Chris van Weel

How should we define health

The WHO definition of health as complete wellbeing is no longer fit for purpose given the rise of chronic disease. Machteld Huber and colleagues propose changing the emphasis towards the ability to adapt and self manage in the face of social, physical, and emotional challenges

Slowing the Deterioration of Asthma and Chronic Obstructive Pulmonary Disease Observed during Bronchodilator Therapy by Adding Inhaled Corticosteroids: A 4-Year Prospective Study

Rates of morbidity and mortality due to asthma and chronic obstructive pulmonary disease (COPD) have increased during the last two decades [1, 2]. These increases might be related to the use of bronchodilator therapy without anti-inflammatory medication [3, 4]. Recently, two studies found that regular bronchodilator treatment had adverse effects on the control of asthma [5] and the progression of asthma and COPD [6]. In a previous study of 160 patients with asthma or COPD [6], we found that continuous treatment with a bronchodilator (ipratropium bromide, 40 g, or salbutamol, 400 g, four times daily) was associated with a much higher annual decline in the forced expiratory volume in 1 second (FEV1) compared with treatment on demand. It is unclear whether an unfavorable course of asthma or COPD during bronchodilator therapy alone can be reversed or decelerated by additional anti-inflammatory therapy with inhaled corticosteroids. We studied 56 of the 160 patients who had an unfavorable disease course during bronchodilator therapy alone (an annual decline in FEV1 of at least 80 mL/y in combination with at least two exacerbations per year). These 56 patients (28 with asthma and 28 with COPD) were also treated with an inhaled corticosteroid (beclomethasone dipropionate, 800 g daily) during years 3 and 4 of the study. We assessed whether the worsening of their disease during bronchodilator therapy alone was reversed or decelerated by additional anti-inflammatory treatment with beclomethasone. The outcome measures were dynamic lung function indices (annual decline in pre- and postbronchodilator FEV1, peak expiratory flow rate [PEFR], and forced inspiratory volume in 1 second [FIV1]), static lung function indices (residual volume [RV], ratio of residual volume to total lung capacity (RV/TLC), inspiratory vital capacity [IVC]), nonspecific bronchial responsiveness (assessed by determining the concentration of histamine that provokes a 20% decrease in FEV1 [Pc 20]), exacerbations, and respiratory symptoms. Methods Patients Patient selection has been previously described [6]. In short, 29 family physicians in the catchment area of the University of Nijmegen, Nijmegen, the Netherlands, selected all patients who were 30 years or older and had symptoms of asthma or COPD. Only patients who showed mild-to-moderate airway obstruction (FEV1 > 50% of the predicted value [7]) or bronchial hyper-responsiveness to histamine (Pc 20 8 mg/mL) were included in the study. Patients dependent on inhaled corticosteroids who had chronic heart failure, malignant disorders, or other severe life-threatening diseases were excluded from the study. Of these patients, 160 (59 with asthma and 101 with COPD) completed the bronchodilator trial. During the 2 years of bronchodilator treatment, a rapid decline in FEV1 ( 80 mL/y) and a relatively high exacerbation rate ( 1/y) were observed in a subgroup of 56 patients (35%). Because of their unfavorable disease course, these patients were selected for additional treatment with inhaled beclomethasone for 2 years. The criteria for diagnosis of asthma or COPD were based on the standards of the American Thoracic Society [8]. Asthma was defined [6, 8] by a combination of factors: bronchial hyper-responsiveness to histamine (Pc 20 8 mg/mL); reversible obstruction (an improvement in FEV1 of more than 15% of the prebronchodilator value 60 minutes after the administration of both salbutamol, 400 g, and ipratropium bromide, 80 g); dyspnea; and allergy (defined as at least one positive result on seven radioallergosorbent tests that assessed sensitivity to pollen from weeds, grasses, and trees; cats and dogs; house dust mite; and Aspergillus fumigatus) or wheezing. Chronic obstructive pulmonary disease was defined [6, 8] by the combination of chronic cough or chronic sputum production for at least 3 months during at least 2 consecutive years; and continuous bronchus obstruction (FEV1 85% of the predicted value). The separate features of asthma and COPD overlap (for instance, some asthmatic patients had chronic cough, and some COPD patients had a Pc 20 8 mg/mL), but the definitions based on feature combinations ensured that no patients with asthma also had COPD and vice versa [6]. The study was approved by the Medical Ethics Committee of the University of Nijmegen. All patients gave informed consent. Study Design and Treatment At the start of the 4-year intervention study, the patients were randomly assigned to one of two parallel treatment regimens: continuous bronchodilator therapy (four times daily) or treatment on demand (dry powder inhalations during symptomatic periods) [6]. The patients used salbutamol, 400 g, during 1 year and ipratropium bromide, 40 g, during