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3.  A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial 
Trials  2011;12:37.
Chronic obstructive pulmonary disease (COPD) is a common disease, associated with cardiovascular disease. Many patients use (long-acting) bronchodilators, whilst they continue smoking alongside. We hypothesised an interaction between bronchodilators and smoking that enhances smoke exposure, and hence cardiovascular disease. In this paper, we report our study protocol that explores the fundamental interaction, i.e. smoke retention.
The design consists of a double-blinded, placebo-controlled, randomised crossover trial, in which 40 COPD patients smoke cigarettes during both undilated and maximal bronchodilated conditions. Our primary outcome is the retention of cigarette smoke, expressed as tar and nicotine weight. The inhaled tar weights are calculated from the correlated extracted nicotine weights in cigarette filters, whereas the exhaled weights are collected on Cambridge filters. We established the inhaled weight calculations by a pilot study, that included paired measurements from several smoking regimes. Our study protocol is approved by the local accredited medical review ethics committee.
Our study is currently in progress. The pilot study revealed valid equations for inhaled tar and nicotine, with an R2 of 0.82 and 0.74 (p < 0.01), respectively. We developed a method to study pulmonary smoke retentions in COPD patients under the influence of bronchodilation which may affect smoking-related disease. This trial will provide fundamental knowledge about the (cardiovascular) safety of bronchodilators in patients with COPD who persist in their habit of cigarette smoking.
Trial registration NCT00981851
PMCID: PMC3048554  PMID: 21310040
4.  Understanding reasons for asthma outpatient (non)‐attendance and exploring the role of telephone and e‐consulting in facilitating access to care: exploratory qualitative study 
Quality & Safety in Health Care  2006;15(3):191-195.
To understand factors influencing patients' decisions to attend for outpatient follow up consultations for asthma and to explore patients' attitudes to telephone and email consultations in facilitating access to asthma care.
Exploratory qualitative study using in depth interviews.
Hospital outpatient clinic in West London.
Nineteen patients with moderate to severe asthma (12 “attenders” and 7 “non‐attenders”).
Patients' main reasons for attending were the wish to improve control over asthma symptoms and a concern not to jeopardise the valued relationship with their doctor. Memory lapses, poor health, and disillusionment with the structure of outpatient care were important factors implicated in non‐attendance. The patients were generally sceptical about the suggestion that greater opportunity for telephone consulting might improve access to care. They expressed concerns about the difficulties in effectively communicating through non‐face to face media and were worried that clinicians would not be in a position to perform an adequate physical examination over the telephone. Email and text messaging were viewed as potentially useful for sending appointment reminders and sharing clinical information but were not considered to be acceptable alternatives to the face to face clinic encounter.
Memory lapses, impaired mobility due to poor health, and frustration with outpatient clinic organisation resulting in long waiting times and discontinuity of care are factors that deter patients from attending for hospital asthma assessments. The idea of telephone review assessments was viewed with scepticism by most study subjects. Particular attention should be given to explaining to patients the benefits of telephone consultations, and to seeking their views as to whether they would like to try them out before replacing face to face consultations with them. Email and text messaging may have a role in issuing reminders about imminent appointments.
PMCID: PMC2464862  PMID: 16751469
outpatient appointments; patient‐caregiver communication; patients' views; telephone; email; asthma
5.  Prevalence and characteristics of patients in a vegetative state in Dutch nursing homes 
Objectives: To establish the prevalence of vegetative state in Dutch nursing homes, describe the patient characteristics, and highlight the possible influence of medical decisions at the end of life.
Design: A cross-sectional survey. The vegetative state was defined according to the Multi Society Task Force on PVS. All Dutch nursing homes were approached to provide data on patients in a vegetative state. In cases of doubt, the researcher discussed the diagnosis with the patient's physician and, if necessary, examined the patient. Information on patients in a vegetative state in care between 2000 and September 2003 and end of life decisions for them were also recorded.
Results: All nursing homes and physicians participated. After assessment of 12 doubtful patients, 32 met the criteria of vegetative state lasting longer than one month, a prevalence of 2/1 000 000. Of these, 30 patients' data were analysed: age 9–90 years; 73% female; duration of vegetative state 2 months–20 years (26 surviving >1 year, 13 >5 years). Stroke was the commonest cause. Between 2000 and September 2003, there were 76 patients in a vegetative state in care of whom 34 died of complications and nine after withdrawal of artificial nutrition and hydration.
Conclusions: The prevalence of vegetative state in Dutch nursing homes has been established for the first time. The figures are lower than suggested in the literature. The study included a heterogeneous group of patients, of which a substantial number survived for many years. The results cannot be explained by a policy of systematically withdrawing artificial nutrition and hydration.
