Direct and indirect costs associated with the onset of seropositive rheumatoid arthritis. Western Consortium of Practicing Rheumatologists.

OBJECTIVE: To examine the direct and indirect costs of rheumatoid arthritis (RA) during the first year of disease. METHODS: As part of a longitudinal observational study, 150 patients with seropositive RA of 5.9 +/- 2.9 mo duration were recruited through the Western Consortium of Practicing Rheumatologists. Subjects completed questionnaires about health care services and resources utilized and about the number of days of usual activity lost as a result of RA during the 6 month period prior to enrolment. RESULTS: Study participants had active RA as evidenced by mean tender and swollen joint counts of 24.9 +/- 13.5 and 20.6 +/- 11.6, respectively, and moderate functional impairment reflected by a mean Health Assessment Questionnaire (HAQ) score of 1.24 +/- 0.7. The average total direct cost of RA was $200/month. Health care visits, medications, and radiographs accounted for 78% of the total direct cost, while expenditures for hospitalizations accounted for only 3.5% of the total. The average number of days of usual activity lost per month because of RA was 3.8 +/- 7.7, translating into an average indirect cost of $281/month. Of the 95 subjects who were gainfully employed prior to disease onset, 12 were disabled and 5 were on sick leave as a result of RA, corresponding to a work disability rate of 18%. Work disabled subjects reported significantly lower total household incomes and higher HAQ disability and global disease activity scores than subjects who continued working. CONCLUSION: In this group of patients with seropositive RA substantial costs, both direct and indirect, were incurred during the first year of disease.

Patient self-report tender and swollen joint counts in early rheumatoid arthritis. Western Consortium of Practicing Rheumatologists.

OBJECTIVE: To determine the correlation between patient self-report joint counts and standard physician joint counts, and to compare pictorial (Mannequin) and text (Rapid Assessment of Disease Activity in Rheumatology, RADAR) formats for obtaining patient self-reports. METHODS: Baseline patient self-report joint counts were mailed and completed by 60 patients with early rheumatoid arthritis (RA) one day before and one day after being examined by a physician. Twenty-seven were randomized to the Mannequin tender and Mannequin swollen joint counts; 33 were randomized to the RADAR tender and swollen joint counts. Agreement between patient and physician self-report joint counts, diagnostic characteristics, and test-retest reliability of patient self-report joint counts was computed. Stepwise regression analyses were performed to identify predictors of patient-physician differences in total joint count. RESULTS: Means and standard deviations of paired patient and physician total joint counts were not different for Mannequin or RADAR forms. Spearman correlations were moderate (0.58 to 0.69 for Mannequin, 0.37 to 0.58 for RADAR). Agreement (intraclass correlations) was 0.65 for the Mannequin and 0.56 for the RADAR forms. Patient test-retest reproducibility was moderate for RADAR tenderness (0.58) and high (r>0.90) for RADAR swollen and both Mannequin forms. Level of patient education predicted patient-physician differences on the RADAR swollen joint counts (p = 0.003), but was not significant in Mannequin forms, suggesting that education was not a factor in accurate completion of Mannequin forms. CONCLUSION: Both pictorial and text format patient self-report joint counts are significantly correlated with physician joint counts. In addition to moderately high patient test-retest reproducibility, this suggests that patient self-reports in both formats may yield accurate measures of improvement in disease activity.

Equivalence of the acute phase reactants C-reactive protein, plasma viscosity, and Westergren erythrocyte sedimentation rate when used to calculate American College of Rheumatology 20% improvement criteria or the Disease Activity Score in patients with early rheumatoid arthritis. Western Consortium of Practicing Rheumatologists.

