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Results for “Randomized trial”

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PubMed1983

Prospective, randomized trial of selective proximal vagotomy with ulcer excision and partial gastrectomy with gastroduodenostomy in the treatment of corporeal gastric ulcer.

In a prospective, randomized trial, selective proximal vagotomy with complete ulcer excision was compared with partial gastrectomy with gastroduodenostomy for the treatment of primary corporeal gastric ulcer in 30 patients. The results were evaluated by clinical follow-up examinations at regular intervals, endoscopy, and blood tests. The mean follow-up period was 3 years for both operations. There was no mortality. Postoperative complications, ulcer recurrence rates, the overall clinical results (Visick classification), and blood test results were similar in the two groups. Three of 15 selective proximal vagotomy patients were classified grade IV due to recurrent ulcer (two patients) or dumping (1 patient), and 2 of 14 partial gastrectomy patients as were classified grades III (epigastric pain) and IV (recurrent ulcer). Considering the risk for late symptoms of impaired resorption and gastric cancer after partial gastrectomy, the similar results with selective proximal vagotomy and partial gastrectomy justify further trials of selective proximal vagotomy with ulcer excision for treatment of corporeal gastric ulcer.

Antacids↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

PubMed1992

Laparoscopic versus open cholecystectomy and the need for a randomized trial: a survey of surgeons and ethical committees in the British Isles.

A questionnaire on the necessity and ethics of a randomized trial to compare laparoscopic cholecystectomy and open cholecystectomy was sent to 200 randomly selected surgeons in the British Isles, of whom 117 replied. Of these, 58% thought that a trial was needed to compare laparoscopic cholecystectomy with open cholecystectomy by either minilaparotomy or the conventional approach. Nearly half (45%) expressed interest in participating in such a trial. A hypothetical protocol for a trial was sent to 40 ethical committees; 25 gave approval and only 3 considered that a trial was unethical (12 refused to comment). This survey shows wide support for a trial comparing laparoscopic cholecystectomy with open cholecystectomy.

Attitude of Health Personnel↗

PubMed1997

Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?

Due to possible methodological and practical problems, many researchers refrain from using a randomized controlled trial design to evaluate procedures already embedded in routine health care. We performed a randomized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians. The trial started after 4 years of feedback and lasted for 2.5 years. With some adaptations a randomized trial proved to be possible. In evaluating health-care procedures that cannot be blinded in a traditional way, asking full and study-specific informed consent may conflict with the validity of the design. In such studies, an alternative procedure is to be considered. Our trial, with doctors as study subjects, was held on an already accepted routine procedure (feedback). This made it possible to refrain from obtaining study-specific informed consent. Consequently, a Hawthorne effect and contamination of the trial arms through information leakage could be avoided. Justification and general criteria for not obtaining full and study-specific informed consent are worked out. In health-care research on the performance of doctors or on interventions into the quality of care, obtaining a general informed consent in advance is an acceptable alternative approach.

Diagnostic Tests, Routine↗

PubMed2003

Unsedated ultrathin EGD is well accepted when compared with conventional sedated EGD: a multicenter randomized trial.

