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Results for “Randomized controlled trials”

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At least 793 records · Page 44Linked to original sources
PubMed1998

The adequacy of reporting randomized, controlled trials in the evaluation of antidepressants.

OBJECTIVE: To evaluate the adequacy of the reports of methodological and statistical aspects of randomized, controlled trials that evaluate antidepressant medications and the degree to which their results can be used in subsequent metaanalyses. DATA SOURCES: Randomized, controlled trials published in English that compared 2 antidepressant drugs with a placebo were reviewed. Papers were located using Medline and reference lists. DATA EXTRACTION: Each paper was evaluated using a checklist, and 3 summary criteria scores were derived: minimal, ideal, and overall. RESULTS: Only 9 of the 69 papers met the minimal criteria to be included in a metaanalysis (which would report the final sample size and an estimate of the mean and of the standard deviation); and 0 met all of the ideal criteria for reporting clinical trials. Out of a possible 100 points, the mean score for the articles was 51, and the highest score was 80. Scores were not related to the citation impact factor of the journal in which they appeared. CONCLUSIONS: Researchers must become more aware of the criteria for reporting clinical trials, and editors must insist more strenuously that these criteria be satisfied.

Antidepressive Agents↗
PubMedDate not supplied

Usefulness of the minute ventilation test in predicting successful extubation in newborn infants: a randomized controlled trial.

OBJECTIVE: We performed a prospective, randomized clinical trial to compare the usefulness of the minute ventilation test (MVT) with clinical judgement in predicting readiness for extubation in preterm newborns with respiratory distress syndrome requiring surfactant therapy and mechanical ventilation. STUDY DESIGN: A total of 42 preterm infants with respiratory distress syndrome were randomized when they reached preselected ventilator settings. The primary outcome measure was the time from study entry to extubation, provided the infant remained extubated for at least 24 hours. RESULTS: Infants evaluated by the MVT were extubated in a significantly shorter period of time (mean of 8 hours) than those evaluated clinically (mean of 36 hours). The extubation failure rate was similar in the two groups. CONCLUSION: The MVT is an easily performed objective measure that can be used to predict readiness for extubation in preterm infants. In this study, it significantly shortened the time for extubation and was not associated with a higher rate of reintubation.

Device Removal↗
PubMed1991

Clinical usefulness of amitriptyline in fibromyalgia: the results of 23 N-of-1 randomized controlled trials.

Twenty-three double blind, randomized, multiple crossover trials (N-of-1 RCT) of amitriptyline were conducted in patients with fibromyalgia. The benefit of amitriptyline was assessed using a symptom questionnaire and count of tender points. To assess the usefulness of the method, the proportion of trials that provided a definite answer was examined. Completing the trial resulted in reaching a high degree of confidence in the final management decision in 74% of trials. In 35% of trials, results led to discontinuation of the drug which otherwise would have been continued indefinitely. The drug benefit, if present, was evident within first 2 weeks of therapy. We concluded that these results support the feasibility and usefulness of N-of-1 RCT in rheumatology practice.

Adult↗
PubMed2002

Anticoagulation with prostaglandins and unfractionated heparin during continuous venovenous haemofiltration: a randomized controlled trial.

BACKGROUND: The objective of this prospective, randomized, controlled clinical study was to compare efficacy, safety, and costs of fixed-dose prostaglandins with adjusted-dose unfractionated heparin as anticoagulants for continuous venovenous haemofiltration. PATIENTS AND METHODS: Perioperative critically ill patients requiring continuous haemofiltration for acute renal failure received unfractionated heparin anticoagulation titrated to achieve an activated clotting time in the extracorporeal system of > 120 s. Patients were randomly assigned to receive a test infusion containing either prostaglandin I2 (5 ng/kg/min; group I; n = 15; 75 filters), prostaglandin E1 (5 ng/kg/min; group E; n = 18; 72 filters), or placebo (group H; n = 17; 63 filters). Heparin and test solutions were infused into the extracorporeal circuit before the haemofilter. All AN69-surface hollow fiber filters were primed with normal saline containing 5.000 IU heparin. RESULTS: The primary outcome measure--adequate haemofilter life span > 24 h--was compared by using Cochran's Q test. There was a significant difference in the frequencies of adequate haemofilter life span between the groups (36% group H, 65% group I, 59% group E; P < 0.05 versus group H). There were 6 bleeding episodes in group H, 2 in group E, and only 1 trivial bleeding episode in group I (P < 0.05 versus group H). Daily costs of haemofiltration were 61% higher in group I and 23% higher in group E than in group H (P < 0.05 versus group H). A heparin-sparing effect of prostaglandins was observed. CONCLUSIONS: Fixed-dose prostaglandins I2 and E1 reduced the incidence of haemofilter failure and bleeding when compared with adjusted-dose unfractionated heparin. There was no significant difference between the two prostaglandin groups. The increase in daily costs for haemofiltration treatment under prostaglandins is not clinically relevant.

