Biomedical subjects

C Bombardier

Publications and source records attributed to C Bombardier.

At least 109 records · Page 6Linked to original sources

PubMed1994

Sensitivity to change of 3 Systemic Lupus Erythematosus Disease Activity Indices: international validation.

OBJECTIVE: Three indices, the SLE Disease Activity Index (SLEDAI), the Systemic Lupus Activity Measure (SLAM) and the British Isles Lupus Assessment Group (BILAG), have been found to be reliable and valid measures of disease activity in patients with systemic lupus erythematosus (SLE). Our aim was to investigate their use and comparative ability to assess change in disease activity over time. METHODS: Clinical and laboratory features of 8 patients with SLE on each of 3 consecutive visits were abstracted and sent in 3 separate packages to physicians from 8 centers. The order of the patient visit summaries was randomized, and the 3 indices rated in one of 6 specific sequences. RESULTS: The 3 indices were significantly (p < 0.01) correlated: SLEDAI/SLAM = 0.61, BILAG/SLAM = 0.55, SLEDAI/BILAG = 0.35. The sequence presented, the order of patients and order of index scoring did not contribute significantly (p > 0.05) to the variation of any of the 3 indices. All 3 indices detected differences among patients (p < 0.01). Differences between visits were detectable with SLEDAI (p = 0.04) but not with SLAM or BILAG: CONCLUSION: Our study confirms that the SLEDAI, SLAM and BILAG are comparable disease activity measures. SLEDAI appears to be sensitive to change in disease activity over time.

Computers↗

PubMed1993

The cost-effectiveness of misoprostol for nonsteroidal antiinflammatory drug-associated adverse gastrointestinal events.

OBJECTIVE: To compare, in a Canadian health care setting, the costs and consequences of 3 strategies of misoprostol prophylaxis for osteoarthritis patients: prophylaxis for all patients taking nonsteroidal antiinflammatory drugs (NSAIDs), for no patients taking NSAIDs, and for only elderly patients (age > or = 60) taking NSAIDs. METHODS: We designed a decision-analysis model which incorporated costs (estimated with ulcer patient profiles and medical records), review, and probabilities (estimated from a companion meta-analysis, selected literature review, and Ontario Ministry of Health Statistics). Effectiveness was defined as the number of episodes of gastric ulceration requiring hospitalization or outpatient management that were averted by each strategy. RESULTS: On average, prophylaxis cost an additional $650 for every additional gastrointestinal event prevented. Prophylaxis for elderly NSAID users was cost saving if the ulcer complication rate in this group exceeds 1.2%, or if either the charges for outpatient ulcer treatment exceed $2,000, or the 3-month price of misoprostol is < or = $90. CONCLUSION: Our results demonstrate that, in this setting, misoprostol prophylaxis may be highly cost effective.

Aged↗

PubMed1993

The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials.

OBJECTIVE: To develop a set of disease activity measures for use in rheumatoid arthritis (RA) clinical trials, as well as to recommend specific methods for assessing each outcome measure. This is not intended to be a restrictive list, but rather, a core set of measures that should be included in all trials. METHODS: We evaluated disease activity measures commonly used in RA trials, to determine which measures best met each of 5 types of validity: construct, face, content, criterion, and discriminant. The evaluation consisted of an initial structured review of the literature on the validity of measures, with an analysis of data obtained from clinical trials to fill in gaps in this literature. A committee of experts in clinical trials, health services research, and biostatistics reviewed the validity data. A nominal group process method was used to reach consensus on a core set of disease activity measures. This set was then reviewed and finalized at an international conference on outcome measures for RA clinical trials. The committee also selected specific ways to assess each outcome. RESULTS: The core set of disease activity measures consists of a tender joint count, swollen joint count, patient's assessment of pain, patient's and physician's global assessments of disease activity, patient's assessment of physical function, and laboratory evaluation of 1 acute-phase reactant. Together, these measures sample the broad range of improvement in RA (have content validity), and all are at least moderately sensitive to change (have discriminant validity). Many of them predict other important long-term outcomes in RA, including physical disability, radiographic damage, and death. Other disease activity measures frequently used in clinical trials were not chosen for any one of several reasons, including insensitivity to change or duplication of information provided by one of the core measures (e.g., tender joint score and tender joint count). The committee also proposes specific ways of measuring each outcome. CONCLUSION: We propose a core set of outcome measures for RA clinical trials. We hope this will decrease the number of outcomes assessed and standardize outcomes assessments. Further, we hope that these measures will be found useful in long-term studies.

Arthritis, Rheumatoid↗

PubMed1993

Validity of rheumatoid arthritis diagnoses listed in the Saskatchewan Hospital Separations Database.