BACKGROUND & AIMS: In the United States, upper gastrointestinal endoscopy is usually performed using intravenous sedation. Sedation increases the rate of both complications and costs of endoscopy. Unsedated esophagogastroduodenoscopy (EGD) using conventional 8-11-mm endoscopes is an alternative to sedated endoscopy but is generally perceived as unacceptable to many American patients. Unsedated EGD using ultrathin 5-6-mm endoscopes is better tolerated. A randomized trial comparing unsedated ultrathin EGD (UT-EGD) with sedated conventional EGD (C-EGD) in a diverse American population is needed. METHODS: In this multicenter, randomized, controlled trial, 80 patients scheduled to undergo elective outpatient EGD were randomized to unsedated UT-EGD or sedated C-EGD. The study was carried out at San Francisco General Hospital, San Francisco Veterans Affairs Medical Center, and the Liver and Digestive Health Medical Clinic, San Jose. RESULTS: Baseline characteristics of patients randomized to unsedated UT-EGD and sedated C-EGD were similar. Moreover, there were no significant differences in overall patient satisfaction and willingness to repeat endoscopy in the same manner among the 2 study groups. There was, however, a significant difference in median total procedure time between the 2 study groups of 1.5 hours (P < 0.0001). The mean (+/- SD) total procedure cost was 512.4 US dollars (+/- 100.8 US dollars) for sedated C-EGD and 328.6 US dollars (+/- 70.3 US dollars) for unsedated UT-EGD (P < 0.0001). CONCLUSIONS: Patients undergoing unsedated UT-EGD are as satisfied as patients undergoing sedated C-EGD and are just as willing to repeat an unsedated UT-EGD. Unsedated UT-EGD was also faster, less costly, and may allow greater accessibility to this procedure.

Adult↗

PubMed2003

Platelet/endothelial biomarkers in depressed patients treated with the selective serotonin reuptake inhibitor sertraline after acute coronary events: the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART) Platelet Substudy.

BACKGROUND: Depression after acute coronary syndromes (ACSs) has been identified as an independent risk factor for subsequent cardiac death. Enhanced platelet activation has been hypothesized to represent 1 of the mechanisms underlying this association. Selective serotonin reuptake inhibitors (SSRIs) are known to inhibit platelet activity. Whether treatment of depressed post-ACS patients with SSRIs alters platelet function was not known. Accordingly, we serially assessed the release of established platelet/endothelial biomarkers in patients treated with sertraline vs placebo in the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART). METHODS AND RESULTS: Plasma samples (baseline, week 6, and week 16) were collected from patients randomized to sertraline (n=28) or placebo (n=36). Anticoagulants, aspirin, and ADP-receptor inhibitors were permitted in this study. Platelet factor 4, beta-thromboglobulin (betaTG), platelet/endothelial cell adhesion molecule-1, P-selectin, thromboxane B2, 6-ketoprostaglandin F1a, vascular cell adhesion molecule-1, and E-selectin were measured by ELISA. Treatment with sertraline was associated with substantially less release of platelet/endothelial biomarkers than was treatment with placebo. These differences attained statistical significance for betaTG (P=0.03) at weeks 6 and 16 and for P-selectin (P=0.04) at week 16. Repeated-measures ANOVA revealed a significant advantage for sertraline vs placebo for diminishing E-selectin and betaTG concentrations across the entire treatment period. CONCLUSIONS: Treatment with sertraline in depressed post-ACS patients is associated with reductions in platelet/endothelial activation despite coadministration of widespread antiplatelet regimens including aspirin and clopidogrel. The antiplatelet and endothelium-protective properties of SSRIs might represent an attractive additional advantage in patients with depression and comorbid coronary artery and/or cerebrovascular disease.

Biomarkers↗

PubMed2003

Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols.

BACKGROUND AND OBJECTIVE: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. DESIGN: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. SETTING: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. PATIENTS: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). INTERVENTIONS: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. MAIN OUTCOME MEASURE: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. OUTLOOK: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Acupuncture Therapy↗

PubMed1999

Statistical issues in a metaregression analysis of randomized trials: impact on the dietary sodium intake and blood pressure relationship.

In a meta-analysis of randomized trials of the effects of dietary sodium interventions on blood pressure, we found substantial heterogeneity among the studies. We were interested in evaluating whether measurement error, known to be a problem for dietary sodium measures, publication bias, or confounding factors could be responsible for the heterogeneity. A measurement error correction was developed that corrects both the slope and the intercept and takes into account the sample size of each study and the number of measurements taken on an individual. The measurement error correction had a minimal effect on the estimates, although it performed well in simulated data. A smoothed scatter plot was used to assess publication bias. Metaregressions provide a convenient way to jointly assess the effects of several factors, but care must be taken to fit an appropriate model.

