Eloy van de Lisdonk

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.

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.

Setting and registry characteristics affect the prevalence and nature of multimorbidity in the elderly

OBJECTIVE The aim of the study was to investigate how settings and registry characteristics affect the prevalence and nature of multimorbidity in elderly individuals. STUDY DESIGN AND SETTING We used data from three population-based studies, two general practitioner registries, one hospital discharge register, and one nursing home registry to estimate the prevalence of multimorbidity. Individuals aged 55 years and over were included. RESULTS Multimorbidity was most prevalent in nursing homes (82%), followed by the general population and general practitioner registries (56%-72%) and the hospital setting (22%). There were large differences in the nature of multimorbidity between settings. Combinations of hypertension, heart disease, and osteoarthritis were dominant in the population-based setting, whereas hypertension in combination with osteoarthritis, obesity, disorders of lipid metabolism, and diabetes dominated in the general practitioner setting. In the hospital setting, combinations of heart diseases had the highest prevalence. Combinations of dementia, hypertension, and stroke were dominant within the nursing home setting. CONCLUSION This study shows that setting and registry characteristics have an important influence on the outcome of multimorbidity studies. We recommend provision of at least information about the setting, the (list of) conditions included, the data collection method, and the time frame used, when reporting about the size and nature of multimorbidity.

Detecting Somatoform Disorders in Primary Care With the PHQ-15

PURPOSE Because recognition and management of patients with somatoform disorders are difficult, we wanted to determine the specificity, sensitivity, and the test-retest reliability of the 15-symptom Patient Health Questionnaire (PHQ-15) for detection of somatoform disorders in a high-risk primary care population. METHODS We studied the performance of the PHQ-15 in comparison with the Structured Clinical Interview for the Diagnostic and Statistical Manual-IV Axis I disorders (SCID-I) as a reference standard. From January through September 2006, we approached patients for participation. This study was conducted in primary care settings in the Netherlands. Patients aged between 18 and 70 years were eligible if they belonged to 1 or more of the following groups: (1) patients with unexplained somatic complaints, (2) frequent attenders, and (3) patients with mental health problems. For the SCID-I interview we invited all patients with a PHQ-15 score of 6 or greater and a random sample of 30% of patients with a PHQ-15 score of less than 6. The primary study outcomes were the sensitivity and specificity for the validity and the κ coefficient for the test-retest reliability. RESULTS Of 2,147 eligible patients, 906 (42%) participated (mean age 48 years, 62% female). At a cutoff level of 3 or more severe somatic symptoms during the past 4 weeks, sensitivity was 78% and specificity 71%. The test-retest reliability was 0.60. CONCLUSIONS The PHQ-15 is a valid and moderately reliable questionnaire for the detection of patients in a primary care setting at risk for somatoform disorders.

The accuracy of Patient Health Questionnaire-9 in detecting depression and measuring depression severity in high-risk groups in primary care.

OBJECTIVE Only half of patients with depressive disorder are diagnosed by their family physicians. Screening in high-risk groups might reduce this hidden morbidity. This study aims to determine the accuracy of the Patient Health Questionnaire-9 (PHQ-9) in (a) screening for depressive disorder, (b) diagnosing depressive disorder and (c) measuring the severity of depressive disorder in groups that are at high risk for depressive disorder. METHOD We compared the performance of the PHQ-9 as a screening instrument and as a diagnostic instrument to that of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) interview, which we used as reference standard. Three high-risk groups of patients were selected: (a) frequent attenders, (b) patients with mental health problems and (c) patients with unexplained complaints. Patients completed the PHQ-9. Next, patients who were at risk for depression (based on PHQ scores) and a random sample of 20% of patients who were not at risk were selected for a second PHQ-9 and the reference standard (SCID-I). We assessed the adequacy of the PHQ-9 as a tool for severity measurement by comparing PHQ-9 scores with scores on the 17-item Hamilton Depression Rating Scale (HDRS-17) in patients diagnosed with a depressive disorder. RESULTS Among 440 patients, both PHQ-9 and SCID-I were analyzed. The test characteristics for screening were sensitivity=0.93 and specificity=0.85; those for diagnosing were sensitivity=0.68 and specificity=0.95. The positive likelihood ratio for diagnosing was 14.2. The HDRS-17 was administered in 49 patients with depressive disorder. The Pearson correlation coefficient of the PHQ-9 to the HDRS-17 was r=.52 (P<.01). CONCLUSION The PHQ-9 performs well as a screening instrument, but in diagnosing depressive disorder, a formal diagnostic process following the PHQ-9 remains imperative. The PHQ-9 does not seem adequate for measuring severity.

