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Results for “Randomized trial”

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At least 199 records · Page 11Linked to original sources

PubMed1984

Immunological and haematological monitoring in bladder cancer patients receiving adjuvant bestatin treatment following radiation therapy. A prospective randomized trial.

In a prospective randomized trial the clinical value of Bestatin, a low molecular weight immunomodulator, is being examined in patients having completed a full course of local radiation therapy for bladder cancer. At termination of irradiation (64 Gy in eight weeks) the patients are divided into two treatment arms: (i) 10 mg of Bestatin orally three times daily without breaks for at least one year and (ii) no further adjuvant treatment. Routine haematological monitoring of 68 patients for a period of up to two years did not reveal any differences between the two groups. Studies on the blood lymphocyte population, however, showed a significantly elevated frequency of cells forming rosettes with sheep erythrocytes after one month of Bestatin treatment. Upon continuation of treatment, however, this value declined and reached the level of the control patients at three months. The frequencies of lymphocytes with Fc-receptors for IgG or complement were unaffected by Bestatin. Spontaneous cytotoxicity against Chang cells appeared to be increased during the first three months of Bestatin treatment in those patients who survived for more than 18 months. No increase was observed in patients who died earlier. Although the above data seem to indicate that Bestatin should be administered at higher doses and intermittently instead of continuously, our preliminary results on disease-free survival in a limited patient material seem to be in favour of the Bestatin treated patients.

Adjuvants, Immunologic↗

PubMed2001

A comparison of generalized linear mixed model procedures with estimating equations for variance and covariance parameter estimation in longitudinal studies and group randomized trials.

Response data in longitudinal studies and group randomized trials are gathered on units that belong to clusters, within which data are usually positively correlated. Therefore, estimates and confidence intervals for intraclass correlation or variance components are helpful when designing a longitudinal study or group randomized trial. Data simulated from both study designs are used to investigate the estimation of variance and covariance parameters from the following procedures: for continuous outcomes, restricted maximum likelihood (REML) and estimating equations (EE); for binary outcomes, restricted pseudo-likelihood (REPL) and estimating equations (EE). We evaluate these procedures to see which provide valid and precise estimates as well as correct standard errors for the intraclass correlation coefficient or variance components. REML seems the better choice for estimating terms related to correlation for models with normal outcomes, especially in group randomized trial situations. Results for REML and EE are mixed when outcomes are continuous and non-normal. With binary outcomes neither REPL nor EE provides satisfactory estimation or inference in longitudinal study situations, while REPL is preferable for group randomized trials.

Cluster Analysis↗

PubMed2000

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO trial group.

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased by 0.5 for the control, 1.0 for the leaflet, 1.6 for the brochure, and 1.4 for the booklet. The brochure and the booklet improved the knowledge score significantly compared with the control. The general attitude was positive at entry (mean 71.5 points). Only the booklet significantly increased the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective. Control Clin Trials 2000;21:223-240

Attitude to Health↗

PubMed2001

Indications for early postoperative intraperitoneal chemotherapy of advanced gastric cancer: results of a prospective randomized trial.

Previous analysis of this prospective randomized trial and meta-analysis of published randomized trials of adjuvant intraperitoneal chemotherapy demonstrated improved survival in patients with advanced gastric cancer. Simple criteria applicable at the time of surgery for patient selection were sought in this analysis. From 1990 to 1995 a series of 248 patients with biopsy-proven gastric cancer were randomized intraoperatively to receive early postoperative intraperitoneal mitomycin C and 5-fluorouracil (125 patients) versus surgery only (123 patients). Gastric resection plus early postoperative intraperitoneal chemotherapy showed improved overall survival compared to surgery only (54% and 38%, respectively; p = 0.0278). There were statistically significant differences in patients with stage III (57% and 23%, respectively; p = 0.0024) and in those with stage IV (28% and 5%, respectively; p = 0.0098) gastric cancer. The improvement in survival rate was statistically significant for the subgroup of patients with gross serosal invasion (52% and 25%, respectively; p = 0.0004) and patients with lymph node metastasis (46% and 22%, respectively; p = 0.0027). The surgeons' impression about lymph node status was unreliable, but assessment of serosal invasion was accurate in 80% of cases. Gross serosal invasion with or without frozen section evaluation of lymph nodes can be used as the major selection criteria for early postoperative intraperitoneal chemotherapy of advanced gastric cancer.