Bias↗

PubMedDate not supplied

Percutaneous endoscopic gastrostomy placement without skin incision: results of a randomized trial.

BACKGROUND: During percutaneous endoscopic gastrostomy (PEG) placement, skin incision is performed as standard practice. We suspected that this time-honored principle is unnecessary. METHODS: In a prospective, randomized trial, 50 adults undergoing PEG placement were randomized to skin incision omission PEG (IOPEG) and standard PEG (SPEG). Two- and 7-day PEG site evaluations were performed to grade stomal infection, bleeding, pain, and overall satisfaction using a standardized scoring system. Median stomal evaluation scores were compared between groups using a Wilcoxon rank-sum test. Completion rates were compared using a t-test. RESULTS: Placement success for the IOPEG and SPEG technique was 22/25 (88%) and 24/25 (96%), respectively (p = NS). Three failed IOPEG attempts required an incision to complete due to increased pull force encountered. One SPEG failed due to inability to transilluminate. Stomal evaluation scores of infection, bleeding, pain, leakage, and patient satisfaction were not significantly different at 2 or 7 days. No serious complications occurred as a result of skin incision omission. CONCLUSIONS: Omitting the skin incision does not significantly alter the placement success rate, patient satisfaction, or the rate of stomal complications, thus dispelling the dogma that a skin incision is mandatory for PEG placement and the myth that incisions reduce infectious complications.

Adult↗

PubMed1991

Physicians promoting bicycle helmets for children: a randomized trial.

Head injury is the leading cause of death and serious morbidity in bicycle accidents. There is good evidence to recommend helmets, yet few children wear them. We evaluated helmet promotion in a randomized trial targeting children presenting to primary care settings for routine ambulatory care. The intervention consisted of physician counseling and take-home pamphlets. The study involved 339 families, 167 in the intervention group and 172 in the control group. In a follow-up telephone call, 2 to 3 weeks later, only 7.2% of the intervention group had purchased helmets, compared with 7.0% of the control group (chi 2 = 0.0056, P = .94). During the latter half of the study, bicycle safety received considerable media attention in Ottawa, and the provincial medical society sponsored a $5 discount campaign. Therefore both groups were subject to community "co-intervention." Nonetheless, we were surprised that physician counseling made no additional impact. Our results and the success of certain community programs suggest that physicians interested in helmet promotion would do better to participate in the design and implementation of multidisciplinary campaigns.

Adolescent↗

PubMed1993

Longterm physical training in rheumatoid arthritis. A randomized trial with different training programs and blinded observers.

The objective was to study the long-term effect (2 years) of different training programs in patients with rheumatoid arthritis. The method was a randomized trial with 75 patients participating. The measured variables included morning stiffness, a pain score, number of swollen joints, a health assessment score, a functional score, ESR, Hb, the cost of medicine, and progression using X-rays of hands and feet. The results showed no effect of training on the disease activity or on the progression of the disease. The conclusion is that although most patients are in favour of training, the present study does not support that training lessons per se affect the disease activity or the progression of the disease.

Adult↗

PubMed2006

Power and money in cluster randomized trials: when is it worth measuring a covariate?

The power to detect a treatment effect in cluster randomized trials can be increased by increasing the number of clusters. An alternative is to include covariates into the regression model that relates treatment condition to outcome. In this paper, formulae are derived in order to evaluate both strategies on basis of their costs. It is shown that the strategy that uses covariates is more cost-efficient in detecting a treatment effect when the costs to measure these covariates are small and the correlation between the covariates and outcome is sufficiently large. The minimum required correlation depends on the cluster size, and the costs to recruit a cluster and to measure the covariate, relative to the costs to recruit a person. Measuring a covariate that varies at the person level only is recommended when cluster sizes are small and the costs to recruit and measure a cluster are large. Measuring a cluster level covariate is recommended when cluster sizes are large and the costs to recruit and measure a cluster are small. An illustrative example shows the use of the formulae in a practical setting.