the other year; both were administered as dry powder inhalations. The sequence of the drugs was determined by random allocation. During years 3 and 4, the 56 patients received 400 g of beclomethasone, two times daily, in combination with 400 g of salbutamol or 40 g of ipratropium bromide, four times daily (all dry powder inhalations). The bronchodilator inhaled during year 2 was also used in years 3 and 4. During the first 2 years of the study, 27 of the 56 patients received bronchodilator therapy on demand (of the 27, 15 had asthma and 12 had COPD). For patients treated on demand, the mean (SE) daily number of dry powder inhalations of salbutamol or ipratropium bromide was 1.2 0.3 in those with asthma and 0.8 0.2 in those with COPD. During years 3 and 4, 28 patients received salbutamol (15 with asthma and 13 with COPD) and 28 received ipratropium bromide (13 with asthma and 15 with COPD). Once every 3 months, inhalation technique and compliance with the prescribed medication were checked. Patients were instructed to rinse their mouths after the dry powder inhalations. During the second year of beclomethasone therapy, a single-blind prospective study was done to assess patient compliance with beclomethasone and the additional bronchodilator. Compliance was measured by counting capsules at the end of a 4-month period. Patients were unaware that their medication was counted after this period. Lung Function, Nonspecific Bronchial Responsiveness, and Reversibility All measurements were carried out by two qualified laboratory assistants during exacerbation-free periods. No bronchodilator was inhaled for at least 8 hours before the pulmonary function tests. At the start and after 24 and 48 months of the study, the inspiratory vital capacity (IVC), residual volume (RV), functional residual capacity (FRC), and total lung capacity (TLC) were assessed using the wet Gould spirometer (Sensormedics, Bilthoven, the Netherlands) according to the standards of the European Coal and Steel Community [7]. The FEV1, bronchial responsiveness to histamine, and the reversibility of airway obstruction were assessed at 6-month intervals using the Microspiro HI-298 (Chest Corporation, Tokyo, Japan) [9]. Moreover, FEV1 and reversibility were also assessed after 1 and 13 months of study [6]. The best of three forced expiratory maneuvers, with the highest sum of the forced vital capacity (FVC) and FEV1, was used for data analysis. The bronchial responsiveness to histamine was measured according to the method described by Cockcroft and colleagues [10]. Results were expressed as the concentration of histamine that provoked a 20% decrease in FEV1 (Pc 20). After the FEV1 had returned to the baseline value, the bronchodilating response (reversibility) was assessed 60 minutes after the administration of both 80 g of ipratropium bromide and 400 g of salbutamol (metered dose aerosol) [6]. The bronchodilating response was expressed as the increase in FEV1 relative to the predicted value of the FEV1. Peak Expiratory Flow Assessments Once a week (on the same day and at the same time), peak expiratory flow rate (PEFR) was measured with the Assess peak flow meter (HealthScan Products, Cedar Grove, New Jersey) [11] in the morning and in the evening. The highest value of three measurements was included in the analysis. The diurnal PEFR index (absolute difference between the evening value and the morning value divided by the highest value) was calculated. Exacerbations Our definition of exacerbation was based on that of Fletcher as modified by Boman and colleagues [12]. When an exacerbation occurred, a 10-day course of oral prednisone was administered. Patients received 25 mg for 2 days, 20 mg for 2 days, 15 mg for 2 days, and so forth. Symptoms and Adverse Effects Using a scale of 0 to 4, all patients recorded, on a weekly basis, the presence and severity of symptoms (cough, phlegm, dyspnea, fatigue, disturbed sleep at night). The adverse effects of medication (dysphonia and oropharyngeal irritation) were recorded by the patients once every 3 months. Moreover, every 6 months, the presence and severity of oral candidiasis were assessed using a questionnaire (no, light, or severe symptoms). Smoking At the start of the study, smoking history was assessed in pack-years. During the study, the average number of cigarettes smoked per day was also recorded in weekly diary entries. Power Calculations Assuming that the clinically relevant, decreased annual decline in FEV1 during beclomethasone treatment is 25 mL/y and that the residual standard deviation is 50 mL/y, the coefficient of variation is 25/50 or 0.5. Based on an of 0.05 and a of 0.20 (power:1 0.2, or 0.8), the required number of patients for the study would be 51. Based on an estimated dropout rate of 10%, the required initial number of study patients would be 56. Statistical Analysis Data on outcome variables obtained before and during beclomethasone therapy were compared. Differences were tested by repeated-measures analysis of variance, the paired Student t-test for normally distributed variables, and the Wilcoxon paired signed-rank test for non-normally distributed variables. Before the analysis, the Pc 20 values were 2log transformed. The an

Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial

BACKGROUND Non-steroidal anti-inflammatory drugs and colchicine used to treat gout arthritis have gastrointestinal, renal, and cardiovascular adverse effects. Systemic corticosteroids might be a beneficial alternative. We investigated equivalence of naproxen and prednisolone in primary care. METHODS We did a randomised clinical trial to test equivalence of prednisolone and naproxen for the treatment of monoarticular gout. Primary-care patients with gout confirmed by presence of monosodium urate crystals were eligible. 120 patients were randomly assigned with computer-generated randomisation to receive either prednisolone (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. Treatment was masked for both patients and physicians. The primary outcome was pain measured on a 100 mm visual analogue scale and the a priori margin for equivalence set at 10%. Analyses were done per protocol and by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN14648181. FINDINGS Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients in each group. After 90 h the reduction in the pain score was 44.7 mm and 46.0 mm for prednisolone and naproxen, respectively (difference 1.3 mm; 95% CI -9.8 to 7.1), suggesting equivalence. The difference in the size of change in pain was 1.57 mm (95% CI -8.65 to 11.78). Adverse effects were similar between groups, minor, and resolved by 3 week follow-up. INTERPRETATION Oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days.

Comorbidity and guidelines: conflicting interests

The fourth epidemiological transition is characterised by an unprecedented increase in chronic degenerative disorders.1 Thus chronic disease is a particularly important area in which to ensure high-quality care. Clinical practice guidelines are increasingly being used for performance indicators. Stephen Campbell and colleagues recently showed substantial improvement in the quality of clinical care in UK general practice when judged on this basis. Reassuring as this result is, this method ignores the reality that 25–50% of people with a chronic disease have comorbidity or multimorbility. (aut.ref.)

Pain-related fear and daily functioning in patients with osteoarthritis.

&NA; There is growing evidence supporting the relationship between pain‐related fear and functional disability in chronic musculoskeletal pain conditions. In osteoarthritis (OA) patients the role of pain‐related fear and avoidance has received little research attention so far. The present study investigates the degree to which pain‐related fear, measured with the Tampa Scale for Kinesiophobia (TSK), influences daily functioning in OA patients. The purpose of the present paper was twofold: (1) to investigate the factor structure of the TSK in a sample of OA patients by means of confirmatory factor analysis; and (2) to investigate the role of pain‐related fear in OA compared to other factors, such as radiological findings and level of pain intensity. The results show that TSK consists of two factors, called ‘activity avoidance’ and ‘somatic focus’, which is in line with other studies in low back pain and fibromyalgia. Furthermore, pain‐related fear occurred to a considerable extent in this sample of osteoarthritis patients and was negatively associated with daily functioning. Level of pain and level of pain‐related fear were significantly associated with functional limitations. Radiological findings were not significant predictors and when compared to pain‐related fear they were not significant. These findings underscore the importance of pain‐related fear in daily functioning of OA patients. Therefore, treatment strategies aiming at reduction of pain‐related fear in OA patients need to be developed and investigated.

The need for research in primary care

Making evidence from scientific studies available to clinical practice has been expected to directly improve quality of care, but this expectation has not been realised. The notion of quality of care is complex, and quality improvement needs medical, contextual, and policy evidence. In primary care, research is needed that takes into account the specific characteristics of its population and the presentation and prevalence of illness and disease. The context of the doctor-patient encounter plays a major part, and needs better understanding. At the policy level, issues of equity must be addressed. The knowledge base for family practice must be expanded by integration of multiple methods of comprehension, so we can bridge the gap between evidence and practice.

Medically unexplained symptoms, somatisation disorder and hypochondriasis: course and prognosis. A systematic review.

OBJECTIVE To study the course of medically unexplained symptoms (MUS), somatisation disorder, and hypochondriasis, and related prognostic factors. Knowledge of prognostic factors in patients presenting persistent MUS might improve our understanding of the naturalistic course and the identification of patients with a high risk of a chronic course. METHODS A comprehensive search of Medline, PsycInfo, CINAHL, and EMBASE was performed to select studies focusing on patients with MUS, somatisation disorder, and hypochondriasis, and assessing prognostic factors. Studies focusing on patients with single-symptom unexplained disorder or distinctive functional somatic syndromes were excluded. A best-evidence synthesis for the interpretation of results was used. RESULTS Only six studies on MUS, six studies on hypochondriasis, and one study on abridged somatisation could be included. Approximately 50% to 75% of the patients with MUS improve, whereas 10% to 30% of patients with MUS deteriorate. In patients with hypochondriasis, recovery rates vary between 30% and 50%. In studies on MUS and hypochondriasis, we found some evidence that the number of somatic symptoms at baseline influences the course of these conditions. Furthermore, the seriousness of the condition at baseline seemed to influence the prognosis. Comorbid anxiety and depression do not seem to predict the course of hypochondriasis. CONCLUSIONS Due to the limited numbers of studies and their high heterogeneity, there is a lack of rigorous empirical evidence to identify relevant prognostic factors in patients presenting persistent MUS. However, it seems that a more serious condition at baseline is associated with a worse outcome.

