Functional status in the treatment of heart failure by captopril: a multicentre, controlled, double-blind study in family practice.
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Aged↗
SEARCH · PubMed Health
Results for “randomized controlled trials as topic”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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The effects of education on anxiety among Chinese patients with heart disease undergoing cardiac catheterization in Hong Kong.
OBJECTIVE: To examine the effects of patient education on anxiety among Chinese patients with heart disease undergoing cardiac catheterization in Hong Kong. DESIGN: Randomized experimental design, data collected on three occasions from subjects. SETTING: A regional major hospital in Hong Kong. SUBJECTS: 62 clients who met the inclusion criteria were randomly allocated into experimental and control groups with 31 subjects in each group. INTERVENTION: Group education before cardiac catheterization. MAIN OUTCOME MEASURES: State Anxiety Inventory (STAI Form Y-1) and Knowledge about Cardiac Catheterization. RESULTS: State anxiety of all subjects reached the highest at the time just before cardiac catheterization and recorded the lowest at the time following the procedure. A lower level of anxiety was experienced by the experimental subjects who received the education intervention when compared with the control subjects who did not receive the education intervention before cardiac catheterization. CONCLUSION: The study provides initial information about anxiety reduction with education intervention among Chinese heart disease patients undergoing cardiac catheterization. It is envisaged that the study may also assist health professionals in developing and designing effective educational programmes for clients prior to cardiac catheterization.
Anxiety↗
Steroids and croup.
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Adrenal Cortex Hormones↗
[Adjuvant chemotherapy of colorectal cancer: what can be learned from meta-analysis?].
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Colorectal Neoplasms↗
Oral ganciclovir for cytomegalovirus retinitis in patients with AIDS: results of two randomized studies.
OBJECTIVE: To determine the relative effectiveness of an oral formulation compared to a standard intravenous regimen of ganciclovir in preventing the progression of cytomegalovirus (CMV) retinitis in patients with AIDS. DESIGN: Two randomized, multicenter 20-week studies of standard intravenous ganciclovir maintenance therapy compared with 3000 mg/day or oral ganciclovir. METHODS: Patients randomized to receive intravenous ganciclovir (5 mg/kg per day) or oral ganciclovir (500 mg six times a day), or to receive intravenous ganciclovir (5 mg/kg per day) or one of two regimens of oral ganciclovir (500 mg six times a day or 1000 mg three times/day). PATIENTS: AIDS patients with newly diagnosed CMV retinitis or who had CMV retinitis treated previously with intravenous ganciclovir for more than 4 weeks, but less than 4 months. MAIN OUTCOME AND MEASURE(S): Primary endpoints were times to first progression of retinitis, time to the occurrence of one or more prospectively observed, severe and dose-limiting adverse events, or 20 weeks. Visual assessments every 2 weeks included indirect ophthalmologic examination (funduscopy), photographs (bilateral, full 9- or 12-field photographs), and Snellen visual acuity assessments. RESULTS: Mean times to progression for intravenous ganciclovir by photographic assessment were 62 days and 66 days, and for oral ganciclovir mean times were 57 days and 54 days. The differences in mean time to progression (oral minus intravenous) was -5 days and -12 days. In the funduscopic assessment, both the mean time to progression and the differences in mean time to progression were longer in both treatment groups. Neutropenia was more common in the intravenous than in the oral ganciclovir treatment groups, but no significant differences were found in other laboratory parameters. CONCLUSIONS: CMV retinitis progression occurs a mean of 5-12 days sooner with oral ganciclovir than with intravenous ganciclovir maintenance treatment. Oral ganciclovir is an effective alternative to intravenous ganciclovir for maintenance therapy of CMV retinitis in patients with AIDS.
AIDS-Related Opportunistic Infections↗
Treatment of small cell lung cancer: the Copenhagen experience.
The present article is a review of recent treatment protocols for patients with small cell lung cancer (SCCL) treated in Copenhagen from 1985 to 1990. Furthermore, preliminary data on long-term survivors (> 5 years) from 9 treatment protocols since 1973 are reviewed. For 484 patients < or = 70 years old, no survival difference was observed between 2 platinum (cis-platinum or carboplatin) containing regimens, while the survival was better in these two induction regimens compared to an alternating control arm. For patients > 70 years old, Etoposide (VP-16) and Teniposide (VM-26) were compared in a randomized fashion. Both drugs were highly active, and no significant difference in activity was observed. All together 1527 patients have been included in clinical trials in the Copenhagen Lung Cancer Study Group since 1973. The rates of 5- and 10-years survivors were 3.5% and 1.8% respectively. Long-term survival can be achieved in all stages of SCCL.
Aged↗
Comparison of evidence of treatment effects in randomized and nonrandomized studies.
