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Robert Landewé

Publications and source records attributed to Robert Landewé.

At least 19 recordsLinked to original sources
PubMed2007

How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis?

PURPOSE: To compare aspects of validity of EuroQol-5 Dimensions (EQ-5D) and Short-Form-6 Dimensions (SF-6D), two indirect utility instruments, and the well-being rating scale (RS) in ankylosing spondylitis (AS). METHODS: EQ-5D, SF-6D and RS were available for 254 patients fulfilling modified New York criteria. 134 patients were part of an observational cohort and 120 were part of a randomised controlled trial (RCT). Aspects of validity assessed were truth (agreement and correlation with external health measures) and discrimination (differentiation between health states, repeatability and detection of treatment effect). RESULTS: Median (range) values were 0.69 (-0.08-1.00) for the EQ-5D, 0.65 (0.35-0.95) for the SF-6D and 0.65 (0.14-1.00) for the RS. Agreement (intraclass correlation coefficient) was moderate (0.46-0.55). Instruments correlated equally with disease activity, functioning and quality of life. The SF-6D showed smaller average differences in utility between patients with better and worse disease compared with the EQ-5D and the RS. The smallest detectable difference (SDD) (in the control group of RCT) was 0.36, 0.17 and 0.33 for EQ-5D, SF-6D and RS, respectively. The ability to detect treatment effect (in the intervention trial) showed standardised effect sizes that were moderate for EQ-5D and SF-6D (0.63 and 0.64) and low for the RS (0.23). CONCLUSION: In patients with AS, EQ-5D, SF-6D and the RS correlate equally well with external measures of health, but have different psychometric properties. The SDD is most favourable for the SF-6D, but it discriminates less well between patients with different disease severities. The RS has a poorer ability to detect treatment effects. It is difficult to recommend one of the instruments.

Adult↗
PubMed2006

The validity of a rheumatoid arthritis medical records-based index of severity compared with the DAS28.

Outcome measures play an extremely important role in clinical trials and observational research. Outcome measures for rheumatoid arthritis cover a whole array of domains, ranging from measures describing the inflammatory process to measures describing the ultimate consequences of long-term disease, such as joint damage, physical function and quality of life. There is a scientific need to be able to quantify what is called the 'severity of rheumatoid arthritis', so that patients with rheumatoid arthritis can be clustered according to their propensity to develop an unfavourable outcome. It is a challenge to find an appropriate measure for severity. One attempt has been the development of the Rheumatoid Arthritis Medical Record-Based Index of Severity. This commentary elaborates on how such a measure of severity should be validated to determine whether it is appropriate for practical use.

Arthritis, Rheumatoid↗
PubMed2006

Association of early radiographic damage with impaired physical function in rheumatoid arthritis: a ten-year, longitudinal observational study in 238 patients.

OBJECTIVE: To investigate the longitudinal relationship between physical disability, disease activity, and radiographic damage over 10 years in patients with rheumatoid arthritis (RA). METHODS: A cohort of 238 consecutively enrolled RA patients from the European Research on Incapacitating Disease and Social Support study (age range 20-70 years, mean disease duration 2.3 years, 68% rheumatoid factor [RF] positive) was followed up longitudinally for 10 years. Assessments at baseline and at years 1, 2, 5, and 10 comprised review of demographic variables, measurement of disease activity with the erythrocyte sedimentation rate (ESR), functional evaluations using the Health Assessment Questionnaire (HAQ) and grip strength (average value of the right and left hand), and radiographs of the hands scored by the van der Heijde modification of the Sharp method. Marginal modeling by generalized estimating equations was used to study the longitudinal relationship between the ESR and modified Sharp radiographic damage score with respect to explaining the HAQ score and grip strength. Age, sex, RF status, and disease duration were entered as covariates. RESULTS: The HAQ score and grip strength were longitudinally associated with the momentary modified Sharp/van der Heijde score as well as with progression in this score, independent of the ESR. Therefore, an increase of 10 units in the modified Sharp/van der Heijde score will result in a 0.03-unit increase in HAQ score and a 0.95-kg decrease in grip strength, after adjustment for the ESR. CONCLUSION: This 10-year observational study provides evidence that both radiographic damage and disease activity are independent contributors to impaired physical function in RA, both early and late in the disease process.

