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Results for “Randomized controlled trial”

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At least 127 records · Page 7Linked to original sources
PubMed1993

Strontium-89 as an adjuvant to external beam radiation improves pain relief and delays disease progression in advanced prostate cancer: results of a randomized controlled trial.

In a multicenter, randomized controlled trial involving 126 patients with endocrine-resistant advanced prostate cancer, all of whom received external beam radiotherapy, additional treatment with a single injected dose of 400 MBq strontium-89 (Metastron) significantly improved overall pain control. Adjuvant therapy with strontium-89 also significantly reduced analgesia requirements compared with placebo and delayed disease progression, as indicated by the requirement for further external beam radiotherapy. On certain measures, patients receiving strontium-89 also showed enhanced quality of life. Accompanying these changes, levels of prostate tumor markers were significantly reduced by strontium-89 treatment. The benefits resulting from adjuvant strontium therapy were associated with tolerable hematologic toxicity. The addition of strontium-89 to external beam radiation had no effect on survival. However, it has clear implications for improved palliation in advanced prostate cancer and may also impact positively on treatment costs.

Aged↗
PubMed1996

Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.

OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

Bibliographies as Topic↗
PubMed2000

Coordination of primary health care for back pain. A randomized controlled trial.

STUDY DESIGN: A randomized controlled trial comparing usual care with a program for the coordination of primary health care (CORE) for the treatment of subacute low-back pain patients. OBJECTIVES: To measure the effectiveness of the CORE program as a mean for implementing clinical practice guidelines for low-back pain in an urban community. SUMMARY OF BACKGROUND DATA: Clinical practice guidelines have been developed for primary care physicians and patients on the clinical management of low-back pain. The implementation of the guidelines in a large community is difficult with the multiplicity of medical and nonmedical back care providers and products. The CORE program was designed to make the guidelines fit in this complex environment. METHODS: One hundred ten workers compensated for low-back pain for 4 to 8 weeks in metropolitan Montreal were randomized in two groups: usual care (N = 56) and the CORE program (N = 54). Coordination of primary health care was performed by two primary care physicians and a nurse in liaison with the treating physicians, and included a complete examination, recommendations for the clinical management, and support to carry out the recommendations. All workers were followed for 6 months. Back pain and functional status were assessed at baseline, 3 months, and 6 months. RESULTS: In the 6-month follow-up, the CORE group returned to work 6.6 days (standard error = 8.9) quicker than the control group, a difference that was not statistically significant. However, the CORE group showed a sustained improvement in pain and functional status with two-fold differences at the end of the 6 months of follow-up. This represented nine points on the Oswestry scale (P = 0.02) and 12 points on the Quebec Back Pain Disability Scale (P = 0.01). The CORE group also used three times less specialized imaging tests of the spine at 3 months (P < 0.01) and exercised twice as much at 6 months (P < 0.05) than the controls. CONCLUSIONS: The therapeutic results for workers with low-back pain could be improved by implementing the clinical practice guidelines with primary care physicians in a large community, without delaying the return to work. The CORE intervention for back pain patients is highly relevant to primary care practice. It is simple in its application, flexible to accommodate physicians' and- patients' preferences in health care, and it is effective on patients' clinical outcome.

Adult↗
PubMedDate not supplied

Equipoise and the ethics of the Canadian Lung Volume Reduction Surgery Trial study: should there be a randomized, controlled trial to evaluate lung volume reduction surgery?

The physical improvement is so great following lung volume reduction surgery that there is growing opinion that a randomized, controlled trial is unnecessary. A randomized, controlled trial, it is argued, would deprive those patients randomly assigned to the nonsurgical treatment arm the 'benefit' of lung volume reduction surgery. Entering a trial in which one arm leads to a surgical intervention and the other to best medical management also poses a variety of ethical difficulties. If one is to be offered surgery, there must be perceived benefit because the physician has an obligation to offer the best possible treatment for his or her patient. If a patient agrees to have surgery, the expectation is that surgery would help. Thus, a patient randomly assigned to the medical arm of a trial may easily believe that he or she is being deprived of surgery that may help them. This paper illustrates this dilemma using the Canadian Lung Volume Reduction Surgery Trial. The authors discuss the concept of 'equipoise' in three dimensions, adding community equipoise to theoretical equipoise and clinical equipoise earlier described by Freedman. The paper concludes that the Canadian Lung Volume Reduction Surgery Trial needs to continue because of the clinical equipoise that drives it.

Attitude of Health Personnel↗
PubMedDate not supplied

Comparison of dietary protein with an oral, branched chain-enriched amino acid supplement in chronic portal-systemic encephalopathy: a randomized controlled trial.

