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C Bombardier

Publications and source records attributed to C Bombardier.

At least 19 recordsLinked to original sources
PubMed1992

Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE.

OBJECTIVE: To standardize outcome measures in systemic lupus erythematosus (SLE). Three indices were identified which could adequately describe outcome (disease activity, damage from disease, and health status); we describe here the development of the Disease Activity Index. METHODS: Twenty-four variables were identified as important factors in a disease activity index. These were used to generate 574 patient profiles, which were rated on a disease activity scale of 0-10 by 14 rheumatologists. A second rating of 10 of the profiles yielded scores that were not significantly different from the first, indicating that experienced clinicians can reliably make global estimates of disease activity. Multiple regression models were used to estimate the relative importance of the 24 clinical variables in the physicians' global rating of disease activity. These were estimated on a "training set" of 75% of physicians' ratings, and then validated on a "testing set," consisting of the remaining 25% of physicians' ratings. RESULTS: The explanatory power of the models in the training set was high (R2 = 0.93). The models' regression coefficients for the organ systems were simplified for easier use in clinical practice. This generated a "weighted" index of 9 organ systems for disease activity in SLE, the SLEDAI, as follows: 8 for central nervous system and vascular, 4 for renal and musculoskeletal, 2 for serosal, dermal, immunologic, and 1 for constitutional and hematologic. The maximum theoretical score is 105, but in practice, few patients have scores greater than 45. The SLEDAI predicted well the physicians' ratings in the testing set (Pearson's correlation coefficients = 0.64-0.79). CONCLUSION: The SLEDAI is a validated model of experienced clinicians' global assessments of disease activity in lupus. It represents the consensus of a group of experts in the field of lupus research.

Central Nervous System↗
PubMed1992

Prognostic indicators of joint destruction in systemic-onset juvenile rheumatoid arthritis.

We retrospectively reviewed the charts and radiographs of 38 patients with systemic-onset juvenile rheumatoid arthritis, attempting to identify early in the disease course the clinical and laboratory observations most predictive of the later development of destructive arthritis. In 12 of the patients, destructive arthritis developed within 2 years of disease onset. When first examined, these patients could not readily be differentiated from those in whom joint destruction did not develop, but they more commonly had hepatosplenomegaly (p less than 0.04), serositis (p less than 0.01), and a lower mean serum albumin concentration (26.7 vs 31.3 gm/L; p less than 0.02). However, by 6 months after onset, patients with destructive arthritis more frequently had persistent systemic symptoms (92% vs 12%; p less than 0.0001), polyarthritis (67% vs 19%; p less than 0.0005), a lower mean hemoglobin level (95 vs 114 gm/L; p less than 0.001), a higher mean leukocyte count (21.2 vs 10 x 10(9)/L; p less than 0.0003), a higher mean platelet count (794 vs 400 x 10(9)/L; p less than 0.0001), and a higher mean erythrocyte sedimentation rate (43 vs 24 mm/hr; p less than 0.05). Multivariate analysis of the results at 6 months revealed that persistent systemic symptoms and a platelet count greater than or equal to 600 x 10(9)/L were the variables most highly predictive of the later development of joint destruction. We conclude that patients at high risk for the development of destructive arthritis may be identified within 6 months of disease onset, thereby indicating the need for more aggressive early therapy.

Adolescent↗
PubMed1992

Potential for inter-observer and intra-observer variability in x-ray review to establish stone-free rates after lithotripsy.

