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Background Parental support is an important element in overweight prevention programs for children. The purpose of this study was to examine everyday life situations in which mothers encounter difficulties encouraging healthy energy balance–related behavior in their school-age children. Methods We formed four focus groups containing 6–9 participants each. The participants were mothers of Dutch, Turkish, or Moroccan descent with a child 8–13 years of age. All focus group sessions were recorded, transcribed, and coded. Content was analyzed conventionally using ATLAS.ti 6. Results Twenty-seven difficult everyday life situations were identified in 14 settings. The five most frequently reported situations were a daily struggle regarding eating vegetables, eating breakfast on time before going to school, eating candy and snacks between meals, and spending excessive time watching television and using the computer. A perceived loss of parental control, the inability to establish rules and the failure to consistently enforce those rules were the most commonly cited reasons for why the mothers experience these situations as being difficult. Conclusions We identified five difficult everyday life situations related to healthy energy balance-related behavior. These five difficult situations were used as the input for developing a web-based parenting program designed to prevent children from becoming overweight. We reasoned that if we use these situations and the underlying reasons, many parents would recognize these situations and are willing to learn how to deal with them and complete the e-learning. Electronic supplementary material The online version of this article (10.1186/s12889-019-6826-x) contains supplementary material, which is available to authorized users.

In order to reduce health inequities, a socio-ecological approach and community engagement are needed to develop sustained interventions with a positive effect on the health of disadvantaged groups. This qualitative study was part of the development phase of a community health promotion programme. The study aimed to provide insight into the perceptions of parents in a disadvantaged neighbourhood about health, and their priorities for the community health programme. It also described the process of integrating these perceptions in the development of a multilevel plan for this programme. Participatory methods were applied to enable the engagement of all groups involved. Ten parents from a low-income neighbourhood in the Netherlands participated in five panel sessions. Parents’ priorities for improving family health were reducing chronic stress and not so much healthy eating and physical activity. They prioritised solutions to reduce their financial stress, to provide a safe place for their children to meet and play and to establish good quality communication with authorities. The programme development process resulted in objectives in which both parents and professionals were willing to invest, such as a safe playground for children. This study shows that target population engagement in health programme development is possible and valuable.

Opvoeding speelt een belangrijke rol bij de aanpak van overgewicht bij kinderen. Dit aspect was in 2010, bij het ontstaan van het Consortium Integrale Aanpak Overgewicht, nog sterk onderbelicht en krijgt pas de laatste jaren meer aandacht in bestaande interventies. Voor het realiseren van een gezond gewicht bij kinderen dienen ouders adequate 1) specifieke opvoedvaardigheden op gezonde energiebalansgerelateerde gedragingen en 2) algemene opvoedingsvaardigheden in te zetten. Ouders dienen daarbij te weten welke energiebalansgerelateerde gedragingen gezond zijn voor hun kind. Het is zinvol om ouders bij deze specifieke en algemene opvoedvaardigheden te ondersteunen. Hierbij helpt een gemeenschappelijk gedragen pedagogische boodschap voor verschillende professionals in de wijk aan ouders. Deze boodschap zou moeten bestaan uit wat belangrijk is om gezond gewicht bij een kind te stimuleren en hoe ouders dit met opvoedvaardigheden voor elkaar kunnen krijgen. Een dergelijke eenduidige boodschap ontbreekt momenteel. Daarnaast ontbreekt een opvoedinterventie die laagdrempelig en makkelijk bereikbaar is voor ouders. Deze opvoedinterventie moet bij voorkeur aanhaken bij bestaande interventies ter preventie van overgewicht en deze interventies effectiever maken. Bestaande professionele richtlijnen zijn gebruikt als basis voor een Delphi-onderzoek onder verschillende professionals om consensus te krijgen over de inhoud van deze gemeenschappelijke pedagogische boodschap. De resultaten van het Delphi-onderzoek zijn gebruikt om de webapp ‘Adviezen voor een gezonde opvoeding’ te ontwikkelen. Dezelfde bestaande professionele richtlijnen, de resultaten van het Delphi-onderzoek en focusgroepgesprekken, en een bestaande, effectief bevonden online cursus zijn gebruikt om de e‑learning ‘Gezonde afspraken met je kind’ te ontwikkelen. Centraal in beide interventies staat het versterken van specifieke en algemene opvoedvaardigheden van ouders om gezond gewicht bij kinderen te bevorderen. De webapp kan als tool gebruikt worden door professionals die werken met basisschoolkinderen en hun ouders, en hiermee de integrale aanpak van overgewicht versterken. De e‑learning kan als tool gebruikt worden door ouders van kinderen van acht tot dertien jaar om specifieke en algemene opvoedvaardigheden aan te leren die helpen de gezonde energiebalansgerelateerde gedragingen bij hun kind te stimuleren en hierover minder dagelijkse conflictsituaties met hun kind te hebben. De e‑learning kan eenvoudig aangehaakt worden aan bestaande interventies ter preventie van overgewicht bij kinderen van acht tot dertien jaar. De gebruikers waarderen de gebruiksvriendelijkheid en bruikbaarheid van beide tools. Dit artikel beschrijft de ontwikkeling van beide interventies en de deelonderzoeken ten behoeve van het bepalen van de inhoud van de interventies, de implementatie en procesevaluatie.

BackgroundTackling the increasing global problem of childhood overweight and obesity requires an integrated approach. Studies increasingly emphasize the importance of the parents' role in interventions designed to prevent overweight in children. The aim of this study was to develop a unified set of recommendations for healthy parenting practices that can be applied by all professionals who work with children age 4-13 years and can contribute to strengthening the integrated approach to childhood overweight.MethodsA modified Delphi procedure was used to reach consensus regarding what these pedagogical recommendations should encompass. The 30 panelists were professionals and researchers who work with children age 4-13 in the domains of health care, overweight, parenting, education, nutrition, and/or sports. The procedure consisted of: i) extracting existing pedagogical recommendations from national guidelines and professional protocols, ii) appraising and prioritizing these recommendations in terms of relevance through two rounds of questionnaires, and iii) meeting to discuss and approve the set of recommendations.ResultsConsensus was reached for one set of eleven pedagogical theme-based recommendations designed to support and instruct parents how to stimulate healthy energy balance‒related behaviors in their child. Each recommendation contained information regarding: i) which behaviors in the child and/or parent are important, ii) why this is important, and iii) how parents can stimulate this behavior by applying parenting skills in daily life. The eleven themes were: modeling, positive parenting, breakfast, varied diet, sugar-sweetened beverages, snacks, physical activity, playing sports, quantity of screen time, screen time during meals, and sleep.ConclusionWe developed a set of recommendations for healthy parenting that can be used by various professionals working with children age 4-13 and can contribute to creating an integrated approach to childhood overweight. We also developed a web-based app called "Recommendations for Healthy Parenting" as a convenient tool for following these recommendations.

