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Biomedical subjects

P Tugwell

Publications and source records attributed to P Tugwell.

At least 19 recordsLinked to original sources
PubMed1992

Cyclosporine in rheumatoid arthritis: documented efficacy and safety.

The experience from eight open studies and five controlled trials of cyclosporine in rheumatoid arthritis is reviewed. A therapeutic approach characterized by low initial doses and slow upward titration appears to minimize the toxicity while retaining sufficient amounts of the efficacy seen with higher doses, although the onset of benefit is slower. In short-term studies, renal dysfunction and other side effects appear to be reversible. However, studies of combinations of cyclosporine and other slow-acting agents, long-term studies, and more renal biopsy specimens are needed to determine the appropriate use of this agent. Cyclosporine holds promise as an important addition to the therapeutic armamentarium for patients with rheumatoid arthritis.

Arthritis, Rheumatoid↗
PubMed1992

Acute low back pain and economics of therapy: the iterative loop approach.

We use the measurement iterative loop as a conceptual framework to examine the economics of common therapies for acute non-specific low back pain. The measurement iterative loop systematically assesses the interlocking facets of an illness from the community health perspective, including quantifying burden of illness, etiology, assessment of therapeutic effectiveness, and economic evaluation of therapies. The iterative loop reveals that: (1) burden of illness, although known to be substantial, is so far inaccurately measured, (2) little is known about such factors as provider and patient compliance; and (3) the economics of therapy can guide us in this time of clinical uncertainty when no therapy appears clearly superior. For therapies with at least some support from randomized controlled trials, bedrest appears to be economically superior. Besides burden of illness, compliance, and current therapies, future research should address such "therapeutic" options as early return to work and patient self-management.

Acute Disease↗
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

Physical disability among Canadians reporting musculoskeletal diseases.

About one million Canadian adults are estimated to have physical disabilities attributed to a musculoskeletal condition, a prevalence of 50.1/1,000 adults (all rates expressed/1,000). The specific musculoskeletal disease rates were arthritis/rheumatism (27.2), back (16.2), "other" (4.6), trauma (3.6) and bone (0.6). More women reported disabling musculoskeletal disease (61.0 versus 38.6, respectively). Prevalence rates increased with age from 6.2 among Canadians aged 15-24 years, to 264.7 aged 85 years and over. Limitations of mobility were more common than those of agility. Adults in institutions reported more disabilities than did adults in households (means 7.7 and 4.4, respectively).

Adolescent↗
PubMed1992

A Canadian population survey on the clinical, epidemiologic and societal impact of migraine and tension-type headache.

Trained telephone interviewers contacted 1,573 adults across Canada about the nature and frequency of headaches suffered by them or by others in their households. Using a table of pain symptoms and other characteristics abstracted from the International Headache Society (IHS) classification, the headaches were assigned to migraine headache, tension-type headache or other diagnostic groups. Of the households sampled, 59% had at least one headache sufferer in residence. The proportion of headache sufferers with migraine was 14%; with tension-type, 36%; and with both, 14%. Migraine headache caused more disability than tension-type headache, with nearly 20% of migraine sufferers taking time off work and disability lasting for a mean of 1 day. It is concluded that the current prevalences of migraine and tension-type headache in Canada fall around the mean of previous studies, that the IHS criteria can form a basis for diagnostic classification and that the functional impact of migraine has been seriously underestimated in the past.

Adolescent↗
PubMed1992

Cyclosporine nephrotoxicity in rheumatoid arthritis: no effect of short term misoprostol treatment.

We assessed the effect of the prostaglandin E1 analog misoprostol on cyclosporine nephrotoxicity in patients with rheumatoid arthritis (RA). Thirteen patients with RA were given cyclosporine with misoprostol tablets, 800 micrograms/day for one week in a randomized, double blind, placebo controlled crossover trial. All had cyclosporine nephrotoxicity, documented by an increase in serum creatinine of at least 15% over the values before the start of cyclosporine treatment. Mean glomerular filtration rate (GFR) (single shot 51Cr-EDTA plasma clearance) at baseline was 77.3 ml/min (SD, 22.0). After misoprostol, it was 80.0 ml/min (SD, 18.9); after placebo, 79.1 ml/min (SD, 20.0). None of these changes were statistically significant. Serum creatinine levels and whole blood cyclosporine levels were also unchanged. Power to detect at least a 5 ml/min rise in GFR was 0.92. Short term misoprostol treatment does not improve the GFR of patients with RA on cyclosporine.

Adult↗
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

The International Clinical Epidemiology Network (INCLEN): a progress report.

