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Results for “Randomized trial”

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At least 613 records · Page 34Linked to original sources

PubMed1999

A randomized trial of hydroxyapatite coated prostheses in total hip arthroplasty.

In a prospective randomized trial, 62 consecutive primary cementless total hip arthroplasties in 55 patients were performed by one surgeon using either hydroxyapatite coated (35 hips) or nonhydroxyapatite coated femoral prostheses (27 hips). The dual tapered femoral stem had a Ti-6AI-4V plasma sprayed circumferential proximal porous coat applied to the proximal 1/3 of the stem. The middle 1/3 had a roughened blasted textured surface, and the distal 1/3 had a smooth surface. The hydroxyapatite coated femoral stems had an additional hydroxyapatite coating applied to the proximal porous coat with use of an air plasma process. The patients in the two groups were not significantly different regarding age (48.2 +/- 9.0 years hydroxyapatite group, 50.4 +/- 8.7 years control group), gender, Charnley class, or length of followup (4.4 +/- 0.7 years hydroxyapatite group, 4.9 +/- 1.0 years control group). Forty-nine patients (54 hips) were available for clinical followup, and 45 patients (50 hips) had radiographic followup. A minimum 3-year followup was recorded. To date, there have been no femoral prostheses failures. No femoral implant has migrated or subsided. Radiographically, the hydroxyapatite coated stems showed trends toward increased distal stem related cortical hypertrophy, increased cancellous condensation and less endosteal cavitation. Two nonhydroxyapatite coated stems had distal endosteal cavitation, whereas no hydroxyapatite coated stems did. There were two cases of acetabular osteolysis (revision in one) and two cases of acetabular cup migration (nonrevised), all occurring in the control group. The overall revision rate was 4%. There was no difference in Harris hip scores at 6 months (80.6 +/- 13.0 points hydroxyapatite group, 83.8 +/- 12.4 points control group) or at last followup (85.6 +/- 15.4 points hydroxyapatite group, 89.7 +/- 13.4 control group). The Harris hip pain scores also were not significantly different at 6 months or at last followup. Multiple linear regression analysis controlling for age, gender, and length of followup revealed no significant predictors of Harris hip or pain scores. The results of this study at an average of 4.6 years do not indicate a significant clinical advantage to the use of hydroxyapatite coated femoral prostheses in primary cementless total hip arthroplasty when judged by the criteria of Harris hip scores and femoral stem survivorship.

Acetabulum↗

PubMed2002

Confirming false adverse reactions to drugs by performing individualized, randomized trials.

One-patient, randomized, double-blind, controlled trials (N-of-1 RCTs) have traditionally been used to assess the efficacy of treatment. At the Drug Safety Clinic, Toronto, this methodology is used to evaluate adverse effects related to medication use, specifically when the symptoms are vague and are in response to more than one medication. Two patients are described with histories of drug allergies to multiple medications; as well, guidelines for conducting N-of-1 trials are summarized. The first patient had a history of prolonged periorbital and generalized weakness lasting up to one week after exposure to a variety of drugs. Because of the ambiguous results of local anesthetic skin testing, an N-of-1 trial was performed using lidocaine without preservative. Two short-lived episodes of blepharospasm and lethargy were observed with placebo; no subjective or objective reaction occurred with active drug. The second patient had a history of prolonged weakness and drowsiness after exposure to many medications; she had been told that she was allergic to all drugs with a benzene ring. During the first N-of-1 trial, generalized weakness was observed with 10 mg of dimenhydrinate and all four placebo doses. During the second N-of-1 challenge using codeine, no unwarranted reactions occurred with either active or placebo drug. Traditional testing of these patients to disprove the clinical symptoms is often difficult because of the anxiety level associated with the patients' past experiences. N-of-1 trials provide a useful alternative for the management of patients with nonspecific symptomatology attributed to drug ingestion.

Administration, Oral↗

PubMed2002

Design and implementation of a randomized trial evaluating systematic care for bipolar disorder.