Contains fulltext : 220953.pdf (Publisher’s version ) (Open Access) BACKGROUND: Parents' underestimation of their child's weight status can hinder active participation in overweight prevention programs. We examined the level of agreement between the parents' perception of their child's weight status and the child's actual weight status, moderating factors, and change over time. METHODS: This cross-sectional study used data collected in 2009 (n = 8105), 2013 (n = 8844) and 2017 (n = 11,022) from a community-based survey conducted among parents of children age 2-12 years in the Netherlands. Parents classified their perception of their child's weight status on a 5-point Likert scale. In 2009 and 2013, the child's BMI was calculated from self-reported data by parents. The level of agreement between the parent's perception of the weight status and the actual weight status was examined using Cohen's kappa. The role of demographic factors on parents' perception were examined using logistic regression. RESULTS: In 2009, 2013 and 2017, 6%, 6% and 5% of the parents, respectively, classified their child as heavy/extremely heavy. In 2009 and 2013, 64.7% and 61.0% of parents, respectively, underestimated the weight status of their overweight child. This was even higher among parents of obese children. Overall, the agreement between the parents' perception and the actual weight status improved from 2009 (kappa = 0.38) to 2013 (kappa = 0.43) (p

Background Studies increasingly emphasize the importance of the parents’ role in interventions designed to prevent overweight in children. The aim of this study was to develop a unified set of recommendations for healthy parenting practices that can be applied by all professionals who work with children age 4-13 years and can contribute to strengthening the integrated approach to childhood overweight. Methods A modified Delphi procedure was used to reach consensus regarding what these pedagogical recommendations should encompass. The 30 panelists were professionals and researchers who work with children in the domains of health care, overweight, parenting, education, nutrition, and/or sports. The procedure consisted of: i) extracting existing pedagogical recommendations from national guidelines and professional protocols, ii) appraising and prioritizing these recommendations in terms of relevance through two rounds of questionnaires, and iii) meeting to discuss and approve the set of recommendations. Results Consensus was reached for one set of eleven pedagogical theme-based recommendations designed to support and instruct parents how to stimulate healthy energy balance-related behaviors in their child. Each recommendation contained information regarding: i) which behaviors are important, ii) why this is important, and iii) how parents can stimulate this behavior by applying parenting skills. The eleven themes were: modeling, positive parenting, breakfast, varied diet, sugar-sweetened beverages, snacks, physical activity, playing sports, quantity of screen time, screen time during meals, and sleep. Conclusions We developed a set of recommendations for healthy parenting that can be used by various professionals working with children age 4-13 and can contribute to creating an integrated approach to childhood overweight. We also developed a web-based app called “Recommendations for Healthy Parenting” as a convenient tool for following these recommendations. Key messages Our set of recommendations for healthy parenting can be used by various professionals who work with school-aged children, thereby helping strengthen the integrated approach to childhood overweight. We developed and released a Dutch web app entitled “11 Recommendations for Healthy Parenting” to provide a convenient tool for easily communicating these recommendations to parents.

Background Parental support is an important element in overweight prevention programs for children. The purpose of this study was to examine everyday life situations in which mothers encounter difficulties encouraging healthy energy balance-related behavior in their school-age children. Methods We formed four focus groups containing 6-9 participants each. The participants were mothers of Dutch, Turkish, or Moroccan descent with a child 8-13 years of age. All focus group sessions were recorded, transcribed, and coded. Content was analyzed conventionally using ATLAS.ti 6. Results Twenty-seven difficult everyday life situations were identified in 14 settings. The five most frequently reported situations were a daily struggle regarding eating vegetables, eating breakfast on time before going to school, eating candy and snacks between meals, and spending excessive time watching television and using the computer. A perceived loss of parental control, the inability to establish rules and the failure to consistently enforce those rules were the most commonly cited reasons for why the mothers experience these situations as being difficult. Conclusions We identified five difficult everyday life situations related to healthy energy balance-related behavior. These five difficult situations were used as the input for developing a web-based parenting program designed to prevent children from becoming overweight. We reasoned that if we use these situations and the underlying reasons, many parents would recognize these situations and are willing to learn how to deal with them and complete the e-learning. Key messages The identified everyday-life-situations in which mothers experience difficulty stimulating healthy EBRBs in their children age 8-13 were used as input for our e-learning program to prevent overweight. Mothers who live in low-SES neighborhoods were easily willing to participate in focus groups and discuss EBRB-related topics.

Background To increase our understanding of the effect of parenting on the child’s likelihood of becoming overweight, we attempted to identify typologies based on how consistently parents apply dietary and sedentary behavior rules, and we examined whether these typologies are associated with energy balance-related behaviors in children and/or with the prevalence of overweight children. Methods Data were obtained from a cross-sectional survey of the Community Health Service in Nijmegen, the Netherlands in which a total of 4,865 parents of children aged 4-12 years participated. Data were collected using validated self-report questionnaires. To identify typologies based on how consistently parents apply dietary and sedentary behavior rules, we performed latent class analyses. We then performed regression analyses to examine the correlation between these typologies and socio-demographic characteristics, dietary and sedentary behaviors, and overweight. Results Latent class analyses revealed the existence of the following four distinct, stable classes/typologies; parents who have: (1) no dietary behavior rules, plus indulgent sedentary behavior rules; (2) indulgent dietary behavior rules, plus no sedentary behavior rules; (3) overall indulgent rules; (4) overall strict rules. Children of parents with overall strict rules (class 4) had significantly healthier dietary and sedentary behaviors compared to the children of parents in the other three classes. Children 8-12 years of age with parents in class 2 were the most likely to be overweight; compared to the children of parents in classes 1, 3, and 4, the parents in class 2 had the lowest level of education and the higher number of Turkish and Moroccan immigrants. Conclusions These results underscore the need for parents to establish strict rules for their children, particularly regarding sedentary behaviour in order to minimize the child’s likelihood of becoming overweight. Key messages The results underscore the need for parents to establish strict rules for their children, particularly regarding sedentary behaviour in order to minimize the child’s likelihood of becoming overweight. These results may contribute to making healthcare professionals aware that children of parents who do not apply sedentary behavior rules are more likely to become overweight.

