The methodological quality of systematic reviews on the treatment of adult major depression needs improvement according to AMSTAR 2: A cross-sectional study.

BACKGROUND: Several standards have been developed to assess methodological quality of systematic reviews (SR). One widely used tool is the AMSTAR. A recent update - AMSTAR 2 - is a 16 item evaluation tool that enables a detailed assessment of SR that include randomised (RCT) or non-randomised studies (NRS) of healthcare interventions. METHODS: A cross-sectional study of SR on pharmacological or psychological interventions in major depression in adults was conducted. SR published during 2012-2017 were sampled from MEDLINE, EMBASE and the Cochrane Database of SR. Methodological quality was assessed using AMSTAR 2. Potential predictive factors associated with quality were examined. RESULTS: In rating overall confidence in the results of 60 SR four reviews were rated "high", two were "moderate", one was "low" and 53 were "critically low". The mean AMSTAR 2 percentage score was 45.3% (standard deviation 22.6%) in a wide range from 7.1% to 93.8%. Predictors of higher quality were: type of review (higher quality in Cochrane Reviews), SR including only randomized trials and higher journal impact factor. LIMITATIONS: AMSTAR 2 is not intended to be used for the generation of a percentage score. CONCLUSIONS: According to AMSTAR 2 the overall methodological quality of SR on the treatment of adult major depression needs improvement. Although there is a high need for summarized information in the field of mental health, this work demonstrates the need to critically assess SR before using their findings. Better adherence to established reporting guidelines for SR is needed.

A psychometric study found AMSTAR 2 to be a valid and moderately reliable appraisal tool.

OBJECTIVES: The objectives of this study were to determine the interrater reliability (IRR) of assessment of multiple systematic reviews (AMSTAR) 2 for reviews of pharmacological or psychological interventions for the treatment of major depression, to compare it to that of AMSTAR and risk of bias in systematic reviews (ROBIS), and to assess the convergent validity between the appraisal tools. STUDY DESIGN AND SETTING: Two groups of four raters were each assigned one of two samples of 30 systematic reviews. All eight raters applied AMSTAR 2 to their sample. Each group also applied either AMSTAR or ROBIS. Fleiss' kappa and Gwet's AC1 were calculated, and agreement between the tools was assessed. RESULTS: The median kappa values as a measure of IRR indicated a moderate agreement for AMSTAR 2 (median = 0.51), a substantial agreement for AMSTAR (median = 0.62), and a fair agreement for ROBIS (median = 0.27). Validity results showed a positive association for AMSTAR and AMSTAR 2 (r = 0.91) as well as ROBIS and AMSTAR 2 (r = 0.84). For the overall rating, AMSTAR 2 showed a high concordance with ROBIS and a lower concordance with AMSTAR. CONCLUSION: The IRR of AMSTAR 2 was found to be slightly lower than the IRR of AMSTAR and higher than the IRR of ROBIS. Validity measurements indicate that AMSTAR 2 is closely related to both ROBIS and AMSTAR.

Progression of specialized intestinal metaplasia at the cardia to macroscopically evident Barrett's esophagus: an entity of concern in the ProGERD study.

OBJECTIVES AND AIMS: Histological Barrett's esophagus, defined as specialized intestinal metaplasia (SIM+) at the cardia without endoscopic suspicion of columnar epithelium, is found frequently in biopsies at the gastro-esophageal junction although its clinical relevance is unknown. The authors aim was to evaluate prospectively the progression of SIM+ to macroscopically evident Barrett's esophagus (BE/SIM+), and to identify risk factors for this progression. METHODS: Data were obtained from a sub-group of patients (no visible BE at presentation, but SIM+) included in the ProGERD study, a prospective evaluation of the clinical course of GERD under routine clinical care. They had esomeprazole 20-40 mg/day for 2-8 weeks. Symptom assessment was performed annually, and endoscopy with biopsy was planned at baseline, after healing treatment and after 2 and/or 5 years. RESULTS: 128 of 171 (74.8%) patients with unequivocal SIM at the z-line after healing were biopsied again after 2 and/or 5 years. At follow-up, 33 (25.8%) of these patients showed progression to BE/SIM+. Factors significantly associated with progression were smoking, a long history of GERD and severe esophagitis at baseline. Patients who had progressed to BE/SIM+ already at 2 years showed consistent findings at 5 years. CONCLUSION: More than 20% of GERD patients with SIM+ in this study were found to have BE/SIM+ within 2-5 years. This finding supports the hypothesis that SIM+ at the cardia could be the missing link explaining increased cancer risk in GERD patients without overt BE and merits further investigation in a prospective study.

