Methods: A comprehensive search of the literature from the most recent decade was conducted. The Cochrane, Ebscohost, Sage, ScienceDirect, SpringerLink, and Wiley databases were used. Results: Three randomized controlled trials were included in this review. Two studies were conducted in the USA and one in the Netherlands. All studies made use of quantitative methodologies. Conclusion: Although each article highlighted significant findings in the respective study, there remains a deficit of empirical information aimed at addressing attachment-related behaviour in adopted children through intervention.

Purpose: The purpose of this study was to conduct a systematic review of classroom-based physical activity interventions that integrate academic content and assess the effectiveness of the interventions on physical activity, learning, facilitators of learning, and health outcomes. Method: Six electronic databases (ERIC, PubMed, Google Scholar, Science Direct, Cochrane Library, and EMBASE) and reference lists were searched for English-language articles, published January 1990 through March 2015, reporting classroom-based interventions that deliberately taught academic content using physically active teaching methods for at least 1 week duration, with physical activity, health, learning, or facilitators-of-learning outcomes. Two authors reviewed full-text articles. Data were extracted onto an Excel spreadsheet, and authors were contacted to confirm accuracy of the information presented. Results: Fifteen studies met the inclusion criteria. Six studies reporting on physical activity levels were found to have medium-to-large effect sizes. All 4 studies reporting learning outcomes showed positive effects of intervention lessons. Teachers and students were pleased with the programs, and enhanced on-task behavior was identified (n = 3). Positive effects were also reported on students' body mass index levels (n = 3). Conclusions: Physically active academic lessons increase physical activity levels and may benefit learning and health outcomes. Both students and teachers positively received and enjoyed these teaching methods. These findings emphasize the need for such interventions to contribute toward public health policy.

The present study evaluated long-term effects of a home-based smoking prevention program targeting smoking-specific parenting in families with children with and without asthma. A total of 1398 non-smoking children ("mean age" 10.1) participated, of which 197 (14.1%) were diagnosed with asthma. Families were blinded to group assignment. The intervention group (n = 684) received booklets with assignments that actively encouraged parents to engage in smoking-specific parenting strategies. Control families (n = 714) received booklets containing basic information about youth smoking. Latent growth curve modeling was used to calculate intercepts and slopes to examine whether there was change in the different parenting aspects over the study period. Regression analyses were used to examine whether a possible change was different for intervention and control condition families with and without a child with asthma. For those smoking-specific parenting aspects that changed over time, families in the intervention and control condition increased similarly. Families with a child with asthma did not engage in parenting at higher levels due to the intervention program than parents of non-asthmatic children. This prevention program did not affect smoking-specific parenting in the Netherlands. Future prevention research could focus on other risk factors for smoking initiation among adolescents with asthma.

Background: The childcare environment offers a wide array of developmental opportunities for children. Providing children with a feeling of security to explore this environment is one of the most fundamental goals of childcare. Objective: In the current study the effectiveness of Video-feedback Intervention to promote Positive Parenting-Child Care (VIPP-CC) was tested on children's wellbeing in home-based childcare in a randomized controlled trial. Methods: Forty-seven children and their caregivers were randomly assigned to the intervention group or control group. Children's wellbeing, caregiver sensitivity, and global childcare quality were observed during a pretest and a posttest. Results: We did not find an overall intervention effect on child wellbeing, but a significant interaction effect with months spent with a trusted caregiver was present. Children who were less familiar with the caregiver showed an increase in wellbeing scores in both the intervention and control group, but for the group of children who were more familiar with the caregiver, wellbeing increased only in the intervention group. Conclusions: Although there was no overall effect of the VIPP-CC on children's wellbeing, the VIPP-CC seems effective in children who have been cared for by the same trusted caregiver for a longer period of time.

Currently, there are many diagnostic self-tests on body materials available to consumers. The aim of this study was to assess the effect of an online decision aid on diagnostic self-testing for cholesterol and diabetes on knowledge among consumers with an intention to take these tests. A randomized controlled trial was designed. A total of 1259 consumers with an intention to use a diagnostic cholesterol or diabetes self-test were selected from an existing Dutch Internet panel. The intervention group was invited to view an online decision aid offering general information on self-testing and test-specific information on cholesterol and diabetes self-testing, including indications for testing, how to perform the test and interpreting the result. The placebo condition consisted of a limited information sheet. Multiple regression analysis showed that the knowledge level in the diabetes arm was higher in the intervention group than in the control group (B = 0.657; 95% CI, 0.011-1.303), as was the number of participants with an informed choice (OR, 1.672; 95% CI, 1.134-2.465). No differences were found in the cholesterol arm. Consumers who are considering doing a self-test should have access to independent information on self-testing and be encouraged to read this information.

The present study aims to contribute to the understanding of the effects of music education, in particular music composition as a classroom activity for fifth- and sixth-graders. The intervention (experimental condition) focused on a three-step-model for music composition, based on the Cultural Historical Activity Theory of education, and has been compared with a teacher-centered approach mainly based on students' reproduction of music (control condition). Results indicated that after the six-month intervention period, students in the experimental group were more engaged in music education compared to students in the control group. The research did not show a statistical difference in learning outcomes with regard to intelligence, academic achievement and music achievement, although the students of the experimental group performed better with regard to reading comprehension than their counterparts in the control group. The authors conclude that music composition as a classroom activity is feasible and useful in elementary schools.

The purpose of the present study was to examine the effects of a program that offered sustained strategic reading instruction on reading abilities of third and fourth graders. The study was conducted among 1,469 children from 40 schools in the Netherlands. Schools were randomly assigned to either the experimental or control group. Multilevel analyses showed positive effects on knowledge of reading strategies after one year of intervention at the end of Grade 3. At the end of Grade 4, there were also positive intervention effects on reading comprehension. No significant interaction effects were determined for age, gender, SES, or ethnic/linguistic background. The intervention effects were also not dependent on the level of the student's nonverbal intelligence, vocabulary, or decoding skills.

