Blindedness in clinical trials of therapies for rheumatoid arthritis: comment on the article by Bresnihan et al.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to W V Epstein.
Explore the source record for details and available documents.
OBJECTIVE: The authors compared outcomes among persons with rheumatoid arthritis (RA) with a rheumatologist versus a non-rheumatologist as the main physician for this condition. METHODS: A cohort of 1,025 persons with rheumatoid arthritis were followed for as long as 11 years. The principal measures were obtained from an annual structured telephone interview conducted by a trained survey worker. All persons with rheumatoid arthritis originally were selected from a random sample of community rheumatologists, but some subsequently had migrated to the practices of non-rheumatologists. The main outcome measures included the number of painful and swollen joints, extent of morning stiffness, a global pain rating, functional status, and a measure of global improvement. RESULTS: The persons with rheumatoid arthritis treated by rheumatologists reported significantly better functional status, fewer painful joints, and a lower overall pain rating, although the magnitude of these differences was small. A significantly greater proportion of the persons with rheumatoid arthritis treated by rheumatologists also reported improvement in a global measure of rheumatoid arthritis outcome and simultaneous improvement in all outcome measures. On all other outcome measures, the point estimate favored those with a rheumatologist as the main rheumatoid arthritis physician, although the differences did not reach statistical significance. CONCLUSIONS: The evidence suggests an advantage for persons with a rheumatologist as the main rheumatoid arthritis physician, but on several of the measures of outcome, the magnitude of the advantage was small. Because the present study was an observational design, the possibility that the advantage among persons with a rheumatologist as the main rheumatoid arthritis physician is an artifact of selection bias cannot be ruled out.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
There are few published reports of the efficacy of slow-acting antirheumatic drugs (SAARDs) specific to the treatment of persons with early rheumatoid arthritis. Two published meta-analyses of the literature on SAARD therapy are reviewed, together with some empirical data on patients with less than 2 years' disease duration treated over an 8-year period. Although the literature suggests short-term benefit of SAARDs compared with placebo therapy, there is little to warrant considering presently available drugs to be disease-remittive agents. Based on known toxicities and purported benefits of available SAARDs, a treatment schema is proposed that responds incrementally to the course of the illness when treatment is started before irreversible joint injury occurs. The advent of new classes of therapeutic agents (eg, biologicals) for the treatment of rheumatoid arthritis warrants examination of present methods for the evaluation of antirheumatic drugs.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
OBJECTIVE: To describe the course of rheumatoid arthritis over 5 years in adults and to evaluate the effect of parenterally administered gold salts on that course. DESIGN: A prospective observational study of adults with rheumatoid arthritis. Data derived from annual interviews with patients from 1983 to 1988 and from physician surveys in 1983 and 1987. SETTING: Rheumatology practices in the community. PATIENTS: The study began in 1982 with 822 adults who had rheumatoid arthritis and were under the care of rheumatologists. INTERVENTIONS: Those selected by rheumatologists in the management of their patients. MEASUREMENTS: Information describing sociodemographic and clinical characteristics, course, and therapy was collected from patients and verified by physician reports. Functional status, measured by the Health Assessment Questionnaire, and the number of painful joints were used as outcome variables. Outcome variables were adjusted for age, sex, disease duration, baseline values of the outcome variable, and the use of four disease-remittive agents other than gold. MAIN RESULTS: Multivariate repeated-measures analysis of variance showed no change in the course of rheumatoid arthritis over 5 years. The use of parenteral gold for at least 2 consecutive years at the start of the observation period produced, on average, no change in the course over 5 years in the two outcome variables. CONCLUSION: In our study of a community-based population of adults with rheumatoid arthritis who were under the care of community rheumatologists, we found that there was, on average, no statistically significant change in function or number of painful joints between 1983 and 1988. Patients receiving parenteral gold therapy for at least 2 consecutive years did not show a statistically significant difference in outcome when compared with those not receiving such therapy.
Explore the source record for details and available documents.
This article examines practice variation among rheumatologists in their use of time and procedures in follow-up outpatient encounters with rheumatoid arthritis patients. It focuses on differences across individual physicians rather than differences in populations of patients. In addition, the total variance is divided into parts due to patient characteristics, the providers' economic and other incentives to do procedures or reduce contact time, individual practice styles, and the random sampling of encounters. Data are taken from a stratified random sampling of U.S. rheumatologists. Analyses are based on 1,154 outpatient follow-up encounters with rheumatoid arthritis patients provided by 66 physicians, each of whom reported at least ten such encounters. There are large differences among the physicians in visit length, number of monitoring procedures used per encounter, and whether the encounter included measurements of complete blood count/urinalysis or erythrocyte sedimentation rate. Individual practice style differences are far more important causes of the variation that was observed among providers than are patient differences or practice incentive differences. It was determined that 5-40% of the cost of specific management activities could be saved by reducing the highest use.
Explore the source record for details and available documents.