Why is it so difficult to evaluate nursing interventions in dementia?

Two recent health technology assessment (HTA) reports published in Germany focused on non-pharmacological interventions for patients with dementia. One of the major results was the poor methodological quality of the studies in this field. This paper concisely presents the main quantitative and qualitative findings of the HTA report published by the German Agency for HTA at the Institute of Medical Information and Documentation (dahta@DIMDI), followed by a detailed discussion of the major methodological problems observed for the inclusion criteria, interventions, the setting, number of patients included, duration of observation, comparators, clinical endpoints, health economics, and, most obvious, the impossibility of blinding and eliminating placebo effects for future clinical studies. We conclude with several suggestions addressing these challenges for future research in this field.

Reduction of common cold symptoms by encapsulated juice powder concentrate of fruits and vegetables: a randomised, double-blind, placebo-controlled trial.

Dietary supplements have been suggested in the prevention of the common cold, but previous investigations have been inconsistent. The present study was designed to determine the preventive effect of a dietary supplement from fruits and vegetables on common cold symptoms. In a randomised, double-blind, placebo-controlled trial, healthcare professionals (mainly nursing staff aged 18-65 years) from a university hospital in Berlin, Germany, were randomised to four capsules of dietary supplement (Juice Plus+®) or matching placebo daily for 8 months, including a 2-month run-in period. The number of days with moderate or severe common cold symptoms within 6 months (primary outcome) was assessed by diary self-reports. We determined means and 95 % CI, and differences between the two groups were analysed by ANOVA. A total of 529 subjects were included into the primary analysis (Juice Plus+®: 263, placebo: 266). The mean age of the participants was 39·9 (sd 10·3) years, and 80 % of the participants were female. The mean number of days with moderate or severe common cold symptoms was 7·6 (95 % CI 6·5, 8·8) in the Juice Plus+® group and 9·5 (8·4, 10·6) in the placebo group (P = 0·023). The mean number of total days with any common cold symptoms was similar in the Juice Plus+® and in the placebo groups (29·4 (25·8, 33·0) v. 30·7 (27·1, 34·3), P = 0·616). Intake of a dietary supplement from fruits and vegetables was associated with a 20 % reduction of moderate or severe common cold symptom days in healthcare professionals particularly exposed to patient contact.

Promotion of physical activity using point-of-decision prompts in Berlin underground stations.

To evaluate point-of-decision prompts in the promotion of stair use in Germany, motivational posters were placed at three underground stations in Berlin. The proportion of passengers using stairs or stairways was counted before, during installation, and two weeks after removal of posters. In total, 5,467 passersby were counted. Stair use increased significantly in women, but not in men. The present pilot study thereby shows that the use of point-of-decision prompts is also feasible in Germany and it provides some evidence of effectiveness. Methodologically rigorous studies are warranted to confirm these findings.

Review Article: Increasing physical activity with point-of-choice prompts--a systematic review.

AIMS: Stair climbing is an activity that can easily be integrated into everyday life and has positive health effects. Point-of-choice prompts are informational or motivational signs near stairs and elevators/escalators aimed at increased stair climbing. The aim of this review was to assess the effectiveness of point-of-choice prompts for the promotion of stair climbing. METHODS: In a systematic search of the literature, studies that assessed the effectiveness of point-of-choice prompts to increase the rate of stair climbing in the general population were identified. No restrictions were made regarding the setting, the duration of the intervention, or the kind of message. RESULTS: A total of 25 studies were identified. Point-of-choice prompts were predominantly posters or stair-riser banners in public traffic stations, shopping malls or office buildings. The 25 studies reported 42 results. Of 10 results for elevator settings, only three reported a significant increase in stair climbing, whereas 28 of 32 results for escalator settings reported a significant increase in stair climbing. CONCLUSIONS: Overall, point-of-choice prompts are able to increase the rate of stair climbing, especially in escalator settings. In elevator settings, point-of-choice prompts seem less effective. The long-term efficacy and the most efficient message format have yet to be determined in methodologically rigorous studies.