CONTEXT: There is substantial debate about whether the results of nonrandomized studies are consistent with the results of randomized controlled trials on the same topic. OBJECTIVES: To compare results of randomized and nonrandomized studies that evaluated medical interventions and to examine characteristics that may explain discrepancies between randomized and nonrandomized studies. DATA SOURCES: MEDLINE (1966-March 2000), the Cochrane Library (Issue 3, 2000), and major journals were searched. STUDY SELECTION: Forty-five diverse topics were identified for which both randomized trials (n = 240) and nonrandomized studies (n = 168) had been performed and had been considered in meta-analyses of binary outcomes. DATA EXTRACTION: Data on events per patient in each study arm and design and characteristics of each study considered in each meta-analysis were extracted and synthesized separately for randomized and nonrandomized studies. DATA SYNTHESIS: Very good correlation was observed between the summary odds ratios of randomized and nonrandomized studies (r = 0.75; P<.001); however, nonrandomized studies tended to show larger treatment effects (28 vs 11; P =.009). Between-study heterogeneity was frequent among randomized trials alone (23%) and very frequent among nonrandomized studies alone (41%). The summary results of the 2 types of designs differed beyond chance in 7 cases (16%). Discrepancies beyond chance were less common when only prospective studies were considered (8%). Occasional differences in sample size and timing of publication were also noted between discrepant randomized and nonrandomized studies. In 28 cases (62%), the natural logarithm of the odds ratio differed by at least 50%, and in 15 cases (33%), the odds ratio varied at least 2-fold between nonrandomized studies and randomized trials. CONCLUSIONS: Despite good correlation between randomized trials and nonrandomized studies-in particular, prospective studies-discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common.
Clinical Trials as Topic↗
Randomized controlled trials--the problem of clinical trials in veterinary science.
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Animals↗
BUCAST: another new antiviral.
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Animals↗
Intrinsic and extrinsic motivation for smoking cessation.
An intrinsic-extrinsic model of motivation for smoking cessation was evaluated with 2 samples (ns = 1.217 and 151) of smokers who requested self-help materials for smoking cessation. Exploratory and confirmatory principal components analysis on a 36-item Reasons for Quitting (RFQ) scale supported the intrinsic-extrinsic motivation distinction. A 4-factor model, with 2 intrinsic dimensions (concerns about health and desire for self-control) and 2 extrinsic dimensions (immediate reinforcement and social influence), was defined by 20 of the 36 RFQ items. The 20-item measure demonstrated moderate to high levels of internal consistency and convergent and discriminant validity. Logistic regression analyses indicated that smokers with higher levels of intrinsic relative to extrinsic motivation were more likely to achieve abstinence from smoking.
Adult↗
CREST: carotid revascularization endarterectomy versus stent trial.
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Angioplasty, Balloon↗
Effects of quetiapine and haloperidol on body mass index and glycaemic control: a long-term, randomized, controlled trial.
The topic of antipsychotic-induced weight-gain and its relationship to glucose metabolism is under-studied. We evaluated the long-term effects of a new-generation antipsychotic, quetiapine and a conventional antipsychotic, haloperidol on body mass index (BMI) and glycaemic control in patients with schizophrenia previously treated with conventional antipsychotics. Forty-five clinically stable patients with schizophrenia participated in this randomized, investigator-blinded, parallel-group comparison of flexible doses of quetiapine and haloperidol treatment over 52 wk. Primary outcome measures were change from baseline in BMI and glycosylated haemoglobin (HBA1c) levels. There were no between-group differences at any of the time-points for BMI (F = 1.90, p = 0.1) and HBA1c (F = 1.17, p = 0.3) values, and there were no significant changes in BMI from baseline for either group. HBA1c levels decreased significantly at end-point for the haloperidol group (-1.5%, p = 0.04), but not for the quetiapine group (-0.3%, p = 0.5). Although the sample was not generally obese (mean baseline BMI 25.5 +/- 6.3 kg/m2), a large proportion exhibited evidence of abnormal glycaemic control prior to randomization (mean HBA1c 6.7 +/- 1.9%), with 48% having values that were at least mildly elevated (HBA1c > 6.1%) and 19% markedly elevated (HBA1c > 7%). The number of subjects with elevated HBA1c values decreased from baseline in both the haloperidol and quetiapine treatment groups. These findings suggest that switching treatment from a conventional antipsychotic to quetiapine is not associated with weight gain or worsening of glycaemic control, even in the long term. The study also highlights the high incidence of unrecognized glucose dysregulation in patients with schizophrenia receiving conventional antipsychotic treatment.
Adolescent↗
Can the provision of information to patients with osteoarthritis improve functional status? A randomized, controlled trial.
After we assessed the functional status of 439 patients with osteoarthritis, we randomly assigned them to 1 of 3 intervention groups or to a control group. The interventions consisted of providing information, and differed only in the method of delivery: by phone, in person at the clinic, or both. Physical health improved (P = 0.02), pain was reduced (P = 0.02), and psychological health improved marginally (P = 0.10) in patients contacted by phone compared with those not contacted by phone. In those contacted only at the clinic, physical health worsened (P = 0.02), but neither pain (P = 0.80) nor psychological health (P = 0.90) differed from the values in patients not contacted at the clinic. We conclude that telephone contact is a useful intervention that can enhance the functional status of patients with osteoarthritis.
