Evaluation of collected outcome measures in axial spondyloarthritis in daily-care rheumatology settings: the experience of the RHEVER network.

OBJECTIVES: Nowadays, the recommended measures for optimal monitoring of axial Spondyloarthritis (ax-SpA) disease activity are either BASDAI and CRP, or ASDAS-CRP. However, there could be a gap between recommendations and daily practice. We aimed to determine the measures collected by rheumatologists in an ax-SpA follow-up visit, and to determine the impact of a meeting (where rheumatologists reached a consensus on the measures to be collected) on the collection of such measures. METHODS: A consensual meeting of a local network of 32 rheumatologists proposed, four months later, to report at least the BASDAI score in the medical file of every ax-SpA patient at every follow-up visit. An independent investigator reviewed the medical files of 10 consecutive patients per rheumatologist, seen twice during the year (e.g. before and after the meeting). The most frequently collected measures were assessed, and then, the frequency of collection before and after the meeting was compared. RESULTS: A total of 456 medical files from 228 patients were reviewed. Treatment (>60%), CRP (51.3%) and total BASDAI (28.5%) were the most reported measures in medical files. Before/After the meeting, the frequencies of collected measures in medical files were 28.5%/51.7%, 51.3%/52.2%, 16.7%/31.6% and 0.9%/6.1% for BASDAI, CRP, BASDAI + CRP and ASDAS, respectively reaching a statistically significance for BASDAI, ASDAS and BASDAI+CRP (p<0.05). CONCLUSIONS: This study revealed a low rate of systematic report of the recommended outcome measures in ax-SpA. However, it suggests that a consensual meeting involving practicing rheumatologists might be relevant to improve the implementation of such recommendations.

Challenges of cardiovascular risk assessment in the routine rheumatology outpatient setting: an observational study of 110 rheumatoid arthritis patients.

OBJECTIVE: An annual assessment of cardiovascular (CV) risk factors in rheumatoid arthritis (RA) is recommended, but its practical modalities have not been determined. The objective was to assess the feasibility and usefulness of a standardized CV risk assessment in RA, performed by rheumatologists during outpatient clinics. METHODS: We used a cross-sectional design within a network of rheumatologists. Each rheumatologist included 5 consecutive unselected patients with definite RA. Data collection included standardized assessment of CV risk factors: blood pressure, interpretation of glycemia and of lipid levels, and calculation of the Framingham CV risk score. Outcome criteria included feasibility (missing data and time taken to assess the patients) and usefulness (the CV risk assessment was considered useful if at least 1 modifiable and previously unknown CV risk factor was evidenced). RESULTS: Twenty-two rheumatologists (77% in office-based practice) assessed 110 RA patients. The mean ± SD age was 57 ± 10 years, and the mean ± SD RA duration was 11 ± 9 years; 50 patients (45%) were treated with biologic agents, and 76% were women. Regarding feasibility, missing data were most frequent for glycemia (27% of patients) and cholesterolemia (14% of patients). The mean ± SD duration of the CV risk assessment was 15 ± 5 minutes. The CV risk assessment was considered useful in 33 patients (30%), evidencing dyslipidemia (15% of patients) or high blood pressure (9% of patients) as the most frequently previously unknown CV risk factor. CONCLUSION: The assessment of CV risk factors is feasible, but labor intensive, during an outpatient rheumatology clinic. This assessment identified modifiable CV risk factors in 30% of the patients. These results suggest that RA patients are not sufficiently assessed and treated for CV risk factors.

Professional practice assessment in ambulatory private rheumatology: a pilot evaluation of the medical file content for rheumatoid arthritis.