A Saskatchewan hospital separations database was compared to abstracted hospital records to determine the reliability of the database (i.e. accuracy with which the computer data reflect the charts from which they were coded) and the validity of classifying rheumatoid arthritis status with the database (i.e. the extent to which rheumatoid arthritis mentioned in the database reflected the condition of the patient). A sample of hospitalized subjects fell into three categories: 144 who never had a database diagnosis of any arthritis, 146 who had a database diagnosis of osteoarthritis, and 142 who had a database diagnosis of rheumatoid arthritis. These 432 people experienced 1717 hospitalizations eligible to match a hospital database listing by date, and 1618 matched. Of the remaining 99, 35 were relatively recent and probably had not yet been entered into the database, 39 were possibly entered incorrectly, and 25 could not be matched in any way. Of 150 hospitalizations with a database diagnosis of rheumatoid arthritis, this diagnosis was in the hospital record for 125. Chart documentation of rheumatoid arthritis status was greatest for subjects who, according to the database, were hospitalized by a rheumatologist: of 73 subjects in this category, abstractions showed 69.9% met > or = 5 American Rheumatism Association criteria, 15.1% met < 5 criteria but had a rheumatologist's diagnosis of rheumatoid arthritis, 1.3% met < 5 criteria and had a rheumatoid arthritis diagnosis by a non-rheumatologist, and 13.7% had no mention of rheumatoid arthritis or its symptoms in any medical record abstracted. In summary, reliability of the database was excellent, but validity depended on the source of diagnosis.

Arthritis, Rheumatoid↗

PubMed1993

Record linkage to conduct an epidemiologic study on the association of rheumatoid arthritis and lymphoma in the Province of Saskatchewan, Canada.

The objective of this effort was to assess the utility of the large automated database in Saskatchewan as a resource for pharmacoepidemiologic studies. To this end a study was undertaken to test the hypothesis that rheumatoid arthritis (RA) increases the risk of cancer, especially lymphoma. This was done by performing a retrospective cohort study based on record linkage data from Saskatchewan Health. From hospital discharge diagnoses in the hospital file an exposed group (RA) and two comparison groups matched to the RA group by age and sex were identified: (1) the RA group consisted of people with a discharge diagnosis of rheumatoid arthritis; (2) the osteoarthritis (OA) group consisted of people with OA discharge diagnoses; and (3) a comparison (CN) group consisted of hospitalized people with no discharge diagnoses of arthritis. Drug exposures were determined by linkage with the Prescription Drug File, cancer outcomes were determined by linkage with the Cancer Foundation file, and length of eligibility in the health plan and demographics information were determined by linkage with the registration file. The data were checked for quality of linkages across files and consistency with study definitions. Of 13,333 identified subjects, 2.8% were excluded because of apparent incorrect assignment to study group or age group or because of ineligibility in health plan during the study period. In order to decrease the possibility of misclassification of exposure (rheumatoid arthritis), hospital discharge diagnoses were used to exclude subjects with any inflammatory rheumatic diseases (IRD) from the CN (7.8%) and OA (8.3%) groups and subjects with IRD other than rheumatoid arthritis (4.6%) from the RA group. To decrease selection bias, those who had cancer within 1 year of enrollment (to exclude those in hospital because of symptoms of undiagnosed cancer) were excluded. Because RA subjects hospitalized by a rheumatologist were most likely to have valid rheumatoid arthritis diagnoses, each analysis was run twice: once with the entire RA group (N = 1210) and once with those in the RA group who were rheumatologist-hospitalized (N = 646). Logistic regression of incidence was used to control for age, sex, and use of individual disease-modifying anti-rheumatoid drugs (DMARDs). For the rheumatologist-hospitalized RA group compared to the CN group, a significant 4-fold greater risk for lymphoma/myeloma was detected when DMARD use was not controlled for, and a 3.4-fold increase in risk was detected even when use of individual DMARDs was controlled for.(ABSTRACT TRUNCATED AT 400 WORDS)

Arthritis, Rheumatoid↗

PubMed1993

A randomized trial of a decisional aid for mental capacity assessments.

The objective of this study was to evaluate the clinical utility of a decisional aid for mental capacity assessments which was developed using a group judgment methodology. This was carried out by a randomized, controlled trial. The subjects comprised 64 University of Toronto psychiatry residents in postgraduate years 1 through 4. Residents were randomized to carry out mental capacity assessments on simulated cases with, or without, the use of the decisional aid. The main outcome measure was the extent of agreement between the mental capacity determinations of residents and those of experts. There was no difference between the intervention and control groups with respect to the overall mean level of agreement with experts (0.87 vs 0.86, p = 0.88; 95% confidence interval for the difference between the study groups, -0.07 to +0.08). A logistic regression analysis, which adjusted for imbalances between the groups, also revealed no difference between the groups in their agreement with experts. The mean time per competency assessment was significantly longer in the intervention group (19.1 vs 10.8 min; p < 0.001). It was concluded that the decisional aid did not improve the ability of the psychiatry residents to make mental capacity assessments on simulated cases. Despite relatively limited formal training, the psychiatry residents had a high level of agreement with experts.