Antibiotics, Antineoplastic↗

PubMed1983

Control of pleural effusions in patients with breast cancer. A randomized trial.

In a controlled randomized trial, 46 patients with pleural effusions secondary to breast cancer were treated at first diagnosis with either intracavitary mustine or talc, to determine which agent produced the more effective pleurodesis. Of the 37 evaluable patients, control of the effusion was achieved in 9/17 (56%) of those treated with mustine and 18/20 (90%) of the talc group (P less than 0.025). This suggests that early treatment with intracavitary talc can effectively palliate this complication of breast cancer.

Breast Neoplasms↗

PubMed1983

Intracoronary fibrinolytic therapy in acute myocardial infarction. Report of a prospective randomized trial.

We performed a randomized trial comparing intracoronary administration of streptokinase versus dextrose placebo within six hours after the onset of symptoms of acute myocardial infarction in 40 patients. The base-line clinical, hemodynamic, and angiographic findings were similar in the control and streptokinase-treated groups. Reestablishment of flow occurred in 12 of 20 patients treated with streptokinase and in 2 of 20 given placebo (P less than 0.05). Left ventricular function, angiographic ejection fraction, and regional wall motion, measured before and immediately after intervention, and serial radionuclide ejection fractions, measured at treatment, at 12 days, and at 5 months, were compared according to type of treatment (streptokinase vs. placebo) and outcome of therapy (reperfusion vs. no reperfusion). No statistically significant differences between groups were found. Thus, although streptokinase was more effective than placebo in achieving reperfusion, we detected no improvement of left ventricular function as a result of reestablished coronary flow.

Adult↗

PubMed1988

Endoscopic hemostasis by local injection of epinephrine and polidocanol in bleeding ulcer. A prospective randomized trial.

The present prospective randomized trial has been carried out to assess the efficacy of the endoscopic injection of epinephrine plus polidocanol, in the prompt treatment of upper gastrointestinal bleeding due to peptic lesions. Over a period of one year, 72 patients were admitted to the study. Thirty-six of these underwent endoscopic treatment (group A), while the others received medical treatment (group B). Definitive hemostasis was achieved in 29 patients in group A, and in 21 in group B (p less than 0.05). Seven patients in group A and 12 in group B underwent emergency surgery for persistent or recurrent bleeding (p = NS). Three patients from group B received endoscopic treatment owing to relative surgical contraindications. It was successful in all of them. Patients from group A needed a significantly lower number of units of packed red cells (p less than 0.05). Our results show that it is justified to employ endoscopic injection as the first therapeutic step in upper GI bleeding due to peptic gastroduodenal lesions.

Adult↗

PubMed1988

Cisplatin (P) versus cyclophosphamide, adriamycin and cisplatin (CAP) for stage III-IV epithelial ovarian carcinoma: a prospective randomized trial.

In 1982 a randomized trial was started to compare a cisplatin-containing polychemotherapy (CAP: cyclophosphamide - CPA 750 mg/m2, adriamycin - ADM 50 mg/m2, cisplatin - P 50 mg/m2 on day 1 every 21 days) with full-dose cisplatin as single agent (P 60 mg/m2/day on days 1 and 2 every 28 days) in 44 patients undergoing exploratory laparotomy or debulking surgery for stage III-IV epithelial ovarian carcinoma with residual disease greater than 5 cm. The response was evaluated at second-look surgery with random biopsies and peritoneal washing. On the basis of the final results the authors underline some data which, although merely indicative (because of the small number of patients) appear to be worth considering since they are in accordance with the latest reports: a) similar response rate (CR + PR = 47%) to first-line treatment in the two groups; b) the CAP treatment may achieve a longer median duration of CRs than the P treatment (20 versus 11 months); c) overall survival seems similar in the two groups of patients (19 versus 18 months), whereas the survival of CRs seems longer in the CAP treated patients (greater than 32 versus 25 months). The authors also discuss some observations on a possible salvage therapy.

