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At least 19 recordsLinked to original sources
PubMed1979

[Use of the computer in teaching rheumatology. Trial application in the diagnosis of an adult polyarthritis].

The immense possibilities offered by the computer can be utilized in medical education, through a free dialogue between the student and the machine thanks to a terminal. A diagnostic simulation program has been carried out in diagnosing adult polyarthritis. This program neccesitates an analysis of diagnostic behavior and, on this basis, the preparing of a diagnostic tree or graph. The reasons leading to the plan adopted in constructing the graph, are discussed. Cases of increasing difficulty are proposed to the student, who must follow the course plan in order to arrive at a diagnosis. This teaching method, applied for thing pedagogical advantages both for the teacher and the student. The operating cost seems reasonable.

Adult↗
PubMed2026

Timeliness of publication of randomized controlled trials in rheumatology: A systematic review.

OBJECTIVE: To systematically review the (1) timeliness of publication of randomized controlled trials (RCTs) in rheumatology, (2) impact of the COVID-19 pandemic on time to publication, and (3) factors associated with publication delays. METHODS: We searched Medline, Embase, EBM Reviews, Cochrane Central Register of Controlled Trials, and Scopus from January 1, 2018, to June 30, 2023 for Phase 3, superiority, parallel-design RCTs that evaluated any treatment for a rheumatologic illness or a rheumatologic treatment for COVID-19 and reported clinical primary efficacy outcome. Outcomes of interest were time to publication after trial completion and publication delay of >2 years after trial completion. RESULTS: 448 RCTs were included in this systematic review. Median time from completion to publication was 549 days and 65.9 % RCTs were published within 2 years of completion. Compared with RCTs on rheumatologic diseases, RCTs on COVID-19 were published sooner (253 vs. 549 days; p < 0.001) and were more likely to be published within 2 years (adjusted OR 9.49, 95 % CI 2.07 to 43.61). Compared with RCTs completed before March 1, 2020, RCTs completed after March 1, 2020, were published sooner (327 vs. 724 days; p < 0.001) and were more likely to be published within 2 years (adjusted OR 9.40, 95 % CI 5.14 to 17.21). Time from RCT completion to submission accounted for most (67 %) of the time to publication. CONCLUSIONS: Publication delay continues to be an important concern in dissemination of clinical research. Most of the delays in publication were attributable to delays in submission to journals after trial completion.

Humans↗
PubMed1991

Can clinical trials in rheumatology be improved?

With our growing dependence on clinical trials to assess the adequacy of available treatments for arthritic patients, attention is increasingly being focused on the tools we use in the design, analysis, and reporting of these studies and the ways in which we can improve them. This review outlines some of the major problems in terms of patient compliance, trial size, inadequate endpoints, and insufficient reporting, and highlights some of the work being done to overcome these difficulties. The greatest emphasis is placed on two issues. Firstly, there is a need for greater stringency in interpreting the results. Thus, more consideration needs to be devoted to the limitations of the measurements used and greater emphasis needs to be placed on analysis on the basis of "intention to treat". Secondly, there is a need to standardize common aspects of the trials, such as the detailed reporting of baseline data, a minimal set of outcome measures, comparable response thresholds, and the inclusion of statistics such as confidence intervals. Implementing these changes will increase comparability and yield a stronger possibility of significant results.

Clinical Trials as Topic↗
PubMed1987

Evaluation of tenoxicam in rheumatology--clinical trial results in Argentina and Brazil.

The therapeutic activity of tenoxicam, a thienothiazine derivative with analgesic and anti-inflammatory properties, has been studied by 15 investigators in Argentina and Brazil. Twenty-nine clinical trials were performed in a total of 747 patients suffering from rheumatoid arthritis (270), cox- and gonarthrosis (190), extra-articular inflammation (250) and acute gout (37). Out of the patients studied, 507 received tenoxicam and 240 were given comparative preparations. In 76% of the patients 20 mg tenoxicam was given as a single daily dose. In most patients duration of treatment was either six weeks or six months. Therapeutic results were evaluated according to the evolution of pain in various conditions as well as that of the articular, clinical and functional status. Once treatment was concluded a global evaluation of efficacy and tolerance was performed. The statistical analysis showed a significant improvement, in comparison to baseline, in all parameters considered under the different conditions. Double-blind studies showed no significant statistical differences between tenoxicam and the comparative preparations. Tolerance to tenoxicam was considered excellent, granting that some patients referred to adverse effects of the gastrointestinal type, such as epigastric discomfort, pyrosis and flatulence of moderate intensity. Tenoxicam is a new non-steroidal anti-inflammatory compound which is well tolerated and has excellent activity in the treatment of diverse rheumatoid conditions.

Activities of Daily Living↗
PubMed1992

Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group.

