Evidence-based guidelines for the use of immunologic tests: anticentromere, Scl-70, and nucleolar antibodies.
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Biomedical subjects
Publications and source records attributed to Daniel H Solomon.
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BACKGROUND: Rheumatoid arthritis may be associated with an increased risk of cardiovascular disease. We compared the incidence rates of myocardial infarction and stroke in subjects with and without rheumatoid arthritis. METHODS AND RESULTS: A prospective cohort study was conducted among the 114 342 women participating in the Nurses' Health Study who were free of cardiovascular disease and rheumatoid arthritis at baseline in 1976. All self-reported cases of rheumatoid arthritis were confirmed by medical record review. Fatal and nonfatal myocardial infarctions and strokes were similarly confirmed. Multivariate pooled logistic regression was used to adjust for potential cardiovascular risk factors. Five hundred twenty-seven incident cases of rheumatoid arthritis and 3622 myocardial infarctions and strokes were confirmed during 2.4 million person-years of follow-up. The adjusted relative risk of myocardial infarction in women with rheumatoid arthritis compared with those without was 2.0 (95% confidence interval [CI], 1.23 to 3.29). For stroke, the adjusted relative risk was 1.48 (95% CI, 0.70 to 3.12). Women who had rheumatoid arthritis for at least 10 years had a risk for myocardial infarction of 3.10 (95% CI, 1.64 to 5.87). CONCLUSION: In this large prospective cohort of women, participants with rheumatoid arthritis had a significantly increased risk of myocardial infarction but not stroke compared with those without rheumatoid arthritis. If these data are confirmed, aggressive coronary heart disease prevention strategies should be tested for persons with rheumatoid arthritis.
OBJECTIVE: Some reports suggest that education programs help arthritis patients better manage their symptoms and improve function. This review of the published literature was undertaken to assess the effect of such programs on pain and disability. METHODS: Medline and HealthSTAR were searched for the period 1964-1998. The references of each article were then hand-searched for further publications. Studies were included in the meta-analysis if the intervention contained a self-management education component, a concurrent control group was included, and pain and/or disability were assessed as end points. Two authors reviewed each study. The methodologic attributes and efficacy of the interventions were assessed using a standardized abstraction tool, and the magnitude of the results was converted to a common measure, the effect size. Summary effect sizes were calculated separately for pain and disability. RESULTS: The search strategy yielded 35 studies, of which 17 met inclusion criteria. The mean age of study participants was 61 years, and 69% were female. On average, 19% of patients did not complete followup (range 0-53%). The summary effect size was 0.12 for pain (95% confidence interval [95% CI] 0.00, 0.24) and 0.07 for disability (95% CI 0.00, 0.15). Funnel plots indicated no significant evidence of bias toward the publication of studies with findings that showed reductions in pain or disability. CONCLUSION: The summary effect sizes suggest that arthritis self-management education programs result in small reductions in pain and disability.
Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities.
Pharmacoepidemiology is the branch of epidemiology that focuses on medications and their outcomes, including both adverse events and intended consequences. Such studies have become more prominent in rheumatology as the number of new medications has grown and prescribing databases have become more available. In the past year, the potential cardiovascular complications associated with selective COX-2 inhibitors have become an important concern. A number of pooled analyses suggest the possibility of an increased risk of acute myocardial infarction, and studies of naproxen have found a possible protective effect. Accumulating evidence supports the contention that early initiation of disease modifying antirheumatid drug therapy improves outcomes of patients with rheumatoid arthritis. Open-label extensions of biologic therapies found continued benefits extending several years with the TNF-alpha antagonists, but concerns have arisen regarding tuberculosis and central nervous system demyelination with these agents. Data continue to be published quantifying the risk of osteoporosis associated with glucocorticoids, and the association between biphosphonate therapy and upper gastrointestinal events appears to be less of a concern that originally described.
