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Biomedical subjects

M Dougados

Publications and source records attributed to M Dougados.

At least 127 records · Page 7Linked to original sources
PubMed2000

The familial form of spondylarthropathy: a clinical study of 115 multiplex families. Groupe Français d'Etude Génétique des Spondylarthropathies.

OBJECTIVE: To investigate the interrelationships among different phenotypes, and their relationship to the HLA-Blocus, in multiplex families with spondylarthropathy (SpA). METHODS: We recruited 115 white French families, each of which had at least 2 members with SpA. Pedigrees were established. Clinical data and pelvic radiographs were collected. The HLA-B27 status of all patients was determined. Analysis was performed to determine the prevalence of SpA manifestations according to sex, disease duration, and HLA-B status, and to examine clustering of specific manifestations in subsets of families. RESULTS: We identified 329 SpA patients. Mean +/-SD age at onset was 24+/-9.4 years. The male:female ratio was 186:143, or 1.3, with few sex differences in disease expression. Axial manifestations and HLA-B27 were each present in 97% of the patients. Inflammatory bowel disease and HLA-B35 were overrepresented in the 7 families containing HLA-B27-negative patients. The frequency of radiographic sacroiliitis increased in parallel with disease duration. Peripheral enthesitis, radiographic sacroiliitis, and psoriasis were evenly distributed in the families. Clustering independent of age was only observed for peripheral arthritis, suggesting that specific factors may predispose individuals to this manifestation. CONCLUSION: Familial SpA appears to be homogeneous, based on the high frequencies of axial skeletal involvement and HLA-B27. The lack of clustering of most manifestations in families suggests that a predominant shared component, including HLA-B27, predisposes individuals to all forms of familial SpA, and that ubiquitous genetic or environmental factors contribute to phenotype diversity.

Adult↗
PubMed2000

Comparison of the responsiveness of symptomatic outcome measures in knee osteoarthritis.

OBJECTIVE: A number of international scientific societies have recommended a core set of domains to be systematically assessed in clinical research studies on osteoarthritis (OA), i.e., pain, function, and patient's overall assessment. This open, longitudinal, observational study compares the responsiveness of different symptomatic variables evaluating these 3 domains in knee OA. METHODS: Patients were individuals with painful knee OA. The collected data were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (0-100) and WOMAC function subscale (0-100), Lequesne's index (0-100), pain after physical activities (visual analog scale [VAS] 100 mm), and patient's global assessment (VAS 100 mm). The procedure used was knee joint lovage. Time of collection was before and 1, 3, and 6 months after the lavage. Analysis was by comparison of the standardized response mean (mean of the changes/SD of the changes) in an intent-to-treat strategy after 1, 3, and 6 months using the jackknife method. RESULTS: Improvement in all dimensions of WOMAC subscale scores and VAS scores was observed at month 1. Lequesne's index was not responsive to change. The standardized response mean was moderate, ranging from 0.00 to 0.40. Comparison of the estimates of the standardized response means using the jackknife method showed a statistically significant difference between Lequesne's index and the WOMAC subscale for function, but not between VAS pain and the WOMAC subscale for pain. CONCLUSION: Most of the evaluated variables have a moderate responsiveness. In knee OA, the WOMAC function scale seems to be more sensitive than Lequesne's index for detecting changes after symptomatic therapy.

Activities of Daily Living↗
PubMed2000

Follow-up of individual patients on two DXA scanners of the same manufacturer.

Measuring and monitoring changes in bone mineral density (BMD) is usually done by dual-energy X-ray absorptiometry (DXA). Replacement of old devices is becoming increasingly frequent. To cross-calibrate two Hologic devices, a QDR 1000 and a QDR 4500A, we measured three phantoms - a Hologic spine phantom, a Hologic block phantom (without and with subregions analysis) and a European Spine Phantom - 20 times each without repositioning on both devices. The mean difference between BMD obtained on the two devices was 0.003, 0.033, 0.051 and -0.045 g/cm2 respectively. We also measured the spine and hip of 60 women aged 19-78 years twice on the same day on both devices. Another group of 30 women aged 52-83 years were measured twice on the QDR 4500 A device (15 days apart). We analyzed the data using Pearson's correlation coefficient, and Bland and Altman's method, and calculated the smallest detectable difference (SDD). Results on the two devices were highly correlated: r2 = 0.99, 0.95, 0.96 for spine, femoral neck and total hip BMD respectively. SDD was higher for scans done on different devices than for those done twice on the same device: the SDDs were 0.048, 0.046 and 0.047 g/cm2 for spine, femoral neck and total hip BMD respectively measured on two different devices, while the equivalent values were 0.034, 0.036 and 0.027 g/cm2 using a single device. The difference in BMD results was not dependent on BMD. Our results suggest that, although devices are properly cross-calibrated, differences among them great enough to be clinically relevant can be observed in vivo.