A randomized study was conducted in 37 hospitalized patients at six cooperating hospitals in which protein-intolerant cirrhotic patients were fed increasing amounts of either dietary protein or a branched-chain enriched amino acid solution (BCAA) until they attained an intake of 80 gm protein per day or equivalent or until they developed stage 2 encephalopathy. All patients initially received 20 gm of dietary protein for 1 week, after which 20 gm of protein or BCAA were added weekly. Nitrogen balance improved from negative to positive in all patients in whom it was measured and increased equally in both groups. Seven of the 20 patients in the protein group and 1 of 17 in the BCAA group developed encephalopathy of stage 2 or greater (p less than 0.05). Changes in each component of the portal-systemic encephalopathy syndrome were compared, and differences were statistically significant for mental status grade (p less than 0.01), asterixis (p less than 0.05), Portal-systemic encephalopathy index (p less than 0.01), but insignificant for Number Connection Test, EEG or ammonia. Plasma amino acid profiles showed an increase in BCAA in the study group. Thus, oral BCAA supplements appear to induce positive nitrogen balance to approximately the same degree as an equivalent amount of dietary protein without inducing encephalopathy as frequently.

Adult↗
PubMed1989

On randomized controlled trials and lifestyle interventions.

Randomized controlled trials (RCT) are viewed as the ultimate method for evaluation. The author claims that RCT do not enable full evaluation of lifestyle interventions in particular. Lifestyle interventions usually affect several diseases not measured by RCTs and the people who have undergone these interventions also have an impact on the lifestyle in their immediate environment. These potential biases indicate that RCTs underestimate the value of lifestyle interventions.

Bias↗
PubMed1996

Omitting nitrous oxide in general anaesthesia: meta-analysis of intraoperative awareness and postoperative emesis in randomized controlled trials.

We have reviewed randomized controlled trials to assess the effectiveness and safety of anaesthetics which omitted nitrous oxide (N2O) to prevent postoperative nausea and vomiting (PONV). Early and late PONV (6 and 48 h after operation, respectively), and adverse effects were evaluated using the numbers-needed-to-treat (NNT) method. In 24 reports with information on 2478 patients, the mean incidence of early and late vomiting with N2O (control) was 17% and 30%, respectively. Omitting N2O significantly reduced vomiting compared with a N2O regimen; the combined NNT to prevent both early and late vomiting with a N2O-free regimen was about 13 (95% confidence intervals (CI) 9, 30). The magnitude of the effect depended on the incidence of vomiting in controls. In studies with a baseline risk higher than the mean of all reports, the NNT to prevent both early and late vomiting with a N2O-free anaesthetic was 5 (95% CI 4, 10). When the baseline risk was lower than the mean, omitting N2O did not improve outcome. Omitting N2O had no effect on complete control of emesis or nausea. The NNT for intraoperative awareness with a N2O-free anaesthetic was 46 compared with anaesthetics where N2O was used. This clinically important risk of major harm reduces the usefulness of omitting N2O to prevent postoperative emesis.

Anesthesia, General↗
PubMed2026

Effectiveness of Embedded Social Media Content on E-cigarette Attitudes and Behaviors: Results from a Randomized Control Trial.

BACKGROUND: This longitudinal randomized controlled trial examined the effects of anti-vaping social media content on e-cigarette attitudes and intentions among U.S. young adults (ages 18-24; n=3,400). METHODS: Targeted content was embedded directly into participants' social media feeds, with varying levels of impressions. RESULTS: Results indicate that increased exposure to anti-vaping messages significantly elevated perceived risk of harm (&#x3b2;=0.11, 95% CI: 0.03-0.20, p < .01) and social unacceptability of e-cigarette use (&#x3b2;=0.10, 95% CI: 0.03-0.18, p < .01), while decreasing intentions to vape (RRR = 0.59, 95% CI: 0.36-0.97, p < .05). Notably, these attitudinal shifts occurred even with relatively low ad exposure and over an extended intervention period, while controlling for the e-cigarette use status (never, former, or current) of participants. Discussion These findings support the effectiveness of digital media campaigns in influencing health-related behaviors and attitudes among young adults. Specifically, embedding anti e-cigarette content directly in the feed of young adults is shown to be effective in shifting attitudes in a space where these young adults are already engaged. Limitations include limited ad impressions and minimal change in ad awareness recall, suggesting future research should explore longer interventions and broader nicotine product messaging.

Humans↗
PubMed2026

Nurse-Led Home-Based Mobile Health Cardiac Rehabilitation Program for Patients With Chronic Heart Failure: A Randomized Controlled Trial.

This 12-week randomized controlled trial evaluated a nurse-led mHealth intervention for patients with chronic heart failure, conceptually informed by Riegel's middle-range theory of self-care of chronic illness. The program integrated wearable activity tracking with weekly nurse-led behavioral coaching, reflecting the core self-care processes of monitoring, maintenance, and management. Compared with usual care, the intervention significantly improved daily step count, 6-minute walk distance, metabolic equivalents, and left ventricular ejection fraction. Findings highlight the effectiveness of theory-informed, nurse-delivered mHealth strategies in enhancing physical activity and cardiopulmonary function, while underscoring the critical role of advanced practice nurses in home-based chronic disease management.

