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Results for “Randomized trial”

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PubMed1997

Health outcomes among African American and Caucasian adults following a randomized trial of an asthma education program.

OBJECTIVES: Re-analysis of a randomized trial of an asthma education program designed to assess the effects of the intervention on emergency department visits, limited days of activity and asthma knowledge and beliefs separately for African American and Caucasian adults with asthma. DESIGN: Two hundred and forty-one respondents between the ages of 18 and 70 were evaluated in two emergency departments (one inner city and one suburban location) of a large, midwestern health care system and were randomized to an intervention or control group. RESULTS: Regardless of race, members of the intervention group showed a decrease in the number of post-intervention emergency department visits (ANOVA interaction between race and group effect p value = 0.93). The greatest decrease occurred during the first four post-intervention months. No differential effect of the asthma education intervention by race was found on the change in asthma knowledge and beliefs over the study period (ANCOVA interaction between race and group effect p value = 0.60). CONCLUSION: This study demonstrates that post-intervention, both African American and Caucasian study participants showed a decrease in emergency department visits and an increase in asthma self-management. This finding is especially important for African Americans, who face increasing asthma mortality and morbidity.

Absenteeism↗

PubMed2003

Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery.

Even the best-designed, randomized controlled trials suffer when patients are lost to follow-up. Incomplete follow-up biases the results of a trial when patients who drop out are different from those who complete follow-up. This is exaggerated further when there are differential dropout rates between study groups. Previous randomized controlled trials in orthopedic trauma have reported up to 28% loss to follow-up. Only by striving to achieve a 0% loss to follow-up rate can we be certain that this type of bias does not affect our results. In our ongoing multicenter, randomized controlled trial comparing reamed and nonreamed intramedullary nailing of tibial shaft fractures, we have implemented several innovative strategies to minimize loss to follow-up. The exclusion criteria and consent process are designed to minimize losses. Study staff are carefully trained in communication and negotiation with patients. Additionally, a central methods center monitors all patient follow-up and aids in finding lost patients. Through these primary, secondary, and tertiary interventions, we have achieved 94% complete 1-year follow-up for the first 440 patients enrolled in the trial. Eleven patients withdrew consent, and we are unable to locate 17 patients. We have successfully minimized the loss to follow-up rate in our trial by incorporating innovative prevention and retention strategies into its design and conduct. Through planning, organization, and committing time and resources to minimizing loss to follow-up, other orthopedic trauma trials can hope to achieve the same high rates of follow-up.

Bias↗

PubMed1985

Randomized trial of imipenem/cilastatin versus gentamicin and clindamycin in mixed flora infections.

Results of a randomized trial comparing imipenem/cilastatin versus the combination of gentamicin plus clindamycin for mixed flora surgical sepsis are reported herein. Seventy-four patients were evaluable, 50 of whom had intra-abdominal sepsis. No imipenem-resistant initially infecting isolates were encountered. When outcome was evaluated on the basis of severity scoring (APACHE II), no difference in mortality was noted. However, therapy in two patients with Pseudomonas emerging from a polymicrobial flora failed with gentamicin, whereas no Pseudomonas failures were noted with imipenem/cilastatin. The major difference noted was in toxicity. There was a 20 percent incidence of nephrotoxicity in gentamicin-treated patients despite serum level monitoring and multiple dose adjustments. The degree of efficacy and the relative tolerability of imipenem/cilastatin in seriously ill surgical patients is demonstrated.

Adult↗

PubMed1998

Six-month physical activity and fitness changes in Project Active, a randomized trial.