The potential for variability among observers interpreting diagnostic tests is well known but has not been well established for radiological imaging of urolithiasis. We measured the inter-observer and intra-observer variability in the reporting of plain abdominal films and tomograms from patients who had undergone extracorporeal shock wave lithotripsy (ESWL). Unlabeled copies of the plain abdominal films and tomograms for 58 patients were individually submitted to 3 different radiologists. Selected films from 25 patients were resubmitted to the same radiologists. We found differences among radiologists reporting plain abdominal films alone 52% of the time and even by the same radiologist rereading the films 24% of the time. Tomograms alone decreased the uncertainty but differences still occurred among radiologists 24% of the time and with themselves 16% of the time. When plain abdominal films and tomograms were read together there were differences among radiologists 28% of the time and with themselves 7% of the time but these were usually minor. We concluded from this study that the plain abdominal film alone was frequently difficult to interpret, resulting in uncertainty about the presence or absence of residual stone fragments. Tomograms alone or a plain abdominal film plus tomograms is superior to a plain abdominal film alone. Finally, radiological assessment with all modalities probably overestimates stone-free rates after ESWL even without consideration of the potential for reporting variability among observers.

Humans↗
PubMed1992

Lithostar extracorporeal shock wave lithotripsy: the first 1,000 patients. Toronto Lithotripsy Associates.

To our knowledge this study of our first consecutive 1,000 patients treated with the Siemens Lithostar device is the largest prospective series reported to date. Treatment results were determined at 3, 12 and 24 months after completion of therapy. The results at 3 months are presented. Complete followup data were available on 801 patients: 674 with renal and 127 with ureteral calculi. Results were analyzed according to stone size, location and number. The average number of shocks per treatment was 3,804 and the retreatment rate was 18.6%. At 3 months the stone-free rate was determined by a plain film of the kidneys, ureters and bladder and plain tomograms for renal calculi, and by an excretory urogram for ureteral calculi. The stone-free rate was 52% for renal and 76% for ureteral calculi. The overall stone-free rate for all calculi was 55.7%. Success rate, defined as stone-free or asymptomatic residual fragments measuring 4 mm. or less, was 72% for renal and 83% for ureteral calculi. The overall success rate for all calculi was 73.9%.

Female↗
PubMed1992

Efficacy and tolerability of enteric-coated naproxen in the treatment of osteoarthritis and rheumatoid arthritis: a double-blind comparison with standard naproxen followed by an open-label trial.

One hundred and twenty-three patients with osteoarthritis (n = 50) or rheumatoid arthritis (n = 73) were enrolled in a 6-week, double-blind, randomized, controlled, parallel trial comparing enteric-coated naproxen with standard naproxen. Ninety-eight patients subsequently entered a 20-week, open-label trial of enteric-coated naproxen. The study demonstrated that naproxen in both its standard formulation and its new enteric-coated formulation is a highly effective form of therapy for osteoarthritis and rheumatoid arthritis. The tolerability profiles of the two formulations were similar in terms of the types of complaints reported. It is concluded that enteric-coated naproxen is an efficacious and well-tolerated formulation for the treatment of osteoarthritis and rheumatoid arthritis.

Adult↗
PubMed1992

Open-label tolerability study of enteric-coated naproxen in the treatment of osteoarthritis and rheumatoid arthritis.

Two hundred and ninety-six patients were enrolled in a 6-month, open-label tolerability study of enteric-coated naproxen in patients with rheumatoid arthritis (n = 174) and osteoarthritis (n = 122). Thirty percent of the patients were greater than 65 years of age. Under standard clinical prescribing conditions, enteric-coated naproxen 500 mg twice daily and 375 mg twice daily demonstrated an acceptable tolerability profile that was not different from what one would expect with standard naproxen.

Adult↗
PubMed1992

Efficacy of cyclosporin A in rheumatoid arthritis: long-term follow-up data and the effect on quality of life.

Cyclosporin A is a potent immunomodulator which was used initially in organ transplantation. It has subsequently been used in the management of various autoimmune conditions. This paper is concerned with experience to date with cyclosporin A in the treatment of rheumatoid arthritis. It considers the major clinical trials, long-term experience, and the impact of cyclosporin A on quality of life.

Arthritis, Rheumatoid↗
PubMed1992

Crosscultural validation and reliability of 3 disease activity indices in systemic lupus erythematosus.

