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Results for “Randomized trial”

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At least 865 records · Page 48Linked to original sources

PubMed2000

Adjuvant intraportal chemotherapy for Dukes B2 and C colorectal cancer also receiving systemic treatment: results of a multicenter randomized trial. Groupe Régional d'Etude du Cancer Colo-Rectal (Belgium).

In a randomized trial, the authors evaluated the possible adjuvant activity of intraportal chemotherapy (with 5-fluorouracil 500 mg/m2/day in continuous infusion for 7 days and mitomycin C 10 mg/m2 at day 7) administered after surgery to half of the patients who underwent a full resection for Dukes B2 or C colorectal cancer. The procedure appeared manageable and safe. Two hundred and sixty patients were initially randomized, among whom 173 were finally considered as fully evaluable after having completed six courses of systemic chemotherapy. The reasons for withdrawal were basically tumoral ones and patients or doctors compliance. After a median follow-up of 4.5 years, no difference could be observed in the patients evolution assessed as relapses or deaths rate, or as relapse-free (at 5 years: 68% in the portal treatment group versus 70% in the control group) or overall survival (at 5 years: 76 versus 74%). The frequency of hepatic metastases (21 versus 18%) was also similar in both groups.

Adult↗

PubMed2001

Effects of preoperative steroid administration on surgical stress in hepatic resection: prospective randomized trial.

HYPOTHESIS: Preoperative administration of methylprednisolone sodium succinate can control surgical stress in patients undergoing hepatic resection. DESIGN: A prospective randomized trial. SETTING: A university hospital department of surgery. PATIENTS: Thirty-three patients who underwent hepatic resection were classified into 2 groups: a control group (n = 16) and a steroid group (n = 17) in which patients were intravenously administered 500 mg of methylprednisolone 2 hours before surgery. MAIN OUTCOME MEASURES: Perioperative levels of interleukin (IL)-6 and IL-10 (serum and peritoneal), immunosuppressive acidic protein, Candida antigen, and other laboratory and clinical variables were measured. RESULTS: Postoperative levels of serum and peritoneal IL-6 and levels of C-reactive protein were significantly lower in the steroid group than in controls. Furthermore, serum and peritoneal IL-10 levels were significantly higher in the steroid group. The total bilirubin value on postoperative day 1 was significantly lower in the steroid group than in controls. Postoperative immunosuppressive acidic protein levels were also significantly lower in the steroid group, as was the positive rate of serum Candida antigen. No differences were found in the incidence of postoperative complications. CONCLUSIONS: Preoperative steroid administration significantly elevated anti-inflammatory cytokine IL-10 levels, suppressed the levels of inflammatory cytokines IL-6 and C-reactive protein, and prevented postoperative elevation of total bilirubin values. Furthermore, postoperative elevation of immunosuppressive acidic protein levels and the positive rate of Candida antigen were suppressed, indicating that the immune response was maintained by preoperative steroid administration.

Acute-Phase Proteins↗

PubMed1994

LCH-I: a randomized trial of etoposide vs. vinblastine in disseminated Langerhans cell histiocytosis. The Histiocyte Society.

An international randomized trial in Langerhans cell histiocytosis (LCH) has been initiated by the Histiocyte Society. This report reviews the rationale, design, and progress of LCH-I, which compares etoposide (VP-16) and vinblastine in the treatment of disseminated LCH. Data on the risk of etoposide-associated (therapy-induced) malignancy, in the setting of histiocytosis, are reviewed. The available evidence leads to the recommendation that the study of etoposide in LCH should be continued.

Drug Administration Schedule↗

PubMed1999

Padres Trabajando por la Paz: a randomized trial of a parent education intervention to prevent violence among middle school children.

This paper reports the results of a randomized trial to test the effectiveness of a theoretically derived intervention designed to increase parental monitoring among Hispanic parents of middle school students. Role model story newsletters developed through the process of Intervention Mapping were mailed to half of a subsample of parents whose children participated in Students for Peace, a comprehensive violence prevention program. The results indicated that parents in the experimental condition (N = 38) who had lower social norms for monitoring at baseline reported higher norms after the intervention than the parents in the control condition (N = 39) (P = 0.009). Children of parents in the experimental group reported slightly higher levels of monitoring at follow-up across baseline values, whereas control children who reported moderate to high levels of monitoring at pre-test reported lower levels at follow-up (P = 0.04). These newsletters are a population-based strategy for intervention with parents that show some promise for comprehensive school-based interventions for youth.

