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N Bellamy

Publications and source records attributed to N Bellamy.

At least 73 records · Page 4Linked to original sources
PubMed1997

Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index.

OBJECTIVE: To study the validity and feasibility of a computerized version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. METHODS: Thirty patients with osteoarthritis (OA) of the knee completed both a paper and a computerized version of WOMAC in random order. The visual analog scaled version of WOMAC, VA3.0, was used. We studied criterion validity by comparing the paper and computerized versions. RESULTS: All patients completed the computerized version without undue difficulty. Criterion validity, based on aggregated subscale scores, was excellent: Pain, ICC = 0.89, Stiffness, ICC = 0.87, Physical Function, ICC = 0.95. CONCLUSION: The computerized version of WOMAC VA3.0 is a valid alternative to the paper version.

Aged↗
PubMed1996

Treating musculoskeletal disease with NSAIDs. Practitioner's guide.

Although not a panacea for all painful conditions, nonsteroidal anti-inflammatory drugs (NSAIDs) are the mainstay of treatment for most musculoskeletal disorders in the western world. This article offers a practical guide to NSAIDs based on six clinical issues that strongly affect the outcome of treatment.

Adult↗
PubMed1995

Osteoporosis in rheumatoid arthritis. A monozygotic co-twin control study.

OBJECTIVE: To quantify the magnitude and distribution of osteoporosis in rheumatoid arthritis (RA). METHODS: Bone mineral density (BMD) was measured by dual x-ray absorptiometry, in a monozygotic co-twin control study. RESULTS: BMD was reduced at most skeletal sites in the twin with RA compared with the co-twin (lumbar spine 4.6%, femoral neck 9.7%, total body 5.7%). Differences in lean soft tissue (5.6% for total body) correlated with differences in BMD between twins at multiple sites. CONCLUSION: Osteoporosis in RA is generalized and may be related to loss of mobility or muscle mass associated with the disease.

Arthritis, Rheumatoid↗
PubMed1995

Variability of skin scores and clinical measurements in scleroderma.

OBJECTIVE: To determine the variability of several clinical outcome measurements commonly used in scleroderma clinical trials. METHODS: Ten researchers, members of a multicenter placebo controlled trial of methotrexate in early diffuse scleroderma, studied the intraobserver and interobserver variability of variables used to assess efficacy in scleroderma trials. RESULTS: For most measures, the variability within an observer was less than that found between observers, and therefore the intraobserver reliability was better than the interobserver reliability. The reliability of the modified Rodnan skin score exceeded the Rodnan skin score. Measures with inherent interpretation such as global assessments and skin scores had more variability than easily performed measurements such as grip strength and oral opening. CONCLUSION: Some of our variability was higher than variability previously reported; this could be due to the large number of examiners and patients in our study.

Female↗
PubMed1995

Health status instruments / utilities.

Rheumatologists and other interested professionals at the OMERACT II conference formed small groups to discuss whether it was sensible to use a generic health status instrument in musculoskeletal disease trials. These instruments promise the possibility of comparison of health status between disease states. However, data is lacking on validity of the current generation of instruments to support their use. Participants had little personal experience with these instruments. After inspection, many voiced strong concerns over comprehensiveness and responsiveness. Many dimensions of health relevant for patients with this group of diseases were felt to be underrepresented. The dimension of adverse effects was universally absent, although this is more a problem of state of the art in trial methodology than a problem of these measures. Although there is little data, the small number of response categories in the dimensions covered, plus the lack of comprehensiveness, make it likely that responsiveness will be low. Further research, especially the adoption of one or more generic measures alongside specific measures, both in trials and in observational studies, is necessary to validate and improve the current generic measures. Until that time, valid conclusions and health policy regarding musculoskeletal diseases cannot be based on generic measures of health status.

Health Status↗
PubMed1995

Outcome measurement in osteoarthritis clinical trials.

The clinical assessment of outcome in osteoarthritis (OA) clinical trials is highly dependent on the use of valid, reliable, and responsive measurement techniques. Despite several decades of clinical studies, and a half-century of development in clinical metrology, we still lack international standards of measurement for OA trials. There have, nevertheless, been several very encouraging developments. In particular, the Osteoarthritis Research Society and the 5th WHO/ILAR Task Force have discussed issues of standardization. The Western Ontario and McMaster Universities Osteoarthritis Index and Lequesne Index have been proposed as important outcome measures. Finally, data have recently been published on observer variability, variance estimation, and sample size determination for OA trials.