We examined the question of what distinguishes persons with musculoskeletal disease who continue working after onset of illness from those who do not. We also investigated why persons with musculoskeletal disease have high rates of work disability relative to those with other chronic conditions of comparable activity limitation. Data regarding 3,100 persons with limitations in activities and chronic disease who were respondents to the 1978 Social Security Administration Survey of Disabled and Non-Disabled Adults were used. Persons with musculoskeletal disease who stopped working had poorer overall health status and physical function, and different work attitudes and working conditions than did those who continued to work. Symptoms of the musculoskeletal condition were poor predictors of whether work disability would result. Persons with musculoskeletal conditions had high rates of work disability, relative to those with other chronic conditions, primarily because of their age, level of comorbidity, and the interaction of the physical limitations imposed by their illness and the requirements of their jobs. They had similar levels of commitment to work and a similar proclivity to seek alternative sources of income as did those with other chronic diseases.
The authors compare health care use and outcomes of a panel of persons with rheumatoid arthritis receiving health care in prepaid group practice and fee-for-service settings. In 1982, they randomly sampled one half of all 114 board-certified or eligible rheumatologists in Northern California. Those who participated provided the names of all patients with rheumatoid arthritis presenting during a 1-month period; 812 of these patients (97% of those listed) were interviewed. In 1984, 745 of them (92% of the baseline cohort) were interviewed; 569 receive care in fee-for-service settings and 176 in prepaid group practice. As in the baseline survey year, the prepaid patients received similar amounts and kinds of health care as their fee-for-service counterparts. The prepaid and fee-for-service patients achieved similar outcomes, as measured by symptoms of illness, functional status, and work disability. The fee-for-service patients reported poorer overall health status. The authors conclude, after 2 years of follow-up study, that patients in prepaid group practice receive similar medical care inputs and achieve outcomes at least as good as those in fee-for-service.
Risk factors for hospitalization in patients with rheumatoid arthritis were analyzed to determine if factors proposed for use in adjusting Medicare capitation payments to prepaid health plans are, in fact, associated with use of costly medical care for this illness. Participating physicians from a random sample of half the rheumatologists in northern California provided us with the names of all patients with rheumatoid arthritis presenting during a 1-month period. We surveyed 754 (89%) of these patients in both 1982-83 and 1984 to obtain information about health care use in the previous 12 months. We found that baseline functional status and prior-year admissions (proposed Medicare adjustment factors), as well as disease-specific severity measures, predicted subsequent admissions. The association of prior with subsequent admissions was independent of disease severity and physician characteristics. Adjusting capitation payments for both health status and prior use will increase incentives for prepaid health plans to enroll patients with rheumatoid arthritis who have high expected medical costs.
Physicians' outcome predictions probably influence their treatment decisions in the ICU. The importance and accuracy of these predictions, however, are poorly defined. We asked 20 ICU physicians to rate the importance of 14 factors used for treatment decisions. Expected functional outcome rated highest. However, physicians' predictions of patient outcome, specifically survival and need for professional nursing care 45 days after ICU admission, had variable accuracy. For example, physicians predicted death for only 41% of adults who died, but survival for 87% of adult survivors. Predictions of survivors' need for professional nursing care proved 100% correct for children after heart surgery, but only 58% to 73% correct for other patient groups. These inaccuracies pose an important ethical question: what is the proper role of outcome predictions in ICU decision-making? We believe outcome predictions have an important role when they are proven accurate and used within the bounds of loyalty to the patients and respect for his wishes.
We assessed the ability of a computerized outpatient medical record (MR) system, the Summary Time-Oriented Record (STOR), to communicate information to clinicians in two randomized single-blind studies. In the first study, physicians were better able to predict their patients' future symptom changes and laboratory test results from outpatient visits to an arthritis clinic when STOR was added to the standard MR than when the standard MR was used alone. In a separate study, the removal of the standard MR did not result in important decrease in the physicians' ability to predict their patients' symptoms and laboratory test results if they had the option of using the full paper record when they thought they needed it. In 134 (26%) of 514 visits, the physicians exercised this option. We conclude that for outpatient visits, the computerized record system STOR operationally added information to that supplied by the full paper MR. This improved flow of information could improve the clinical decision process.
This study compares the use of health care services (hospital and ambulatory) by patients with rheumatoid arthritis who were under the care of rheumatologists in prepaid and fee-for-service arrangements. Participating physicians from a random sample of half the rheumatologists in northern California maintained a log of all their patients with well-established diagnoses of rheumatoid arthritis. We interviewed 822 of their patients, using a structured, validated phone survey to obtain information about health care use. Patients in prepaid plans had about the same number and type of hospitalizations and the same rate of surgery as those receiving fee-for-service care. However, fee-for-service patients made more ambulatory visits. We conclude that the use of expensive services (hospital admissions and surgery) for the care of patients with rheumatoid arthritis is not different in fee-for-service and prepaid settings.