OBJECTIVE: Professional Practice Assessment (PPA) has become an obligation for all physicians in France, however its modalities remain unclear. The objective of this work was to evaluate the feasibility and accuracy of a PPA for private practice rheumatologists performed in the context of a network. METHODS: A list of items considered mandatory to collect during an outpatient visit for rheumatoid arthritis, was prepared by the network. Non hospital-based rheumatologists, members of the network then evaluated some of their patient files selected by chronological order over a one-month period of time using this list. These files were then assessed by another private rheumatologist, member of the group, randomly allocated, using the same list of items. RESULTS: Eighty percent of the private-practice doctors accepted to participate. The mean time to evaluate 15 patient files was 2 hours. Agreement between auto-evaluation and external evaluation for each file was good (agreement statistic, 0.75-1.0). Items mandatory to collect were collected in a high proportion of cases (84.6%). CONCLUSION: PPA can be performed in the context of a network, auto-evaluation is a valid method and when the list of items is decided on by the network, the data are collected satisfactorily.

Arthroscopic evaluation of potential structure modifying activity of hyaluronan (Hyalgan) in osteoarthritis of the knee.

OBJECTIVE: Several reported studies suggest that repeated intra-articular injections of hyaluronan result in sustained relief from pain and functional disability in patients with knee osteoarthritis. Several in vivo data suggest that hyaluronan might have a beneficial structural effect in osteoarthritis. The objective of the study was to evaluate the potential structure-modifying effects of Hyalgan (500-730 kDa molecular weight), a highly-purified sodium hyaluronate. DESIGN: Patients with painful knee osteoarthritis (ACR criteria) were enrolled in a prospective, controlled study of 1-year duration. After randomization, either conventional therapy or three cycles (every 3 months) of three intra-articular injections of Hyalgan (once a week during 2 weeks) were given. Clinical outcome was added using pain visual analog score (VAS), functional impairment: Lequesne's index, quality of life: arthritis impact measurement scale (AIMS2) and structural outcome using X-rays: joint space narrowing and arthroscopy: global assessment using VAS, SFA scoring and grading systems. RESULTS: Of the 39 recruited patients, 36 completed the 1-year trial (19 in the Hyalgan group and 17 in the control group). There was no difference between groups at entry. Between-group comparison for changes in clinical parameters reached statistical significance for the quality of life index (AIMS2: -0.4 +/- 0.7 vs 0.2 +/- 0.9 in the Hyalgan and control groups respectively, P < 0.05). Deterioration in the structural parameters was less in the Hyalgan group, with a statistically significant difference for two of the three evaluated parameters (overall assessment of chondropathy: +5.1 +/- 12.7 vs 16.7 +/- 18.3, P = 0.016; SFA scoring system: +3.7 +/- 7.3 vs +9.0 +/- 11.5, P = 0.05) in the Hyalgan and control groups, respectively. CONCLUSIONS: This study supports existing data concerning the favorable symptomatic effect of intra-articular injections of Hyalgan in osteoarthritis of the knee and suggests that repeated intra-articular injections of Hyalgan might delay the structural progression of the disease. Other studies are required to confirm these results and to determine the long-term monitoring of osteoarthritic patients using such local therapy.

Arthroscopic evaluation of chondropathy in osteoarthritis of the knee.

OBJECTIVE: To evaluate arthroscopic findings as a potential measurement of severity and outcome of chondropathy. METHODS: 110 patients with knee osteoarthritis (OA) were included in a cross sectional study and 41 of them in a one year longitudinal study. The evaluation of OA performed once in the cross sectional study and twice (at entry and after one year) in the longitudinal study, included clinical, radiological and arthroscopic variables evaluating disease activity and severity. Arthroscopy was performed. under local anesthesia in an outpatient procedure using a small arthroscope. Chondropathy was evaluated by the overall assessment of the investigator by visual analog scale and the Société Française d'Arthroscopie (SFA) scoring and grading systems, which represent a composite index taking into account depth, size, and localization of the articular cartilage lesions. RESULTS: The intrinsic validity of the arthroscopic variables was suggested by highly significant correlation (R2 = 80-85%) between the overall assessment of the investor and the SFA systems. There was also highly significant correlation (p < 0.01) between the arthroscopic and radiological variables. Intraobserver reliability of the arthroscopic quantification of chondropathy was better than interobserver reliability. In the cross sectional study, severity of chondropathy correlated with both age and body mass index. In the longitudinal study there was statistically significant worsening in the severity of chondropathy and statistically significant correlation between the changes in the severity of chondropathy and changes in functional impairment. CONCLUSION: We conclude that arthroscopy might be considered a relevant measurement of OA outcome for research purposes.

