PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomized controlled trials”

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.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,099 records · Page 61Linked to original sources
PubMed1984

The evaluation of low dose pre-operative X-ray therapy in the management of operable rectal cancer; results of a randomly controlled trial.

824 patients with operable rectal carcinoma were randomly allocated to be treated by surgery alone, 2000 rad in 10 daily fractions and 500 rad as a single fraction. No difference has been demonstrated in the actuarial survival rates to 5 years. The local recurrence-free and metastasis-free rates are similar in all groups. There is also no evidence that the pre-operative radiotherapy benefited patients in subgroups by Dukes' stage. The complication rates were also similar in the three treatment groups.

Clinical Trials as Topic↗
PubMed2003

Outpatient, sequential, parenteral-oral antibiotic therapy for lower risk febrile neutropenia in children with malignant disease: a single-center, randomized, controlled trial in Argentina.

BACKGROUND: Recent reports and previous randomized trials conducted at the authors' institution suggested that children with lower risk febrile neutropenic (LRFN) may benefit from substitution of oral antibiotic therapy for parenteral therapy. The objective of this study was to determine the efficacy of parenteral-oral outpatient therapy in the management of children with LRFN who were receiving treatment for malignant disease. METHODS: From August 2000 to April 2002, 135 children with a median age of 7.5 years (range, 1.6-15.8 years) who had a total of 177 episodes of LRFN were included in a prospective, randomized, single-institution trial. Children with LRFN received a single dose of ceftriaxone and amikacin and completed a risk-assessment work-up. All patients were discharged immediately and, at 24 hours, were allocated randomly to two groups: Group A (89 episodes) received oral ciprofloxacin, and Group B (88 episodes) received intravenous ceftriaxone. RESULTS: Most patients (61% in Group A and 51% in Group B) were receiving treatment for leukemia (P value not significant [NS]). Twenty-eight children (31%) in Group A and 22 children (25%) in Group B displayed unexplained fever (P value NS). No significant differences in sites of initial infection were found between the two groups. The median duration of neutropenia was 4.2 days and 4.7 days for Group A and Group B, respectively (P value NS); the median duration of fever was 2.3 days and 2.6 days, respectively (P value NS); and the median duration of antibiotic treatment was 4.5 days and 4.8 days, respectively (P value NS). The overall results of the study were excellent. Only four treatment failures in Group A (5%) and 6 treatment failures in Group B (7%) were observed. These patients were readmitted to the hospital and did well with appropriate treatment. CONCLUSIONS: In children with LRFN who are receiving treatment for malignant disease, outpatient oral ciprofloxacin after 24 hours of a single dose of intravenous ceftriaxone and amikacin was as safe and efficacious as parenteral ceftriaxone. Outpatient management and early antibiotic withdrawal were safe for both groups.

Administration, Oral↗
PubMed1991

The effect of dietary supplementation with vitamins A, C and E on cell-mediated immune function in elderly long-stay patients: a randomized controlled trial.

Thirty elderly long-stay patients were randomly allocated to receive either placebo or dietary supplementation with vitamins A, C and E for 28 days. Nutritional status and cell-mediated immune function were assessed before and after the period of supplementation. Following vitamin supplementation, cell-mediated immune function improved as indicated by a significant increase in the absolute number of T cells (p less than 0.05), T4 subsets (p less than 0.05), T4 to T8 ratio (p less than 0.01) and the proliferation of lymphocytes in response to phytohaemagglutinin (p less than 0.01). In contrast, no significant changes were noted in the immune function of the placebo group. We conclude that supplementation with the dietary antioxidants vitamins A, C and E can improve aspects of cell-mediated immune function in elderly long-stay patients.

Aged↗
PubMed2003

A randomized controlled trial of a patient-accessible electronic medical record.

Legal and technologic trends are making medical records more patient-accessible. The Health Insurance Portability and Accountability Act (HIPAA) stipulates that "patients must be able to see and get copies of their records, and request amendments." Medical records are more commonly being stored in electronically, and methods have been developed to share these records with patients in a secure format.1,2 Previous studies of patient-accessible medical records generally only provided limited exposure to the medical record and lacked controls for bias and confounding.3 We performed a 12-month randomized controlled trial of a patient-accessible medical record to further assess the effects of such a program.

Health Status↗
PubMed2000

Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia.

BACKGROUND: Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial. METHODS AND RESULTS: A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3)). CONCLUSIONS: Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible.

Blood Flow Velocity↗
PubMed1984

Impact of randomized controlled trials on the progress of therapy in cardiovascular diseases.