Adult↗

PubMed1990

[A randomized trial of endocrine therapy, chemotherapy, and chemo-endocrine therapy in advanced breast cancer].

A randomized trial of endocrine therapy (adreno-oophorectomy, H), chemotherapy (FAC, C), chemoendocrine therapy (FAC + tamoxifen, H'C, or FAC + adreno-oophorectomy, HC) was performed in 114 advanced breast cancer patients from September, 1979 to December, 1983, and 106 were evaluable. The response to H, C, H'C, and HC was shown to be 33% (10/30), 54% (14/26), 59% (17/29), and 76% (16/21), respectively. There was a significantly higher response rate in HC group than H group. Higher but not significantly different response was obtained by H'C as compared with H. There were no significant differences in the overall survival among the treatment arms. However, patients treated with H survived longer (greater than 5 years). These results suggest that higher response obtained by chemotherapy, alone or in combination with endocrine therapy does not seem to contribute to the prolongation of survival of the patients.

Adrenalectomy↗

PubMed1979

One-dose antibiotic prophylaxis against wound infection after appendicectomy: a randomized trial of clindamycin, cefazolin sodium and a placebo.

Two hundred and fifty patients were admitted to a prospective randomized trial of single dosage prophylaxis against wound infection after appendicectomy. There were 12 exclusions, 72 patients received placebo, 81 received 600 mg i.m. clindamycin phosphate and 85 received 1 1 g i.m. cefazolin sodium, the agent being given in the anaesthetic room. Clindamycin produced a significant reduction in the overall rate of wound infection from 33 per cent in the controls to 17 per cent. In cases with a gangrenous or perforated appendix the infection rate in controls was 78 per cent; this was reduced to 44 per cent by a single dose of clindamycin. Cefazolin significantly reduced the number of aerobic organisms isolated from wound infections, but did not significantly reduce the incidence of wound infection. We conclude that anaerobic organisms are more important than faecal aerobic organisms in the pathogenesis of wound infection after appendicectomy.

Adult↗

PubMed1994

Factors influencing noncompliance and contamination in a randomized trial of "Western" (r1) versus "Japanese" (r2) type surgery in gastric cancer.

BACKGROUND: A randomized trial was undertaken comparing the Western R1 resection with limited N1-level lymphadenectomy and the Japanese R2 resection with extended lymphadenectomy, including the N2-level for curative resection of gastric cancer patients. After 389 patients were entered in the trial, protocol deviations were observed that reduced the intended distinction between the two types of lymphadenectomy: noncompliance, i.e., no substantiation of lymphadenectomy by nodal yields of indicated stations, and contamination, i.e., extension of lymphadenectomy outside the allocated level of nodal clearance. METHODS: To identify factors underlying these protocol deviations, the authors analyzed the influence of six patient-, tumor, and treatment-related characteristics on the magnitude of deviations per patient, and on the incidence of deviations per lymph node station. RESULTS: Protocol deviations were influenced by the following station-specific factors: (1) the number of nodes per station; (2) the clarity of anatomical station definition; (3) the location of stations; (4) local conventions on the type of gastrectomy; and (5) technical features to allow complete en bloc dissection. Furthermore, nonspecific factors such as inadequate retrieval of nodes, incomplete dissection, and careful selection of clinically overt metastases outside the allocated level of nodal clearance were randomly distributed over stations, and they, too, contributed to the deviations. CONCLUSIONS: Based on the findings, the authors took additional steps to preserve the distinction between limited and extended lymphadenectomy and to improve the accuracy of nodal staging. These factors should be considered when standardization of both surgicopathologic trials and clinical protocols for the treatment of gastric cancer is pursued.

Adult↗

PubMed1993

A randomized trial of ethics education for medical house officers.

