Citizens' perspectives on healthy weight approaches in low SEP neighborhoods: a qualitative study from a systems perspective.

BACKGROUND: The physical and the social environment are important predictors of healthy weight, especially in low socioeconomic position (SEP) neighborhoods. Many Dutch municipalities have implemented a healthy weight approach (HWA). Yet, there is room for improvement. This system science study examined what influences the utilization of HWA facilities and activities, and what aspects can help to achieve a desired systems change (also called leverage point themes (LPTs)) in the HWA system as perceived by citizens living in low SEP neighborhoods. METHOD: All research phases were performed with four citizens co-researchers. Forty-seven citizens living in low SEP neighborhoods were semi-structurally interviewed about the neighborhood HWA facilities and municipal HWA activities. A rapid coding qualitative analysis approach was applied per topic. The topics were citizens' healthy living description, personal circumstances, and satisfaction with foot and cycle paths, sports facilities, playgrounds, green spaces, museums and theaters, community centers, churches, healthcare, school, food supplies, contact with neighborhood, unfamiliar and/or unused activities, familiar and used activities, unavailable but desired (lacking) activities, and reaching citizens. RESULTS: The utilization of HWA facilities and activities was influenced by the overarching themes of social cohesion, familiarity, reaching citizens, maintenance, safety, physical accessibility, financial accessibility, social accessibility, fit with personal context, and fit with the neighborhood's specific needs. Different overarching themes stood out across different facilities and activities. LPTs indicated the overarching themes needed in combination with one another for a specific activity or facility to increase utilization. For example, the LPT regarding foot and cycle paths was "accessible, safe, and maintained foot and cycle paths". The LPTs regarding familiar and used activities were "customized activities; information provision (e.g., about possibilities to join without paying); social contact, meeting others, and everyone feels included". CONCLUSION: Conducting inclusive qualitative research from a systems perspective among citizens living in low SEP neighborhoods has contributed valuable insights into their needs. This enables practical implementation of HWAs by providing a deeper understanding of the LPTs within the HWA system. LPTs can help HWA stakeholders to further develop current HWAs toward systems approaches. Future research could study the leverage points that may contribute to LPT implementation.

Development of a checklist to assess potentially effective components in combined lifestyle interventions for children with overweight or obesity.

BACKGROUND: In the Netherlands, Combined Lifestyle Interventions (CLIs), offered in primary care, aim to reduce the number of children with overweight or obesity. CLIs are carried out by a multidisciplinary team and focus on dietary advice and guidance, exercise and behaviour change. These CLIs are not uniformly designed and vary in protocols to suit the local circumstances. Due to the variation in content of CLIs it is difficult to investigate their effectiveness. To enable a proper evaluation of CLIs, we first need to unravel the 'black boxes' of CLIs by identifying the various potentially effective components. METHODS: First of all we identified potentially effective components in literature. Subsequently we organized an online consultation with experts with diverse backgrounds and asked if they could add potentially effective components. These components were then assembled into a checklist meant to determine the presence or absence of potentially effective components in CLIs for children. RESULTS: 42 experts participated. We identified 65 potentially effective components for CLIs for children with overweight or obesity that we categorized into three themes: content, organisation and implementation. CONCLUSIONS: Based on literature and expert opinions we developed a practical 65-item checklist to determine the presence of potentially effective components in a CLI. This checklist can be used in the development of CLIs as well as evaluation of CLIs.

Leverage point themes within Dutch municipalities' healthy weight approaches: A qualitative study from a systems perspective.

INTRODUCTION: Despite all efforts of national and local approaches, obesity rates continue to rise worldwide. It is increasingly recognized that the complexity of obesity should be further addressed by incorporating a systems perspective when implementing approaches. Such an approach has four interconnected system levels: events, structures, goals, and beliefs, in which small changes ('leverage points') can lead to substantial changes in the functioning of the entire system. The current research examined the functioning of five Dutch municipalities' healthy weight approaches (HWAs) and the leverage point themes that can be identified in their system. METHODS: Thirty-four semi-structured interviews were conducted with various stakeholders about the HWA, including policy advisors, care professionals, practice professionals, and citizens. An inductive thematic analysis was performed. RESULTS: Three main themes were identified: 1) HWA organization structure, 2) collaboration between professionals, and 3) citizen participation. Across all system levels, we identified leverage point themes. The upper-levels events and structures occurred the most and were explained by underlying goals and beliefs. Leverage point themes regarding "HWA organization structure" were municipal processes, such as perceived impact; diversity of themes, activities, and tasks; network; and communication strategies, such as messages about the HWA. Leverage point themes regarding "collaboration between professionals" were linking pins, indicating central players within the network; motivation and commitment including support base; and stimulating one another to work on the HWA by spurring other professionals into action. Lastly, leverage point themes under "citizen participation" included reaching the target group, e.g., look for entry points; and citizens' motivation, including customization. DISCUSSION: This paper provides unique insights into HWAs' leverage point themes that can lead to substantial changes in how the entire system functions and makes suggestions about underlying leverage points to help stakeholders improve their HWA. Future research could focus on studying leverage points within leverage point themes.