Canada↗
PubMed1995

Sample size calculations in scleroderma: a rational approach to choosing outcome measurements in scleroderma trials.

Subjects with both diffuse and limited scleroderma were studied to calculate the baseline characteristics of several commonly used outcome measurements in order to provide parameters for sample size calculations for scleroderma clinical trials. From these estimates, outcome measurements were chosen as potentially responsive to change in clinical trials if their sample sizes were not prohibitively large. Forty-five patients with scleroderma were systematically assessed to determine the means and standard deviations whereby sample size calculations can be performed using this information. Examples of sample sizes were determined for the entire group, and for 2 subsets: those with diffuse scleroderma and those with diffuse disease of recent onset. Many baseline characteristics were significantly different in patients with diffuse compared to limited systemic sclerosis. The baseline values were different for the Health Assessment Questionnaire (HAQ) disability score, Functional Index, grip strength, oral aperture, finger-to-palm distance, skin score, and physician global assessment. Sample sizes can vary widely depending upon the outcome measurement chosen and the range of deltas used within the different scleroderma subsets. Sample size requirements for many outcome measures are extremely large due to marked variability in the baseline measures. Primary outcome measures in scleroderma trials should be chosen which have adequate power to detect a minimal clinically relevant change in the primary outcome measurements at the sample sizes employed. All other outcome measures should be ranked as secondary. Skin scores, global assessments, and grip strength measurements require smaller sample sizes than the other outcome measurements which were studied. Sample sizes in future trials will vary depending upon the proportion of patients with diffuse and limited scleroderma who are included.

Female↗
PubMed1995

A multicenter study of nabumetone and diclofenac SR in patients with osteoarthritis.

OBJECTIVE: To conduct the first Canadian study of the comparative efficacy and safety of nabumetone and diclofenac SR in patients with primary osteoarthritis (OA) of the hip, knee and shoulder. METHODS: Nabumetone 1000-1500 mg po daily was compared to diclofenac SR 100-150 mg po daily in a 6-month, double blind, randomized, controlled, multicenter, parallel trial. Initial starting doses were nabumetone 1000 mg daily and diclofenac SR 100 mg daily, with optional subsequent one-level dose titration permitted after 2 weeks on lower dose up to 1500 mg nabumetone and 150 mg diclofenac SR. The primary outcome measures were overall pain and disease activity as assessed by physician and patient. Secondary efficacy measures included tenderness, swelling, limitation of motion, duration of morning stiffness, acetaminophen consumption, physician and patient global assessment, and patient evaluation of efficacy and tolerability. Following an initial screening visit and a 2 to 7 day nonsteroidal antiinflammatory drug free washout period (i.e., randomization), patients were assessed at Weeks 2, 8, 14, 20, and 26. RESULTS: In all, 382 patients [nabumetone (n = 192), diclofenac SR (n = 190)] participated in the trial. Improvement in all efficacy variables was noted, but there was no statistically significant difference between drugs. Significantly fewer (p = 0.01) patients reported upper gastrointestinal (GI) adverse experiences in the nabumetone group. Significantly fewer (p < 0.04) patients withdrew from the study for adverse experiences in the nabumetone (14%) than the diclofenac SR (23%) group, particularly from upper abdominal pain (p < 0.04) and dyspepsia (p = 0.02). Three patients treated with diclofenac SR and none with nabumetone developed upper GI ulcers or bleeds. The number of patients experiencing clinically important elevations in transaminases (p < 0.04) or BUN/creatinine (p < 0.03) was significantly lower in the nabumetone group. CONCLUSION: Nabumetone is efficacious and well tolerated in patients with OA of the hip, knee or shoulder. In this group of patients it was similar in efficacy and superior in tolerability to diclofenac SR.

Adult↗
PubMed1994

Guidelines for testing slow acting drugs in osteoarthritis.

