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Results for “Randomized trial”

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PubMed1994

Evaluation of the extent of lymphadenectomy in a randomized trial of Western- versus Japanese-type surgery in gastric cancer.

PURPOSE: In the context of a prospective, randomized trial of gastric cancer treatment, comparing Western surgical resection with limited lymphadenectomy (R1) versus Japanese surgical resection with extended lymphadenectomy (R2), we analyzed adherence to the specified surgical-pathologic guidelines. PATIENTS AND METHODS: Following evaluation of 389 patients, we quantified noncompliance (ie, performance of less dissection than specified) and contamination (ie, performance of more extensive dissection than specified). Of 389 patients, pathologic data permitted identification of 237 eligible patients treated with curative intent. RESULTS: Noncompliance occurred in 84% of R1 and R2 cases, with magnitude significantly (P < .001) higher in R2 cases versus R1 cases. Contamination occurred in 48% of R1 cases and 52% of R2 cases, with the magnitude of contamination moderate and equally distributed between the two groups. The contamination in R1 resections and the noncompliance in R2 resections lead to a partial homogenization of the groups, undermining the likelihood of detecting any potential therapeutic advantage to R2 dissection. CONCLUSION: The observed tendency to perform R1 resections combined with insufficient retrieval of lymph nodes underlines the need for increased surgical-pathologic standardization in this trial. Potential remedies are discussed. Proper conduct of clinical trials requires reliable means of standardizing performance of the surgical-pathologic team, an elusive but important goal.

Adenocarcinoma↗

PubMed1985

Selection, follow-up, and analysis in the Health Insurance Plan Study: a randomized trial with breast cancer screening.

Critical decisions made 20 years ago by those who planned the randomized trial at the Health Insurance Plan (HIP) of Greater New York to determine the efficacy of periodic screening for breast cancer are detailed. These decisions affected the age group to be screened, screening modalities, frequency of screening, sample size, primary measures for testing efficacy, and period of follow-up (long term). Results of follow-up, 16 years after entry, indicate that mortality due to breast cancer continues to be lower among study women than controls. Numerically, the differential has been stable; relatively, it has decreased. It is estimated that the study group would have experienced about a 30% reduction in breast cancer mortality if screening had been maintained. Relative case survival rates over a 14-year period after diagnosis show changes in contours of trend lines that result from screening. The study group's trend is slightly concave in contrast to the usual convex curve for the controls. The contour of the curve is more decidedly concave among subjects detected through mammography alone than for other subgroups detected through screening, although the relative survival rate remains highest in the mammography only group. Uncertainty persists about effects of screening in the HIP study on breast cancer mortality among women aged 40-49 years at entry.

Adult↗

PubMed1990

Quality-of-life changes and hearing impairment. A randomized trial.

OBJECTIVE: To assess whether hearing aids improve the quality of life of elderly persons with hearing loss. SETTING: Primary care clinics at a Bureau of Veterans Affairs hospital. PATIENTS: One hundred and ninety-four elderly veterans who were identified as being hearing impaired from a screening survey involving 771 consecutive clinic patients. Of the original 194, 188 (97%) completed the trial. INTERVENTION: Subjects were randomly assigned to either receive a hearing aid (n = 95) or join a waiting list (n = 99). MAIN ENDPOINTS: A comprehensive battery of disease-specific and generic quality-of-life measures were administered at baseline, 6 weeks, and 4 months. MEASUREMENTS AND MAIN RESULTS: Persons assigned to the two groups were similar in age, ethnicity, education, marital status, occupation, and comorbid diseases. At baseline, 82% of subjects reported adverse effects on quality of life due to hearing impairment, and 24% were depressed. At follow-up, a significant change in score improvements for social and emotional function (34.0; 95% CI, 27.3 to 40.8; P less than 0.0001), communication function (24.2; CI, 17.2 to 31.2; P less than 0.0001), cognitive function (0.28; CI, 0.08 to 0.48; P = 0.008), and depression (0.80; CI, 0.09 to 1.51; P = 0.03) was seen in subjects who received hearing aids compared with those assigned to the waiting list. Six drop-outs (three per group), no crossovers, and no significant changes in cointerventions were seen. Average, self-reported, daily aid use in the hearing aid group was 8 hours. CONCLUSION: Hearing loss is associated with important adverse effects on the quality of life of elderly persons, effects which are reversible with hearing aids.

