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Results for “Randomized trial”

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PubMed1997

A randomized trial of cardiovascular risk factor reduction: patterns of attrition after randomization and during follow-up.

BACKGROUND: The Preventive Cardiology Center compared two intensities of behavior modification for cardiovascular disease (CVD) risk factors in persons at risk and their families. Characteristics of drop-outs both before and after intervention were compared with subjects who completed the 6-month trial. METHODS: A total of 333 individuals of all ages were enrolled in the study and randomly assigned by family to a single-session ('skills' group-low-intensity) or a five-session ('practice' group-high intensity) intervention. Baseline and follow-up assessments included a personal and family health questionnaire, nutritional intake survey, and clinic visit to obtain blood pressure, lipids, and height and weight data. RESULTS: Two hundred and forty adults over 18 years of age were randomly assigned to one of the two intervention groups. Of these, 68 subjects (28.3%) did not participate in the intervention. Multivariate analysis revealed that these 'early drop-outs' were significantly more likely to be non-white and to have had a lower LDL cholesterol. Of the 172 subjects attending the intervention, 70 (40.7%) did not attend the 6-month follow-up ('late drop-outs'). Multivariate analysis revealed that, compared with follow-up attendees, non-attendees were significantly more likely to be white and to be current smokers. CONCLUSIONS: Both early and late drop-outs in a randomized trial of CVD risk reduction were significantly different than continuing participants in several key factors. These differences suggest the use of caution in both interpreting and making generalizations about behavioral trials of risk factor reduction when attrition is high.

Adolescent↗

PubMed1998

Overview of randomized trials in laparoscopic inguinal hernia repair.

There are more than 20 randomized trials that compare laparoscopic with open hernia repair. Results of these show a longer operating time, less postoperative pain, a faster return to normal activity, and increased costs for laparoscopic over open hernia repair. Recurrence rates are lower for laparoscopic compared with open nonmesh repairs.

Hernia, Inguinal↗

PubMed2006

Estimates of intraclass correlation coefficient and design effect for surveys and cluster randomized trials on injection use in Pakistan and developing countries.

BACKGROUND: To assess injection practices and to test interventions aimed at reducing unsafe injections in developing countries, cluster surveys and cluster randomized trials are needed. The design of cluster-based studies requires estimates of intraclass correlation coefficients that have to be obtained from previous studies. This study presents such estimates. METHODS: Data were derived from a cross-sectional study of injection use and health seeking in Pakistan that used 34 clusters to select 1150 study subjects aged > or =3 months. We analysed variance to separate its components. RESULTS: Most of intraclass correlation coefficients were in the range of 0.01-0.05. For proportion of injections received during last 3 months, mean number of injections received and health seeking during the past 3 months the intraclass correlation coefficients were 0.02, 0.04 and 0.02, respectively. CONCLUSION: These estimates can be useful in designing cluster surveys and cluster randomized trials for injection safety in Pakistan and other developing countries.

Adolescent↗

PubMed2006

Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial.

In a prospective randomized study, we found that the addition of a preoperative duplex scan before varicose vein (VV) surgery reduced recurrences and reoperations after 2 years. The aim of the present study was to investigate whether this correlates with an improved quality of life (QoL). We studied 293 patients scheduled for VV surgery with or without preoperative duplex. QoL was assessed preoperatively at 1 month, 1 year, and 2 years with the Short Form-36 (SF-36). Scores were compared with matched reference groups from the Swedish population. The 237 complete responders (81%) had a mean age of 47 (range 22-73) years, 169 (71%) were women, and 43 (18%) had skin changes. Both groups of VV patients scored significantly worse than the reference group in the domain Bodily Pain preoperatively (p < 0.001) and better after 1 year (p = 0.04), with no difference found after 2 years. There was no significant difference in QoL between the duplex and control groups at any time. We conclude that preoperative duplex before VV surgery did not significantly improve QoL after 2 years in spite of improved surgical results. VV surgery per se improved QoL as measured with the SF-36.

Adult↗

PubMed1992

Hepatic arterial infusion of floxuridine in patients with liver metastases from colorectal carcinoma: long-term results of a prospective randomized trial.

