Inappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users.
We have designed a cluster randomized controlled clinical trial to assess the (cost-) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care.
We will select all patients using antidepressants for over 9 months from 45 general practices. Patients will be diagnosed using the Composite International Diagnostic Interview (CIDI) version 3.0, extended with questions about the psychiatric history and previous treatment strategies. General practices will be randomized to either the intervention or the control group. In case of overtreatment, defined as the absence of a proper indication according to current guidelines, a cessation advice is given to the general practitioner. In the control groups no specific information is given. The primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up. Secondary outcomes are dimensional measures of psychopathology and costs.
This study protocol provides a detailed overview of the design of the trial. Study results will be of importance for refining current guidelines. If the intervention is effective it can be used in managed care programs.
Depression; Anxiety; Composite International Diagnostic Interview (CIDI); Randomized controlled trial; General practice; Depressive disorder; Anxiety disorders
Evidence-based diabetes guidelines generally neglect comorbidity, which may interfere with diabetes management. The prevalence of comorbidity described in patients with type 2 diabetes (T2D) shows a wide range depending on the population selected and the comorbid diseases studied. This exploratory study aimed to establish comorbidity rates in an unselected primary-care population of patients with T2D.
This was a cohort study of 714 adult patients with newly diagnosed T2D within the study period (1985-2007) in a practice-based research network in the Netherlands. The main outcome measures were prevalence and incidence density rates of chronic comorbid diseases and disease clusters. All chronic disease episodes registered in the practice-based research network were considered as comorbidities. We categorised comorbidity into 'concordant' (that is, shared aetiology, risk factors, and management plans with diabetes) and 'discordant' comorbidity. Prevalence and incidence density were assessed for both categories of comorbidity.
The mean observation period was 17.3 years. At the time of diabetes diagnosis, 84.6% of the patients had one or more chronic comorbid disease of 'any type', 70.6% had one or more discordant comorbid disease, and 48.6% and 27.2% had three or more chronic comorbid diseases of 'any type' or of 'discordant only', respectively. A quarter of those without any comorbid disease at the time of their diabetes diagnosis developed at least one comorbid disease in the first year afterwards. Cardiovascular diseases (considered concordant comorbidity) were the most common, but there were also high rates of musculoskeletal and mental disease. Discordant comorbid diseases outnumbered concordant diseases.
We found high prevalence and incidence density rates for both concordant and discordant comorbidity. The latter may interfere with diabetes management, thus future research and clinical practice should take discordant comorbidity in patients with T2D into account.
type 2 diabetes; comorbidity; primary care; prevalence; incidence
Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6–11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care.
This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved.
This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in primary and specialized care for paediatric asthma in the Netherlands will be recommended.
This study is registered by clinicaltrial.gov (NCT01109745)
Asthma; Quality of life; Children; Primary care; Specialized care; Self-management; Randomized controlled trial (RCT)
Unexplained symptoms are associated with depression and anxiety. This association is largely based on cross-sectional research of symptoms experienced by patients but not of symptoms presented to the GP.
To investigate whether unexplained symptoms as presented to the GP predict mental disorders.
Design and setting
Cross-sectional and longitudinal analysis of data from a practice-based research network of GPs, the Transition Project, in the Netherlands.
All data about contacts between patients (n = 16 000) and GPs (n = 10) from 1997 to 2008 were used. The relation between unexplained symptoms episodes and depression and anxiety was calculated and compared with the relation between somatic symptoms episodes and depression and anxiety. The predictive value of unexplained symptoms episodes for depression and anxiety was determined.
All somatoform symptom episodes and most somatic symptom episodes are significantly associated with depression and anxiety. Presenting two or more symptoms episodes gives a five-fold increase of the risk of anxiety or depression. The positive predictive value of all symptom episodes for anxiety and depression was very limited. There was little difference between somatoform and somatic symptom episodes with respect to the prediction of anxiety or depression.
Somatoform symptom episodes have a statistically significant relation with anxiety and depression. The same was true for somatic symptom episodes. Despite the significant odds ratios, the predictive value of symptom episodes for anxiety and depression is low. Consequently, screening for these mental health problems in patients presenting unexplained symptom episodes is not justified in primary care.
anxiety; depression; mental health; primary care; somatisation; symptoms, unexplained
Communication is a key competence for health care professionals. Analysis of registrar and GP communication performance in daily practice, however, suggests a suboptimal application of communication skills. The influence of context factors could reveal why communication performance levels, on average, do not appear adequate. The context of daily practice may require different skills or specific ways of handling these skills, whereas communication skills are mostly treated as generic. So far no empirical analysis of the context has been made. Our aim was to identify context factors that could be related to GP communication.
