Search PubMed⌕ Search

Biomedical subjects

J Ruof

Publications and source records attributed to J Ruof.

15 recordsLinked to original sources

[Health economics research in the area of chronic polyarthritis].

Costs of illness are of major economic relevance in rheumatoid arthritis (RA) as in other chronic diseases. Overall costs of 15,000 Euro/year: 10,000 Euro indirect costs, and 5000 Euro direct costs are estimated, respectively. A further detailed analysis of direct costs underlines that inpatient care (50%) is the most prominent cost driver. Medication costs are also evaluated in detail since they are expected to gain importance with the introduction of the more expensive biologicals. While annual costs for regular disease modifying drugs (DMARDs) vary from 160 to 5000 Euro per patient, costs for the new biologicals amount up to 20,000 Euro (100-125% of the current estimated overall costs). For a comparison of different therapeutic strategies, costs are related to effectiveness in cost-effectiveness analyses. Based on present clinical trials, the ratios of medication costs and response according to the ACR 20-criteria of various DMARDs and biologicals are compared. The most cost-effective medication is sulfasalzine, followed by methotrexate, and leflunomide. Combining etanercept and methotrexate is preferable to methotrexate monotherapy and the combination of infliximab and methotrexate. This review shows that important economic issues in RA have already been addressed by applying cost-of-illness analyses and cost-effectiveness analyses. However, the knowledge about cost-effective therapeutic options is still scarce. Thus, primary data will have to be obtained using standardized approaches. These economic findings can be taken into account in the development of disease-management recommendations for RA-therapy.

Antirheumatic Agents↗

Indirect medical costs in early rheumatoid arthritis: composition of and changes in indirect costs within the first three years of disease.

OBJECTIVE: To investigate 1) the magnitude of indirect costs, 2) changes in cost components, and 3) correlations between changes in cost and social, clinical, and occupational variables within the first 3 years of rheumatoid arthritis (RA). METHODS: We evaluated the indirect costs per person-year in 133 consecutive gainfully employed out-patients with early RA, in a prospective multicenter followup study. Costs due to RA-related sick leave, work disability, and other work loss were assessed using the human capital approach. Variables associated with reduction in lost productivity were tested by multivariate logistic regression analysis. RESULTS: Mean +/- SEM annual indirect costs were $11,750 +/- 1,120 per person. During the 3-year period of observation, a marked reduction in the costs associated with sick leave was seen, which exceeded the increase in costs due to work disability and other work loss. This phenomenon resulted in an overall reduction in indirect costs of 21%. The final logistic regression model of reduced loss of productivity included 3 variables: no problems with standing (odds ratio [OR] 7.1), no problems with working speed (OR 4.1), and no problems with outdoor work (OR 3.1). CONCLUSION: High indirect costs in early RA were demonstrated. An overall decrease of costs can be seen in the first 3 years, due to the reduction in sick leave. Since the absence of problems due to strenuous working conditions was found to be associated with a reduction in indirect costs, it is assumed that early intensified vocational rehabilitation, apart from controlling disease activity by adequate treatment, might help to reduce indirect costs.

Arthritis, Rheumatoid↗

Quality of partnership in patients with erectile dysfunction after sildenafil treatment.

OBJECTIVE: A comprehensive investigation on the quality of partnership of male patients with erectile dysfunction (ED) after treatment with sildenafil vs. untreated patients, as perceived by both the patients and their female partners. METHODS: This report describes an observational, cross-sectional exploratory study comparing ED patients responsive to sildenafil with ED patients prior to therapy. Assessments included the 'International Index of Erectile Function' (IIEF) and the 'Partnerschaftsfragebogen' (PFB), a partnership questionnaire used in German-speaking countries. The comparability of the two study groups was examined using a stepwise logit model. Significant intergroup differences regarding demographics and history were identified and included as confounding variables in the assessment of Quality of Partnership differences using ANCOVA. A regression analysis was performed to determine the association between the mean total IIEF scores and Quality of Partnership measures. RESULTS: 105 patients were included in the study. After adjustment for confounding variables, the groups varied significantly with respect to Quality of Partnership as perceived by men (mean score PFB 61.8 +/- 13.9 vs. 54.4 +/- 15.5; p<0.001) and women (mean score PFB 63.1 +/- 13.6 vs. 57.0 +/- 14.7; p = 0.006). In men, all three PFB subscales (quarreling, tenderness, togetherness) differed significantly between the two study groups. In the female partners, the tenderness and togetherness domains varied significantly. Erectile function correlated highly significantly with tenderness and togetherness in both the male patients and their partners. CONCLUSION: Our data indicate that the Quality of Partnership reported by both the men and their female partners is significantly better in appropriately treated ED patients than in untreated controls.

Cross-Sectional Studies↗

Development of a matrix of cost domains in economic evaluation of rheumatoid arthritis.