OBJECTIVE: In an additive cohort of patients with early rheumatoid arthritis (RA), to determine the effect of substituting one acute phase reactant for another on the number of patients satisfying the American College of Rheumatology (ACR) 20% preliminary criteria for improvement, and on calculated Disease Activity Scores (DAS). METHODS: A total of 251 patients with 6.4 months average disease duration had detailed clinical assessments at entry and 6, 12, and 24 months in a multicenter prospective longterm observational study. Matched erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and plasma viscosity (PV) assays were done at 366 time points. Disease modifying antirheumatic drugs were not started until after the baseline evaluation. RESULTS: After 6, 12, and 24 months, 50%, 53%, and 57% of patients were responders, as defined by the ACR 20% improvement criteria. The difference in response rates when ESR, CRP, or PV was used as the acute phase reactant ranged from 0.4% at 12 months to 3% at 24 months. Percentile distributions of the 366 matched CRP, ESR, and PV values were used to prepare a nomogram that can be used to calculate the other acute phase reactant values if the value of one is known. When the nomogram was used to impute ESR values from observed PV or CRP values, average DAS scores calculated with the actual ESR values were not different from average DAS scores calculated from the imputed ESR values. CONCLUSION: ESR, CRP, and PV are equally useful in calculating ACR 20% response rates in patients with active early RA. A nomogram can be used to impute ESR values from CRP or PV values; use of the imputed ESR values is as accurate as use of the actual ESR values to calculate average DAS.

The relationship between socioeconomic status and recently diagnosed rheumatoid arthritis.

OBJECTIVE: To examine the role of socioeconomic status (SES) in physical functioning, pain, and depressive symptoms among newly diagnosed rheumatoid arthritis (RA) patients with severe disease. METHODS: Data are from 118 non-Hispanic patients of European origin at baseline of a longitudinal study of early, severe RA. Outcome measures with the Health Assessment Questionnaire (HAQ) functional disability index, the HAQ visual analog pain scale, and the Center for Epidemiologic Studies Depression Scale. Hierarchical regression analyses were conducted using a health status block (disease activity and comorbidities), a non-SES related social structure block (age, sex and Lubben Social Network Scale), and indicators of SES (income and education). RESULTS: Non-SES related social structure and SES were important independent determinants of functional disability and depressive symptoms, but both they and the health status variables were unrelated to pain. Further, neither income nor education was related to disease activity or comorbidities. CONCLUSION: It cannot be argued from these data that poorer health status explains the link between SES and disability and depressive symptoms. Although, at baseline, the psychosocial effects of early RA are more severe for those with SES, the disease does not appear to be more severe. It may be that the biologic impact of status differentials will become clearer as the effects of treatment and the course of the disease unfold over time.

[Electronic data processing-assisted high dosage therapy with stem cell transplantation at the Donauspital]. / EDV-unterstützte Organisation der Hochdosistherapie mit Stammzelltransplantation im Donauspital.

Organization of high dose chemotherapy with stem cell transplantation essentially requires EDV-support. "ONCOBASE" has been adapted into the Donauspital network on May 1, 1992. We report about the 2-year clinical experience with ONCOBASE: 1. ONCOBASE effectively supports communication between the ward, ambulance and hospital pharmacy (where all cytostatics are prepared). 2. ONCOBASE provides better surveillance concerning all therapeutic procedures including cytostatic drugs and supportive therapies. 3. ONCOBASE allows the generation of medical letters which include all drugs and supportive therapies delivered. 4. Since ONCOBASE is a database program, all informations concerning the patients are registered. These include cumulative drug doses, information on side effects, blood cell kinetics after previous therapies, kinetics of tumor markers and results of further examinations. 5. ONCOBASE permits rapid data exchange with other hospital networks using the communication data record governed by the "Arbeitskreis für EDV der deutschen Gesellschaft für Hämatoonkologie".

Cyclosporine in systemic sclerosis. Results of a forty-eight-week open safety study in ten patients.