Adult↗

PubMed1991

Low-molecular-weight heparinoid compared with warfarin for prophylaxis of deep-vein thrombosis in patients who are operated on for fracture of the hip. A prospective, randomized trial.

In a randomized, prospective trial, a low-molecular-weight heparinoid (Org 10172 [Lomoparan]) was compared with warfarin for efficacy and safety in preventing deep-vein thrombosis in 263 patients who had an operatively treated fracture of the hip. One group of patients received Org 10172 in a dose of 750 units subcutaneously every twelve hours until the ninth postoperative day; on the seventh postoperative day, warfarin was added to the regimen. The other group received only warfarin. Both drugs were begun preoperatively, immediately after the admission evaluation. In the patients who received warfarin, the desired prothrombin time was one and one-half times the control level. Deep-vein thrombosis was detected by 125I-fibrinogen scanning and impedance plethysmography and was confirmed by phlebography and compression ultrasonography. Deep-vein thrombosis was found in nine (7 per cent) of the 132 patients who received Org 10172 and in twenty-eight (21 per cent) of the 131 patients who received warfarin (p less than 0.001). Adverse reactions were not significantly different in the two groups. Major bleeding complications occurred in eight patients in the Org-10172 group, only four of whom were receiving the drug at the time of bleeding, and in five patients who were receiving warfarin (not significant). There was no difference in intraoperative loss of blood or in requirements for transfusion. We concluded that the low-molecular-weight heparinoid Org 10172 is a safe, convenient, effective antithrombotic agent for the prevention of venous thrombosis after an operation for fracture of the hip.

Aged↗

PubMedDate not supplied

Bacteriuria during urinary tract catheterization: suprapubic versus urethral route: a prospective randomized trial.

In this randomized prospective trial urethral and suprapubic routes were compared in terms of tolerance and infectious potential. Daily bacteriuria determined infectious danger and patients were interrogated on the pain and discomfort induced by their catheter every day. Identical single dose pre-operative antibiotic prophylaxis was routinely applied. Patients (n = 50) were divided into two similar groups (25 suprapubic catheters and 25 urethral catheters). Four patients in the suprapubic group were excluded. All specimen cultured by suprapubic catheter remained sterile. Nine patients with urethral catheterization eventually developed bacteriuria. The difference became significant on the third day of catheterization (p < 0.05) and increased on days 4 and 5 (p < 0.01). Between the two groups, pain and discomfort did not achieve statistical significance. Suprapubic catheterization is preferable to the alternative using the urethral route in terms of improving urine sterility.

Aged↗

PubMed2003

Randomized trials, generalizability, and meta-analysis: graphical insights for binary outcomes.

BACKGROUND: Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" METHOD: For three different outcome measures, absolute difference (DIF), relative risk (RR), and odds ratio (OR), we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox.) RESULTS: For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. CONCLUSION: The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

Data Interpretation, Statistical↗

PubMed1987

Graft survival and long-term renal function after sequential conventional cyclosporin A therapy in cadaver kidney transplantation--a prospective randomized trial.

In a prospective randomized trial 50 renal transplant patients (group A) received a sequential course of 14 days conventional immunosuppression (Lymphocytoglobulin (ALG), azathioprine, steroids) and cyclosporin and steroids thereafter, while 50 patients (group B) received the conventional immunosuppression for 7 days followed by cyclosporin and steroids. In the latter group ALG was tolerated for the whole period while in the first group conversion from conventional to cyclosporin A therapy had to be performed after a mean of 11 days, due to ALG intolerance. Actual patient survival rates 1 year posttransplant were 100% in both groups and graft survival rates 96% in group A and 86% in group B (P less than 0.05). There was a mean dialysis frequency per patient of 0.7 +/- 2.0 in group A and 1.8 +/- 3.4 in group B (P = 0.064). Serum creatinine 1 year posttransplant was 1.8 +/- 0.8 mg/dl in group A and 2.2 +/- 1.4 in group B. A total of 58 patients had a serum creatinine of less than 2 mg/dl at the time of conversion to cyclosporin. These patients had a significantly better graft survival rate (98.3%) and serum creatinine 1 year posttransplant (1.6 +/- 0.5 mg/dl) than the 40 patients with a serum creatinine of more than 2 mg/dl at the time of conversion (85%; 2.4 +/- 1.4 mg/dl), indicating that a delayed onset of cyclosporin therapy might benefit the kidney in the immediate posttransplant period when it is susceptible to nephrotoxicity due to the damage from hypothermic storage.