Acute Kidney Injury↗
PubMed1989

Preterm birth prevention: evaluation of a prospective controlled randomized trial.

Over a 3-year period 5457 indigent patients were scored for risk of preterm birth and 4595 women were delivered at greater than or equal to 20 weeks' gestation. Patients at high risk (18.1%) were randomized into control and intervention groups. The latter group received weekly cervical examinations and instruction regarding subtle symptoms and signs of preterm labor. Medical providers received similar instruction. There was no difference in preterm births between control and intervention groups (20.8% vs. 22.1%). Medical providers, convinced of preterm birth prevention during year 1 of the study, defeated the study design by giving preterm birth precautions to all patients. In turn, preterm births decreased from 13.7% (year 1) to 9.3% (year 2, p less than 0.001) and remained stable in year 3 (8.7%). Preterm births during year 1 and the 8 months preceding year 1 were not different. Significant differences in preterm births between private and indigent study patients during these two periods (p less than 0.001) disappeared during years 2 and 3 of the study.

Clinical Trials as Topic↗
PubMed2003

A randomized controlled trial of blood flow and stenosis surveillance of hemodialysis grafts.

BACKGROUND: It is widely accepted that hemodialysis graft surveillance combined with correction of stenosis reduces thrombosis and prolongs graft survival. Nevertheless, few randomized controlled trials have evaluated this approach. METHODS: In this randomized controlled trial, 101 patients were assigned to control, flow (Qa), or stenosis groups, and were followed for up to 28 months. All patients had monthly Qa measured by ultrasound dilution and quarterly percent stenosis measured by duplex ultrasound. Referral for angiography was based on the following criteria: (1) control group (N = 34), clinical criteria; (2) flow group (N = 32), Qa <600 mL/min or clinical criteria; and (3) stenosis group (N = 35), stenosis>50% or clinical criteria. Stenosis >or=50% during angiography was corrected by preemptive percutaneous transluminal angioplasty (PTA). RESULTS: The preemptive PTA rate in the control group (0.22/patient year) was two thirds the rate in the flow group (0.34/patient year), and was highest in the stenosis group (0.65/patient year, P < 0.01). The percentage of grafts that thrombosed was similar in the control (47%) and flow groups (53%), but reduced in the stenosis group (29%, P = 0.10). Two-year graft survival was similar in the control (62%), flow (60%), and stenosis groups (64%) (P = 0.89). CONCLUSION: Qa and stenosis surveillance were not associated with improved graft survival, although thrombosis was reduced in the stenosis group. The most important factors in this result may be that monthly Qa and quarterly stenosis measurements were not accurate or timely indicators of risk of thrombosis or progressive stenosis. This study does not support the concept that Qa or stenosis surveillance are superior to aggressive clinical monitoring.

Angioplasty, Balloon↗
PubMed2005

(Cost)-effectiveness of case-management by district nurses among primary informal caregivers of older adults with dementia symptoms and the older adults who receive informal care: design of a randomized controlled trial [ISCRTN83135728].

BACKGROUND: Dementia is an incurable disease with devastating consequences for both patients and their relatives. The objective of this study is to describe the study protocol of a randomized controlled trial with assignment to either usual care or case-management by district nurses, among informal caregivers of older adults with dementia symptoms who live at home and the older adults who receive informal care. METHODS/DESIGN: In this randomized controlled trial, effectiveness as well as cost-effectiveness of case-management is evaluated. It concerns case-management in early-detected patients with dementia symptoms and their primary informal caregivers. Participants are followed up to twelve months after baseline assessment. The main outcome measure of the effect evaluation is the caregiver's sense of competence to care for the older person with dementia symptoms. The economic evaluation is performed from a societal perspective. DISCUSSION: This is one of the first trials on case-management that includes an economic evaluation. In addition, it concerns a tailor-made intervention in early-detected patients with dementia symptoms and their caregivers. The results of this randomized controlled trial will provide valuable information for health professionals and policy makers on effectiveness and cost-effectiveness of early tailor-made case-management for patients and their informal caregivers. Moreover, positive effects will challenge current health care systems to move to more pro-active approaches for this group.

