How is atrial fibrillation detected in everyday healthcare? Results of a Dutch cohort study.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia with serious potential consequences when left untreated. For timely treatment, early detection is imperative. We explored how new AF is detected in patients aged ≥ 65 years in Dutch healthcare. METHODS: The study cohort consisted of 9526 patients from 49 Dutch general practices in the usual-care arm of the Detecting and Diagnosing Atrial Fibrillation study. We automatically extracted data from the electronic medical records and reviewed individual records of patients who developed AF. Patient selection started in 2015, and data collection ended in 2019. RESULTS: We included 258 patients with newly diagnosed AF. In 55.0% of the patients, the irregular heartbeat was first observed in general practice and in 16.3% in the cardiology department. Cardiologists diagnosed most cases (47.3%), followed by general practitioners (GPs; 33.7%). AF detection was triggered by symptoms in 64.7% of the patients and by previous stroke in 3.5%. Overall, patients aged 65-74 years more often presented with symptoms than those aged ≥ 75 years (73.5% vs 60.6%; p = 0.042). In 31.5% of the patients, AF was diagnosed incidentally ('silent AF'). Silent-AF patients were on average 2 years older than symptomatic-AF patients. GPs less often diagnosed silent AF than symptomatic AF (21.0% vs 39.0%; p = 0.008), whereas physicians other than GPs or cardiologists more often diagnosed symptomatic AF than silent AF (34.6% vs 11.9%; p < 0.001). Most diagnoses were based on a 12-lead electrocardiogram (93.8%). CONCLUSION: Diagnosing AF is a multidisciplinary process. The irregular heartbeat was most often detected by the GP, but cardiologists diagnosed most cases. One-third of all newly diagnosed AF was silent.

Correction to: How do Dutch general practitioners detect and diagnose atrial fibrillation? Results of an online case vignette study.

Following publication of the original article [1], the authors opted to remove the authors full name from.

How do Dutch general practitioners detect and diagnose atrial fibrillation? Results of an online case vignette study.

BACKGROUND: Detection and treatment of atrial fibrillation (AF) are important given the serious health consequences. AF may be silent or paroxysmal and remain undetected. It is unclear whether general practitioners (GPs) have appropriate equipment and optimally utilise it to detect AF. This case vignette study aimed to describe current practice and to explore possible improvements to optimise AF detection. METHODS: Between June and July 2017, we performed an online case vignette study among Dutch GPs. We aimed at obtaining at least 75 responses to the questionnaire. We collected demographics and asked GPs' opinion on their knowledge and experience in diagnosing AF. GPs could indicate which diagnostic tools they have for AF. In six case vignettes with varying symptom frequency and physical signs, they could make diagnostic choices. The last questions covered screening and actions after diagnosing AF. We compared the answers to the Dutch guideline for GPs on AF. RESULTS: Seventy-six GPs completed the questionnaire. Seventy-four GPs (97%) thought they have enough knowledge and 72 (95%) enough experience to diagnose AF. Seventy-four GPs (97%) could order or perform ECGs without the interference of a cardiologist. In case of frequent symptoms of AF, 36-40% would choose short-term (i.e. 24-48 h) and 11-19% long-term (i.e. 7 days, 14 days or 1 month) monitoring. In case of non-frequent symptoms, 29-31% would choose short-term and 21-30% long-term monitoring. If opportunistic screening in primary care proves to be effective, 83% (58/70) will support it. CONCLUSIONS: Responding GPs report to have adequate equipment, knowledge, and experience to detect and diagnose AF. Almost all participants can order ECGs. Reported monitoring duration was shorter than recommended by the guideline. AF detection could improve by increasing the monitoring duration.

Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

OBJECTIVES: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). DESIGN: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. SETTING: Four rehabilitation centres in the Netherlands. SUBJECTS: A total of 122 patients participated in the trial. MAIN OUTCOME MEASURES: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. RESULTS: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. CONCLUSION: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.

Exploring the process when developing a lifestyle intervention in primary care for type 2 diabetes: a longitudinal process evaluation.