The relationship between randomized controlled trials (RCTs) and progress in therapy is a major concern for sponsors, public health authorities, investigators and patients. At present, only indirect approaches can provide insights into the relationship. Few studies have addressed this problem. From available evidence, it seems unlikely that RCTs have played a significant role in developing more appropriate therapies for cardiovascular diseases. Several reasons might explain this unexpected situation: poor application and lack of understanding of the methodology of RCTs, as well as inadequacies of the doctors' information system, are the leading ones.

Cardiovascular Agents↗
PubMed1982

A randomized controlled trial of complete bed rest versus ambulation in the management of proteinuric hypertension during pregnancy.

Forty patients participated in a randomized controlled trial of complete bed rest versus ambulation as desired in the management of proteinuric hypertension during pregnancy. Daily increases in serum human placental lactogen and oestriol concentrations were greater in the rested group. An especially 'at risk' group of 10 patients with both hyperuricaemia and severe fetal growth retardation was identified. Strict confinement to bed in these cases seemed to encourage the development of the premonitory symptoms of eclampsia, but was associated with a better prognosis for the fetus.

Adult↗
PubMed2006

Validity of the impact factor of journals as a measure of randomized controlled trial quality.

OBJECTIVE: To assess whether the impact factor, a measure of the frequency with which journal articles are cited in the scientific literature, is a proxy measure of the quality of articles reporting the results of randomized controlled trials. METHOD: The quality of trials included in an ongoing Cochrane review concerned with the antidepressant fluoxetine was assessed using the Cochrane Collaboration Depression, Anxiety, and Neurosis quality assessment instrument, the Jadad scale, and the quality criterion of the Cochrane Collaboration Handbook. Journal impact factors were extracted from the Journal Citation Report. RESULTS: A total of 131 articles reported results from 132 clinical trials comparing fluoxetine with other antidepressants. The relationship between trial quality and the impact factor of journals where these studies were published, stratified by period of publication, revealed that journals with impact factors above 4 points published only trials with above-average overall quality ratings, while journals with impact factors below 4 points published both high- and low-quality trials. The Jadad scale revealed similar quality in trials published in journals with high, medium, and low impact factors (Pearson chi(2) = 0.298, p = .861), and the quality criterion of the Cochrane Collaboration Handbook showed unclear randomization in the majority of trials and in all 15 trials published in high-impact factor journals (Pearson chi(2) = 4.678, p = .096). CONCLUSION: The impact factor of journals is not a valid measure of randomized controlled trial quality.

Bibliometrics↗
PubMed1997

Comparison of carotid endarterectomy outcomes from randomized controlled trials and Medicare administrative databases.

OBJECTIVE: To compare the characteristics and outcomes demonstrated for participants in randomized controlled trials of carotid endarterectomy with those of the Medicare patient population who received the procedure in 1989. DESIGN: Historical cohort study using Medicare claims data. SETTING: Medicare beneficiary population aged 65 years and older. PATIENTS: Medicare patients 65 years and older who received carotid endarterectomy during 1989. MAIN OUTCOME MEASURES: Perioperative mortality rate and occurrence of transient ischemic attack, stroke, and death within 2 years of surgery. RESULTS: The risk for death within 2 years of the procedure was substantially higher among Medicare patients who received surgery in hospitals with perioperative mortality rates greater than rates demonstrated in the trials (odds ratio, 1.36; 95% confidence interval, 1.29-1.44) and among those with comorbidity that exceeded trial participation criteria (odds ratio, 1.72; 95% confidence interval, 1.64-1.84). CONCLUSIONS: Although carotid endarterectomy trials demonstrate the efficacy of the procedure, this evidence only applies to patients and hospitals with characteristics comparable to those of the trial participants. The importance of this consideration is demonstrated by the substantially higher odds of death experienced among Medicare patients receiving the procedure who had a level of comorbidity that exceeded that of the trial participants or who received their surgery in a hospital with a perioperative mortality rate that exceeded the experience of the hospitals in the trials.

Aged↗
PubMed2026

Adductor Canal Block and Local Anesthetic Versus Local Anesthetic Alone in ACL Reconstruction: A Double-Blind Randomized Controlled Trial.