OBJECTIVES: Everyday care of bipolar disorder typically falls short of evidence-based practice. This report describes the design and implementation of a randomized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder. METHODS: Computerized records of a large health plan were used to identify all patients treated for bipolar disorder. Following a baseline diagnostic assessment, eligible and consenting patients were randomly assigned to either continued usual care or a multifaceted intervention program including: development of a collaborative treatment plan, monthly telephone monitoring by a dedicated nurse care manager, feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers, as-needed outreach and care coordination, and a structured psychoeducational group program (the Life Goals Program by Bauer and McBride) delivered by the nurse care manager. Blinded assessments of clinical outcomes, functional outcomes, and treatment process were conducted every 3 months for 24 months. RESULTS: A total of 441 patients (64% of those eligible) consented to participate and 43% of enrolled patients met criteria for current major depressive episode, manic episode, or hypomanic episode. An additional 39% reported significant subthreshold symptoms, and 18% reported minimal or no current mood symptoms. Of patients assigned to the intervention program, 94% participated in telephone monitoring and 70% attended at least one group session. CONCLUSIONS: In a population-based sample of patients treated for bipolar disorder, approximately two-thirds agreed to participate in a randomized trial comparing alternative treatment strategies. Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program. Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care.

Adolescent↗

PubMed1999

[Results of a prospective randomized trial with induction chemotherapy for cancer of the oral cavity and tonsils].

Although induction chemotherapy administered prior to local therapy produces encouraging initial response rates in head and neck cancer, randomized studies have failed to demonstrate an improvement in survival rates. All randomized studies included only patients with advanced stage III and IV disease. In our opinion, this is the main reason for the low rate of complete responses demonstrated in the randomized trials (maximum 18%). Frei et al. estimate that a 40%-50% complete response rate is necessary before improved survival rates are seen. To date, such complete response rates with induction chemotherapy have only been attainable in resectable T2-T3, N0-N2 disease. Therefore, we initiated a prospective randomized trial including only patients with the mentioned disease stages. Patients (pts) were randomized to receive either induction chemotherapy with three cycles of carboplatin/5-FU prior to surgery and radiotherapy (arm A, 70 pts) or standard treatment with surgery and radiotherapy (arm B, 74 pts). Patients were classified according to primary tumour site and neck disease. The observed remission rate after chemotherapy confirmed the primary estimated rate for this subgroup of patients with head and neck cancer (CR: 43%, PR: 37%, NR: 15%, PD: 5%). After a follow-up of 12-96 months overall survival was 58% in arm A and 45% in arm B (n.s.). Disease-free survival in arm A (61%) is statistically significantly better than in arm B (43%, P=0. 03). Therefore, we recommend further controlled trials to investigate the role of induction chemotherapy in patients with primary resectable carcinomas of the oral cavity and tonsils and stage T2-T3 and N0-N2 disease prior to surgery.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1989

Classical external indwelling central venous catheter versus totally implanted venous access systems for chemotherapy administration: a randomized trial in 100 patients with solid tumors.

A prospective randomized trial was organized at the Institut Gustave-Roussy to assess the reliability of classical external catheters (CE) versus totally implanted access systems (TI) for delivering intravenous chemotherapy for a duration of at least 6 months. The analysis was performed on the 96 patients whose implantation succeeded (CE 46, TI 50). Failure was defined as loss of ability to function (followed by removal) within the 6-month period of the survey. Patients dying with functional catheters were considered as censored (15 cases) at the time of death. Twenty-four access systems were removed. The removal-free curves differ significantly (P less than 0.001), favoring the TI access systems. The main reasons for removal were: catheter fall (CE6, (TI 0), migration (CE 1, TI 1), infection (CE 5, TI 1), thrombotic occlusion (CE 1, TI 0) and venous complications (CE 1 thrombosis plus 1 pulmonary embolism, TI 1 thrombosis). In addition, a survey by questionnaire demonstrated a significantly better patient activity rate (P = 0.02) and hygiene (P less than 0.001) in the TI group. This prospective randomized study demonstrates that totally implanted access systems are more reliable, safer and better tolerated than classical external catheters for solid tumor patients undergoing intravenous chemotherapy for longer than 6 months.

Antineoplastic Agents↗

PubMed2004

Drug-eluting stents: from randomized trials to the real world.