PMCID: PMC1739352  PMID: 16170089
6.  Validity of spirometric testing in a general practice population of patients with chronic obstructive pulmonary disease (COPD) 
Thorax  2003;58(10):861-866.
Objective: To investigate the validity of spirometric tests performed in general practice.
Method: A repeated within subject comparison of spirometric tests with a "gold standard" (spirometric tests performed in a pulmonary function laboratory) was performed in 388 subjects with chronic obstructive pulmonary disease (COPD) from 61 general practices and four laboratories. General practitioners and practice assistants undertook a spirometry training programme. Within subject differences in forced expiratory volume in 1 second and forced vital capacity (ΔFEV1 and ΔFVC) between laboratory and general practice tests were measured (practice minus laboratory value). The proportion of tests with FEV1 reproducibility <5% or <200 ml served as a quality marker.
Results: Mean ΔFEV1 was 0.069 l (95% CI 0.054 to 0.084) and ΔFVC 0.081 l (95% CI 0.053 to 0.109) in the first year evaluation, indicating consistently higher values for general practice measurements. Second year results were similar. Laboratory and general practice FEV1 values differed by up to 0.5 l, FVC values by up to 1.0 l. The proportion of non-reproducible tests was 16% for laboratory tests and 18% for general practice tests (p=0.302) in the first year, and 18% for both in the second year evaluation (p=1.000).
Conclusions: Relevant spirometric indices measured by trained general practice staff were marginally but statistically significantly higher than those measured in pulmonary function laboratories. Because of the limited agreement between laboratory and general practice values, use of these measurements interchangeably should probably be avoided. With sufficient training of practice staff the current practice of performing spirometric tests in the primary care setting seems justifiable.
PMCID: PMC1746497  PMID: 14514938
7.  Self-management of asthma in general practice 
Thorax  2003;58(8):735-736.
PMCID: PMC1746774  PMID: 12886000
8.  Self-management of asthma in general practice, asthma control and quality of life: a randomised controlled trial 
Thorax  2003;58(1):30-36.
Background: A study was undertaken to determine the effectiveness of asthma self-management in general practice.
Methods: Nineteen general practices were randomly allocated to usual care (UC) or self-management (SM). Asthma patients were included after confirmation of the GP diagnosis. Follow up was 2 years. Patients kept diary cards and visited the lung function laboratory every 6 months. Outcomes were number of successfully treated weeks, limited activity days, asthma specific quality of life, forced expiratory volume in 1 second (FEV1), FEV1 reversibility, concentration of histamine provoking a fall in FEV1 of 20% or more (PC20 histamine), and amount of inhaled steroids.
Results: A total of 214 patients were included in the study (104 UC/110 SM; one third of the total asthma population in general practice); 62% were female. The mean percentage of successfully treated weeks per patient in the UC group was 72% (74/103 weeks) compared with 78% (81/105 weeks) in the SM group (p=0.003). The mean number of limited activity days was 1.2 (95% CI 0.5 to 1.9) in the SM group and 3.9 (95% CI 2.5 to 5.4) in the UC group. The estimated increase in asthma quality of life score was 0.10 points per visit in the UC group and 0.21 points per visit in the SM group (p=0.055). FEV1, FEV1 reversibility, and PC20 histamine did not change. There was a saving of 217 puffs of inhaled steroid per patient in favour of the SM group (p<0.05).
Conclusion: Self-management lowers the burden of illness as perceived by patients with asthma and is at least as effective as the treatment usually provided in Dutch primary care. Self-management is a safe basis for intermittent treatment with inhaled corticosteroids.
PMCID: PMC1746452  PMID: 12511716
9.  Pharmacologic treatment of migraine 
Canadian Family Physician  2005;51(6):838-843.
To compare guidelines (not the primary studies) for pharmacologic treatment of migraine as to methods of guideline development; recommendations, particularly on triptans; and quality of supporting evidence (with emphasis on comparative studies of triptans versus ergot alkaloids and nonsteroidal anti-inflammatory drugs [NSAIDs]).
We searched MEDLINE via PubMed for guidelines on migraine management published since 1990 in any language; in addition, we browsed the Internet for information.
We found nine clinical guidelines on migraine; one guideline, not supported by references, was excluded.
Preference for triptans is not well founded and is largely based on comparisons with placebo. Too few studies compared new drugs with established ones (NSAIDs or dihydroergotamine). Guidelines that propose a hierarchy for selection of drugs are opinion-based rather than evidence-based.
The current lack of evidence from comparative studies seriously limits development of evidence-based clinical practice guidelines for pharmacologic treatment of migraine.