[Human papilloma virus (HPV) testing for cervical carcinoma screening]. / Tests auf das Humanpapillomavirus (HPV) in der Zervixkarzinomfrüherkennung.

Cytology-based screening for cervical cancer has been criticised because of its high percentage of false-negative results. Considering HPV testing as an integral part of the screening process has been discussed as a way to address this issue in Germany. The aim of our study was to review trials comparing HPV testing with cytology in cervical cancer screening. Based on a systematic literature review, 14 studies with 85,820 women could be included. Generally HPV testing was more sensitive, but less specific than cytology. Based on the pooled data, sensitivity and specificity for HPV testing were 91% and 90%, respectively, whereas sensitivity and specificity for cytology amounted to 66% and 96%, respectively. Based on these results, including HPV testing in primary cervical cancer screening might lead to a reduction of false-negative results. Due the lower specificity false-positive test results would increase though.

Prevalence of modifiable cardiovascular risk factors in German adolescents.

BACKGROUND: The distribution and clustering of cardiovascular risk factors among German adolescents is only poorly understood. OBJECTIVES: To describe the prevalence of major modifiable cardiovascular disease (CVD) risk factors and the clustering of risk factors in German adolescents aged 11-17 years. DESIGN: Cross-sectional study. METHODS: The German Health Interview and Examination Survey for Children and Adolescents was conducted between 2003 and 2006. The prevalence of major CVD risk factors (smoking, obesity, physical inactivity, hypertension, dyslipidaemia and diabetes) and their clustering among 6813 11-17 year old adolescents was calculated according to age and sex. Associations with sociodemographic variables were investigated in multivariate logistic regression analysis. RESULTS: The prevalence of all risk factors apart from diabetes and obesity increased significantly across age groups. At the age of 17 years smoking and physical inactivity were the most frequent risk factors. In addition to age, most consistent and strongest associations were observed between socioeconomic status and CVD risk factors. Although the age of 11 years the majority of boys and girls were free of CVD risk factors, at age 17 years more than three-quarters were exposed to at least one risk factor. CONCLUSION: Results indicate that the prevalence of CVD risk factors is increasing rapidly across age groups from 11 to 17 years. In late adolescence the majority of boys and girls are exposed to one or more CVD risk factor. Preventive actions will have to be expanded substantially to reduce the future burden of CVD.

Sex-specific differences in allergic sensitization to house dust mites: a meta-analysis.

BACKGROUND: The prevalence of allergic airway diseases in childhood is higher in boys than in girls but switches toward a female predominance in adolescents and adults. The sex-specific prevalence of allergic sensitization to 1 of the most common allergens worldwide, house dust mite (HDM), has not been examined systematically by age group and species. OBJECTIVE: To systematically review the literature to examine sex-specific differences in the prevalence of allergic sensitization to HDM. METHODS: On the basis of a systematic MEDLINE search for population-based studies published between 1990 and 2007, we conducted meta-analyses of male to female ratios for sensitization to 2 different species of HDMs (Dermatophagoides pteronyssinus and Dermatophagoides farinae) separately for children and adults. RESULTS: We included data from 7,822 children and 18,522 adults from 15 studies. The prevalence of sensitization to D pteronyssinus was significantly higher in boys vs girls (male to female ratio, 1.39; 95% confidence interval [CI], 1.13-1.71) and in men vs women (male to female ratio, 1.40; 95% CI, 1.22-1.61). For sensitization to D farinae, the significant male predominance in adults was even more pronounced (male to female ratio, 1.95; 95% CI, 1.37-2.79), but there were no sex-specific differences in children (male to female ratio, 0.90; 95% CI, 0.56-1.46). CONCLUSIONS: In adults, the male predominance in sensitization to HDM seems to be contrary to the prevalence of allergic airway symptoms, which has a female predominance. The male predominance is even higher in allergic sensitization to D farinae than to D pteronyssinus. Further research is necessary regarding sex-specific differences in allergy and asthma.