Adult↗
PubMed2006

Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab: results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study.

OBJECTIVE: To determine whether the effects of anti-tumor necrosis factor alpha (TNFalpha) in reducing the signs and symptoms of ankylosing spondylitis (AS) coincide with a reduction in spinal inflammation as detected by magnetic resonance imaging (MRI). METHODS: Pre- and postgadolinium T1 and STIR MR images of the spine were acquired at baseline and at week 24 in patients with AS who participated in a multicenter, randomized, double-blind, placebo-controlled study. Patients were randomly assigned at an 8:3 ratio to receive infusions of infliximab (5 mg/kg) or placebo at weeks 0, 2, and 6 and then every 6 weeks thereafter. MR images were obtained and evaluated independently by 2 readers who were blinded to the treatment allocation and time sequence of the images. RESULTS: A total of 194 patients in the infliximab group and 72 patients in the placebo group had evaluable images at baseline and week 24. About 80% of the patients had at least 1 active spinal lesion at baseline, as assessed by MRI. The improvement in the MRI Activity Score after 6 months was significantly greater in the patients who received infliximab (mean 5.02, median 2.72) than in those who received placebo (mean 0.60, median 0.0) (P < 0.001). Almost complete resolution of spinal inflammation was seen in most patients who received infliximab, irrespective of baseline activity. CONCLUSION: Patients with AS who received infliximab therapy showed a decrease in spinal inflammation as detected by MRI, whereas those who received placebo showed persistent inflammatory spondylitis.

Adult↗
PubMed2006

Disconnect between inflammation and joint destruction after treatment with etanercept plus methotrexate: results from the trial of etanercept and methotrexate with radiographic and patient outcomes.

OBJECTIVE: To determine the relationship between disease activity and radiographic progression of joint destruction in patients with rheumatoid arthritis (RA) treated with methotrexate (MTX), those treated with etanercept, and those treated with the combination of MTX plus etanercept. METHODS: Baseline, 12-month, and 24-month data from the Trial of Etanercept and Methotrexate with Radiographic and Patient Outcomes database were analyzed. The dependent variable was the 1-year change in the modified Sharp/van der Heijde score (Sharp score); therefore, 2 interval changes per patient were available. Interval change in the Sharp score was modeled by time (years), treatment, disease activity, and the interaction (disease activity x treatment). Disease activity was reflected by the time-averaged Disease Activity Score (taDAS) and the time-averaged C-reactive protein (taCRP) level, which were calculated per 1-year interval. Generalized mixed linear modeling (GMLM) was used to adjust for within-patient correlation. RESULTS: GMLM confirmed a significant interaction between treatment and the taCRP level and taDAS with respect to the change in Sharp score (P = 0.012 and P = 0.03, respectively). In patients treated with MTX alone, radiographic progression increased with an increasing taCRP level or taDAS, although progression rates were low in patients whose disease was in remission and in those with low-to-moderate disease activity. This relationship was less clear in patients treated with etanercept and was absent in those who received combination therapy. CONCLUSION: Combination therapy with MTX plus etanercept uncouples the classic relationship between disease activity and radiographic progression in patients with RA.

Antirheumatic Agents↗
PubMed2006

Imaging in ankylosing spondylitis.

The introduction of symptomatically highly effective anti-tumour necrosis factor alpha therapies for ankylosing spondylitis (AS) has generated interest in the use of imaging to evaluate the potential structure-modifying properties of these agents. Several approaches have been developed to score the plain radiographic abnormalities in AS. Of these, the modified Stoke AS Spinal Score is the most responsive to change, although responsiveness is limited and requires a minimum of 2 years before significant change becomes apparent in patients on standard therapies. Magnetic resonance imaging (MRI) is the most sensitive imaging abnormality, and the advent of fat-suppression imaging allows detection of bone marrow inflammation in the sacroiliac joints as one of the earliest abnormalities in AS. Limited studies have shown that spinal inflammation can be scored reliably using either a system that evaluates the entire spine or a system that limits evaluation to only the most severely affected spinal segments. Both methods also demonstrate excellent responsiveness. The prognostic significance of acute changes on MRI remains unclear. Reliable approaches to the evaluation of chronic changes are yet to be developed. MRI represents a major advance in the diagnostic evaluation of AS.