Bone loss during gonadotropin releasing hormone agonist treatment and use of nasal calcitonin.

Gonadotropin releasing hormone (GnRH) agonists have shown to be effective in the treatment of several sex-hormone-dependent conditions. However, their use could be limited by the bone loss they induce. To evaluate the use of nasal salmon calcitonin (sCT) in preventing this bone loss, 40 patients with endometriosis were treated for 6 months with triptoreline (3.75 mg monthly) and calcium (1 g daily), and randomized in three groups-placebo, sCT 100 IU daily and sCT 200 IU daily-in a prospective double-masked study. Dual-energy X-ray absorptiometry and biochemical parameters were used to evaluate the benefit of the treatment. At baseline, there were no statistically significant differences between the groups. After 6 months, estradiol and biochemical markers of bone metabolism were at postmenopausal levels, with no difference between the groups. There was no difference in bone loss in the three groups, at all sites. Mean lumbar bone loss was 4.01 +/- 2.59% (mean +/- SD) in this population. In this study dosages of 100 IU and 200 IU daily of nasal sCT were insufficient to prevent bone loss during GnRH agonist treatment.

Are classification criteria for spondylarthropathy useful as diagnostic criteria?

The authors used data from a study conducted under the auspices of the Société Française de Rhumatologie to evaluate the sensitivity and specificity of the individual items of two sets of criteria for spondylarthropathy. The study included 124 patients with spondylarthropathy and 1,964 controls. They found that the spondylarthropathy criteria with the highest sensitivities and specificities were useful not only for classifying patients but also for assisting in the diagnosis of spondylarthropathy.

[Chondroscopy: a new method for measuring osteoarthritis?]. / La chondroscopie: un nouvel intrument de mesure de l'arthrose?

Arthroscopy allows direct visual examination of joint cavity components and is useful for the diagnosis, treatment and evaluation of lesions. We investigated the contribution of arthroscopy to the evaluation of joint cartilage. The severity of cartilage lesions can be assessed using a total 100-mm visual analog scale (0 = no chondropathy; 100 = the worst possible lesions) or a more objective system based on the site, depth, and surface area of the lesions. This latter system was developed by the French Society for Arthroscopy (Société Française d'Arthroscopie) and provides a score and a class (SFA score and SFA grade). We investigated whether this system has the characteristics required of an evaluation tool, i.e., simplicity, reproducibility, clinical relevance, sensitivity to change, and discriminant capacity. Arthroscopy is an invasive procedure. However, we introduced several simplifications, including use of local rather than general anesthesia, performance on an outpatient basis, elimination of the tourniquet (to avoid muscular dysfunction), and use of a small arthroscope. This simplified technique is called chondroscopy. Intra-observer reproducibility is far better than inter-observer reproducibility. We found a good correlation between the two arthroscopy scales (visual analog scale and SFA scale). Chondroscopy and roentgenographic evaluations of cartilage lesions were closely correlated. Changes in the severity of cartilage lesions were correlated with changes in functional impairment. Chondroscopy proved capable of demonstrating statistically significant changes in cartilage lesions due to knee osteoarthritis between two evaluations done only one year apart, even in a small sample of patients (less than 20). A preliminary study of repeated hyaluronic acid injections suggested that chondroscopy may be capable of identifying truly chondromodulating agents.

Predictive factors for the longterm outcome of spondyloarthropathies.