Long-term results of quality of life after standard laparoscopic vs. robot-assisted laparoscopic fundoplications for gastro-oesophageal reflux disease. A comparative clinical trial.

BACKGROUND: The role of telematic surgical approach in gastro-oesophageal reflux disease (GERD) is still unclear. METHODS: The aim of the study is to assess disease specific symptoms and quality of life in patients with GERD treated with either traditional laparoscopic (TL) or robot-assisted fundoplication using the Da Vinci system (DV) in long-term follow-up. RESULTS: Eighty patients underwent a fundoplication in 2003. Four years later all patients were given a standardized questionnaire and 59 (74%) replied. The TL group included 44 patients (18 male/26 female) and the DV group 15 patients (9 male/6 female); the mean operating time was 116 min for the TL group and 207 min for the DV group (p < 0.001). The mean GIQLI score was 106 points for TL and 107 points in the DV (p > 0.05). CONCLUSIONS: Although a safe and feasible procedure, high functional costs of the Da Vinci system and longer operating time prevent this operation from being the standard surgical procedure for GERD.

Concepts of care for people with dementia.

INTRODUCTION: Today there are approximately one million people with dementia in Germany. If current demographic trends continue, this number is likely to rise substantially in the coming years. In the older population, dementia is the most frequent reason for long-term care. Because most forms of dementia cannot be cured, the aim of treatment is to delay disease progression and to maintain functioning and quality of life. RESEARCH QUESTIONS: What is the evidence on different approaches to the long-term usual care of patients with dementia in terms of common endpoints such as quality of life, and social behaviour? How is the cost-effectiveness of these concepts to be evaluated? Which ethical, social, or legal issues are discussed in this context? METHODS: Based on a systematic literature review, we include randomized, controlled studies that had at least 30 participants and investigated one or more of the following approaches of dementia care: validation therapy/emotion-oriented usual care, ergotherapy, sensory stimulation, relaxation techniques, reality orientation therapy, and reminiscence therapy. Studies had to be published after 1996 (after 1990 for the economic part) in English or German. RESULTS: A total of 20 studies meet the inclusion criteria. Of these, three focus on validation therapy/emotion-oriented usual care, five on ergotherapy, seven on different kinds of sensory stimulation, two on reality orientation, two on reminiscence therapy, and one on a type of relaxation technique. There are no significant differences between the intervention and control groups in two of the three studies on validation therapy or emotion-oriented usual care, in two of the five studies on ergotherapy, in three of the seven studies on sensory stimulation, in both of the two studies on reminiscence therapy, and in the one study on relaxation. In the remaining ten studies, seven report some positive results in favour of the respective interventions, and three studies (ergotherapy, aroma therapy, and music/massage) report positive effects with respect to all of the endpoints measured. Six publications present economic results for usual-care-concepts. One study reports additional costs of 16 GBP (24.03 Euro (2006)) per patient per week for occupational therapie. Two publications declare incremental cost of 24.30 USD (25.62 Euro (2006)) per mini-mental-state-examination-(MMSE)-point gained per month respectively 1,380,000 ITL (506.21 Euro (2006)) per MMSE-point gained. Two publications focus on mixed interventions. One study reports the additional costs of an activity program (1.13 USD (1.39 Euro (2006)) per day per patient) and the other additional time for the usual care for mobile demented patients (average of 45 minutes per day per patient). WITH RESPECT TO ETHICAL AND SOCIAL ASPECTS THE DISCUSSION FOCUSSES ON THE PROBLEM OF AUTONOMY: dementia does not necessarily mean inability to decide over the participtation in studies. Legal questions address the financial situation of patients, the organisation of their care and the legal representation of dementia patients. DISCUSSION: Only a few studies on the nursing interventions considered in this report are methodologically robust. Most of the studies have a small number of participants and show substantial differences in terms of their inclusion criteria, implementation, and endpoints. THIS HETEROGENEITY IS REFLECTED IN THE RESULTS: in half of the studies, the interventions have no positive effects compared to the control group. The other half of the studies reports some positive effects with regard to specific endpoints. All of the economic studies are, from a methodologial and a thematic standpoint, not suitable to answer the questions raised. Ethical, social and legal aspects are discussed but not systematically analysed. CONCLUSION: The studies conducted to date do not provide sufficient evidence of neither efficacy nor cost-effectiveness for any of the nursing interventions considered in the present HTA. However, lack of evidence does not mean lack of efficacy. Instead, more methodologically sound studies are needed. Particullary desireable are studies reflecting the framework of dementia care in Germany. This holds also for the healtheconomic evaluations of the chosen interventions.

