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Biomedical subjects

M Boers

Publications and source records attributed to M Boers.

At least 127 records · Page 7Linked to original sources
PubMed1993

Is group physical therapy superior to individualized therapy in ankylosing spondylitis? A randomized controlled trial.

PURPOSE: To study the effects of adding supervised group physical therapy to unsupervised individualized therapy in ankylosing spondylitis. METHODS: One hundred forty-four patients were randomized to exercises at home, or the same plus weekly group physical therapy for 9 months. Endpoints were spinal mobility, fitness (maximum work capacity by ergometry), functioning (Sickness Impact Profile, Health Assessment Questionnaire for the Spondylarthropathies, and Functional Index), and patient's global assessment of change on a 10-cm visual analogue scale. RESULTS: Thoracolumbar flexion and extension increased by an average of 0.5 cm (9%) after home exercises, and by 0.9 cm (16%) after group therapy. Maximum load in ergometry decreased by 2 W (1%) after home exercises, but increased by 7 W (4%) after group therapy. Global assessment improved by 0.3 (6%) after home exercises, and by 1.7 (34%) after group therapy. These three differences were statistically significant. There were no significant differences in chest expansion, cervical rotation, or the self-assessments of functioning. CONCLUSIONS: Group physical therapy proved superior to individualized therapy in improving thoracolumbar mobility and fitness, and had an important effect on global health reported by the patients.

Activities of Daily Living↗
PubMed1993

Measures to assess ankylosing spondylitis: taxonomy, review and recommendations.

OBJECTIVE: To critically review the current use and scope of measures to assess patients with ankylosing spondylitis (AS). METHODS: Studies in English reported between January, 1986 and August, 1991 were identified both through computer searches of Index Medicus and manual searches of bibliographies. Only studies where assessment of patients with AS was a main topic were included. Information was extracted to classify measures as (1) physician assessed, (2) patient reported or (3) other assessments. RESULTS: Physician assessed measures prevailed in 34 (79%) of the 43 studies included. Patient reported measures were mentioned in 29 (67%). Most physician assessed measures (67%) focussed on mobility, most patient reported measures (65%) focussed on discomfort. Single item global assessment by physician or patient, the most generic measure, was reported in 7 (16%) and in 17 (40%) studies, respectively. One study reported a measure which specifically addressed the patient's priorities regarding treatment risks. Other measures were reported in 22 (51%) studies, i.e., laboratory tests in all 22, and additionally radiographs in 2, and various measures in 6 studies. Side effects (by reports or otherwise) were noted in 26 (60%) studies. CONCLUSION: Current assessment in AS incompletely encompasses the spectrum of relevant health status outcomes. Specifically, more attention should be paid to the patient's point of view.

Classification↗
PubMed1993

A method for achieving consensus on rheumatoid arthritis outcome measures: the OMERACT conference process.

We describe the process used during the international Conference on Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). The objectives of the conference were (1) to broaden consensus on the minimum number of outcome measures to be included in all RA clinical trials in rheumatoid arthritis (RA); (2) to achieve consensus on criteria for (a) minimum clinically important improvement in patients with RA and (b) minimum important differences between treatment groups in RA clinical trials; and (3) to decide whether aggregate outcome measures (indices) are useful in the assessment of patients and trials. A combination of plenary sessions and structured nominal groups were employed during the conference. Simulated patient profiles and clinical trial profiles were used to generate discussion. The objective of the nominal group exercises was to capture each participant's judgments of the relative importance of each outcome measure and the degree of change required to indicate clinical improvement. Considerable discussion ensued on the content of the core set of outcome measures. An electronic interactive voting machine was used to obtain participants' views on a core set of outcome measures and methodological issues. To permit further discussion of outcome measures, the group explored the use of aggregate outcome measures (indices) in patient care and trials only in a preliminary way. A final plenary session dealt with patient perceptions of minimum important differences, a new classification of antirheumatic drugs, and a repeat of part of the preconference questionnaire. Concluding statements and future plans were developed at the conclusion of the meeting.

Arthritis, Rheumatoid↗
PubMed1993

OMERACT conference questionnaire results. OMERACT Committee.

Just prior to the OMERACT conference, participants completed a questionnaire that solicited explicit opinions on the issues discussed at the conference. The response rate was 77%. To determine the minimum level of important difference in a clinical trial comparing 2 active drugs, participants were asked to think of each of 6 separate measures in turn as designated primary outcome measure. In this situation, to decide that an important difference between the 2 groups was present, participants required a median of 20% difference in painful joints, swollen joints, and in disability, 30% in pain and patient global assessment, and 40% in physician global assessment. On each measure, between 3 to 12% of participants felt they could not decide on an important difference in that situation. Similar questions were asked for the minimum important improvement in a patient; required levels of improvement were similar but slightly higher than the responses given for trials, and more participants felt they could not decide. Correspondents indicated that acute phase reactants are also very important for assessing minimum levels of important difference and improvement in trials and patients. A large majority was in favor of applying an index of aggregated outcome measures if sensible and valid: 72% in patients, and 93% in trials.

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

The validity of pooled outcome measures (indices) in rheumatoid arthritis clinical trials.

