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D van der Heijde

Publications and source records attributed to D van der Heijde.

At least 73 records · Page 4Linked to original sources
PubMed2002

Reliability of self assessed joint counts in ankylosing spondylitis.

OBJECTIVE: To determine the reliability of self reported joint counts to assess pain or swelling in ankylosing spondylitis (AS). METHODS: 217 outpatients fulfilling the modified New York criteria for AS were asked to mark painful joints and swollen joints on two mannequins presenting 44 and 40 joints respectively. A doctor or research nurse assessed the same joints for pain and swelling on the same day, after completion by the patient, without information on the results of the patient's assessment. RESULTS: Forty six (21%) patients reported one or more swollen joints (mean number of swollen joints 0.5, range 0-8); the doctor found one or more swollen joints in 54 (25%) of the patients (mean number of swollen joints 0.8, range 0-31). The overall agreement on the number of swollen joints between patients and doctor was moderate (intraclass correlation coefficient (ICC) 0.53). Agreement on individual swollen joints was poor to moderate (kappa 0.1-0.64). 128 (60%) patients reported tender joints (mean number of joints 2.4, range 0-26). The doctors reported one of more tender joints in 50% of the patients (mean number of tender joints 2.2, range 0-34). The overall agreement was also moderate (ICC 0.71). The agreement on individual tender joints was again poor to moderate (kappa 0.19-0.43). There was only high concordance between doctors and patients on the absence of swollen joints (82%). The concordance on the presence of monoarthritis, oligoarthritis, or polyarthritis was low (17-22%). CONCLUSION: Owing to these discrepancies in assessment of individual joints and total number of affected joints, joint counts in AS assessed by doctors cannot be replaced by joint counts reported by the patients. Patients are only able to judge if their joints are not swollen.

Adolescent↗
PubMed2002

Staging of patients with ankylosing spondylitis: a preliminary proposal.

Patients with ankylosing spondylitis (AS) are characterised by a wide range of clinical presentations, radiographic profiles, and outcomes, which are not well differentiated by current diagnostic and classification systems for the disorder. Inadequacies in these systems may limit clinicians' ability to manage their patients with AS appropriately and act as an obstacle to reasonable comparison of therapeutic trial results. A standardised staging system for AS is therefore proposed that would provide a more detailed categorisation of patients based on assessment of structural damage, peripheral joint and organ involvement, presence of concomitant diseases, and the severity and extent of disease activity and functional impairment. The proposed system needs to be evaluated closely and amended as needed to assure its usefulness in clinical and research settings.

Anti-Inflammatory Agents↗
PubMed2002

Treatment trials in ankylosing spondylitis: current and future considerations.

Emerging treatment options in ankylosing spondylitis (AS) are giving new hope to patients with this chronic and potentially disabling disease. Clinical development of new treatments requires that rigorous and well controlled trials be conducted to demonstrate safety and efficacy. A number of classification systems have been developed in recent years as a result of enhanced understanding of the pathogenesis of AS. Although new outcome measures have been developed and a consensus has been reached on the use of assessment instruments in clinical trials, there is still need for improvement and implementation. The ASsessments in Ankylosing Spondylitis (ASAS) Working Group has addressed some of these dilemmas by establishing a core set of domains for the evaluation of AS and by selecting specific assessment methods for each domain. They have also published improvement criteria for assessing short term improvement with symptom modifying antirheumatic drugs and are presently in the process of developing response criteria for disease controlling antirheumatic treatment. Various experts are also currently examining discrepancies and inadequacies of classification systems for AS. Imaging studies, magnetic resonance imaging, in particular, may provide better classification criteria in the near future. In addition to consensus on outcome assessment and classification of AS, lessons learnt from clinical trials in rheumatoid arthritis (RA) may serve as a template for AS. Guidance provided by the United States Food and Drug Administration (FDA) for clinical trials in RA may be of particular use. The FDA has defined the claims that sponsors can receive for RA products and the clinical trial data that would be expected to be submitted to support such claims.

Acute-Phase Proteins↗
PubMed2002

Imaging and scoring in ankylosing spondylitis.