OBJECTIVE: To determine the predictive factors of outcome in patients with spondyloarthropathy (European Spondyloarthropathy Study Group or Amor criteria) monitored by a single investigator. METHODS: Classification of longterm outcome on a 3-grade scale. Candidate predictive factors: presence or not of 12 clinical or biological variables during the first 2 years of the disease, collected by history at the time of the first visit. Univariate analysis to pick up the factors statistically correlated with severity and then odds ratio and 95% confidence interval (CI) for each variable were calculated. RESULTS: Of the 328 patients with spondyloarthropathy, 151 had a followup of > or = 10 years and minor disease (81), severe (28), or moderate disease (42). Seven variables at entry were correlated with disease severity (odds ratio; CI 95%); hip arthritis (22.85; 4.43-118); erythrocyte sedimentation rate > 30 mm/h (7; 4.84-9.50); poor efficacy of nonsteroidal antiinflammatory drugs (8.33; 2.56-27.10); limitation of lumbar spine (7; 2-25); sausage-like finger or toe (8.45; 1.48-9); oligoarthritis (4.25; 1.38-13.10); onset < or = 16 years (3.47; 1.06-12.75). If none of these factors is present at entry a mild outcome can be predicted (sensitivity: 92.5%; specificity: 78%). If a hip is involved or if 3 factors are present, a severe outcome is predictable (sensitivity: 50%) and a mild disease practically excluded (specificity: 97.5%). CONCLUSION: Predictive factors of poor or benign longterm outcome could be defined very early after onset of spondyloarthropathy in a set of patients monitored by one observer.

[The carpus-metacarpus-index distance: a measurement for quantifying radiological lesions in rheumatoid polyarthritis. Comparison with Larsen's scores and Steinbrocker's index]. / La distance "carpe-médius-index": une mesure pour quantifier les lésions radiologiques de la polyarthrite rhumatoïde. Comparaison aux scores de Larsen et de Steinbrocker.

The carpus-to-digits distance measured on a posteroanterior roentgenogram of the hands and wrists takes into account 18 different joints. This study demonstrates that the carpus-to-digit distance is a simple, reproducible score which reliably reflects progression of roentgenological rheumatoid arthritis lesions and is correlated with Larsen's lesion score and with Steinbrocker's index, but not with Larsen's erosion score during the first two years after onset of the disease. Larsen's erosion score and similar parameters should be preferred for clinical studies of recent-onset rheumatoid arthritis. The carpus-to-digit distance, which requires neither a reference film not observer training, is appropriate for long-term clinical studies.

The SFA system for assessing articular cartilage lesions at arthroscopy of the knee.

We proposed to establish a system of assessing severity of chondropathy taking into account localization, size, and depth of cartilage lesions. The design of the study was prospective and multicenter. The subjects were 755 patients who had undergone arthroscopy of the knee. Criteria for assessment of severity of chondropathy were as follows: (a) Physician's overall assessment using a 100-mm-long Visual Analogue Scale, and (b) size, grade, and localization of cartilage lesions recorded on a diagram. We used multivariate parametric and nonparametric analyses. The analyses resulted in two systems of assessing severity of chondropathy: SFA scoring for the three compartments of the knee, which is a continuous variable, and SFA grading, which is a semiquantitative variable. These systems seem to be of clinical relevance. However, more studies are required to further validate them and their capacity to detect changes in severity of chondropathy.

[Evaluation of a quality of life scale (AIMS2) in rheumatology]. / Evaluation d'une échelle de qualité de vie (AIMS2) en rhumatologie.