OBJECTIVES: A thorough understanding of the processes involved in lifestyle interventions is needed in order to close the gap between research and daily practice. This study explored the processes involved in the provision of a lifestyle intervention to patients with type 2 diabetes mellitus (T2DM) by health care professionals in primary care. STUDY DESIGN: Mixed methods. METHODS: Health care professionals were asked to intensify lifestyle interventions for patients with T2DM in a routine care setting. Data were collected by serial interviews with health care professionals and patients, recorded consultations, an activity questionnaire and biomedical information. Qualitative data were analysed using a framework analysis with a phenomenological approach. RESULTS: The lifestyle intervention developed by the health care professionals included motivational interviewing, a nutrition and physical activity diary, and a multidisciplinary approach [physiotherapist, dietician, general practitioner and diabetes practice nurse (DPN)]. Participants and health care professionals were positive about the intervention, and patients were more active (P = 0.027), lost weight (P = 0.031) and had lower levels of glycated haemoglobin (P = 0.012). However, qualitative data showed that patients were passive during the consultation, and did not ask questions about ways to improve their lifestyle. DPNs did not use motivational interviewing optimally; provided patients with information that was difficult to understand; and were easily satisfied with the efforts of the patients. CONCLUSIONS: Lifestyle intervention for patients with T2DM is difficult in routine primary care. DPNs should adapt to the knowledge level of the patients, and patients must be stimulated to take an active role in their treatment. Patients and health care professionals should become equal partners in determining mutually agreeable treatment plans and goals.

[How much do patients and health professionals (really) know? The surplus value of a home visit to the patient with polypharmacy by the practice nurse, to support medication reviews in primary care]. / Wat weten de patiënt en zijn hulpverlener: de meerwaarde van een huisbezoek door de praktijkondersteuner bij de medicatiebeoordelingen van patiënten met polyfarmacie in de eerste lijn.

BACKGROUND: Polypharmacy in older people should be addressed by an annual review of the chronic medication. In the PIL-study this was done by an integrated approach by GP, practice nurse, pharmacist, specialist and patient. All patients were first visited at home by the practice nurse. RESEARCH QUESTIONS: What 'over the counter' (OTC) medications do polypharmacy patients use? Do they know the indications of the prescribed medication? Does medication use according to the patient match with medication use according to the records of GP and pharmacist? METHOD: Inclusion criteria were: age 60 years or older, daily use of five or more chronic medications, mental competence, and adequate command of the Dutch language. All patients were visited at home by the practice nurse, who made an inventory of the actual drug use. RESULTS: Five hundred fifty patients used a total of 5576 drugs, including 527 (9.4%) OTC medication. Patients knew the indication of 64% of the prescribed medication. The number of prescribed drugs that a patient actually used did not match the numbers known to GP and pharmacist. In 60.4% of all medication prescriptions there was complete agreement between GP, pharmacist and patient. On a patient level agreement was 18.7%. CONCLUSIONS: Home visits by the nurse practitioner to make an inventory of the medication as reported by the patient seem to have an added value.

Comparative analysis of the reproducibility and applicability of the condom catheter method for noninvasive urodynamics in two Dutch centers.

OBJECTIVES: We compared the applicability and reproducibility of the condom catheter method for noninvasive urodynamics in two Dutch studies. MATERIALS AND METHODS: A longitudinal study of changes in bladder contractility secondary to benign prostatic enlargement is taking place at the Erasmus MC in Rotterdam. Volunteers aged 38-77 years will be studied three times in 5 years. The first series of measurements has been completed in 1,020 men. A randomized controlled trial to test the effect of additional water intake on bladder function has been completed at the University of Maastricht. 184 subjects aged 55-77 years with International Prostate Symptom Scores of 8-19 were investigated twice in 6 months. Bladder contractility was measured noninvasively with the condom method. Two consecutive measurements were attempted in each subject. Reproducibility was tested according to Bland and Altman and compared by calculating the normalized standard deviation of the differences by dividing by the difference. RESULTS: The success rate for single measurements was 95% in both studies. The success rates for double measurements varied from 87 to 90%. The normalized standard deviation of the differences between the double measurements was 0.15 for the longitudinal noninvasive study and randomized controlled trial at baseline, and 0.13 for the randomized controlled trial at 6 months. CONCLUSION: Both studies showed good reproducibility of the noninvasive method comparable to invasive urodynamics.

Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis.