PURPOSE: A multicentric randomized study that compared patients who received intrahepatic arterial infusion (HAI) to a group of patients who did not receive HAI (control group) was performed for unresectable hepatic metastases from primary colorectal carcinoma. PATIENTS AND METHODS: One hundred sixty-six patients were assigned randomly to HAI of floxuridine (5 fluoro-2'deoxyuridine [FUDR]) 0.3 mg/kg/d for 14 days every 4 weeks or to the control group; this latter group, depending on the investigator's choice, was either under observation or received systemic fluorouracil (5-FU). The same regimen of systemic 5-FU also was administered to the HAI group in the event of extrahepatic progression. No crossover from the control group to the HAI group was permitted. The mean duration of follow-up was 54 months (range, 31 to 72), and 163 patients were analyzed. RESULTS: A significant improvement was observed in the survival rate for the 81 patients assigned to HAI group (P less than .02) with a 1-year survival rate of 64% versus 44% in the control group (82 patients). The 2-year survival rate was 23% versus 13%. The median survival was 15 months versus 11 months for the HAI group and the control group, respectively. Survival was better for patients with a less than 30% liver involvement, and for those treated in more specialized centers. The hepatotoxic effects of HAI were observed in 47 patients (chemical hepatitis [n = 28], and biliary sclerosis [n = 19]). The 1-year rate of sclerosing cholangitis was equal to 25%. Gastrointestinal toxicity was infrequent and consisted of gastritis or diarrhea. CONCLUSIONS: Therapy with HAI of FUDR improves the survival of patients with liver metastases over colorectal carcinoma. However, the methods that are used to diminish the toxicity of HAI and efficient systemic chemotherapy, such as a combination of 5-FU and leucovorin, are required to prevent extrahepatic metastases.

Colorectal Neoplasms↗

PubMed2004

Transurethral holmium laser enucleation of the prostate compared with transvesical open prostatectomy: 18-month follow-up of a randomized trial.

PURPOSE: This ongoing randomized study aims to find out whether transurethral holmium laser enucleation of the prostate (HoLEP) could be an alternative to open transvesical prostatectomy in patients with prostates >100 g. PATIENTS AND METHODS: A series of 120 urodynamically obstructed patients were randomized to HoLEP or open prostatectomy, 60 patients to each group. The HoLEP was performed with high-powered Ho:YAG lasers at 80 to 100 W (2.0 J, 40-50 Hz) and 550-nm bare laser fibers. The American Urological Association Symptom Scores, peak urinary flow rates, and postvoiding residual urine volumes were evaluated preoperatively and at 1, 3, 6, 12, and 18 months postoperatively. All complications were noted. RESULTS: By the Mann-Whitney test, there was no significant difference between the HoLEP and open surgery groups in patient age (69.0 years HoLEP v 71.0 years open surgery), prostate volume (115 cc [range 100-230 cc] v 113 cc [100-230 cc], or weight of resected tissue (94 g [range 57-220 g] v 96 g [range 61-220 g]). There were significant differences in the mean operative time (136 v 91 minutes; P< 0.0001), mean hemoglobin loss (1.9 v 2.8 g/dL; P< 0.0001), median catheter time (1 day v 6 days; P< 0.0001), and median hospital stay (2 days v 10 days; P< 0.0001). Both HoLEP and open prostatectomy resulted in pronounced and lasting postoperative improvements in Symptom Scores, peak urinary flow rates, and postvoiding residual volumes (P< 0.0001). The differences between HoLEP and open prostatectomy were not significant at any interval for any parameter. Blood transfusions were required in 0 HoLEP patients v 8 open surgery patients. Arterial bleeding occurred in three patients in each group. Secondary apical resection was required in two HoLEP patients and no open surgery patients. Bladder neck contracture occurred in none of the HoLEP patients and two of those having open surgery. Thus, the total number of patients having complications was 7 with HoLEP and 13 with open surgery. There were no deaths in either group. CONCLUSIONS: The HoLEP appears to be an endourologic alternative to open surgical enucleation of the prostate for large glands. It entails significantly less blood loss and a much shorter catheter time and hospital stay. The perioperative outcome strongly favors the holmium procedure. The rate of late complications is equally low with each procedure. The postoperative micturition improvement was significant and lasting and was equivalent in the two groups.

Aged↗

PubMed1988

The failure of antimotion sickness medication to improve reading in developmental dyslexia: results of a randomized trial.