We report the results of a randomized trial to assess the impact of an innovative ethics curriculum on the knowledge and confidence of 85 medical house officers in a university hospital programme, as well as their responses to a simulated clinical case. Twenty-five per cent of the house officers received a lecture series (Limited Intervention or LI), 25 per cent received lectures and case conferences, with an ethicist in attendance (Extensive Intervention or EI), and 50 per cent served as controls. A post-intervention questionnaire was administered. Knowledge scores did not differ among the groups. Confidence regarding ethical issues was significantly greater in the aggregate intervention group (3.9 on a 1 to 5 scale) compared to the control group (3.6). Confidence regarding procedural issues related to ethics was significantly higher for the EI group than for the controls (4.0 v 2.8). Responses to a simulated case showed that significantly fewer house officers in the EI group would intubate a patient for whom such therapy would be futile (EI = 57 per cent, LI = 87 per cent, Controls = 82 per cent). We conclude that ethics education can have an impact on house officers' confidence and their responses to a simulated case, and that the EI was more effective than the LI. Such results have implications regarding the implementation of ethics education during residency.

Baltimore↗

PubMed2003

Using the expected survival to explain differences between the results of randomized trials: a case in advanced ovarian cancer.

PURPOSE: A meta-analysis of randomized trials in advanced ovarian cancer showed a longer survival with cyclophosphamide, doxorubicin, and cisplatin (CAP) than with cyclophosphamide and cisplatin (CP; P =.009). In contrast, the results of the large International Collaborative Ovarian Neoplasm Study (ICON2) showed no survival difference between CAP and carboplatin (P =.98). In this article, we show how these discrepant results can be reconciled through the estimation of expected survival curves. MATERIALS AND METHODS: A proportional hazards model, fitted to the meta-analysis data, was used to construct the expected survival curve for each treatment arm of the ICON2 trial. Expected survival curves were compared with observed survival curves in the ICON2 trial at all time points using a nonparametric test. RESULTS: The prognostic model for survival obtained in the meta-analysis included extent of residual disease, age, histologic grade, and International Federation of Gynecology and Obstetrics stage. When this model was applied to the ICON2 data, there was no difference between the expected and observed curves in the CAP arm. In contrast, the observed survival curve for carboplatin was far superior to the expected survival curve for CP (P <.01). CONCLUSION: These analyses provide indirect evidence that better results are achieved with carboplatin alone at an optimally tolerated dose, compared with the CP combination at a cisplatin dose of 50 to 60 mg/m2. The expected survival may provide valuable insight when direct comparisons between randomized groups yield discrepant results across different studies.

Adult↗

PubMed2003

Practical aspects of randomization and blinding in randomized clinical trials.

Randomization and blinding are important tools in determining the effectiveness of a new intervention and ensuring the validity of a clinical trial. However, randomness and haphazardness are not equivalent. Randomization cannot overcome poor experimental design or technique. Several types of randomization including historical controls and pseudorandomization are discussed, as well as methods of treatment allocation, stratification, and minimization techniques. The importance of decreasing bias and the advantages and disadvantages of blinding in randomized clinical trials are also covered.

Bias↗

PubMed1985

Design and study similarities and contrasts: the Veterans Administration, European, and CASS randomized trials of coronary artery bypass graft surgery.

There are three large randomized trials of early elective coronary artery bypass graft surgery vs early medical therapy in selected patients with stable angina pectoris: the Veterans Administration Study (or VA Study) with enrollment in 1972 to 1974, the European Coronary Surgery Study Group (or European Study) with enrollment in 1973 to 1976 and the Coronary Artery Surgery Study (CASS) with enrollment in 1975 to 1979. Design and other similarities and contrasts for the three trials are presented. For example if 50% luminal diameter narrowing is used to define a significantly diseased vessel and patients with left main coronary artery disease are eliminated from the VA and European studies, the percentages of patients with one-, two-, and three-vessel disease are: VA 16%, 34%, and 50%; European 0%, 43%, and 57%; CASS 19%, 31%, and 51%. The VA and European studies enrolled patients with NYHA anginal classes I through IV, whereas CASS enrolled patients with Canadian Heart Association classes I and II, as well as patients asymptomatic for chest pain after a myocardial infarction. Other study features of note include the differing geographic locations and time of enrollment. In the VA Study, surgery was performed within 2 months on 94% of those randomly assigned to surgery; the mean time to surgery (of those not crossing over to medicine) in CASS was 54 days; and the European Study had a mean delay of 3.9 months. The characteristics of the clinics, socioeconomic environments, and medical care and referral systems may be important to interpreting results, although they were not clearly specified.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2005

Modern embryo transfer catheters and pregnancy outcome: a prospective randomized trial.