No consensus exists on the appropriate (set of) endpoints to be reported in rheumatoid arthritis clinical trials. The traditional endpoints are not comprehensive, show overlap, and are insensitive to change. A single, pooled outcome measure or index may be an alternative. However, such an index must be valid and acceptable. An overview of the existing indices suggests several options are available. To date, practical experience with these indices in trials is limited.

Arthritis, Rheumatoid↗
PubMed1992

Cyclosporine in rheumatoid arthritis.

The efficacy and toxicity of cyclosporine in the treatment of patients with rheumatoid arthritis (RA) are reviewed. Most of the early trials were restricted to patients with intractable RA. The initial daily dose of cyclosporine was 5 to 10 mg/kg, which is now considered high. Of 283 cyclosporine-treated patients in nine studies, 8% discontinued the drug prematurely because of inefficacy and 17% because of adverse reactions. Cyclosporine improves clinical parameters but does not influence the erythrocyte sedimentation rate. The most important side effects are gastrointestinal intolerance and nephrotoxicity. The former is of minor importance with the present dosage schedule (starting daily dose, 2.5 mg/kg), and increments should follow the principle "go low, go slow." Guidelines are given to avoid or reduce nephrotoxicity. It may be beneficial to administer cyclosporine early in the course of RA.

Arthritis, Rheumatoid↗
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

No effect of misoprostol on renal function of rheumatoid patients treated with diclofenac.

Non-steroidal anti-inflammatory drugs can reversibly decrease renal function in patients with rheumatoid arthritis (RA). To test whether orally administered prostaglandins could mitigate this decrease, we studied the effect of misoprostol in 24 RA patients during treatment with diclofenac in a randomized, placebo-controlled crossover trial. At baseline, 21 patients had a creatinine clearance below 80 ml/min/1.73 m2. The two treatment phases (with either misoprostol, 600 micrograms daily, or matching placebo tablets) were separated by a washout phase in which diclofenac (150 mg daily) was continued. After treatment with misoprostol/diclofenac the glomerular filtration rate was 72 +/- 5 ml/min (mean +/- standard error), and the effective renal plasma flow was 295 +/- 21 ml/min. After treatment with placebo/diclofenac, the corresponding values were 71 +/- 5 ml/min and 296 +/- 21 ml/min, respectively. We concluded that misoprostol has no effect on the renal function of RA patients treated with diclofenac.

Adult↗
PubMed1991

Long acting drug combinations in rheumatoid arthritis: a formal overview.

We compared the benefits and risks of combinations of long acting antirheumatic drugs with those of the same drugs used singly in the treatment of rheumatoid arthritis. We searched the literature through MEDLINE (1966-89), Index Medicus (1956-65), Excerpta Medica (1982-89), Science Citation Index (1982-89), and bibliographic review of located articles. Of a total of 341 citations, we identified 7 prospective trials that specifically addressed the stated purpose. We independently assessed the quality of the selected trials, using published methodological criteria and summarized the effect of treatment on arthritis activity and the incidence of side effects. The trials we evaluated tested various drug combinations. Because of deficiencies in methods and reporting, only 3 trials had sufficient quality to yield strong or moderately strong evidence. None conclusively demonstrated benefit of a drug combination: 2 suggested such benefit, including 1 also suggesting increased toxicity; the 3rd suggested only increased toxicity. The other 4 trials yielded weak evidence to support both increased efficacy and toxicity. The advantages of any antirheumatic drug combination remain unproven. Because these advantages are likely to be modest, they can only be shown in rigorously designed trials enrolling large numbers of patients. Methods and reporting of antirheumatic drug trials should be standardized to allow combining of study results.

Anti-Inflammatory Agents↗
PubMed1991

Comparison of cyclosporine and D-penicillamine for rheumatoid arthritis: a randomized, double blind, multicenter study.

Ninety-two patients with active rheumatoid arthritis (RA) were entered in a randomized double blind study of 24 weeks comparing cyclosporine (initial daily dose 5 mg/kg) with D-penicillamine (initial daily dose 250 mg). The groups were well balanced in baseline characteristics. In the cyclosporine group, 10 patients stopped prematurely, one because of inefficacy. In the D-penicillamine group, 9 patients stopped prematurely, 3 because of inefficacy. The 2 antirheumatic drugs were equally effective in reducing disease activity, except for a significant (p = 0.005) decrease in erythrocyte sedimentation rate with D-penicillamine treatment. We conclude that under the conditions of this trial, cyclosporine can serve as an alternative to D-penicillamine for the treatment of patients with RA.

Adolescent↗
PubMed1991

Longterm cyclosporine therapy in rheumatoid arthritis.

Sixteen patients who had shown a good clinical response to cyclosporine therapy during a randomized 6-month double blind study comparing cyclosporine with D-penicillamine in active rheumatoid arthritis, had an opportunity to participate in an open study with cyclosporine. The initial daily dose of cyclosporine was 5 mg/kg. Before the planned maximal duration of 18 months, there were 6 premature discontinuations, 2 because of inefficacy, 2 because of side effects, and 2 for other reasons. During the study there was an improvement in all clinical variables. Even under the strict conditions of our trial there was an irreversible loss of about 15% of renal function. Suggestions are given to minimize the chance of nephrotoxicity.

Adult↗