Drug-eluting stents have been developed to prevent in-stent restenosis following percutaneous coronary revascularization. In a number of randomized trials, polymer-coated sirolimus- and paclitaxel-eluting stents have been proven to markedly reduce the incidence of angiographic restenosis and repeat revascularization when compared to bare metal stents. Effectiveness of sirolimus-eluting stents in the prevention of restenosis has been confirmed in many subsets of patients and lesions not included in randomized trials, such as in-stent restenosis, chronic total occlusion, acute myocardial infarction, and others. Very promising data in the real world are emerging for utilization of paclitaxel-eluting stents as well. Other drug-eluting stents gave less brilliant results or even true failures, whilst a number of new drugs and stent platforms are under clinical or preclinical evaluation. In this review we describe the main clinical trials on drug-eluting stents, and the most recent informations derived from observational studies and registries. Moreover, preliminary results on new drug-eluting stents are summarized.

Angioplasty, Balloon, Coronary↗

PubMed2002

Is periprostatic local anesthesia for transrectal ultrasound guided prostate biopsy associated with increased infectious or hemorrhagic complications? A prospective randomized trial.

PURPOSE: Periprostatic local anesthesia for prostate biopsy requires 2 or more extra needle punctures and injection of the local anesthetic through the highly colonized rectum. To our knowledge we report the first prospective randomized trial to assess the infectious or hemorrhagic complications associated with this method. MATERIALS AND METHODS: A total of 100 consecutive patients with sterile urine cultures underwent transrectal ultrasound guided prostate biopsy. They were randomized to receive a periprostatic nerve block or no anesthesia. Patients were evaluated for the amount of rectal and urethral bleeding, and symptoms and signs of infection after biopsy. RESULTS: The amount of urethral bleeding was slight and similar in the 2 groups. Rectal bleeding was significantly less in the patients who received anesthesia. High fever (greater than 37.8C) was more frequent in the nerve block group and 2 patients in this group required rehospitalization. Bacteriuria in post-biopsy urine cultures was significantly more common in the anesthesia group. CONCLUSIONS: Our results suggest that periprostatic local anesthesia for prostate biopsy does not increase the risk of urethral bleeding. It is associated with a decreased incidence of rectal bleeding, presumably due to decreased patient discomfort. The incidence of bacteriuria was significantly higher in the anesthesia group. High fever and hospitalization due to infectious complications were also more common in the local anesthesia group, although not statistically significant. Prospective randomized trials seem warranted to determine the optimum antibiotic prophylaxis regimen in patients undergoing biopsy with a periprostatic nerve block.

Aged↗

PubMed2000

The effects of radiation therapy on quality of life of women with breast carcinoma: results of a randomized trial. Ontario Clinical Oncology Group.

BACKGROUND: The purpose of this study was to evaluate the effect of breast irradiation on quality of life, including cosmetic outcome, for patients enrolled in a clinical trial. METHODS: Between 1984 and 1989, a randomized trial was conducted in Ontario, Canada, in which women with lymph node negative breast carcinoma who had undergone lumpectomy and axillary lymph node dissection were randomized to either breast irradiation or no further treatment. A modified version of the Breast Cancer Chemotherapy Questionnaire (BCQ) was administered to women at baseline, 1 month (4 weeks), and 2 months (8 weeks) after randomization. Irritation of the skin of the breast, breast pain, and appearance of the breast to the patient were also assessed every 3 months for the first 2 years of the study. RESULTS: Of 837 patients, 416 were randomly allocated to radiation therapy and 421 to no further treatment. The mean change in quality of life from baseline to 2 months was -0.05 for the radiation group and +0.30 for the control group. The difference between groups was statistically significant (P = 0.0001). Longer term radiation therapy increased the proportion of patients who were troubled by irritation of the skin of the breast and breast pain. Radiation therapy did not increase the proportion of patients at 2 years who were troubled by the appearance of the treated breast; 4.8% in irradiated and nonirradiated patients (P = 0.62). CONCLUSIONS: Breast irradiation therapy had an effect on quality of life during treatment. After treatment, irradiated patients reported increased breast symptoms compared with controls. However, no difference was detected between groups at 2 years in the rates of skin irritation, breast pain, and being upset by the appearance of the breast.