PURPOSE: Project Active is a randomized clinical trial (N = 235) comparing a lifestyle physical activity program with a structured exercise program in changing physical activity (total energy expenditure [kcal.kg-1.d-1]) and cardiorespiratory fitness (VO2peak in mL.kg-1.min-1). METHODS: Sedentary but healthy adults (N = 235) aged 35-60 years received 6 months of intensive intervention. RESULTS: Analysis of covariance (ANCOVA), adjusting for baseline measure, age, gender, body mass index (BMI), cohort, and ethnicity, showed that at 6 months both lifestyle and structured groups significantly increased energy expenditure over baseline (P < 0.001). The mean increases +/- SE, 1.53 +/- 0.19 kcal.kg-1.d-1 for the lifestyle group and 1.34 +/- 0.20 kcal.kg-1 d-1 for the structured group, were not significantly different between groups (P = 0.49). For cardiorespiratory fitness, both groups had significant increases from baseline (P < 0.001). Mean increases +/- SE were 1.58 +/- 0.33 mL.kg-1.min-1 and 3.64 +/- 0.33 mL.kg-1.min-1 for the lifestyle and structured groups, respectively. This was significantly greater in the structured group (P < 0.001). We also studied changes in intensity of physical activity. Both groups significantly increased moderate intensity activity from baseline, but the increase was significantly greater in the lifestyle group than the structured group (P = 0.02). In contrast, the structured group increased its hard activity more than the lifestyle group, but the difference was not significantly different (P = 0.02). In contrast, the structured group increased its hard increased (P < 0.01) for both groups by 0.25 kcal.kg-1.d-1. CONCLUSION: Both intervention approaches are effective for increasing physical activity and fitness over a 6-month period in initially sedentary men and women.

Adult↗

PubMed2003

Stenting versus surgical bypass grafting for coronary artery disease: systematic overview and meta-analysis of randomized trials.

BACKGROUND: Coronary angioplasty and coronary artery bypass grafting (CABG) are both major techniques for the management of coronary artery disease, but CABG is associated with a lower incidence of repeat revascularization. Recent studies comparing angioplasty with stenting vs CABG have yielded conflicting results, with some suggesting improved survival with stenting, and others the opposite. We thus undertook a systematic overview of the randomized trials comparing stenting vs CABG in coronary artery disease. METHODS: MEDLINE (January 1986-February 2003), ISI Current Contents, the Cochrane Controlled Trial Register, LILACS and the American Heart Association, American College of Cardiology, European Society of Cardiology, and Transcatheter Cardiovascular Therapeutics conference proceedings were among the databases we searched. Abstraction was performed in a non-blinded manner on pre-specified forms. The random-effect odds ratios for death, myocardial infarction, stroke, repeat revascularization, and symptomatic angina were computed for the longest available follow-up. RESULTS: Nine randomized trials (3283 patients, representing only 6% of all screened subjects) with an average follow-up of 28 months were included in the analysis, while four studies were excluded because they were still unpublished, ongoing, or with non-systematic stenting. No study used drug-eluting stents. The odds ratios for stenting vs CABG were 0.82 (95% confidence interval-CI 0.57-1.18, p = 0.3) for the occurrence of death, non-fatal myocardial infarction or stroke, 4.6 (95% CI 3.5-5.9, p < 0.00001) for repeat revascularization, and 2.3 (95% CI 1.8-2.8, p < 0.00001) for symptomatic angina. Heterogeneity tests were not statistically significant. The results of sensitivity analysis were similar even after stratification for single vessel, off-pump, single center or high-quality studies. CONCLUSIONS: Overall and event-free survival after conventional stenting for coronary artery disease are similar to those after CABG, but surgery is still associated with a significantly lower incidence of repeat revascularization and symptoms. The role of next-generation drug-eluting stents in widening the indications for stenting and overcoming restenosis will need to be assessed in future observational and randomized studies comparing stenting vs CABG.

Angioplasty, Balloon, Coronary↗

PubMed2002

Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial.