Humans↗
PubMed2006

Magnetic resonance imaging changes of sacroiliac joints in patients with recent-onset inflammatory back pain: inter-reader reliability and prevalence of abnormalities.

To study the inter-reader reliability of detecting abnormalities of sacroiliac (SI) joints in patients with recent-onset inflammatory back pain by magnetic resonance imaging (MRI), and to study the prevalence of inflammation and structural changes at various sites of the SI joints. Sixty-eight patients with inflammatory back pain (at least four of the five following criteria: symptom onset before age 40, insidious onset, morning stiffness, duration >3 months, improvement with exercise--or three out of five of these plus night pain) were included (38% male; mean age, 34.9 years [standard deviation 10.3]; 46% HLA-B27-positive; mean symptom duration, 18 months), with symptom duration <2 years. A MRI scan of the SI joints was made in the coronal plane with the following sequences: T1-weighted spin echo, short-tau inversion recovery, T2-weighted fast-spin echo with fat saturation, and T1-spin echo with fat saturation after the administration of gadolinium. Both SI joints were scored for inflammation (separately for subchondral bone and bone marrow, joint space, joint capsule, ligaments) as well as for structural changes (erosions, sclerosis, ankylosis), by two observers independently. Agreement between the two readers was analysed by concordance and discordance rates and by kappa statistics. Inflammation was present in 32 SI joints of 22 patients, most frequently located in bone marrow and/or subchondral bone (29 joints in 21 patients). Readers agreed on the presence of inflammation in 85% of the cases in the right SI joint and in 78% of the cases in the left SI joint. Structural changes on MRI were present in 11 patients. Ten of these 11 patients also showed signs of inflammation. Agreement on the presence or absence of inflammation and structural changes of SI joints by MRI was acceptable, and was sufficiently high to be useful in ascertaining inflammatory and structural changes due to sacroiliitis. About one-third of patients with recent-onset inflammatory back pain show inflammation, and about one-sixth show structural changes in at least one SI joint.

Adult↗
PubMed2005

Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study.

OBJECTIVE: To evaluate different methods of presentation and analysis of radiographic data in a rheumatoid arthritis (RA) randomized controlled trial. METHODS: A double-blind randomized controlled trial including 682 patients with active RA who were treated with methotrexate, etanercept, or a combination of the 2 drugs was used for this study. Probability plots of the change from baseline to year 1 were produced to visualize progression, and were compared with usual descriptive statistics. The primary analysis of the trial (based on annualized actual mean change from baseline in total Sharp score at 1 year, using linear imputation) was challenged using various ways of handling missing information with alternative imputation methods, and by various statistical analyses including analysis of covariance (ANCOVA) and mixed model analysis on both raw and log-transformed data. RESULTS: Probability plots provided detailed insight into the differentiated treatment effects between the 3 arms of this study. As adjuncts to formal hypothesis testing, these plots were more useful for presenting data than were summary descriptive statistics or use of preset cutoff points to define lack of progression. Additional analyses presented here support the results obtained with the per-protocol analysis that showed an advantage of the combination treatment compared with the monotherapy arms and for etanercept versus methotrexate alone. Various ways of handling missing information confirmed the robustness of the results. In addition, both ANCOVA and mixed model analyses on raw and on log-transformed data produced similar results. CONCLUSION: We suggest a panel of alternative analysis methods and alternative ways of handling missing information to verify that the radiographic results reported in an randomized controlled trial are not influenced by technical factors, such as interpolation, handling of missing data, and choice of statistical tests.

Adult↗
PubMed2005

Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial.