OBJECTIVE: To assess trends in knee magnetic resonance imaging (MRI) use and accompanying management changes to determine whether indications for this test have changed over time. DATA SOURCES: Large administrative database containing health care information for 587,010 people living in 1 state who were enrolled in the Medicare or Medicaid programs. They all had used health services during 3 consecutive years between 1991 to 1995. METHODS: We performed a retrospective cohort study examining the rates of lower extremity MRI in successive years and calculated the proportion of patients who were seen by a knee specialist or underwent knee surgery subsequent to the MRI. RESULTS: The annual rate of knee MRI was 1.4 per 1000 person-years in 1991 and increased by 140% to 3.4 per 1000 person-years by 1995 (P = 0.001). Approximately half of patients who underwent a knee MRI in 1991 had a diagnosis of internal derangement of the knee in the prior year; this figure dropped to 35% in 1995 (P < 0.001). The percentage of patients undergoing a knee MRI who had no record of any knee diagnosis in the prior year grew from 13% in 1991 to 33% in 1995 (P < 0.001). Over the 5 years of the study, the percentage of patients whose knee MRI was followed by specialist care or knee surgery decreased from 68% to 58%, a relative change of 15% (P < 0.005). CONCLUSION: Knee MRI use increased sharply during the study period, but the proportion of such patients who had a prior diagnosis of internal derangement or subsequently saw a knee specialist or underwent knee surgery decreased. This finding indicates that the criteria for knee MRI appear to have broadened substantially during this period.
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OBJECTIVE: Nonselective nonsteroidal antiinflammatory drugs (NSAID) are well known to cause an increased risk of gastrointestinal (GI) hemorrhage, congestive heart failure, and hypertension, but the cost of such adverse effects has not been rigorously defined. We calculated the excess risk and costs associated with the major adverse effects of prescription nonselective NSAID. METHODS: This study involved a retrospectively collected random cohort of 41,826 continuously enrolled patients over 65 years old in the New Jersey Pharmaceutical Assistance to the Aged and Disabled or Medicaid programs. We calculated the adjusted rates and costs of major adverse effects associated with nonselective NSAID, including hospitalization for GI hemorrhage, gastroprotective drug use, ambulatory upper GI procedures, antihypertensive drug use, and hospitalization and medication use to treat congestive heart failure. RESULTS: Eighteen percent of patients filled > or = 1 new prescription for a nonselective NSAID during the study year. All adverse effects studied were more common in patients filling prescriptions for nonselective NSAID than in those not. Average annual costs for the adverse effects studied were 1,234 (1998 US dollars) in nonselective NSAID users compared with 1,036 (1998 US dollars) for controls. After adjusting for sociodemographic factors, other health care utilization, and relevant comorbid diseases, the average annual cost for the major nonselective NSAID related adverse effects studied was 117 (1998 US dollars) higher for patients filling a nonselective NSAID prescription than for those who did not. Nonselective NSAID users with > or = 4 risk factors for nonselective NSAID related adverse effects had average excess costs of 316 (1998 US dollars) over controls, whereas those with no risk factors had an average excess cost of only 75 (1998 US dollars) . CONCLUSION: The excess cost of nonselective NSAID related adverse effects is modest in low risk patients, but much higher in patients with specific risk factors. This approach of stratifying patients based on the risk of nonselective NSAID associated adverse effects can help clinicians and policymakers determine which patients might be the most appropriate candidates for treatment options costlier than nonselective NSAID.
A case of tuberculous osteomyelitis of the proximal humerus is described. The relevant literature is reviewed with attention to epidemiologic data. Issues highlighted include the frequent presentation in a subacute course without systemic illness; the value of plain radiography and especially magnetic resonance imaging; the importance of obtaining a tissue diagnosis; and the high rate of cure with medical therapy. Although rare in Western countries, skeletal tuberculosis is not uncommon in endemic areas and in migrants from such areas. With the growing use of biologic therapies, rheumatologists must be familiar with the diagnosis and treatment of tuberculosis in all its forms.