Breast Neoplasms↗

PubMed2000

A medical research council randomized trial in patients with primary cerebral non-Hodgkin lymphoma: cerebral radiotherapy with and without cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy.

BACKGROUND: The role of chemotherapy in the treatment of patients with primary central nervous system lymphoma (PCL) remains unclear, with no randomized trials available to aid in the interpretation of the current data. The Medical Research Council therefore conducted the current randomized trial to assess the impact on survival of postradiotherapy chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in nonimmunocompromised adult patients with pathologically proven PCL. METHODS: After surgery, patients were randomized at a ratio of 1:2 to radiotherapy alone (RT: 40 grays [Gy] in 20 fractions to the whole brain followed by a 14-Gy boost to the tumor plus a 2-cm tumor margin) or to the same radiotherapy followed by six cycles of CHOP chemotherapy given at 3-week intervals (RT-CHOP). The target sample size was 90 patients, which allowed 90% power to detect a doubling of the median survival time. RESULTS: Between 1988 and 1995, 53 patients were randomized: Fifteen patients were randomized to RT, and 38 patients were randomized to RT-CHOP. The trial closed earlier than planned through poor accrual. The median patient age was 57 years, 57% of the patients were male, and 75% of the patients had unifocal disease. The median number of chemotherapy cycles received was 6 (mean, 4 cycles). Forty-three patients have died, and the median follow-up of survivors is 5 years (range, 1-9 years). There was no evidence of a benefit from RT-CHOP with respect to overall survival (hazard ratio [HR], 1.19; 95% confidence interval, 0.51-2.76) after adjustment for prognostic factors (patient age and neurologic performance status) in an analysis in which HR > 1 favored the control (RT) group. CONCLUSIONS: CHOP has no clear role in the postradiotherapy treatment of patients with PCL. Chemotherapy is poorly tolerated and largely palliative in older, less fit patients. In younger patients, initial chemotherapy designed to penetrate the blood-brain barrier warrants further investigation.

Adult↗

PubMed1989

A randomized trial of conjunctival autografting for pterygium in the tropics.

This is the first report of a randomized trial of the conjunctival autografting technique for pterygium removal. This trial was conducted in the Caribbean where risk of pterygium recurrence is considered to be high. Although not statistically significant, there was a lower recurrence rate in grafted cases (21% of 19 cases) than in controls done by the bare sclera technique (37% of 16 cases). The author found that age of the patient was strongly associated with recurrence regardless of which procedure was used. Findings of this study emphasize the importance of randomized controlled trials in assessing the efficacy of specific procedures for pterygium removal.

Adult↗

PubMed1998

Should we adjust for covariates in nonlinear regression analyses of randomized trials?

The analyses of the primary objectives of randomized clinical trials often are not adjusted for covariates, except possibly for stratification variables. For analyses with linear models, adjustment is a precision issue only. We review the literature regarding logistic and Cox (proportional hazards) regression models. For these nonlinear analyses, omitting covariates from the analysis of randomized trials leads to a loss of efficiency as well as a change in the treatment effect being estimated. We recommend that the primary analyses adjust for important prognostic covariates in order to come as close as possible to the clinically most relevant subject-specific measure of treatment effect. Additional benefits would be an increase in efficiency of tests for no treatment effect and improved external validity. The latter is particularly relevant to meta-analyses.

Bias↗

PubMed1998

Analysis of data from group-randomized trials with repeat observations on the same groups.

This study used Monte Carlo simulations to evaluate the performance of alternative models for the analysis of group-randomized trials having more than two time intervals for data collection. The major distinction among the models tested was the sampling variance of the intervention effect. In the mixed-model ANOVA, the sampling variance of the intervention effect is based on the variance among group x time-interval means. In the random coefficients model, the sampling variance of the intervention effect is based on the variance among the group-specific slopes. These models are equivalent when the design includes only two time intervals, but not when there are more than two time intervals. The results indicate that the mixed-model ANOVA yields unbiased estimates of sampling variation and nominal type I error rates when the group-specific time trends are homogenous. However, when the group-specific time trends are heterogeneous, the mixed-model ANOVA yields downwardly biased estimates of sampling variance and inflated type I error rates. In contrast, the random coefficients model yields unbiased estimates of sampling variance and the nominal type I error rate regardless of the pattern among the groups. We discuss implications for the analysis of group-randomized trials with more than two time intervals.