Yield of opportunistic targeted screening for type 2 diabetes in primary care: The Diabscreen study

PURPOSE In screening for type 2 diabetes, guidelines recommend targeting high-risk individuals. Our objectives were to assess the yield of opportunistic targeted screening for type 2 diabetes in primary care and to assess the diagnostic value of various risk factors. METHODS In 11 family practices (total practice population = 49,229) in The Netherlands, we conducted a stepwise opportunistic screening program among patients aged 45 to 75 years by (1) identifying high-risk individuals (=1 diabetes risk factor) and low-risk individuals using the electronic medical record, (2) obtaining a capillary fasting plasma glucose measurement, repeated on a separate day if the value was greater than 110 mg/dL, and (3) obtaining a venous sample if both capillary fasting plasma glucose values were greater than 110 mg/dL and at least 1 sample was 126 mg/dL or greater. We calculated the yield (percentage of invited patients with undiagnosed diabetes), number needed to screen (NNS), and diagnostic value of the risk factors (odds ratio and area under the receiver operating characteristic curve). RESULTS We invited for a first capillary measurement 3,724 high-risk patients seen during usual care and a random sample of 465 low-risk patients contacted by mail. The response rate was 90% and 86%, respectively. Ultimately, 101 high-risk patients (2.7%; 95% confidence interval [CI], 2.2%–3.3%; NNS = 37) and 2 low-risk patients (0.4%; 95% CI, 0.1%–1.6%; NNS = 233) had undiagnosed diabetes (P <.01). The prevalence of diabetes among patients 45 to 75 years old increased from 6.1% to 6.8% as a result. Among diagnostic models containing various risk factors, a model containing obesity alone was the best predictor of undiagnosed diabetes (odds ratio = 3.2; 95% CI, 2.0–5.2; area under the curve=0.63). CONCLUSIONS The yield of opportunistic targeted screening was fair; obesity alone was the best predictor of undiagnosed diabetes. Opportunistic screening for type 2 diabetes in primary care could target middle-aged and older adults with obesity.

Screening for depression in high-risk groups: prospective cohort study in general practice

BACKGROUND Currently only about half of the people who have major depressive disorder are detected during regular health care. Screening in high-risk groups might be a possible solution. AIMS To evaluate the effectiveness of selective screening for major depressive disorder in three high-risk groups in primary care: people with mental health problems, people with unexplained somatic complaints and people who frequently attend their general practitioner. METHOD Prospective cohort study among 2005 people in high-risk groups in three health centres in The Netherlands. RESULTS Of the 2005 people identified, 1687 were invited for screening and of these 780 participated. Screening disclosed 71 people with major depressive disorder: 36 (50.7%) already received treatment, 14 (19.7%) refused treatment and 4 individuals did not show up for an appointment. As a final result of the screening, 17 individuals (1% of 1687) started treatment for major depressive disorder. CONCLUSIONS Screening for depression in high-risk populations does not seem to be effective, mainly because of the low rates of treatment initiation, even if treatment is freely and easily accessible.

The design of the Dutch EASYcare study: a randomised controlled trial on the effectiveness of a problem-based community intervention model for frail elderly people [NCT00105378]