Implementation of Combined Lifestyle Interventions for Children with Overweight or Obesity: Experiences of Healthcare Professionals in Multiple Communities.

BACKGROUND: To counteract children with obesity, different protocols for combined lifestyle interventions (CLIs) are implemented by healthcare providers (HCPs). To understand the effects of CLI, we studied the implementation process, facilitators and barriers experienced by HCPs. METHODS: A multiple case study design in which community-based CLIs (n = 4), implemented in a total of ten different communities, are conceptualized as a "case". Qualitative data were collected via group interviews among HCPs (n = 48) regarding their implementation protocol, their network involvement and the adoption of the CLI in a community. Transcripts were coded and analysed using ATLAS.ti. RESULTS: Barriers were the absence of a proper protocol, the low emphasis on the construction of the network and difficulty in embedding the CLI into the community. Funding for these activities was lacking. Facilitating factors were the involvement of a coordinator and to have everyone's role regarding signalling, diagnosis, guidance and treatment clearly defined and protocolled. HCPs suggested adding certain professions to their team because they lacked expertise in parenting advice and providing mental support to children. CONCLUSIONS: Carrying out and adapting the content of the CLI to the community was experienced as easier compared to the management of the organizational aspects of the CLI. For these aspects, separate funding is essential. In the future, mapping the characteristics of a community will help to clarify this influence on the implementation even better.

The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: Results of a two-armed cluster randomized controlled trial.

INTRODUCTION: Although parental support is an important component in programs designed to prevent overweight in children, current programs pay remarkably little attention to the role of parenting. We therefore developed a web-based parenting program entitled "Making a healthy deal with your child". This e-learning program can be incorporated into existing overweight prevention programs. The aim of this study was to determine the effectiveness of this e-learning program. MATERIALS AND METHODS: The effectiveness was examined in a two-armed cluster randomized controlled trial. The participants were 475 parent-child dyads of children 9-13 years of age in the Netherlands who participated in an existing schoolclass-based overweight prevention program. At the school grade level, parents were randomly assigned to either the intervention or the control condition. Measurements were taken from both parents and children at baseline, and 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, and parental self-efficacy. Linear mixed effects models and generalized linear mixed effects models were conducted in R. RESULTS: Intention-to-treat analyses and completers only revealed no significant effects between the intervention and control condition on energy balance-related behaviors of the child and parenting skills after correction for multiple testing. The parents' mean satisfaction with the e-learning program (on a 10-point scale) was 7.0±1.1. CONCLUSIONS: Although parents were generally satisfied with the parenting program, following this program had no significant beneficial effects regarding the children's energy balance-related behaviors or the parenting skills compared to the control condition. This program may be more beneficial if used by high-risk groups (e.g. parents of children with unhealthy energy balance-related behaviors and/or with overweight) compared to the general population, warranting further study.

The degree of consistency of applying parental dietary and sedentary behavior rules as indicators for overweight in children: a cross-sectional study.

BACKGROUND: Review studies increasingly emphasize the importance of the role of parenting in interventions for preventing overweight in children. The aim of this study was to examine typologies regarding how consistently parents apply energy-balance related behavior rules, and the association between these typologies and socio-demographic characteristics, energy balance-related behaviors among school age children, and the prevalence of being overweight. METHODS: For this cross-sectional study, we had access to a database managed by a Municipal Health Service Department in the Netherlands. In total, 4,865 parents with children 4-12 years of age participated in this survey and completed a standardized questionnaire. Parents classified their consistency of applying rules as "strict", "indulgent", or "no rules". Typologies were identified using latent class analyses. We used regression analyses to examine how the typologies differed with respect to the covariates socio-demographic characteristics, children's energy balance-related behaviors, and weight status. RESULTS: We identified four stable, distinct parental typologies with respect to applying dietary and sedentary behavior rules. Overall, we found that parents who apply "overall strict EBRB rules" had the highest level of education and that their children practiced healthier behaviors compared to the children of parents in the other three classes. In addition, we found that parents who apply "indulgent dietary rules and no sedentary rules" had the lowest level of education and the highest percentage of non-Caucasians; in addition, their children 8-12 years of age had the highest likelihood of being overweight compared to children of parents with "no dietary rules". CONCLUSIONS: Parents' consistency in applying rules regarding dietary and sedentary behaviors was associated with parents' level of education and ethnic background, as well as with children's dietary and sedentary behaviors and their likelihood of becoming overweight. Our results may contribute to helping make healthcare professionals aware that children of parents who do not apply sedentary behavior rules are more likely to become overweight, as well as the importance of encouraging parents to apply strict dietary and sedentary behavior rules. These results can serve as a starting point for developing effective strategies to prevent overweight among children.