High-dose therapy has become a common treatment for myeloma. The objective of this study (Intergroupe Francophone du Myélome [IFM] 9502 trial) was to compare in a prospective and randomized trial the 2 most widely used conditioning regimens before autologous stem cell transplantation in newly diagnosed symptomatic patients younger than 65 years old: 8 Gy total body irradiation plus 140 mg/m(2) melphalan (arm A) versus 200 mg/m(2) melphalan (arm B). A total of 282 evaluable patients were compared--140 in arm A and 142 in arm B. Baseline characteristics and disease response to 4 cycles of the VAD regimen performed before randomization and autologous stem cell transplantation were identical in the 2 treatment arms. In arm B, hematologic recovery was significantly faster for both the duration of neutropenia and thrombocytopenia, transfusion requirements were also significantly lower, and the median duration of hospitalization was significantly shorter. In arm A, the incidence of severe mucositis was significantly increased. The median duration of event-free survival was similar in both arms (21 vs 20.5 months, P =.6), but the 45-month survival was 65.8% in arm B versus 45.5% in arm A (P =.05). This difference might be attributed in part to better salvage regimens after relapse in arm B compared with arm A. We conclude that 200 mg/m(2) melphalan is a less toxic and at least as effective conditioning regimen when compared with 8 Gy total body irradiation with 140 mg/m(2) melphalan. This regimen should be considered as the standard of care before autologous stem cell transplantation in multiple myeloma.

Adult↗

PubMed1997

Surgery for primary intracerebral hemorrhage: is it safe and effective? A systematic review of case series and randomized trials.

BACKGROUND AND PURPOSE: The surgical treatment of primary intracerebral hemorrhage (PICH) varies throughout the world, mainly because of the lack of evidence of its safety and effectiveness. This study compares the outcome of patients with PICH who are treated surgically with those who are not. METHODS: We conducted a systematic overview (meta-analysis) of all studies of the outcome of surgery for PICH by means of a Medline search of relevant randomized trials and case series published since 1966. Cited references and presentations were also reviewed. RESULTS: The 15 case series of surgery for PICH involving a total of 1524 patients (654 treated surgically) are potentially confounded and the results inconclusive. The pooled results of the three randomized controlled trials of open craniotomy and one trial of endoscopic evacuation for supratentorial PICH in a total of 349 patients (173 treated surgically) indicate a nonsignificant increase in odds of death and dependency at 6 months for patients treated surgically (odds ratio, 1.23; 95% confidence interval, 0.77 to 1.98). The odds of death or dependency at 6 months were 2.1 (1.1 to 4.1) for patients undergoing craniotomy and 0.45 (0.2 to 1.0) for endoscopic evacuation. CONCLUSIONS: There is insufficient evidence of the risks and benefits of surgery for PICH. Further randomized trials are needed to identify whether there is a favorable treatment effect of surgery, the types of PICH and patients who are likely to benefit and not benefit, and the safety and effectiveness of the different surgical interventions.

Cerebral Hemorrhage↗

PubMed1998

Stent implantation in acute myocardial infarction using a heparin-coated stent: a pilot study as a preamble to a randomized trial comparing balloon angioplasty and stenting.

Preliminary experience with primary stenting in myocardial infarction has suggested a greater benefit in clinical outcome than has been obtained with direct balloon angioplasty. However, subacute thrombosis (SAT) remains a limitation for this new mode of therapy. In the BENESTENT II Pilot and main trials, the incidence of SAT with the heparin-coated Palmaz-Schatz stent was only 0.15%. Therefore, as a preamble to a large randomized trial, the feasibility and safety of the use of the Heparin-Coated Palmaz-Schatz trade mark Stent in Acute Myocardial Infarction (AMI) was tested in 101 patients enrolled between April and September 1996 in 18 clinical centres. In 101 stent-eligible AMI patients, as dictated by protocol, a heparin-coated stent was implanted. The primary objectives were to determine the in-hospital incidence of major adverse cardiac events (MACE: death, MI, target lesion revascularization) and bleeding complications, while the secondary objectives were the procedural success rate and the MACE, the restenosis and reocclusion rates at 6.5 months. Stent implantation (n 3 129 stents) was successful in 97 patients of the 101 who were included in this trial. During their hospital stay, two patients died and no patient experienced re-infarction, ischaemia prompting re-PTCA or CABG. Four patients suffered a bleeding complication, three major and one minor, of whom three required surgical repair. At 210 days follow-up, 81% of the patients were event free. At 6.5 months restenosis was documented in 18% of the 88 patients who underwent follow-up angiography, including three total occlusions. The results, both with respect to QCA and the occurrence of MACE, compare favourably with studies using elective stenting in both stable and unstable angina patients. As a result of this pilot study, a large randomized trial comparing direct balloon angioplasty with direct stenting in 900 patients with AMI was initiated in December 1996.