Absorptiometry, Photon↗
PubMed2000

Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative.

BACKGROUND: The domains of pain, function and patient's global assessment are identified as core variables and frequently measured in clinical trials of patients with osteoarthritis (OA) of the hip and knee. OBJECTIVE: To develop response criteria for OA of hip and knee based on the domains of pain, function and patient's global assessment. METHODS: A methodology was developed by an interaction of the Osteoarthritis Research Society International Standing Committee on Clinical Trials, biostatisticians, pharmaceutical company representatives and health agency representatives. Data from previously conducted placebo-controlled clinical trials were normalized and collated. Data were subset by location of OA (knee, hip), active agent used in the clinical trial (non-steroidal anti-inflammatory drug, other agent) and route of administration (oral, intra-articular). Statistical analysis identified response criteria which best discriminate active agent from placebo. RESULTS: Based on the analysis of data from 14 studies (totaling 1886 patients) and consensus opinion, the optimal responder criteria set differed for location of OA, active agent to be used, and route of administration. Because of nearly identical statistical results, two sets of responder criteria are proposed: (1) 'high' pain response or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment; (2) 'high' response for either pain or function or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment. The sensitivity (i.e., the percentage of responders in the active group) ranged from 52 to 96% and the specificity (i.e., the percentage of nonresponders in the control group) from 47 to 73%. CONCLUSION: Based on data from clinical trials, two sets of responder criteria have been developed that can categorize an individual's responses to treatment in a clinical trial. These responder criteria require validation in additional datasets.

Aged↗
PubMed2000

Sodium hyaluronate therapy in osteoarthritis: arguments for a potential beneficial structural effect.

OBJECTIVES: Currently, available therapies for managing osteoarthritis (OA) provide symptomatic relief. Theoretical evidence suggests that exogenous hyaluronan (HA) administered as an intra-articular injection may slow disease progression. The purpose of this review is to discuss cellular and immunologic effects of HA that could affect OA progression and to present data from a clinical trial that evaluated HA structural effects. METHODS: The medical and scientific literature regarding the cellular, immunologic, and structural effects of HA on the joint environment and function are reviewed. RESULTS: Cellular effects of exogenous HA that affect the joint include increasing endogenous HA synthesis, stimulating proteoglycan synthesis, and inhibiting the release of chondrodegrading enzymes. The immunologic effects of HA are inhibition of mononuclear cell phagocytosis and leukocyte migration, chemotaxis, and phagocytosis. Also, HA is a free radical scavenger. In a pilot study using arthroscopy, cartilage deterioration was less in the HA-treated group compared with the control group. CONCLUSIONS: Considerable evidence supports the positive effects of HA on joint cellular and immunologic function. However, further clinical studies are needed to determine whether these effects are valuable in altering the progression of OA.

Animals↗
PubMed2000

Quantitative ultrasound in postmenopausal osteoporosis.

Ultrasound has been proposed as a low-cost, radiation-free method for osteoporosis assessment in postmenopausal women. Large prospective studies have shown that ultrasound parameters can be used for fracture risk estimate in this population, providing that adequate quality control is performed. The places of both ultrasound and the current gold standard method for bone assessment, dual energy x-ray absorptiometry, are still to be determined. Further studies are needed on the diagnosis of osteoporosis using ultrasound, because current diagnostic thresholds, designed by the World Health Organization, do not apply to this-new technology. Monitoring of skeletal changes and treatment effects by ultrasound cannot be recommended.

Absorptiometry, Photon↗
PubMed2000

EULAR recommendations for the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT).

