Biomedical subjects

J Ruof

Publications and source records attributed to J Ruof.

7 recordsLinked to original sources

PubMed1999

Evaluation of a German version of the Bath Ankylosing Spondylitis Functional Index (BASFI) and Dougados Functional Index (D-FI).

OBJECTIVE: Transcultural adaptation of the two most widely used and accepted functional indices in ankylosing spondylitis, the Bath Ankylosing Spondylitis Functional Index (BASFI) and Dougados Functional Index (D-FI). METHODS: The instruments were translated and tested for internal consistency (Cronbach's coefficient alpha), test-retest reliability (intraclass correlation coefficient, ICC), construct validity (testing for association with Schober's test, finger floor distance, occiput wall distance, frequency and duration of awakenings at night, and a visual analog scale pain), and responsiveness (standardized response mean, SRM). RESULTS: The study sample consisted of 72 patients of a randomized, controlled clinical trial receiving either Diclofenac or placebo. Visual assessment of distribution patterns revealed a ceiling effect of both instruments. Both questionnaires had a high internal consistency (Cronbach alpha: 0.81 [BASFI], 0.85 [D-FI] and a high test-retest reliability (ICC: 0.92 [BASFI], 0.89 [D-FI]). The limited responsiveness to Diclofenac treatment (SRM: 0.46 [BASFI], 0. 33 [D-FI]) may be related to the selected study sample. The BASFI was significantly correlated with all tested validation parameters. The D-FI was only significantly correlated with finger floor distance, occiput wall distance, and duration of awakenings at night. CONCLUSION: The transculturally adapted version of both functional indices are valid, reliable, and internally consistent. Because of psychometric advantages, the BASFI may be preferred in clinical trial settings.

Activities of Daily Living↗

PubMed1999

Development and validation of a self-administered systemic sclerosis questionnaire (SySQ).

OBJECTIVE: To develop a self-administered systemic sclerosis questionnaire (SySQ) covering condition-specific functional limitation and symptoms. METHODS An initial item pool was generated by open patient interviews. A preliminary questionnaire was devised using 62 systemic sclerosis (SSc; scleroderma) patients. Factor analysis was used for further selection and grouping of items into distinct scales. The retrieved scales were tested for internal consistency and test-retest reliability. Spearman's rank correlation and Wilcoxon's rank sum test were used to examine hypothesized associations of the SySQ with various clinical and laboratory features. RESULTS: Altogether 32 SySQ items were selected and aggregated into 12 scales addressing 'pain', 'stiffness', 'coldness', 'complex functions', 'strength of hands', 'rising', 'walking', shortness of breath', 'upper airway symptoms', 'eating', 'swallowing' and 'heartburn/regurgitation'. Internal consistency ranged from 0.93 ('complex functions') to 0.73 ('heartburn/regurgitation'); Spearman's correlation coefficient for test retest reliability ranged from 0.93 to 0.73 (P < 0.001). While the scales were associated with corresponding functional impairments, there was generally less association with morphological impairments. CONCLUSION: The SySQ is a valid and reliable condition-specific measure in patients with SSc. Individually applicable scales cover a wide spectrum of general and organ-specific SSc symptoms and functional limitation. After further validation with respect to its ability to measure change, it may be used in clinical, health services and epidemiological research.

Adult↗

PubMed1999

Evaluation of costs in rheumatic diseases: a literature review.

The aim of our review was to examine recently published cost-evaluations presenting originally developed data in rheumatic conditions. We identified 21 articles: 9 presenting original data on rheumatoid arthritis and/or osteoarthritis; 7 focusing on other musculoskeletal conditions such as back pain, scleroderma, Lyme disease, and fibromyalgia; and 5 assessing costs in total knee and hip arthroplasty. Most of the studies originated in the United States. In contrast to earlier reviews in this journal, fewer studies focused on only pharmacoeconomic aspects. In reviewing these studies, we found a lack of standardization in cost-assessment leading to a limited comparability of study results. As main tasks to improve the evidence achieved by performing cost-evaluations in clinical settings, we identified a standardization of main cost-components that should be covered by each clinical trial and the assessment of validity, reliability, and comparability of different data sources used to collect cost-data.

Arthritis, Rheumatoid↗

PubMed1999

Comparison of the Dougados Functional Index and the Bath Ankylosing Spondylitis Functional Index. A literature review.