Journal Article↗

PubMed1995

A prospective randomized trial of absorbable staple fixation of skin grafts for burn wound coverage.

A prospective randomized trial of absorbable versus metal skin staples for securing skin grafts to excised burn wounds was performed in 20 patients. The absorbable staples were easy to use and efficacious in securing the skin grafts, except to edematous fatty tissue. Aesthetically, the absorbable staples yielded as good or better results when compared with metal staples resulting from a lack of tissue distortion. A decrease of 61.4 minutes of the most significantly painful portion of the postoperative dressing change (i.e., staple removal) would have been avoided by using absorbable staples. The overall cost of using the absorbable staples for small burns was comparable with metal staples; however, the cost difference was significantly greater for large burns.

Adult↗

PubMed2004

Study design for a prospective randomized trial of extracranial-intracranial bypass surgery for adults with moyamoya disease and hemorrhagic onset--the Japan Adult Moyamoya Trial Group.

This article summarizes the study design and organization of a multicenter, prospective randomized trial of extracranial-intracranial (EC-IC) bypass for treating adult patients with moyamoya disease who suffered episodes of intracranial bleeding. The Japan Adult Moyamoya Trial will determine whether the combination of EC-IC bypass with risk factor modifications affects the prognosis and the incidence of recurrent bleeding attacks. Direct bypass such as superficial temporal artery-middle cerebral artery anastomosis is essential and indirect bypass procedures alone such as encephalo-duro-arterio-synangiosis or encephalo-myo-synangiosis are not dealt with in this trial. Power calculations are based on an assumption of alpha=0.05 with an annual event rate of 8% significant morbidity and mortality per year in the non-surgical group and 4% in the surgical group. The study has an 80% rate of accuracy for detection of a 20% difference between the two groups in events in a 5-year follow up.

Adult↗

PubMed2003

Current treatment strategies in ANCA-positive renal vasculitis-lessons from European randomized trials.

Antineutrophil cytoplasmic antibody (ANCA)-positive renal vasculitis is the most common cause of rapidly progressive (crescentic) glomerulonephritis. Its life-threatening natural course may be modified substantially by current treatment modalities. The European Vasculitis Study Group (EUVAS) developed a subclassification of ANCA-positive vasculitides based on the disease severity at presentation, and have organized (so far) two waves of clinical trials. The first wave of randomized clinical trials had the aim of optimizing the existing therapeutic regimens; the second wave concentrated on testing some newer therapeutic approaches. Here, the design and available results of the first wave and the design of some second wave trials are reviewed briefly. The potential of the new targeted approaches (e.g. anti-tumour necrosis factor therapy) is also briefly mentioned.

Antibodies, Antineutrophil Cytoplasmic↗

PubMed2006

A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery.