BACKGROUND: Osteoarthritis (OA) is the most common joint disease encountered throughout Europe. A task force for the EULAR Standing Committee for Clinical Trials met in 1998 to determine the methodological and logistical approach required for the development of evidence based guidelines for treatment of knee OA. The guidelines were restricted to cover all currently available treatments for knee OA diagnosed either clinically and/or radiographically affecting any compartment of the knee. METHODS: The first stage was the selection of treatment modalities to be considered. The second stage comprised a search of the electronic databases Medline and Embase using a combination of subject headings and keywords. All European language publications in the form of systematic reviews, meta-analyses, randomised controlled trials, controlled trials, and observational studies were included. During stage three all the relevant studies were quality scored. The summary statistics for validated outcome measures, when available, were recorded and, where practical, the numbers needed to treat and the effect size for each treatment were calculated. In the fourth stage key clinical propositions were determined by expert consensus employing a Delphi approach. The final stage ranked these propositions according to the available evidence. A second set of propositions relating to a future research agenda was determined by expert consensus using a Delphi approach. RESULTS: Over 2400 English language publications and 400 non-English language publications were identified. Seven hundred and forty four studies presented outcome data of the effects of specific treatments on knee OA. Quantitative analysis of treatment effect was possible in only 61 studies. Recommendations for the management of knee OA based on currently available data and expert opinion are presented. Proposals for a future research agenda are highlighted. CONCLUSIONS: These are the first clinical guidelines on knee OA to combine an evidence based approach and a consensus approach across a wide range of treatment modalities. It is apparent that certain clinical propositions are supported by substantial research based evidence, while others are not. There is thus an urgent need for future well designed trials to consider key clinical questions.

Combined Modality Therapy↗
PubMed2000

Radiographic assessment of hip osteoarthritis progression: impact of reading procedures for longitudinal studies.

OBJECTIVE: To compare radiographic reading procedures and evaluate their impact on sample size in hip osteoarthritis (OA) longitudinal studies. METHODS: Pelvic radiographs performed twice, three years apart, in 104 patients with hip OA were read by a single reader using the Kellgren and Lawrence system, joint space narrowing scale, and joint space width (JSW). Reading procedures were (a) films read as single radiographs, (b) films grouped by patient but read in random order, (c) films grouped by patient and chronologically ordered, all with landmarks for JSW measurements, (d) films read as single radiographs, without landmarks for JSW measurements. JSW was measured at the narrowest point with a 0.1 mm graduated magnifying glass. RESULTS: More Kellgren and Lawrence or joint space narrowing grades were modified respectively with the single (42% and 37%) than with the paired (32% and 23%) or chronologically ordered (34% and 29%) reading procedures. Variability of JSW progression was principally related to mean progression (88.3%) and landmarks (almost 10%). Standardised response means were -0.71 with the paired reading procedure with landmarks, -0.68 with the single reading procedure with landmarks, -0.65 with the single reading procedure without landmarks. With landmarks, 10% more patients would be needed using single than paired reading. Using single reading, 10% more patients would be needed without landmarks than with landmarks. CONCLUSION: Kellgren and Lawrence grading seems to be influenced by the reading procedure, as is joint space narrowing grading, for assessing hip OA. Paired reading procedure with landmarks for JSW should be recommended in longitudinal studies.

Disease Progression↗
PubMed1999

Effects of joint lavage and steroid injection in patients with osteoarthritis of the knee: results of a multicenter, randomized, controlled trial.

OBJECTIVE: To evaluate the efficacy of joint lavage and intraarticular steroid injection, alone and in combination, in the treatment of patients with symptomatic knee osteoarthritis (OA). METHODS: Ninety-eight patients with painful tibiofemoral OA were enrolled in a prospective, randomized, controlled, 2 x 2 factorial-design trial of 6 months' duration. The 4 treatment groups consisted of 1) intraarticular placebo (1.5 ml of 0.9% normal saline), 2) intraarticular corticosteroids (3.75 mg of cortivazol in 1.5 ml), 3) joint lavage and intraarticular placebo, and 4) joint lavage and intraarticular corticosteroid. Outcome measures evaluated at baseline, week 1, week 4, week 12, and week 24 included severity of pain (100-mm visual analog scale [VAS]), global status (100-mm VAS), and Lequesne's functional index. RESULTS: No interaction between steroid injection and joint lavage was demonstrated. Patients who had undergone joint lavage had significantly improved pain VAS scores at week 24 (P = 0.020). In contrast, corticosteroid injection had no long-term effect (P = 0.313); corticosteroid injection was associated with a decrease in pain only at week 1 (P = 0.003) and week 4 (P = 0.020). After week 4, Lequesne's functional index was not significantly improved regardless of the assigned treatment. CONCLUSION: Compared with placebo, both treatments significantly relieved pain but did not improve functional impairment. The effects of the 2 treatments were additive. Cortivazol provided short-term relief of pain (up to week 4). The effects of joint lavage persisted up to week 24.