The preliminary core set for endpoints in ankylosing spondylitis (AS) clinical trials includes physical function. The objective of this review was to compare properties and performance of the 2 most widely used measures of functional capacity in AS: the Dougados Functional Index (DFI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). A MEDLINE search was performed covering the years 1988 through April 1998. AS studies were identified and selected if they included the DFI and/or the BASFI. Additional studies were identified by scrutinizing the references cited in the retrieved articles and by correspondence with the authors of the 2 questionnaires. The instruments were examined with respect to development, truth, discrimination, and feasibility. We identified 27 articles dealing with the instruments. Both are valid and reliable measures of functional capacity in AS. While the DFI was sensitive to change in one disease controlling (DC-ART) and in 4 symptom modifying antirheumatic drug (SMARD) clinical trials, the BASFI is not sufficiently tested in these settings. The only direct comparison of both indices in a physical therapy setting confirmed 4 other studies that suggested a better discriminative capacity of the BASFI in physical therapy clinical trials. Two likely reasons for the lack of responsiveness of the DFI in these settings are the distribution of baseline scores showing a tendency towards normal values and the less sensitive scoring system. Discriminative capacity of the BASFI was found to be superior in patients with mild functional disability. It remains to be seen whether the BASFI performs as well as or better than the DFI in SMARD and DC-ART clinical trials.

Activities of Daily Living↗

PubMed1999

Validity aspects of erythrocyte sedimentation rate and C-reactive protein in ankylosing spondylitis: a literature review.

The preliminary core set for endpoints in disease controlling antirheumatic therapy includes acute phase reactants. The objective of this clinically oriented literature review was to examine and compare the validity of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) in ankylosing spondylitis (AS) clinical trials. A MEDLINE search was performed covering the years 1967 through April 1998. AS studies were identified and selected if they included ESR and/or CRP and either presented data about their relation with disease activity or were designed as longitudinal clinical trials. Additional studies were identified by scrutinizing references cited in the retrieved studies. The selected studies were examined for truth (association with disease activity), discriminative power (sensitivity to change and discrimination between active and inactive treatment in longitudinal clinical trials), and feasibility (e.g., applicability and costs) of ESR and CRP in AS. We identified 12 articles on the association of ESR and/or CRP with disease activity and 13 longitudinal clinical trials reporting ESR and/or CRP data. Although the applied definitions or disease activity proved very inhomogenous, there was some evidence that both acute phase reactants are correlated with disease activity. In terms of discriminative capacity the available data are inconclusive. Relevant feasibility aspects are general availability, technically simple measurement, and an advantage in the cost of ESR and central laboratory facilities for CRP. Acute phase reactants do not comprehensively represent the disease process in AS. Their worth in AS clinical trials is limited. Based on the currently existing data neither measure is clearly superior in terms of validity. When selecting an acute phase reactant, feasibility aspects may be most relevant in choice of measure.

Antirheumatic Agents↗

PubMed1999

Comparative responsiveness of 3 functional indices in ankylosing spondylitis.

OBJECTIVE: To compare the responsiveness of the Bath Ankylosing Spondylitis Functional Index (BASFI), the Dougados Functional Index (DFI), and the ankylosing spondylitis-specific version of the Health Assessment Questionnaire (HAQ-S). METHODS: Using data from a placebo controlled, randomized clinical trial we designed a responsiveness model including both hypothesized improvement (n = 39; continuous diclofenac treatment) and hypothesized deterioration (n = 40; patients who withdrew from the clinical trial because of a flare) of functional performance. Instrument responsiveness was examined using 4 statistics including standardized response mean (SRM), effect size (ES), the Guyatt method, and the variance method. Ceiling and floor effects were visualized using histograms for cross sectional and time-path diagrams for longitudinal analysis. RESULTS: The BASFI ranked superior compared to the DFI and HAQ-S in detecting both improvement and deterioration of functional performance. All 4 responsiveness statistics consistently confirmed this superiority of the BASFI. However, the median baseline scores of all 3 questionnaires were close to the lower end of the instrument and the score distribution showed skewed patterns. CONCLUSION: The BASFI appears to be more responsive than the DFI and the HAQ-S in situations of both improvement and deterioration of functional performance. However, addition of particular difficult items may improve the performance of the BASFI as well as of the other 2 instruments.

Adult↗

PubMed1998

[Cost-effectiveness--limits between optimization and rationing].

Although rationing is an important feature in the German health care system, this topic is not discussed in an explicit and structured way. Currently, most rationing decisions are not based on systematic data on costs and outcomes of diseases and medical interventions. A major task of future research will be to provide health policy makers with data on direct costs, indirect costs, effectiveness, and utility of medical interventions and to integrate these data into decision analysis models. Interdisciplinary work-groups should be set up, combining clinical and economic knowledge. On the other hand, official grants are needed to perform unbiased research in this field covering the various areas of medical care.

Cost-Benefit Analysis↗