'Improving Health through Reducing Stress': Parents' Priorities in the Participatory Development of a Multilevel Family Health Programme in a Low-Income Neighbourhood in The Netherlands.

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.

A set of pedagogical recommendations for improving the integrated approach to childhood overweight and obesity: A Delphi study.

BACKGROUND: Tackling 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. 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 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. 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 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. CONCLUSION: 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.

Parents' underestimation of their child's weight status. Moderating factors and change over time: A cross-sectional study.

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<0.05), but remained unsatisfactory. The parents' underestimation of their child's overweight/obesity status was associated with the child's age in 2009 and 2013 (2-7 years; OR: 0.18), the child's gender in 2009 (male; OR: 0.55), and the parents' education level in 2009 (middle and high education; OR: 0.56 and 0.44 respectively). CONCLUSIONS: Parents' underestimation of their child's weight status remains alarmingly high, particularly among parents of young, obese children. This underestimation is a barrier to preventing childhood overweight/obesity. Healthcare professionals should take this underestimation into consideration and should actively encourage parents to take steps to prevent overweight/obesity in their children.

Everyday life situations in which mothers experience difficulty stimulating healthy energy balance-related behavior in their school-age children: a focus group study.

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.

The role of the general practitioner in multidisciplinary teams: a qualitative study in elderly care.

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.

The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: study protocol for a two-armed cluster randomized controlled trial.

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.

Academic collaborative centres for health promotion in the Netherlands: building bridges between research, policy and practice.

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.

Serotonin receptor 3A polymorphism c.-42C > T is associated with severe dyspepsia.

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.

Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial.

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.

Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study.

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.

Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR.

OBJECTIVES: This 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). METHOD: The 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. RESULTS: Patients 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 >or=3; 63% vs 48% and 54%; P =.0002-P <.0001). Device-related (type I) endoleaks were more frequently observed at early postoperative arteriography in group C compared with groups A and B (9.9% vs 3.7% and 6.8%; P =.01-P <.0001). Postoperatively systemic complications were more frequently present in group C (17.4% vs 12.0% in group A and 12.6% in group B; P <.0001 and.001). The first-month mortality was approximately twice as high in group C compared with the other groups combined (4.1% vs 2.1%; P <.0001). Late rupture was most frequent in group C. Follow-up results at midterm were less favorable in groups C and B compared with group A (freedom from rupture, 90%, 98%, and 98% at 4 years in groups C, B, and A, respectively; P <.0001 for group C vs groups A and B). Aneurysm-related death was highest in group C (88% freedom at 4 years, compared with 95% in group B and 97% in A; P =.001 and P <.0001, respectively; group B vs A, P =.004). The annual rate of aneurysm-related death in group C was 1% in the first 3 years, but accelerated to 8.0% in the fourth year. Incidence of unrelated death also was higher in groups C and B than in group A (76% and 82% freedom at 4 years vs 87%; P <.0001 for both comparisons). Ratio of aneurysm-related to unrelated death was 23%, 21%, and 50% in groups A, B, and C, respectively. Cox models demonstrated that the correlation between large aneurysms (group C) and all assessed outcome events was independent and highly significant. Older generation devices had an independent association with aneurysm-related and unrelated deaths (P =.02 and P =.04, respectively). However, this correlation was less strong than large aneurysm diameter (P =.0001 and P =.0009, respectively). CONCLUSIONS: The midterm outcome of large aneurysms after EVAR was associated with increased rates of aneurysm-related death, unrelated death, and rupture. Reports of EVAR should stratify their outcomes according to the diameter of the aneurysm. Large aneurysms need a more rigorous post-EVAR surveillance schedule than do smaller aneurysms. In small aneurysms EVAR was associated with excellent outcome. This finding may justify reappraisal of currently accepted management strategies.

Frequency, predictive factors, and consequences of stent-graft kink following endovascular AAA repair.

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.

The significance and management of different types of endoleaks.

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.

Tracheostomy for long-term ventilated patients: a postal survey of ICU practice in The Netherlands.

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.