OBJECTIVE: A 2-year randomized controlled trial was performed to test the hypothesis that long-term, continuous treatment with nonsteroidal antiinflammatory drugs (NSAIDs), in comparison with NSAID treatment on demand only, influences radiographic progression in patients with ankylosing spondylitis (AS). METHODS: Patients with AS (n = 215), who had previously participated in a 6-week, randomized, double-blind clinical trial that compared celecoxib, ketoprofen, and placebo, were randomly allocated to receive either continuous treatment with NSAIDs or on-demand treatment with NSAIDs for a period of 2 years. All patients began treatment with celecoxib, at a starting dosage of 100 mg twice daily; patients could increase this dosage to 200 mg twice daily or could switch to another NSAID while maintaining the same treatment strategy. Structural changes were assessed by radiographs of the lumbar and cervical spine and scored according to the modified Stoke Ankylosing Spondylitis Spine Score by one observer who was blinded to the treatment strategy and temporal order of the radiographs. Statistical analyses included a between-group comparison of 1) radiographic progression scores (by Mann-Whitney U test), 2) time-averaged values of variables reflecting signs and symptoms of AS (by linear regression analysis), and 3) the frequency of reported site-specific adverse events (by chi-square test or Fisher's exact test, as appropriate). RESULTS: Complete sets of radiographs were available for 76 of the 111 patients in the continuous-treatment group and for 74 of the 104 patients in the on-demand group. The mean +/- SD scores for radiographic progression were 0.4 +/- 1.7 in the continuous-treatment group and 1.5 +/- 2.5 in the on-demand treatment group (P = 0.002). Parameters reflecting signs and symptoms were not statistically significantly different between groups. The between-group difference in radiographic progression did not disappear after adjusting for baseline values of radiographic damage or disease activity variables and for time-averaged values of disease activity variables, nor after input of missing data. Relevant adverse events tended to occur more frequently in the continuous-treatment group than in the on-demand group (for hypertension, 9% versus 3%; for abdominal pain, 11% versus 6%; for dyspepsia, 41% versus 38%), but the differences were not statistically significant. CONCLUSION: A strategy of continuous use of NSAIDs reduces radiographic progression in symptomatic patients with AS, without increasing toxicity substantially.

Adult↗
PubMed2005

Imaging in spondylitis.

PURPOSE OF REVIEW: The purpose of this review is to describe and evaluate recent findings with respect to imaging in ankylosing spondylitis. The review includes articles from the literature that were published in 2004. RECENT FINDINGS: Three types of articles are described: methodological studies aimed at validating scoring methods for detecting inflammation and structural damage by plain radiography and magnetic resonance imaging, descriptive reviews on imaging in ankylosing spondylitis and two studies evaluating miscellaneous aspects of imaging. Methodological studies showed promising psychometric properties of scoring methods for assessing structural damage of the spine by plain radiography, and for assessing inflammation of the spine by magnetic resonance imaging. Based on methodological qualifications, a method of preference (the modified Stoke ankylosing spondylitis spine score) could be identified for assessing 2-year change in structural damage. A number of reviews outlined the particular potential of magnetic resonance imaging in evaluating characteristics of inflammation and structural changes in ankylosing spondylitis. Two unrelated studies showed the potential yields of multidetector computed tomography in detecting spinal fractures in ankylosing spondylitis, and of magnetic resonance imaging in detecting shoulder problems in ankylosing spondylitis. SUMMARY: MRI inflammation may become an important outcome measure in clinical trials in ankylosing spondylitis patients, and plain radiography may be used to assess 2-year progression of structural damage of the spine in ankylosing spondylitis. The descriptive reviews may serve as an introduction in the field of imaging in ankylosing spondylitis, and the studies on multidetector computed tomography and magnetic resonance imaging in shoulder problems may have direct impact for the treatment of patients with ankylosing spondylitis in the clinical context.

Arthrography↗
PubMed2005

Selection of a method for scoring radiographs for ankylosing spondylitis clinical trials, by the Assessment in Ankylosing Spondylitis Working Group and OMERACT.