PMCID: PMC1479536  PMID: 15986940
10.  Differences in health status between long-term and short-term benzodiazepine users. 
BACKGROUND: Despite generally accepted advice to keep treatment short, benzodiazepines are often prescibed for more than six months. Prevention of long-term benzodiazepine use could be facilitated by the utilisation of risk indicators for long-term use. However, the characteristics of long-term benzodiazepine users described in the literature are based on studies in which long-term users were compared with non-users. Thus these characteristics may be imprecise. AIM: To study the characteristics of long-term benzodiazepine users by comparing their demographic data and health status (mental and physical) with those of short-term users. DESIGN OF STUDY: Cross-sectional comparison of short-term and long-term benzodiazepine users. SETTING: Patients from 32 GP practices of the Nijmegen Health Area, The Netherlands. METHOD: The characteristics of 164 short-term and 158 long-term benzodiazepine users in general practice were compared, using interview data and morbidity referral and prescription data from GP records. RESULTS: Long-term benzodiazepine users were (a) older, (b) had a more severe history of mental health problems for which they had received more serious treatment, (c) used more psychotropic drugs, (d) had a higher hospital specialist consultation frequency, (e) had more diagnoses of the following: diabetes, asthma, chronic obstructive pulmonary disease, hypertension a serious skin disorder, and (f) reported a lower perceived general health status. There were no sex differences. CONCLUSION: Specific risk characteristics of long-term benzodiazepine users can be used to develop a risk profile for the management of benzodiazepines in general practice. We believe that (somatic) secondary care also contributes to benzodiazepine use. It may be worthwhile to coordinate care for benzodiazepine users between GPs and hospital specialists.
PMCID: PMC1316082  PMID: 12392119
11.  Cardiovascular risk factors and disease in general practice: results of the Nijmegen Cohort Study. 
The relationship between risk factors and cardiovascular disease (CVD) was determined using data from the Nijmegen Cohort study, an 18-year prospective study. In 1977, cardiovascular risk factors were measured in 7092 Caucasian males and females from six general practices: age, smoking, serum cholesterol, blood pressure, body mass index and a family history of CVD were related to subsequent CVD mortality and morbidity. Most patients had more than one risk factor in particular among men. A significant relationship between risk factors and CVD was demonstrated. In men, a relative risk (RR) of 1.8 was found for both high blood pressure and smokers. A positive family history yielded a RR of 1.8. The risk increased gradually with the number of risk factors; 38% of the group with all risk factors suffered a CVD within 18 years. In women, comparable RRs were found but the low absolute risk of CVD should indicate against the treatment of cardiovascular risk factors.
PMCID: PMC1314233  PMID: 11887878
12.  Insulin therapy in poorly controlled type 2 diabetic patients: does it affect quality of life? 
BACKGROUND: Strict glycaemic control in type 2 diabetic patients is recommended in a number of treatment protocols. However, although better glycaemic control prevents or postpones chronic diabetic complications, it remains uncertain how this affects quality of life in the short and long term. AIM: To study the impact of insulin therapy on glycaemic control and quality of life in type 2 diabetic patients, with secondary failure on maximal oral medication. DESIGN OF STUDY: Two separate sets of analyses were performed: a longitudinal analysis of those patients converted to insulin therapy and a comparison of 12-week outcomes between the two randomisation groups. SETTING: Ten general practices, participating in the Nijmegen Monitoring Project. METHOD: Patients, poorly controlled on maximal oral therapy, were stratified with respect to age and sex, and randomly allocated to insulin therapy in two different schedules: (a) after a 12-week period with enhanced compliance to diet and oral therapy: or (b) as soon as secondary failure was established. Patients were referred to a diabetologist to start insulin therapy and were referred back to their general practitioner (GP) as soon as glycaemic control was stable. We assessed fasting blood glucose, HbA1c functional health, and quality of life (Sickness Impact Profile, COOP/WONCA charts, Diabetes Symptom Checklist) at baseline, after the patient was referred back to the GP, and nine months later. RESULTS: Of the 38 included patients, three patients dropped out and seven patients were not switched over to insulin therapy. In patients starting insulin therapy, mean HbA1c and fasting blood glucose level decreased from 9.5% to 7.6%, and from 12.0 mmol to 8.4 mmol, respectively (P < 0.001). The better control was accompanied by a decrease in hyperglycaemic complaints (P = 0.01). No increase in hypoglycaemic complaints was found. There were no statistically significant changes in quality-of-life parameters. After 12 weeks, patients directly referred to insulin therapy showed a statistically significant improvement in HbA1c and fasting glucose level, in contrast to patients with enhanced compliance. Quality-of-life scores did not significantly differ statistically. CONCLUSION: Insulin therapy in poorly controlled type 2 diabetic patients from general practice resulted in a significant clinical improvement of glycaemic control, accompanied by a reduction of hyperglycaemic complaints, without an increase in hypoglycaemic complaints or an adverse influence on quality of life.
