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Biomedical subjects

R Altman

Publications and source records attributed to R Altman.

At least 37 records · Page 2Linked to original sources
PubMed1997

Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.

Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials, and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization/International League of Associations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further international harmonization of measurement procedures used to establish beneficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique). These evidence based preferences, achieved with a high degree of consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborative Project goals.

Clinical Trials, Phase III as Topic↗
PubMed1996

Comparison of high-dose with low-dose aspirin in patients with mechanical heart valve replacement treated with oral anticoagulant.

BACKGROUND: There are no reported studies on the safety and efficacy of low-dose aspirin with low-intensity oral anticoagulation in patients with heart valve replacement. In this study, we compared the use of 100 mg/d aspirin with 650 mg/d aspirin in the prevention of systemic embolism and vascular death in patients with heart valve replacement who were being treated with oral anticoagulants with a target international normalized ratio (INR) of 2.0 to 3.0. METHODS AND RESULTS: Four hundred nine of 416 consecutive patients who had cardiac valve replacement were randomized in open allocation into one of two groups; both groups were treated with oral anticoagulant therapy with a target INR of 2.0 to 3.0. Two hundred seven patients who received 100 mg/d aspirin for an average of 24.1 months were compared with 202 patients who received 650 mg/d aspirin for an average of 21.7 months in a randomized-treatment, open-allocation study. There were no significant differences in systemic embolism, vascular death, or total death rates between the low- and high-dose aspirin treatment groups (0.5 and 1.1, 1.2 and 0.5, and 4.6 and 2.5 per 100 patients/y, respectively). The total number of hemorrhagic events was 13.4 per 100 patients/y in the high-dose aspirin group and 7.9 per 100 patients/y in the low-dose aspirin group (P = .035), but the rate of bleeding was influenced by dipyridamole in the 650-mg aspirin group. CONCLUSIONS: In patients with mechanical heart valve replacements, low-dose aspirin (100 mg/d) in conjunction with oral anticoagulants at an INR of 2.0 to 3.0 is as effective as the use of high-dose aspirin (650 mg/d) in the prevention of systemic embolism.

Administration, Oral↗
PubMed1996

Effect of comprehensive intervention program on survival of patients with human immunodeficiency virus infection.

BACKGROUND: In October 1989, an early intervention program (EIP) for human immunodeficiency virus (HIV) infection was initiated in New Jersey to provide medical care and social services to the enrollees. OBJECTIVE: To assess the overall effect of the EIP on the survival of HIV-infected patients. METHODS: Patient information collected through June 30, 1993, was analyzed from the Jersey City Medical Center EIP clinic. Survival from enrollment to death was calculated for patients who received follow-up at the clinic (active) and for those who only had the enrollment visit (inactive). The data were matched with the New Jersey death certificate registry. RESULTS: Of 938 patients enrolled from October 1989 to December 1991, 767 had T-cell subsets determined within 3 months of enrollment: 641 patients were active and 126 were inactive. At entry, inactive patients had a lower median CD4+ T-cell count and were more likely to be symptomatic than active patients. Among the 640 active and 125 inactive patients analyzed for survival (survivors > or = 2 months), there were 144 (22.5%) and 48 (38.4%) deaths, respectively. Kaplan-Meier analysis indicated longer survival for active patients than for inactive patients (P < .001, Wilcoxon's test for homogeneity of strata); eg, survival probability at 2 years was 86% for active patients and 64% for inactive patients. Active patients also had longer survival than inactive patients when stratified by CD4+ T-cell levels or by clinical status. Only active and inactive patients with both CD4+ T-cell levels lower than 0.20 x 10(9)/L (< 200/microL) and symptoms of HIV or acquired immunodeficiency syndrome had similar survival rates. Survival was not influenced by sex, race, or HIV transmission category. CONCLUSION: Participation in the EIP was associated with longer survival of HIV-infected patients.

Adolescent↗
PubMed1996

Coagulation and fibrinolytic parameters in patients with pulmonary hypertension.