Child↗

PubMed1987

The ethics of randomized clinical trials.

Randomized clinical trials pose a number of fundamental ethical problems to which morally sensitive investigators must give careful consideration. The randomized double-blind clinical trial is ethically justified and the preferred method of demonstrating therapeutic effectiveness and safety. Alternate methods such as crossover and self-controlled designs, the use of historical controls, observational methods, and practitioner's clinical trials also exist and have their place in certain circumstances. The use of randomized double-blind clinical trials must assure adequate explanation of the research plan to the patient, the documentation of informed consent, adequate consideration of safety, and an acceptably low risk/benefit ratio.

Clinical Trials as Topic↗

PubMed1988

Prospective randomized trial of polytetrafluoroethylene and Dacron aortic prosthesis. I. Perioperative results.

Over a two year period 80 patients were entered into a prospective randomized trial comparing polytetrafluoroethylene (PTFE) and Dacron infrarenal aortic reconstructions. Fifty-four patients were treated for aneurysm (30 single tubed grafts; 24 bifurcation grafts), and 26 patients were treated for occlusive disease (26 bifurcation grafts). The groups were matched for age, sex and preoperative risk factors. Five patients died after operation (6.3%) including two from hemorrhage, but there were no significant differences in mortality and morbidity between the PTFE and Dacron groups. The volume of blood lost at operation (1930 +/- 1340 ml, all patients); the volume of blood transfused (2.98 +/- 2.43 units); the volume of crystalloids infused (3050 +/- 1390 ml); the intraoperative heparin dosage (67.9 +/- 20.5 mg); the clamp time (71.6 +/- 34.5 min); and the total operating time (228.1 +/- 78.3 min) also showed no significant differences between PTFE and Dacron. The ankle systolic pressure index rose more for PTFE (0.96 +/- 0.24) than for Dacron (0.82 +/- 0.20; P less than 0.002) at the time of discharge. This partially reflects a difference in the index between the groups before operation (PTFE 0.79 +/- 0.30; Dacron 0.72 +/- 0.32), but it may also indicate that PTFE is less thrombogenic than Dacron.

Aged↗

PubMed2006

Ovarian stimulation with daily late follicular phase administration of low-dose human chorionic gonadotropin for in vitro fertilization: a prospective, randomized trial.

OBJECTIVE: Evaluate the effectiveness of a new ovarian stimulation (OS) protocol before IVF. DESIGN: Prospective clinical randomized trial. SETTING: Private centers. PATIENT(S): Three hundred and twenty-three intended-to-treat women candidates for IVF. INTERVENTION(S): Patients were divided into three groups and administered the following treatments: group A, recombinant hFSH from day 3 until follicles reached 13-14 mm, when recombinant hFSH was lowered to 75 IU daily and daily injections of 200 IU of hCG and a GnRH antagonist were administered until final maturation; group B, recombinant hFSH and a GnRH antagonist; group C, recombinant hFSH and a GnRH agonist. MAIN OUTCOME MEASURE(S): Primary outcome was the number of mature oocytes. Secondary outcomes included average initial and total recombinant hFSH dosage, serum E2 level on day of ovulation, number of oocytes retrieved, fertilization, number of top-quality embryos, endometrial thickness, implantation rate, pregnancy rate (PR), and incidence of ovarian hyperstimulation syndrome (OHSS). RESULT(S): The numbers of oocytes retrieved, mature oocytes, fertilization, top-quality embryos, and embryos transferred were comparable in all groups. Implantation rate, PR, and incidence of OHSS were also comparable. The total dose of recombinant hFSH was significantly lower in group A (1,674.7 +/- 59.4 IU, vs. 2,197.9 +/- 77.8 IU in group B and 2,156.7 +/- 80.9 IU in group C). CONCLUSION(S): This new OS protocol permits follicles and oocytes to fully develop, helps generate top-quality embryos, avoids premature ovulation, establishes clinical pregnancies, reduces administration of recombinant hFSH, minimizes costs, and does not increase the chances of OHSS.