A purposive sample of real-life videotaped GP consultations was analyzed (N = 17). As a frame of reference we chose the MAAS-Global, a widely used assessment instrument for medical communication. By inductive reasoning, we analyzed the GP behaviour in the consultation leading to poor item scores on the MAAS-Global. In these cases we looked for the presence of an intervening context factor, and how this might explain the actual GP communication behaviour.
We reached saturation after having viewed 17 consultations. We identified 19 context factors that could potentially explain the deviation from generic recommendations on communication skills. These context factors can be categorized into doctor-related, patient-related, and consultation-related factors.
Several context factors seem to influence doctor-patient communication, requiring the GP to apply communication skills differently from recommendations on communication. From this study we conclude that there is a need to explicitly account for context factors in the assessment of GP (and GP registrar) communication performance. The next step is to validate our findings.
A growing number of prognostic indices for chronic obstructive pulmonary disease (COPD) is developed for clinical use. Our aim is to identify, summarize and compare all published prognostic COPD indices, and to discuss their performance, usefulness and implementation in daily practice.
We performed a systematic literature search in both Pubmed and Embase up to September 2010. Selection criteria included primary publications of indices developed for stable COPD patients, that predict future outcome by a multidimensional scoring system, developed for and validated with COPD patients only. Two reviewers independently assessed the index quality using a structured screening form for systematically scoring prognostic studies.
Of 7,028 articles screened, 13 studies comprising 15 indices were included. Only 1 index had been explored for its application in daily practice. We observed 21 different predictors and 7 prognostic outcomes, the latter reflecting mortality, hospitalization and exacerbation. Consistent strong predictors were FEV1 percentage predicted, age and dyspnoea. The quality of the studies underlying the indices varied between fairly poor and good. Statistical methods to assess the predictive abilities of the indices were heterogenic. They generally revealed moderate to good discrimination, when measured. Limitations: We focused on prognostic indices for stable disease only and, inevitably, quality judgment was prone to subjectivity.
We identified 15 prognostic COPD indices. Although the prognostic performance of some of the indices has been validated, they all lack sufficient evidence for implementation. Whether or not the use of prognostic indices improves COPD disease management or patients' health is currently unknown; impact studies are required to establish this.
COPD; index; multidimensional; prognosis
Patient safety can be at stake in both hospital and general practice settings. While severe patient safety incidents have been described, quantitative studies in large samples of patients in general practice are rare. This study aimed to assess patient safety in general practice, and to show areas where potential improvements could be implemented.
We conducted a retrospective review of patient records in Dutch general practice. A random sample of 1,000 patients from 20 general practices was obtained. The number of patient safety incidents that occurred in a one-year period, their perceived underlying causes, and impact on patients' health were recorded.
We identified 211 patient safety incidents across a period of one year (95% CI: 185 until 241). A variety of types of incidents, perceived causes and consequences were found. A total of 58 patient safety incidents affected patients; seven were associated with hospital admission; none resulted in permanent disability or death.
Although this large audit of medical records in general practices identified many patient safety incidents, only a few had a major impact on patients' health. Improving patient safety in this low-risk environment poses specific challenges, given the high numbers of patients and contacts in general practice.
Depression is highly prevalent in advanced cancer patients, but the diagnosis of depressive disorder in patients with advanced cancer is difficult. Screening instruments could facilitate diagnosing depressive disorder in patients with advanced cancer. The aim of this study was to determine the validity of the Beck Depression Inventory (BDI-II) and a single screening question as screening tools for depressive disorder in advanced cancer patients.
Patients with advanced metastatic disease, visiting the outpatient palliative care department, were asked to fill out a self-questionnaire containing the Beck Depression Inventory (BDI-II) and a single screening question “Are you feeling depressed?” The mood section of the PRIME-MD was used as a gold standard.
Sixty-one patients with advanced metastatic disease were eligible to be included in the study. Complete data were obtained from 46 patients. The area under the curve of the receiver operating characteristics analysis of the BDI-II was 0.82. The optimal cut-off point of the BDI-II was 16 with a sensitivity of 90% and a specificity of 69%. The single screening question showed a sensitivity of 50% and a specificity of 94%.