OBJECTIVE: To evaluate safety and efficacy of cyclosporin A (CSA) treatment in systemic sclerosis (SSc). METHODS: Ten patients with < or = 60 months of SSc were entered into a 48-week open study of CSA. Patients with hypertension or azotemia were excluded. Concurrent use of nonsteroidal antiinflammatory agents or diuretics was not permitted. The extent of cutaneous and visceral involvement at 48 weeks and at study entry were compared. RESULTS: Adverse reactions (especially nephrotoxicity) were frequent, usually transient, often dose-limiting, and usually associated with CSA doses > or = 3-4 mg/kg/day. Skin thickening decreased significantly (P < 0.001), while pulmonary and cardiac involvement remained unchanged. CONCLUSION: CSA should undergo blinded controlled study in patients with SSc.

Cardiac score. A semiquantitative measure of cardiac involvement that improves prediction of prognosis in systemic sclerosis.

Cardiac involvement, assessed yearly by a semiquantitative cardiac scoring technique (the sum of 2 variables, scored 0 or 1 for left axis deviation, and 0 or 2 for moderate-large pericardial effusion) and outcome at 10 years were evaluated in 90 systemic sclerosis (SSc) patients enrolled in a 3-year prospective drug trial. Higher cardiac scores were associated with decreased survival. The inverse relationship of survival with cardiac score was more significant than the relationship between survival and any of the cardiopulmonary variables individually (P less than 0.0000003). Predicted 6-year survival was 79% in patients with a cardiac score of 0, 51% in those with a score of 1, 15% in those with a score of 2, and 0% in those with a score of 3. We conclude that a simple 2-variable weighted cardiac score, derived from routine electrocardiography and echocardiography, is a useful predictor of survival in patients with SSc, and we propose that the application of this cardiac score be tested in other populations of SSc patients.

Skin score. A semiquantitative measure of cutaneous involvement that improves prediction of prognosis in systemic sclerosis.

Cutaneous sclerosis, assessed yearly by a semiquantitative skin scoring technique (sum of 10 body areas, each scored on a scale of 0-3 for tethering, by clinical palpation), and outcome at 10 years were evaluated in 90 systemic sclerosis patients enrolled in a 3-year, prospective drug trial. The inverse relationship of survival to the skin score at study entry (increasing skin score associated with decreasing survival) (P less than 0.003) was more significant than was the relationship found by using classification schemata that rely only on distribution of cutaneous sclerosis. Six-year survival was 40% in patients with entry skin scores greater than or equal to 15 and 73% when skin scores were less than 15 (P less than 0.005). An entry skin score greater than or equal to 15 was associated with a high risk of early fatal renal and cardiac complications.

Immunosuppression with chlorambucil, versus placebo, for scleroderma. Results of a three-year, parallel, randomized, double-blind study.

Placebo and chlorambucil (0.05-0.1 mg/kg/day) were compared as treatments for scleroderma in a 3-year, randomized, double-blind, parallel study of 65 patients. Slopes of change over time, calculated for each organ system of each patient, failed to show significant differences between treatment groups. An immunosuppressive effect in the chlorambucil-treated group was shown by decreases in the white blood cell counts (P = 0.02), platelet counts (P = 0.04), lymphocyte counts (P = 0.001), IgA/IgM concentrations (P less than or equal to 0.05), and wheal size on mumps skin tests (P = 0.02). Three years of immunosuppressive treatment with chlorambucil did not benefit this scleroderma population.

Clinical and serological comparison of 17 chronic progressive systemic sclerosis (PSS) and 17 CREST syndrome patients matched for sex, age, and disease duration.

This study compares the clinical and serological differences between 17 PSS and 17 carefully matched CREST patients. Patients were matched for sex, age by decade, and, importantly, disease duration (11.2 +/- 9.2 vs. 12.0 +/- 9.3 years). Muscular and skin involvement were greater for the PSS groups (p less than 0.02) and pulmonary involvement was also greater (p less than 0.05), at least for non-smoking PSS patients. On the other hand no clinically significant differences were found between groups for other visceral involvement--including comparisons of gastrointestinal, cardiovascular, and renal involvement. There were also no laboratory differences except in anti-RNP antibody (p less than 0.04).