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Results for “randomized controlled trial (RCT)”

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At least 145 records · Page 8Linked to original sources

PubMed2005

Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. STUDY DESIGN: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb > or =9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb > or =9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.

Anemia↗

PubMed2000

Physical activity, falls, and fractures among older adults: a review of the epidemiologic evidence.

OBJECTIVES: Assess the relationship between physical activity and risk for falls and osteoporotic fractures among older adults. DESIGN: Review and synthesis of published literature. MEASUREMENTS: We searched the literature using MEDLINE, Current Contents, and the bibliographies of articles identified. We included randomized controlled trials (RCT) of the effects of physical activity on the incidence of falls and case-control and prospective cohort studies of the association of physical activity with osteoporotic fracture risk. We also summarized mechanisms whereby physical activity may influence risk for falls and fractures. RESULTS: Observational epidemiologic studies and randomized clinical trials evaluating the effectiveness of physical activity programs to prevent falls have been inconclusive. However, many studies have lacked adequate statistical power, and recent trials suggest that exercise, particularly involving balance and lower extremity strength training, may reduce risk of falling. There is consistent evidence from prospective and case-control studies that physical activity is associated with a 20-40% reduced risk of hip fracture relative to sedentary individuals. The few studies that have examined the association between physical activity and risk of other common osteoporotic fractures, such as vertebral and wrist fractures, have not found physical activity to be protective. CONCLUSIONS: Epidemiologic studies suggest that higher levels of leisure time physical activity prevent hip fractures and RCTs suggest certain exercise programs may reduce risk of falls. Future research needs to evaluate the types and quantity of physical activity needed for optimal protection from falls and identify which populations will benefit most from exercise.

Accidental Falls↗

PubMed2000

Which therapeutic interventions in critical care medicine have been shown to reduce mortality in prospective, randomized, clinical trials? A survey of candidates for the Belgian Board Examination in Intensive Care Medicine.

OBJECTIVE: To highlight the lack of randomized controlled trial (RCT) evidence in support of accepted therapeutic interventions in the intensive care unit by assessing the ability of Intensive Care Board Examination candidates to cite relevant studies. DESIGN: As part of the Board Examination for Intensive Care Medicine in Belgium, candidates were asked to name accepted therapeutic interventions that have been shown to reduce mortality in RCTs. SETTING: Survey of doctors. SUBJECTS: Candidates for the 1998 Board Examination for Intensive Care Medicine in Belgium. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: Of the 46 candidates, 25 (54%) gave no response and 3 (7%) stated that no such study exists; 16 responses from 13 doctors were considered acceptable answers. CONCLUSIONS: Candidates for the Board Examination of Intensive Care in Belgium were unable to list many accepted interventions in critical care medicine that are supported by RCT evidence. The RCT may not be the most appropriate tool for assessing the value of an intervention in the intensive care environment.

Belgium↗

PubMedDate not supplied

Obtaining the evidence for clinically effective wound care.

In tissue viability, as in other aspects of health care, there is increasing recognition of the need for healthcare interventions to be supported by good research evidence. The randomized controlled trial (RCT) is considered to provide the most accurate evidence of effectiveness. This article discusses some of the problems that arise when researchers attempt to obtain the relevant evidence. They include funding, sample selection, sample size, recruitment of patients, and mortality and attrition rates. These points are illustrated by means of a case study. In this study an RCT was undertaken to compare two dressings for the management of pressure sores. Problems arose with recruitment of patients to the study. Relevant issues associated with this are discussed and recommendations for future recruitment are presented.

Aged↗

PubMed2004

Cell salvage does not minimize perioperative allogeneic blood transfusion in abdominal vascular surgery: a systematic review.

PURPOSE: To determine whether the use of cell salvage reduces the proportion of patients receiving at least one unit of allogeneic packed red blood cells during the perioperative period of an elective vascular surgery. SOURCE: We identified all relevant articles through the combined use of electronic searches of the MEDLINE and EMBASE databases, the Cochrane library as well as hand searching of all randomized clinical trials and review articles. The electronic search included articles published between 1966 and April 2001. The search included textword searches using "autotransfusion," "cell salvage," "device," or Medical Subject Headings "autologous blood transfusion" or a "randomized controlled trials" filter. PRINCIPAL FINDINGS: Five randomized controlled trials (RCT) were identified involving cell salvage and vascular surgeries. In infra renal abdominal aortic aneurysm surgery the risk ratio (the risk of receiving at least one unit of allogeneic red cells) was 0.37 [95% confidence intervals (CI) of 0.06 to 2.36]. In elective aorto-femoral bypass surgery the risk ratio was 0.97 (95% CI of 0.66 to 1.42). The pooled risk ratio for cell salvage in vascular surgery was 0.67 (95% CI of 0.35 to 1.28). CONCLUSION: Cell salvage, a commonly used technique to recover red cells from the operative field, has been the subject of several studies in vascular surgery. There is insufficient evidence to recommend the routine use of cell salvage in elective abdominal aortic aneurysm and aorto-femoral bypass surgeries. A large RCT would elucidate whether cell salvage is effective as a blood conservation technique.