Purpose: The purpose of this paper is to evaluate the effects of the Dutch "Skills for Life" programme on students' health behaviours, bullying behaviour and suicidal ideation. Design/methodology/approach: The effectiveness of the "Skills for Life" programme on health behaviour outcomes was evaluated at three points in time in using a cluster randomized controlled study design with a follow-up of 20 months. In total, 27 schools and 1,394 students were included. Findings: The programme was judged to be well implemented in just under half of cases. The outcome results for the experimental group (EG) compared with controls present a complex picture at the three different time points used for evaluation. There was a clearly positive effect on levels of alcohol consumption and a clearly negative effect on smoking across time. There was a mixed picture over time for suicide ideation and for bullying including sexual bullying (although the prevalence rates for bullying were low and thus results should be treated with caution). There were generally more positive impacts on students with lower educational levels including less suicidal ideation and less bullying. Research limitations/implications: Limitations were the dropping out of several schools during the study and the low level of fidelity of the curriculum. Social emotional learning (SEL) programs can be part of a health promoting school framework but should be more tailored to disadvantaged school populations. Originality/value: The findings indicate that students with a less optimal starting position, when it comes to health related behaviours, benefit most from a SEL programme. This indicates that schools with disadvantaged school populations could benefit most from a Health Promoting School approach.

Novel word learning is reported to be problematic for children with severe language impairments (SLI). In this study, we tested electronic storybooks as a tool to support vocabulary acquisition in SLI children. In Experiment 1, 29 kindergarten SLI children heard four e-books each four times: (a) two stories were presented as video books with motion pictures, music, and sounds, and (b) two stories included only static illustrations without music or sounds. Two other stories served as the control condition. Both static and video books were effective in increasing knowledge of unknown words, but static books were most effective. Experiment 2 was designed to examine which elements in video books interfere with word learning: video images or music or sounds. A total of 23 kindergarten SLI children heard 8 storybooks each four times: (a) two static stories without music or sounds, (b) two static stories with music or sounds, (c) two video stories without music or sounds, and (d) two video books with music or sounds. Video images and static illustrations were equally effective, but the presence of music or sounds moderated word learning. In children with severe SLI, background music interfered with learning. Problems with speech perception in noisy conditions may be an underlying factor of SLI and should be considered in selecting teaching aids and learning environments.

The aim of this study was to evaluate the effect of a Nordic hamstring exercise intervention on biceps femoris long head, semitendinosus, and semimembranosus muscle's activity and relative contributions through multichannel electromyography. Twenty-four injury-free male basketball players (mean age 20 [3] y) were randomly assigned to a 12-week intervention (n = 13) or control group (n = 11). The primary outcome measures were normalized muscle activity (percentage of maximal voluntary isometric contraction, %MVIC) and relative contribution of hamstring muscles over 12 weeks. No effects were found on any of the primary outcome measures. Between-group differences over 12 weeks were 2.7%MVIC (95% confidence interval 95% CI, −0.7 to 6.1) for the biceps femoris long head, 3.4%MVIC (95% CI, −1.4 to 8.2) for the semitendinosus, and 0.8%MVIC (95% CI, −3.0 to 4.6) for the semimembranosus, P =.366. Between-group differences over 12 weeks were 1.0% relative contribution (%con; 95% CI, −3.0 to 5.1) for the biceps femoris long head, 2.2% relative contribution (95% CI, −2.8 to 7.2) for the semitendinosus, and −3.3% relative contribution (95% CI, −6.4 to −0.1) for the semimembranosus P =.258. A positive value implies a higher value for the Nordic group. A Nordic hamstring exercise intervention did not affect the level of muscle activity and relative contribution of hamstring muscles in performance of the Nordic hamstring exercise. [ABSTRACT FROM AUTHOR]

Purpose: As the effect evaluation of our randomized controlled trial the "Comprehensive Approach of Reintegration for clients with Multiple problems" (CARm) showed no superior effect on re-integration into paid employment of the clients when compared with clients of the care as usual, we conducted this process evaluation to gain insight into whether the intervention was conducted according to protocol. Methods: Using questionnaires on recruitment, reach, dose delivered, dose received, fidelity, context, and satisfaction we collected data from 40 labour experts of the Public Employment Service of the Dutch Social Security Institute, and from 166 disability benefit recipients dealing with multiple problems. Results: Only few of the labour experts provided the key elements of the intervention to their clients. Between the clients of both groups were no significant differences in the dose received. More than half of the labour experts of the intervention group reported organizational changes. Conclusion: The lack of effect of the CARm intervention was almost certainly caused by implementation failure. Once again this study showed the importance of involving all stakeholders in developing and the conduct of the intervention, and of clarifying the consequences for the organization, to ensure that it can be conducted according to protocol. IMPLICATIONS FOR REHABILITATION: A Strength based intervention was developed to improve re-integration into paid employment of disability benefit recipients facing multiple problems and a process evaluation was carried out. Organizations should provide sufficient time to support their professionals by implementing this intervention into practice. Protocol adherence is crucial to value intervention results in practice. [ABSTRACT FROM AUTHOR]

Introduction: Providing oral care is an essential part of basic nursing care but receives little priority in daily practice, with a risk of adverse events. Also, nurses report many barriers to adequate provision of oral care, such as time restraints, insufficient materials, fear of causing pain, lack of knowledge and a negative attitude towards providing oral care. Methods: We performed a cluster‐randomized, stepped‐wedge study to explore the effect of the the implementation of a new nursing evidence‐based oral care protocol on nurses' knowledge, attitude and protocol adherence. The study population included both nursing students, graduated nurses and patients in selected wards. The implementation strategy included oral and written information, instruction videos and reminders. Nurses' knowledge and attitude towards oral care were assessed at baseline and after the implementation of the protocol with a validated 47‐item questionnaire with a score range of 0–100. Secondarily, nurses' protocol adherence to teeth brushing, measured in Activities of Daily Living (ADL) dependent patients, was evaluated. The Standards for Reporting Implementation Studies (StaRI) Statement was used. Results: At baseline, the questionnaire was completed by 226 nurses; after implementation by 283. Knowledge had significantly improved from 68.8 to 72.3. Nurses' attitude improved not significantly. Protocol adherence was assessed in 73 ADL‐dependent patients at baseline, in 51 after implementation. Adherence to teeth brushing significantly decreased in patients with permanent teeth. Also, adherence to both teeth brushing and usage of soap decreased in patients with (partial) dentures. Conclusion: Nurses' knowledge and attitude of oral care increased somewhat after the implementation of a new nursing evidence‐based protocol. After implementation, there was an unexplained decreased adherence to oral care in ADL‐dependent patients. [ABSTRACT FROM AUTHOR]