Aged↗
PubMed1997

Multidisciplinary rehabilitation for chronic back pain in an outpatient setting: a controlled randomized trial.

Based on existing models for pain chronicity and effective treatment strategies for patients with chronic low back pain, a multidisciplinary rehabilitation programme for an outpatient group setting was developed. The main treatment components address the patient's physical functional capacity (functional restoring), cognitive and affective processes (pain management strategies), and behavioural and ergonomical aspects (back school elements). Short-term (immediately after intervention) and long-term effects (at 6-months follow-up) of the intervention were assessed in a randomized controlled study. Dependent variables were pain measures, functional capacity, disability, muscular strength and endurance, pain and posture-related self-efficacy, attitudes, depression, well-being, behavioural habits and posture assessed by a standardized behavioural observation method. Immediately after the intervention, patients in the treatment group (n=36) showed significant improvement over patients in the control group (n=29) in all variables except depression and muscular strength and endurance. At 6-months follow-up, compared to pretreatment scores, patients continued to show beneficial effects in pain intensity and frequency, posture, posture-related self-efficacy and well-being. In contrast to post-treatment results, there were also significant improvements in strength and endurance. Overall results testify to the effectiveness of the intervention programme. Future studies (with larger sample sizes) should aim at a further improvement of functional capacity and disability perception, an analysis of differential treatment effects, and strategies for an improved long-term maintenance of the changes induced by the programme.

Clinical Trial↗
PubMed2004

De novo femoropopliteal stenoses: endovascular gamma irradiation following angioplasty--angiographic and clinical follow-up in a prospective randomized controlled trial.

PURPOSE: To assess and report the follow-up results of a randomized controlled trial on centered endovascular gamma irradiation performed after percutaneous transluminal angioplasty (PTA) for de novo femoropopliteal stenoses. MATERIALS AND METHODS: Thirty patients who underwent PTA for de novo femoropopliteal stenoses were randomly assigned to undergo 14-Gy centered endovascular irradiation (irradiation group, n = 15) or no irradiation (control group, n = 15). Intraarterial angiography was performed 6, 12, and 24 months after treatment; duplex ultrasonography (US), the day before and after PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Treadmill tests and interviews were performed the day before PTA and 1, 3, 6, 9, 12, 18, and 24 months later. Results of angiography, duplex US, treadmill tests, and interviews were evaluated with the nonpaired t or the Fisher exact test. RESULTS: Baseline characteristics did not differ significantly between the two groups. Mean absolute individual changes in degree of stenosis, compared with the degrees of stenosis shortly after PTA, in the irradiation group versus in the control group were -10.6% +/- 22.3 versus 39.6% +/- 24.6 (P <.001) at 6 months, -2.0% +/- 34.2 versus 40.6% +/- 32.6 (P =.002) at 12 months, and 7.4% +/- 43.2 versus 37.7% +/- 34.5 (P =.043) at 24 months. The rates of target lesion restenosis at 6 (P =.006) and 12 (P =.042) months were significantly lower in the irradiation group. The numbers of target lesion re-treatments were similar between the groups, but target vessel re-treatments were more frequent in the irradiation group. There were no significant differences in interview or treadmill test results between the two groups at t test analysis. CONCLUSION: The degree of stenosis was significantly reduced 6, 12, and 24 months after angioplasty of de novo femoropopliteal stenoses in the patients who underwent endovascular irradiation.

Aged↗
PubMed2006

Self-management versus conventional management of oral anticoagulant therapy: A randomized, controlled trial.

BACKGROUND: The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management. METHODS: This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints - assessed in per-protocol analyses - were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement. RESULTS: There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p=0.09). Self-management was significantly better (0.16 vs. 0.24, p=0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p=0.14) using self-management. CONCLUSION: The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.

Journal Article↗
PubMed1998

Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial.