The BDI-II seems an adequate screening tool for a depressive disorder in advanced cancer patients. The sensitivity of a single screening question is poor.
Depression; Advanced cancer; Validation; Screening tool; BDI-II
Changes in the burden of chronic obstructive pulmonary disease (COPD) and its exacerbations on primary health care are not well studied.
To identify trends in the prevalence of physician-diagnosed COPD and exacerbation rates by age, sex, and socioeconomic status in a general practice population.
Design of study
Trend analysis of COPD data from a 27-year prospective cohort of a dynamic general practice population.
Data were taken from the Continuous Morbidity Registration Nijmegen.
For the period 1980–2006, COPD and COPD exacerbation data were extracted for patients aged ≥40 years. Data were standardised for the composition of the Continuous Morbidity Registration population in the year 2000. Regression coefficients for trends were estimated by sex, age, and socioeconomic status. Rate ratios were calculated for prevalence differences in different demographic subgroups.
During the study period, the overall COPD prevalence decreased from 72.7 to 54.5 per 1000 patients per year. The exacerbation rate decreased from 44.1 to 31.5 per 100 patients, and the percentage of patients with COPD who had exacerbations declined from 27.6% to 21.0%. The prevalence of COPD increased significantly in women, in particular those aged ≥65 years with low socioeconomic status. Decreases in exacerbation rates and percentages of patients with exacerbations were independent of sex, age, and socioeconomic status.
The decline in COPD prevalence and exacerbation rates suggests a reduction of the burden on Dutch primary care. The increase of the prevalence in women indicates a need to focus on this particular subgroup in COPD management and research.
chronic obstructive pulmonary disease; family practice; prevalence; trends
The oral prednisolone test is widely used to distinguish chronic obstructive pulmonary disease (COPD) patients who might benefit from inhaled steroid treatment. Previous studies used selected patient groups that did not represent the large COPD population in primary care.
The study included smokers and exsmokers with chronic bronchitis or COPD from primary care, who underwent prednisolone testing (30 mg for 14 days) before randomization in a three-year follow-up randomized controlled trial (COOPT Study). Spirometry was performed before and after the test. Responders and nonresponders were classified according to international criteria. Effectiveness of inhaled fluticasone relative to placebo was compared in terms of health status (Chronic Respiratory Disease Questionnaire), exacerbations, and postbronchodilator forced expiratory volume in one second (FEV1), using repeated measurement analysis.
Two hundred eighty-six patients recruited from 44 primary care practices were randomized. Nine percent to 16% of the COPD population was classified as responder, depending on the international guideline criteria used. On average, responders did not reach the minimum clinically important difference in health status (0.29 points/year, P = 0.05), although a borderline significant effect of inhaled fluticasone was noted. Possible clinically relevant reductions in exacerbation rate (rate ratio 0.67) and FEV1 decline (39 mL/year) occurred in responders, but did not reach statistical significance.
Oral steroid testing identifies a limited proportion of COPD patients, but does not reveal any clinically relevant benefit from inhaled steroid treatment on health status. No significant effects on exacerbation rate and lung function decline occurred.
COPD; primary care; oral steroid testing; prednisolone test
Persistent presentation of medically unexplained symptoms (MUS) is troublesome for general practitioners (GPs) and causes pressure on the doctor-patient relationship. As a consequence, GPs face the problem of establishing an ongoing, preferably effective relationship with these patients. This study aims at exploring GPs' perceptions about explaining MUS to patients and about how relationships with these patients evolve over time in daily practice.
A qualitative approach, interviewing a purposive sample of twenty-two Dutch GPs within five focus groups. Data were analyzed according to the principles of constant comparative analysis.
GPs recognise the importance of an adequate explanation of the diagnosis of MUS but often feel incapable of being able to explain it clearly to their patients. GPs therefore indicate that they try to reassure patients in non-specific ways, for example by telling patients that there is no disease, by using metaphors and by normalizing the symptoms. When patients keep returning with MUS, GPs report the importance of maintaining the doctor-patient relationship. GPs describe three different models to do this; mutual alliance characterized by ritual care (e.g. regular physical examination, regular doctor visits) with approval of the patient and the doctor, ambivalent alliance characterized by ritual care without approval of the doctor and non-alliance characterized by cutting off all reasons for encounter in which symptoms are not of somatic origin.