Purpose: A scoping review of randomized controlled trials (RCTs) of parenting and family-based interventions that aim to reduce severe and persistent conduct problems among 10–17 year-olds. The review also examined feasibility for conducting a network meta-analysis of common therapy elements measured by RCTs. Materials and methods: The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA- ScR). Searches were conducted in ERIC, PsycINFO, and MEDLINE without limits on publication year, language or publication country. Study methodological quality was assessed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for RCTs. Results: Twenty-five eligible RCTs were identified. The studies trialed nine interventions, with Multisystemic Therapy (MST) being the most evaluated (N = 10), followed by Functional Family Therapy (FFT, N = 4), and Treatment Foster Care Oregon (TFCO, N = 3). Only 10 of the 25 RCTs revealed treatment effect on conduct problems, including 6 of 9 MST, 1 of 4 FFT and all 3 TFCO trials. Discussion: Surprisingly few RCTs of parenting and family-based interventions have been carried out exclusively with this population. Available data suggests that MST and FFT have uncertain effectiveness for reducing severe and persistent conduct problems. While the quality of the reviewed studies was generally high, only two reported substantive data on common therapy elements. Conclusion: There is need for more RCTs of parenting and family-based interventions delivered for older children and adolescents with severe and persistent conduct problems. Future RCTs should systematically measure common therapy elements with a view to advancing intervention science. [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]

Objective Design Setting Population Methods Main Outcome Measures Results Conclusion To evaluate whether physical function and quality of life was influenced by discharge on the same‐day after a total laparoscopic hysterectomy.Multicentre non‐inferiority randomised controlled trial.Five teaching hospitals and two university hospitals in the Netherlands.Patients undergoing laparoscopic hysterectomy for benign or premalignant disease.Following informed consent, participants were allocated 1:1 either to same‐day discharge (SDD) or next‐day discharge (NDD).The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ‐5D‐5L).Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07–0.57]). As the upper limit of the 95% CI does not exceed the non‐inferiority margin of 4 points, non‐inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found.This research demonstrates same‐day discharge after laparoscopic hysterectomy is non‐inferior to next day discharge in physical function 7 days after surgery. [ABSTRACT FROM AUTHOR]

Background: Disease recurrence remains one of the biggest concerns in patients after resection of pancreatic ductal adenocarcinoma (PDAC). Despite (neo)adjuvant systemic therapy, most patients experience local and/or distant PDAC recurrence within 2 years. High-level evidence regarding the benefits of recurrence-focused surveillance after PDAC resection is missing, and the impact of early detection and treatment of recurrence on survival and quality of life is unknown. In most European countries, recurrence-focused follow-up after surgery for PDAC is currently lacking. Consequently, guidelines regarding postoperative surveillance are based on expert opinion and other low-level evidence. The recent emergence of more potent local and systemic treatment options for PDAC recurrence has increased interest in early diagnosis. To determine whether early detection and treatment of recurrence can lead to improved survival and quality of life, we designed an international randomized trial. Methods: This randomized controlled trial is nested within an existing prospective cohort in pancreatic cancer centers in the Netherlands (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) (Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the "Trials within Cohorts" (TwiCs) design. All PACAP/PACOPS participants with a macroscopically radical resection (R0-R1) of histologically confirmed PDAC, who provided informed consent for TwiCs and participation in quality of life questionnaires, are included. Participants randomized to the intervention arm are offered recurrence-focused surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19–9 testing, and contrast-enhanced computed tomography (CT) of chest and abdomen every three months during the first 2 years after surgery. Participants in the control arm of the study will undergo non-standardized clinical follow-up, generally consisting of clinical follow-up with imaging and serum tumor marker testing only in case of onset of symptoms, according to local practice in the participating hospital. The primary endpoint is overall survival. Secondary endpoints include quality of life, patterns of recurrence, compliance to and costs of recurrence-focused follow-up, and the impact on recurrence-focused treatment. Discussion: The RADAR-PANC trial will be the first randomized controlled trial to generate high level evidence for the current clinical equipoise regarding the value of recurrence-focused postoperative surveillance with serial tumor marker testing and routine imaging in patients after PDAC resection. The Trials within Cohort design allows us to study the acceptability of recurrence-focused surveillance among cohort participants and increases the generalizability of findings to the general population. While it is strongly encouraged to offer all trial participants treatment at time of recurrence diagnosis, type and timing of treatment will be determined through shared decision-making. This might reduce the potential survival benefits of recurrence-focused surveillance, although insights into the impact on patients' quality of life will be obtained. Trial registration: Clinicaltrials.gov, NCT04875325. Registered on May 6, 2021. [ABSTRACT FROM AUTHOR]

Background Based on observational studies and randomised controlled trials (RCTs), the benefit–harm balance of antihypertensive treatment in older adults with dementia is unclear. Objective To assess whether discontinuing antihypertensive treatment reduces neuropsychiatric symptoms (NPSs) and maintains quality of life (QoL) in nursing home residents with dementia. Design Open-label, blinded-outcome RCT. Randomisation 1:1, stratified by nursing home organisation and baseline NPS. Trial registration: NL7365. Subjects Dutch long-term care residents with moderate-to-severe dementia and systolic blood pressure (SBP) ≤160 mmHg during antihypertensive treatment. Exclusion criteria included heart failure NYHA-class-III/IV, recent cardiovascular events/procedures or life expectancy <4 months (planned sample size n  = 492). Measurements Co-primary outcomes NPS (Neuropsychiatric Inventory-Nursing Home [NPI-NH]) and QoL (Qualidem) at 16 weeks. Results From 9 November 2018 to 4 May 2021, 205 participants (median age 85.8 [IQR 79.6–89.5] years; 79.5% female; median SBP 134 [IQR 123–146] mmHg) were randomised to either antihypertensive treatment discontinuation (n  = 101) or usual care (n  = 104). Safety concerns, combined with lacking benefits, prompted the data safety and monitoring board to advice a premature cessation of randomisation. At 16-week follow-up, no significant differences were found between groups for NPI-NH (adjusted mean difference 1.6 [95% CI –2.3 to 5.6]; P  = 0.42) or Qualidem (adjusted mean difference − 2.5 [95% CI –6.0 to 1.0]; P  = 0.15). Serious adverse events (SAEs) occurred in 36% (discontinuation) and 24% (usual care) of the participants (adjusted hazard ratio 1.65 [95% CI 0.98–2.79]). All 32-week outcomes favoured usual care. Conclusion Halfway through this study, a non-significant increased SAE risk associated with discontinuing antihypertensive treatment was observed, and an associated interim analysis showed that significant worthwhile health gain for discontinuation of antihypertensive treatment was unlikely. This unbeneficial benefit–harm balance shows that discontinuation of antihypertensive treatment in this context does not appear to be either safe or beneficial enough to be recommended in older adults with dementia. [ABSTRACT FROM AUTHOR]