BACKGROUND: Effective postoperative analgesia is crucial for early recovery after anterior cruciate ligament reconstruction (ACLR). Local infiltration analgesia (LIA) and adductor canal block (ACB) are common regional techniques, but their combined efficacy remains unclear. PURPOSE: To compare the effectiveness of LIA alone versus LIA combined with ACB in patients undergoing ACLR, with primary outcomes including postoperative opioid consumption and quadriceps function. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A double-blind randomized controlled trial enrolled 100 patients undergoing ACLR under general anesthesia. Patients were randomized into 2 groups: LIA + sham (saline injection) (n = 50) and LIA + ACB (n = 50). The primary outcome was postoperative opioid consumption in the first 24 hours. Secondary outcomes included visual analog scale (VAS) pain score, quadriceps function assessed by straight leg raise (SLR) at 3 hours, Quality of Recovery-15 (QoR-15) score, and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week. Statistical analysis was performed using t tests and chi-square tests with a P value <.05 considered significant. RESULTS: There was no significant difference in 24-hour opioid consumption between the LIA + ACB and LIA-only groups (P = .109). Similarly, VAS pain scores at 24 hours postoperatively showed no significant differences between the groups (P = .0804). Early functional recovery, assessed by SLR performance at 3 hours, was equivalent between groups (P = .6711). Additionally, QoR-15 scores on postoperative day 1 and KOOS values at 1 week demonstrated no significant differences (P = .6486 and P = .9054, respectively). Intraoperative opioid consumption was not different between the groups (P = .127). CONCLUSION: These findings indicate that the addition of ACB to LIA does not yield postoperative analgesic in ACLR. Consequently, LIA alone suffices for routine ACLR, potentially enabling clinicians to optimize perioperative workflows without incurring the additional time, financial burden, and resources associated with routine ACB administration. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04721119.

Humans↗
PubMed2005

A systematic review of trial methodology, using the placebo groups of randomized controlled trials in paediatric postoperative pain.

Trial methodology was evaluated in paediatric analgesic studies. Databases were searched for randomised, placebo controlled studies of systemic paracetamol, NSAIDs and opioids administered for acute postoperative pain in children. Eighty-three studies met the inclusion criteria and 40 were included for the analysis. Analgesics were administered for established postoperative pain in two studies only. In all other studies they were administered in a prophylactic manner. As study design and sensitivity are particularly demanding in studies using pre-emptive dosing of analgesics, the placebo groups were analysed for issues of study sensitivity. Postoperative pain outcomes included pain scores in 34, rescue analgesia in 36, time to first rescue analgesia in 15, pain on activity in eight, number of patients with pain in six, pain relief in three, global efficacy rating in two and analgesic consumption via PCA in four studies. Twenty of 36 studies reported criteria for rescue analgesia that varied from 20 to 77% of the maximum pain intensity. Need of rescue analgesia showed more often differences between study groups than time to first rescue analgesia or pain intensity. Rescue analgesia was administered to 21-100% of the patients in the placebo groups where no other analgesics were given perioperatively. Most patients in the placebo groups had pain that was greater than 30% of the maximum. In conclusion, analysis of the methodology showed several aspects of trial design that can be improved in future studies. Placebo control groups can be used in paediatric analgesic studies to demonstrate internal sensitivity.

Analgesia, Patient-Controlled↗
PubMed2003

A meta-analysis of randomized controlled trials evaluating the efficacy of epinephrine for the treatment of acute viral bronchiolitis.

BACKGROUND: Controversy exists surrounding the use of bronchodilators for bronchiolitis. Epinephrine hydrochloride is being used with increasing frequency in this group; however, its efficacy has not been systematically reviewed. OBJECTIVE: To systematically review randomized controlled trials comparing inhaled or systemic epinephrine vs placebo or other bronchodilators. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, primary authors, and reference lists. STUDY SELECTION: Studies were included if they (1) were randomized, controlled trials; (2) involved children 2 years or younger with bronchiolitis; and (3) presented quantitative outcomes. DATA EXTRACTION: Two reviewers independently extracted data and assessed study quality. DATA SYNTHESIS: We included 14 studies (7 inpatient, 6 outpatient, and 1 patient status unknown). Thirteen of forty-five comparisons were significant. Among outpatients, results favored epinephrine compared with placebo for clinical score at 60 minutes (standardized mean difference [SMD], -0.81; 95% confidence interval [CI], -1.56 to -0.07), oxygen saturation at 30 minutes (weighted mean difference [WMD], 2.79; 95% CI, 1.50-4.08), respiratory rate at 30 minutes (WMD, -4.54; 95% CI, -8.89 to -0.19), and improvement (odds ratio, 25.06; 95% CI, 4.95-126.91); among inpatients, for clinical score at 60 minutes (SMD, -0.52; 95% CI, -1.00 to -0.03). Among outpatients, results favored epinephrine compared with albuterol sulfate (salbutamol) for oxygen saturation at 60 minutes (WMD, 1.91; 95% CI, 0.38-3.44), heart rate at 90 minutes (WMD, -14.00; 95% CI, -22.95 to -5.05), respiratory rate at 60 minutes (WMD, -7.76; 95% CI, -11.35 to -4.17), and improvement (odds ratio, 4.51; 95% CI, 1.93-10.53); among inpatients, respiratory rate at 30 minutes (WMD, -5.12; 95% CI, -6.83 to -3.41). CONCLUSIONS: Epinephrine may be favorable compared with placebo and albuterol for short-term benefits among outpatients. There is insufficient evidence to support the use of epinephrine among inpatients. Large, multicentered trials are required before routine use among outpatients can be strongly recommended.