Aged↗

PubMed1986

Randomized trial of chlorambucil for primary biliary cirrhosis.

Twenty-four patients with primary biliary cirrhosis were entered into a prospective, randomized trial of chlorambucil therapy. Thirteen patients received chlorambucil (0.5-4 mg/day) and 11 patients received no therapy; all have been followed for 2-6 yr (mean, 4.1 yr). Two control but no treated patients died. Average serum bilirubin, serum aspartate aminotransferase activities, and albumin levels improved or remained unchanged in treated patients but worsened in controls. Serum alkaline phosphatase levels did not change in either group. Immunoglobulin M levels decreased and became normal in all treated patients but in only 3 control patients. Liver biopsy histology revealed an improvement in inflammatory cell infiltrate in treated patients in comparison with controls, but no significant change in degree of fibrosis or the histologic stage of disease. Side effects of therapy included bone marrow suppression necessitating discontinuation of the drug in 4 patients. These findings indicate that chlorambucil therapy may retard the progression of primary biliary cirrhosis. Whether such therapy will ultimately decrease morbidity and improve survival in this disease can only be demonstrated by large-scale, placebo-controlled trials.

Adult↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

PubMed1985

Indications for coronary artery bypass surgery in patients with chronic angina pectoris: implications of the multicenter randomized trials.

The three major randomized studies of medical vs surgical therapy in patients with coronary artery disease have had a major impact in the management of patients with this disease. For the most part, these multicenter trials have provided concordant information regarding the influence of surgery on survival in asymptomatic or mildly symptomatic patients. It has been demonstrated that coronary artery bypass surgery improves survival in patients with stenosis of the left main coronary artery. Bypass surgery probably should be performed in most patients with this lesion, although studies have identified low-risk subgroups in whom surgery may not improve survival. There are also concordant data that survival is not enhanced by surgery in mildly symptomatic patients with either one- or two-vessel disease. The important discrepancies regarding the role of surgery in three-vessel disease have been resolved to a major extent. Long-term follow-up studies in the Veterans Administration Cooperative Study and the Coronary Artery Surgery Study (CASS) demonstrate improved survival with surgical management in patients with three-vessel disease and left ventricular dysfunction. The remaining controversy regards management of patients with three-vessel disease and normal left ventricular function; this may be resolved by studies indicating that inducible left ventricular ischemia in patients with three-vessel disease and preserved left ventricular function at rest identifies patients at higher risk during medical management. Different proportions of such patients entered into the multicenter studies may explain the discordant results in three-vessel disease and normal left ventricular function reported by the European trial and CASS.(ABSTRACT TRUNCATED AT 250 WORDS)

Angina Pectoris↗

PubMed1988

Antiplatelet agents in the secondary prevention of stroke: meta-analysis of the randomized control trials.

Randomized control trials of antiplatelet agents in the prevention of stroke following transient ischemic attacks have had conflicting results. The decision to employ aspirin instead of placebo as the control regimen in trials testing newer antiplatelet agents emphasizes the need for an accurate estimate of the efficacy of older drugs. A meta-analysis of seven randomized control trials comparing aspirin and/or sulfinpyrazone or dipyridamole with placebo was performed. For aspirin compared with placebo, a nonsignificant reduction in stroke of 15% (odds ratio 0.85, 95% confidence interval 0.60-1.19; chi 2 = 0.78, p greater than 0.30) was found. For aspirin combined with sulfinpyrazone or dipyridamole compared with placebo, a 39% reduction in stroke was observed (odds ratio 0.61, 95% confidence interval 0.39-0.95; chi 2 = 4.22, p less than 0.05); at the same time a 350% increase in gastrointestinal hemorrhage or peptic ulcer was noted (odds ratio 3.5, 95% confidence interval 1.26-9.75; chi 2 = 4.61, p less than 0.05). A trend in reduction of strokes for men was observed (odds ratio 0.58, 95% confidence interval 0.32-1.07; chi 2 = 2.52, p less than 0.15) for any regimen containing aspirin. The significant benefit of aspirin-combination therapy on stroke must be interpreted cautiously because of a number of possible biases. It is still conceivable that aspirin alone may decrease the incidence of stroke by as much as 40%, but a sample of greater than 13,000 patients would be needed to confirm the benefit observed in our analysis.

Aspirin↗

PubMed2003

Methods to reduce the impact of intraclass correlation in group-randomized trials.