Radiographs are important for assessing structural damage in patients with ankylosing spondylitis (AS); this technology was selected by the international ASsessment in Ankylosing Spondylitis (ASAS) Working Group as an important domain for assessing outcome in clinical trials. The selection of a preferred scoring method based on the OMERACT filter still needs to be undertaken. This article describes the scientific basis for and process of making the selection. Finally, both the ASAS Working Group and OMERACT participants voted for the modified Stoke AS Spinal Score (mSASSS) as the preferred scoring method for use in clinical trials in AS.

Clinical Trials as Topic↗
PubMed2004

The influence of peripheral arthritis on disease activity in ankylosing spondylitis patients as measured with the Bath Ankylosing Spondylitis Disease Activity Index.

OBJECTIVES: To assess the differences in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) between patients with and without peripheral arthritis/enthesitis. To investigate whether scores on the BASDAI change by omitting the 2 questions on peripheral disease. METHODS: Disease activity was assessed on a 10-cm visual analog scale and by BASDAI. Alternative BASDAIs were constructed by omitting the peripheral joints question and/or the enthesitis question. Correlations between the alternative BASDAIs and other measures of disease activity were calculated. Generalized estimating equations (GEE) were used to assess whether having peripheral arthritis influenced BASDAI and alternative BASDAI scores, and to assess whether peripheral arthritis influenced the score of the individual questions of the BASDAI. RESULTS: At baseline, the BASDAI was calculated in 214 patients. In patients with peripheral arthritis (n = 56), the mean (SD) BASDAI score was 4.4 (2.3) as compared with 3.1 (1.9) (P < 0.0001) in the patients without peripheral arthritis (n = 158). The relationship between arthritis and the BASDAI score appeared to be truly longitudinal (GEE regression coefficient beta = 0.64; 95% confidence interval 0.28-1.00). Peripheral arthritis was significantly longitudinally associated with all separate item scores of the BASDAI. Omitting the peripheral joints and/or enthesitis question from the BASDAI questionnaire only partially explained the difference in BASDAI score between the 2 groups. CONCLUSION: Disease activity measured by the BASDAI is higher in patients with concomitant peripheral disease compared with patients with disease restricted to the axial skeleton. The increased BASDAI score in patients with peripheral arthritis is partially explained by increased overall disease activity as well as by a disproportionate contribution of the peripheral joints question to the overall score.

Adult↗
PubMed2004

Markers for type II collagen breakdown predict the effect of disease-modifying treatment on long-term radiographic progression in patients with rheumatoid arthritis.

OBJECTIVE: To investigate in a randomized clinical trial setting with an aggressive combination-therapy arm and a mild-monotherapy arm, whether therapy-induced changes in urinary C-terminal crosslinking telopeptide of type I collagen (CTX-I) and type II collagen (CTX-II) predict 5-year radiographic progression in patients with rheumatoid arthritis (RA). METHODS: Patients had participated in the COBRA (Combinatietherapie Bij Reumatoïde Artritis) trial comparing aggressive step-down combination therapy (the COBRA regimen, including temporary high-dose prednisolone, temporary low-dose methotrexate, and sulfasalazine [SSZ]) and mild monotherapy (SSZ). Urinary CTX-I and CTX-II levels were measured at baseline and 3, 6, 9, and 12 months after initiation of treatment. Radiographs were scored according to the modified Sharp/van der Heijde method (mean of 2 independent readers who were aware of the sequence). Individual long-term radiographic progression was estimated, using baseline radiographs and all radiographs obtained during the followup period, by simple linear regression analysis (curve fitting). RESULTS: Both COBRA therapy and SSZ monotherapy produced a significant decrease in urinary CTX-I and CTX-II levels at 3 months, and this decrease was amplified at 6 months. COBRA therapy suppressed CTX-II (change from baseline levels -36% and -43% at 3 and 6 months, respectively), but not CTX-I, significantly better than did SSZ (-17% and -21% at 3 and 6 months, respectively) at 3 and 6 months. The magnitude of the decrease in urinary CTX-II levels at 3 months significantly predicted long-term (5-year) radiographic progression (beta = 0.48 [95% confidence interval (95% CI) 0.13, 0.83]). This effect was independent of the change in disease activity and inflammation indices at 3 months. Patients whose CTX-II levels were normalized (<150 ng/mmoles of urinary creatinine) at 3 months had a significantly higher chance of radiographic stability (no progression over 5 years) than did patients whose CTX-II levels were increased both at baseline and at 3 months (odds ratio 4.5 [95% CI 1.5, 13]). CONCLUSION: The individual CTX-II response measured after 3 months of therapy in patients with active RA who had increased CTX-II levels at baseline independently predicts long-term radiographic progression. Urinary CTX-II levels may be used as early markers of treatment efficacy in patients with RA.