Human papillomavirus (HPV) vaccination for the prevention of HPV 16/18 induced cervical cancer and its precursors.

INTRODUCTION: Essential precondition for the development of cervical cancer is a persistent human papillomavirus (HPV) infection. The majority - approximately 70% - of cervical carcinomas is caused by two high-risk HPV types (16 and 18). Recently, two vaccines have been approved to the German market with the potential to induce protection against HPV 16 and HPV 18 among additional low-risk virus types. OBJECTIVES: To analyse whether HPV vaccination is effective with regard to the reduction of cervical cancer and precursors of cervical carcinoma (CIN), respectively? Does HPV vaccination represent a cost-effective alternative or supplement to present screening practice? Are there any differences concerning cost-effectiveness between the two available vaccines? Should HPV vaccination be recommended from a health economic point of view? If so, which recommendations can be conveyed with respect to a (re)organization of the German vaccination strategy? Which ethical, social and legal implications have to be considered? METHODS: Based on a systematic literature review, randomized controlled trials (RCT) looking at the effectiveness of HPV vaccination for the prevention of cervical carcinoma and its precursors - cervical intraepithelial neoplasia - have been identified. In addition, health economic models were identified to address the health economic research questions. Quality assessment of medical and economic literature was assured by application of general assessment standards for the systematic and critical appraisal of scientific studies. RESULTS: Vaccine efficacy in prevention of CIN 2 or higher lesions in HPV 16 or HPV 18 negative women, who received all vaccination doses, ranges between 98% and 100%. Side effects of the vaccination are mainly associated with injection site reactions (redness, turgor, pain). No significant differences concerning serious complications between the vaccination- and the placebo-groups were reported. Results of base case scenarios in the identified health economic modeling analyses range from approximately 3,000 Euro to 40,000 Euro per additional QALY (QALY = Quality-adjusted life year) and approximately 9,000 Euro to 65,000 Euro per additional life year (LYG), respectively. DISCUSSION: The included studies show that both available HPV vaccines are effective in preventing HPV 16 and HPV 18 infections and probable resulting premalignant lesions of the cervix. However, the duration of protection is currently unclear. With regard to side effects, the vaccination can be considered as secure. Nevertheless, the number of cases within the clinical studies is not sufficient to determine the occurrence of rarely occurring (severe) adverse events in a reliable way. A reduction in the incidence and induced mortality through cervical cancer in Germany is not only depending on the vaccine's clinical efficacy. Effects of the new technology on the overall participation rate in screening programs and the resulting vaccination rate and immunization status are also important factors. The results of identified health economic models vary substantially due to the heterogeneity of methodological approaches as well as chosen input parameters. However, almost all model-based analyses reached the conclusion that the implementation of a vaccination with lifelong protection can be considered as cost-effective, if the present screening practice continues. A comparison of the two vaccines shows, that the cost effectiveness ratios are more favorable with the quadrivalent vaccine than with the bivalent alternative when considering QALY as primary outcome parameter. The reason for this finding might be that in the case of the quadrivalent vaccine the prevention of genital warts can also be incorporated into the analysis. Variations of the duration of protection as well as the discounting rate were identified as the primary influencing factors of cost-effectiveness results. CONCLUSION: Implementation of HPV vaccination might lead to a reduction of cervical cancer in immunized women. However, uptake of immunization should be accompanied by further studies in order to assess long-term effectiveness and safety aiming at an optimization of possible implementation processes. High numbers of participants are of particular importance regarding immunization. This has to be backed up by programs to optimize early detection - as this affects even those women who already underwent immunization. Since cost-effectiveness evidence might be significantly affected by the unclear duration of protective benefits, a final verdict on the vaccination's cost-effectiveness in the German setting is not possible. Hence, risk-sharing-agreements between third-party payers and manufacturers would pose an option to balance the consequences of uncertainty towards the duration of protection on cost-effectiveness.