Aged↗
PubMed1998

Pharmacodynamic efficacy, clinical safety, and outcomes after prolonged platelet Glycoprotein IIb/IIIa receptor blockade with oral xemilofiban: results of a multicenter, placebo-controlled, randomized trial.

BACKGROUND: Parenteral administration of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor blockers can reduce ischemic complications of coronary angioplasty. Orally active GP IIb/IIIa blockers may allow more sustained receptor antagonism with the potential for long-term secondary prevention. The pharmacodynamic efficacy, clinical safety, and outcomes after prolonged receptor blockade with an orally active GP IIb/IIIa antagonist are not known. The Oral Glycoprotein IIb/IIIa Receptor Blockade to Inhibit Thrombosis (ORBIT) Trial is a multicenter, placebo-controlled, randomized trial of xemilofiban, an oral platelet GP IIb/IIIa blocking agent, administered to patients after percutaneous coronary intervention. METHODS AND RESULTS: After successful elective percutaneous coronary intervention, 549 patients were randomized to receive either placebo or xemilofiban in a dose of 15 or 20 mg. Stented patients randomized to placebo also received ticlopidine 250 mg orally BID for 4 weeks. Patients who received abciximab during the coronary intervention and who were randomized to receive xemilofiban were administered a reduced dosage (10 mg TID for 2 weeks) followed by the randomized maintenance dose of 15 or 20 mg BID for 2 more weeks. All patients received 325 mg aspirin PO QD. Ex vivo platelet aggregation in response to 20 micromol/L ADP and 4 microg/mL collagen was measured over time after the initial dose of study drug and at days 14 and 28 of long-term therapy in 230 patients. All patients were followed clinically for 90 days. Xemilofiban inhibited platelet aggregation to both ADP and collagen with peak levels of inhibition that were similar at 14 and 28 days of long-term oral therapy. Plasma levels of xemilofiban correlated with the degree of platelet inhibition. Peak platelet inhibition on day 1 correlated with the subsequent occurrence of insignificant or mild bleeding events. Although this study was not powered to evaluate differences in clinical outcomes, a trend (P=0.04) was observed for reduction of cardiovascular events at 3 months in patients not treated with abciximab who received the highest dose (20 mg) of xemilofiban studied. CONCLUSIONS: Xemilofiban inhibited platelet aggregation and was well tolerated during 28 days of long-term oral therapy. The observed trend in reduction of cardiovascular events in follow-up awaits confirmation in the larger-scale phase III study (EXCITE trial) currently in progress.

Administration, Oral↗
PubMed2001

Application of random effect ordinal regression model for outcome evaluation of two randomized controlled trials.

Cluster randomization is often used in intervention trials, yet when individuals nested within clusters are considered as the units of analysis for outcome evaluation, it cannot be assumed that the observations are statistically independent. Observations that are not statistically independent also result when repeated measures are taken over time for the same individual. Ignoring clustered observations when performing data analysis can lead to the erroneous conclusion that the intervention under study had a statistically significant effect. Moreover, individual responses are often collected on ordinal scales; thus models for continuous or categorical data are usually not appropriate. We applied a random effect ordinal regression model to data sets from two randomized controlled intervention trials that measured graded scale non-independent responses. The first trial compared two school programmes for AIDS prevention in terms of impact (i.e., changes in the frequency of condom use). The second trial used the MOS-HIV questionnaire to measure the quality of life of new AIDS cases four times over a one-year follow-up period (only results of the role-functioning scale are reported). Regarding the first data set, the effect of the intervention was not significant, and the post-intervention frequency of condom use was mainly attributable to the pre-intervention frequency (p<0.01), with no differences among schools. Regarding the second data set, a borderline significant increase in the role-functioning scale scores was observed over the follow-up period; the results differed only slightly by intervention group; a significant (p<0.01) intra-individual correlation of 0.4 was found.

Acquired Immunodeficiency Syndrome↗
PubMed2000

Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar.

We investigated the clinical effects of a food bar enriched with L-arginine and a combination of other nutrients known to enhance the activity of endothelium-derived nitric oxide (EDNO) in individuals with claudication from atherosclerotic peripheral arterial disease. The study was a 2-week, double-blind, placebo-controlled trial of subjects randomized to three groups (two active bars, one active and one placebo bar, and two placebo bars per day) followed by an 8-week open-label period. Subjects (n=41) were outpatient volunteers with intermittent claudication. Pain-free and total walking distances were measured by variable-grade, treadmill exercise testing. Quality of life was assessed using the Medical Outcome Survey (SF-36). After 2 weeks of treatment, the pain-free walking distance increased 66% while the total walking distance increased 23% in the group taking two active bars/day. The general and emotional/social functioning components of the SF-36 also improved. These effects were not observed in the one active bar/day and placebo groups. The effects were maintained after 10 weeks and, in addition, an improvement in walking distance was observed in the group taking one active bar. These findings reveal that use of a nutrient bar designed to enhance EDNO activity improves pain-free and total walking distance as well as quality of life in individuals with intermittent claudication.