CONTEXT: Prediction models to identify healthy individuals at high risk of cardiovascular disease have limited accuracy. A low ankle brachial index (ABI) is an indicator of atherosclerosis and has the potential to improve prediction. OBJECTIVE: To determine if the ABI provides information on the risk of cardiovascular events and mortality independently of the Framingham risk score (FRS) and can improve risk prediction. DATA SOURCES: Relevant studies were identified. A search of MEDLINE (1950 to February 2008) and EMBASE (1980 to February 2008) was conducted using common text words for the term ankle brachial index combined with text words and Medical Subject Headings to capture prospective cohort designs. Review of reference lists and conference proceedings, and correspondence with experts was conducted to identify additional published and unpublished studies. STUDY SELECTION: Studies were included if participants were derived from a general population, ABI was measured at baseline, and individuals were followed up to detect total and cardiovascular mortality. DATA EXTRACTION: Prespecified data on individuals in each selected study were extracted into a combined data set and an individual participant data meta-analysis was conducted on individuals who had no previous history of coronary heart disease. RESULTS: Sixteen population cohort studies fulfilling the inclusion criteria were included. During 480,325 person-years of follow-up of 24,955 men and 23,339 women, the risk of death by ABI had a reverse J-shaped distribution with a normal (low risk) ABI of 1.11 to 1.40. The 10-year cardiovascular mortality in men with a low ABI (< or = 0.90) was 18.7% (95% confidence interval [CI], 13.3%-24.1%) and with normal ABI (1.11-1.40) was 4.4% (95% CI, 3.2%-5.7%) (hazard ratio [HR], 4.2; 95% CI, 3.3-5.4). Corresponding mortalities in women were 12.6% (95% CI, 6.2%-19.0%) and 4.1% (95% CI, 2.2%-6.1%) (HR, 3.5; 95% CI, 2.4-5.1). The HRs remained elevated after adjusting for FRS (2.9 [95% CI, 2.3-3.7] for men vs 3.0 [95% CI, 2.0-4.4] for women). A low ABI (< or = 0.90) was associated with approximately twice the 10-year total mortality, cardiovascular mortality, and major coronary event rate compared with the overall rate in each FRS category. Inclusion of the ABI in cardiovascular risk stratification using the FRS would result in reclassification of the risk category and modification of treatment recommendations in approximately 19% of men and 36% of women. CONCLUSION: Measurement of the ABI may improve the accuracy of cardiovascular risk prediction beyond the FRS.

[The Dr A.H. Heineken Prize for Medicine 2008 awarded to Sir Richard Peto]. / Dr.A.H.Heineken-prijs voor de Geneeskunde 2008 toegekend aan Sir Richard Peto.

The increasingly strong interaction between biomedical and epidemiological research is one of the most important steps forward in medicine and public health since World War II. Crucial breakthroughs were the development of powerful observational epidemiological studies, the introduction of convincingly designed clinical trials, and meta-analyses to objectively summarise the results of multiple studies. For this progress, the work of Sir Richard Peto (born in 1943), epidemiologist and statistician at the University of Oxford, Great Britain, has been essential. Peto combined innovative methodological contributions with large-scaled empirical studies, often based on worldwide collaborations, with a special focus on smoking and health, treatment of breast cancer, and cholesterol-lowering interventions. His work both produced and evoked an impressive evidence base to improve clinical and public health practice. In accordance with the advice of a selection committee of the Royal Netherlands Academy of Arts and Sciences, he was awarded the Dr A.H. Heineken Prize for Medicine on 2 October 2008.

[Influenza vaccination in the elderly: effectiveness not in doubt]. / Griepvaccinatie bij ouderen: geen twijfel aan de effectiviteit.

In a recent review the effectiveness of influenza vaccination in the elderly was brought into question. Selection bias, which would occurr if healthy people were more likely to be vaccinated than their infirm peers, and the use of non-specific outcomes, such as death from all causes, were considered to have contributed to the effectiveness of the vaccine as to morbidity and mortality being overestimated. However, a recent study has shown that even when potential bias and residual confounding were addressed, influenza vaccination was associated with a significant reduction in the risk of influenza-related morbidity and mortality among community-dwelling elderly persons. Direct estimates of influenza-related morbidity were hampered by delayed and insufficiently sensitive diagnostics. Excess studies, however, comparing morbidity and mortality during periods with and without influenza predominance, present reliable indirect estimates in favour of vaccination. While the vaccination rate of high-risk subjects in The Netherlands is traditionally high, the age limit for influenza vaccination was lowered from 65 to 60 in 2008, taking into account influenza-related morbidity and mortality in healthy people aged 60 to 65 years and the undisputed effectiveness of vaccination against influenza.