Acute Disease↗
PubMed1993

Multicenter randomized, controlled trial of a preterm birth prevention program. Collaborative Group on Preterm Birth Prevention.

OBJECTIVE: The results of a randomized, controlled trial of a preterm birth prevention program at five centers with primarily low-income populations are presented. STUDY DESIGN: Pregnant women at high risk for preterm labor were independently randomized into intervention and control groups at each of five centers (2395 women). Specially trained staff instructed women in the intervention group to recognize early signs of preterm labor and to notify the staff should any sign of preterm labor occur, and women came in weekly for pelvic examinations after 20 to 24 weeks' gestation. Because the intervention had very different and contrary effects on preterm birth rates across these sites, the analysis focused on patient risks and on measures of the process of care as possible explanations for the differences in outcomes. RESULTS: The observed spontaneous preterm birth rates, when averaged for all sites, were not lower in the intervention group than in the control groups (16.1% vs 15.4% for < 37 completed weeks' gestation, 11.9% vs 10.9% for < 36 completed weeks). There was substantial heterogeneity of program effects between centers (p < 0.01 for homogeneity test statistic). The differences in intervention effects between centers were explainable only in part by patient risk characteristics (p < 0.10 for homogeneity test statistic). The only intermediate measure of the process of care that tended to differentiate among sites with positive intervention effects was the rate of hospital admission for preterm labor. Sites with elevated admission rates in the intervention group versus the control group tended to have negative intervention effects on outcomes. CONCLUSION: Because the preterm birth prevention program did not show a reliable benefit and because the reasons for varied outcomes are not understood, the use of the program cannot be recommended for predominantly low-income populations.

Female↗
PubMed2006

Quality of randomized controlled trials reporting in the primary treatment of brain tumors.

PURPOSE: To assess the reporting quality of randomized controlled trials (RCTs) in the primary treatment of brain tumors and to identify significant predictors of quality. PATIENTS AND METHODS: Two investigators searched MEDLINE, EMBASE, and bibliographies of retrieved articles for RCTs in the primary treatment of brain tumors published between January 1990 and December 2004. We assessed the quality of overall reporting and key methodologic factors reporting (allocation concealment, blinding, and intention to treat [ITT]). Two investigators also rated articles independently using items from the revised Consolidated Standards of Reporting Trials statement. A generalized estimated equation was used to generate regression models that identified significant factors associated with quality of reporting. RESULTS: We retrieved 74 relevant RCTs that randomly assigned 14,498 brain tumor patients. The quality of overall reporting has improved during the last 15 years, but eight of the 15 methodologic items were reported in less than 50% of trials. In the appraisal of the reporting quality of key methodologies, allocation concealment, blinding, and adherence to the ITT principle were reported in less than 30% of articles. Multivariable regression models revealed that an impact factor more than 1.66, publication after 1995, and sample size more than 280 were significant factors associated with better overall reporting, whereas complete industrial funding, impact factors more than 2.64, and positive primary outcomes were predictors of higher ratings of the three most important methodologic qualities. CONCLUSION: Despite improvement in general reporting quality, key methodologies that safeguard against biases may still benefit from better description. Significant factors associated with better reporting may act as surrogates for other characteristics.

Brain Neoplasms↗
PubMed2005

Postoperative adjuvant therapy with tamoxifen, tegafur plus uracil, or both in women with node-negative breast cancer: a pooled analysis of six randomized controlled trials.