Adult↗

PubMed1993

Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines.

Clinicians and researchers without a suitable health-related quality of life (HRQOL) measure in their own language have two choices: (1) to develop a new measure, or (2) to modify a measure previously validated in another language, known as a cross-cultural adaptation process. We propose a set of standardized guidelines for this process based on previous research in psychology and sociology and on published methodological frameworks. These guidelines include recommendations for obtaining semantic, idiomatic, experiential and conceptual equivalence in translation by using back-translation techniques and committee review, pre-testing techniques and re-examining the weight of scores. We applied these guidelines to 17 cross-cultural adaptation of HRQOL measures identified through a comprehensive literature review. The reporting standards varied across studies but agreement between raters in their ratings of the studies was substantial to almost perfect (weighted kappa = 0.66-0.93) suggesting that the guidelines are easy to apply. Further research is necessary in order to delineate essential versus optional steps in the adaptation process.

Cross-Cultural Comparison↗

PubMed1993

The optimal use of cyclosporin A in rheumatoid arthritis: efficacy and outcome measures including quality of life.

The debate as to which outcome measures are appropriate in clinical trials involving RA has been in progress for some time. A recent critique (Felson DT et al. Arthritis Rheum 1990;33:140-9) addressed some of the problems that have been raised and suggested solutions. Shortcomings noted included multiple measures, lack of standardization and insensitive measures. This paper discusses those and other areas of concern in the light of the findings of consensus meetings that have taken place recently and which suggest that agreement is within reach.

Arthritis, Rheumatoid↗

PubMed1993

Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee.

OBJECTIVE: To further the development of criteria for clinically important changes in outcomes seen in rheumatoid arthritis (RA) patients and trials. METHODS: Small group discussions and voting on specially designed profiles based on a 6 factor 2 level factorial design for changes seen in patients and trials. The purpose was to bring out the implicit opinions of participants on these issues, to complement the explicit opinions expressed in the OMERACT questionnaire. This took place at a conference of rheumatologists, methodologists, biostatisticians, regulatory, pharmaceutical and biotechnology industry personnel with an interest in therapies for patients with RA. Data from patients with RA and randomized clinical trials of second line drugs in patients with RA formed the basis to create 64 patient profiles and 64 trial profiles. The profiles contained information on changes in 6 measures: swollen joint count, tender joint count, pain, patient global assessment, physician global assessment and physical disability. The profiles were prepared on 4" x 5" cards and presented to the participants in packages of 64 in random order, in 2 different group sessions. Participants were assigned to 8 groups that contained a mix of all types of participants, with a majority of clinicians in each group. In the patient profile session, individual participants scored whether the profile represented important improvement. In the trial profile session, participants did likewise for important difference between the drugs. After structured discussion the group then voted: consensus was defined as agreement by at least 70% of the group. We decided that an important improvement or difference was present in the profiles on which at least 6 of the 8 groups had achieved consensus. The changes in the profiles showing important improvement or difference can be used to suggest minimum criteria for each of the 6 measures. RESULTS: The lower quartile of the change present in the patient profiles with important improvement varied from 17% (swollen joints) to 49% (disability); the median of these quartiles was 36%. The lower quartile of the differences present in the trial profiles with important differences varied from 13% (tender joints) to 26% (physician global); the median of these quartiles was 18%. CONCLUSIONS: This approach has provided a beginning for less arbitrary definition of criteria for important change in patients and trials. It might be suggested that for patients, an improvement of at least 36% should be clinically important, while an active drug needs to be at least 18% better than placebo to be clinically important.

Arthritis, Rheumatoid↗

PubMed1993

A reliability study of SLEDAI: a disease activity index for systemic lupus erythematosus.

SLEDAI, a disease activity index for systemic lupus erythematosus (SLE) has been validated against other such indices and its reliability has been shown by specialists in SLE. To assess its reliability among less experienced clinicians, we conducted a reliability study with 3 rheumatology trainees and 9 patients with SLE according to a Latin square design. SLEDAI easily distinguished between patients (p = 0.0009), and physician variability was not statistically significant (p = 0.27). Inter and intraobserver agreement were 78.7 and 98.0%, respectively. SLEDAI was thus shown to be a reliable instrument among less experienced observers for the assessment of disease activity in SLE.

Education, Medical, Graduate↗

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↗