Similarities, overlap and differences between burnout and prolonged fatigue in the working population.

BACKGROUND: Burnout and prolonged fatigue are related but distinct concepts that have seldom been empirically compared. AIM: To examine similarities, overlap and differences between burnout and prolonged fatigue. DESIGN: Observational study. METHODS: We analysed baseline data from the Maastricht Cohort Study on Fatigue at Work (n = 12 140). The discriminative abilities of the Checklist Individual Strength (CIS) and the Maslach Burnout Inventory-General Survey (MBI-GS) were evaluated using principal component analysis. Overlap, similarities and differences regarding health, work and demographic factors between subgroups were assessed. RESULTS: The discriminative abilities of the CIS and MBI-GS appeared to be moderate. Prolonged fatigue and burnout cases overlapped considerably. The subgroup consisting of cases with concurrent fatigue and burnout tended to have poorer outcomes in terms of health and work factors than the subgroups with either prolonged fatigue or burnout. Similar patterns were found for subjective fatigue and exhaustion. DISCUSSION: There appear to be some relevant differences between burnout and prolonged fatigue, with respect to work and health factors. Burnout and prolonged fatigue can occur both separately and simultaneously. Having both conditions simultaneously seems to be associated with worse outcomes than having either alone.

Alcohol intake and cardiovascular disease and mortality: the role of pre-existing disease.

OBJECTIVES: Pre-existing conditions have been postulated as possible causes of the J-shaped relationship between alcohol intake and cardiovascular disease. Two research questions have been addressed in this paper. First, whether never drinkers and former drinkers differ from moderate drinkers in terms of health, and if so, which health problems contribute to this difference. Second, whether the U-shaped relationship between current alcohol intake and cardiovascular disease or all-cause mortality could in part be explained by difference in pre-existing disease burden. DESIGN, SETTING AND PARTICIPANTS: A prospective case-cohort, the Lifestyle and Health Study, consisting of 16,210 men and women aged between 45 and 70 years. Alcohol intake and risk factors were assessed at baseline with a self-administered questionnaire. Medical information was obtained from general practitioners. Cardiovascular events and mortality were followed for a period of 5 years (1996-2001). MAIN RESULTS: Never drinkers and former drinkers were less healthy than moderate drinkers. They rated their health more often as poor, and often had more diseases, such as cardiovascular disease, diabetes, and also alcohol-related diseases. The difference in disease burden did not change the observed relationship between alcohol intake and cardiovascular events, and only partially changed the U-shaped relationship between alcohol intake and all-cause mortality. CONCLUSIONS: The found difference in health between never drinkers and former drinkers compared with moderate drinkers appeared to be only a partial explanation of the observed relationships between alcohol intake and cardiovascular disease, and between alcohol intake and all-cause mortality.

Lower prevalence of heart disease but higher mortality risk during follow-up was found among nonrespondents to a cohort study.

OBJECTIVE: The primary aim was to assess the association between response behavior and health status at baseline, and survival in a 5-year follow-up period. A secondary aim was to assess whether reasons for nonresponse were associated with health status at baseline. STUDY DESIGN AND SETTING: Data came from a prospective study cohort consisting of 31,349 men and women aged 45-70 years. Objective retrospective and prospective health information derived from general practitioner registries was available for both respondents and nonrespondents. RESULTS: Results show that among respondents coronary heart disease was more prevalent. Compared with respondents, noncontacts had a higher mortality risk during follow-up. Refusals had hypercholesterolemia more often than did noncontacts, and coronary heart disease or diabetes mellitus less often. CONCLUSION: The paradoxical results that respondents are less healthy at baseline but prospectively have a lower mortality risk may point to a selection effect indicating that the 'worried ill' are more inclined to participate. This effect could imply that observed relationships between risk factors or behaviors and outcomes in cohort studies may be attenuated.

The effects of 6 months of increased water intake on blood sodium, glomerular filtration rate, blood pressure, and quality of life in elderly (aged 55-75) men.