This study reports intraclass correlation (ICC) for dependent variables used in group-randomized trials (GRTs). The authors also document the effect of two methods suggested to reduce the impact of ICC in GRTs; these two methods are modeling time and regression adjustment for covariates. They coded and analyzed 1,188 ICC estimates from 17 published, in press, and unpublished articles representing 21 studies. Findings confirm that both methods can improve the efficiency of analyses shown to be valid across conditions common in GRTs. Investigators planning GRTs should obtain ICC estimates matched to their planned analysis so that they can size their studies properly.

Analysis of Variance↗

PubMed1985

Treatment of neutropenic infection: a randomized trial comparing latamoxef (moxalactam) with cephradine plus tobramycin.

Sixty neutropenic patients with infection were studied in a randomized trial comparing treatment with latamoxef (moxalactam) alone or with cephradine and tobramycin. The two treatment groups were comparable in respect to their clinical sites of infection, degree of neutropenia underlying malignancy, and organisms. Forty-two bacterial isolates were obtained from various clinically infected sites. All but two of these isolates were sensitive to latamoxef (30 highly sensitive, ten moderately sensitive). In contrast 29 of the isolates were resistant to cephradine and eight were resistant to both cephradine and tobramycin. Control of infection was achieved in 72% of patients treated with latamoxef and 55% treated with cephradine plus tobramycin. Latamoxef appears to be an effective antibiotic for the treatment of neutropenic patients with infection.

Adult↗

PubMed1999

Randomized trial of intermittent antegrade warm blood versus cold crystalloid cardioplegia.

BACKGROUND: We performed a prospective randomized trial to compare intermittent antegrade warm blood cardioplegia with intermittent antegrade and retrograde cold crystalloid cardioplegia. METHODS: Two hundred consecutive patients scheduled for isolated coronary bypass surgical procedures were randomized into two groups: Group 1 (n = 92) received cold crystalloid cardioplegia with moderate systemic hypothermia, group 2 (n = 108) received intermittent antegrade warm blood cardioplegia with systemic normothermia. Preoperative, intraoperative, and postoperative data were prospectively collected. RESULTS: For the same median number of distal anastomoses, cardiopulmonary bypass duration and total ischemic arrest duration (57.3 +/- 20.5 versus 75 +/- 22.1 minutes, p < 0.001) were shorter in group 2 than in group 1. Apart from a higher right atrial pressure in the cold cardioplegia group, no hemodynamic difference was observed. Aspartate aminotransferase, creatine kinase-MB fraction, and cardiac troponin I levels were significantly lower in group 2 than in group 1. Outcome variables were not significantly different. CONCLUSIONS: Intermittent antegrade warm blood cardioplegia results in less myocardial cell damage than cold crystalloid cardioplegia, as assessed by the release of cardiac-specific markers. This beneficial effect has only marginal clinical consequences. Normothermic bypass has no deleterious effect on end-organ function.

Aged↗

PubMed2000

Randomized trial of fecal diversion for sphincter repair.

PURPOSE: Fecal diversion for sphincter repair is controversial. This randomized trial assessed whether fecal diversion would improve primary wound healing and functional outcome after sphincter repair. METHODS: Thirty-three patients with fecal incontinence requiring sphincter repair were recruited, but only 27 agreed to be randomly assigned to a defunctioning stoma (n = 13) or no stoma (n = 14). Patients were assessed by the Cleveland Clinic Incontinence Score (0-20) and anal physiology; the mean follow-up was 34 (range, 16-47) months. RESULTS: Incontinence score improved significantly in both groups (stoma, 13.5-7.8; P = 0.0072; no stoma, 14-9.6; P = 0.0470): No difference was found between the two groups. Maximum resting pressure and maximum squeeze pressure increased significantly only in the no-stoma group (maximum resting pressure, 52.4-71.3 cm H2O; maximum squeeze pressure, 87.3-100.7 cm H2O; P < 0.0001). There was no significant difference in functional outcome (stoma, 7.8; no stoma, 9.6; P = 0.4567) or the number with complications of sphincter repair (stoma, 5; no stoma, 3; P = 0.4197). However, stoma-related complications occurred in 7 of 13 patients having a stoma (parastomal hernia, 2; prolapsed stoma, 1; incisional hernia at the stoma site requiring repair, 5; and wound infection at the closure site, 1). CONCLUSION: Fecal diversion in sphincter repair is unnecessary, because it gives no benefit in terms of wound healing or functional outcome, and it is a source of morbidity.