Abdomen↗

PubMed2004

Randomized controlled trials on hepato-biliary-pancreatic surgery.

The randomized controlled trial (RCT) plays an important role not only in the performance of evidence-based medicine but also in the establishment of therapeutic guidelines. In this review, I analyzed RCTs on hepato-biliary-pancreatic surgery, particularly on malignant diseases. The number of RCTs on hepato-biliary-pancreatic cancers is smaller than that on other types of cancers. This might be related to their low resectability. In liver surgery, a recent increase in RCTs of operative techniques has almost established a standard transection method. In biliary tract and pancreatic cancers, only a few RCTs have been performed concerning operative strategy. Therefore, many issues should be solved by an adequate RCT observing statements of the Consolidated Standards of Reporting Trials.

Biliary Tract Neoplasms↗

PubMed2006

Addition of estradiol to progesterone for luteal supplementation in patients stimulated with GnRH antagonist/rFSH for IVF: a randomized controlled trial.

BACKGROUND: The role of progesterone for luteal support in stimulated cycles for IVF is well established. However, controversy still surrounds the benefit of additional supplementation with estradiol (E2) in GnRH agonist (GnRHa) cycles, while no such data are available for GnRH antagonists. The aim of this randomized controlled trial (RCT) was to compare ongoing pregnancy rates in patients stimulated with recombinant FSH (rFSH) and GnRH antagonist for IVF, who received micronized progesterone for luteal phase supplementation, with or without the addition of E2. METHODS: Two hundred and one patients underwent ovarian stimulation with a fixed dose of 200 IU rFSH and GnRH antagonist. Patients were randomized to receive, for luteal phase supplementation, either 600 mg of micronized progesterone vaginally (n=100, progesterone group) or 600 mg of micronized progesterone and 4 mg of E2 valerate orally (n=101, progesterone/E2 group). The main outcome measure was ongoing pregnancy at 12 weeks per patient randomized. RESULTS: Demographics, stimulation parameters and embryological data were comparable for the two groups compared. Twenty-six ongoing pregnancies were achieved in the progesterone (26%) and 30 in the progesterone/E2 group (29.7%). (Difference: 3.7 and 95%, CI: -15.8 to 8.6%). CONCLUSION: It appears that the addition of E2 to progesterone in the luteal phase after stimulation with rFSH and GnRH antagonist does not enhance the probability of pregnancy.

Chorionic Gonadotropin↗

PubMed2004

Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute.

BACKGROUND: Low-radiation-dose spiral CT (LDCT) scanning is capable of detecting lung neoplasms in asymptomatic individuals. To determine whether such detection can reduce lung cancer mortality, a randomized controlled trial (RCT) of LDCT scanning is necessary. METHODS: The feasibility of conducting an RCT in asymptomatic individuals who are at high risk for lung cancer was explored in the Lung Screening Study (LSS), a 12-month special project of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. During the fall of 2000, six PLCO screening centers recruited a total of 3,318 heavy or long-term smokers who were not participants in the PLCO trial and randomized them to receive either a screening LDCT scan (1,660 participants) or screening posteroanterior view chest radiograph (CXR) [1,658 participants]. RESULTS: The screens were completed on 96% of subjects in the LDCT scan arm and 93% of subjects in the CXR arm. A total of 20.5% of screened subjects in the LDCT scan arm and 9.8% of those in the CXR arm had findings that were suspicious for lung cancer. Thirty lung cancers in subjects in the LDCT arm and 7 lung cancers in patients in the CXR arm were diagnosed following a positive screening result. Additional data from the LSS indicated that, among persons who were at elevated risk for lung cancer, CT scan use was not pervasive, interest in participating in an RCT of LDCT scanning was strong, and few subjects randomized to CXR either refused their examination or sought a CT scan after their study CXR. INTERPRETATION: The results of the LSS demonstrated convincingly the feasibility of an RCT of LDCT scanning in the United States.