Aged↗
PubMed1999

[Effectiveness of synthetic antioxidants in treatment of patients with peptic ulcer (an open randomized controlled trial)].

Two randomized groups of ulcer patients were compared. 102 patients of group 1 were treated with synthetic antioxidants (dibunol, probucol, emoxipine), while 100 patients of group 2 received a conventional treatment. Treatment results in group 1 appeared better: shortening of ulcer scarring, higher percentage of ulcer healing for 2 and 4 weeks, fall in the number of relapses during the first year of the follow-up, improvement in lipid peroxidation and antioxidant activity.

Adult↗
PubMed1997

Is there an evidence base for the practice of ENT surgery?

In order to assess the strength of the 'evidence base' for the practice of otolaryngology a review of recent journal articles was undertaken. A review of all articles published during the period 1990-1994 in five major general otolaryngology journals was performed. The articles were classified according to a standardized scheme from the abstract or, if necessary, the full paper. Papers were grouped into observational studies (descriptive or analytical, hypothesis-testing), controlled trials, randomized controlled trials, audits, non-clinical and others. One true meta-analysis was found. Randomized controlled trials comprised 0.7%-4% of articles across the journals studied; other controlled trials comprised 0.8-2%; and other analytical studies 7.6-21.9%. Very few true audits were seen. Descriptive studies were by far the commonest type of paper seen. This literature review suggests there is a poor evidence base for our specialty if one regards randomized controlled trials as the gold standard.

Animals↗
PubMed2001

Oral appliances for the management of severe snoring: a randomized controlled trial.

The aim of this randomized controlled trial was to assess the effectiveness of a mandibular advancement appliance (MAA) in managing severe snoring. Twenty-eight adults with severe snoring and normal overnight oximetry were recruited from sleep disorder clinics. A maxillary placebo appliance and a MAA were worn by each subject for a period of 4-6 weeks each. Questionnaires at baseline and after each appliance period assessed bed partners' reports of snoring severity (loudness and number of nights per week), and patients' records of daytime sleepiness. Twenty-five subjects completed the entire trial. The MAA was significantly more effective than the placebo in reducing the frequency and loudness of snoring, the reported daytime sleepiness and the frequency of morning tiredness. Excessive salivation was the most commonly reported complication. It was concluded that the custom-made MAA was significantly more effective than the placebo in managing the main symptoms of severe snoring. However, not all subjects' partners reported an improvement with the MAA, with 84 per cent reporting a reduction in snoring loudness and 76 per cent reporting snoring on fewer nights per week.

Adult↗
PubMed1998

Effect of two training regimens on bone mineral density in healthy perimenopausal women: a randomized controlled trial.

The aim of this randomized controlled trial was to evaluate the effects of 18 months of calisthenics and endurance training regimens on bone mineral density (BMD) in perimenopausal women. Clinically healthy sedentary female volunteers (n = 105) aged 52-53 years were randomly assigned to a calisthenics (n = 36), endurance (n = 34), or control (n = 35) group. The calisthenics training (2.6 times per week on average, 50 minutes per session) consisted of rhythmic strength-endurance exercises by large muscle groups, and the endurance training (3.2 times per week, 50 minutes) consisted of walking, stair climbing, ergometer cycling, and jogging at a controlled heart rate zone corresponding to 55-75% of the individual maximal oxygen uptake (VO2max) of the subjects. The control subjects performed a light stretching program once a week The BMD of the lumbar spine (L2-L4), right femoral neck, calcaneus, and distal radius was measured by dual-energy X-ray absorptiometry at 0, 4, 8, 10, 14, and 18 months, and the maximal isometric strength during trunk extension and flexion, leg extension, and arm flexion and the VO2max by ergospirometry were evaluated at 0, 8, 10, and 18 months of intervention. The VO2max improved significantly (p = 0.021) in the endurance group. The linear trend of the femoral neck BMD in the endurance group, as determined by generalized linear models, was significantly different (p = 0.043) from that of the control group, the trend indicating a maintenance of the prestudy BMD. In the calisthenics group, the training effect was not significant. However, the distal radius BMD of the endurance group showed a significant negative trend (p = 0.006). These results suggest that multiexercise endurance training maintains the BMD the clinically important femoral neck of perimenopausal women. This form of endurance training proved also to be feasible for healthy perimenopausal women.

Absorptiometry, Photon↗