Adult↗
PubMed2004

Progression of rheumatoid arthritis on plain radiographs judged differently by expert radiologists and rheumatologists.

OBJECTIVE: In a former study a panel of rheumatologists was used to assess which progression in radiological joint damage due to rheumatoid arthritis (RA) on hand and foot radiographs taken at one-year intervals was considered the minimally clinically important difference (MCID). We compare the judgments of the panel of rheumatologists with the judgments of 2 musculoskeletal radiologists. METHODS: Two experienced musculoskeletal radiologists evaluated independently the same hand and foot radiographs as assessed by the panel of rheumatologists. Progression was defined as important if the radiologist would state it as substantial progression in their report. Two readers, different from the radiologists and rheumatologists, independently obtained the Sharp/van der Heijde scores. Receiver operating characteristic curve analyses were performed to quantify the minimally important progression defined by the radiologists expressed in Sharp/van der Heijde change-scores. The change-score with the highest accuracy represented the minimally important progression and was compared with the MCID defined by the panel of rheumatologists for 4 different settings (early versus advanced RA and mild versus high disease activity). RESULTS: The minimally important progression defined by the radiologists was estimated at 6.5 Sharp/van der Heijde units. This was larger than the MCID defined by the panel of rheumatologists in 3 of the 4 clinical settings (3.0-4.5 units) and similar to the setting "advanced RA, mild disease activity." The panel of rheumatologists was inclined to change therapy in cases not reported as substantially progressive by the radiologists. The Sharp/van der Heijde progression scores of the radiographs on which the radiologists and rheumatologists disagreed related better with the rheumatologists' opinions. CONCLUSION: Changes that were not regarded as substantial by the radiologists were judged clinically important by the rheumatologists in 3 of the 4 clinical settings. Thus, the radiologists appeared to be reserved in judging changes as important.

Arthritis, Rheumatoid↗
PubMed2004

Measurement of spinal mobility in ankylosing spondylitis: comparison of occiput-to-wall and tragus-to-wall distance.

OBJECTIVE: To investigate if the tragus-to-wall distance (TWD) is more reliable compared to the occiput-to-wall distance (OWD) as a measurement for thoracic spine extension in patients with ankylosing spondylitis (AS). METHODS: Data from the OASIS cohort, an international longitudinal observational study on outcome in AS, were used. Measurements of OWD and TWD were performed at baseline and at 6, 12, 18, and 24 months. Paired data of Tx and Tx+6 months were used to perform test-retest measurements (intraclass correlations, limits of agreement, and interperiod correlation matrix). Bland and Altman plots were constructed to investigate the agreement between both observations, assuming that there was no true change between 0 and 6 months. To investigate whether a change in disease activity would have influenced the results, limits of agreement were calculated in a subgroup of patients with a stable Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; defined as a maximum BASDAI change of +/- 1) between T0 and T6 and compared with the results of the whole group. Limits of agreement were also calculated for kyphosed patients only. RESULTS: The test-retest intraclass correlations were between 0.94 and 0.96 for OWD and between 0.93 and 0.95 for TWD. The direct measurement-remeasurement correlation calculated by extrapolation of the interperiod correlation regression line was 0.92 for OWD and 0.90 for TWD. OWD and TWD showed comparable reliability on the entire value of scores. The lower 95% limit of agreement was between -3.4 cm and -2.5 cm for OWD and between -3.4 cm and -3.1 cm for TWD. The upper limit of agreement was between 3.1 cm and 4.2 cm for OWD and between 2.9 cm and 3.9 cm for TWD. In all patients as well as in kyphosed patients only, limits of agreement were comparable between OWD and TWD. The patterns of the scatterplots according to Bland and Altman were similar for OWD and TWD. Measurement error was more pronounced in kyphosed patients compared to patients with a normal thoracic extension. However, over the entire range of kyphosis, measurement error was similar. CONCLUSION: OWD and TWD are equally reliable in assessing thoracic spine extension. Although the TWD is in general easier to perform in AS patients compared to OWD, we recommend the OWD measurement over TWD: in OWD measurement a value of zero easily distinguishes patients with normal thoracic spine extension from kyphosed patients.

