Patient adherence to prescribed medication instructions for dyspepsia: the DIAMOND-study.

BACKGROUND: Insight into patient adherence is needed to enable an effect evaluation of medication for dyspepsia. OBJECTIVES: Adherence was explored by investigating two adherence outcome measures (completeness and intake fidelity) using data from the DIAMOND-study. METHODS: The DIAMOND-study is a pragmatic RCT comparing a 'step-up' with a 'step-down' treatment strategy. In step 1 participants (n =653) were instructed to use five pills/day for maximally 30 days: an antacid 4dd plus a placebo 1dd ('step-up') or a proton pump inhibitor 1dd plus a placebo 4dd ('step-down'). If the complaints persisted, step 2 was started (H(2)-receptor antagonist 2dd), and subsequently step 3 (five pills/day, placebo and verum vice versa from step 1). Completeness was assessed by pill counts, intake fidelity by patient questionnaires measuring the degree to which patients adhered to specific instructions concerning timing, frequency, dose and way of intake. RESULTS: In step 1, patients used on average 3.9 pills/day (78% of the prescribed doses), in step 2, 1.7 pills/day (85%) and in step 3, 3.6 pills/day (72%). For the four times daily pills, half of the patients used less than 80% of the prescribed pills per day. This was one third of the patients for the twice daily pills and one quarter for the once daily pills. There were no completeness differences between active or placebo medication and no differences between the study arms. As regards intake fidelity, 70% of the patients made one or more errors in the medication intake. CONCLUSION: There is room for improvement in adherence rates for dyspepsia medication.

Towards an integrated community approach of overweight prevention: the experiences of practitioners and policymakers.

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.

Influence of gastric mucosal status on success of stepwise acid suppressive therapy for dyspepsia.

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.

Which patient-related factors determine self-perceived patient adherence to prescribed dyspepsia medication?

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.

Psychopathology is associated with dyspeptic symptom severity in primary care patients with a new episode of dyspepsia.

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.

The development of a minimal intervention strategy to address overweight and obesity in adult primary care patients in The Netherlands.

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.

Measuring the severity of upper gastrointestinal complaints: does GP assessment correspond with patients' self-assessment?

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.

Meta-analysis: the diagnostic value of alarm symptoms for upper gastrointestinal malignancy.

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.

Impact of smoking on endovascular abdominal aortic aneurysm surgery outcome.

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.

Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry.

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.