OBJECTIVES: To study whether there are any negative or positive effects of 6 months of increased fluid intake in reasonably healthy elderly men. DESIGN: Randomized trial. SETTING: Community-based. PARTICIPANTS: One hundred forty-one healthy participants aged 55 to 75. INTERVENTION: One group was given the advice to increase their daily fluid intake by 1.5 L of water; the other group was given placebo medication (8 mL inactive syrup per day). MEASUREMENTS: At 6 months blood sodium, glomerular filtration rate (GFR), blood pressure, and quality of life (QOL) were measured. The changes in water turnover were measured using deuterium. RESULTS: Most subjects did not manage to increase their fluid intake by 1.5 L. The average increase in the intervention group was approximately 1 L. Twenty-four-hour water turnover in the water group was 359 mL (95% confidence interval=171-548) higher than that of the control group at 6-month follow-up. Blood pressure, sodium level, GFR, and QOL did not change significantly in either group during the intervention period. In addition, the cases reporting a worsening on the effect measures were equally distributed over the two study groups. CONCLUSION: The advice to increase fluid intake by 1.5 L had no negative effects in reasonably healthy men aged 55 to 75.

Chronic fatigue syndrome-like caseness as a predictor of work status in fatigued employees on sick leave: four year follow up study.

OBJECTIVE: To assess whether CFS-like caseness (meeting the criteria for chronic fatigue syndrome (CFS)) predicts work status in the long term. METHODS: Prospective study in a sample of fatigued employees absent from work. Data were collected at baseline and four years later, and included CFS-like caseness and work status (inactive work status and full work incapacity). RESULTS: CFS-like cases at baseline were three times more likely to be unable to work at follow up than fatigued employees who did not meet CFS criteria at baseline (ORs 3-3.3). These associations grew even stronger when demographic and clinical confounders were controlled for (ORs 3.4-4.4). CONCLUSION: A CFS-like status (compared to non-CFS fatigue) proved to be a strong predictor of an inactive work status and full work incapacity in the long term. Since little is known about effective interventions that prevent absenteeism and work incapacity or facilitate return to work in subjects with chronic fatigue, there is a great need for powerful early interventions that restore or preserve the ability to work, especially for workers who meet criteria for CFS.

Towards a 'patient-centred' operationalisation of the new dynamic concept of health: a mixed methods study.

OBJECTIVE: To evaluate among stakeholders the support for the new, dynamic concept of health, as published in 2011: 'Health as the ability to adapt and to self-manage', and to elaborate perceived indicators of health in order to make the concept measurable. DESIGN: A mixed methods study: a qualitative first step with interviews and focus groups, followed by a quantitative survey. PARTICIPANTS: Representatives of seven healthcare stakeholder domains, for example, healthcare providers, patients with a chronic condition and policymakers. The qualitative study involved 140 stakeholders; the survey 1938 participants. RESULTS: The new concept was appreciated, as it addresses people as more than their illness and focuses on strengths rather than weaknesses. Caution is needed as the concept requires substantial personal input of which not everyone is capable. The qualitative study identified 556 health indicators, categorised into six dimensions: bodily functions, mental functions and perception, spiritual/existential dimension, quality of life, social and societal participation, and daily functioning, with 32 underlying aspects. The quantitative study showed all stakeholder groups considering bodily functions to represent health, whereas for other dimensions there were significant differences between groups. Patients considered all six dimensions almost equally important, thus preferring a broad concept of health, whereas physicians assessed health more narrowly and biomedically. In the qualitative study, 78% of respondents considered their health indicators to represent the concept. CONCLUSIONS: To prevent confusion with health as 'absence of disease', we propose the use of the term 'positive health' for the broad perception of health with six dimensions, as preferred by patients. This broad perception deserves attention by healthcare providers as it may support shared decision-making in medical practice. For policymakers, the broad perception of 'positive health' is valuable as it bridges the gap between healthcare and the social domain, and by that it may demedicalise societal problems.

[What do older patients on polypharmacy know about their prescribed drugs?]. / Wat weten ouderen met polyfarmacie van hun pillen?

OBJECTIVE: To identify factors associated with appropriate knowledge about the indications for drugs prescribed to older patients on polypharmacy. DESIGN: Cross-sectional study. METHOD: In a primary care setting, patients aged 60 years and over who were taking five or more prescribed drugs simultaneously were asked about their medication by conducting home interviews and postal questionnaires. Multiple logistic regression analysis was used to evaluate the association between medication knowledge and explanatory variables such as medication use, sex, age, residential status and educational level. RESULTS: Seven hundred and fifty-four participants, mean age 73.2 years, reported an average daily intake of nine (SD 3.0) prescribed drugs. Only 15% of the patients were able to recall the indication for each of their prescribed drugs. Variables that were negatively associated with correct reporting of all indications were: taking many prescribed drugs (≥ 10 vs. ≤ 5 drugs: odds ratio (OR) 0.05), age 80 years or over (vs. 60-69 years: OR 0.47) and male sex (vs. females: OR 0.53). Patients living with a partner were more knowledgeable than patients living alone (OR 2.11). We did not find an association with educational level. CONCLUSION: Among older patients using five or more prescribed drugs, there was little understanding of the indications for their drugs, especially among patients taking the highest number of drugs, patients aged 80 years or over, and men. Patients living independently with a partner were more knowledgeable than others.