BACKGROUND: The antimetabolite methotrexate has been shown in placebo-controlled trials to be effective in adults with rheumatoid arthritis. Methotrexate may also be effective in children with resistant juvenile rheumatoid arthritis, but the supporting data are from uncontrolled trials. METHODS: Centers in the United States and the Soviet Union participated in this randomized, controlled, double-blind trial designed to evaluate the effectiveness and safety of orally administered methotrexate. Patients received one of the following treatments each week for six months: 10 mg of methotrexate per square meter of body-surface area (low dose), 5 mg of methotrexate per square meter (very low dose), or placebo. The use of prednisone (less than or equal to 10 mg per day) and two nonsteroidal antiinflammatory drugs was also allowed. RESULTS: The 127 children (mean age, 10.1 years) had a mean duration of disease of 5.1 years; 114 qualified for the analysis of efficacy. According to a composite index of several response variables, 63 percent of the children who received low-dose methotrexate improved, as compared with 32 percent of those in the very-low-dose group and 36 percent of those in the placebo group (P = 0.013). As compared with the placebo group, the low-dose group also had significantly larger mean reductions from base line in the number of joints with pain on motion (-11.0 vs. -7.1), the pain-severity score (-19 vs. -11.5), the number of joints with limited motion (-5.4 vs. -0.7), and the erythrocyte sedimentation rate (-19.0 vs. -6 mm per hour). In the methotrexate groups only three children had the drug discontinued because of mild-to-moderate side effects; none had severe toxicity. CONCLUSIONS: Methotrexate given weekly in low doses is an effective treatment for children with resistant juvenile rheumatoid arthritis, and at least in the short term this regimen is safe.

Administration, Oral↗
PubMed1990

Auranofin in the treatment of juvenile rheumatoid arthritis. Results of the USA-USSR double-blind, placebo-controlled trial. The USA Pediatric Rheumatology Collaborative Study Group. The USSR Cooperative Children's Study Group.

A 6-month double-blind, parallel, randomized, placebo-controlled multicenter trial of auranofin (0.15-0.20 mg/kg/day) was conducted in 231 children with juvenile rheumatoid arthritis (JRA) in the United States and in the Union of Soviet Socialist Republics. Approximately 80% of the children had polyarticular disease. The auranofin-treated patients showed greater mean decreases from baseline in 11 of the 12 articular disease indices measured than did the placebo-treated subjects after 3 months of therapy, and in 9 of the 12 indices after 6 months. However, the actual intergroup mean differences were relatively small and were not statistically significant. According to the physician's global assessment, 69% of the auranofin-treated patients and 61% of the placebo-treated patients demonstrated clinically significant improvement from baseline after 6 months (P = 0.24). Children whose disease onset occurred less than 2 years prior to entry improved more than did those who had arthritis for a longer period. In addition, those with polyarticular involvement at baseline improved more than did patients with mild disease. However, these relationships were observed in both the auranofin- and placebo-treated groups, and again, there were no significant intergroup differences. Diarrhea was the most common adverse effect of auranofin. We conclude that the clinical efficacy of auranofin is modestly higher than that of placebo in the treatment of JRA, as evidenced by the consistent trends observed in the data. However, the magnitude of the individual intergroup differences is not statistically significant. Auranofin appears to be very safe in children with JRA.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1989

Clinical trials in fibrositis: a critical review and future directions.

A critical appraisal of the design of clinical trials which examined the effectiveness of various interventions in fibrositis was conducted. Therapeutic interventions included physical fitness, biofeedback, acupuncture, dothiepin, imipramine, cyclobenzaprine, S-adenosylmethionine and amitriptyline. The design and analysis of the randomized, controlled studies render their results reliable. Major areas for methodologic improvement in future trials were identified. Standardized, validated and reliable diagnostic and outcome criteria need to be established. Factors which could predict response need to be identified to enable the selection of the most appropriate patient population for inclusion in future studies. Finally, the incorporation of measures of patient function will result in more clinically meaningful outcome evaluation.

Fibromyalgia↗
PubMed2026

Timing of OMERACT core domain measurement in gout clinical trials: a systematic review of randomised trials.

AIMS: The Outcome Measures in Rheumatology (OMERACT) initiative has endorsed core domain sets for gout trials. The aims of this study were to evaluate the time points and frequencies at which the gout core domains are measured in existing gout urate-lowering therapy and gout flare trials, and whether all collected measurements were reported. METHODS: Urate-lowering therapy (n = 29) and gout flare randomised clinical trials (n = 14) from 2005 were identified from a prior systematic review of core domain reporting. Data were extracted for the time points and frequencies at which each core domain was measured, as well as whether all collected measurements were reported. RESULTS: In urate-lowering therapy trials, the core domains were measured at seven different frequencies. Serum urate and gout flares were most commonly measured monthly, and tophus burden was most commonly measured three monthly. Reporting of all collected measurements varied, from 24/29 (83%) trials for serum urate to 0/2 (0%) trials for activity limitation. In gout flare trials, core domains were measured at nine different frequencies. Pain, joint tenderness and joint swelling were most commonly measured monthly. Reporting of all collected measurements varied, from 13/14 (93%) trials for pain to 3/8 (37.5%) trials for joint tenderness. CONCLUSION: In both urate-lowering therapy and gout flare trials, there is substantial variability in when the core domains are measured, and reporting of collected measurements is inconsistent. This work provides the foundation for a consensus process to establish standardised time points and frequencies for measuring the OMERACT-endorsed gout core domains.

Gout↗