Although there have been no randomized clinical trials of the efficacy of antimotion sickness medication treatment of developmental dyslexia, some children are treated in this way. We have performed two evaluations of such treatments. In Experiment 1, 12 children participated in a double-blind within-subject crossover design to test the acute (2-day) administration of four preparations: 10 mg methylphenidate, 12.5 mg meclizine, both methylphenidate and meclizine, or placebo. Improvements obtained with each drug were scattered across measures of reading fluency, balance and coordination, and eye movements, suggesting that a chronic trial would be justified. In Experiment 2, six children from Experiment 1 received 12.5 mg meclizine b.i.d. for 3 months and placebo for 3 months in a double-blind within-subject crossover design. Meclizine had no effect on reading, but it significantly improved ocular motor stability during steady fixation. This study thus failed to support the hypothesis that meclizine is of benefit in developmental dyslexia.

Child↗

PubMed2006

A randomized trial of a brief mental health intervention for primary care patients.

This randomized trial is a first evaluation of a brief psychotherapeutic intervention for primary care patients. Sixty-two participants were randomly assigned to the intervention or to treatment as usual. As compared with treatment as usual, the intervention led to significant reductions in symptoms of anxiety and depression. The reduction was maintained for 3 months after the end of treatment, but some return of symptoms occurred by 6 months after treatment. The treatment was well accepted by patients. This study provides good preliminary evidence for the effectiveness of this intervention.

Adult↗

PubMed2007

Developments in cluster randomized trials and Statistics in Medicine.

The design and analysis of cluster randomized trials has been a recurrent theme in Statistics in Medicine since the early volumes. In celebration of 25 years of Statistics in Medicine, this paper reviews recent developments, particularly those that featured in the journal. Issues in design such as sample size calculations, matched paired designs, cohort versus cross-sectional designs, and practical design problems are covered. Developments in analysis include modification of robust methods to cope with small numbers of clusters, generalized estimation equations, population averaged and cluster specific models. Finally, issues on presenting data, some other clustering issues and the general problem of evaluating complex interventions are briefly mentioned.

Bayes Theorem↗

PubMed1991

[Comparison of three different fractionations in radiotherapy for esophageal carcinoma--a prospective randomized trial on 80 patients].

A prospective randomized clinical trial on three different kinds of fractionation in radiotherapy for 80 patients with esophageal carcinoma was carried out from March 1987 to September 1987. The fractionation schemes were: Group A- routine fractionation; Group B- accelerated hyperfractionation with twice-a-day irradiation; and Group C- accelerated hyperfractionation with three-times-a-day irradiation. The 2-year survival rates of the respective groups were: Group A- 18.5% (5/27); Group B- 44.4% (12/27); and Group C- 26.9% (7/26). The difference in survivals was statistically significant between Groups B and C (P less than 0.05) but not between Groups A and C (P greater than 0.05). Though with limited duration of follow-up, the authors prefer the twice-a-day accelerated hyperfractionation scheme for esophageal carcinoma.

Adult↗

PubMed1995

A prospective, randomized trial of sclerotherapy versus ligation in the management of bleeding esophageal varices.

We conducted a prospective, randomized trial comparing sclerotherapy and ligation in 120 patients with acute bleeding of esophageal varices. All the patients were cirrhotic, 59 received sclerotherapy, and 61 received ligation. Treatment was repeated regularly until the varices were obliterated. The mean follow-up period was 295 +/- 120 days and 310 +/- 105 days for the sclerotherapy and ligation groups, respectively. The control of active bleeding was 12/15 (80%) in the sclerotherapy group and 18/19 (94%) in the ligation group (P = .23). The numbers of treatment sessions required to achieve variceal obliteration were 6.5 +/- 1.2 in the sclerotherapy group and 3.8 +/- 0.4 in the ligation group (P < .001). Recurrent bleeding from the gastrointestinal tract was 51% in the sclerotherapy group compared with 33% in the ligation group (P < .05). Recurrent bleeding from esophageal varices was 36% in the sclerotherapy group and 11% in the ligation group (P < .01). However, bleeding from ectopic varices and congestive gastropathy was less common in the sclerotherapy group (7%) than in the ligation group (18%) (P = .05). Significant complications were encountered in 19% of the sclerotherapy group and in 3.3% of the ligation group (P < .01). Comparison of Kaplan-Meier estimates of time to death of both groups showed a significantly lower mortality in the ligation group (P = .011). Both sclerotherapy and ligation can effectively arrest active bleeding from esophageal varices. However, ligation is more effective than sclerotherapy in decreasing the risk of rebleeding from esophageal varices with fewer complications. Ligation can also achieve obliteration of esophageal varices more rapidly than sclerotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1997

[Clinical efficacy of post-TUR prophylactic chemotherapy for superficial bladder cancer--the result of co-operative prospective randomized trial].