Rheumatologists from 4 countries, representing 8 rheumatology centers, tested 3 systemic lupus erythematosus (SLE) disease activity indices: the SLE Disease Activity Index (SLEDAI) from Toronto; the Systemic Lupus Activity Measure (SLAM) from Boston and the British Isles Lupus Assessment Group (BILAG) for their reproducibility and validity in the assessment of real patients. Seven patients representing a spectrum of disease manifestations and activity were each examined by 4 of 7 observers from all centers except Toronto, using a Youden square design. Each observer completed all 3 indices and a category rating scale for disease activity on each of the 4 patients seen. All 3 indices detected differences among patients. There was no detectable observer effect among the 7 observers with each of the 3 indices. There was a detectable order effect with the SLAM. The 3 indices are comparable and reproducible for evaluating disease activity in SLE.

Boston↗
PubMed1991

Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs. A meta-analysis.

OBJECTIVE: To describe the relative risk for serious gastrointestinal complications due to non-aspirin nonsteroidal anti-inflammatory drug (NSAID) exposure among NSAID users as well as in selected subgroups. DESIGN: Overview and meta-analysis. DATA IDENTIFICATION: A literature search of English-language studies examining the association between NSAIDs and adverse gastrointestinal events for the period 1975 to 1990 identified using MEDLINE and communicating with three internationally recognized experts. DATA ANALYSIS: A qualitative summary of study characteristics and a critical appraisal of study quality were done. The results of 16 primary studies were selected and combined statistically. Summary estimates were weighted by sample size and quality score. MAIN RESULTS: The overall odds ratio of the risk for adverse gastrointestinal events related to NSAID use, summarized from 16 studies (9 case-control and 7 cohort) was 2.74 (95% Cl, 2.54 to 2.97). The summary odds ratios were as follows: elderly patients, (aged greater than or equal to 60 years), 5.52 (Cl, 4.63 to 6.60); patients under 65 years of age, 1.65 (Cl, 1.08 to 2.53); women, 2.32 (Cl, 1.91 to 2.82); and men, 2.40 (Cl, 1.85 to 3.11). The summary odds ratio for NSAID users receiving concomitant corticosteroids compared with NSAID users not receiving corticosteroids was 1.83 (Cl, 1.20 to 2.78). The summary odds ratio for the first gastrointestinal event was 2.39 (Cl, 2.16 to 2.65). The relative risk for a subsequent or unspecified gastrointestinal event was 4.76 (Cl, 4.05 to 5.59). The summary odds ratio for less than 1 month of NSAID exposure was 8.00 (Cl, 6.37 to 10.06); for more than 1 month but less than 3 months of exposure, the summary odds ratio was 3.31 (Cl, 2.27 to 4.82); and for more than 3 months of exposure, the summary odds ratio was 1.92 (Cl, 1.19 to 3.13). CONCLUSIONS: Users of NSAIDs are at approximately three times greater relative risk for developing serious adverse gastrointestinal events than are nonusers. Additional risk factors include age greater than 60 years, previous history of gastrointestinal events, and concomitant corticosteroid use. Another possible risk factor is the first 3 months of NSAID therapy. The risk for serious gastrointestinal events appears to be equal among men and women. These data represent summary statistics from 16 studies and cannot be considered generalizable to all NSAID users.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1991

Effects of occupational therapy home service on patients with rheumatoid arthritis.

Because there is little information about the efficacy of home occupational therapy, we decided to assess the effects of a home service on patients with rheumatoid arthritis. 105 patients aged 18-70 years, on stable medical therapy, were randomised to receive a 6-week comprehensive programme of occupational therapy (experimental group, 53 patients) or to receive no such treatment (control group, 52). At 6 weeks, control patients received the experimental regimen, and experimental patients were continued on treatment as needed up to 12 weeks. Outcomes were measured at baseline, 6, and 12 weeks with a global functional capacity score (functional score). At 6 weeks the functional score for the experimental group was significantly higher than that for the control group (mean difference = 8.1, 95% Cl 1.7 to 15.8, p = 0.012). Control patients at 12 weeks showed a similar improvement to experimental patients at 6 weeks, and between 6 and 12 weeks the experimental patients were stable. Occupational therapy leads to a statistically significant and clinically important improvement in function in patients with rheumatoid arthritis.