The International Clinical Epidemiology Network (INCLEN) was established in 1982 to strengthen the research capacity of medical schools in the developing world through the development of Clinical Epidemiology Units (CEUs). The role of these units is to promote a rational approach to clinical and health care decision making, drawing on the methods of clinical epidemiology, biostatistics, health economics and health social science. This paper summarizes the evolution of the INCLEN model and the experience to date. Progress with Phase 1, the designation of sites for CEU development and the provision of advanced research training by developed country training centres has been substantial. The network now consists of 27 units: 26 in developing country medical schools in Asia, Latin America, India and Africa and 1 in France. More than 60% of the target of 270 fellows have completed training and returned to take up faculty positions in their unit. The remainder will be trained and on site by 1995. The non-return rate of fellows (2%) is very low. Research productivity is significant given only 60 fellows have been working in their CEUs for more than 3 years following the completion of training. An appropriate balance between hospital and community-based research is evident and changes in clinical and health care policy have been made based on the research conducted. The educational responsibilities of all units include courses and workshops in critical appraisal and clinical epidemiology for medical trainees and colleagues. Graduate training programs have emerged in 3 units so far. Major challenges lie ahead as we move into Phase 2 of the project--self sustainability and the transfer of training responsibility to the CEUs. The problems encountered during Phase 1 will need to be addressed. These include time protection for research, the limited availability of research funds, the low priority given to research careers and the poor linkage between health researchers and government policy makers. Our experience echos the recommendations of the recent report of the Commission on Health Research for Development, namely that donors and national governments should give increased priority to the role of health research in less developed countries. We conclude that with continuing support and special attention to the problems encountered, the INCLEN approach can contribute to ensuring that the medical establishment is part of the solution rather than the problem faced by health systems in less developed countries.

Developing Countries↗
PubMed1991

Methodologic challenges in the development of utility measures of health-related quality of life in rheumatoid arthritis.

Utility measures of health-related quality-of-life (HRQL) are unique in that they focus on patient preferences for alternative health conditions and combine benefit and toxicity into one number. This paper addresses the application of utility measurement techniques to assess HRQL in rheumatoid arthritis (RA). More specifically, the measurement issues and empirical evaluation strategies relevant to establishing the usefulness of utility measures in clinical trials and "n of 1" studies in RA are presented. First, utilities are reviewed within the context of RA and the other measures of benefit and toxicity currently in use. Second, the key methodologic challenges relevant to the development of HRQL measures of RA treatment impact are identified. Finally, a new utility instrument suitable for use in both parallel group and "n of 1" drug trials in RA is presented. The work described also addresses the interpretation of utility values and hence their acceptability to clinicians, researchers and policy makers and may aid initiatives to establish HRQL as one of the criteria for approval by federal drug regulatory agencies. Given that patient preferences constitute a central concept within the framework of HRQL, further empirical evaluation of utility measures of preference is fundamental to improving the HRQL measurement tool-kit.

Arthritis, Rheumatoid↗
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↗
PubMed1990

Measurement of functional status, quality of life, and utility in rheumatoid arthritis.

In 40 years of development in the area of quality of life, the goal of applicability to the individual patient has not been accomplished. During the 1980s, we strived to improve the applicability of these instruments by refining disease-specific measures and developing patient-specific measures so that the sensitivity of these tools to clinically important change could be increased and comparative indices across conditions could be established. Finding the balance between brevity, reliability, and comprehensiveness will improve practicality. The reliability of serial measurements using the various instruments in individual patients and in small groups of patients needs to be established. In the absence of a gold standard, validity will continue to be derived from testing new measures against accepted clinical measures. The ideal tool for use in clinical practice has not yet been developed. At this time, the clinician may choose among the many reliable and valid questionnaires assessing functional status, health status, and utility, according to his or her purpose. The information gathered from these instruments may help identify patients' problems, set treatment priorities, direct interventions, monitor the longitudinal course of disease, and assist in program evaluation and policy planning.

Activities of Daily Living↗
PubMed1990

A controlled comparison of piroxicam and diclofenac in patients with osteoarthritis.

Eighty patients with osteoarthritis were randomly assigned to either piroxicam (20 mg daily) or diclofenac (75-150 mg daily) in a 12-week double-blind, parallel groups study. In the 70 patients who completed the study, both medications were effective; statistically significant improvement was observed on all assessments of efficacy. However, no statistically significant differences between the two drugs were seen on any of the efficacy parameters measured. There was a trend towards better tolerance in the piroxicam treated patients, although this was not statistically significant; 3 of the 40 piroxicam treated patients versus 6 of the 40 patients on diclofenac were discontinued from the trial due to intolerable adverse events.

Activities of Daily Living↗