PURPOSE: This article reports the results of a pooled analysis of six randomized trials conducted to study the efficacy of uracil and tegafur (UFT) in the adjuvant treatment of node-negative breast cancer patients. PATIENTS AND METHODS: Six randomized controlled trials on node-negative breast cancer patients were conducted from 1992 through 1995 in Japan that included the three, three-arm trials (control [no adjuvant], UFT, and tamoxifen [TAM] groups) and the three, four-arm trials (control, UFT, TAM, and UFT plus TAM groups). Pooled analysis was performed on the data obtained from these six trials (involving 2,934 patients). RESULTS: Overall survival was compared between the UFT group (including both the UFT group and the TAM plus UFT group) and the non-UFT group (control group and TAM group). A significant difference (P = .04) was observed in 5-year survival rates between the UFT (95.9%) and the non-UFT (94.0%) groups. Overall survival was also compared between the TAM group (TAM group and TAM plus UFT group) and the non-TAM group (control group plus UFT group). The 5-year survival rate (95.2%) in the TAM group was not significantly different from that (93.9%) in the non-TAM group, but the subset analysis showed a significant (P = .01) improvement in the estrogen receptor-positive subset. CONCLUSION: Adjuvant UFT improves the overall survival of node-negative breast cancer patients. Given that UFT has milder adverse effects, it is suggested that UFT can be a useful alternative to doxorubicin and cyclophosphamide, or cyclophosphamide, methotrexate, and fluorouracil in the adjuvant treatment for node-negative breast cancer.

Aged↗
PubMed2003

Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus.

OBJECTIVE: To appraise systematically the study design and quality of reporting of randomized controlled trials (RCT) on systemic lupus erythematosus (SLE) and to identify potential defects and biases. METHODS: RCT with at least 5 patients with SLE were retrieved from MEDLINE, EMBASE, and the Cochrane Library. We analyzed study design, quality of reporting, and trial results. RESULTS: Ninety-four trial reports (37 on lupus nephritis) were eligible with 2,257 SLE patients (n = 795 in lupus nephritis trials). Median sample size was 28 patients. Fifty-one trials (54.3%) were double blind, but only 31 (33.0%) mentioned the randomization mode, only 19 (20.2%) described allocation concealment, and only 7 (7.5%) were adequately powered. Sixty-three trials (67%) described adequately reasons for withdrawals. Nephritis trials had on average longer followup (p = 0.001) and were less likely to be double blind (p < 0.001), to describe reasons for withdrawals [both overall (p = 0.008) and per arm (p = 0.009)] and to involve a comparison against placebo or no treatment (p < 0.001). Larger trials scored higher on several quality characteristics. Significant efficacy or trend for efficacy was claimed in 72 reports (76.6%) and this was even more common in trials published in 1999-2002 (89.5%). Significant efficacy was found more frequently in trials that clearly specified withdrawals per arm (p = 0.001) and outcomes (p = 0.001) and used intention-to-treat analyses (p = 0.03). Besides outcome specification, no other quality variables seemed to improve significantly over time. CONCLUSION: Several aspects of the design and reporting of RCT on SLE can be improved. Larger, adequately powered, and accurately reported trials are needed.

Bias↗
PubMed2005

Nurse follow-up of patients with diabetes: randomized controlled trial.

AIM: This paper reports a study comparing the outcomes of diabetic patients undergoing either early discharge or routine care. BACKGROUND: The hospital is not the best place to monitor the glycaemic control of patients with diabetes with no other morbidity or complications. It is an unnatural environment in which diet is planned and the activity level is low. The hospital is also an expensive place in which to treat patients. METHODS: This randomized controlled trial was conducted in the medical department of a regional hospital in Hong Kong. A total of 101 patients who needed glycaemic monitoring, but who were otherwise fit for discharge, were recruited. The control group continued to receive routine hospital care. The study group was discharged early and received a follow-up programme which included a weekly or biweekly telephone call from a nurse. FINDINGS: When compared with the control group, the study group had a greater decrease in HbA1c at 24 weeks, although the statistical difference was marginal (7.6 vs. 8.1, P = 0.06), a higher blood monitoring adherence score at both 12 weeks (5.4 vs. 3.6, P < 0.001) and 24 weeks (5.3 vs. 3.5, P < 0.001), and a higher exercise adherence score at 12 weeks (5.3 vs. 3.4, P = 0.001) and 24 weeks (5.5 vs. 3.2, P < 0.001). The study group had a shorter hospital stay (2.2 vs. 5.9, P < 0.001), and the net savings were HK$11,888 per patient. CONCLUSION: It is feasible to integrate treatment into the real life environments of patients with diabetes, and nurse-led transitional care is a practical and cost-effective model. Nurse follow-up is effective in maintaining optimal glycaemic control and enhancing adherence to health behaviours. Management of glycaemic control is better done in the community than in the hospital.

Adult↗