OBJECTIVES: To evaluate the feasibility, relevance, and sensitivity of the French version of the revised Arthritis Impact Measurement Scale (AIMS2) in patients with rheumatoid arthritis or osteoarthritis of the hip. METHODS: translation of the English-language AIMS2 into French using the back-to-back technique; evaluation of feasibility on the basis of a) time needed to complete the AIMS2; b) percentage of questionnaires with at least one missing answer or one answer indicating that the question was misunderstood; evaluation of relevance on the basis of correlations between AIMS2 scores and conventional parameters for evaluating the activity of rheumatoid arthritis (85 patients); evaluation of sensitivity on the basis of total hip replacement-induced improvements in AIMS2 scores versus other conventional scores used to evaluate activity of osteoarthritis of the hip (48 patients). RESULTS: feasibility, mean time needed to complete the AIMS2 was 23 minutes in rheumatoid arthritis patients and 26 minutes in osteoarthritis patients. Forty per cent of patients failed to answer at least one question and 21% misunderstood at least one question; relevance: conventional parameters used in rheumatoid arthritis accounted for 51% of AIMS2 score variance, suggesting that the AIMS2 provided information not supplied by conventional parameters. SENSITIVITY: after total hip replacement for osteoarthritis, there were statistically significant decreases in all AIMS2 scores (with the exception of function and work). CONCLUSION: These data suggest that the AIMS2 score is not an easy evaluation tool but is both relevant and sensitive. These findings require confirmation by longitudinal studies.

[Criteria for classification of spondylarthropathies in children]. / Critères de classification des spondylarthropathies chez les enfants.

BACKGROUND: The term spondylarthropathy is used for several different entities including undifferentiated forms. The latter are particularly frequent in children and often not recognized. Two sets of criteria, the Amor and the European Spondylarthropathy Study Group (ESSG) criteria, primarily devised for adults, were evaluated in a pediatric population. METHODS: Three hundred and ten consecutive patients referred to one pediatric rheumatology center over 6 months were prospectively assessed, whatever the rheumatic complaint. Twenty two items were analysed for each patient and compared with the criteria proposed by Amor (17 items) and the ESSG (12 items). RESULTS: The Amor criteria performed better than the ESSG criteria. The sensitivity was 84 and 69.7%, and the specificity 96.1 and 92.2% for the Amor and the ESSG criteria, respectively. The sensitivity for pauci-arthritis was much higher in children, but the specificity was lower than in adults. The sensitivity of spinal involvement was very low in children. The undifferentiated type accounted for 81% of all definite spondylarthropathies. Definite and possible spondylarthropathies were 17% of the total referral over the 6 months, i.e. one patient in 6. CONCLUSIONS: These two sets of criteria, particularly the Amor criteria, can help pediatricians to recognize the undifferentiated type of spondylarthropathy, in the absence of spinal or any other characteristic manifestation.

Chondroscopy: a new method for scoring chondropathy.

The purpose of this study was to evaluate the performance (simplicity, reproducibility, relevance) of chondroscopy as a method for evaluating cartilage damage. Chondroscopy consisted in endoscopic evaluation of the knee using a 2.7-mm Storz arthroscope under local anesthesia and recorded on videotape. Scoring of chondropathy was based on physician's overall assessment using a 100-mm-length visual analogue scale (VAS) and size and grade of cartilage lesions. Reproducibility was evaluated by variability (coefficient of variation [CV]) in the reading of chondroscopic evaluations of five patients five times by one physician and one time each by four different physicians. The correlations between scoring of chondropathy (VAS) and radiological articular joint space narrowing, demographic data (sex, age, weight), and disease characteristics (localization, etiology, activity) were studied in 84 outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of osteoarthritis of the knee. The grade and size of the lesions were both correlated with the physician's overall assessment (r = 0.713 and r = 0.816, respectively). These two variables accounted for 72% of the variance of the VAS (multiple regression analysis). Intraobserver reproducibility was better than interobserver reproducibility (CV, 9% and 37%, respectively). There was a strong correlation between the scoring of chondropathy (VAS) and radiological joint space narrowing (r = .646, P < .0001). Moreover, in 17 of 33 patients without radiological joint space narrowing, VAS was > 20 mm. At variance, the body mass index was the single clinical variable found to correlate with the scoring of chondropathy (r = .282, P < .001).(ABSTRACT TRUNCATED AT 250 WORDS)

High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a 1 year placebo-controlled trial.