OBJECTIVE: Although many trials have been conducted to evaluate the benefits of off-pump coronary surgery, few have concentrated on graft patency. We sought to evaluate the impact of off-pump surgery on completeness of revascularization and graft patency compared with conventional surgery. METHODS: A systematic literature search was undertaken of all randomized trials of off-pump coronary surgery in MEDLINE, EMBASE, the Cochrane Library Controlled Trials Register, the National Research Register, and abstracts from major conferences. RESULTS: In total, 132 publications were identified. From this number, we excluded 43 without a conventional surgery arm and 80 that did not evaluate graft patency. One trial was excluded for selective angiography and one abstract was excluded because of insufficient information. A total of 7 trials were eligible for overview. On initial analysis, the relative risk of graft patency in off-pump coronary surgery compared with conventional surgery was 0.959 (95% confidence interval 0.936-0.983; P = .001). The analysis was repeated after excluding one specific trial because of clinical and statistical heterogeneity (chi2(6) = 27.78; P < .001), and a relative risk of 0.953 (95% confidence interval 0.927-0.980; P = .001) was obtained with no further evidence of heterogeneity (chi2(5) = 5.35; P = .374). In 5 trials that included the mean number of grafts performed per arm, the standardized mean difference in revascularization comparing off-pump with conventional surgery was -0.164 (-0.286 to -0.043; P = .008). CONCLUSION: In a meta-analysis of randomized trials, patients undergoing off-pump coronary surgery had a lower rate of revascularization and lower graft patency than did patients undergoing conventional coronary surgery.

Coronary Artery Bypass, Off-Pump↗

PubMed1998

[Tonsillectomy by electrical dissection versus blunt dissection: a study of 838 cases (Randomized trial of 207 cases and non-randomized prospective study of 631 cases].

Tonsillectomy is one of the most common operations performed in the world and various techniques and instruments have evolved for this purpose. We report the results of two prospective studies: in the first study, blunt dissection was compared with electrodissection tonsillectomy (207 cases), and in the second study, 631 patients had their tonsils removed using only the electrodissection technique. Although electrodissection tonsillectomy is not common in Spain, in our experience it is simple, reliable and easy to learn. Its advantages include minimal bleeding, shorter operating time, and less postoperative hemorrhage. The postoperative morbidity is similar to that of blunt dissection.

Adult↗

PubMed1987

Early termination of a prospective, randomized trial comparing teicoplanin and flucloxacillin for treating severe staphylococcal infections.

In a prospective, randomized trial, teicoplanin (at a 400-mg intravenous loading dose followed by 200 mg/day intravenously or intramuscularly) was compared with flucloxacillin (8 g/day) in patients with severe staphylococcal infections. Teicoplanin proved unsatisfactory for the following reasons: failures or relapses were more frequent in the teicoplanin group, and blood levels were difficult to predict and tended to be low 24 hr after the loading dose. Future trials with this agent should use much-higher doses.

Adult↗

PubMed2002

Prospective randomized trial of lisuride infusion versus oral levodopa in patients with Parkinson's disease.

Motor complications are a major source of disability for patients with advanced Parkinson's disease. Surgical therapies provide benefit to some, but these treatments are expensive and associated with adverse effects. Current research indicates that motor complications are associated with abnormal, intermittent, pulsatile stimulation of denervated dopamine receptors using short acting dopaminergic agents such as levodopa. Retrospective studies suggest that the use of longer-acting more continuous dopaminergic therapies can improve both motor fluctuations and dyskinesia. We performed a prospective, long-term (4-year) trial comparing patients randomized to receive subcutaneous infusion of the dopamine agonist lisuride versus conventional therapy with oral levodopa and dopamine agonists. We demonstrate that patients receiving lisuride infusions experienced a significant reduction in both motor fluctuations and dyskinesia compared with patients receiving standard dopaminergic therapies. Benefits persisted for the 4-year duration of the study. Mean Unified Parkinson's Disease Rating Scale scores in "ON" and "OFF" states did not significantly change between baseline and 4 years for patients in the lisuride group, but deteriorated in patients in the levodopa group. This study indicates that continuous lisuride infusion can be beneficial for patients with advanced Parkinson's disease and reverse established motor fluctuations and dyskinesia.

Administration, Oral↗

PubMed1989

Human thrombin plus 5 per cent ethanolamine oleate injected to sclerose oesophageal varices: a prospective randomized trial.