An adequate diagnosis for interstitial lung disease (ILD) is important for clinical decision making and prognosis. In most patients with ILD, an accurate diagnosis can be made by clinical and radiological data assessment, but in a considerable proportion of patients, a lung biopsy is required. Surgical lung biopsy (SLB) is the most common method to obtain tissue, but it is associated with high morbidity and even mortality. More recently, transbronchial cryobiopsy has been introduced, with fewer adverse events but a lower diagnostic yield than SLB. The aim of this study is to compare two diagnostic strategies: a step-up strategy (transbronchial cryobiopsy, followed by SLB if the cryobiopsy is insufficiently informative) versus immediate SLB. The COLD study was a multicentre, randomised controlled trial in six hospitals across the Netherlands. We included patients with ILD with an indication for lung biopsy as assessed by a multidisciplinary team discussion. Patients were randomly assigned in a 1:1 ratio to the step-up or immediate SLB strategy, with follow-up for 12 weeks from the initial procedure. Patients, clinicians, and pathologists were not masked to the study treatment. The primary endpoint was unexpected chest tube drainage, defined as requiring any chest tube after transbronchial cryobiopsy, or prolonged (>24 h) chest tube drainage after SLB. Secondary endpoints were diagnostic yield, in-hospital stay, pain, and serious adverse events. A modified intention-to-treat analysis was performed. This trial is registered with the Dutch Trial Register, NL7634, and is now closed. Between April 8, 2019, and Oct 24, 2021, 122 patients with ILD were assessed for study participation; and 55 patients were randomly assigned to the step-up strategy (n=28) or immediate SLB (n=27); three patients from the immediate SLB group were excluded. Unexpected chest tube drainage occurred in three of 28 patients (11%; 95% CI 4–27%) in the step-up group, and the number of patients for whom the chest tube could not be removed within 24 h was 11 of 24 patients (46%; 95% CI 2–65%) in the SLB group, with an absolute risk reduction of 35% (11–56%; p=0·0058). In the step-up strategy, the multidisciplinary team diagnostic yield after transbronchial cryobiopsy alone was 82% (64–92%), which increased to 89% (73–96%) when subsequent SLB was performed after inconclusive transbronchial cryobiopsy. In the immediate surgery strategy, the multidisciplinary team diagnostic yield was 88% (69–97%). Total in-hospital stay was 1 day (IQR 1–1) in the step-up group versus 5 days (IQR 4–6) in the SLB group. One (4%) serious adverse event occurred in step-up strategy versus 12 (50%) in the immediate SLB strategy. In ILD diagnosis, if lung tissue assessment is required, a diagnostic strategy starting with transbronchial cryobiopsy, followed by SLB when transbronchial cryobiopsy is inconclusive, appears to result in a significant reduction of patient burden and in-hospital stay with a similar diagnostic yield versus immediate SLB. Netherlands Organisation for Health Research and Development (ZonMW) and Amsterdam University Medical Centers. [ABSTRACT FROM AUTHOR]

Introduction: Lifestyle interventions combining caloric restriction with resistance exercise have the potential to preserve lean mass during weight loss. Additional protein intake can further improve lean mass. However, it is unclear whether these effects are sustained after completion of the intervention. This study aimed to evaluate the long‐term effect of a 3‐month lifestyle intervention, with or without supplementation of a protein drink, to preserve lean mass in older adults with obesity and type 2 diabetes at 6 months post‐intervention. Methods: Adults (n = 123) aged ≥55 years with obesity and type 2 diabetes were enrolled in a 3‐month intensive lifestyle intervention including a hypocaloric diet, resistance exercise and high‐intensity interval training. Participants were randomized to either receive a leucine and vitamin D‐enriched protein drink or an isocaloric control drink. The 3‐month intervention was followed by a 6‐month phase without intervention. At baseline, 3 and 9 months (follow‐up) body composition, physical functioning, physical activity and quality of life were assessed. Statistical analyses were performed using linear mixed models. Results: Body weight loss was largely sustained at follow‐up (−2.1 kg compared to baseline, 95% CI [−2.8, −1.5]) and comprised a sustained loss of fat mass (−2.6 kg, 95% CI [−3.2, −2.0]) with a simultaneous gain of lean mass (+0.7 kg, 95% CI [+0.2, +1.2]). Improvements in 400 m walk speed (+0.05 m/s, 95% CI [+0.03, +0.08]) and chair stand test time (−1.5 s, 95% CI [−1.9, −1.1]) were sustained at follow‐up. There were no differences in these changes between the protein supplementation group and the control group at follow‐up. Conclusions: Older adults with obesity and type 2 diabetes preserved their lean mass, their loss of fat mass and their improvements in physical functioning at 6 months post‐intervention. Protein supplementation during intervention did not affect outcomes at follow‐up. [ABSTRACT FROM AUTHOR]

Background Structural nutrition interventions like a sugar tax or a product reformulation are strongly supported among the public health community but may cause a considerable backlash (e.g. inspiring aversion to institutions initiating the interventions among citizens). Such a backlash potentially undermines future health-promotion strategies. This study aims to uncover whether such backlash exists. Methods We fielded a pre-registered randomized, population-based survey experiment among adults from the Longitudinal Internet Studies for the Social Sciences panel (n  =   1765; based on a random sampling of the Dutch population register). Participants were randomly allocated to the control condition (brief facts about health-information provision/nudging), or one of two experimental groups (the same facts, expanded with either a proposed sugar tax on or reformulation of sugar-sweetened beverages). Ordinary least squares regression was used to estimate the proposed interventions' effects on four outcome variables: trust in health-promotion institutions involved; perceptions that these institutions have citizens' well-being in mind (i.e. benevolence); perceptions that these institutions' perspectives are similar to those of citizens (i.e. alignment of perspectives); and attitudes toward nutrition information. Results Trust, perceived benevolence and perceived alignment of perspectives were affected negatively by a proposed sugar tax (−0.24, 95% CI −0.38 to −0.10; −0.15, −0.29 to −0.01; −0.15, −0.30 to 0.00) or product reformulation (−0.32, −0.46 to −0.18; −0.24, −0.37 to −0.11; −0.18, 0.33 to −0.03), particularly among the non-tertiary educated respondents. Conclusions Sugar taxes or product reformulations may delegitimize health-promotion institutions, potentially causing public distancing from or opposition to these bodies. This may be exploited by political and commercial parties to undermine official institutions. Trial registration https://osf.io/qr9jy/?view%5fonly=5e2e875a1fc348f3b28115b7a3fdfd90. Registered 3 February 2022. [ABSTRACT FROM AUTHOR]

