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Biomedical subjects

M Boers

Publications and source records attributed to M Boers.

At least 109 records · Page 6Linked to original sources
PubMed1997

Limited bone loss due to corticosteroids; a systematic review of prospective studies in rheumatoid arthritis and other diseases.

OBJECTIVE: To clarify the relation between changes in bone density, the treated disease, and dose of corticosteroids prescribed. METHODS: MEDLINE database (1966-95) and bibliographic searches selected cohorts of patients with rheumatoid arthritis (RA) and non-RA patients, studied by reliable serial bone density measurements. RESULTS: Two randomized controlled trials in early RA found greater lumbar bone loss after corticosteroid treatment (pooled effect size at 6 mo 3.9%; 95% CI: 1.9, 6.0%). The other studies included 66 patients with RA taking mean 7 mg prednisone/day; 371 "untreated" RA patients; and 216 non-RA patients taking mean 20 mg prednisone/day. Lumbar bone mass changed (weighted mean) 0.0% (-0.6, 0.7%) per year in steroid treated RA, -0.6% (-0.9, -0.2%) in untreated RA, and -4.7% (-5.2, -4.3%) in non-RA. Femoral neck changed -3.0% (-4.2, -1.8%), -0.7% (-1.0, -0.3%), and -1.5% (-2.5, -0.4%), respectively. In RA, most bone was lost in the first half year, and in early or uncontrolled disease. CONCLUSION: In patients with RA bone loss is limited, influenced by the interaction of disease characteristics and low dose corticosteroid therapy. In contrast, non-RA patients taking higher doses of corticosteriods may loss clinically relevant amounts of bone (i.e., > 5%) within one year.

Arthritis, Rheumatoid↗
PubMed1997

Taking baths: the efficacy of balneotherapy in patients with arthritis. A systematic review.

OBJECTIVE: To review English, French, German, and Dutch language studies of the effectiveness of balneotherapy. Balneotherapy (hydrotherapy or spa therapy) is one of the oldest forms of therapy for patients with arthritis. One of the aims of balneotherapy is to relieve pain. METHODS: We performed a systematic review that included randomized and nonrandomized studies. Quality scores of the studies were determined using a criteria list. RESULTS: Most studies report positive findings, but all studies showed methodological flaws. A quality of life measurement was never reported as an outcome measure. None of the randomized clinical trials included intention-to-treat analysis or comparison of effects between groups. CONCLUSION: Because of the methodological flaws a conclusion about the efficacy of balneotherapy cannot be provided from studies we reviewed. We conclude that most flaws found could be avoidable in future research.

Arthritis↗
PubMed1995

American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis.

OBJECTIVE: Trials of rheumatoid arthritis (RA) treatments report the average response in multiple outcome measures for treated patients. It is more clinically relevant to test whether individual patients improve with treatment, and this identifies a single primary efficacy measure. Multiple definitions of improvement are currently in use in different trials. The goal of this study was to promulgate a single definition for use in RA trials. METHODS: Using the American College of Rheumatology (ACR) core set of outcome measures for RA trials, we tested 40 different definitions of improvement, using a 3-step process. First, we performed a survey of rheumatologists, using actual patient cases from trials, to evaluate which definitions corresponded best to rheumatologists' impressions of improvement, eliminating most candidate definitions of improvement. Second, we tested 20 remaining definitions to determine which maximally discriminated effective treatment from placebo treatment and also minimized placebo response rates. With 8 candidate definitions of improvement remaining, we tested to see which were easiest to use and were best in accord with rheumatologists' impressions of improvement. RESULTS: The following definition of improvement was selected: 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. Additional validation of this definition was carried out in a comparative trial, and the results suggest that the definition is statistically powerful and does not identify a large percentage of placebo-treated patients as being improved. CONCLUSION: We present a definition of improvement which we hope will be used widely in RA trials.

Adult↗
PubMed1995

Assessing the activity of rheumatoid arthritis.