BACKGROUND: Vascular endothelium reacts to various pathophysiologic stimuli by releasing several autocoids and cytokines that can be used along with the coagulation and fibrinolytic markers for the diagnosis of hemostatic alterations. Several newer markers for vascular distress, such as tissue plasminogen activator (TPA), tissue plasminogen activator inhibitor-1 (PAI-1), TPA/PAI-1 complex, and the newly reported inhibitor of the coagulation process, namely, tissue factor pathway inhibitor (TFPI), have been implicated in the pathogenesis of pulmonary hypertension. METHODS: To investigate the behavior of endothelial cells at basal and time-dependent venous stasis-induced changes, various markers were measured in patients with primary and secondary pulmonary hypertension and compared with healthy human volunteers (controls) without any family history of thromboembolism or history of hypertensive disorders. The right atrial pressure (RAP) and pulmonary arterial pressure were measured and the hemostatic parameters were correlated to determine the relevance of these parameters with the alterations in the present indices. RESULTS: A fibrinolytic deficit exists in patients with pulmonary hypertension, indicated by the prolongation of the euglobulin clot lysis time at basal conditions and after the venous occlusion test. This defect was mainly due to increased production of PAI-1 by endothelium (patients 59.8 +/- 22.3 AU/ml; controls 30.3 +/- 14.5 AU/ml; p = 0.005). We also report for the first time that a decrease in tissue factor pathway inhibitor antigen was also observed in these patients when RAP was > 9 mmHg [controls 95.6 +/- 61.6 ng/ml; patients with RAP > 9 mmHg 47.2 +/- 19.2 ng/ml (p = 0.044); patients with RAP > 9 mmHg 96.6 +/- 32.4 ng/ml (p = 0.002 compared with patients with RAP > 9 mmHg)], indicating endothelial cell and hemostatic disturbances. CONCLUSIONS: We conclude that the euglobulin clot lysis time was prolonged in patients with pulmonary hypertension compared with controls. The impairment of the fibrinolytic system was due to an elevated concentration of PAI-1. In RAP > 9 mmHg, an additional prothrombotic factor is the decrease in plasma tissue factor pathway inhibitor antigen. It appears from this study that antithrombotic treatment is indicated in these patients.

Adolescent↗
PubMed1996

Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone.

Alendronate, an aminobisphosphonate, is much more potent than etidronate, an older bisphosphonate, in inhibiting osteoclast-mediated bone resorption, and unlike etidronate, therapeutic doses of alendronate are not associated with abnormal mineralization. In the present study, we compared the effectiveness, safety, and tolerability of 6 months of daily oral administration of alendronate (40 mg) with those of etidronate (400 mg) in 89 patients with clinically active Paget's disease. The primary efficacy end point was the percent change in serum alkaline phosphatase. Other end points included changes in urinary deoxypyridinoline excretion, pain, functional impairment scores, and radiological osteolysis. Tetracycline-labeled bone biopsies were obtained for histomorphometric analysis from a subset of 43 patients at the 6-month visit. The alendronate-treated group had significantly greater decreases in both serum alkaline phosphatase (79% vs. 44%) and urinary deoxypyridinoline (75% vs. 51%) than the etidronate-treated group (P < 0.001 in both cases). Normalization of serum alkaline phosphatase was much more frequent in alendronate-treated patients (63.4% vs. 17.0%; P < 0.001). Alendronate was well tolerated and had a safety profile similar to that of etidronate. Histomorphometry revealed decreased bone turnover and no qualitative abnormalities, including no direct negative effects on bone mineralization, with alendronate treatment. One patient receiving etidronate developed frank osteomalacia. Alendronate appears to be a highly effective treatment for Paget's disease of bone that offers an important therapeutic advance over etidronate.

Administration, Oral↗
PubMed1996

An evaluation of the TransFER model for sharing clinical decision-support applications.

TransFER is a formal model designed to facilitate the sharing of decision-support applications across institutions with heterogeneous clinical databases. The TransFER model provides a mechanism to automatically customize database queries based on a reference schema of clinical data and an encoded set of database mappings. In this paper, we describe the elements of the TransFER model and we present the results of a formal evaluation we conducted to assess the utility and generality of the model. The results suggest that the TransFER has significant potential for automating query translation and facilitating application sharing, but that further work on the representation of temporal semantics, on the modeling of missing data, and on the optimization of complex queries is required.

Decision Making, Computer-Assisted↗
PubMed1995

Efficacy and Safety of Low-Dose Streptokinase plus Desmopressin in Acute Myocardial Infarction: A Pilot Study.