GPs feel difficulties in explaining the symptoms. GPs report that, when patients keep presenting with MUS, they focus on maintaining the doctor-patient relationship by using ritual care. In this care they meticulously balance between maintaining a good doctor-patient relationship and the prevention of unintended consequences of unnecessary interventions.
The recognition and treatment of depressive- and anxiety disorders is not always in line with current standards. The results of programs to improve the quality of care, are not encouraging. Perhaps these programs do not match with the problems experienced in family practice. This study aims to systematically explore how FPs perceive recognition, diagnosis and management of depressive and anxiety disorders.
focus group discussions with FPs, qualitative analysis of transcriptions using thematic coding.
The FPs considered recognising, diagnosing and managing depressive- and anxiety disorders as an important task. They expressed serious doubts about the validity and usefulness of the DSM IV concept of depressive and anxiety disorders in family practice especially because of the high frequency of swift natural recovery. An important barrier was that many patients have difficulties in accepting the diagnosis and treatment with antidepressant drugs. FPs lacked guidance in the assessment of patients' burden. The FPs experienced they had too little time for patient education and counseling. The under capacity of specialised mental health care and its minimal collaboration with FPs were experienced as problematic. Valuable suggestions for solving the problems encountered were made
Next to serious doubts regarding the diagnostic concept of depressive- and anxiety disorders a number of factors were identified which serve as barriers for suitablemental health care by FPs. These doubts and barriers should be taken into account in future research and in the design of interventions to improve mental health care in family practice.
The validity and usefulness of incident reporting and other methods for identifying adverse events remains unclear. This study aimed to compare five methods in general practice.
In a prospective observational study, with five general practitioners, five methods were applied and compared. The five methods were physician reported adverse events, pharmacist reported adverse events, patients' experiences of adverse events, assessment of a random sample of medical records, and assessment of all deceased patients.
A total of 68 events were identified using these methods. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. No overlap between the methods was detected. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number.
A mix of methods is needed to identify adverse events in general practice.
Supporting self-management intends to improve life-style, which is beneficial for patients with mild osteoarthritis (OA). We evaluated a nurse-based intervention on older OA patients' self-management with the aim to assess its effects on mobility and functioning.
Randomized controlled trial of patients (≥ 65 years) with mild hip or knee OA from nine family practices in the Netherlands. Intervention consisted of supporting patients' self-management of OA symptoms using a practice-based nurse. Outcome measures were patients' mobility, using the Timed Up and Go test (TUG), and patient reported functioning, using an arthritis specific scale (Dutch AIMS2 SF).
Fifty-one patients were randomized to the intervention group and 53 to the control group. Patient-reported functioning improved on four scales in the intervention group compared to one scale in the control group. However, this result was not significant. Mobility improved in both groups, without a significant difference between the two groups. There were no differences between the groups regarding consultations with family physicians or physiotherapists, or medication use.
A nurse-based intervention on older OA patients' self-management did not improve self-reported functioning, mobility or patients' use of health care resources.
As morbidity registrations generally do not make distinct first and following myocardial infarctions, it is still unclear as to what extent the falling rates of myocardial infarctions are caused by lower incidences of first myocardial infarctions.
To investigate the incidence of first myocardial infarctions in a general practice population.
Data were taken from the Continuous Morbidity Registration (CMR) Nijmegen, which has been collecting data from four general practices since 1971. For the 1975–2003 period, sex-specific and age-specific yearly incidence rates were obtained from the registration data of the CMR. Trends were studied with Poisson regression.
During the study period, 827 patients with a first myocardial infarction were identified. The incidence of first myocardial infarctions has declined since 1986 to 2.1 per 1000 for men and to 1.5 per 1000 for women. The average age of getting a first myocardial infarction increased with 3 years for men and slightly decreased for women. Since 1986, the incidence of sudden cardiac death from a first myocardial infarction has considerably declined for men and women to 0.9 and 0.7 per 1000 respectively.
A slight, significant, decline in incidence of first myocardial infarctions was found. From the mid eighties a mean annual decline of 3.5% in death from first myocardial infarction was observed. Though the variance in rates of coronary heart diseases is not unambiguous, this may indicate an effect of primary prevention. The decline was more pronounced in men, with an increasing age of getting a first myocardial infarction.
epidemiology; family practice; myocardial infarction; vital statistics