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BACKGROUND: Antineutrophil cytoplasmic antibodies (ANCAs) are strongly associated with Wegener granulomatosis, Churg-Strauss angiitis, microscopic polyangiitis, and pauci-immune glomerulonephritis, referred to collectively as ANCA-associated vasculitis (AAVs). It is unclear how accurate ANCA measurement is for diagnosing AAV in diverse populations or whether proposed ANCA test-ordering guidelines improve test performance. METHODS: We assembled a retrospective case series of hospitalized and ambulatory patients from 2 academic medical centers to assess the diagnostic accuracy of ANCA measurement by enzyme-linked immunosorbent assay in identifying cases of AAV. In addition, we assessed the effect of applying proposed ANCA test-ordering guidelines on test performance. RESULTS: For ANCA testing, sensitivity was 81%; specificity, 98%; positive predictive value, 54%; and negative predictive value, 99%. There were no significant changes in operating characteristics after applying the guideline criteria. Using guidelines would have decreased ANCA test ordering by 23% and would have decreased the false-positive rate by 27%. No cases of AAV would have been missed if only patients fulfilling the guidelines were ANCA tested. CONCLUSION: A positive result on an enzyme-linked immunosorbent assay ANCA test, as it is currently ordered, is not a definitive diagnostic indicator of AAV. Compliance with guidelines for ANCA testing would decrease the number of false-positive results and has the potential to reduce total test expenditures.
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BACKGROUND: Although aspirin has been shown to protect patients from acute myocardial infarction (AMI), the effect of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) is not clear. OBJECTIVE: To determine whether NSAIDs have a similar effect or whether they differ in their effect on the risk of AMI. METHODS: We performed a case-control study of AMI in a large health care database containing information on all filled prescriptions, hospitalizations, diagnoses, and procedures for all patients covered by the New Jersey Medicaid or Medicare and Pharmaceutical Assistance for the Aged and Disabled programs. We identified 4425 patients hospitalized for AMI between January 1, 1991, and December 31, 1995, and 17 700 control subjects. Multivariate models were constructed to control for potential confounders. RESULTS: A quarter of the cases and controls had filled a prescription for an NSAID in the 6 months before theirAMI (cases) or a randomly assigned index date (controls); 9% had filled a prescription for an NSAID that overlapped with their date of AMI or index date. Overall, NSAID users had the same risk of AMI as nonusers, whether such use was measured on the index date (adjusted odds ratio, 1.04; 95% confidence interval, 0.92-1.18; P =.55) or at any time in the prior 6 months (adjusted odds ratio, 1.00; 95% confidence interval, 0.92-1.08; P =.92). However, use of naproxen was associated with a significant reduction in the risk of AMI (adjusted odds ratio, 0.84; 95% confidence interval, 0.72-0.98; P =.03). CONCLUSIONS: Although NSAIDs have anti-inflammatory and antiplatelet effects similar to those of aspirin, we did not find that these drugs confer a protective effect against AMI. However, use of one specific NSAID, naproxen, appeared to be associated with a reduced rate of AMI, an effect recently suggested by a large randomized controlled trial as well.
OBJECTIVE: Mortality and complication rates after total hip replacement (THR) are inversely associated with the volume of THRs performed at hospitals and by individual surgeons. It is not clear, however, why a higher volume of such procedures is associated with better outcomes. We evaluated the contribution of hospital structural characteristics to the volume-outcome relationship in THR by examining the rates and predictors of postoperative complications. METHODS: We analyzed data pertaining to 5,211 Medicare patients who underwent primary THR in 1995 or 1996 at 167 hospitals in Colorado, Pennsylvania, and Ohio. Data were derived from several sources, including Medicare Part A and Part B claims, the American Board of Medical Specialties, a hospital survey regarding institution-specific characteristics and structural aspects of the care setting, and the American Hospital Association 1995 Annual Survey. Multivariate models were constructed to determine whether hospital structure or surgeon-associated factors may underlie the relationship between volume of THRs and the occurrence of perioperative orthopedic adverse events, defined as deep wound infection or hip dislocation within 90 days of surgery. RESULTS: Of the patients studied, 2.6% experienced an orthopedic adverse event after THR. Sixty-nine percent fewer events occurred in hospitals where >100 THRs in Medicare patients were performed annually, compared with hospitals where <or=25 THRs were performed. In univariate analyses, several hospital-level factors were associated with a reduced (approximately 50%) risk of adverse events, including private (versus public) ownership, membership in the Council of Teaching Hospitals, presence of any residency training program, availability of a dedicated orthopedic nursing unit, and existence of operating rooms with laminar flow exhaust systems. However, the only hospital-level factor associated with adverse events in multivariate models was the use of laminar flow exhaust systems. When surgeon volume was added to the models, it was the strongest predictor of adverse events, with hospital volume and hospital-level factors having no appreciable association with adverse events. CONCLUSION: Hospital-level factors were not independent predictors of the association between hospital volume and orthopedic adverse events. The volume of THRs performed by individual surgeons is the most important determinant of orthopedic complications and should be considered in efforts to improve THR outcomes.