Adult↗

PubMed1994

A randomized trial of intrahepatic arterial infusion of 4'-epidoxorubicin with Lipiodol versus 4'-epidoxorubicin alone in the treatment of hepatocellular carcinoma.

We conducted a prospective randomized trial to evaluate the efficacy of Lipiodol in intrahepatic arterial infusion chemotherapy for patients with hepatocellular carcinoma (HCC). A total of 38 patients with unresectable HCCs and underlying cirrhosis were entered in this trial, and 36 of them were evaluable. Every 4 weeks, 17 patients received 70 mg of 4'-epidoxorubicin (epirubicin) alone (group A), whereas 19 patients received a Lipiodol emulsion containing the same dose of epirubicin (group B) through the hepatic artery. A tumor response (CR+PR) was observed in 12% of group A patients and in 42% of group B patients. The group B patients showed a significantly higher response rate than the group A patients. There was a tendency for an increased duration of survival (P = 0.09) in the group B patients. These results suggested that the infusion of the Lipiodol emulsion with epirubicin was more effective than epirubicin alone for the treatment of these patients with HCC.

Aged↗

PubMed2002

Surgical treatment variation in a prospective, randomized trial of chemoradiotherapy in gastric cancer: the effect of undertreatment.

BACKGROUND: Intergroup 0116 (Southwest Oncology Group 9008), a national, multicenter, two-armed, prospective, randomized trial of adjuvant postoperative chemoradiotherapy, has demonstrated significant benefit. METHODS: We prospectively captured complete surgical information, including the treatment of various lymph node stations, for 553 of the 556 eligible participants in this trial. Before any survival analysis, we coded D level by using the Japanese general rules and used the Maruyama program to estimate the likelihood of disease in undissected regional node stations, defining the sum of these estimates as the Maruyama Index of Unresected Disease (MI). We analyzed survival with Cox multivariate regression. RESULTS: Fifty-four percent of participating patients underwent D0 lymphadenectomy. The median MI was 70 (range, 0-429). In contrast to D level, MI proved to be an independent prognostic factor, even with adjustment for the potentially linked variables of T stage and number of positive nodes. We detected no significant interaction between surgical or pathologic variables and the favorable effect of adjuvant treatment, but the power to detect such interaction was generally low. CONCLUSIONS: MI, a measure of unresected regional nodal disease in gastric cancer, proved an independent predictor of survival. Surgical undertreatment, as observed in this trial, clearly undermined survival.

Chemotherapy, Adjuvant↗

PubMedDate not supplied

Increasing women's compliance with opportunistic cervical cancer screening: a randomized trial.

Our objective was to evaluate the efficacy and acceptability of two interventions designed to increase opportunistic cervical cancer screening. We designed a randomized trial of two interventions additional to usual care. We recruited 17 male general practitioners selected at random from the inner metropolitan region of Sydney, Australia. The patients were 202 women, between 20 and 65 years of age, eligible for a Pap smear. We allocated minimal and maximal interactional interventions to obtain consent for a Pap smear. Our main outcome measure was women's having a Pap smear during the consultation or within one month. We also measured acceptability of interventions to practitioners and women. These were our results: minimal: 55% of women had a Pap smear; maximal: 67% of women had a Pap smear; total when both approaches are combined: 61%. We conclude that brief advice is as effective as maximal persuasion in increasing women's compliance with opportunistic screening in routine consultations. Both interventions were acceptable to women. Practitioners preferred the minimal intervention. We demonstrate opportunistic screening is an effective and acceptable way to encourage women at risk to have a Pap smear.

Adult↗