We have performed a prospective randomized clinical trial of post-operative prophylactic therapy for superficial bladder cancer since October in 1991. The criteria were as follows; age < or = 80 y.o., Ta/T1, TCC G1/G2, without CIS lesion and resectable cancer by TUR. The therapeutic arm was divided into three as follows: arm A intracystic instillation with Epirubicin; arm B: oral administration with 5-FU; arm C: combination of arm A and arm B. The number of registered patients were 20 in arm A, 18 in arm B, and 18 in arm C. The patient characteristics in every group were not significantly different. The prophylactic efficacy of arm A was superior to that in the other two groups.

Administration, Intravesical↗

PubMed1997

Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients' self-ratings?

The assessment of physical symptoms is a key component of quality of life studies in palliative care, but is often hampered by missing data from patient-completed questionnaires. In two large multicentre randomized trials of palliative treatment conducted by the Medical Research Council Lung Cancer Working Party, Involving over 700 patients, patients completed Rotterdam Symptom Checklists and doctors reported on eleven of the same physical symptoms at each assessment, using the same 4-point severity scale. Ratings by doctors and patients were compared with respect to compliance, severity, and outcomes for the respective trials. Doctors provided more data than patients: 66% vs. 52% in the first 6 months in one trial, 58% vs. 61% in the other. Comparisons of over 33,000 symptom assessments showed 78% complete agreement between doctor and patient, 18% disagreement by one, 4% two, and 1% three grades (complete disagreement). There was no change in levels of agreement over time, but increasing disagreement with increasing symptom severity, and a consistent bias towards doctors underestimating severity. Nevertheless, the two methods of data collection resulted in similar between-treatment conclusions. Therefore, in randomized trials the doctors' assessments of key physical symptoms may be sufficient for the between-treatment comparison. However, the fact that doctors underestimate symptom severity 15% of the time has important implications for palliative interventions.

Attitude of Health Personnel↗

PubMed1995

Prospective randomized trials on cytoreduction in ovarian cancer.

Ovarian cancer remains the main cause of death from gynaecological malignancy in England and Wales. Since the reports by Griffiths et al. in the 1970s that optimal cytoreduction to less than or equal to 1.5 cm is associated with an increase in survival there has been a gradual trend towards more radical surgery aimed at maximal tumour reduction. Since these first reports many others have made similar observations, so that now maximal surgical endeavour aimed at cytoreduction is almost standard practice. However, the majority of these reports are based on retrospective analysis, small numbers, poor standardization of treatment and other methodological inconsistencies. To date, no prospective randomized trials have been completed to confirm Griffiths's findings. The authors propose the case for a randomized trial before accepting a new and potentially morbid procedure as standard practice.

Female↗

PubMed1988

Cardiac rehabilitation after myocardial infarction. Combined experience of randomized clinical trials.

Randomized clinical trials of cardiac rehabilitation following myocardial infarction have typically demonstrated a lower mortality in treated patients, but with a statistically significant reduction in only one trial. To overcome the problem of not being able to detect small but clinically important benefits in mortality in randomized clinical trials of exercise and risk factor rehabilitation after myocardial infarction with small numbers of patients, we carried out a meta-analysis on the combined results of ten randomized clinical trials that included 4347 patients (control, 2145 patients; rehabilitation, 2202 patients). The pooled odds ratios of 0.76 (95% confidence intervals, 0.63 to 0.92) for all-cause death and of 0.75 (95% confidence intervals, 0.62 to 0.93) for cardiovascular death were significantly lower in the rehabilitation group than in the control group, with no significant difference for nonfatal recurrent myocardial infarction. These results suggest that, for appropriately selected patients, comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infarction.