The aim of our study was to comprehensively review and critically appraise the cost domains used in economic evaluations of the rheumatic diseases and to use this information to propose standardization of cost domains. The literature search identified 210 abstracts, 32 of which included original cost data. The listed cost categories were grouped into 3 major areas: (direct) health care costs, other (direct) disease related costs, and productivity costs (indirect costs). The number of individual cost categories was reduced by considering the following criteria: (1) inclusion of all relevant cost domains; (2) avoidance of double counting; (3) summarizing of related categories under one representative heading; (4) feasibility of level of aggregation. After adjustment for synonymous labeling, 38 cost categories remained. The subsequent development of a classification scheme of cost categories led to a set of 19 separate cost domains including 7 outpatient, 3 inpatient, 6 other disease related, and 3 productivity cost domains. This literature review indicates that cost assessment in economic evaluations in rheumatoid arthritis lacks standardization. A preliminary scheme to categorize cost assessment in rheumatic conditions is presented. The adoption of standards for economic evaluation would greatly facilitate national and international comparisons.

Arthritis, Rheumatoid↗

Cost assessment instrument in rheumatology: evaluation of applied instrument characteristics.

We compared the major characteristics of internationally applied cost assessment instruments (CAI) in rheumatic conditions. Fifteen utilization questionnaires were identified and assessed using a structured approach. The forms differed considerably with respect to applied characteristics: length (3-113 items), recall period (between 1 week and 1 year), format (2 interview, 13 self-administered), response categories, cost units (physical vs monetary), and cost domains covered. While all included a gross assessment of outpatient and inpatient costs, the level of disaggregation differed. Only a few CAI included an assessment of other direct disease related costs (e.g., home remodeling or home health care services) and out-of-pocket expenditure. Productivity costs were included in all but 2 CAI. Efforts to further standardize the applied CAI should (1) be based on sound psychometric data, (2) define a required core set of cost domains covered, (3) discriminate between generic and relevant disease related cost components, and (4) examine the feasibility of developing international standards for cost data.

Arthritis, Rheumatoid↗

[Guidelines for lowering lipids are too infrequently observed. Results of a retrospective study of coronary heart disease patients].

UNLABELLED: The aim of this retrospective analysis was to investigate adherence to treatment guidelines in the secondary prevention of coronary heart disease. 3720 CHD patients treated in 591 doctor's offices throughout Germany were investigated. End points were serum lipid levels at week-6, i.e. screening investigation, and 5 weeks after discontinuation of the lipid-lowering medication (week-1). 3383 of the 3720 (90.9%) patients had LDL-C levels > = 115 mg/dl, and 3563 (95.8%) > = 100 mg/dl. At week-6 mean LDL-C was 167.7 +/- 43.5 and mean total cholesterol was 258.8 +/- 47.8 mg/dl. 5 weeks after discontinuation of lipid-lowering treatment, mean LDL-C increased by 5.6%, and mean total cholesterol by 3.7% in comparison with baseline at week-6. 2346 (69.3%) of the patients with LDL-C > = 115 at week-6 did not receive any prior lipid-lowering medication. Also, patients receiving lipid-lowering medication demonstrated an insufficient lipid decrease (only 14.4% of all treated patients had LDL-C levels < 115 mg/dl, and only 6.8% had levels < 100 mg/dl. CONCLUSION: So far, lipid-lowering guidelines for the secondary prevention of CHD are not being adequately implemented. Appropriate action to remedy this situation (e.g. establishment of Disease Management Programs) is needed. The aggressive use of lipid-lowering drugs is a must if the goals of the treatment guidelines are to be met, and morbidity and mortality of CHD lowered.

Anticholesteremic Agents↗

[Cyclooxygenase-2 (Cox-2) selective inhibitors: socioeconomic and pharmaco-epidemiologic aspects].

Health authorities of several European countries recently introduced guidelines for socioeconomic evaluations. Additionally the activities of OMERACT (Outcome Measures in Rheumatoid Arthritis Clinical Trials) indicate an increasing awareness for the need of socioeconomic studies in rheumatology. The planned 2000 OMERACT meeting in Toulouse will address transfer of socioeconomic standards into rheumatology. In terms of cost effectiveness of selective Cox-2 inhibitors, a reference has to be made to the preceding discussion of cost effectiveness of Misoprostol. In addition, there are two models examining the cost effectiveness of Cox-2 inhibitors: a Canadian model comparing Nabumetone and Naproxen and an unpublished model assessing the cost effectiveness of Celecoxib (ACCES: Arthritis Cost Consequence Evaluation System). German data indicate that gastrointestinal bleedings account for 32.9% of all adverse drug events leading to a hospital admission. Further data assessing the morbidity due to adverse effects of nonsteroidal anti-inflammatory drugs are needed. Such data would allow the quantification of possible savings related to the usage of Cox-2 inhibitors in Germany.

Antirheumatic Agents↗

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↗

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↗

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↗

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↗

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↗

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↗

[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↗