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C Bombardier

Publications and source records attributed to C Bombardier.

At least 55 records · Page 3Linked to original sources
PubMed1999

Function and health-related quality of life: results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group.

OBJECTIVE: To assess the efficacy of leflunomide or methotrexate compared with placebo in improving function and health-related quality of life in patients with active rheumatoid arthritis (RA), and to examine correlations between response status (as defined by the American College of Rheumatology [ACR] response criteria) and improvement in these measures. METHODS: This 52-week, multicenter, doubleblind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health Assessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work productivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Improvement in the PET top 5 and SF-36 scales and component scores were compared with ACR response rates. RESULTS: Clinically meaningful and statistically significant (P<0.0001) improvement in measures of function and heath-related quality of life (MHAQ scores, all scales and disability index of the HAQ, weighted top 5 score of the PET, 5 of 8 scales and physical component score of the SF-36, and work productivity) was seen during treatment with leflunomide in comparison with placebo. Methotrexate administration resulted in significant improvements (P<0.05) in comparison with placebo in the MHAQ scores, HAQ disability index, weighted top 5 score of the PET, physical component score of the SF-36, and bodily pain scale. Compared with methotrexate, leflunomide administration resulted in significantly (P<0.01) more improvement in the MHAQ scores, 5 of 8 scales and disability index of the HAQ, weighted top 5 score of the PET, and 2 of 8 scales and physical component score of the SF-36. Improvements in the PET score, SF-36 physical component score, and work productivity correlated with the ACR responder rates of > or =20% and > or =50% improvement. CONCLUSION: Significant improvements in function and health-related quality of life occurred in patients with RA during treatment with leflunomide or methotrexate. These findings were clinically meaningful and correlated with the ACR response status.

Adjuvants, Immunologic↗
PubMed1999

Clinimetric and psychometric strategies for development of a health measurement scale.

Clinimetrics and psychometrics, two accepted methods for developing multiitem health measurement scales, have fundamentally different aims and methods that have seldom been compared and never prospectively. The purpose of this study was to determine whether these two methodologies provided comparable scales in the development of an upper extremity disability measure. Psychometric analysis involved field testing a 70-item questionnaire on 407 patients. Equidiscriminatory item total correlation (EITC) was used to select the top 30 items. Clinimetric testing used the mean importance and severity ratings of the 70 items by 76 patients to select the top 30 items. Clinimetric and psychometric analyses were performed independently. Cronbach's alpha was 0.97 for the top 30 items selected by EITC and 0.96 for the items selected based on patient's ratings. The two scales (after clinician modification to improve face validity) shared 16 items in common (P=0.10). The intraclass correlation coefficient of the patient scores on the two 30-item scales was 0.93 before clinician input and 0.97 after. The mean (and standard deviation) difference between scales was 9.1 (8.8) before and 1.7 (5.2) after clinician input. A scale developed with a clinimetric strategy can measure a complex (so-called heterogeneous) clinical phenomenon (thought to be composed of several patient attributes) but still fulfill psychometric criteria for "homogeneity." Thus, these strategies for the development of health measurement scales, which have been considered potentially opposite or conflicting, may be complementary.

Adult↗
PubMed1999

How should importance and severity ratings be combined for item reduction in the development of health status instruments?

Patients' ratings of the severity and importance of items are often used to select items for health status instruments. The purpose of this study was to compare six different methods of combining severity-importance ratings. Two different patient groups separately rated the importance and severity of their complaints; (i) 76 patients with upper-extremity disorders rated 70 upper-extremity-related questions; and (ii) 86 patients with hip arthrosis rated 22 questions relating to their hip problem. The rank ordering of the items using the six different methods in the two populations were very similar (tau(bi) = 0.91 and 0.87, respectively). Furthermore, the six methods when used to choose 30 upper-extremity items shared 25 items in common and shared 9 (of 10) hip items in the second group. In conclusion, the results of item reduction were not affected by the method of creating importance-severity ratings.

