What Parents of Children Born with a Cleft Lip and/or Palate Want to Know About the Care for their Child.

OBJECTIVE: Adequate health information that matches the needs of care recipients is a prerequisite for patient-centered care. To facilitate the provision of tailored and timely information, it isimportant to understand the information needs of parents of children and adolescents with cleft lip and/or palate (CL/P) themselves, and in addition they were asked how they experienced the provided care-related information. DESIGN: A cross-sectional study employing questionnaires and semi-structured interviews. SETTING: Participants were recruited from a cleft palate-craniofacial care unit in a major tertiary hospital in the Netherlands. PARTICIPANTS: Participants were parents or guardians of children with CL/P, and two adolescents with CLP. They were recruited through the outpatient clinic during multidisciplinary consultation or after clinical admission. RESULTS: In total, fifty-five questionnaires were completed by parents or guardians and eleven interviews were conducted with nine parents of children with CL/P and two adolescents with CL/P. In general, participants reported to be satisfied with provided information during hospital admission or multidisciplinary cleft team consultations (mean 8.0, scale 0-10). In addition, 25.5% (n = 14) indicated that information to prepare for hospital admission was lacking (eg, practical information). Thematic qualitative analysis yielded five main information needs: 1) Clear communication during the care process, 2) Overview of the care trajectory, 3) Specific care plan information, 4) Presentation of information and 5) Guidance and support. CONCLUSIONS: Our findings emphasize the importance of gaining insights into wishes and information needs from care recipients who can provide insights in their information needs. With these findings, information provision should be redesigned to improve and to foster the further transition to family-centered care.

A usability evaluation of the perceived user friendliness, accessibility, and inclusiveness of a personalized digital care pathway tool.

OBJECTIVE: This study aimed to acquire insight into the perceived user friendliness, accessibility and inclusiveness of a personalized digital care pathway. MATERIALS & METHODS: Usability of the tool was tested in an experimental setting. Mixed methods data collection consisted of scenario-based eye tracking tests in a web- or mobile-based prototype of the tool, followed by a questionnaire assessing user friendliness (System Usability Scale; SUS) and a structured interview. Inclusiveness was assessed by subgroup comparisons based on language proficiency, age and education level. Via purposive sampling a heterogeneous population of users (N = 24) was recruited. Eye tracking was used to measure gaze behavior. RESULTS: Overall, participants were satisfied with the tool (scale 0-10, 7.5; SD = 1.29). User friendliness of the mobile version (68.3; SD = 21.6) was higher than the web version (50.9; SD = 17.3) measured by SUS score (0-100). With regard to accessibility, eye tracking scenarios showed that the menu bar was hard to find (17% mobile, 55% web). In all scenario's, information was found faster in the mobile version than the web version. Attention was easily drawn to images. Regarding inclusiveness of the tool, we found significantly longer completing time of the scenario tasks for low language proficiency (p-value = 0.029) and higher age subgroups (p-value = 0.049). Lower language proficiency scored a significant lower SUS score (p-value = 0.012). CONCLUSIONS: Overall, user friendliness and accessibility were positively evaluated. Assessment of inclusiveness emphasized the need for tailoring digital tools to those with low language proficiency and/or an older age. Co-creation of digital care tools with users is therefore important to match users' needs, make tools easily understandable and accessible to all users, and ultimately result in better uptake and impact.

Do better nights lead to better days? Guided internet-based cognitive behavioral therapy for insomnia in people suffering from a range of mental health problems: Protocol of a pragmatic randomized clinical trial.

BACKGROUND: Insomnia is the transdiagnostically shared most common complaint in disorders of anxiety, stress and emotion regulation. Current cognitive behavioral therapies (CBT) for these disorders do not address sleep, while good sleep is essential for regulating emotions and learning new cognitions and behaviours: the core fundaments of CBT. This transdiagnostic randomized control trial (RCT) evaluates whether guided internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) (1) improves sleep, (2) affects the progression of emotional distress and (3) enhances the effectiveness of regular treatment of people with clinically relevant symptoms of emotional disorders across all mental health care (MHC) echelons. METHODS: We aim for 576 completers with clinically relevant symptoms of insomnia as well as at least one of the dimensions of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), posttraumatic stress disorder (PTSD) or borderline personality disorder (BPD). Participants are either pre-clinical, unattended, or referred to general- or specialized MHC. Using covariate-adaptive randomization, participants will be assigned to a 5 to 8-week iCBT-I (i-Sleep) or a control condition (sleep diary only) and assessed at baseline, and after two and eight months. The primary outcome is insomnia severity. Secondary outcomes address sleep, severity of mental health symptoms, daytime functioning, mental health protective lifestyles, well-being, and process evaluation measures. Analyses use linear mixed-effect regression models. DISCUSSION: This study can reveal for whom, and at which stage of disease progression, better nights could mean substantially better days. TRIAL REGISTRATION: International Clinical Trial Registry Platform (NL9776). Registered on 2021-10-07.

Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial.

BACKGROUND: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders.  METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ). DISCUSSION: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression. TRIAL REGISTRATION: Netherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955.

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

BACKGROUND: EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. METHODS: This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. DISCUSSION: The process evaluation will provide a comprehensive account of what was necessary to implement the EuroFIT program in professional football clubs within a trial setting and how outcomes were affected by the program. This will allow us to re-appraise the program's conceptual base, optimise the program for post-trial implementation and roll out, and offer suggestions for the development and implementation of future initiatives to promote health and wellbeing through professional sports clubs. TRIAL REGISTRATION: ISRCTN81935608 . Registered on 16 June 2015.

Body mass index, waist circumference and skin-fold thickness in 12- to 14-year-old Dutch adolescents: differences between 2003 and 2011.

OBJECTIVES: The aim of this study was to compare anthropometrics of 12- to 14-year-old Dutch adolescents attending lower levels of education in 2011 with adolescents measured in 2003. METHODS: We used baseline data from two trials evaluating a school-based obesity prevention programme in 2003 (randomized controlled trial with 18 schools) and in 2011 (cluster controlled trial with 29 schools). We measured adolescents' body height and weight, skin-fold thickness, and waist circumference in 2003 (n = 1000; response rate 76%) and 2011 (n = 1898; response rate 86%). We used multivariable multilevel linear or logistic regression analyses stratifying for gender, ethnicity and prevocational education track (vocational or theoretical) where appropriate. RESULTS: In boys, prevalence of overweight, waist circumference, triceps, biceps and subscapular skin-folds were significantly higher in 2011. This was also true for vocational girls, except for the subscapular skin-fold. Girls, attending the theoretical track, had a significantly larger waist circumference, but thinner subscapular and suprailiac skin-fold thickness in 2011. CONCLUSIONS: The increased prevalence of overweight and obesity in Dutch adolescents attending prevocational education is worrisome. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN87127361 and Current Controlled Trials ISRCTN92755979.

Weight status of European preschool children and associations with family demographics and energy balance-related behaviours: a pooled analysis of six European studies.

This study aimed to (i) gain insight in the prevalence of overweight indices in European preschoolers (4-7 years); (ii) identify energy balance-related behaviours associated with overweight/obesity; and (iii) identify children at risk for overweight/obesity. Secondary analyses of six European data sets were conducted according to standardized protocols. Based on objectively measured height and weight, prevalence of overweight and obesity across the countries ranged from 8% to 30% and 1% to 13%, respectively, with highest rates in Southern European countries (i.e. Spain and Greece). Positive associations between sedentary behaviours and overweight indices were found. Physical activity and dietary behaviours were not associated, possibly because of methodological limitations. Children of parents with high body mass index or low socioeconomic status were at increased risk of overweight/obesity. In conclusion, large differences in prevalence of overweight and obesity among preschoolers across Europe were observed. Future obesity prevention interventions in preschoolers should target screen time giving specific attention to children from overweight and/or low socioeconomic status parents. There is a need for high methodological quality studies, preferably with a long-term prospective design using sensitive, valid and reliable measures of behaviours, assessing whether and which physical activity and dietary behaviours are associated with overweight in preschoolers.

Energy balance-related behaviours associated with overweight and obesity in preschool children: a systematic review of prospective studies.

The current review aimed to systematically identify dietary, physical activity and sedentary behaviours in preschool children (4-6 years of age) that are prospectively related to overweight or obesity later in childhood. Prospective studies published between January 1990 and June 2010 were selected from searches in PubMed, EMBASE, PsycINFO, CINAHL and Cochrane Library. Studies examining the prospective association between at least one relevant behaviour measured during preschool period (children aged 4-6 years at baseline) in relation to at least one anthropometric measurement at follow-up (age <18 years) were included. Harvest plots were used to summarize the results and draw conclusions from the evidence. Of the 8,718 retrieved papers, 23 papers reporting on 15 different study samples were included in this review. Strong evidence was found for an inverse association between total physical activity and overweight. Moderate evidence was observed for a positive association between television viewing and overweight. Because of the heterogeneity in the assessed dietary behaviours, insufficient evidence was found for an association between dietary intake or specific dietary behaviours and overweight. These results suggest that interventions aiming to prevent overweight among preschool children should focus on promotion of total physical activity and limitation of screen time and that further research is needed to establish whether and which dietary behaviours are important for obesity prevention in this age group. However, despite the lack of evidence for dietary behaviours from the present review, future interventions may already target specific dietary behaviours that are highly prevalent and for which there a clear rationale as well as preliminary evidence that these behaviours are associated with overweight.