Efficacy and cost-effectiveness of the 13C-urea breath test as the primary diagnostic investigation for the detection of Helicobacter pylori infection compared to invasive and non-invasive diagnostic tests.

BACKGROUND: Helicobacter pylori (H. pylori) is one of the most common bacterial infections in humans. There is a risk factor for gastric or duodenal ulcers, gastric cancer and MALT (Mucosa Associated Lymphoid Tissue)-Lymphomas. There are several invasive and non-invasive methods available for the diagnosis of H. pylori. The (13)C-urea breath test is a non-invasive method recommended for monitoring H. pylori eradication therapy. However, this test is not yet used for primary assessment of H. pylori in Germany. OBJECTIVES: What are the clinical and health economic benefits of the (13)C-urea breath test in the primary assessment of H. pylori compared to other invasive and non-invasive methods? METHODS: A systematic literature search including a hand search was performed for studies investigating test criteria and cost-effectiveness of the (13)C-urea breath test in comparison to other methods used in the primary assessment of H. pylori. Only studies that directly compared the (13)C-urea breath test to other H. pylori-tests were included. For the medical part, biopsy-based tests were used as the gold standard. RESULTS: 30 medical studies are included. Compared to the immunoglobulin G (IgG) test, the sensitivity of the (13)C-urea breath test is higher in twelve studies, lower in six studies and one study reports no differences. The specificity is higher in 13 studies, lower in three studies and two studies report no differences. Compared to the stool antigen test, the sensitivity of the (13)C-urea breath test is higher in nine studies, lower in three studies and one study reports no difference. The specificity is higher in nine studies, lower in two studies and two studies report no differences. Compared to the urease test, the sensitivity of the (13)C-urea breath test is higher in four studies, lower in three studies and four studies report no differences. The specificity is higher in five studies, lower in five studies and one study reports no difference. Compared to histology, the sensitivity of the (13)C-urea breath test is higher in one study and lower in two studies. The specificity is higher in two studies and lower in one study. One study each compares the (13)C-urea breath test to the (14)C-urea breath test and the polymerase chain reaction (PCR) test, respectively, and reports no difference in sensitivity and specificity with the (14)C-urea breath test, and lower sensitivity and higher specificity compared to PCR. The statistical significance of these differences is described for six of the 30 studies. Nine health economic evaluations are included in the Health Technology Assessment (HTA) report. Among these studies, the test-and-treat strategy using the (13)C-urea breath test is compared to test-and-treat using serology in six analyses and to test and treat using the stool antigen test in three analyses. Thereby, test-and-treat using the breath test is shown to be cost-effective over the serology based strategy in three models and is dominated by a test-and-treat strategy using the stool antigen test in one model. A cost-effectiveness comparison between the urea breath test approach and the empirical antisecretory therapy is carried out in four studies. Of these, two studies report that the strategy using the urea breath test is cost-effective over the empirical antisecretory therapy. In two studies, test-and-treat using the (13)C-urea breath test is compared to the empirical eradication therapy and in five studies to endoscopy-based strategies. The breath test approach dominates endoscopy in two studies and is dominated by this strategy in one study. DISCUSSION: All included medical and economic studies are limited to a greater or lesser extent. Additionally, the results of the studies are heterogeneous regarding medical and economic outcomes respectively. Thus, the majority of the medical studies do not report the statistical significance of the differences in sensitivity and specificity. In direct comparisons the (13)C- urea breath test shows higher sensitivity and specificity than the IgG and stool antigen tests. In comparison to the urease test, results for sensitivity are inconsistent, and the specificity is slightly higher for the (13)C-urea breath test. There are not enough results for comparisons between the (13)C-urea breath test and the (14)C-urea breath test, histology and PCR to describe tendencies. The included economic studies suggest that the test-and-treat strategy using the (13)C-urea breath test is cost-effective compared to test-and-treat using serology as well as empirical antisecretory therapies. Due to a lack of valid studies, it is not possible to assess the breath test approach in comparison to test-and-treat using the stool antigen test and the empirical eradication therapy respectively, regarding the cost-effectiveness. The results of economic analyses comparing test-and-treat using the breath test to endoscopy strategies are too heterogeneous to draw any conclusions. Overall, none of the included economic models is able to completely capture the complexity of managing patients with dyspeptic complaints. CONCLUSIONS/RECOMMENDATIONS: Based on available medical and economic studies, there is no sufficient evidence to recommend test and-treat using (13)C-urea breath testing for the detection of H. pylori infection as the standard procedure for the management of uninvestigated dyspepsia in the German health care system. In addition, it must be considered that the DVGS guidelines of the Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DVGS) recommend endoscopy based methods for the management of patients with dyspeptic complaints.