Activities of Daily Living↗
PubMed1999

Capturing health care utilization after occupational low-back pain: development of an interviewer-administered questionnaire.

The aim of this study was to develop and test the feasibility and validity of a patient questionnaire to assess health care utilization after occupational low-back pain (LBP). Items generated after a literature search were revised and refined on the basis of their face and content validity (judged by a group of practitioners) and pretested with six lay subjects who had LBP. The 73-item questionnaire was then tested in interviews with subjects with acute, subacute, or chronic LBP. Its validity was judged by comparison with a prospective patient diary and with care-provider reports. Chance-corrected agreement was estimated using the kappa statistic. Response rates were 78%, 70%, and 59% for interview, diary, and provider reports, respectively. Eighty of 102 eligible workers completed the interview in an average of 45 minutes (SD = 17.7). Most LBP subjects (90.1%) found it easy to answer. In the opinion of the interviewer, 94.7% of subjects showed adequate comprehension and ability to recall. With a few exceptions, there was moderate to substantial agreement between the interview and the patient diary (most K values between 0.38 and 0.78). Overall, subjects reported more health care services to the interviewer than they recorded in the diary. Owing to the low response rate from providers, comparison with provider reports had to be restricted to 48 subjects and to physicians' reports only. Agreement between interviews and physicians' reports was substantial in use of plain X-rays (kappa = 0.79) and computed tomography scans (kappa = 0.85), but physicians often reported referrals not volunteered by the subjects. Agreement on prescription medications was fair (kappa = 0.29-0.46) with no systematic over reporting or under reporting. Our interviewer-administered questionnaire had better return rate than the patient diary and provider reports. It was easy to administer and understand. On the basis of our comparison with patient diaries and physicians' reports, we conclude that this questionnaire is a sufficiently valid source of health care utilization data in subjects with LBP.

Adult↗
PubMed1999

What do we know about the reliability and validity of physical examination tests used to examine the upper extremity?

The literature regarding the reliability and validity of commonly used clinical tests for disorders of the upper extremity was reviewed. Formal literature search, standard texts, and experts in the field of upper extremity were consulted to locate relevant articles. Range of motion and strength testing of the upper limb have been shown to be reliable, while various tests used for the diagnosis of conditions in the upper limb, such as carpal tunnel syndrome and rotator cuff tendinopathy, have been shown to have varying degrees of validity. Overall, however, we determined that there is little evidence regarding the reliability and validity of physical examination for the upper extremity and specifically less information available regarding the reliability of diagnostic physical examination tests and the validity of impairment measures used for the upper limb. Further studies in this area are warranted in view of the impact of these findings on the treatment of patients.

Arm↗
PubMed1999

Physician enthusiasm as an explanation for area variation in the utilization of knee replacement surgery.

BACKGROUND: Explanations for regional variation in the use of many medical and surgical treatments is controversial. OBJECTIVES: To identify factors that might be amenable to intervention, we investigated the determinants of regional variation in the use of knee replacement surgery. RESEARCH DESIGN: We examined the effect of the following factors: characteristics and opinions of surgeons; family physicians and rheumatologists; patients' severity of disease before knee replacement; access to knee-replacement surgery; surgeons' use of other surgical treatment; and county population characteristics. OUTCOMES MEASURE: County utilization rates of knee replacement in Ontario, Canada. RESULTS: Counties that had higher rates of knee replacement had older patients (P = 0.0001), higher percentage of medical school affiliated hospital beds (P = 0.04), with more male (P = 0.02) non-North American trained referring physicians (P = 0.002) and orthopedic surgeons who had higher propensities to operate and better perceptions of outcome (P = 0.0001). CONCLUSIONS: After controlling for population characteristics and access to care (including the number of hospital beds, and the density of orthopaedic and referring physicians), orthopaedic surgeons' opinions or enthusiasm for the procedure was the dominant modifiable determinant of area variation. Thus, research needs to focus on the opinions of surgeons which may be important in reducing regional variation for knee replacement.