Background: Various physical fitness qualities such as muscle strength, speed and endurance are related to soccer performance. Accordingly, the combination of strength and endurance training (i.e., concurrent training [CT]) is an often-encountered training regimen in soccer. Less is known about the effects of CT sequencing on performance in young soccer players. The aim of this study was to assess the sequencing effects of strength and intermittent endurance training applied within the same training session (intrasession) on measures of physical fitness and soccer performance in young soccer players. Methods: Fifty male adolescent soccer players volunteered to participate in this study which was conducted in the Netherlands in 2019. Players were randomly assigned to a strength-endurance (SE) or an endurance-strength (ES) group in matched pairs based on their countermovement jump (CMJ) performance at baseline. Both groups completed a 12-weeks in-season training program with two weekly CT sessions. Training sessions consisted of 15 min plyometric exercises and 15 min soccer-specific intermittent endurance training. Both groups performed the same training volumes and the only difference between the groups was the CT intrasession sequencing scheme (SE vs. ES). Pre and post intervention, proxies of muscle power (CMJ, squat jump [SJ]), linear sprint speed (30-m sprint test), agility (Illinois test with / without ball), and soccer performance (ball kicking velocity) were tested. Results: Data from 38 players aged 14.8 ± 1.0 years (body height 172.9 ± 8.1 cm, body mass: 57.0 ± 7.2 kg, soccer experience: 8.8 ± 2.8 years, age from peak-height-velocity [PHV]: +1.2 ± 1.0 years) were included. Significant main time effects were found for CMJ (p = 0.002, d = 0.55), SJ (p = 0.004, d = 0.51), the Illinois agility test with ball (p = 0.016, d = 0.51), and ball kicking velocity (p = 0.016, d = 0.51). Significant group-by-time interactions were observed for 30-m linear sprint speed (p < 0.001, d = 0.76) with ES showing greater improvements (p = 0.006, d = 0.85, Δ-5%). Conclusions: Both CT-sequencing types improved performance in the tests administered. The intrasession CT sequencing (SE vs. ES) appears not to have a major impact on physical fitness adaptations, except for linear sprint speed which was in favor of ES. Key points: • This study examined the effects of intrasession concurrent training. Findings showed that strength-endurance and endurance-strength sequencing resulted in similar changes in most measures of physical fitness in adolescent male soccer players. • If the goal is to improve linear sprint speed, endurance-strength sequencing appears to be better suited. • More research is needed to acquire further knowledge on concurrent training and effects of different types of sequencing schemes (e.g., training day, microcycle) as well as the strength training (e.g., power training) and endurance training type (e.g., high intensity interval training). [ABSTRACT FROM AUTHOR]

An Elimination Diet (ED) may be effective in reducing symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), but has never been compared to an active control condition [i.e., Healthy Diet (HD)]. In a two-armed RCT, a total of N = 165 children (5–12 years) with ADHD were randomized by means of minimization (1:1) to either an ED (N = 84) or HD (N = 81) within two Dutch child and adolescent psychiatry centers. The design included a non-randomized comparator arm including N = 58 children being treated with Care as Usual (CAU). Treatment allocation was unblinded. The primary outcome was a 5-point ordinal measure of respondership based on a combination of parent and teacher ratings on ADHD and emotion regulation, determined after 5 weeks of treatment. Ordinal regression analyses were done on an intention-to-treat basis. Fewer ED (35%) than HD (51%) participants showed a partial to full response, despite overall good-to-excellent treatment adherence (> 88%) and comparable high parental prior believes. A younger age and higher problem severity predicted a better respondership. CAU-preferring participants responded more often favorably (56%) compared to ED—but not HD—participants. Small-to-medium improvements in physical health (blood pressure, heart rate, and somatic complaints) were found in response to ED/HD versus decrements in response to CAU (74% received psychostimulants). The lack of superiority of the ED versus HD suggests that for the majority of children, dietary treatment response is not rooted in food-allergies/-sensitivities. The comparable results for treatment with HD and CAU are remarkable given that CAU participants were probably 'easier to treat' than HD (and ED) participants with proportionally fewer with a (suboptimal/non-response to) prior treatment with medication (4% versus 20%). Further assessment of long-term effects is needed to evaluate the potential place of dietary treatment within clinical guidelines. The trial is closed and registered in the Dutch trial registry, number NL5324 (https://www.onderzoekmetmensen.nl/en/trial/25997). [ABSTRACT FROM AUTHOR]