Background We developed a web-based parenting program for parents entitled “Making a healthy deal with your child”. This e-learning program can be incorporated into existing prevention programs, thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle. Methods The effectiveness was studied in a two-armed cluster randomized controlled trial. We recruited 548 parent-child dyads of children 9-13 years in the Netherlands who participated in an existing school-based overweight prevention program. Primary outcomes included the child’s dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices (set of rules, modeling, monitoring), and parental self-efficacy. Multilevel multiple regression analyses in Mplus were conducted. Results 87% of the parent-child dyads participated in the study and 47% of the parents in the intervention group completed 2 or more episodes of the e-learning. The score that parents gave to the e-learning is a 7.Main effect analyses showed in the intention-to-treat analyses that the the parents in the intervention group have more strict rules regarding eating snacks (0.046) and children of parents in the intervention group drink more milk (p = 0.018) and less sugar sweetened beverages (p = 0.024). The completers only analyses showed that the children of parents in the intervention group eat more vegetables and fruit, drink more water and less sugar sweetened beverages, and had less screentime than the children in the control group. Conclusions The e-learning program showed small indications to be effective. A second effectiveness study is currently being investigated. If the e-learning proves to be effective it can be easily incorporated into existing overweight prevention programs for children, as well as activities regarding Youth Health Care. Key messages The e-learning can easily incorporated into existing overweight prevention programs for children. www.gezondeafsprakenmetjekind.nl

Background In the region of the Municipality Health Services Gelderland-South, each municipality has its own health broker. He or she advises the local policy makers, signals/pleads for addressing health problems, and facilitates effective approaches. By doing this health brokers try to strengthen the local health promoting system. To show the results of health brokers and to monitor changes of the local health promoting system, the MHS needs a monitoring instrument. The aim of this study was to develop this instrument and to test it in practice. Methods Participatory action (qualitative) research is used to develop an online questionnaire. Structured group processes with the health brokers has led to the identification and definition of eight variables, reflecting the health promoting system: collaboration, support, integrated approach, visibility of results, health monitor data assessment, consistency, reach of the target population and sustainability. A literature study identified appropriate instruments. The online questionnaire is expanded to test the reliability, to evaluate the usability and to gain insight into the strength of the health promoting system in 16 municipalities. Results The questionaire is based on validated questionaires like the Coordinated Action Checklist, and contains 28 items. Sumscores per variable ranged from 0 (weak) to 100 (strong). Health brokers and their partners (N = 147, 4-9 per municipality) filled out the questionnaire. Support and collaboration had the highest mean scores (70,5 resp. 69,8), and visibility of results and sustainability the lowest (61,3 resp. 59,4). Differences between municipalities were identified and can be used to know which variables can be improved. The test-retest reliability (mean r = 0,713) and the Crohnbachs alphas (all > 0,70) were reasonable good. Conclusions The questionnaire can help to provide useful insights in the strengths and weaknesses of the local health promoting system. Key messages Eight variables reflect the health promoting system: collaboration, support, integrated approach, visibility of results, health monitor data assessment, consistency, reach and sustainability. The questionnaire can help to provide useful insights in the strengths and weaknesses of the local health promoting system.

Background Combined Lifestyle Interventions (CLIs), offered in primary care, aim to prevent childhood overweight/obesity. Combined means the intervention focuses on optimalising nutrition behaviour, physical activity and mental health, provided by a multidisciplinary team. Although the effectiveness of CLIs is still not clear, CLIs are already implemented in daily practice in the Netherlands. These CLIs are not uniformly designed and have variations in protocols to suit the needs of their community. Due to the many different CLIs it is difficult to investigate their effectiveness. To be able to investigate effectiveness of GLIs, we first need to unravel the ’black boxes’ of CLIs and identify their (potential) effective elements. Methods First, we carried out a literature study on elements that may contribute to the effectiveness of a GLI (the so called potential elements). Next, we organized an online brainstorm session, where experts such as researchers and paramedics could add or specify potential elements. We made all elements measurable, with help of experts. These elements were incorporated into a tool to check presence of potential elements in CLIs. This tool was tested on reliability by comparing the results of four researchers who assessed protocols of six CLIs. Results 42 experts participated in the brainstorm session. The literature study and brainstorm session together resulted in 54 potential elements for CLIs for overweight/obese children, categorized in four themes: organization, content, role of parents and role of experts. For all six protocols, a minimum of 85% of the potential elements in the tool have been scored the same by the four assessors. Conclusions We developed a reliable tool to determine potential effective elements in a CLI. In future studies, this tool can be used to identify specific elements that are effective in CLIs for overweight/obese children by comparing the tool with health effects of CLIs. Key messages We were able to develop a reliable instrument to better analyze the factors that contribute to positive health effects of combined lifestyle interventions for children with overweight or obesity. the developed tool with potential effective elements must be filled in for more CLIs, where after we can find corresponding elements in the most effective CLIs.

Background Health inequalities persist, and policymakers, researchers and practitioners seek for effective ways to positively impact the health of disadvantaged people. Researchers point to a multi-component program with an integral design including various perspectives and involving different stakeholders. Few studies address the perspectives on health of disadvantaged people themselves. This study describes what parents in a socially disadvantaged situation and professionals working in that community perceived as 1) priority aspects to improve family health 2) barriers and facilitators for health behaviour changes 3) important health program activities. Methods Design: Community-based participatory action research. 10 parents participated in 6 panel meetings. 46 professionals received 4 panel meetings summaries. 18 parents and 25 professionals responded to questions in (panel) meetings and consultation by phone and e-mail. Results (preliminary) 1) Parents’ top priorities for improving health were: less stress related to finances and communication with related organizations, followed by a safe place for kids to meet. Of the program financers’ aims (reducing tobacco, alcohol use and overweight) reducing overweight got relatively most support of parents. 2) Parents perceived their family financial situation as barrier to behaviours reducing stress and overweight. 3) Program activities related to reducing stress got more support from parents and professionals than activities related to reducing overweight. Conclusions Insight in the perspectives of disadvantaged parents and professionals resulted in a program plan supported by them, aiming to reduce stress and overweight. Most participating parents and professionals committed themselves to invest time in program activities execution. Key messages Disadvantaged parents perceived reducing stress related to finances as top priority to improve family health. They perceived family finances as barrier to behaviours reducing stress and overweight. Community-based participatory action research with disadvantaged parents and professionals can result in an integrated family health program plan with stakeholder support.