Adult↗
PubMed1999

Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies?

The juxtaposition of economic and clinical evaluation raises new issues in the design of clinical trials. Recent pharmacoeconomic guidelines provide some direction, but do not deal with the appropriate timing of economic evaluations in the drug developmental process. Ideally, pharmacoeconomic data should be available at the time of the regulatory and formulary decision making. Current pivotal phase III trials do not provide these data; they are designed to test safety and efficacy (does the drug work under optimal circumstances?) and not to answer questions about the effectiveness of a drug, the more relevant question for economic analysis (does the drug work in usual care?). The use of more "naturalistic" designs for some phase III randomised trials has been suggested. These so called "effectiveness trials" more closely reflect routine clinical practice. They use a more flexible dosage regimen, and a "usual care" instead of a placebo comparator. Patients randomised are more representative of actual practice and outcomes include quality of life and utility measures. They are more suited to provide the data needed to estimate the real benefit of the treatment in actual care. When costs are applied and compared with these benefits, you can estimate the efficiency of allocating resources to this new drug. Increasing the use of effectiveness trials in phase III would decrease the need for economic modelling.

Antirheumatic Agents↗
PubMed1999

Patient based methods for assessing adverse events in clinical trials in rheumatology. Progress report for the OMERACT Drug Toxicity Working Party. Outcome Measures in Rheumatology.

There has been increasing recognition in recent years that the measurement of drug related toxicities in rheumatology clinical trials has been sub-optimal. The OMERACT Drug Toxicity Working Party was established to address this issue. The first task of the working party was to identify a minimum set of attributes of drug related toxicity that would be important to patients, clinicians, investigators, and policymakers. The working party then developed consensus on a standard set of properties for instruments to measure these attributes. Existing instruments in the field of rheumatology were ascertained by literature review and by contact with experts in the field. Four instruments were ascertained and evaluated using the guidelines developed by the working party. This report outlines the progress and preliminary results of these activities.

Antirheumatic Agents↗
PubMed1998

Outcome measures for low back pain research. A proposal for standardized use.

STUDY DESIGN: An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. OBJECTIVES: To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies. SUMMARY OF BACKGROUND DATA: Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction with care. METHODS: The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such, as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. RESULTS: First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care. CONCLUSION: Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6-item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.

Clinical Trials as Topic↗
PubMed1998

Preventing disability from work-related low-back pain. New evidence gives new hope--if we can just get all the players onside.

Despite the publication in the mid-1990s of comprehensive practice guidelines for the management of acute low-back pain, both in the United States and elsewhere, this ubiquitous health problem continues to be the main cause of workers' compensation claims in much of the Western world. This paper represents a synthesis of the intervention studies published in the last 4 years and is based on a new approach to categorizing these studies that emphasizes the stage or phase of back pain at the time of intervention and the site or agent of the intervention. Current thinking suggests that medical management in the first 3-4 weeks after the onset of pain should be generally conservative. Several studies of rather heterogeneous interventions focusing on return to work and implemented in the subacute stage (3-4 to 12 weeks after the onset of pain) have shown important reductions in time lost from work (by 30% to 50%). There is substantial evidence indicating that employers who promptly offer appropriately modified duties can reduce time lost per episode of back pain by at least 30%, with frequent spin-off effects on the incidence of new back-pain claims as well. Finally, newer studies of guidelines-based approaches to back pain in the workplace suggest that a combination of all these approaches, in a coordinated workplace-linked care system, can achieve a reduction of 50% in time lost due to back pain, at no extra cost and, in some settings, with significant savings.

Absenteeism↗
PubMed1998

Trends in hospital use for mechanical neck and back problems in Ontario and the United States: discretionary care in different health care systems.