Consumer Behavior↗
New developments in medical clinical trials.
This paper reviews several new developments and long-standing good practices for conducting clinical trials. Discussion starts with the need for clear statements of study objectives, proceeds to clarify target and sample population, and elaborates on primary vs. secondary variables with the need for alpha adjustment in the presence of multiple outcomes. Here we also review the issue of surrogate endpoints. Study design issues--including blinding, randomization, and multicenter studies--come next. Then we discuss the current trend of the replacement of placebo-controlled trials by active controlled non-inferiority trials, the increasing use of Independent Data Monitoring Committees, the prominence of analysis on Intention-to-Treat samples, and the importance of imputation of missing data. We close with a brief discussion of the unit of analysis, the role of newer statistical analysis methods, safety issues, subset analysis, and, most importantly, clinical significance.
Clinical Trials Data Monitoring Committees↗
The role of diastolic blood pressure when treating isolated systolic hypertension.
OBJECTIVE: To assess the role of treated diastolic blood pressure (DBP) level in stroke, coronary heart disease (CHD), and cardiovascular disease (CVD) in patients with isolated systolic hypertension (ISH). DESIGN: An analysis of the 4736 participants in the Systolic Hypertension in the Elderly Program (SHEP) was undertaken. The SHEP was a randomized multicenter double-blind outpatient clinical trial of the impact of treating ISH in men and women aged 60 years and older. MAIN OUTCOME MEASURES: Cox proportional hazards regression analysis, with DBP and systolic blood pressure (SBP) as time-dependent covariables. RESULTS: After adjustment for the baseline risk factors of race (black vs other), sex, use of antihypertensive medication before the study, a composite variable (diabetes, previous heart attack, or stroke), age, and smoking history (ever vs never) and adjustment for the SBP as a time-dependent variable, we found, for the active treatment group only, that a decrease of 5 mm Hg in DBP increased the risk for stroke (relative risk, [RR], 1.14; 95% confidence interval [CI], 1.05-1.22), for CHD (RR, 1.08; 95% CI, 1.00-1.16), and for CVD (RR, 1.11; 95% CI, 1.05-1.16). CONCLUSIONS: Some patients with ISH may be treated to a level that uncovers subclinical disease, and some may be overtreated. Further studies need to determine whether excessively low DBP can be prevented by more careful titration of antihypertensive therapy while maintaining SBP control. It is reassuring that patients receiving treatment for ISH never perform worse than patients receiving placebo in terms of CVD events.
Aged↗
Cromolyn sodium in the management of systemic mastocytosis.
A multicenter, double-blind, placebo-controlled trial of the efficacy of oral cromolyn sodium (200 mg orally four times per day) was conducted in 11 patients with systemic mastocytosis who had been maintained with the drug on an individualized compassionate-need basis. Efficacy was measured by physician assessment of overall disease severity based on history and physical examination at specified intervals and by the average daily patient symptom diary scores for each of three mastocytosis-related symptoms that had previously appeared to be alleviated by the use of this drug. Efficacy variables were compared for a 4-week baseline period, during which patients received open-labeled cromolyn sodium, and at 4-week intervals during a 16-week period of random assignment to cromolyn sodium or placebo. Overall disease severity and symptoms recorded in patient diaries were graded on a scale of 0 (absent) to 5 (incapacitating). The average physician assessment of disease severity and symptom scores of the patients in the placebo-treated group increased significantly during the randomization phase relative to patients in the cromolyn sodium-treated group, reflecting an exacerbation of symptoms with drug withdrawal (p less than 0.05 and less than 0.028, respectively). When the symptom scores were analyzed separately for gastrointestinal manifestations of disease (diarrhea, abdominal pain, nausea, and vomiting), cromolyn sodium treatment was significantly beneficial relative to placebo (p less than 0.02), whereas the benefit for nongastrointestinal manifestations did not reach statistical significance.
Cromolyn Sodium↗
Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial.
The Cytomegalovirus Retinitis Retreatment Trial was a multicenter clinical trial designed to evaluate three treatments for the treatment of relapsed CMV retinitis; (1) foscarnet; (2) 'high-dose' ganciclovir, and (3) combination foscarnet and ganciclovir. Two hundred seventy-nine patients were enrolled and randomly assigned to one of these three regimens. Patients were followed monthly for 6 months and every 3 months thereafter. Outcomes of interest included: (1) mortality; (2) retinitis progression; (3) change in retinal area affected by CMV; (4) loss of visual field; (5) loss of visual acuity; (6) quality of life; and (7) treatment side effects.
Acquired Immunodeficiency Syndrome↗