Background In the western world, a growing number of the older people live at home. In the Netherlands, GPs are expected to play a pivotal role in the organization of integrated care for this patient group. However, little is known about how GPs can play this role best. Our aim for this study was to unravel how GPs can play a successful role in elderly care, in particular in multidisciplinary teams, and to define key concepts for success. Methods A mixed qualitative research model in four multidisciplinary teams for elderly care in the Netherlands was used. With these four teams, consisting of 46 health care and social service professionals, we carried out two rounds of focus-group interviews. Moreover, we performed semi-structured interviews with four GPs. We analysed data using a hybrid inductive/deductive thematic analysis. Results According to the health care and social service professionals in our study, the role of GPs in multidisciplinary teams for elderly care was characterized by the ability to ‘see the bigger picture’. We identified five key activities that constitute a successful GP role: networking, facilitating, team building, integrating care elements, and showing leadership. Practice setting and phase of multidisciplinary team development influenced the way in which GPs fulfilled their roles. According to team members, GPs were the central professionals in care services for older people. The opinions of GPs about their own roles were diverse. Conclusions GPs took an important role in successful care settings for older people. Five key concepts seemed to be important for best practices in care for frail older people: networking (community), facilitating (organization), team building (professional), integrating care elements (patient), and leadership (personal). Team members from primary care and social services indicated that GPs had an indispensable role in such teams. It would be advantageous for GPs to be aware of this attributed role. Attention to leadership competencies and to the diversity of roles in multidisciplinary teams in GP training programmes seems useful. The challenge is to convince GPs to take a lead, also when they are not inclined to take this role in organizing multidisciplinary teams for older people.

Item does not contain fulltext BACKGROUND: Fighting overweight effectively asks for a community-based coherent integrated approach. The first step in improving the local prevention of overweight is to retrieve practice-based information on the interventions used and the experiences of practitioners. OBJECTIVES: A variety of practitioners and policymakers in three different cities in The Netherlands were interviewed to investigate: what kind of interventions are used in practice today? What is helpful and what does not to implement these interventions? What is needed? How is the collaboration between the parties involved? METHODS: Three observers classified all statements systematically according to the four categories from the implementation model by Fleuren M, Wiefferink K, Paulussen T (Determinants of innovation within health care organizations: literature review and Delphi study. Int J Qual Health Care 2004; 16: 107-123). RESULTS: In Nijmegen, 29 interventions for the prevention or treatment of overweight were identified for the target group youth and 22 for adults. In Wijchen, these were, respectively, 22 and 13 interventions, and in Maasdriel, 24 interventions were found for youth. Most interventions addressed healthy eating and/or physical activity, a few paid attention to psychological or pedagogical aspects. Most participants were satisfied with the intervention(s) they used. For the question 'what does not work?', 61% of the answers were related to characteristics of the organization or social and political context of the intervention. Merely, all sectors expressed difficulties in involving parents. CONCLUSIONS: Many different interventions are applied in everyday practice within each city, but in a fragmented way. Too little attention is being paid to pedagogical aspects and to involving parents in preventing overweight.

Van Marrewijk CJ, Mujakovic S, Fransen GA, Numans ME, De Wit NJ, Muris JW, Van Oijen MG, Jansen JB, Grobbee DE, Knottnerus JA, Laheij RJ. Zuurremmers: hoog inzetten, of juist laag? Het DIAMOND-onderzoek naar effectiviteit en kosten van de stepup- en de step-downbenadering bij maagklachten in de eerste lijn. Huisarts Wet 2009;52(8):374-81.

Contains fulltext : 79835.pdf (Publisher’s version ) (Closed access) Patient adherence to medical treatment for dyspepsia is disappointing, whereas adherence is crucial for a proper evaluation of treatment. This prospective study used elements of the Integrated Change Model and Weiner's Attribution Theory to describe patients' important cognitions and their interrelationships regarding self-perceived adherence to short-term medical treatment for dyspepsia. Patient questionnaires measured the predictors before treatment and self-perceived adherence after treatment. Approximately one-quarter of the patients indicated that they were non-adherent (n = 347). Univariate and multiple linear regression analyses revealed several significant predictors that explained 44% of the variance in self-perceived adherence. Patients with a low educational level, patients who claimed to regularly forget their medication in general, patients with a low self-efficacy or a low intention were less likely to be adherent. These results may indicate targets for interventions designed to improve adherence to medical treatment for dyspepsia. For instance, asking about expected difficulties in taking acid suppressants (e.g. forgetfulness or medication use at weekends) and making action plans to overcome these difficulties (e.g. using reminders) may result in improved adherence rates. Such an approach may reach a substantial number of patients since one in five patients in our study experienced some difficulties in taking medication.

Contains fulltext : 80182.pdf (Publisher’s version ) (Closed access) BACKGROUND: The most effective initial treatment strategy of dyspepsia is still under debate. Individual biological characteristics, such as condition of gastric mucosa, might contribute to selection of the most appropriate acid suppression treatment strategy. AIM: To assess whether pre-treatment testing of gastric mucosal status is relevant for treatment success in an RCT comparing step-up and step-down therapies in newly diagnosed dyspepsia patients. METHODS: Baseline serum samples were collected to assess gastric mucosal status using serum levels of pepsinogens-I&II, gastrin-17, and Helicobacter pylori IgA/IgG-antibodies. The 6-month treatment success was compared between step-up and step-down for patients with serum diagnoses: normal; gastritis; corpus atrophy or antrum atrophy. RESULTS: In all, 519 patients (M/F: 249/270, age: 47 (18-85) years, 29%H. pylori+) were randomized to step-up (n = 293) or step-down (n = 226). Normal mucosa, gastritis and corpus atrophy were diagnosed serologically in 70%, 28% and 2% of the patients, evenly distributed between the strategies (P = 0.65). Treatment success was achieved in respectively, 69%, 70% and 70% for the serum diagnosis groups, and did not differ between the strategies. CONCLUSIONS: Dyspepsia treatment success could not be predicted by gastric mucosal status. Therefore, serum diagnosis of gastric mucosal status is no useful tool for patient allocation to acid suppressive treatment strategies.