Adult↗
PubMed2003

Patient compliance in rheumatoid arthritis, polymyalgia rheumatica, and gout.

OBJECTIVE: (1) To explore patient compliance with prescribed drug regimens in the setting of usual care for outpatients with rheumatoid arthritis (RA), gout, and polymyalgia rheumatica (PMR) by utilizing electronic medication event monitors (MEMS(R)) to register openings of the medication package. (2) To examine the influence of disease, frequency of intake of the drug, and class of drug on compliance. (3) To explore the influence of demographic factors, quality of life measures, coping, health status, and functional ability as potential predictors of patient compliance. METHODS: A total of 127 consenting consecutive patients were enrolled: 81 patients with RA, 33 taking nonsteroidal antiinflammatory drugs (13 diclofenac TID and 20 naproxen BID) and 48 taking disease modifying antirheumatic drugs [25 sulfasalazine (SSZ) BID and 23 methotrexate (MTX) once weekly]; 17 patients with PMR starting with prednisolone QD; and 29 patients with gout starting with colchicine (12, QD) or starting with uric acid lowering agents (17, QD). All patients received first prescriptions and were instructed to take the medication as prescribed. Followup was 6 months (gout 12 mo). All patients were aware of the monitoring capability of the package. At baseline a series of questionnaires was completed. We summarized the dosing histories as "taking compliance" (percentage of total prescribed doses taken), "correct dosing" (percentage of doses taken as prescribed), and "timing compliance" (percentage of doses taken within +/- 25% of prescribed interdose intervals). RESULTS: A total of 26,685 days (> 73 patient-years) were monitored. Compliance expressed as "taking compliance," mean (95% CI), "correct dosing," mean (95% CI), and "timing compliance," mean (95% CI) are: naproxen: 82% (75-90), 68% (57-80), 48% (34-61); diclofenac: 77% (61-93), 67% (47-87), 39% (21-57); MTX: 107% (98-117), 81% (75-87), 83% (76-90); SSZ: 72% (60-84), 55% (44-67), 25% (18-33); prednisolone: 96% (89-102), 88% (83-92), 82% (74-89); colchicine: 65% (48-81), 44% (26-62), 32% (18-46); and uric acid lowering agents: 84% (76-92), 74% (63-85), 65% (52-79). Missed doses occurred more frequently than taking of extra doses: in RA, on 10% of all monitored days there was no evidence of dosing, while on 3% of all monitored days extra doses were taken. In PMR and gout these data are 10% and 4%, and 15% and 7%, respectively. We observed a decline of compliance over time in all study medication groups. Multiple regression analyses showed that the class of medication (symptom modifying or disease controlling), the dosing frequency, the patient's sex, coping pattern (avoidance, passive reaction pattern, and expression of emotions), and the overall health (total Nottingham Health Profile score) together explained 67% of the variance in taking compliance (adjusted R2) (p = 0.002). CONCLUSION: Studying patient compliance with prescribed drug regimens utilizing electronic medication event monitors in RA, gout, and PMR showed that large differences exist in compliance between the various medication groups. Compliance declines over time. A regression model shows that it is possible to relate differences in patient compliance to a number of medication and patient related factors.

Activities of Daily Living↗