New compounds appear to improve symptoms of osteoarthritis (OA), and others are putative chondroprotective agents. We suggest experimental designs for studying the effects of these agents in subjects with hip and knee OA. The course of the articular cartilage lesion is the primary outcome measure to be assessed in putative chondroprotective agent trials. Serial radiographic studies suggest that the annual rate of joint space narrowing in patients with hip or knee OA is about 0.25 mm. Other approaches to quantitation of cartilage loss, e.g., radiographic measurement of the area of joint space, ultrasonography, magnetic resonance imaging and fiberoptic arthroscopy (for knee OA) are under investigation.

Antirheumatic Agents↗
PubMed1994

A comparative study of signal versus aggregate methods of outcome measurement based on the WOMAC Osteoarthritis Index. Western Ontario and McMaster Universities Osteoarthritis Index.

OBJECTIVE: To compare signal versus aggregate measurement strategies using the VA3.0S version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index. METHODS: Seventy patients with OA of the knee were asked to identify a signal item for each of the 3 dimensions of the WOMAC OA Index at baseline and termination of a 12-week, double blind, randomized, controlled trial. RESULTS: The signal method detected statistically significant alterations in health status at relatively small sample sizes and with a relative efficiency close to or at unity. In addition to a low prevalence of deterioration in nonsignal items, we observed some inconsistency in signal selection. CONCLUSION: Signal methods of measurement may provide an alternative approach to outcome measurement provided issues of nonsignal deterioration and the consistency of signal selection can be addressed.

Aged↗
PubMed1994

A Canadian survey of current methotrexate prescribing practices in rheumatoid arthritis.

OBJECTIVE: To conduct a cross sectional survey of methotrexate (MTX) prescribing practices of Canadian rheumatologists in their treatment of rheumatoid arthritis (RA). METHODS: A 15-item questionnaire was mailed to 197 rheumatologists with a 79% response rate after 3 mailings. RESULTS: The usual starting dose was 7.5 mg/week (range = 2.5-15.0) and the usual maximum dose prescribed was 15 mg/week (range = 10-50); 81% routinely coadministered MTX and non-steroidal antiinflammatory drugs; 28% routinely used folic acid prophylaxis; 97% of respondents performed regular assessments of liver function. Only 17% requested a liver biopsy after a certain time and 23% after a certain cumulative dose. Sixty-two percent performed pre-MTX liver biopsy on patients with liver function abnormalities. Only 14% of respondents routinely performed pulmonary function tests. Ninety-one percent of respondents noted that 1-50% (mode = 10%) of patients refused to accept MTX therapy after it had been recommended, usually because of fear of side effects. CONCLUSION: Despite potential toxicity, the majority of respondents used MTX in the treatment of adult RA.

Arthritis, Rheumatoid↗
PubMed1993

Outcome measurement in scleroderma clinical trials.

Clinical trials in scleroderma were reviewed to assess the clinimetric properties of frequently used outcome measures. Twenty-seven controlled intervention studies were found in the English literature; nine demonstrated effective therapy. The outcome measures used included skin involvement, functional status, physical performance (grip strength, oral aperture), and internal organ involvement (pulmonary, gastrointestinal, renal, and cardiac). Very few outcome measures detected between- or within-group differences even when an active drug was compared with a placebo. Skin measures were found to yield statistical differences in seven studies, patient global assessment in three, and physician global assessments in four. Internal organ measures detected differences between groups only rarely; the pulmonary diffusing capacity was statistically different twice. Physical performance measures (eg, grip strength and oral aperture) never yielded statistical differences, and in only one of five trials did a functional assessment detect statistical differences. To show drug efficacy in future trials in scleroderma, better outcome measures need to be developed and a consensus obtained on which outcomes to use so that potentially effective therapies can be tested in a standardized fashion against a placebo or current therapy. Currently, because of a lack of clinimetric data on outcome measures, therapeutic inefficacy cannot be differentiated from a lack of sensitivity in the outcome measures used. In the future, outcome measures should be chosen on the basis of the adequacy of their reliability, construct, and content validity and be sensitive to change. Ideally, outcome measures also should have criterion validity, ie, show a strong association between the measure (such as a skin score) and an irrefutable gold standard (such as skin pathology).

Clinical Trials as Topic↗