Fransen GAJ, Mesters I, Van Marrewijk CJ, Mujakovic S, Knottnerus JA, Muris JWM. Leefstijladviezen, medicatie-instructies en het belang van therapietrouwe bij maagklachten. Huisarts Wet 2007;50(9):445-52.

BACKGROUND: With the advent of empirical treatment strategies for patients with dyspeptic symptoms, it becomes increasingly important to select patients with a high risk of having cancer for immediate endoscopy. Usually alarming symptoms are used for this matter, but their diagnostic value is by no means clear. AIM: To investigate the diagnostic value of alarm symptoms for upper gastrointestinal malignancy. METHODS: Meta-analysis of studies describing prevalence of alarm symptoms in patients with and without endoscopically verified upper gastrointestinal malignancy were identified through a Medline search. The prevalence, pooled sensitivity, specificity, positive and negative predictive values were calculated. RESULTS: About 17 case studies and nine cohort studies were selected. The mean prevalence of gastrointestinal malignancies in the cohort studies was 2.8% of 16,161 patients. Five cohort studies indicated that 25% of the patients diagnosed with upper gastrointestinal malignancy had no alarm symptoms. The pooled sensitivities of individual alarm symptoms varied from 9 to 41%, the pooled positive predictive value ranged from 4.6 to 7.9%, and was 5.9% for 'having any alarm symptom'. The pooled negative predictive value was 99.4% for 'having any alarm symptom'. CONCLUSION: The risk of upper gastrointestinal malignancy in any individual without alarm symptoms is very low, but approximately one in four patients with upper gastrointestinal cancer have no alarm symptoms at the time of diagnosis.

Contains fulltext : 58169.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Smoking plays a major role in deficiencies of the vascular system, and seems to have consequences for the treatment of cardiovascular diseases. We hypothesized that smokers have a higher mortality and more complications after endovascular abdominal aortic aneurysm surgery than non-smokers. METHODS: We assessed mortality and complications of 3270 patients who underwent endovascular abdominal aortic aneurysm surgery in Europe between January 1994 and July 2001. Survival and (post) operative complications were assessed by smoking status. RESULTS: Mortality did not significantly differ between smokers and non-smokers. Smokers had a higher number of intra-operative additional procedures, but a lower number of late endoleaks in comparison to non-smokers. In addition, smokers had a reduced risk of late type II endoleaks in comparison with non-smokers. CONCLUSION: There seems to be no significant difference in endovascular abdominal aortic aneurysm surgery outcome between smokers and non-smokers, although there were significant differences in intra-operative additional procedures and late endoleaks.

Contains fulltext : 139902.pdf (Publisher’s version ) (Closed access) OBJECTIVES: Although small, the risk of rupture after EVAR remains a major concern. The aim of this study was to identify mechanisms of late aneurysm rupture after endovascular repair. METHODS: Patients who suffered a proven aneurysm rupture after EVAR were identified from the EUROSTAR (European Collaborators on Stent-graft Techniques for Abdominal Aortic Aneurysm Repair) registry. Complications preceding rupture were studied to identify common patterns and possible mechanisms of late rupture. RESULTS: A rupture was documented in 34 patients resulting in death of 21 (62%). Adverse events documented during previous follow-up in these patients included endoleak (30%), migration (18%), limb occlusion (12%) and kinking (12%). The findings at time of rupture were documented in 24 patients and including endoleak: Type III (10), Type I (9), Type II (1); stent-graft disintegration (2) and migration (3). Aneurysm diameter changes could be ascertained in 24 patients and had increased in only seven. CONCLUSION: The importance of graft-related endoleak, stent-graft disintegration and migration in the causation of aneurysm rupture was confirmed. Poor compliance with follow-up schedule was also identified as a common feature. However, the absence of complications in some patients, who attended regularly for follow-up, highlights the difficulty of predicting rupture after EVAR.

Purpose: To determine from the EUROSTAR registry the incidence of stent-graft kink, predictive factors for kinking, and the consequences of this complication on graft patency and aneurysm exclusion. Methods: From January 1994 to June 2002, 4613 patients who underwent endovascular aneurysm repair were registered in the EUROSTAR registry. Presence of kink was determined according to the information available on the follow-up Case Record Form. The population was divided into those with and without stent-graft kink. Patient characteristics, morphological aneurysm features, team experience, type of device, period of implantation, and outcome were compared between the groups by univariate analysis. Significant factors were subsequently submitted to a multivariate Cox proportional hazard analysis. Results: One hundred seventy (3.7%) patients were reported as having a kink of the stent-graft during a mean follow-up of 21 months (range 1–72). Gender, neck angulation, team experience, period of implantation, ASA classification, and device type were independent predictors of kink. The presence of a kink was significantly associated with type I endoleaks (proximal and distal), type III endoleaks (midgraft), graft stenosis, graft limb thrombosis, graft migration, and conversion to open repair. No relationship was found between a decrease in the aneurysm diameter and the occurrence of stent-graft kink. Conclusions: Kinks of stent-grafts were infrequent events in the intermediate term. Patients most at risk were women with angulated aortic necks treated by a minimally experienced team. Kinks are potentially damaging events because they may lead to delayed device-related endoleaks, graft stenosis, thrombosis, and conversion to open repair. They appear more closely associated to graft migration than to aneurysm diameter reduction.

Item does not contain fulltext OBJECTIVE: To assess the frequency, timing, technique, and follow-up of tracheostomy for long-term ventilated patients in different intensive care units (ICUs) in The Netherlands. DESIGN AND SETTING: Postal questionnaire, survey on retrospective data. A questionnaire was sent to all ( n=63) ICUs with six or more beds suitable for mechanical ventilation and officially recognized by The Netherlands Intensive Care Society. Pediatric ICUs were excluded. MEASUREMENTS AND RESULTS: There was an 87% ( n=55) response rate of contacted ICUs. The number of tracheostomies per year per unit varied widely (range 1-75), most ICUs (42%) performing between 11 and 25 tracheostomies per year. In 44% of ICUs ( n=24) tracheostomy was not performed on a routine basis. In 25% of ICUs ( n=14) tracheostomies were performed during the second week of ventilation. Surgical tracheostomy and percutaneous procedures were technique of first choice in 38% and 62% of ICUs, respectively. In only 7% of units were late follow-up protocols in use. Thirty-two units (58%) reported a total of 56 major complications. CONCLUSIONS: Timing and technique of tracheostomy varies widely in Dutch ICUs. The percutaneous technique is the procedure of choice for tracheostomy in most of these units. Late follow-up protocols are rarely in use.