PMCID: PMC1314043  PMID: 11462311
14.  Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis 
Thorax  1999;54(1):7-14.
BACKGROUND—The role of inhaled corticosteroids in the long term management of chronic obstructive pulmonary disease (COPD) is still unclear. A meta-analysis of the original data sets of the randomised controlled trials published thus far was therefore performed. The main question was: "Are inhaled corticosteroids able to slow down the decline in lung function (FEV1) in COPD?"
METHODS—A Medline search of papers published between 1983 and 1996 was performed and three studies were selected, two of which were published in full and one in abstract form. Patients with "asthmatic features" were excluded from the original data. Ninety five of the original 140 patients treated with inhaled corticosteroids (81 with 1500 µg beclomethasone daily, six with 1600 µg budesonide daily, and eight with 800 µg beclomethasone daily) and 88 patients treated with placebo (of the initial 144 patients) were included in the analysis. The effect on FEV1 was assessed by a multiple repeated measurement technique in which points of time in the study and treatment effects (inhaled corticosteroids compared with placebo) were investigated.
RESULTS—No baseline differences were observed (mean age 61 years, mean FEV1 45% predicted). The estimated two year difference in prebronchodilator FEV1 was +0.034 l/year (95% confidence interval (CI) 0.005 to 0.063) in the inhaled corticosteroid group compared with placebo. The postbronchodilator FEV1 showed a difference of +0.039 l/year (95% CI -0.006 to 0.084). No beneficial effect was observed on the exacerbation rate. Worsening of the disease was the reason for drop out in four patients in the treatment group compared with nine in the placebo group. In the treatment group six of the 95 subjects dropped out because of an adverse effect which may have been related to the treatment compared with two of the 88 patients in the placebo group.
CONCLUSIONS—This meta-analysis in patients with clearly defined moderately severe COPD showed a beneficial course of FEV1 during two years of treatment with relatively high daily dosages of inhaled corticosteroids.

PMCID: PMC1745350  PMID: 10343624
15.  Sex differences in cardiovascular disease: are women with low socioeconomic status at high risk? 
BACKGROUND: Cardiovascular disease is still portrayed as a typical male disease, and men are more often submitted to invasive procedures or referred earlier. AIM: To explore sex differences in morbidity and referral patterns in cardiovascular disease in general practice, and the role of age and socioeconomic status. METHOD: Data were obtained from a continuous morbidity registration project in the Netherlands from 1986 to 1995 in which 12,000 patients were followed over 10 years. The effects of sex, age, and socioeconomic status on morbidity of cardiovascular disease and the referral patterns were established. RESULTS: The sex difference in morbidity becomes smaller with increasing age. Morbidity was highest in the lower socioeconomic status in general and for angina pectoris in particular. Women with angina pectoris with low socioeconomic status have a relative risk of 2.24 (CI = 1.17-3.26) compared with women with high socioeconomic status. In men, no significant difference was found between the socioeconomic status groups. For angina pectoris the sex difference in referral to the specialist was most significant: 50.6% and 26.6% (P = 0.002) for men and women respectively. CONCLUSION: For women, low socioeconomic status was associated with relatively higher morbidity of angina pectoris and myocardial infarction than for men. Women are less likely to be referred than men are, in particular for angina pectoris.
PMCID: PMC1313580  PMID: 10824339
16.  Long-term effect of treatment of female incontinence in general practice. 
The British Journal of General Practice  1998;48(436):1735-1738.
BACKGROUND: Urinary incontinence in women can be treated successfully by the general practitioner. However, little is known about the long-term effects of conservative treatment. AIM: To evaluate the long-term effect of treatment of female incontinence by the general practitioner (pelvic floor exercises, and bladder training) in female urinary incontinence. METHOD: A total of 88 women, aged between 20 and 65, who had participated in a controlled trial between 1987 and 1990, were contacted to participate in a five-year follow-up study. Stress incontinence and urge incontinence were treated by means of pelvic floor exercises and bladder training respectively, while a mixed incontinence was treated by bladder training followed by pelvic floor exercises. The outcome measures were a constructed scale for the severity of the incontinence, a seven-day bladder chart, and a questionnaire concerning patients' opinions. All patients were evaluated by an independent researcher. RESULTS: Compared with the one-year follow-up, the number of continent women remained the same, but a significantly greater number of patients worsened. Forty per cent of the women stayed in the same category of severity, while 45% moved into the contiguous categories. The weekly frequency of wet episodes increased significantly, with a mean increase of 2.65 episodes. Women with mixed incontinence were especially prone to relapse in the long-term. Compliance with the exercises had a positive influence on the outcomes, with 67% of the women expressing satisfaction with the results. CONCLUSIONS: Despite a decline in the effect of conservative treatment in the long-term, the majority of the women are satisfied with their treatment. Patient compliance is the key to long-term success.