Aged↗
PubMed1999

Intensified-dose (4 gm/m2) cyclophosphamide and granulocyte colony-stimulating factor administration for hematopoietic stem cell mobilization in refractory rheumatoid arthritis.

OBJECTIVE: To evaluate the feasibility, safety, and efficacy of intensified-dose cyclophosphamide (ID-CYC), followed by granulocyte colony-stimulating factor (G-CSF) administration for collection of peripheral blood hematopoietic stem cells (HSC), for patients with severe, refractory rheumatoid arthritis (RA). METHODS: Four patients with severe refractory RA were enrolled in this open study. They received a single infusion of CYC (4 gm/m2) at day 0 followed by G-CSF (5 microg/kg/day) from day 6 until the last day of leukapheresis (performed at the time of hematopoietic recovery) to harvest peripheral blood HSC. Patients were monitored for disease activity, adverse effects, and hematopoietic reconstitution following this procedure. RESULTS: For all patients, administration of ID-CYC induced an early, dramatic improvement of disease activity. Long-term followup indicates that partial disease relapse was observed for all patients. No adverse effect was directly attributable to the treatment procedure. For most patients, HSC collection was sufficient to provide a graft enriched in CD34+ cells by positive selection as well as an unselected rescue graft. CONCLUSION: Patients with severe, refractory RA can benefit from ID-CYC. This procedure, followed by G-CSF administration, appears safe and technically suitable. In addition, it allows immediate improvement of RA activity that can occasionally persist beyond 6 months.

Adult↗
PubMed1999

Accuracy and precision of 62 bone densitometers using a European Spine Phantom.

Dual-energy absorptiometry (DXA) is widely used for bone mineral density measurements. Different types of devices are available. Differences between devices from either the same manufacturer or different manufacturers can lead to difficulties in clinical practice when patients are followed on different machines. We calculated the accuracy and precision of 62 DXA devices from two manufacturers (51 Hologic, 11 Lunar) using a European Spine Phantom (ESP, semi-anthropomorphic). The ESP was measured 5 times on each device without repositioning. Accuracy was assessed by comparing bone mineral density (BMD, g/cm(2)) values measured on each device with the actual value of the phantom. Precision was assessed by the coefficient of variation (CVsd), using the root mean square average. The limits of agreement were estimated from the differences between each replicate measurement of BMD and the estimated true value for a particular manufacturer, according to Bland and Altman. The results confirm the difference between devices from different manufacturers (18.5%). Mean CVsd values were 0.57% and 0.64% for Hologic and Lunar respectively. The limits of agreement among devices from the same manufacturer were 0.026 g/cm(2) and 0.025 g/cm(2) for Hologic and Lunar respectively. Differences in extreme results between devices from the same manufacturer were on average 5.4% and 3.6% for Hologic and Lunar respectively. Results of different devices from the same manufacturer are highly comparable, although unpredictable differences exist that may be clinically relevant.

Absorptiometry, Photon↗
PubMed1999

Assessing smallest detectable change over time in continuous structural outcome measures: application to radiological change in knee osteoarthritis.

Interpreting changes in continuous structural outcome measures is a common problem in clinical research and in daily practice. We propose a method for estimating whether difference observed between two successive measures in an individual constitutes a statistically relevant change or a change induced by variability. This statistically relevant change is based on an analysis of reproducibility. The continuous structural outcome measure investigated as an example was joint space width (JSW) measurement on standard X-rays, which is known to be the primary end-point for assessing structural osteoarthritis progression. The results of the present study demonstrate that cutoffs are closely dependent on all sources of variabilities in JSW measurement such as joint positioning, radiographic procedure, and the measurement process itself. Therefore, we suggest to determine cutoffs for each study using a representative sample of the population studied and using the procedures and methods of measurement of the specific study. This approach may easily be extended to other continuous structural outcome measures.

Aged↗