Disease activity in rheumatoid arthritis is not easily measured. The validity of current measures has been reviewed. Recent international efforts have resulted in consensus over a minimum (WHO/ILAR) core set of endpoints in RA trials: pain, patient and physician (assessor) global assessment, physical disability, swollen joint count, tender joint count, acute phase reactants; and for studies of one or more years' duration: radiographs of joints. The near future will hopefully see validation of new measures, also in terrains not currently covered by the core set.

Arthritis, Rheumatoid↗
PubMed1995

Interactive conference voting. The OMERACT II Committee. Outcome Measures in Rheumatoid Arthritis Clinical Trial Conference.

We describe and analyze opinion polling results from interactive voting procedures undertaken before and after presentations during the Outcome Measures in Rheumatoid Arthritis Clinical Trials Conference (OMERACT II) in Ottawa, Canada, June 30-July 2, 1994. The scoring procedure was a matched voting design; when a participant used the same keypad at the beginning and end of voting, change within a participant could be estimated. Participants, experienced in the rheumatic diseases included clinicians, researchers, methodologists, regulators, and representatives of the pharmaceutical industry. Patients under consideration were those with any rheumatic diseases. Questions were constructed to evaluate the change in voting behavior expected from the content of the presentation. Statistically significant and substantively important changes were evident in most questions.

Arthritis, Rheumatoid↗
PubMed1995

A framework to classify burden of illness measures.

Although criteria sets and health status instruments address the burden of illness, they serve different functions. We propose a framework to classify burden of illness measures. The taxonomy is primarily based upon the scope of conditions and the scope of patients or people the instrument aims at, but also takes the scope of health status dimensions and time into consideration. It is useful to understand the purpose of specific instruments or criteria sets and the differences between several categories in our application of these tools.

Classification↗
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

The validity of radiography as outcome measure in rheumatoid arthritis.

Radiographic imaging of hand (and foot) joints is regarded as one of the gold standards of outcome for rheumatoid arthritis. Outcome can be defined as suffering or loss of health caused by the disease process, and process as the abnormal physiological consequences that follow from the cause of the disease. By these definitions and through a review of validity components, I propose that radiographic damage may be best viewed as a unique and important measure of past process, and possibly as a proxy for outcome.

Arthritis, Rheumatoid↗
PubMed1994

Wrist splints in rheumatoid arthritis: a question of belief?

Wrist splints are often used in the treatment of rheumatoid arthritis (RA). We applied a questionnaire to RA patients and rheumatologists to assess wrist splint use and to assess the policy of prescription. We related the reported use to patient satisfaction, severity of disease and physician's advice. Of 44 RA patients admitted to our hospital in 1990, 32 received one or more splints. Most patients (23) had both a wrist immobilization splint and a wrist activity splint (Futuro cock-up splint). The response rate to the questionnaire sent to all (n = 109) Dutch rheumatologists was 83%; 89 of 91 rheumatologists prescribed splints. Each rheumatologist prescribed yearly a mean of 30 immobilization splints (min-max: 2-120) and 51 activity splints (min-max: 4-170). Both types were mainly prescribed to relieve pain and reduce inflammation. From the patients' point of view, only the wrist activity splints were worth regular and continued use. Our findings suggest that if one prescribed splints, more attention should be paid to patient education and compliance.

Adult↗
PubMed1994

World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials.

The WHO/ILAR core set of endpoints for rheumatoid arthritis clinical trials signifies progress in a continuing worldwide effort. This core set includes the following measures: pain, patient global assessment, physical disability, swollen joints, tender joints, acute phase reactants, and physician global assessment; in studies of one or more years' duration, radiographs of joints should be performed.

Antirheumatic Agents↗
PubMed1994

Endpoints in rheumatoid arthritis.