• Long-term follow-up study after polypectomy comparing hysteroscopic tissue removal systems. • Recurrence and/or persistence of abnormal uterine bleeding was not significantly different. • Polyp recurrence or hysterectomy was not reported in the manually driven group. The aim of this follow-up study is to compare a manually driven hysteroscopic tissue removal system (ResectrTM 9 Fr) with a motor driven system (TruclearTM) in terms of long-term clinical outcomes such as abnormal uterine bleeding and polyp recurrence. This is a follow-up of a multicenter randomized controlled trial comparing a manually and motor driven hysteroscopic tissue removal system for polypectomy. This prospective cohort study was performed at Ghent University Hospital (Ghent, Belgium) and Catharina Hospital Eindhoven (Eindhoven, the Netherlands). The trial was registered at Clinicaltrials.gov (Trial ID = NCT05337605, April 2022). Seventy-five women with abnormal uterine bleeding who participated in the randomized controlled trial and had pathological confirmation of the diagnosis of an endometrial polyp, were contacted. Fifty-five women (70.67 %) were willing to participate in this follow-up study. The primary outcome was the recurrence and/or persistence of abnormal uterine bleeding and the time to the recurrence of abnormal uterine bleeding. Secondary outcomes were polyp recurrence and time to polyp recurrence, symptom relief, satisfaction score regarding symptom relief and general satisfaction score regarding the surgical procedure. In the manually driven group, the mean time to the recurrence or persistence of abnormal uterine bleeding was 26 months (95 % CI 20 – 32). In the motor driven group, the mean time to the recurrence or persistence of abnormal uterine bleeding was 29 months (95 % CI 23– 34). A log-rank test showed a non-significant difference between both groups (P =.77). There was no significant difference in polyp recurrence (P =.22) or symptom relief between the two groups (P =.67). Additionally, the groups did not differ in satisfaction scores regarding symptoms or polypectomy (P =.16 and P =.61, respectively). This long-term follow-up study showed no statistically significant difference in the recurrence and persistence of abnormal uterine bleeding between a manually and motor driven hysteroscopic tissue removal system for polypectomy. [ABSTRACT FROM AUTHOR]

Background/objectives: We investigated whether dietary interventions, i.e. a fasting mimicking diet (FMD, Prolon®) or glycocalyx mimetic supplementation (EndocalyxTM) could stabilize microvascular function in Surinamese South-Asian patients with type 2 diabetes (SA-T2DM) in the Netherlands, a patient population more prone to develop vascular complications. Subjects/methods: A randomized, placebo controlled, 3-arm intervention study was conducted in 56 SA-T2DM patients between 18 and 75 years old, for 3 consecutive months, with one additional follow up measurement 3 months after the last intervention. Sublingual microcirculation was assessed with SDF-imaging coupled to the GlycoCheckTM software, detecting red blood cell velocity, capillary density, static and dynamic perfused boundary region (PBR), and the overall microvascular health score (MVHS). Linear mixed models and interaction analysis were used to investigate the effects the interventions had on microvascular function. Results: Despite a temporal improvement in BMI and HbA1c after FMD the major treatment effect on microvascular health was worsening for RBC-velocity independent PBRdynamic, especially at follow-up. Glycocalyx supplementation, however, reduced urinary MCP-1 presence and improved both PBRdynamic and MVHSdynamic, which persisted at follow-up. Conclusions: We showed that despite temporal beneficial changes in BMI and HbA1c after FMD, this intervention is not able to preserve microvascular endothelial health in Dutch South-Asian patients with T2DM. In contrast, glycocalyx mimetics preserves the microvascular endothelial health and reduces the inflammatory cytokine MCP-1. Clinical study registration: NCT03889236. [ABSTRACT FROM AUTHOR]

This study evaluated the effect of a tailored, multifaceted improvement strategy on hand hygiene compliance in long-term care facilities (LTCFs). We also performed a process evaluation to explore the mechanisms through which our strategy brought about change. We conducted a stepped-wedge cluster-randomized controlled trial with a sequential rollout of the improvement strategy to all participating LTCFs. The strategy consisted of education, training, reminders, observation sessions (including feedback), and team meetings (including feedback). The study included nursing professionals from 14 LTCFs (23 wards) in the Netherlands. Hand hygiene compliance was observed during 5 measurement periods using WHO's "Five Moments for Hand Hygiene." Multilevel analyses and corresponding tests were completed on an intention-to-treat basis. The absolute intervention effect of overall hand hygiene compliance (primary outcome measure) was 13% (95% CI 9.3-16.7, P <.001), adjusted for time and clustering. The adjusted absolute effect was 23% (95% CI 7-39, P <.002) before a clean and aseptic procedure, 18% (95% CI 10-26, P <.001) after touching a resident, 14% (95% CI 7-22, P <.003) before touching a resident, 10% (95% CI 5-15, P <.001) after contact with body fluid, and 1% (95% CI –11 to 13, P =.8) after touching a resident's surroundings. With the exception of leadership, participants at LTCFs with more exposure to the intervention components showed statistically significantly more improvement than those at facilities with lower exposure scores. Our strategy was successful in improving hand hygiene compliance. LTCFs with more team members exposed to the different intervention components, demonstrated a greater effect from the intervention. To strengthen the impact of our intervention, we recommend that future improvement strategies provide more support to managers to ensure they are better equipped to take on their leadership roles and enable their teams to improve and maintain hand hygiene compliance. [ABSTRACT FROM AUTHOR]

Purpose: Home visitation program effects are generally small, which may be caused by flexible intervention content leading to inconsistent outcomes. In this study we therefore examined whether the effectiveness of a Dutch home visitation program (i.e., Supportive Parenting) can be improved by adding structured intervention components targeting key risk factors for child maltreatment: parental sense of competence, perceived stress, parental anger, and PTSD symptoms. Method: Participants were randomly assigned to an experimental group (n = 74) that received four additional intervention components in two home visits, or a control group (n = 60) that received regular Supportive Parenting. Outcomes were assessed before (T1) and after (T2) the first, and before (T3) and after (T4) the second home visit. Effects were examined using ANCOVA for primary outcomes: parental sense of competence, perceived stress, parental anger, and PTSD symptoms, and secondary outcomes: risk of child maltreatment, parental warmth, and negative parenting. Moderation effects were examined for T1 scores, child temperament and life events. Results: Mothers who received the intervention components showed less stress compared to the control group at T3 and T4. There were no differences between groups on other outcomes and no moderation effects, although parental sense of competence reduced and anger increased within the experimental group specifically. Conclusion: The structured components may enhance the effectiveness of Supportive Parenting to reduce parenting stress. Future research into how other outcomes can be improved is needed. [ABSTRACT FROM AUTHOR]

Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical resection. The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial. This international, non-randomised, phase 2 study was conducted in seven centres in Australia and one centre in the Netherlands. Eligible patients aged 18 years or older had biopsy-confirmed diagnosis of primary renal cell cancer, with only a single lesion; were medically inoperable, were at high risk of complications from surgery, or declined surgery; and had an Eastern Cooperative Oncology Group performance status of 0–2. A multidisciplinary decision that active treatment was warranted was required. Key exclusion criteria were a pre-treatment estimated glomerular filtration rate of less than 30 mL/min per 1·73 m2, previous systemic therapies for renal cell cancer, previous high-dose radiotherapy to an overlapping region, tumours larger than 10 cm, and direct contact of the renal cell cancer with the bowel. Patients received either a single fraction SABR of 26 Gy for tumours 4 cm or less in maximum diameter, or 42 Gy in three fractions for tumours more than 4 cm to 10 cm in maximum diameter. The primary endpoint was local control, defined as no progression of the primary renal cell cancer, as evaluated by the investigator per Response Evaluation Criteria in Solid Tumours (version 1.1). Assuming a 1-year local control of 90%, the null hypothesis of 80% or less was considered not to be worthy of proceeding to a future randomised controlled trial. All patients who commenced trial treatment were included in the primary outcome analysis. This trial is registered with ClinicalTrials.gov , NCT02613819 , and has completed accrual. Between July 28, 2016, and Feb 27, 2020, 70 patients were enrolled and initiated treatment. Median age was 77 years (IQR 70–82). Before enrolment, 49 (70%) of 70 patients had documented serial growth on initial surveillance imaging. 49 (70%) of 70 patients were male and 21 (30%) were female. Median tumour size was 4·6 cm (IQR 3·7–5·5). All patients enrolled had T1–T2a and N0–N1 disease. 23 patients received single-fraction SABR of 26 Gy and 47 received 42 Gy in three fractions. Median follow-up was 43 months (IQR 38–60). Local control at 12 months from treatment commencement was 100% (p<0·0001). Seven (10%) patients had grade 3 treatment-related adverse events, with no grade 4 adverse events observed. Grade 3 treatment-related adverse events were nausea and vomiting (three [4%] patients), abdominal, flank, or tumour pain (four [6%]), colonic obstruction (two [3%]), and diarrhoea (one [1%]). No treatment-related or cancer-related deaths occurred. To our knowledge, this is the first multicentre prospective clinical trial of non-surgical definitive therapy in patients with primary renal cell cancer. In a cohort with predominantly T1b or larger disease, SABR was an effective treatment strategy with no observed local failures or cancer-related deaths. We observed an acceptable side-effect profile and renal function after SABR. These outcomes support the design of a future randomised trial of SABR versus surgery for primary renal cell cancer. Cancer Australia Priority-driven Collaborative Cancer Research Scheme. [ABSTRACT FROM AUTHOR]

Introduction: Due to the heterogeneity in language trajectories and differences in language exposure, a lot of bilingual children could use some extra support for the acquisition of the school language to reduce the risk of language problems and learning difficulties. Enhancing bilingual children's narrative abilities in the school language could be an efficient approach to advance the general school language abilities as well. Therefore, this study aimed to investigate whether a narrative intervention could improve both general and narrative school language abilities of typically developing bilingual (Turkish-Dutch) children. Methods: Nineteen Turkish-Dutch bilingual children (6–9.9 years) were enrolled in this single-arm early efficacy study. The intervention procedure was administered in the school language (Dutch) and based on a test-teach-retest principle with two baseline measurements. At baseline 1, the expressive, receptive, and narrative language abilities were determined. The second baseline measurement consisted of a second measurement of the narrative abilities. Subsequently, a weekly 1-h group-based intervention was implemented during 10 sessions. After the intervention phase, the expressive, receptive, and narrative language abilities were tested again. Results: After the intervention, the children produced significantly more story structure elements compared to both baseline measurements. No significant differences were found for microstructure narrative measures. The participants had significantly higher scores on the expressive and receptive language measurements post-intervention. Conclusion: These findings suggest that the intervention could be an efficient approach to stimulate the second language development of bilingual children. [ABSTRACT FROM AUTHOR]

Purpose: A barrier for reemployment of people with mental health issues/mental illness (MHI) is workplace stigma and discrimination. In this RCT the effectiveness of a stigma-awareness intervention addressing finding work, retaining work and decisional stress were evaluated. Methods: A cluster RCT was conducted in 8 Dutch municipal practices. Randomisation took place at practice level. Participants were unemployed people with MHI, receiving social benefits. The intervention consisted of a decision aid for workplace disclosure for participants and a 2 × 3 h stigma-awareness training for their employment specialists. Primary outcomes were measured at baseline, 3-, 6- and 12-months. Multilevel analyses, containing random intercepts of participants nested in organizations, were conducted to analyse the effects of the intervention. Results: Participants (N = 153) were randomized to an experimental (n = 76) or control group (n = 77). At six months, significantly more participants of the experimental group (51%) had found work compared to the control group (26%). At twelve months, significantly more participants of the experimental group (49%) had retained work compared to the control group (23%). Intention-to-treat analyses showed that randomization to the experimental group was associated with finding (OR(95%CI) = 7.78(1.33–45.53), p = 0.02) and retaining (OR(95%CI) = 12.15(2.81–52.63), p < 0.01) work more often at twelve months. Analyses showed that the experimental and control group did not differ in decisional stress. Conclusions: Our stigma awareness intervention was effective for finding and retaining work. As the percentage of people who found and retained work almost doubled, this suggests that on a societal level, a vast number of unemployed people could be reemployed with a relatively simple intervention. Trial Registration: The study was retrospectively registered at the Dutch Trial Register (TRN: NL7798, date: 04-06-2019). [ABSTRACT FROM AUTHOR]

Background: Nowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of up to 20%. Snare tip soft coagulation (STSC) is considered an effective technique to reduce recurrence rates. However, clinical trials on STSC have mainly been conducted in expert referral centers. In these studies, polyp recurrence was assessed optically, and additional adjunctive techniques were excluded. In the current trial, we will evaluate the efficacy and safety of STSC in daily practice, by allowing adjunctive techniques during EMR and the use of both optical and histological polyp recurrence to assess recurrences during follow-up. Methods: The RESPECT study is a multicenter, parallel-group, international single blinded randomized controlled superiority trial performed in the Netherlands and Germany. A total of 306 patients undergoing piecemeal EMR for LSLs or sessile colorectal polyps sized 20–60 mm will be randomized during the procedure after endoscopic complete polyp resection to the intervention or control group. Post-EMR defects allocated to the intervention group will be treated with thermal ablation with STSC of the entire resection margin. Primary outcome will be polyp recurrence by optical and histological confirmation at the first surveillance colonoscopy after 6 months. Secondary outcomes include technical success and complication rates. Discussion: The RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification. Trial registration: ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025. [ABSTRACT FROM AUTHOR]