In this pilot study the combined use of desmopressin, which releases tissue plasminogen activator from vascular endothelium, and a low dose of streptokinase as a new thrombolytic regimen for acute myocardial infarction is proposed. Eighteen patients with acute myocardial infarction were treated intravenously with 150,000 U (4 patients) or 250,000 U (14 patients) of streptokinase infused over 10 minutes, followed by 24 µg of desmopressin infused over 5-10 minutes. Aspirin and beta-blockers were administered at admission, and heparin and oral anticoagulants were started at the end of the thrombolytic regimen. Hemostatic parameters were studied before and 30, 60, 120, and 240 minutes after starting thrombolytic therapy. Fifteen patients (83.3%) had evidence of clinical reperfusion. Angiography was performed with a mean delay of 8.8 hours (range 1.5-22 hours) from the start of thrombolytic therapy. Fourteen patients (77.8%) had patency of the infarct-related artery: 10 patients (55.6%) achieved TIMI grade 3, and 4 patients (22%) achieved TIMI grade 2. Two patients (one TIMI grade 1 and one TIMI grade 2) underwent coronary angioplasty. No patient died during the in-hospital period. At 18 months follow-up, all patients are alive. No major or minor bleeding was detected. The significant decline in plasma fibrinogen and in the euglobulin lysis time, and the increase in fibrinogen/fibrin degradation products, indicate a plasma lytic state. Crosslinked fibrin degradation products increased from 310 +/- 120 ng/ml to 670 +/- 310 ng/ml (p = 0.009), suggesting that fibrin digestion occurred in vivo. This pilot study provides data supporting the feasibility and efficacy of a new and more economic thrombolytic treatment of acute myocardial infarction without hemorrhagic complications.

Journal Article↗
PubMed1995

Long-term efficacy and tolerability of simvastatin in a large cohort of elderly hypercholesterolemic patients.

The long-term efficacy and tolerability of simvastatin, a 3-hydroxy-3-methylglutaryl-co-enzyme A (HMG-CoA) reductase inhibitor, was assessed during a 24-month follow-up period in 168 elderly hypercholesterolemic patients. After completing a 4 week double blind dose ranging study with simvastatin, 47 males and 122 females over 62 years of age with type II hyperlipidemia, a total cholesterol level above 6.5 mmol/l and clinically manifest cardiovascular disease were included in this extended study. A total of 159 patients completed the 12-month follow-up period and 141 patients were monitored over the full 24 months. All patients were started on 10 mg simvastatin once daily and the dosage was increased until the target levels of low density lipoprotein (LDL) cholesterol between 2.3 mmol/l (90 mg/dl) and 3.6 mmol/l (140 mg/dl) were reached. Fifty percent of patients reached the targeted LDL cholesterol goal of < 3.6 mmol/l (140 mg/dl) during the study. At study completion, 65 patients (39%) were taking 40 mg simvastatin per day, 56 patients (33%) 20 mg, 42 patients (25%) 10 mg and 5 patients (3%) only used 5 mg per day. Sixteen patients (9%) received concomitant lipid lowering therapy. Over 2 years, the mean decrease in LDL cholesterol ranged from 36% to 38%, the median decrease in triglycerides was 12% to 19% and the mean increase in high density lipoprotein (HDL) cholesterol ranged from 9% to 10%, respectively. Seven patients discontinued simvastatin because of adverse clinical or laboratory events, but only in two (1.1%) was this considered to be drug-related. Side-effects were mild and most frequently gastrointestinal in nature. Mean changes in asparate aminotransferase (AST) were not significantly different from zero and mean changes in alanine aminotransferase (ALT) and creatine phosphokinase (CPK) showed a small increase. We conclude that simvastatin is an efficacious and well-tolerated treatment for hypercholesterolemia in elderly individuals for extended periods.

Aged↗
PubMed1995

Oral anticoagulant treatment with and without aspirin.

For preventing thromboembolic events, the concurrent use of oral anticoagulant and antiplatelet drugs has been proposed. In prosthetic heart valves the use of moderate intensity anticoagulants [International Normalized Ratio (INR) 2-3] plus aspirin (100 mg/day) decreases the amount and severity of embolic episodes. The possibility that the same regimen could provide benefit in the prevention of thrombotic events in other arterial diseases is also indicated by the ATACS trial in unstable angina. The ongoing studies in ischemic heart diseases will also give the answer to this possibility.