Development of endovascular abdominal aortic aneurysm repair (EVAR) has been accompanied by previously unencountered complications. The most challenging but least understood of these complications is the incomplete seal of the endovascular graft (endoleak), a phenomenon that has a variety of causes. An important consequence of endoleakage may be persistent pressurization of the aneurysm sac, which may ultimately lead to post-EVAR rupture. Data of 110 European centers were recorded in a central database (EUROSTAR). Patient, anatomic characteristics, and operative and device details were correlated with the occurrence of different types of endoleaks. Outcome events during follow-up, particularly expansion of the aneurysm, incidence of conversion to open repair, and post-EVAR rupture were assessed in the different categories of endoleaks and in a group of patients without any endoleak. Type I and III endoleak were associated with an increased frequency of open conversions or risk of rupture of the aneurysm. Device-related endoleaks also correlated with an increased need for secondary interventions. These types of endoleaks need to be treated without delay, and when no other possibilities are present, an open conversion to avert the risk of rupture should be considered. Type II endoleaks do not pose an indication for urgent treatment. However, they may not be harmless, because there was a frequent association with enlargement of aneurysm and reinterventions. Our findings suggest that more frequent surveillance examinations are indicated than in patients without collateral endoleak. The indication for intervention is primarily dictated by documented expansion of the aneurysm.

Contains fulltext : 154169.pdf (Publisher’s version ) (Open Access) BACKGROUND: Although parental support is an important component in overweight prevention programs for children, current programs pay remarkably little attention to the role of parenting. To close this gap, we developed a web-based parenting program for parents entitled "Making a healthy deal with your child". This e-learning program can be incorporated into existing prevention programs, thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle. Here, we report the research design of a study to determine the effectiveness of our e-learning program. METHODS/DESIGN: The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial. Parents of children 9-13 years of age who live in the Nijmegen region, the Netherlands, and who participated in the existing school-based overweight prevention program "Scoring for Health" were invited to participate in this study. Our goal was to recruit 322 parent-child dyads. At the school grade level, parents were randomly assigned to either the intervention group (which received e-learning and a brochure) or the control group (which received only the brochure); the participants were stratified by ethnicity. Measurements were taken from both the parents and the children at baseline, and then 5 and 12 months after baseline. Primary outcomes included the child's dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices (e.g., set of rules, modeling, and monitoring), and parental self-efficacy. DISCUSSION: We hypothesize that children of parents who follow the e-learning program will have a healthier diet, will be less sedentary, and will have a higher level of physical activity compared to the children in the control group. If the e-learning program is found to be effective, it can be incorporated into existing overweight prevention programs for children (e.g., "Scoring for Health"), as well as activities regarding Youth Health Care. TRIAL REGISTRATION: Dutch Trial Register: NTR3938 . Date of registration: April 7(th), 2013.

Contains fulltext : 108336.pdf (Publisher’s version ) (Closed access) A logical and promising next step for the development of an effective infrastructure for health promotion in the Netherlands are Academic Collaborative Centres (ACCs). Their aims are to bridge the gap between research, policy and practice; make better use of available knowledge and strengthen the evidence base for health promotion practice. To understand their position, they must be seen in light of the strong growth in health promotion in the Netherlands. Since the 1970s, the emphasis in health promotion has shifted from simple unidimensional interventions to much more comprehensive and integrated programmes. Comprehensive research programmes, which explicitly involve actual practice and policy, are also thus called for. These developments are described in this article. There is considerable and widespread enthusiasm about the establishment of ACCs in the Netherlands. Experiences from the first 5 years of collaboration between research, policy and practice within the ACCs, however, shows research to still have the dominant position. The different groups of stakeholders in the public health infrastructure are also shown to perceive and appreciate the current infrastructure rather differently. These findings are similar to results found in the USA. The predominance of research has recently led the Netherlands Organization for Health Research and Development (ZonMw) to impose stricter criteria and guidelines for the funding of such centres. These measures are aimed at eliciting a shift of power from science to practice. They seem to be a promising contribution to bridging the gap between research, policy and practice.

Contains fulltext : 81791.pdf (Publisher’s version ) (Closed access) BACKGROUND: Personality and psychiatric disorders are reported to be more common in dyspeptic patients with severe complaints, but it remains unclear whether this association exists for patients with mild and moderate dyspepsia. AIM: To study the association between dyspeptic symptom severity and psychopathology, major life events and coping ability in patients with a new episode of dyspepsia. METHODS; Dyspeptic symptom severity was measured using the validated eight symptom Veldhuyzen van Zanten questionnaire. Psychopathology was measured using the Symptom Check List-90 (SCL 90). Major life events were measured with a modified version of the Social Readjustment Rating Scale (SRRS). Coping styles were measured by a short version of the Utrecht Coping Questionnaire, distinguishing six coping styles. Linear regression was used to assess the relationship between dyspepsia symptom severity and psychological factors. RESULTS: In all, 664 patients with a new episode of uninvestigated dyspepsia, aged >18 years were included. Dyspeptic symptom severity was positively correlated with the presence of depression (P < 0.01), somatization symptoms (P < 0.01), use of an active coping style (P < 0.01) and negatively correlated with age (P < 0.01). CONCLUSIONS: Primary care patients consulting with dyspepsia have higher levels of depression and somatization especially at younger age. An active coping style is associated with dyspepsia symptom severity.