BackgroundBecause of their complex clinical presentations and needs frail elderly people require another approach than people who age without many complications. Several inpatient geriatric health services have proven effectiveness in frail persons. However, the wish to live independently and policies that promote independent living as an answer to population aging call for community intervention models for frail elderly people. Maybe models such as preventive home visits, comprehensive geriatric assessment, and intermediate care qualify, but their efficacy is controversial, especially in frail elderly persons living in the community. With the Dutch EASYcare Study Geriatric Intervention Programme (DGIP) we developed a model to study effectiveness of problem based community intervention models in frail elderly people.Methods/DesignDGIP is a community intervention model for frail elderly persons where the GP refers elderly patients with a problem in cognition, mood, behaviour, mobility, and nutrition. A geriatric specialist nurse applies a guideline-based intervention with a limited number of follow up visits. The intervention starts with the application of the EASYcare instrument for geriatric screening. The EASYcare instrument assesses (instrumental) activities of daily life, cognition, mood, and includes a goal setting item. During the intervention the nurse regularly consults the referring GP and a geriatrician. Effects on functional performance (Groningen Activity Restriction Scale), health related quality of life (MOS-20), and carer burden (Zarit Burden Interview) are studied in an observer blinded randomised controlled trial. 151 participants were randomised over two treatment arms – DGIP and regular care – using pseudo cluster randomisation. We are currently performing the follow up visits. These visits are planned three and six months after inclusion. Process measures and cost measures will be recorded. Intention to treat analyses will focus on post intervention differences between treatment groups.DiscussionThe design of a trial evaluating the effects of a community intervention model for frail elderly people was presented. The problem-based participant selection procedure satisfied; few patients that the GP referred did not meet our eligibility criteria. The use of standard terminology makes detailed insight into the contents of our intervention possible using terminology others can understand well.

Vascular outcomes in patients with screen-detected or clinically diagnosed type 2 diabetes: Diabscreen study follow-up

PURPOSE Screening guidelines for type 2 diabetes recommend targeting high-risk individuals. Our objective was to assess whether diagnosis of type 2 diabetes based on opportunistic targeted screening results in lower vascular event rates compared with diagnosis on the basis of clinical signs or symptoms. METHODS In a prospective, nonrandomized, observational study, we enrolled patients aged 45 to 75 years from 10 family practices in the Netherlands with a new diagnosis of type 2 diabetes, detected either by (1) opportunistic targeted screening (n = 359) or (2) clinical signs or symptoms (n = 206). Patients in both groups received the same guideline-concordant diabetes care. The main group outcome measure was a composite of death from cardiovascular disease (CVD), nonfatal myocardial infarction, and nonfatal stroke. RESULTS Baseline vascular disease was more prevalent in the opportunistic targeted screening group, mainly ischemic heart disease (12.3% vs 3.9%, P = .001) and nephropathy (16.9% vs 7.1%, P = .002). After a mean follow-up of 7.7 years (SD = 2.4 years) and 7.1 years (SD = 2.7 years) for the opportunistic targeted screening and clinical diagnosis groups, respectively, composite primary event rates did not differ significantly between the 2 groups (9.5% vs 10.2%, P = .78; adjusted hazard ratio 0.67, 95% confidence interval, 0.36-1.25; P = .21). There were also no significant differences in the separate event rates of deaths from CVD, nonfatal myocardial infarction, and nonfatal strokes. CONCLUSIONS Opportunistic targeted screening for type 2 diabetes detected patients with higher CVD morbidity at baseline when compared with clinical diagnosis but showed similar CVD mortality and major CVD morbidity after 7.7 years. Opportunistic targeted screening and guided care appears to improve vascular outcomes in type 2 diabetes in primary care.

The effect on caregiver burden of a problem-based home visiting programme for frail older people

OBJECTIVE caregiver effects of geriatric care models focusing primarily at the patient have not been consistently studied. We studied caregiver effects of a nurse-led comprehensive geriatric evaluation and management (GEM) programme for community-dwelling frail older people that showed-in a randomised comparison with usual care--health-related quality of life benefits for the care receivers. METHODS this randomised trial included 110 caregiver/patient dyads who were followed up for 6 months. Primary analyses were intention-to-treat analyses of caregiver burden assessed with Zarit Burden Interview (ZBI; 0-88; higher means more burden). Preplanned subgroup analyses were conducted for cognition, living arrangement and patient/caregiver co-residence. RESULTS overall, perceived caregiver burden showed no significant differences between study groups in changes over time. However, perceived burden was at baseline more than eight points higher in caregivers sharing a household with patients (n = 23) compared to caregivers living separately (n = 87). The intervention performed better in caregivers living together with the patient than in caregivers living separately (P for interaction = 0.04). Co-resident caregivers experienced six-Zarit point improvement compared with four-point deterioration in the non-co-resident caregivers. CONCLUSIONS GEM at home benefited patients, but maybe not caregivers. Caregiver effects are related to whether caregivers live with the patient or not.