OBJECTIVES: The effectiveness of an exercise intervention for people in early and midstage Parkinson's disease (stages 2 and 3 of Hoehn and Yahr) in improving spinal flexibility and physical performance in a sample of community-dwelling older people is described. DESIGN AND SETTING: Fifty-one men and women, aged 55-84 years, identified through advertisement, local support groups, and local neurologists were enrolled into a randomized, controlled trial. Subjects were assigned randomly to an intervention or a usual care arm (i.e., no specific exercise). Of the original 51 participants, 46 completed the randomized, controlled trial. Participants in the exercise arm (n = 23) received individual instruction three times per week for 10 weeks. Participants in the usual care arm (n = 23) were "wait listed" for intervention. MEASUREMENTS: Changes over 10 weeks in spinal flexibility (i.e., functional axial rotation) and physical performance (i.e., functional reach, timed supine to stand) were the primary outcome measures. RESULTS: MANOVA conducted for the three primary outcome variables demonstrated significant differences (P < or = .05) between the two groups. Further analysis using ANOVA demonstrated significant differences between groups in functional axial rotation and functional reach for the intervention compared with the control group. There was no significant difference in supine to sit time. CONCLUSION: Study results demonstrate that improvements in axial mobility and physical performance can be achieved with a 10-week exercise program for people in the early and midstages of PD.

Aged↗
PubMed1995

Temporomandibular disorders after early Class II treatment with bionators and headgears: results from a randomized controlled trial.

Symptoms and signs of temporomandibular disorders were assessed in children enrolled in a randomized controlled trial of early treatment for Class II malocclusion. Children (mean age of 9.8 years) were assigned to a treatment protocol (bionator, n = 60; observation, n = 60; headgear/bite plane, n = 71) using randomized block stratification. Temporomandibular joint (TMJ) sounds, joint capsule pain to palpation, and muscle pain to palpation were scored as binary responses (present/absent in a subject). Determinations were made by blinded, calibrated examiners initially (DC1) and after a Class I molar correction was achieved or 2 years had elapsed (DC3). Univariate relationships among explanatory factors (group assignment, gender, age, time interval between DC1 and DC3, Class II severity, mandibular plane angle, preparatory treatment, whether Class I molar relation was achieved) and binary responses were explored using Chi square tables and ANOVA methods. Logistic regression modeled the relationship between binary responses and the explanatory variables. At DC1, the 3 groups were equivalent in the explanatory variables (P > .05). Subjects with a TMJ sound, joint pain, and/or muscle pain at follow-up were more likely those who had the sign at baseline (P < .01). Early treatment with bionators and headgear/bite planes did not place healthy children without these signs at risk for developing these signs. Only increasing age (for the development of sounds, P < .04) and failure to achieve a Class I molar relation (for development of muscle pain, P < .04) placed sign-free children at greater risk. Subjects with TMJ pain at baseline were 7 times more likely to have pain at follow-up if they had been treated with a headgear/bite plane or observed than if they had been treated with a bionator (P = .007). We conclude that an immediate benefit or risk for children receiving early Class II treatment with bionators and headgear/bite planes with respect to temporomandibular joint function does not exist with the prospect that Class II children with TMJ capsule pain may benefit from bionator therapy.

Activator Appliances↗
PubMed2001

Monitoring of psychological well-being in outpatients with diabetes: effects on mood, HbA(1c), and the patient's evaluation of the quality of diabetes care: a randomized controlled trial.

OBJECTIVE: To investigate whether monitoring and discussing psychological well-being in outpatients with diabetes improves mood, glycemic control, and the patient's evaluation of the quality of diabetes care. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of 461 outpatients with diabetes who were randomly assigned to standard care or to the monitoring condition. In the latter group, the diabetes nurse specialist assessed and discussed psychological well-being with the patient (with an interval of 6 months) in addition to standard care. The computerized Well-being Questionnaire was used for this purpose. Primary outcomes were mood, HbA(1c), and the patient's evaluation of the quality of diabetes care at 1-year follow-up. The number of referrals to the psychologist was analyzed as a secondary outcome. Intention-to-treat analysis was used. RESULTS: The monitoring group reported better mood compared with the standard care group, as indicated by significantly lower negative well-being and significantly higher levels of energy, higher general well-being, better mental health, and a more positive evaluation of the quality of the emotional support received from the diabetes nurse. The two groups did not differ for HbA(1c) or in their overall evaluation of the quality of diabetes care. In the monitoring condition, significantly more subjects were referred to the psychologist. CONCLUSIONS: Monitoring and discussing psychological well-being as part of routine diabetes outpatient care had favorable effects on the mood of patients but did not affect their HbA(1c). Our results support the recommendation to monitor psychological well-being in patients with diabetes.

Adult↗
PubMed1997

A prospective randomized controlled trial of oral ciprofloxacin in acute ulcerative colitis.