OBJECTIVE: Embryo transfer (ET) is the final crucial step in IVF treatment. The type of catheter used can affect the pregnancy rate (PR). In this prospective, randomized trial we compared the clinical PR between the Wallace and the Cook K-Jet embryo transfer catheters. DESIGN: Prospective, randomized clinical trial. SETTING: A National Health Service Assisted Reproduction Unit. PATIENT(S): One hundred fifty women undergoing a fresh ET. Age more than 40 years, a high basal FSH, a previous difficult ET, or more than six previous ETs were the exclusion criteria. INTERVENTION(S): Women undergoing a fresh ET were randomized at the time of ET to either the Cook K-Jet or Wallace embryo transfer catheter. The randomization was stratified according to age and the number of previous ETs. MAIN OUTCOME MEASURE(S): Clinical PR. RESULT(S): There was no significant difference in the clinical PR between the Wallace and the Cook catheters (22/75 [29.3%] and 23/75 [30.6%], relative risk [RR]: 0.96 [95% confidence interval 0.58-1.58]). CONCLUSION(S): There is no significant difference in the PRs achieved by modern, soft, double-lumen ET catheters.

Adult↗

PubMed2006

A randomized trial of a multicomponent home intervention to reduce functional difficulties in older adults.

OBJECTIVES: To test the efficacy of a multicomponent intervention to reduce functional difficulties, fear of falling, and home hazards and enhance self-efficacy and adaptive coping in older adults with chronic conditions. DESIGN: A prospective, two-group, randomized trial. Participants were randomized to a treatment group or no-treatment group. SETTING: Urban community-living older people. PARTICIPANTS: Three hundred nineteen community-living adults aged 70 and older who reported difficulty with one or more activities of daily living. INTERVENTION: Occupational and physical therapy sessions involving home modifications and training in their use; instruction in strategies of problem-solving, energy conservation, safe performance, and fall recovery techniques; and balance and muscle strength training. MEASUREMENTS: Outcome measures included self-rated functional difficulties with ambulation, instrumental activities of daily living, activities of daily living, fear of falling, confidence performing daily tasks, and use of adaptive strategies. Observations of home hazards were also conducted. RESULTS: At 6 months, intervention participants had less difficulty than controls with instrumental activities of daily living (P=.04, 95% confidence interval (CI)=-0.28-0.00) and activities of daily living (P=.03, 95% CI=-0.24 to -0.01), with largest reductions in bathing (P=.02, 95% CI=-0.52 to -0.06) and toileting (P=.049, 95% CI=-0.35-0.00). They also had greater self-efficacy (P=.03, 95% CI=0.02-0.27), less fear of falling (P=.001, 95% CI=0.26-0.96), fewer home hazards (P=.05, 95% CI=-3.06-0.00), and greater use of adaptive strategies (P=.009, 95% CI=0.03-0.22). Benefits were sustained at 12 months for most outcomes. CONCLUSION: A multicomponent intervention targeting modifiable environmental and behavioral factors results in life quality improvements in community-dwelling older people who had functional difficulties, with most benefits retained over a year.

Accident Proneness↗

PubMed1988

Randomized trial of beta-lactam regimens in febrile neutropenic cancer patients.