Activities of Daily Living↗
PubMed1991

Kidney biopsy in systemic lupus erythematosus. II. Survival analyses according to biopsy results.

Renal biopsy specimens from 123 patients with systemic lupus erythematosus (SLE) seen between 1970 and 1984 were assessed according to the World Health Organization classification and according to the presence of proliferative, active, or chronic renal lesions. Survival analysis was used to study the determinants of mortality. Survival rates were higher for patients with minimal lesions, intermediate for patients with focal or diffuse proliferative nephritis, and low for patients with glomerular sclerosis. The presence of proliferative and chronic lesions was associated with a higher risk of dying. Renal biopsy results are helpful in predicting prognosis for all-cause mortality in patients with SLE.

Adult↗
PubMed1991

The utility of the Psychosomatic Symptom Checklist among hospitalized patients.

We examined the utility of the Psychosomatic Symptom Checklist in an inpatient medical setting with particular emphasis on the putative ability of the PSC to discriminate psychosomatic from nonpsychosomatic patients. First, 80 hospitalized psychosomatic patients were compared to 80 hospitalized medical patients on the PSC. Second, a sample of 187 psychosomatic patients was studied to examine the relationship among psychosomatic distress, depression, and functional impairment. The results indicate that while psychosomatic patients scored significantly higher than comparable medical patients on the PSC, discriminant analyses indicate that the PSC is not able to identify psychosomatic patients in an inpatient medical setting. Factor analyses and correlations show that the PSC is positively related to increased depression and decreased functional status. Results are interpreted in light of current psychosomatic theory.

Depression↗
PubMed1991

A comparison of health-related quality-of-life measures for rheumatoid arthritis research. The Auranofin Cooperating Group.

Twenty-eight instruments measuring pain, clinical, functional, and global characteristics were administered to 303 patients in a six-month randomized clinical trial of auranofin and placebo in the treatment of patients with rheumatoid arthritis. The instruments were compared with respect to their responsiveness in detecting a treatment effect, the time involved in administering the instrument, the need for the presence of an interviewer, and ease of administration. The instruments' ability to detect a treatment effect was the deciding characteristic in the clinical, pain, and global categories in choosing the preferred instrument. The counts of tender and swollen joints were found to be the most responsive clinical measures, the 10-cm pain line was the most responsive and the fastest to administer of the pain instruments, and the categorical self-assessment of arthritis was the most responsive global measure. In the functional ability category, the Health Assessment Questionnaire (HAQ), the Keitel Functional Assessment, and the Quality of Well-Being (QWB) Questionnaire were equally responsive. The HAQ was the shortest and the only self-administered questionnaire. The QWB has had the most extensive validation work but was a complex instrument requiring intensive interviewer training. The Keitel was the most time-consuming instrument, but had the advantage of high interobserver agreement. The design of future trials can be guided by the information obtained in this study on their relative efficiencies and ease of use.

Adult↗
PubMed1991

Clinical utility and specificity of anticardiolipin antibodies.