Ankylosing spondylitis (AS) is the prototype of the spondyloarthritides (SpA). AS is a disease subset but also a possible outcome of SpA. Early diagnosis of sacroiliitis, the most frequent clinical symptom frequently accompanied by inflammatory back pain and other inflammatory lesions of the spine such as spondylitis and spondylodiscitis, can be visualized early by magnetic resonance imaging (MRI). Spinal inflammation can be demonstrated by MRI using either the fat-saturating short tau inversion recovery (STIR) technique or by application of the contrast agent gadolinium-diethylenetriamine pentaacetic acid (DTPA). This is especially useful in early and active disease, in young women and in children, and for the differential diagnosis of septic sacroiliitis. Because of the efficacy of the novel biological agents directed against tumour necrosis factor-alpha (TNF-alpha) - such as infliximab and etanercept - in SpA there is a need for spinal imaging techniques more sensitive than conventional X-rays. The available scoring tools are reviewed and novel approaches using MRI are presented.

Adult↗
PubMed2001

Efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis: a six-week controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug.

OBJECTIVE: To evaluate the short-term efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis (AS). METHODS: The study was a 6-week randomized, double-blind, placebo-controlled trial with 3 treatment arms: placebo, ketoprofen 100 mg twice daily, and celecoxib 100 mg twice daily. Patients who had AS according to the modified New York criteria, without peripheral synovitis and with active disease (pain > or =40 mm on a 100-mm visual analog scale [VAS] and an increase in pain of at least 30% after nonsteroidal antiinflammatory drug withdrawal) were eligible for study. Primary outcome measures were change in pain intensity (VAS) and change in functional impairment (Bath Ankylosing Spondylitis Functional Index [BASFI]). RESULTS: Of the 246 randomized patients, 76 were allocated to receive placebo, 90 ketoprofen, and 80 celecoxib. There were no statistically significant differences between treatment groups at study entry. During the 6 weeks of the study, the decrease in pain and functional impairment was greater in the active treatment groups than in the placebo group, with a trend in favor of celecoxib when the 2 active treatments were compared. The mean changes were -13 mm, -21 mm, and -27 mm (P = 0.006) for pain and 1, -6, and -12 (P = 0.0008) for BASFI score in the placebo, ketoprofen, and celecoxib groups, respectively. During treatment, the number of patients reporting epigastric pain was 6 (8%), 13 (14%), and 10 (13%) in the placebo, ketoprofen, and celecoxib groups, respectively. CONCLUSION: The results of this study confirm the clinically relevant antiinflammatory effect of celecoxib at a 200-mg daily dosage, with significant improvement of both pain and function in patients with AS.

Adult↗
PubMed2001

Rhemulatologists' performance in dailiy practice.

OBJECTIVE: To assess rheumatologists' performance for 8 rheumatologic conditions and to explore possible explanatory factors. METHODS: After written informed consent was obtained, 27 rheumatologists (21% of all Dutch rheumatologists) practicing in 16 outpatient departments were each visited by 8 incognito "standardized patients" (SPs). The diagnoses of these 8 cases account for about 23% of all new referred patients in the Netherlands. Results for ordered lab tests as well as real radiographs with corresponding results from a radiologist were simulated. Information from the visits was obtained from the SPs, who completed predefined case-specific checklists, and by collecting data on resource utilization. Feedback was provided. RESULTS: Altogether 254 encounters took place, of which 201 were first visits and 53 were followup visits. SPs were unmasked twice during a visit. There was considerable variation in resource utilization (lab tests and imaging) between cases and between rheumatologists. Mean costs per rheumatologist ranged from US $ 4.67 to $ 65.36 per visit for lab tests and from US $ 33.15 to $ 226.84 per visit for imaging tests. No significant correlations were seen between resource utilization costs and number of years of clinical experience or performance on checklist scores. Rheumatologists with longer experience had lower total item checklist scores (r = -0.47; P < 0.05). CONCLUSION: A considerable variation in resource utilization was found among 27 Dutch rheumatologists. The information obtained is an excellent source for discussion on the appropriateness of care.

Adult↗
PubMed2001

Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis.