Contains fulltext : 80843.pdf (Publisher’s version ) (Closed access) BACKGROUND: Substantial physician workload and high costs are associated with the treatment of dyspepsia in primary health care. Despite the availability of consensus statements and guidelines, the most cost-effective empirical strategy for initial management of the condition remains to be determined. We compared step-up and step-down treatment strategies for initial management of patients with new onset dyspepsia in primary care. METHODS: Patients aged 18 years and older who consulted with their family doctor for new onset dyspepsia in the Netherlands were eligible for enrolment in this double-blind, randomised controlled trial. Between October, 2003, and January, 2006, 664 patients were randomly assigned to receive stepwise treatment with antacid, H(2)-receptor antagonist, and proton pump inhibitor (step-up; n=341), or these drugs in the reverse order (step-down; n=323), by use of a computer-generated sequence with blocks of six. Each step lasted 4 weeks and treatment only continued with the next step if symptoms persisted or relapsed within 4 weeks. Primary outcomes were symptom relief and cost-effectiveness of initial management at 6 months. Analysis was by intention to treat (ITT); the ITT population consisted of all patients with data for the primary outcome at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00247715. FINDINGS: 332 patients in the step-up, and 313 in the step-down group reached an endpoint with sufficient data for evaluation; the main reason for dropout was loss to follow-up. Treatment success after 6 months was achieved in 238 (72%) patients in the step-up group and 219 (70%) patients in the step-down group (odds ratio 0.92, 95% CI 0.7-1.3). The average medical costs were lower for patients in the step-up group than for those in the step-down group (euro228 vs euro245; p=0.0008), which was mainly because of costs of medication. One or more adverse drug events were reported by 94 (28%) patients in the step-up and 93 (29%) patients in the step-down group. All were minor events, including (other) dyspeptic symptoms, diarrhoea, constipation, and bad/dry taste. INTERPRETATION: Although treatment success with either step-up or step-down treatment is similar, the step-up strategy is more cost effective at 6 months for initial treatment of patients with new onset dyspeptic symptoms in primary care.

Contains fulltext : 70788.pdf (Publisher’s version ) (Closed access) BACKGROUND: Currently, overweight and obesity do not receive the attention they deserve from the Dutch GPs, mostly because of a lack of an effective intervention strategy to tackle this difficult health problem. OBJECTIVE: To develop a minimal intervention strategy (MIS) addressing overweight and obesity among adult primary care patients, resulting in a prototype. METHODS: Following the intervention mapping protocol, the MIS is based on literature study, existing interventions, psychosocial theories, stakeholder interviews and a questionnaire study among stakeholders. This led to the development of a prototype of the MIS materials: a screening flow chart and a treatment flow chart, a manual and patient education materials. A pre-test among 42 general practitioners and practice nurses was conducted to investigate the usefulness of the MIS materials at first sight. RESULTS: The stakeholder interviews and the questionnaire study resulted in insight on what the MIS should look like. For instance, the stakeholders indicated that the treatment needs to focus on helping patients to eat more healthy and exercise more, using techniques like motivational interviewing. The pre-test showed that most participants were enthusiastic about the materials, although they made some suggestions on improvements. CONCLUSION: The MIS materials seem to be useful and promising. A future pilot test is needed to investigate its usefulness in daily practice and to further improve the materials in preparation for a process and effect evaluation.

Background. Questionnaires are frequently used to measure the severity of gastrointestinal (GI) complaints. These questionnaires can either be filled out by the physicians or by the patients, but it is not clear whether these scores correspond. This study aimed to investigate the interrater agreement between physician-reported severity and patient-reported severity concerning the patients’ upper GI complaints. Methods. In a prospective observational study, the severity of eight GI complaints was registered by both patients and GPs independently on a seven-point scale (n = 316) before and after treatment with esomeprazole. Weighted kappa values for the agreement on the severity and simple kappa values for the agreement on the absence or presence of symptoms were calculated. Results. The weighted kappa values ranged from 0.14 to 0.68 indicating poor to moderate agreement. The agreement on the presence or absence of symptoms was similar. Several systematic differences in scoring were found: the GPs tended to underestimate the severity of belching, nausea, early satiety, vomiting and upper and lower abdominal pain. Furthermore, the treatment effect for belching and lower abdominal pain was more often overestimated, while the treatment effect for nausea was more often underestimated by the GP. Conclusion. The agreement between GP and patient is low. The differences in scoring should be kept in mind when comparing physician-reported outcomes with patient-reported outcomes.

The present study investigated the influence of pulsatile or nonpulsatile flow delivery with a centrifugal pump for cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG) in two randomized groups of 19 patients each. All patients received a standard anaesthetic and surgical protocol. Pulsatile perfusion during CPB was created by accelerating the baseline pump speed of the Sarns centrifugal pump at a rate of 50 cycles per minute. Measurements included perioperative systemic haemodynamics and oxygen exchange, total haemolytic complement (CH 50), polymorphonuclear (neutrophil) granulocyte (PMN) count and plasma granulocyte elastase bound to α1-proteinase inhibitor (E-α 1-PI). Laboratory measurements were corrected for haemodilution. During and after CPB there were only a few significant differences between the groups in systemic haemodynamics and oxygenation, i.e. a lower mean arterial blood pressure after the end of CPB in the nonpulsatile group (65 mmHg, SD = 11 vs 76 mmHg, SD = 11) and a lower SvO2 during rewarming on CPB in the nonpulsatile group (62%, SD = 8 vs 67%, SD = 8). The decrease in percentage of PMNs in the total white blood cell count during CPB was greater in the nonpulsatile group than in the pulsatile group (from 61 to 46% vs 63 to 53% of prebypass value). The steep increase of PMN count at the end of CPB and postoperatively was comparable in both groups. The maximal decrease of CH50 levels, occurring after surgery, was significantly higher in the nonpulsatile group (70%, SD = 15 vs 79%, SD = 16, of baseline value), suggesting a greater complement activation. E-α1-PI levels increased significantly in both groups during and after CPB with higher peak levels, obtained at one hour after admission to an intensive care unit, in the nonpulsatile group (316 μg/l, SD = 102) than in the pulsatile group (247 μg/l, SD = 106). There was a partly inverse correlation between the peak postoperative elastase levels and the PaO2/FiO2 ratios at the first postoperative morning. This ratio was significantly lower in the nonpulsatile group (211, SD = 56) than in the pulsatile group (247, SD = 62). Postoperative respiratory tract infection was more frequent in the nonpulsatile group (n = 9) than in the pulsatile group (n = 2). Adding a pulsatile component to centrifugal blood pumping during CPB may have benefits with regard to the possibly detrimental whole body inflammatory response to CPB. Further studies are warranted to investigate whether these differences will affect clinical outcome.