Fifty cirrhotic Japanese patients with oesophageal varices underwent sclerotherapy in a prospective randomized trial carried out to examine the effects of human thrombin given concomitantly with the sclerosant 5 per cent ethanolamine oleate. The two groups (25 patients each) were comparable with regard to size of the oesophageal varices, and the aetiology and severity of the liver disease. Twenty-five patients, 13 and 12 in the thrombin + and - groups, respectively, had at least one episode of variceal bleeding. The remaining 25 were given prophylactic injections. There was a significantly lower rate of occurrence of bleeding from injection sites when the injection needle was removed at the initial session of sclerotherapy in the thrombin + group, where human thrombin was injected (0.2-0.3 ml, 100-150 units per injection) just before removal of the injection needle. Endoscopy at 1 week after the initial session showed a significantly (P less than 0.05) higher rate of disappearance of red colour signs on varices in the thrombin + group (96 per cent) than in the thrombin - group (72 per cent). Fibrin degradation product E-fraction (FDP-E) values increased 1 h, 1 day and 6 days after the initial session of sclerotherapy in the two groups. The rate of increase in FDP-E values 1 h after sclerotherapy was significantly larger (P less than 0.001) in the thrombin + than in the thrombin - group. There was no clinical sign of disseminated intravascular coagulation. Administration of human thrombin plus a sclerosant seems to be useful and efficacious, especially for patients with huge oesophageal varices.

Endoscopy↗

PubMed2005

Improving the quality of life of patients with prostate carcinoma: a randomized trial testing the efficacy of a nurse-driven intervention.

BACKGROUND: Treatments for clinically localized prostate carcinoma are accompanied by sexual, urinary, and bowel dysfunction and other sequelae that can result in significant distress and reduced well being. Methods capable of improving quality of life are needed that can be integrated into clinical practice. To address this need, a nurse-driven, cancer care intervention was developed and tested. METHODS: Within 6 weeks after completing treatment, 99 patients, along with their partners, were enrolled into a prospective, controlled trial and were randomized to receive the cancer care intervention or to receive standard care. Participants in the intervention arm met once each month for 6 months with an oncology nurse intervenor, who helped patients identify their quality-of-life needs using an interactive computer program. The intervener then provided education and support tailored to participants' needs. Primary outcome variables included 1) disease-specific quality of life, including sexual, urinary, and bowel outcomes and cancer worry; 2) depression; 3) dyadic adjustment; and 4) general quality of life. Outcomes data were collected prior to randomization and again at 4 months, 7 months, and 12 months posttreatment. RESULTS: Patients in the intervention arm experienced long-term improvements in quality-of-life outcomes related to sexual functioning and cancer worry compared with patients who received standard care. Baseline depression moderated the impact of the intervention on several other quality-of-life outcomes. CONCLUSIONS: The findings of the current study indicated that a computer-assisted, nurse-driven intervention was capable of providing durable improvements in the quality of life of men who underwent treatment for clinically localized prostate carcinoma.

Aged↗

PubMed1991

Weight loss in women participating in a randomized trial of low-fat diets.

We examined weight changes over 1 and 2 y in 303 women enrolled in a low-fat dietary-intervention trial. Participants were randomly assigned to an intervention group that received intensive instruction in maintaining a low-fat diet or to a control group. After 1 y intervention-group women had decreased fat intake by 45.3 g (from 39.2% to 21.6% energy from fat) and weight by 3.1 kg (all P less than 0.0001); control-group women decreased fat intake by 8.8 g (from 38.9% to 37.3% energy from fat) and weight by 0.4 kg. In both univariate analyses and multivariate models, weight loss was more strongly associated with change in percent energy from fat than with change in total energy intake. These data, which are consistent with both epidemiologic and clinical studies, suggest that body adiposity is a function both of energy balance and the proportion of energy derived from fat.

Aged↗