Analysis of Variance↗

PubMed2000

A systematic survey of 13 randomized trials of non-steroidal anti-inflammatory drugs for the prevention of heterotopic bone formation after major hip surgery.

We performed a systematic survey of randomized trials to determine the effects of perioperative NSAIDs on the occurrence of heterotopic bone formation, gastrointestinal side-effects and long-term clinical outcomes after major hip surgery. 13 trials involving 4,129 individuals were identified. Overall, in 12 small trials of medium-to-high-dose regimens, there was a 57% reduction (95% confidence interval 51%-63%) in the risk of heterotopic bone formation. The results of one large trial of low-dose aspirin differed markedly (2% reduction (95% CI 12% reduction to 15% increase)). The NSAID regimens studied had no definite effect on gastrointestinal complications, and data about the effects of NSAIDs on pain and function were too few, and too incompletely reported, to draw conclusions about their effects on these outcomes. Routine prophylaxis against heterotopic bone formation with NSAIDs may be a useful adjuvant therapy for patients undergoing major hip surgery, but the overall balance of risks and benefits requires assessment in a large-scale randomized trial.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1995

Definition of the role of enterococcus in intraabdominal infection: analysis of a prospective randomized trial.

BACKGROUND: The role of enterococcus in intraabdominal infection is controversial. This study examines the contribution of enterococcus to adverse outcome in a large intraabdominal infection trial. METHODS: A randomized prospective double-blind trial was performed to compare two different antimicrobial regimens in combination with surgical or percutaneous drainage in the treatment of complicated intraabdominal infections. A total of 330 valid patients was enrolled from 22 centers in North America. RESULTS: In 330 valid patients, 71 had enterococcus isolated from the initial drainage of an intraabdominal focus of infection. This finding was associated with a significantly higher treatment failure rate than that of patients without enterococcus (28% versus 14%, p < 0.01). In addition, only Acute Physiology and Chronic Health Evaluation II score and presence of enterococcus were significant independent predictors of treatment failure when stepwise logistic regression was performed (p < 0.01 and < 0.03). Risk factors for the presence of enterococcus include age, Acute Physiology and Chronic Health Evaluation II, preinfection hospital length of stay, postoperative infections, and anatomic source of infection. There was no difference between the clinical trial treatment regimens with regard to overall failure, failure associated with enterococcus, or frequency of enterococcal isolation. CONCLUSIONS: This study is the first to report enterococcus as a predictor of treatment failure in complicated intraabdominal infections. This trial also identifies several significant risk factors for the presence of enterococcus in such infections.

Abscess↗

PubMed2003

Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial.

PURPOSE: This is a prospective, Phase III multicenter randomized trial to assess the effectiveness of concurrent intravenous mitomycin C, oral 5-fluorouracil (5-FU), and radiotherapy (RT) in locally advanced carcinoma of the cervix. METHODS AND MATERIALS: Between January 1988 and November 1994, 926 patients with locally advanced carcinoma of the cervix, FIGO Stage IIB-IVA, were entered into this study. The patients were randomized into four arms, as follows: Arm 1: conventional RT; Arm 2: conventional RT and adjuvant chemotherapy; Arm 3: conventional RT plus concurrent chemotherapy; Arm 4: conventional RT plus concurrent chemotherapy and adjuvant chemotherapy. Concurrent chemotherapy consisting of intravenous mitomycin C at 10 mg/m(2) was given on Days 1 and 29, and oral 5-FU at 300 mg/day was administered on Days 1-14 and 29-42 during RT. Adjuvant chemotherapy of 5-FU orally at 200 mg/day was given for three courses of 4 weeks, with a 2-week rest every 6 weeks. Six centers participated in the trial. RESULTS: The median follow-up time was 89 months. Acute side effects were generally higher in concurrent arms, but most of the patients tolerated the treatment well. Bone marrow toxicity was also higher in concurrent arms. The 5-year actuarial disease-free survival (DFS) was 48.2%, 54.1%, 64.5%, and 59.7% for arms 1, 2, 3, and 4, respectively. The pattern of failure revealed a significant increase in locoregional recurrence in the nonconcurrent chemoradiotherapy arm. The local recurrence was 25.5%, 20.6%, 14.3%, and 17.6% for arms 1, 2, 3, and 4, respectively. The metastatic rates were not significantly different in all four arms. At the time of analysis, there were no increases in late side effects, especially in gastrointestinal and genitourinary systems. CONCLUSIONS: Concurrent chemotherapy, mitomycin C, and 5-FU together with conventional RT showed an improved DFS rate when compared with conventional RT alone in patients with locally advanced carcinoma of the cervix.