Adult↗

PubMed1999

Suprascapular nerve block for the treatment of frozen shoulder in primary care: a randomized trial.

BACKGROUND: Frozen shoulder is a common problem in general practice, but its treatment is difficult since none of the currently used therapies are proven to be effective. AIM: To assess the effectiveness of suprascapular nerve block to relieve pain and improve range of movement, and its suitability for use in primary care. This small study by a single practitioner aims to justify a larger multicentred trial. METHOD: A randomized trial of 30 patients to compare a single suprascapular nerve block with a course of intra-articular injections. Patients' pain levels and ranges of movement were assessed over a 12-week period. RESULTS: Suprascapular nerve block produced a faster and more complete resolution of pain and restoration of range of movement than a series of intra-articular injections. These differences were confirmed by statistical analysis using the Mann-Whitney U-test (P < 0.01 for pain levels and P < 0.05 for range of abduction and external rotation.) CONCLUSIONS: This study suggests that suprascapular nerve block is a safe and effective treatment for frozen shoulder in primary care, and justifies a larger multicentred trial using independent blinded assessment. Such a study should include a third group treated by suprascapular nerve block without steroid; a more comprehensive assessment of patient debility.

Anesthetics, Local↗

PubMed2003

Pacemaker therapy for prevention of syncope in patients with recurrent severe vasovagal syncope: Second Vasovagal Pacemaker Study (VPS II): a randomized trial.

CONTEXT: Three previous small randomized trials have reported that pacemaker therapy is beneficial for patients with severe recurrent vasovagal syncope. However, because these trials were not double blind, they may have been biased in their assessment of outcomes and had a placebo effect of surgery. OBJECTIVE: To determine if pacing therapy reduces the risk of syncope in patients with vasovagal syncope. DESIGN, SETTING, AND PATIENTS: A randomized double-blind trial of pacemaker therapy in outpatients referred to syncope specialists at 15 centers from September 1998 to April 2002. In the year prior to randomization, patients had had a median of 4 episodes of syncope. Patients were followed up for up to 6 months. INTERVENTION: After implantation of a dual chamber pacemaker, 100 patients were randomly assigned to receive dual-chamber pacing (DDD) with rate drop response or to have only sensing without pacing (ODO). MAIN OUTCOME MEASURE: Time to first recurrence of syncope. RESULTS: No patients were lost to follow-up. Of the 52 patients randomized to ODO, 22 (42%) had recurrent syncope within 6 months compared with 16 (33%) of 48 patients in the DDD group. The cumulative risk of syncope at 6 months was 40% (95% confidence interval [CI], 25%-52%) for the ODO group and 31% (95% CI, 17%-43%) for the DDD group. The relative risk reduction in time to syncope with DDD pacing was 30% (95% CI, -33% to 63%; 1-sided P =.14). Lead dislodgement or repositioning occurred in 7 patients. One patient had vein thrombosis, another had pericardial tamponade leading to removal of the pacemaker system, and a third had infection involving the pacemaker generator. CONCLUSIONS: In this double-blind randomized trial, pacing therapy did not reduce the risk of recurrent syncope in patients with vasovagal syncope. Because of the weak evidence of efficacy of pacemaker therapy and the risk of complications, pacemaker therapy should not be recommended as first-line therapy for patients with recurrent vasovagal syncope.

Adult↗

PubMed1985

Postoperative albumin infusion therapy based on colloid osmotic pressure. A prospectively randomized trial.