Adult↗

PubMed1994

Falciparum malaria in eastern Thailand: a randomized trial of the efficacy of a single dose of mefloquine.

Reported are the results of a randomized trial of a single dose of mefloquine (15 mg/kg or 25 mg/kg body weight) for the treatment of uncomplicated multidrug-resistant falciparum malaria. Of the 110 adult patients enrolled in the study 57 were randomly assigned to the 15 mg/kg group and 53 to the 25 mg/kg group. The baseline characteristics of the patients did not differ significantly in the two groups, except that those in the 15 mg/kg group had lower haemoglobin levels. Adverse effects following treatment were commoner in the 25 mg/kg group, but not significantly so. Seven patients (6%) did not complete the 42-day follow-up. The parasitological failure rates in the 15 and 25 mg/kg groups were, respectively, 50% (28/56) and 43% (25/53) on day 28, and 62% (33/53) and 56% (28/50) on day 42. Treatment failures were not correlated with the serum mefloquine concentrations on day 2, and 13 out of 19 patients with serum mefloquine concentrations > 2000 micrograms/l on day 2 showed an R response during the follow-up. The mean ratio between the concentrations of the (SR)-(-) and (RS)-(+) enantiomers of mefloquine on day 2 was 3.37, indicating that there are differences in their pharmacokinetics. Re-treatment of patients who showed an R response with seven days of quinine (30 mg.kg-1.day-1)+tetracycline (25 mg.kg-1.day-1) was successful in 93% of the cases.

Adult↗

PubMed1986

Prospective, randomized trial of nasogastric suction in patients with acute pancreatitis.

The efficacy of nasogastric (NG) suction was evaluated in a prospective, randomized trial in 60 patients with acute pancreatitis of mild to moderate severity. Group I, NG (29 patients) was treated with NG suction, and group II, no NG (31 patients) was treated without NG suction. The presentation, cause of pancreatitis, and clinical parameters at the time of admission of the two groups were similar. The use of NG suction had no discernible benefit during hospitalization. There were no differences in duration of abdominal pain, the interval until bowel sounds returned, the need for narcotic administration, or the length of time intravenous fluid therapy was needed. When compared with group II, no NG, patients in group I, NG tended to resume oral intake later (5.0 +/- 0.3 versus 3.9 +/- 0.5 days) and remain hospitalized longer (13.1 +/- 2.6 versus 10.7 +/- 2.0 days). The incidence of serious complications, such as pancreatic abscess, pseudocyst, biliary obstruction, or pulmonary failure, was no different between the groups. This study demonstrates that the routine use of NG suction in patients with acute pancreatitis of mild to moderate severity is of no benefit in altering the clinical course.

Acute Disease↗

PubMed2004

Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group.

Conventional chemotherapy has failed to substantially prolong survival for patients with advanced follicular lymphoma. To improve outcomes, the German Low-Grade Lymphoma Study Group (GLSG) initiated a randomized trial to compare the effect of potentially curative myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) with interferon-alpha (IFN-alpha) maintenance therapy in first remission. Three hundred seven patients (younger than 60 years) with follicular lymphoma were recruited into the trial from 130 institutions. After 2 cycles of cyclophosphamide-doxorubicin-vincristine-prednisone (CHOP) or mitoxantrone-chlorambucil-prednisone (MCP) induction chemotherapy, patients were randomly assigned to either the ASCT or the IFN-alpha group. The respective therapy was started when patients achieved complete or partial remission after induction chemotherapy. Two hundred forty patients with follicular lymphoma are evaluable for the comparison of ASCT and IFN-alpha. In patients who underwent ASCT, the 5-year progression-free survival (PFS) rate was 64.7%, and in the IFN-alpha arm it was 33.3% (P < .0001). As expected, acute toxicity was higher in the ASCT group, but early mortality was below 2.5% in both study arms. In this randomized, multicenter trial, high-dose radiochemotherapy followed by ASCT significantly improved PFS compared with IFN-alpha in patients with follicular lymphoma when applied as consolidation in first remission. Longer follow-up is necessary to determine the effect of ASCT on overall survival.

Adolescent↗

PubMed2004

Patient-controlled versus nurse-administered sedation with propofol during colonoscopy. A prospective randomized trial.