Long-term effectiveness of interventions promoting physical activity: a systematic review.

BACKGROUND: This systematic review aims to evaluate the long-term effectiveness of physical activity interventions targeted at healthy adults and to identify effective intervention components. METHODS: The systematic search in Pubmed, Embase, the Cochrane Library and Psycinfo identified literature published in English and German between January 2001 and June 2007. We included randomised controlled trials investigating physical activity interventions for healthy adults with a minimum study duration of 12 months. Two researchers independently assessed publications according to pre-defined inclusion criteria and methodological quality was rated according to the SIGN criteria. Study characteristics and outcome measures were extracted, and pooled effect estimates with 95% confidence intervals calculated. RESULTS: Of 5508 identified publications 25 studies met the inclusion criteria. There was substantial heterogeneity in study quality, intervention strategies and intervention effects. Compared to no-intervention and minimal-intervention control, gains in weekly energy expenditure and physical fitness of up to 975 kcal and 11% were achieved, respectively. Booster interventions were used in 16 studies. CONCLUSIONS: There is evidence for long-term increases in physical activity behaviour and physical fitness. To improve uptake of physical activity additional tailored exercise prescription strategies seem promising. Booster interventions such as phone, mail or internet can help to facilitate long-term effectiveness.

Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis.

BACKGROUND: Over the past several decades, numerous large cohort studies have attempted to quantify the protective effect of physical activity on cardiovascular and all-cause mortality. The aim of the authors' review was to provide an up-to-date overview of the study results. METHODS: In a systematic MEDLINE search conducted in May 2007, the authors included cohort studies that assessed the primary preventive impact of physical activity on all-cause and cardiovascular mortality. The authors reported risk reductions on the basis of comparison between the least active and the most active population subgroups, with the least active population subgroup as the reference group. Random-effect models were used for meta-analysis. RESULTS: A total of 33 studies with 883,372 participants were included. Follow-up ranged from 4 years to over 20 years. The majority of studies reported significant risk reductions for physically active participants. Concerning cardiovascular mortality, physical activity was associated with a risk reduction of 35% (95% confidence interval, 30-40%). All-cause mortality was reduced by 33% (95% confidence interval, 28-37%). Studies that used patient questionnaires to assess physical activity reported lower risk reductions than studies that used more objective measures of fitness. CONCLUSIONS: Physical activity is associated with a marked decrease in cardiovascular and all-cause mortality in both men and women, even after adjusting for other relevant risk factors.