In a prospectively randomized trial of 220 patients, 106 were given albumin when their colloid osmotic pressure (COP) fell below 24 cm H2O and 114 were given albumin when their COP fell below 29 cm H2O. There was no difference in the postoperative course between the two groups; however, by using the lower COP limit the postoperative albumin consumption in the intensive care unit was reduced significantly and thus the costs of treatment were lowered. In the case of extremely low COP, the prognosis of the disease worsened, indicating that the COP is of prognostic value. The albumin supply, however, did not influence the final outcome of the patients under these circumstances because it treated only a characteristic symptom and not the cause of the disease.

Abdomen↗

PubMed2002

Comparison of tests for categorical data from a stratified cluster randomized trial.

Two features commonly exhibited by randomized trials of health promotion interventions are cluster randomization and stratification. Ignoring correlations between individuals within clusters can lead to an inflated type I error rate and hence a P-value which overstates the significance of the result. This paper compares several methods for analysing categorical data from a stratified cluster randomized trial. We propose an extension of a method from survey sampling that uses the design effect to reduce the effective sample size. We compare this with three methods from Zhang and Boos that extend the standard Cochran-Mantel-Haenszel (CMH) statistic by using appropriate covariance matrices, and with a bootstrap method. The comparison is based on empirical type I error rates from a simulation study, in which the number of clusters randomized is small, as in most public health intervention studies. The method that performs consistently well is one of the Zhang and Boos extensions of the standard CMH statistic.

Alcohol Drinking↗

PubMed1984

Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria.

The Coronary Artery Surgery Study (CASS) includes a randomized trial of coronary artery bypass surgery and medical therapy in the management of patients with mild or moderate stable angina pectoris or free of angina but with a documented history of myocardial infarction. While 780 patients at 11 participating institutions entered the randomized trial, 1,315 patients at the same institutions met randomization criteria but declined participation in the randomized study; they constitute the "randomizable" patients. Half the randomized patients were assigned to surgery and half to the medical group. Of the 1,315 randomizable patients, 43% started with surgical therapy and 57% constitute the medical group. Follow-up periods average 64 months (range 46 to 92). The only entry characteristic in which the randomized and randomizable medical groups differ importantly is the extent of coronary artery disease, which is less extensive in the latter. The two surgical groups also differ in this respect, but with more extensive disease in the randomizable group. At 5 year follow-up, 24% of the medically-assigned randomized patients and 22% of the medically-started randomizable patients have had coronary bypass surgery. Survival in the medically-randomized and randomizable patient groups is similar in the aggregate (both 92% at 5 years) and also in all subgroups based on clinical classification, the number of diseased vessels, the presence of proximal left anterior descending coronary artery disease and ejection fraction. Survival for the surgically-assigned randomized patients and the surgically-started randomizable patients is also similar in the aggregate (95 and 94%, respectively) and in all subgroups. It is concluded that the randomized patients in CASS are not a special or atypical subset of those eligible for randomization. The data from the randomizable patients thus support and extend the inference of the generally very good survival of both the medically- and surgically-assigned patients of the randomized trial.

Adult↗

PubMed1992

Antiemetic efficacy of high-dose metoclopramide and dexamethasone in patients receiving cisplatin chemotherapy: a randomized trial.

In a prospective randomized trial we compared the antiemetic efficacy of metoclopramide (MCP) and dexamethasone (DXM). A total of 172 patients receiving chemotherapy based on cisplatin 100 mg/m2/day were randomly allocated to four groups. CP was administered in 5 doses of 1.5 mg/kg (group A), 2 mg/kg (group C), or combined with 4 doses of DXM 4 mg/6 h (MCP: 1.5 mg/kg in group B; 2 mg/kg in group D). Vomiting was decreased in the DXM groups compared to groups A and C (p < 0.002), and the duration of nausea was greater in group A than in group D (P < 0.004). A greater disturbance in appetite was observed in group A compared to groups B (p < 0.028), D(p < 0.001) and C (p < 0.045). Activity problems were greater in group A than in C (p < 0.003) and D(p < 0.005). We noticed that a small increase in MCP (0.5 mg/kg) did not influence the antiemetic effect. The addition of DXM did not significantly alter the antiemetic results at the lower MCP dose, but improved them when MCP was slightly increased. We conclude that DXM slightly improves the antiemetic effect of MCP and the effects are related to the MCP dose.

Adult↗