Urinary Incontinence in Women and the Effects on their Lives

The aim of this study was to assess and analyse the effects of urinary incontinence in women and to examine the relationship between these effects and the type and severity of incontinence. 110 women aged 20 to 65 who had reported urinary incontinence to their general practitioners underwent a comprehensive history and a complete urodynamic evaluation. The reported consequences of incontinence included low self-esteem, changing life-style in order to avoid potentially embarrassing situations, and all kinds of practical worries. Fear of the odour played the most important part and was mentioned as being the worst effect in 40% of the cases. Most of the women appeared to cope adequately with the unpleasant aspects of this condition. More effects were associated with urge incontinence than with stress incontinence, while there was a significant relationship between the objective severity of the incontinence and its psychosocial impact. The main conclusion is that although urinary incontinence is not a severe physical disability, a spectrum of psychological problems is associated with it. In particular, the fear of being smelt was of the utmost importance.

A Diagnostic Rule for Acute Gouty Arthritis in Primary Care Without Joint Fluid Analysis

BACKGROUND Most cases of acute gouty arthritis are diagnosed in primary care and without joint fluid analysis in many instances. Our objectives were to estimate the validity of this diagnosis by family physicians and to develop a diagnostic rule. METHODS Patients with monoarthritis recruited in an open Dutch population with gout by family physician diagnosis were enrolled in a diagnostic study (March 24, 2004, through July 14, 2007). Validity variables were estimated using 2 x 2 tables, with the presence of synovial monosodium urate crystals as the reference test. For development of the diagnostic rule, clinical variables (including the presence of synovial monosodium urate crystals) were collected within 24 hours. Statistically significant variables and predefined variables were separately entered in multivariate logistic regression models to predict the presence of synovial monosodium urate crystals. Diagnostic performance of the models was tested by receiver operating characteristic curve analysis. The most appropriate model was transformed to a clinically useful diagnostic rule. RESULTS Three hundred twenty-eight patients were included in the study. The positive and negative predictive values of family physician diagnosis of gout were 0.64 and 0.87, respectively. The most appropriate model contained the following predefined variables: male sex, previous patient-reported arthritis attack, onset within 1 day, joint redness, first metatarsophalangeal joint (MTP1) involvement, hypertension or 1 or more cardiovascular diseases, and serum uric acid level exceeding 5.88 mg/dL (to convert serum uric acid level to micromoles per liter, multiply by 59.485). The area under the receiver operating characteristic curve for this model was 0.85 (95% confidence interval, 0.81-0.90). Performance did not change after transforming the regression coefficients to easy-to-use scores and was almost equal to that of the statistically optimal model (area under the receiver operating characteristic curve, 0.87; 95% confidence interval, 0.83-0.91). CONCLUSIONS The validity of family physician diagnosis of acute gouty arthritis was moderate in this study. An easy-to-use diagnostic rule without joint fluid analysis was developed for their use.

Improving health care globally: a critical review of the necessity of family medicine research and recommendations to build research capacity.

An invitational conference led by the World Organization of Family Doctors (Wonca) involving selected delegates from 34 countries was held in Kingston, Ontario, Canada, March 8 to12, 2003. The conference theme was “Improving Health Globally: The Necessity of Family Medicine Research.” Guiding conference discussions was the value that to improve health care worldwide, strong, evidence-based primary care is indispensable. Eight papers reviewed before the meeting formed the basic material from which the conference developed 9 recommendations. Wonca, as an international body of family medicine, was regarded as particularly suited to pursue these conference recommendations: Research achievements in family medicine should be displayed to policy makers, health (insurance) authorities, and academic leaders in a systematic way. In all countries, sentinel practice systems should be developed to provide surveillance reports on illness and diseases that have the greatest impact on the population’s health and wellness in the community. A clearinghouse should be organized to provide a central repository of knowledge about family medicine research expertise, training, and mentoring. National research institutes and university departments of family medicine with a research mission should be developed. Practice-based research networks should be developed around the world. Family medicine research journals, conferences, and Web sites should be strengthened to disseminate research findings internationally, and their use coordinated. Improved representation of family medicine research journals in databases, such as Index Medicus, should be pursued. Funding of international collaborative research in family medicine should be facilitated. International ethical guidelines, with an international ethical review process, should be developed in particular for participatory (action) research, where researchers work in partnership with communities. When implementing these recommendations, the specific needs and implications for developing countries should be addressed. The Wonca executive committee has reviewed these recommendations and the supporting rationale for each. They plan to follow the recommendations, but to do so will require the support and cooperation of many individuals, organizations, and national governments around the world.