OBJECTIVES: The aim of this prospective, randomized, controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis. METHODS: Seventy consecutive patients with mild (n = 37) or moderately active (n = 33) ulcerative colitis were randomized to receive oral ciprofloxacin (250 mg b.i.d., n = 34) or placebo (n = 36) for 14 days. In addition, they were given oral prednisolone (initial dose 20 or 40 mg for mild and moderately active ulcerative colitis, respectively) and rectal betamethasone enemas (2 g at night) for 7-9 weeks. All patients were receiving olsalazine (0.5 g twice daily). At study entry, the groups were similar with respect to age, sex, extent, duration, and severity of disease, and previous treatments. Patients were assessed clinically, endoscopically, and histologically before, at the end of the trial (day 14), and on completion of steroid treatment, or at any time worsening of symptoms or a complication of ulcerative colitis occurred. RESULTS: At the end of the study, 24 patients (70.5%) in the ciprofloxacin group and 26 patients (72%) in the placebo group achieved remission (p > 0.1, Yates chi 2). Ten patients in each group necessitated higher doses of oral (n = 12) or intravenous (n = 8) steroids. Of the latter patients, two underwent emergency colectomy without perioperative deaths. Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment. CONCLUSIONS: A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission.

Acute Disease↗
PubMed2006

Two-year internet-based randomized controlled trial for weight loss in African-American girls.

OBJECTIVE: A randomized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention. RESEARCH METHODS AND PROCEDURES: Fifty-seven overweight (mean BMI percentile, 98.3) African-American girls (mean age, 13.2 years) were randomly assigned to an interactive behavioral internet program or an internet health education program, the control condition. Overweight parents were also participants in the study. Forty adolescent-parent dyads (70%) completed the 2-year trial. Outcome data including BMI, body weight, body composition, and weight loss behaviors were collected at baseline and at 6-month intervals. A computer server tracked use of the web sites. RESULTS: An intention-to-treat statistical approach was used, with the last observation carried forward. In comparison with the control condition, adolescents in the behavioral program lost more mean body fat (BF) (-1.12 +/- 0.47% vs. 0.43 +/- 0.47% BF, p < 0.05), and parents in the behavioral program lost significantly more mean body weight (-2.43 +/- 0.66 vs. -0.35 +/- 0.64 kg, p < 0.05) during the first 6 months. This weight loss was regained over the next 18 months. After 2 years, differences in fat for adolescents (-0.08 +/- 0.71% vs. 0.84 +/- 0.72% BF) and weight for parents (-1.1 +/- 0.91 vs. -0.60 +/- 0.89 kg) did not differ between the behavioral and control programs. DISCUSSION: An internet-based weight management program for African-American adolescent girls and their parents resulted in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time.

Adipose Tissue↗
PubMed2001

A pharmacy discharge plan for hospitalized elderly patients--a randomized controlled trial.

OBJECTIVES: to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients. DESIGN: randomized controlled trial. SUBJECTS AND SETTINGS: we randomized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care. INTERVENTIONS: the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient. A copy was given to the patient and to all relevant professionals and carers. This was followed by a domiciliary assessment by a community pharmacist. In the control group, patients were discharged from hospital following standard procedures that included a discharge letter to the general practitioner listing current medications. OUTCOMES: the primary outcome was re-admission to hospital within 6 months. Secondary outcomes included the number of deaths, attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period, together with patients' general well-being, satisfaction with the service and knowledge of and adherence to prescribed medication. RESULTS: we recruited 362 patients, of whom 181 were randomized to each group. We collected hospital and general practice data on at least 91 and 72% of patients respectively at each follow-up point and interviewed between 43 and 90% of the study subjects. There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months. There were no significant differences in any of the secondary outcomes. CONCLUSIONS: we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes.

Aged↗
PubMedDate not supplied

[Randomized controlled trials: a controversial past and a future of regulation and rejection].

The quality of randomized controlled clinical trials has a pivotal role in their external validity. There are no definite protocols to evaluate the quality of already published studies, whereas international guidelines for the preparation of randomized controlled trials are available. This review outlines some milestones in the development of guidelines for randomized controlled trials and presents the Revised Consort Statement which includes 22 items, sub divided into sections (title and abstract, introduction, methods, results and discussion) and a flow chart. The aim of this analysis is to provide clinical researchers with a valuable working tool. Finally, future guidelines for systematic reviews of randomized controlled studies are presented according to the Cochrane Collaboration model.

Double-Blind Method↗