Administration, Oral↗
PubMed1994

Importance of thrombosis and thrombolysis in silent ischaemia: comparison of patients with acute myocardial infarction and unstable angina.

OBJECTIVE: To investigate whether plaque rupture and thrombosis have a role in silent ischaemia as well as in unstable angina. DESIGN: Prospective analysis of the results of haemostatic diagnostic tests at the moment of developing silent ischaemia at rest. SETTING: Coronary care unit. PATIENTS: 22 patients with acute myocardial infarction, 12 patients with symptomatic angina (unstable angina), and 10 normal volunteers (control group). INTERVENTIONS: Continuous cardiac monitoring detected 15 asymptomatic episodes (silent ischaemia) in 6 patients with unstable angina. Blood samples were obtained at admission and when an asymptomatic alteration was detected and 10 minutes later. MAIN OUTCOME MEASURES: Comparisons of concentrations of tissue plasminogen activator, urokinase type plasminogen activator, tissue plasminogen activator inhibitor-1, cross-linked fibrin degradation products, von Willebrand factor, and thrombin-antithrombin III complexes in patients and controls at admission; same comparisons in patients with silent ischaemia at the start of an episode and 10 minutes later. RESULTS: Tissue plasminogen activator concentrations were raised at admission in patients with acute myocardial infarction (mean (SD) 14.2 (6) ng/ml) and in patients with unstable angina (10.1 (2.5) ng/ml) in comparison with controls (5.1 (2.7) ng/ml, p < 0.01 and < 0.05 respectively). There was no differences between the two groups of patients, however. Similar results were observed at the start of a silent ischaemic episode (9.8 (1.9) ng/ml) and 10 minutes later (10.5 (2.9) ng/ml) compared with controls (p < 0.05). Tissue plasminogen activator inhibitor-1 concentrations were raised in patients with acute myocardial infarction (45.1 (15) ng/ml) compared with volunteers (20.6 (16) ng/ml, p < 0.01). In patients with silent ischaemia tissue plasminogen activator inhibitor-1 concentrations were slightly but not significantly increased. Concentrations of cross-linked fibrin degradation products (D dimer) increased during unstable angina (2150 (350) ng/ml) and silent ischaemia (2270 (450) ng/ml) compared with the concentrations in volunteers (340 (80) ng/ml) and patients with acute myocardial infarction (310 (120) ng/ml; p < 0.01). CONCLUSIONS: The results suggest that thrombosis mediates the pathophysiological mechanisms of silent ischaemia and unstable angina.

Angina, Unstable↗
PubMed1994

Guidelines for testing slow acting drugs in osteoarthritis.

New compounds appear to improve symptoms of osteoarthritis (OA), and others are putative chondroprotective agents. We suggest experimental designs for studying the effects of these agents in subjects with hip and knee OA. The course of the articular cartilage lesion is the primary outcome measure to be assessed in putative chondroprotective agent trials. Serial radiographic studies suggest that the annual rate of joint space narrowing in patients with hip or knee OA is about 0.25 mm. Other approaches to quantitation of cartilage loss, e.g., radiographic measurement of the area of joint space, ultrasonography, magnetic resonance imaging and fiberoptic arthroscopy (for knee OA) are under investigation.

Antirheumatic Agents↗
PubMed1994

A survey of patient access to electronic mail: attitudes, barriers, and opportunities.

The use of electronic mail (e-mail) is increasing among both physicians and patients, although there is limited information in the literature about how patients might use e-mail to communicate with their physician. In our university-based internal medicine clinic, we have studied attitudes toward and access to e-mail among patients. A survey of 444 patients in our clinic showed that 46% of patients in the clinic use e-mail, and 89% of those with e-mail use it at work. Fifty-one percent would use e-mail all or most of the time to communicate with the clinic if it were available, and many of the communications that currently take place by phone could be replaced by e-mail. Barriers to e-mail use include privacy concerns among patients who use e-mail in the workplace, choosing the appropriate tasks for e-mail, and methods for efficiently triaging electronic messages in the clinic.

Adult↗