Established solid phase assays for anticardiolipin antibodies (aCL) are often characterized by high levels of nonspecific binding. As a result, only very high levels of aCL have been reported to be associated with a variety of clinical conditions including systemic lupus erythematosus (SLE), recurrent intravascular thrombosis and unexplained recurrent fetal loss. We have developed an ELISA replacing direct evaporation of soluble cardiolipin with cardiolipin micelles in physiological saline as the antigen binding step in the assay. Levels of IgG aCL were detected in various sera at dilutions of 1/100 to 1/3200, showing improved assay sensitivity. Assay specificity was determined using double stranded DNA and ovalbumin as irrelevant binding antigens and no crossreactivity was found. The controversial use of Tween 20 in the assay was investigated and results showed it decreases nonspecific binding without interfering in antibody detection. This assay has enabled us to identify differences in the prevalence and level of aCL antibodies in sera from healthy nonpregnant controls (0/25 positive), healthy pregnant controls (5/47 positive for IgG and 8/47 positive for IgM) and from women with unexplained recurrent fetal loss (16/62 and 14/62 positive, respectively). We support the observation that aCL are not normally distributed, and therefore nonparametric methods of statistical analysis are necessary to determine population prevalence. We confirm that aCL IgM are a relatively nonspecific finding, and extreme caution must be used in basing any clinical decisions on the presence of this antibody alone.

Adolescent↗
PubMed1990

Low-dose cyclosporin versus placebo in patients with rheumatoid arthritis.

144 patients with severe rheumatoid arthritis from six centres were randomised to receive oral cyclosporin or placebo for 6 months. The initial daily dose of cyclosporin was 2.5 mg/kg, which was increased cautiously with monitoring of serum cyclosporin levels and creatinine; the mean stabilisation dose was 3.8 mg/kg. There were significant improvements in the cyclosporin-treated patients compared with the controls in the major outcomes of reduction of active joints (23% improvement), pain (24%), and functional status (16%); global improvement was 27%. In the cyclosporin group serum creatinine increased by a mean of 15.6 mumols/l and mean arterial blood pressure by 6.27 mmHg; these increases were controlled in all but 2 patients by dose adjustment without withdrawal from the study.

Activities of Daily Living↗
PubMed1990

Methotrexate in rheumatoid arthritis. Impact on quality of life assessed by traditional standard-item and individualized patient preference health status questionnaires.

In a double-blind, randomized trial of methotrexate vs placebo in rheumatoid arthritis, the effect of treatment on physical, social, and emotional function was measured in two different ways: the same, standard measurements in all patients, and individualized measurements selected by the patients at the start of the trial as representing the functions they most wanted to have improved by treatment. On the standard measurements, methotrexate-treated patients fared better than placebo-treated patients in their physical, social, and emotional function by 11%, 5%, and 6%, respectively, results that, although statistically significant, were small. However, methotrexate-treated patients were 29% better in the individualized measures, a result that was both highly statistically significant and greater than the differences in the standard measurements or in joint counts, grip strength, proximal interphalangeal joint circumference, morning stiffness, or walking time. Because the individualized measurements were as efficient as the best direct joint examination measures, yet reflected functional outcomes of greatest importance to individual patients, they constitute useful measures for such trials.

Adult↗
PubMed1990

The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee.

To develop criteria for the classification of fibromyalgia, we studied 558 consecutive patients: 293 patients with fibromyalgia and 265 control patients. Interviews and examinations were performed by trained, blinded assessors. Control patients for the group with primary fibromyalgia were matched for age and sex, and limited to patients with disorders that could be confused with primary fibromyalgia. Control patients for the group with secondary-concomitant fibromyalgia were matched for age, sex, and concomitant rheumatic disorders. Widespread pain (axial plus upper and lower segment plus left- and right-sided pain) was found in 97.6% of all patients with fibromyalgia and in 69.1% of all control patients. The combination of widespread pain and mild or greater tenderness in greater than or equal to 11 of 18 tender point sites yielded a sensitivity of 88.4% and a specificity of 81.1%. Primary fibromyalgia patients and secondary-concomitant fibromyalgia patients did not differ statistically in any major study variable, and the criteria performed equally well in patients with and those without concomitant rheumatic conditions. The newly proposed criteria for the classification of fibromyalgia are 1) widespread pain in combination with 2) tenderness at 11 or more of the 18 specific tender point sites. No exclusions are made for the presence of concomitant radiographic or laboratory abnormalities. At the diagnostic or classification level, the distinction between primary fibromyalgia and secondary-concomitant fibromyalgia (as defined in the text) is abandoned.

Adult↗