A three-arm prospective randomized trial was designed to compare the efficacies of piperacillin plus vancomycin, ceftazidime plus vancomycin, or all three drugs as initial therapy for fever in neutropenic cancer patients. The objectives were to determine whether a broad-spectrum penicillin was as effective as a broad-spectrum cephalosporin and whether two beta-lactam antibiotics were more effective than one. Four hundred and seventy of the 519 febrile episodes entered in the study could be evaluated for response. Ceftazidime plus vancomycin was significantly more effective than piperacillin plus vancomycin, considering all febrile episodes (79 percent versus 61 percent, p = 0.001), documented infections (79 percent versus 57 percent, p = 0.004), gram-negative infections (88 percent versus 47 percent, p = 0.001), and bacteremias (81 percent versus 51 percent, p = 0.01). The addition of piperacillin to ceftazidime (piperacillin plus ceftazidime and vancomycin versus ceftazidime plus vancomycin) did not improve the response rate and was associated with a significantly higher incidence of skin rash. Vancomycin plus ceftazidime provides adequate antibiotic coverage for initial treatment of fever in neutropenic patients. This combination was equally effective, less expensive, and less toxic than the double beta-lactam combination used in this study.

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 article 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 Comment. 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 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, 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.

Publishing↗

PubMed1990

Antibiotic prophylaxis in lower-extremity amputations due to ischemia. A prospective, randomized trial of cephalothin versus methicillin.

The efficiency of prophylactic antibiotic therapy in amputation surgery was studied in a prospective, randomized trial of a first-generation cephalosporin (cephalothin) compared with a narrow-spectrum beta-lactam stable penicillin (methicillin). Eighty-eight patients received cephalothin 2 g X 4 on the day of operation, while 86 patients received methicillin 1 g X 4. The patients were followed up for 21 days. Infected wounds occurred in 14.8% of the patients in the cephalothin group, compared with 14% in the methicillin group. The frequency of deep infections was 10.2% versus 4.7% (P = 0.1611). The reamputation frequency was 18.2% in the cephalothin group compared with 12.8% in the methicillin group; the frequency of below-knee reamputation was 18.4% versus 7.7% (P = 0.1469). No clostridial infections were found. The study did not demonstrate any significant difference between cephalothin and methicillin in the prophylaxis for lower-extremity amputations, although the latter drug tended to be the best choice.

Adult↗

PubMed2003

The effects of alternative study designs on the power of community randomized trials: evidence from three studies of human immunodeficiency virus prevention in East Africa.

BACKGROUND: Randomized intervention trials in which the community is the unit of randomization are increasingly being used to evaluate the impact of public health interventions. In the design of community randomized trials (CRT), the power of the study is likely to be affected by two issues: the matching or stratification of communities, and the number and size of the communities to be randomized. METHODS: Data from three East African community intervention trials, designed to evaluate the impact of interventions to reduce human immunodeficiency virus (HIV) incidence, are used to compare the efficiency of different trial designs. RESULTS: Compared with an unmatched design, stratification reduced the between-community variation in the Mwanza trial (from 0.51 to 0.24) and in the Masaka trial (from 0.38 to 0.28). The reduction was smaller in the Rakai trial where the selected communities were more homogeneous (from 0.15 to 0.11). For all trials, individual matching of communities produced estimates of between-community variation similar to those from the stratified designs. The linear association between HIV prevalence and incidence was strong in the Mwanza trial (correlation coefficient R = 0.83) and the Masaka trial (R = 0.83), but weak in the Rakai trial (R = 0.28). Unmatched study designs that use smaller communities tend to increase between-community variation, but reduce the design effect and improve study power. CONCLUSIONS: These empirical data suggest that selection of homogeneous communities, or stratification of communities prior to randomization, may improve the power of CRT.

Community Health Services↗

PubMed1984

Continuity of outpatient medical care in elderly men. A randomized trial.

P6 an outpatient repeatedly sees the same practitioner, is his care influenced? This double-blind randomized trial examines the effects of outpatient health care provider continuity on the process and outcome of the medical care for 776 men aged 55 years and older. Participants were randomized to two different groups of provider care: provider discontinuity and provider continuity. The outcome of the continuity group was significantly different from that of the discontinuity group. During an 18-month period, patients who had been randomized to the continuity group had fewer emergent admissions (20% v 39%) and a shorter average length of stay (15.5 v 25.5 days). These patients also perceived that the providers were more knowledgeable, thorough, and interested in patient education. We conclude that continuity of outpatient provider care for men aged 55 years and older results in more patient satisfaction, shorter hospitalizations, and fewer emergent hospital admissions.

Aged↗