The Outcome Measures in Rheumatoid Arthritis Clinical Trials Conference has significantly contributed to the field of clinical outcome measurement. Agreement was achieved in designating a preliminary core set of 8 endpoints to be used as a minimum in every rheumatoid arthritis (RA) clinical trial of > or = 1 year: acute phase reactants, disability, pain, patient global assessment, physician global assessment, swollen joint count, tender joint count, and radiographic studies of joints. The discussions and nominal group exercises provided a mandate for full scale testing of approaches to compare the validity of different assessment techniques available for these 8 measures; to determine the minimum level of clinical importance for each of the measures; and to refine and validate the aggregation of outcome measures into indices, taking special care to ensure credibility in the eyes of clinicians, patients, and policy makers. The discussions made it clear that to select one intervention definitively over another, one must additionally consider outcomes such as drug toxicity, costs, and mortality. These aspects need to be explored systematically at subsequent conferences.

Antirheumatic Agents↗
PubMed1994

Comparison between self-report measures and clinical observations of functional disability in ankylosing spondylitis, rheumatoid arthritis and fibromyalgia.

OBJECTIVE: To study concordance between self-report measures and clinical observations of functional disability in ankylosing spondylitis (AS), rheumatoid arthritis (RA), and fibromyalgia (FM). METHODS: 35 patients with AS completed 9 selected items of the Functional Index questionnaire, whereas 12 patients with RA and 13 with FM completed 7 selected items of the Arthritis Impact Measurement Scales. Five days later, all 60 patients and 4 controls actually performed the selected activities, which were recorded on video. The tapes were assessed in random order by 12 observers (6 occupational therapists and 6 physicians). Both patients and observers indicated functional disability on a 10 cm visual analog scale (VAS). RESULTS: Interobserver agreement was high (Cronbach's alpha 0.98). All observers scored the 4 healthy controls as having no disability at all. Mean discordance scores (VAS patients minus VAS observers) for the selected items were negligible in AS [-0.17 cm (p = 0.30)], moderate in RA [+1.10 cm (p = 0.06)] and high in FM [+2.44 cm (p < 0.01)]. CONCLUSION: Discordance between self-report questionnaires and observed functional disability is a feature most striking in FM. In validation of self-report questionnaires of functional disability the appropriate spectrum of rheumatological diagnoses should be considered.

Adult↗
PubMed1993

The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials.

OBJECTIVE: To develop a set of disease activity measures for use in rheumatoid arthritis (RA) clinical trials, as well as to recommend specific methods for assessing each outcome measure. This is not intended to be a restrictive list, but rather, a core set of measures that should be included in all trials. METHODS: We evaluated disease activity measures commonly used in RA trials, to determine which measures best met each of 5 types of validity: construct, face, content, criterion, and discriminant. The evaluation consisted of an initial structured review of the literature on the validity of measures, with an analysis of data obtained from clinical trials to fill in gaps in this literature. A committee of experts in clinical trials, health services research, and biostatistics reviewed the validity data. A nominal group process method was used to reach consensus on a core set of disease activity measures. This set was then reviewed and finalized at an international conference on outcome measures for RA clinical trials. The committee also selected specific ways to assess each outcome. RESULTS: The core set of disease activity measures consists of a tender joint count, swollen joint count, patient's assessment of pain, patient's and physician's global assessments of disease activity, patient's assessment of physical function, and laboratory evaluation of 1 acute-phase reactant. Together, these measures sample the broad range of improvement in RA (have content validity), and all are at least moderately sensitive to change (have discriminant validity). Many of them predict other important long-term outcomes in RA, including physical disability, radiographic damage, and death. Other disease activity measures frequently used in clinical trials were not chosen for any one of several reasons, including insensitivity to change or duplication of information provided by one of the core measures (e.g., tender joint score and tender joint count). The committee also proposes specific ways of measuring each outcome. CONCLUSION: We propose a core set of outcome measures for RA clinical trials. We hope this will decrease the number of outcomes assessed and standardize outcomes assessments. Further, we hope that these measures will be found useful in long-term studies.

Arthritis, Rheumatoid↗