Nighttime heartburn in patients with gastroesophageal reflux disease under routine care.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a common disorder. The aim of our study was to describe the prevalence of nighttime heartburn and its associations with esophagitis, Barrett's esophagus, and extra-esophageal symptoms. METHODS: Data were collected as part of the ongoing Progression of Gastroesophageal Reflux Disease (ProGERD) study. Based on endoscopy results, patients were categorized as having nonerosive GERD, erosive GERD, or Barrett's esophagus. ORs and 95% CIs derived from logistic regression analysis were calculated for the association between nighttime heartburn and GERD complications. RESULTS: The overall prevalence of nighttime heartburn for at least 1 of 3 years was 49%, and 21% of patients reported nighttime heartburn in all 3 years. According to multivariate analysis, chronic nighttime heartburn was associated with globus sensation (OR 1.79, 95% CI 1.29-2.47) and erosive GERD (OR 1.67, 95% CI 1.29-2.15). Compared to continuous proton pump inhibitor (PPI) intake, noncontinuous PPI therapy (OR 2.26, 95% CI 1.73-2.96) and medication other than PPIs (OR 2.46, 95% CI 1.67-3.62) were also associated with chronic nighttime heartburn. CONCLUSIONS: The prevalence of nighttime heartburn in GERD patients under routine care was high, even in patients on continuous PPI therapy. Nighttime heartburn was not associated with Barrett's esophagus or most extra-esophageal symptoms.

Association of body mass index with heartburn, regurgitation and esophagitis: results of the Progression of Gastroesophageal Reflux Disease study.

BACKGROUND: Overweight and obesity are believed to be risk factors for gastroesophageal reflux disease (GERD). The aim of the present study was to analyze the impact of body mass index (BMI) on the severity and frequency of reflux symptoms and esophagitis in a large cohort of reflux patients. METHODS: As part of the Progression of Gastroesophageal Reflux Disease (ProGERD) study, 6215 patients with clinically assessed GERD were included in the present investigation (53% male, 52 +/- 14 years; 47% female, 56 +/- 14 years). Heartburn and regurgitation symptoms were assessed using the validated Reflux Disease Questionnaire. Endoscopies were performed and patients were subsequently classified as having non-erosive or erosive disease. To examine the association between BMI, GERD symptoms, and esophagitis, odds ratios (OR) and 95% confidence intervals (95%CI) were calculated using logistic regression models. RESULTS: In patients with GERD, higher BMI was associated with more frequent and more severe heartburn and regurgitation, as well as with esophagitis. The effects were more pronounced for regurgitation than for heartburn. The strongest association was between obesity and severity of regurgitation symptoms (women: OR 2.11, 95%CI 1.60-2.77; men: OR 2.15, 95%CI 1.59-2.90). Obese women, but not men, had an increased risk of severe esophagitis compared to women with normal weight (OR 2.51, 95%CI 1.53-4.12). CONCLUSIONS: In patients with GERD, higher BMI was associated with more severe and more frequent reflux symptoms and esophagitis.

Review on the medical and health economic evidence for an inclusion of colposcopy in primary screening programs for cervical cancer.

INTRODUCTION: With 3.2% of all cancer cases in 2002, cervical carcinoma is the tenth most common cancer in Germany and causes 1.8% of all cancer deaths in women in Germany. To date diagnosis in Germany solely has been based on cervical cytology which has been criticised due to its low sensitivity and consequently high rate of false negative results. OBJECTIVES: How does colposcopy compare to cytological tests in terms of sensitivity and specificity, and what may be the effects of changes in screening for cervical carcinoma in Germany? Is there health economic evidence that may foster an inclusion of colposcopy into national screening programms? METHODS: A systematic literature review was performed, including studies that compared colposcopy to cervical cytology in terms of sensitivity and specificity. In addition, a systematic review of the relevant health economic literature was performed to analyse cost-effectiveness issues relevant to the German setting. RESULTS: A total of four studies fulfilled the inclusion criteria, of which only two were of high methodologic quality. In all studies, the sensitivity of colposcopy was lower than that of cytology. In three studies the specificity of colposcopy was lower than that of cytology, in one study specificity of colposcopy and cytology was similar. No health economic data suggesting positive effects of adding colposcopy in primary screening could be identified. DISCUSSION: Only few studies have compared the test criteria of colposcopy with those of cytology for screening in cervical cancer. In all studies, sensitivity of colposcopy was even lower than the sensitivity of cytology, which has been critisized because of its low sensitivity. CONCLUSION: Based on the present data, an inclusion of colposcopy in primary cervical cancer screening programmes can not be recommended.