Aged↗

PubMed2006

A randomized trial of teaching clinical skills using virtual and live standardized patients.

BACKGROUND: We developed computer-based virtual patient (VP) cases to complement an interactive continuing medical education (CME) course that emphasizes skills practice using standardized patients (SP). Virtual patient simulations have the significant advantages of requiring fewer personnel and resources, being accessible at any time, and being highly standardized. Little is known about the educational effectiveness of these new resources. We conducted a randomized trial to assess the educational effectiveness of VPs and SPs in teaching clinical skills. OBJECTIVE: To determine the effectiveness of VP cases when compared with live SP cases in improving clinical skills and knowledge. DESIGN: Randomized trial. PARTICIPANTS: Fifty-five health care providers (registered nurses 45%, physicians 15%, other provider types 40%) who attended a CME program. INTERVENTIONS: Participants were randomized to receive either 4 live cases (n=32) or 2 live and 2 virtual cases (n=23). Other aspects of the course were identical for both groups. RESULTS: Participants in both groups were equivalent with respect to pre-post workshop improvement in comfort level (P=.66) and preparedness to respond (P=.61), to screen (P=.79), and to care (P=.055) for patients using the skills taught. There was no difference in subjective ratings of effectiveness of the VPs and SPs by participants who experienced both (P=.79). Improvement in diagnostic abilities were equivalent in groups who experienced cases either live or virtually. CONCLUSIONS: Improvements in performance and diagnostic ability were equivalent between the groups and participants rated VP and SP cases equally. Including well-designed VPs has a potentially powerful and efficient place in clinical skills training for practicing health care workers.

Adult↗

PubMed1990

Randomized trial of Dilapan and Laminaria as cervical ripening agents before induction of labor.

A randomized trial was conducted to evaluate the comparative effectiveness of Dilapan cervical dilators and Laminaria japonicum as cervical ripening agents before induction of labor at term. Patients with Bishop scores of 4 or less and a fetal or maternal indication for induction at 34 or more weeks' gestation were eligible for the study. The outcome variables of interest were Bishop score upon removal of the devices, number of devices used, induction-to-delivery time, and induction-to-complete dilatation time. In the Dilapan group, an average of 4.3 devices per patient was used, compared with 9.7 devices in the laminaria group (P less than .01). Among patients who eventually achieved complete dilatation, the mean (+/- SD) time for the Dilapan group was 10.8 +/- 6.1 hours, compared with 14.7 +/- 9.2 hours with laminaria. For women undergoing induction of labor at term with an unripe cervix, Dilapan appeared to be a preferable alternative to Laminaria japonicum because its use may result in a shorter induction-to-delivery interval with fewer devices required to obtain significant cervical ripening.

Adult↗

PubMed1997

Surgery in primary supratentorial intracerebral hematoma: a meta-analysis of randomized trials.

OBJECTIVES: To examine through a meta-analysis whether a treatment strategy of surgery plus the routine medical management saves lives and reduces disability in survivors of primary supratentorial intracerebral hematoma compared to routine medical management alone. MATERIAL AND METHODS: Computerized bibliographic search of published research, conference proceedings, monographs and experts yielded 373 articles, of which only four were randomized trials. The methodological quality of the trials was assessed by two observers (weighted kappa = 0.8). Two independent reviewers abstracted the data on patient sample, type of surgery and outcomes in terms of death and dependence versus independence. Based on the nature of the intervention and the results of test for homogeneity, we analyzed the results of craniotomy and endoscopic evacuation separately. RESULTS: Review of the three trials of craniotomy suggests that it increases the risk of death or dependence (pooled risk difference 13%, 95% CI 3% to 23%), though the study with the largest sample size was conducted in the pre-CT period. Reanalysis of the endoscopic evacuation trial data showed decrease in risk of death or dependence (risk difference -18%, 95% CI -36% to 0%), the effect being similar across the different subgroups of patients according to the site of hematoma, but probably larger in patients aged less than 60 years or hematoma size of more than 50 cc. CONCLUSIONS: The role of craniotomy and stereotactic surgery has not been adequately studied in randomized trials. The results of a single trial suggest that endoscopic evacuation is a promising form of treatment in patients with primary supratentorial intracerebral hematoma, but this finding needs confirmation in a larger trial.

Activities of Daily Living↗