Background The association between anxiety and depression related traits and dyspepsia may reflect a common genetic predisposition. Furthermore, genetic factors may contribute to the risk of having increased visceral sensitivity, which has been implicated in dyspeptic symptom generation. Serotonin (5-HT) modulates visceral sensitivity by its action on 5-HT3 receptors. Interestingly, a functional polymorphism in HTR3A, encoding the 5-HT3 receptor A subunit, has been reported to be associated with depression and anxiety related traits. A functional polymorphism in the serotonin transporter (5-HTT), which terminates serotonergic signalling, was also found associated with these psychiatric comorbidities and increased visceral sensitivity in irritable bowel syndrome, which coexistence is associated with higher dyspeptic symptom severity. We investigated the association between these functional polymorphisms and dyspeptic symptom severity. Methods Data from 592 unrelated, Caucasian, primary care patients with dyspepsia participating in a randomised clinical trial comparing step-up and step-down antacid drug treatment (The DIAMOND trial) were analysed. Patients were genotyped for HTR3A c.-42C > T SNP and the 44 bp insertion/deletion polymorphism in the 5-HTT promoter (5-HTTLPR). Intensity of 8 dyspeptic symptoms at baseline was assessed using a validated questionnaire (0 = none; 6 = very severe). Sum score ≥20 was defined severe dyspepsia. Results HTR3A c.-42T allele carriers were more prevalent in patients with severe dyspepsia (OR 1.50, 95% CI 1.06-2.20). This association appeared to be stronger in females (OR 2.05, 95% CI 1.25-3.39) and patients homozygous for the long (L) variant of the 5-HTTLPR genotype (OR 2.00, 95% CI 1.01-3.94). Females with 5-HTTLPR LL genotype showed the strongest association (OR = 3.50, 95% CI = 1.37-8.90). Conclusions The HTR3A c.-42T allele is associated with severe dyspeptic symptoms. The stronger association among patients carrying the 5-HTTLPR L allele suggests an additive effect of the two polymorphisms. These results support the hypothesis that diminished 5-HT3 mediated antinociception predisposes to increased visceral sensitivity of the gastrointestinal tract. Moreover, the HTR3A c.-42C > T and 5-HTTLPR polymorphisms likely represent predisposing genetic variants in common to psychiatric morbidity and dyspepsia.

The present prospective study compared the standard nonpulsatile twin roller pump with the Sarns centrifugal pump, in the pulsatile mode, as arterial pumps for extracorporeal circulation during coronary artery bypass grafting (CABG). The study was conducted in two consecutive groups of 25 patients receiving a standard anaesthetic and surgical protocol. The investigated parameters included haemodynamic profiles, oxygen exchange, blood gas and acid-base homeostasis, haematology, coagulation and complement consumption. With comparable settings for pump flow, gas flow and delivered oxygen concentrations, there was no difference between the groups in the main haemodynamic parameters during cardiopulmonary bypass (CPB). However, a tenfold lower dose of sodium nitroprusside was required to keep systemic vascular resistance within physiologic limits during CPB in the centrifugal group (C group) compared with the roller group (R group). During rewarming oxygen extraction was higher in the C group than in the R group. During the first eight hours after CPB no differences in haemodynamics, oxygenation parameters and pulmonary shunt between the groups were observed. During, as well as after, CPB there was no significant difference in blood gas and acid-base homeostasis between either group. Average postoperative blood loss via chest tubes, total transfusions of blood products, haemoglobin and coagulation did not differ between the two groups. However, the white blood cell count, corrected for changes in haematocrit, decreased during the early phase of CPB in the R group, but not in the C group. It was concluded that, since no major differences in clinical outcome were observed in the present study, the Sarns centrifugal pump is a safe alternative to the roller pump during routine cardiac surgery and should be further studied in a larger number of patients.

ObjectivesThis study was undertaken to determine the effect of the preoperative diameter of abdominal aortic aneurysms on the midterm outcome after endovascular abdominal aneurysm repair (EVAR).MethodThe data for 4392 patients who had undergone EVAR were analyzed. Patients were enrolled over 6 years to June 2002 in the EUROSTAR database. Outcomes were compared between three groups defined by the preoperative diameter of the aneurysm: group A (n = 1962), 4.0 to 5.4 cm; group B (n = 1528), 5.5 to 6.4 cm; and group C (n = 902), 6.5 cm or larger. Patient characteristics, details of aortoiliac anatomy, operative procedures, old or current device generation, and postoperative complications in the three patient groups were compared. Outcome events included aneurysm-related death, unrelated death, conversion, and post-EVAR rupture of the aneurysm. Life table analysis and log-rank tests were used to compare outcome in the three study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcome events.ResultsPatients in group C were significantly older than patients in groups A and B (73 years vs 70 and 72 years, respectively; P = .003 – P < .0001 for different group comparisons), and more frequently were at higher operative risk (American Society of Anesthesiologists classification ≥3; 63% vs 48% and 54%; P = .0002–P

Contains fulltext : 51512.pdf (Publisher’s version ) (Open Access) BACKGROUND: Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the successes as well as the problems we experienced the quality of future pragmatic trials may benefit. DISCUSSION: The first challenge concerned choosing the clinically most relevant interventions to compare and enable blinded comparison, since two interventions had very different appearances. By adding treatment steps to one treatment arm and adding placebo to both treatment arms both internal and external validity were optimized. Nevertheless, although blinding is essential for a high internal validity, it should be warily considered in a pragmatic trial because it decreases external validity. Choosing and recruiting a representative selection of participants was the second challenge. We succeeded in retrieving a representative relatively large patient sample by carefully choosing (few) inclusion and exclusion criteria, by random selection, by paying much attention to participant recruitment and taking the participant's reasons to participate into account. Good and regular contact with the GPs and patients was to our opinion essential. The third challenge was to choose the primary outcome, which needed to reflect effectiveness of the treatment in every day practice. We also designed our protocol to follow every day practice as much as possible, although standardized treatment is usually preferred in trials. The aim of this was our fourth challenge: to limit the number of protocol deviations and increase external validity. SUMMARY: It is challenging to design and conduct a pragmatic trial. Thanks to thorough preparation, we were able to collect highly valid data. To our opinion, a critical deliberation of where on the pragmatic--explanatory spectrum you want your trial to be on forehand, in combination with consulting publications especially on patient recruitment procedures, has been helpful in conducting a successful trial.