Treatment expectations influence the outcome of multidisciplinary rehabilitation treatment in patients with CFS.

OBJECTIVE: To improve the effectiveness of treatment in patients with chronic fatigue syndrome it is worthwhile studying factors influencing outcomes. The aims of this study were (1) to assess the association of expectancy and credibility on treatment outcomes, and (2) to identify baseline variables associated with treatment expectancy and credibility. METHODS: 122 patients were included in a randomized controlled trial of whom 60 received cognitive behavioural therapy (CBT) and 62 multidisciplinary rehabilitation treatment (MRT). Expectancy and credibility were measured with the credibility and expectancy questionnaire. Outcomes of treatment, fatigue, and quality of life (QoL), were measured at baseline and post-treatment. Multiple linear regressions were performed to analyse associations. RESULTS: In explaining fatigue and the physical component of the QoL, the effect of expectancy was significant for MRT, whereas in CBT no such associations were found. The main effect of expectancy on the mental component of QoL was not significant. For credibility, the overall effect on fatigue and the physical component of QoL was not significant. In explaining the mental component of QoL, the interaction between treatment and credibility was significant. However, the effects within each group were not significant. In the regression model with expectancy as dependent variable, only treatment centre appeared significantly associated. In explaining credibility, treatment centre, treatment allocation and depression contributed significantly. CONCLUSIONS: For clinical practice it seems important to check the expectations of the patient, since expectations influence the outcome after MRT.

The validity and ethics of giving placebo in a randomized nonpharmacologic trial was evaluated.

OBJECTIVE: When studying the effects of a non-pharmacologic intervention, the choice of a control group is often difficult. In a study on the effectiveness of increased water intake on voiding dysfunction in elderly men we used an unusual design. This article addresses the internal validty and ethics of this design. STUDY DESIGN AND SETTING: The randomized trial we evaluated had a 6-month follow-up period and was carried out among 141 elderly men with moderate lower urinary tract symptoms. The experimental group was given the instruction to drink more water, the control group received placebo medication. The participants were not informed that there was a 50% chance of receiving placebo. We measured whether the prior expectations and preferences were comparable for the two study groups, whether blinding was preserved throughout the study period, and whether the participants considered this design ethical. RESULTS: Prior to randomization, patients had higher expectations for the experimental intervention, but there was not statistically significant difference in their preference. During the study period, two out of 71 patients in the control group unmasked the placebo. In general, both groups fully agreed with the informed consent procedure. CONCLUSION: This design can be considered when the effects of a non-pharmacologic interventions are studied.

Clinical items not helpful in differentiating viral from bacterial lower respiratory tract infections in general practice.

OBJECTIVE: Incorrect and unnecessary antibiotic prescribing enhancing bacterial resistance rates might be reduced if viral and bacterial lower respiratory tract infections (LRTI) could be differentiated clinically. Whether this is possible is often doubted but has rarely been studied in general practice. STUDY DESIGN AND SETTING: This was an observational cohort study in 15 general practice surgeries in the Netherlands. RESULTS: Etiologic diagnoses were obtained in 112 of 234 patients with complete data (48%). Viral pathogens were found as often as bacterial pathogens. Haemophilus (para-) influenzae was most frequently found. None of the symptoms and signs correlated statistically significantly with viral or bacterial LRTI. Erythrocyte sedimentation rate >50 (odds ratio [OR] 2.3-3.3) and C-reactive protein (CRP) >20 (OR 2.1-4.6) were independent predictors for viral LRTI and bacterial LRTI when compared with microbiologically unexplained LRTI. CONCLUSION: Extensive history-taking and physical examination did not provide items that predict viral or bacterial LRTI in adult patients in daily general practice. We could not confirm CRP to differentiate between viral and bacterial LRTI.