Purpose: There is a substantial need to perform studies to evaluate crestal bone loss (CBL) and implant success when using a newly introduced low-speed drilling protocol. Therefore, this study aimed to evaluate the mean CBL and implant success rate by placing implants utilizing two drilling protocols, ie, standard and low-speed drilling protocols. Materials and Methods: A randomized controlled clinical trial was carried out in patients who required dental implants to restore their esthetics and function. The patients were recruited from a university hospital (Academic Centre for Dentistry Amsterdam [ACTA], the Netherlands). Based on the inclusion criteria, patients were randomized to two study groups: (1) control group, standard drilling protocol; and (2) test group, low-speed drilling protocol without saline irrigation. The mean CBL and the implant success rate were evaluated after 12 months of implant placement. Results: Twenty-three patients (15 men and 8 women with a mean age of 57.5 ± 10.7 years) contributed to the study. Forty Camlog screw-line implants were placed (20 implants per study group). After 12 months of implant placement, the mean CBL of implants placed with the standard protocol and the low-speed protocol was 0.206 ± 0.251 mm and 0.196 ± 0.178 mm, respectively. No statistically significant difference could be recorded among both groups (P = .885). Concerning implants placed in the maxilla, the standard drilling group and low-speed drilling group showed a mean CBL of 0.252 ± 0.175 mm and 0.251 ± 0.175 mm, respectively, compared with 0.173 ± 0.210 mm and 0.141 ± 0.172 mm in the mandible, with no significant difference. The success rate of dental implants at 12 months was 95% in the control group and 90% in the test group. Conclusion: Within the limitations of this study, it can be concluded that implants placed with the low-speed drilling protocol without saline irrigation exhibited a similar CBL compared with implants placed with the standard drilling protocol. However, a higher success rate was recorded especially in type 1–quality bone for the control group compared with the test group. Further randomized clinical trials with greater sample sizes and extended follow-up times should be performed to obtain stronger evidence and a better understanding of the influence of drilling speed on mean CBL and long-term implant success. [ABSTRACT FROM AUTHOR]

Introduction: This paper reports on the effects of a 9-week vitality training that employed behaviour-change techniques and was evaluated using a randomised controlled trial (RCT) in three large companies based in the Netherlands. Methods: A total of 84 adult employees from three participating organisations in the Netherlands were enrolled in the study. A parallel group RCT design was employed and participants were assigned using individual random assignment to either an intervention (n = 38) or a waitlist control group (n = 46). The intervention consisted of a 9-week vitality training employing the behaviourchange techniques of self-persuasion, implementation intentions, and selfefficacy, which was delivered in-house over five fortnightly 2-hour sessions. Primary outcomes (i.e., reported energy and stress) and secondary outcomes (i.e., reported daily life satisfaction and work capacity) were assessed prior to, immediately after, and 3 months following the intervention. Results: A mixed MANOVA revealed a significant interaction effect between treatment group and time period for the combination of reported energy, stress, daily life satisfaction, and work capacity. Subsequent univariate ANOVAs revealed significant interactions between treatment group and time period for reported energy, stress, and daily life satisfaction; however, not for reported work capacity. Improvements in outcomes were observed for both groups following their completion of the vitality training; however, not all improvements reached statistical significance. Reported self-efficacy regarding managing work-life balance was found to mediate the relationship between the effects of the intervention and reported energy; however, such an effect was not found for stress. Discussion: An intervention drawing upon evidence-based behaviourchange techniques shows promise for improving indicators associated with burnout; although, it is recommended that in future research a larger-scale evaluation be conducted over a longer time period with an active control group to establish effectiveness. [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]

Deliberate reflection on initial diagnosis has been found to repair diagnostic errors. We investigated the effectiveness of teaching students to use deliberate reflection on future cases and whether their usage would depend on their perception of case difficulty. One-hundred-nineteen medical students solved cases either with deliberate-reflection or without instructions to reflect. One week later, all participants solved six cases, each with two equally likely diagnoses, but some symptoms in the case were associated with only one of the diagnoses (discriminating features). Participants provided one diagnosis and subsequently wrote down everything they remembered from it. After the first three cases, they were told that the next three would be difficult cases. Reflection was measured by the proportion of discriminating features recalled (overall; related to their provided diagnosis; related to alternative diagnosis). The deliberate-reflection condition recalled more features for the alternative diagnosis than the control condition (p =.013) regardless of described difficulty. They also recalled more features related to their provided diagnosis on the first three cases (p =.004), but on the last three cases (described as difficult), there was no difference. Learning deliberate reflection helped students engage in more reflective reasoning when solving future cases. [ABSTRACT FROM AUTHOR]

Objective: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. Methods: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face‐to‐face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention‐to‐treat population was distress severity (Brief Symptom Inventory; BSI‐18) immediately post‐intervention (T1). Results: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention‐to‐treat analysis, the intervention significantly reduced distress immediately post‐intervention (−3.86 points, 95% CI −7.00 to −0.73) and at 7 months post‐randomization (−3.88 points, 95% CI −6.95 to −0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer‐specific distress were significantly lower in the intervention arm. Self‐efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. Conclusions: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. Trial Registration: Netherlands Trial Register NTR6025. [ABSTRACT FROM AUTHOR]

Objective: This process evaluation aimed to gain insight into the implementation of the VolleyVeilig Youth program by Dutch volleyball clubs within the context of an effectiveness trial. Methods: We applied the UK Medical Research Council framework for process evaluations and assessed the context, implementation and mechanisms of impact. Trainers participating in the effectiveness trial were asked to complete a questionnaire at the end of the study. A subsample of the trainers based on the self‐reported adherence score was invited to participate in an interview accordingly. We used a thematic analysis to present the data. Results: Thirty‐one trainers (100%) completed the questionnaire, and seven agreed to participate in an interview. Although adherence gradually decreased over the volleyball season, most trainers reported partially adhere with the program until the end of the study. The main themes included factors associated with the (1) VolleyVeilig Youth program, (2) trainer, (3) players, and (4) volleyball club. Conclusion: Although (partial) adherence to the VolleyVeilig Youth program was high in this study, implementation strategies must be developed to target the barriers reported by the trainers before the program can be successfully implemented nationwide in the Netherlands. [ABSTRACT FROM AUTHOR]