Adenocarcinoma↗

PubMed2004

A randomized trial of local anaesthetic in treatment of quinsy.

A prospective randomized trial was undertaken in 30 adult patients with quinsy to determine the most efficacious method of local anaesthetic (LA) for aspiration, and incision and drainage of the abscess. Patients were randomized to receive either topical spray or spray and infiltration over the site of the collection. Pain was assessed on a visual analogue scale. Our results show, following analysis with Mann-Whitney U-test, a statistically significant lower mean pain scores for the infiltration group compared with the spray group during aspiration (P < 0.001), incision and drainage (P < 0.001), 30 min after incision (P < 0.01) and cumulative results during treatment (unpaired t-test P < 0.001). The authors recommend that infiltration be the method of choice of LA in aspiration and incision of peri-tonsillar abscess.

Adult↗

PubMed1989

Methodologic considerations in the design and conduct of randomized trials: the U.S. Physicians' Health Study.

For treatments whose hypothesized risk reductions are small to moderate in size, on the order of 10%-30%, observational epidemiologic studies may not be reliable, since the amount of uncontrolled confounding could easily be as great as the likely reduction in risk. In such cases, randomized trials may be the only epidemiologic design strategy able to provide clear answers to research questions. However, the choice of design features and proper conduct of a randomized trial are crucial to the ability of the study to provide reliable results. In planning a study, five principal issues should be considered: design efficiency, completeness of follow-up, level of compliance, size of the probable risk reduction, and accumulation of sufficient numbers of outcome measures. Careful attention to these design considerations will enhance a trial's ability to provide definitive research results. The importance of these issues can be illustrated by examining the design and conduct of the ongoing Physicians' Health Study, a randomized, double-blind, placebo-controlled trial of aspirin in the reduction of cardiovascular disease and beta-carotene in the prevention of cancer.

Adult↗

PubMed1988

Chemotherapy for non-small cell lung cancer: a randomized trial of cisplatin/vindesine v no chemotherapy.

Separate but almost identical randomized trials testing the role of chemotherapy in non-small cell lung cancer (NSCLC) were started in Southampton, United Kingdom (UK) and in several centers in Australia. Between 1983 and 1987, 201 patients were assigned to either a chemotherapy arm: cisplatin 120 mg/m2 every 4 weeks and vindesine 3 mg/m2 weekly, or a no chemotherapy arm. Of 188 evaluable patients, 157 were randomized in Australia and 31 in Southampton. Objective responses after two cycles of cisplatin/vindesine were seen in 26 patients (28%). Median survival was 23 weeks for the treatment arm and 16 weeks in the no treatment arm (P = NS). Analysis of those patients with limited disease showed a median survival of 43 weeks for the chemotherapy arm and 26 weeks for the non-treatment arm (this difference approaches statistical significance). Toxicity was severe in the treatment arm, and all patients experienced subjective toxicity; 17 (18%) had WHO (World Health Organization) grade 3-4 myelotoxicity, 73% had grade 3-4 nausea and vomiting. There is a modest trend towards improved overall survival in patients with limited disease treated with chemotherapy. Because chemotherapy is palliative, future studies should have an appropriate control arm and should measure quality of life.

Antineoplastic Combined Chemotherapy Protocols↗