Hyaluronic acid is a natural component of cartilage and is considered not only as a lubricant in joints but also as playing a physiological role in the trophic status of cartilage. Hyalectin, a selected fraction of hyaluronic acid extracted from cocks' combs, has exhibited efficacy in animal models of osteoarthritis. To assess the efficacy and tolerability of intra-articular injections of hyalectin, we conducted a prospective, randomized, placebo-controlled trial of 1 years' duration in 110 patients with painful hydarthrodial osteoarthritis of the knee. At entry and once a week for 3 weeks, aspiration of the knee effusion and intra-articular injections of either hyalectin 20 mg (H) or its vehicle (C) were performed. The vehicle acted as the control treatment. Four weeks after the last injection, the improvement was greater in the H group compared with the C group (pain: -35.5 +/- 26.4 mm vs -25.8 +/- 21.4, P = 0.03, Lequesne's functional index: -3.8 +/- 4.3 vs -2.3 +/- 3.3, P = 0.03). During the 1 year follow-up, the need to perform supplementary local therapies (joint fluid aspiration because of painful hydarthrodial episodes and/or local corticosteroid injections) was more frequent in group C (44% vs 30%, P = 0.03). Moreover, at the final visit, the physician's overall assessment of efficacy was in favor of H (77% vs 54%, P = 0.01) and the improvement in the functional index was greater in group H (-4.4 +/- 5.1 vs -2.7 +/- 4.1, P = 0.05). This study suggests that intra-articular injections of hyalectin may (1) improve clinical condition and (2) have a long-term beneficial effect in patients with osteoarthritis of the knee.

[Comparative efficacy of ketoprofen related to the route of administration (intramuscular or per os). A double-blind study versus placebo in rheumatoid arthritis]. / Efficacité comparée du kétoprofène en fonction de sa voie d'administration (intra-musculaire ou per os). Une étude en double aveugle contre placebo au cours de la polyarthrite rhumatoïde.

Evidence of the analgesic effects of nonsteroidal antiinflammatory drugs in human diseases is easy to collect. However, demonstration of differences in the activity of NSAIDs according to the route of administration is considerably more difficult. Forty patients with rheumatoid arthritis were given either one intramuscular injection of 100 mg ketoprofen with two placebo capsules or one intramuscular injection of placebo with two 50 mg ketoprofen capsules. Analysis of changes in pain severity over the six-hour study period failed to disclose any statistically significant differences between the two groups. However, time to peak effectiveness (Tmax) was significantly shorter with the intramuscular route (194 +/- 118 minutes) than with the oral route (276 +/- 111 minutes) (p = 0.029). Although intramuscular NSAID therapy is rarely warranted in RA patients, these findings suggest that RA may serve as a clinical model for evaluating the effectiveness of a NSAID according to the route of administration.

Low bone mineral density in patients with inflammatory bowel disease.

To assess the prevalence and risk factors for low bone mineral density in inflammatory bowel disease, we studied 61 consecutive patients, mean age 36 +/- 11 years. Twenty-seven had a Crohn's disease and 34 ulcerative colitis (including 13 with ileoanal anastomosis). Three patients, two women and one man (32, 70, and 45 years old, respectively) had vertebral crush fractures. Bone mineral density measured by dual energy x-ray absorptiometry at spine and femoral level was more than 2 SD below normal values in 23% of the patients, all of them having received steroid therapy. Eighteen patients (29%) had never received steroid therapy; their bone mineral density was not different than those who had. Univariate analysis showed a positive correlation between bone mineral density and body weight or oral calcium intakes, and a negative correlation with steroid daily dose. After ileoanal anastomosis, bone mineral density was not different from other groups and showed a positive correlation with time elapsed since coloproctectomy. We concluded that bone mineral density is low in patients with inflammatory bowel disease and exposes them to the risk of bone fracture. Bone mineral density after ileoanal anastomosis may increase with time after surgery.