OBJECTIVES: Patient-controlled sedation (PCS) with propofol, is well tolerated and reduces recovery time and staff required during endoscopic interventions. "Who" administers the drug proves economically crucial. With the aim of maintaining safety, medical quality, and patient satisfaction, this study investigates PCS versus nurse-administered propofol sedation (NAPS) in a cohort of consecutive patients. METHODS: One hundred and fourteen patients, aged 22-90 yr, undergoing only colonoscopy participated in this prospective randomized trial. Patients were randomly assigned to either PCS or NAPS. If patients declined randomization for different reasons of reluctance to PCS they were assigned to a standard nurse-sedated control group. All patients received pethidine presedation for analgesia. Visual analogue scales followed patient anxiety level, tolerability, pain, and satisfaction, and endoscopist's assessment of the procedure. RESULTS: Given the choice, 35% of the patients who were rather younger and more anxious declined randomization to PCS. The mean total dose of propofol needed in this group was higher, but the patients had a tendency to rate the global tolerance and the pain of the examination as less comfortable compared to the two randomized groups. Self-administration of propofol created a significantly different drug profile and higher medication costs. With regard to the safety parameters there was no difference between PCS and NAPS. In their global assessments, the patients and endoscopists tended to prefer NAPS. CONCLUSIONS: Individual patient characteristics and attitudes toward self-control are crucial for PCS. While being a viable option for patients who are able and willing to handle, this technique is not applicable in a considerable portion of everyday patients.

Adult↗

PubMed1994

Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment.

A double-blind randomized trial was performed involving 162 patients with age-associated memory impairment (AAMI) selected and followed by their general practitioners. Two intervention methods--a drug and a cognitive therapy--were assessed in combination. Three randomized parallel groups of 54 patients each, aged 55 years and over, were followed and treated for 3 months. After a placebo wash-out period of 10 days, one group received 2.4 g of piracetam, another group, 4.8g, and the third, a placebo. A total of 135 patients, 45 in each group, completed the study. Combined therapy was most effective in patients whose baseline performance on memory tests was lowest. The best results were observed with 4.8 g of piracetam, especially when training sessions began after 6 weeks of drug treatment. This result was confirmed by the global impression of the principal investigator.

Aged↗

PubMed1984

Dihydroergotamine in prevention of infusion thrombophlebitis. A randomized trial.

The efficiency of subcutaneous dihydroergotamine in preventing infusion thrombophlebitis was assessed in a randomized trial. One hundred and fourteen postoperative patients were studied. They furnished a total of 160 infusion sites. The difference between treatment and control group with regard to incidence of infusion thrombophlebitis was not significant (p greater than 0.05). Accordingly dihydroergotamine has no substantial effect.

Clinical Trials as Topic↗

PubMed1991

Antiemetic regimens in outpatients receiving cisplatin and non-cisplatin chemotherapy. A randomized trial comparing high-dose metoclopramide plus methylprednisolone with and without lorazepam.

Results of a randomized trial on antiemesis for cisplatin (CDDP) and non-CDDP chemotherapy-induced vomiting are reported. One hundred and sixty-three outpatients received 282 chemotherapy courses (141 with CDDP and 141 without CDDP). Patients were randomly assigned to receive either high-dose metoclopramide plus methylprednisolone (arm A) or the same drugs plus lorazepam (arm B). In both arms a high protection rate for vomiting was obtained, on the whole without statistically significant differences. Patients who received lorazepam had, however, significantly fewer nausea episodes during first day post-chemotherapy (p less than 0.05). Arm B was also superior in anxiety control during the first day of chemotherapy (p less than 0.01). Both regimens were significantly more effective in patients who had not been given chemotherapy previously (p less than 0.01). No differences in antiemetic protection were found between CDDP and non-CDDP courses. No significant differences were found in premonitory vomiting control between the two arms of the trial. Toxicity was very mild with both regimens, although sedation was significantly higher in arm B (p less than 0.001). We conclude that high-dose metoclopramide plus methylprednisolone is a highly effective combination for chemotherapy-induced nausea and vomiting, and that it is quite suitable for outpatient use. Lorazepam did not significantly increase the antiemetic potency of the combination, nor did it improve premonitory vomiting control, although it gave a better control of acute nausea and anxiety.

Antineoplastic Agents↗