OBJECTIVE: To develop criteria for symptomatic improvement in patients with ankylosing spondylitis (AS), using outcome domain data from placebo-controlled clinical trials of nonsteroidal antiinflammatory drugs (NSAIDs). METHODS: Patient data from 5 short-term, randomized, controlled trials were used to assess equivalence, reliability, and responsiveness of multiple items in the 5 outcome domains for AS treatment: physical function, pain, spinal mobility, patient global assessment, and inflammation. At least one measure per domain was responsive (standardized response mean of > 0.5), except for the spinal mobility domain, which was omitted from the criteria. We developed and tested candidate improvement criteria in a random two-thirds subset from the 3 largest trials and used the remaining one-third for validation. These 3 largest trials included 923 patients (631 receiving NSAIDs, 292 in placebo groups). We selected the multiple domain definition that best distinguished NSAID treatment from placebo by chi-square test and that had a placebo response rate of < or = 25%. RESULTS: Candidate definitions were changes in single domains and in multiple measure indices, as well as combinations of improvements in multiple domains. Worsening in a domain was defined as a change for the worse of > or = 20% and a net change for the worse of > or = 10 units on a scale of 0-100. Partial remission (for comparison purposes) was defined as an end-of-trial value of < 20/100 in each of the 4 domains. Among 20 candidate criteria, change of > or = 20% and > or = 10 units in each of 3 domains and absence of worsening in the fourth discriminated best in the development subset (51% of patients improved with NSAIDs, 25% with placebo; chi2 = 36.4, P < 0.001). Results were confirmed in the validation subset. Almost all patients satisfying the definition of partial disease remission at the end of the trial had also improved by this criterion. Among all 923 patients, improvement rates using this criterion were 49% for NSAID-treated patients and 24% for placebo-treated patients. CONCLUSION: Although further validation using data from new trials is still needed, we conclude that we have developed a clinically valid, easy-to-use measure of short-term improvement in AS.

Adult↗
PubMed2001

Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial.

OBJECTIVE: To determine the efficacy of combined spa-exercise therapy in addition to standard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis (AS). METHODS: A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 (mean age 48 +/- 10 years; male:female ratio 25:15) was treated in a spa resort in Bad Hofgastein, Austria; group 2 (mean age 49 +/- 9 years; male:female ratio 28:12) in a spa resort in Arcen, The Netherlands. The control group (mean age 48 +/- 10 years; male:female ratio 34:6) stayed at home and continued their usual drug treatment and weekly group physical therapy during the intervention weeks. Standardized spa-exercise therapy of 3 weeks duration consisted of group physical exercises, walking, correction therapy (lying supine on a bed), hydrotherapy, sports, and visits to either the Gasteiner Heilstollen (Austria) or sauna (Netherlands). After spa-exercise therapy all patients followed weekly group physical therapy for another 37 weeks. Primary outcomes were functional ability, patient's global well-being, pain, and duration of morning stiffness, aggregated in a pooled index of change (PIC). RESULTS: Analysis of variance showed a statistically significant time-effect (P < 0.001) and time-by-treatment interaction (P = 0.004), indicating that the 3 groups differed over time with respect to the course of the PIC. Four weeks after start of spa-exercise therapy, the mean difference in PIC between group 1 and controls was 0.49 (95% confidence interval [CI] 0.16-0.82, P = 0.004) and between group 2 and controls was 0.46 (95% CI 0.15-0.78, P = 0.005). At 16 weeks, the difference between group 1 and controls was 0.63 (95% CI 0.23-1.02, P = 0.002) and between group 2 and controls was 0.34 (95% CI--0.05-0.73; P = 0.086). At 28 and 40 weeks, more improvement was found for group 1 compared with controls (P = 0.012 and P = 0.062, respectively) but not for group 2 compared with controls. CONCLUSION: In patients with AS, a 3-week course of combined spa-exercise therapy, in addition to drug treatment and weekly group physical therapy alone, provides beneficial effects. These beneficial effects may last for at least 40 weeks.

Exercise Therapy↗
PubMed2001

Withdrawal from labour force due to work disability in patients with ankylosing spondylitis.

OBJECTIVE: To investigate withdrawal from the labour force because of inability to work owing to ankylosing spondylitis (AS) and to determine the characteristics of patients with no job because of work disability attributable to AS. METHODS: A postal questionnaire was sent to 709 patients with AS aged 16-60 years followed up by a rheumatologist. Kaplan-Meier survival statistics were used to assess the time lapse between diagnosis and withdrawal from work. Standardised incidence ratios were calculated to compare withdrawal from the labour force in patients with AS and the general population. Determinants of withdrawal were assessed by Cox's proportional hazard regression analysis using variables assumed to be time independent. Cross sectional characteristics of patients without a job owing to disability were further analysed by simple and multiple regression analyses. RESULTS: A total of 658 patients returned the questionnaire. Of 529 patients with a paid job before diagnosis of AS, 5% had left the labour force within the first year after the diagnosis, 13% after 5 years, 21% after 10 years, 23% after 15 years, and 31% after 20 years. Age and sex adjusted risk for withdrawal was 3.1 (95% CI 2.5 to 3.7) times higher than in the general population. In patients with AS, determinants of withdrawal from work were older age at diagnosis, manual work, and coping strategies characterised by limiting or adapting activities. Patients with work disability at the time of the study were older, came from a lower social class, and were more likely to have total hip replacement, peripheral arthritis, or comorbidity. Moreover, they reported worse physical function (BAS-FI), experienced lower quality of life, and more often had extraspinal disease than those with a job. CONCLUSION: Withdrawal from work is 3.1 times higher in patients with AS than expected in the general population. Within patients, higher age at diagnosis, manual work, and unfavourable coping strategies are important determinants of withdrawal. Patients without a job experience a lower quality of life.