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OBJECTIVE: To examine rheumatologists' management practices for patients with rheumatoid arthritis (RA) taking glucocorticoids seen at one academic medical rheumatology practice. METHODS: All patients diagnosed with RA making at least 2 visits to the practice who were noted to be taking glucocorticoids on an index visit in January or February 1999 were included in a retrospective chart review. RESULTS: Of the 623 eligible patients identified with RA, 236 patients were taking glucocorticoids at their index visit and were included in this study. The mean daily dosage of prednisone (or its equivalent) was 8.8 mg and the mean duration of use during the 2-year chart review was 15.4 months. Twenty-three percent of the study population underwent bone densitometry, and 42% were prescribed a medication that reduces bone loss (not including calcium and/or vitamin D). Calcium and/or vitamin D were noted on the medication lists of 25% of patients. Factors associated with not undergoing bone densitometry in adjusted logistic models included male patient sex and premenopausal status in women. No physician factors were significantly related to performing bone densitometry. Variables associated with not receiving prescription treatment of osteoporosis were male patient sex, premenopausal status, and having at least 1 comorbid condition. CONCLUSION: Patients with RA taking oral glucocorticoids did not routinely undergo bone densitometry and/or receive prescription medications for osteoporosis. Men and premenopausal women were less likely to undergo bone densitometry and to receive a prescription medication for osteoporosis than postmenopausal women. Interventions to improve detection and prevention of glucocorticoid-induced osteoporosis are necessary.
Unstable angina and non-Q-wave myocardial infarction (MI) are common and costly clinical events, but there is considerable uncertainty about optimal clinical management of these syndromes. We developed a prediction rule to help clinicians determine which patients with unstable angina or non-Q-wave MI are likely to "fail" medical therapy and ultimately require cardiac catheterization within 6 weeks of presentation. Subjects were 733 patients presenting with unstable angina or non-Q-wave MI enrolled in the TIMI IIIB trial and randomized to initial medical management. We developed a prediction rule based on logistic regression analysis of baseline data from history, physical examination, electrocardiogram, and blood studies. The outcome of interest was "failure" of medical therapy, defined as need for coronary catheterization within 42 days. Significant predictors of "failing" medical therapy included ST segment depression >or= .1 mV (odds ratio, OR, = 2.7, 95% confidence interval, CI, 1.8-4.1), accelerated angina in the prior 2 months (OR = 1.8, 95% CI 1.2-2.6), nitrate use in the prior week (OR = 1.6, 95% CI 1.1-2.2), exertional angina in the prior 2 months (OR = 1.6, 95% CI 1.1-2.2), and cardiac troponin I (cTnI) >or= 0.4 ng/mL (OR = 1.4, 95% CI 1.1-1.9). We used these variables to build a risk score by assigning point values based on these ORs. The risk score had a moderate ability to predict which patients would subsequently fail medical therapy and undergo cardiac catheterization (c = 0.682). Out of a total risk score of 13, failure of medical therapy occurred in 86% of patients who had a risk score >or= 8 (n = 111), 78% of patients who had a risk score >or= 6 (n = 240), and 72% of patients who had a risk score >or= 4 (n = 438). At scores of < 2 (n = 88), 40% of patients failed medical therapy. Although the management of unstable angina is in constant evolution, clinicians will always be faced with determining which patients should be managed most invasively. The simple prediction rule we present can be applied to patients with unstable angina or non-Q-wave MI at the time of presentation to predict which patients have a high probability of failing medical therapy. Such a rule may be useful for identifying patients who should be considered for early cardiac catheterization.