OBJECTIVE: To describe and compare trends in hospital admission rates for mechanical neck and back problems between 1982 and 1992 in Ontario and the United States. DESIGN: A descriptive analysis of hospital admissions, with data for Ontario extracted from the Canadian Institute for Health Information database and data for the US extracted from the National Hospital Discharge Survey. SETTING: All acute care hospitals in Ontario and a probability sample of acute care hospitals in the US. PATIENTS: Adults aged 20 years or more who were admitted to an acute care hospital for mechanical neck or back problems in 1982, 1987 or 1992. Mechanical neck and back problems were defined using an algorithm developed by the study team. OUTCOME MEASURE: Hospital admission rate per 100,000 adults. RESULTS: Between 1982 and 1992 the hospital admission rate for medically treated cases decreased by 52% in Ontario and by 75% in the US. Over the same period the admission rate for surgically treated cases increased by 14% and by 35% respectively. By 1992 the admission rate for medically treated cases in the US was 23% higher than that in Ontario, whereas the rate for surgically treated cases was 164% higher. CONCLUSIONS: The hospital-based medical or surgical treatment of mechanical neck and back problems provides an example of discretionary care. The higher admission rates for surgery in the US may reflect a larger supply of surgical specialists and imaging units. Further work is needed to confirm these findings for other types of discretionary care and to compare the appropriateness of care and clinical outcomes for discretionary care in these 2 jurisdictions.

Adult↗
PubMed1998

The cost-effectiveness of misoprostol in preventing serious gastrointestinal events associated with the use of nonsteroidal antiinflammatory drugs.

OBJECTIVE: To reexamine the cost-effectiveness of misoprostol, using data from a recently published placebo-controlled trial of misoprostol in > 8,000 patients with rheumatoid arthritis (RA) taking nonsteroidal antiinflammatory drugs (the Misoprostol Ulcer Complications Outcome Safety Assessment [MUCOSA] study). METHODS: Actual clinical events and the rates of endoscopies and upper gastrointestinal (GI) radiographic series, hospitalizations, and surgery for these events were derived from the MUCOSA study and used in a decision analysis. Estimates of costs for the management of these events were derived from the Ontario Case Cost Project database and published economic evaluations; costs were adjusted to 1994 Canadian dollars. Incremental cost-effectiveness (from the viewpoint of the provincial health care plan in Canada) was calculated for the original trial population (risk of a serious GI complication 1%) and for the subsets of patients with medium (3%) and high (6%) risk. RESULTS: For the original study population, averting 1 serious GI complication by prescribing misoprostol would cost an additional $94,766 (Canadian; range $60,286-137,146). For patients with previous peptic ulcer disease (medium risk), the cost would be $14,943 (range $10,912-32,157), and for patients with previous peptic ulcer disease and age > 75 (high risk), the cost would be $4,101 (range $-220 to $18,146). CONCLUSION: Prescribing misoprostol for all patients with RA who are > or =52 years old costs $94,766 for each additional GI event averted. However, when patients at higher risk are specifically selected, the cost per averted GI complication is markedly reduced. These results, based on actual serious event rates and actual data on endoscopies and upper GI series, hospitalizations, and surgeries, provide a better estimate of the true cost-effectiveness of misoprostol than previous analyses based on endoscopic data and modeling of all resource utilizations.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1998

The reliability of physical examination for carpal tunnel syndrome.

The goal of this study was to determine the interobserver and intraobserver reliability of static and moving two-point discrimination, Semmes-Weinstein monofilament testing, Tinel's test, manual motor testing of abductor pollicis brevis, vibration and Phalen's test in the diagnosis of carpal tunnel syndrome. Twelve patients with suspected carpal tunnel syndrome were examined in an outpatient setting. The interobserver reliability was satisfactory for all tests except for Semmes-Weinstein monofilament testing. Intraobserver reliability was also satisfactory for all tests. Static two point discrimination had higher reliability than moving two-point discrimination. Seven tests for the diagnosis of carpal tunnel syndrome were reliable in the hands of skilled health care professionals. Hand surgeons and hand therapists examined patients more reliably than occupational health workers.