Adaptation, Psychological↗
PubMed2001

Employment, work disability, and work days lost in patients with ankylosing spondylitis: a cross sectional study of Dutch patients.

OBJECTIVE: To evaluate employment status, work disability, and work days lost in patients with ankylosing spondylitis (AS). METHODS: A questionnaire was sent to 709 patients with AS aged 16-60. The results of 658 of the patients could be analysed. RESULTS: After adjustment for age, labour force participation was decreased by 15.4% in male patients and 5.2% in female patients compared with the general Dutch population. Work disability (all causes) was 15.7% and 16.9% higher than expected in the general population for male and female patients respectively. In particular, the proportion of those with a partial work disability pension was increased. Patients with a paid job lost 5.0% of work days as the result of having AS, accounting for a mean of 10.1 days of sick leave due to AS per patient per year in addition to the national average of 12.3 unspecified days of sick leave. CONCLUSION: This study on work status in AS provides data adjusted for age and sex, and the differences from the reference population were significant. The impact of AS on employment and work disability is considerable. Work status in patients with AS needs more attention as an outcome measure in future research.

Absenteeism↗
PubMed2001

Radiographic progression in rheumatoid arthritis: does it reflect outcome? Does it reflect treatment?

Although there is clear face validity that structural damage is related to outcome, it is difficult to prove this. Recently, more evidence became available that structural damage, as assessed on plain films, is indeed related to disease activity in clinical trials and therefore can be used to assess the effect of treatment. Also, a relationship between structural damage and outcome, mainly defined as physical disability, was established. Several examples of findings in recent publications are presented which lead to the following conclusions. There is a relation between the response to treatment measured as clinical disease activity and measured as radiographic progression in most clinical therapeutic trials. A strong relation between local inflammation and progression of damage in the individual joint is present. This is robust evidence for the hypothesis that inflammation leads to structural damage. There is a good relation between the damage in small and large joints as assessed on plain films. Damage measured in small joints is a good substitute for overall damage. Disease activity is always strongly correlated with functional disability throughout the disease course. There is an increasing relation between disability and structural damage with increasing disease duration.

Arthritis, Rheumatoid↗
PubMed2001

Recent rheumatoid arthritis clinical trials using radiographic endpoints--updated research agenda.

Recent randomized controlled trials of traditional and newly developed therapies provide evidence that we have interventions that potentially slow or prevent structural damage in active rheumatoid arthritis, as measured using radiography. These trials also provide a unique opportunity for exploratory data analysis to generate hypotheses apropos the pathogenesis and determinants of radiographic progression and functional disability; they also facilitate further study of the methodological issues regarding imaging measurement.

Arthritis, Rheumatoid↗
PubMed2001

Foundations of the minimal clinically important difference for imaging.

This article develops a generic conceptual framework for defining and validating the concept of minimal clinically important difference. We propose 3 approaches. The first uses statistical descriptions of the population ("distribution based"), the second relies on experts ("opinion based"), and a third is based on sequential hypothesis formation and testing ("predictive/data driven based"). The first 2 approaches serve as proxies for the third, which is an experimentally driven approach, asking such questions as "What carries the least penalty?" or "What imparts the greatest gain?" As an experimental approach, it has the expected drawbacks, including the need for greater resources, and the need to tolerate trial and error en route, compared to the other 2 models.

Arthritis, Rheumatoid↗
PubMed2001

Reliability of measures of disease activity and disease damage in rheumatoid arthritis: implications for smallest detectable difference, minimal clinically important difference, and analysis of treatment effects in randomized controlled trials.

We evaluate measurement properties of common rheumatoid arthritis (RA) assessments. Included are a comprehensive literature review and new data on the reliability and smallest detectable difference (SDD) for different classes of these measures. We found that certain common measures such as joint counts, pain, and patient global all had poor reliability and showed large SDD compared to multi-item measures of physical/psychological function or compared to radiographic measures. We discuss the implications of these findings on the use of composite endpoints such as the ACR20 or the EULAR responder index in RA clinical trials, particularly the introduction of misclassification bias that arises from differential measurement error. Finally, we consider generically how the concept of the SDD might or might not relate to the concept of the minimal clinically important difference.

Aged↗