PMCID: PMC1313263  PMID: 10198479
17.  Testing bronchial hyper-responsiveness: provocation or peak expiratory flow variability? 
BACKGROUND: Assessing bronchial hyper-responsiveness (BHR) is a main diagnostic criterion of asthma. Provocation testing is not readily available in general practice, but peak expiratory flow (PEF) is. Several guidelines promote the use of PEF variability as a diagnostic tool for BHR. This study tested the agreement between histamine challenge testing and PEF variability, and the consequences for diagnosing asthma. AIM: To investigate the possibility of assessing BHR by PEF variability, using a histamine provocation test as a reference. METHOD: Subjects with signs of symptoms indicating asthma (persistent or recurrent respiratory symptoms or signs of reversible bronchial obstruction) (n = 323) were studied. They had been identified in a population screening for asthma. A histamine provocation test and PEF variability were assessed over a three-week period. Asthma was defined as signs or symptoms together with a reversible airflow obstruction or BHR to the histamine challenge test. BHR was defined as a PC20 histamine of < or = 8 mg/ml or a PEF variability of > or = 15%. Overall correlation between PC20 and PEF variability was calculated using Spearman's rho. Furthermore, a decision tree was constructed to clarify the role of BHR in diagnosing asthma. RESULTS: Thirty-two patients had a reversibility in forced expiratory volume in 1 second (FEV1) of > or = 9% predicted, 131 patients showed a PC20 of < or = 8 and 11 patients had a PEF variability of > or = 15%. Overall correlation was poor at only -0.27 (P < 0.0001). One hundred and fourteen of the 131 patients diagnosed as having asthma when the histamine challenge test was used were not diagnosed by PEF variability. CONCLUSION: PEF variability cannot replace bronchial provocation testing in assessing BHR. This indicates that PEF variability and bronchial provocation do not measure the same aspects of BHR. If BHR testing is required in diagnosing asthma, a bronchial provocation test has to be used in general practice as well.
PMCID: PMC1313077  PMID: 9302787
18.  Spirometry in general practice: the performance of practice assistants scored by lung function technicians. 
Recently, spirometers have become available for use within general practice as an alternative to peak flow meters. This study investigates whether practice assistants, after comprehensive training, can effectively carry out spirometry with patients suffering from asthma and other chronic obstructive pulmonary diseases. A scoring system, consisting of 20 items, was devised to determine the effectiveness of the assistants' instructions and to assess the patient's subsequent use of the spirometer. About half the instructions and half the patient performance items were considered to be carried out satisfactorily.
PMCID: PMC1312874  PMID: 9115793
19.  Home birth. 
BMJ : British Medical Journal  1996;313(7068):1276-1277.
PMCID: PMC2352708  PMID: 8942683
25.  Relationship between practice organization and cardiovascular risk factor recording in general practice. 
The British Journal of General Practice  1998;48(428):1054-1058.
BACKGROUND: Research findings suggest that the level of cardiovascular risk factor recording in general practice is not yet optimal. Several studies indicate a relation between the organization of cardiovascular disease prevention at practice level and cardiovascular risk factor recording. AIM: To explore the relation between the organization of cardiovascular disease prevention and risk factor recording in general practice. METHOD: A cross-sectional study was conducted using data on adherence to selected practice guidelines and on cardiovascular risk factor recording from 95 general practices. Practice guidelines were developed beforehand in a consensus procedure. Adherence was assessed by means of a questionnaire and practice observations. Risk factor recording was assessed by an audit of 50 medical records per practice. RESULTS: Factor analysis of risk factor recording revealed three dimensions explaining 76% of the variance: recording of health-related behaviour, recording of clinical parameters, and recording of medical background parameters. Adherence to the guideline 'proactively invite patients to attend for assessment of cardiovascular risk' was related to a higher recording level in all three dimensions. Practice characteristics did not show a consistent relationship to the level of risk factor recording. CONCLUSION: This study indicates that the presence of a system of proactive invitation was related to the recording of cardiovascular risk factors in medical records in general practice.
PMCID: PMC1410003  PMID: 9624746

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