Adult↗
PubMed1998

A review of cost-effectiveness analyses in rheumatology and related disciplines.

A MEDLINE search of the 1996 and 1997 literature yielded two reviews of the methodology of cost-effectiveness analyses (CEAs) in the field of rheumatology and eight original CEAs evaluating slow-acting antirheumatic agents (two studies), total hip arthroplasty for patients with osteoarthritis (one study), educational intervention for patients with fibromyalgia (one study), interventions for patients with low back pain (three studies), and hormone replacement therapy for women with osteoporosis (one study). Most CEAs relied on modelling of data that were assembled from various sources; however, in one CEA a cost-effectiveness comparison was based on data collected prospectively within a randomized clinical trial. Extensive sensitivity analyses were conducted by a majority of the studies. The CEAs of slow-acting antirheumatic agents provided results that were difficult to interpret given extensive modelling and reliance on expert estimates. Only one CEA was supported by an industry grant. Most of the studies were of high quality and met current methodologic requirements, including the use of discounting, sensitivity analysis, and incremental analysis. However, the major shortcoming of these recent studies continues to be the use of estimated costs instead of prospectively measured resource utilization data presented in terms of separate physical units.

Cost-Benefit Analysis↗
PubMed1998

Health-related quality of life after knee replacement.

A cross-sectional, community-based survey of a random sample of 1750 of 242,311 Medicare recipients was performed. The patients were at least sixty-five years old and had had a primary or revision knee replacement (either unilaterally or bilaterally) between 1985 and 1989. Three samples were surveyed separately: a national sample (to reflect the United States as a whole) and samples from Indiana and the western part of Pennsylvania (sites chosen for convenience to assess the validity of the findings for the national sample on a regional level). Each sample was stratified by race, age, residence (urban or rural), and the year of the procedure. Valid and reliable questionnaires were used to elicit the participants' assessments of pain, physical function, and satisfaction two to seven years after the knee replacement. Of the 1486 patients who were eligible for inclusion in the survey, 1193 (80.3 per cent) responded. The mean age of the respondents was 72.6 years. Eight hundred and forty-nine respondents (71.2 per cent) were white, and 849 (71.2 per cent) were women. The participants reported that they had little or no pain in the knee at the time of the survey, regardless of the age at the time of the knee replacement, the body-mass index, or the length of time since the knee replacement. After adjustment for potential confounding variables, predictors of better physical function after the replacement were an absence of problems with the contralateral knee, primary knee replacement (rather than revision) (Indiana sample only), and a lower body-mass index (Indiana and western Pennsylvania samples). Four hundred and fifteen (85.2 per cent) of the 487 patients in the national sample were satisfied with the result of the knee replacement. In what we believe to be the first community-based study of the outcome of knee replacement, patients reported having significant (p = 0.0001) and persistent relief of pain, improved physical function, and satisfaction with the result two to seven years postoperatively. The findings of the present study suggest that age and obesity do not have a negative impact on patient-relevant outcomes (pain and physical function). Dissemination of these findings has the potential to increase appropriate referrals for knee replacement and thereby reduce the pain and functional disability due to osteoarthrosis of the knee.

Aged↗
PubMed1998

A randomized controlled trial to assess the incidence of new onset hypertension in patients after shock wave lithotripsy for asymptomatic renal calculi.

PURPOSE: To answer the question of whether extracorporeal shock wave lithotripsy (ESWL*) induces hypertension, a prospective, randomized controlled trial of normotensive patients with asymptomatic renal calculi was designed. MATERIALS AND METHODS: Patients were randomized to receive immediate ESWL versus observation, reserving ESWL for the onset of symptoms. The rates of new onset hypertension were evaluated for both groups. RESULTS: There was no observed difference in the incidence of hypertension between the treatment and observation groups. CONCLUSIONS: The risk of hypertension in patients undergoing ESWL therapy is similar to that of a control cohort of initially observed asymptomatic patients.

Adult↗