Aged↗

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↗

PubMed2005

Final results of the Lung Screening Study, a randomized feasibility study of spiral CT versus chest X-ray screening for lung cancer.

The Lung Screening Study (LSS) was a pilot study designed to assess the feasibility of conducting a large scale randomized controlled trial (RCT) of low radiation dose spiral computed tomography (LDCT) versus chest X-ray (CXR) for lung cancer screening. Baseline results of LSS have been previously reported. Here, we report on the findings at the year one screen and on the final results of the LSS study. A total of 1660 subjects were randomized to the LDCT arm and 1658 to the CXR arm. Compliance with screening declined from 96% at baseline to 86% at year one in the LDCT arm and declined from 93% at baseline to 80% at year one in the CXR arm. Positivity rates for the year one screen were 25.8% for LDCT and 8.7% for CXR. Cancer yield was significantly less at year one for LDCT, 0.57%, than at baseline, 1.9%; cancer yield for CXR increased from 0.45% at baseline to 0.68% at year one. Forty lung cancers in the LDCT arm and 20 in the CXR arm were diagnosed over the study period. Stage I cancers comprised 48% of cases in the LDCT arm and 40% in the CXR arm. A total of 16 stage III-IV cancers were observed in the LDCT arm versus nine in the CXR arm. The LSS has established the feasibility of a RCT comparing annual spiral CT to chest X-ray for lung cancer screening.

Aged↗

PubMed2006

Modified directly observed therapy to facilitate highly active antiretroviral therapy adherence in Beira, Mozambique. Development and implementation.

As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention's success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants' work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients.

Adult↗

PubMed2002

Randomized clinical trials in gastric cancer.

A total of 52 prospective, randomized controlled trials (RCT), published from 1975 to 2000, were reviewed for gastric cancer. The primary focus of these efforts has been the use of chemotherapy in patients with metastatic or locally advanced disease, accounting for 23 of the 52 trials. In comparison, there were only six surgical trials evaluating the extent of either primary resection or lymphadenectomy.

Evidence-Based Medicine↗

PubMed2001

Economic analysis of randomized, controlled trials.

To facilitate the comparison of different treatment strategies, measures have been developed that bring together clinical, quality-of-life, and economic outcomes into summary measures such as the quality-adjusted life year, cost-effectiveness, and cost-utility ratios. A number of different types of economic evaluations have been developed, including cost-minimization, cost-effectiveness, and cost-utility analyses. Performance of economic analyses in association with randomized, controlled trials (RCT) has gained increasing enthusiasm in recent years. However, economic measures in RCTs are often outcomes of secondary interest and associated with frequent missing data and inadequate sample size. Variability in the cost measures used and the lack of agreement on clinically meaningful cost differences further limit the conclusions derived from such studies. Economic analyses should be limited to large trials with important trade-offs between efficacy and cost. The strengths and limitations of such analyses are discussed, and guidelines are offered for proper economic analyses in randomized, controlled trials.

Costs and Cost Analysis↗

PubMed2004

Randomized trial of problem-based versus didactic seminars for disseminating evidence-based guidelines on asthma management to primary care physicians.

INTRODUCTION: This randomized controlled trial (RCT) investigated the effectiveness of and satisfaction with small-group problem-based learning (PBL) versus a didactic lecture approach to guideline dissemination in asthma management controlling for confounders common in comparative educational interventions. METHODS: Sites were selected as either lecture or PBL using simple randomization. All participants were exposed to similar educational resources to ensure treatment equivalency. Instruments included standardized program/speaker evaluation forms and a validated case-based questionnaire with a visual analogue scale measuring the level of confidence of responses. The latter was presented immediately pre- and post-intervention and 3 months later. The statistician was blinded to intervention groups. RESULTS: Overall, 52 family physicians agreed to participate, 23 in the PBL sessions (mean 4.6 per group) and 29 in the didactic lecture sessions (mean 7.25). There was no significant difference between the groups with respect to the knowledge gained at each test administration. Participants rated the lecturer or facilitator equally well as having established a positive learning environment. PBL participants rated the perceived educational value of the program higher than did lecture participants (4.36 vs. 3.93; p = .04). Both groups experienced a significant increase in asthma-related knowledge post-intervention. Attrition rates for the 3-month post-test were 14% for PBL participants versus 32% for lecture-based participants. DISCUSSION: PBL was as effective in knowledge uptake and retention as lecture-based continuing medical education (CME) programs. Further study is warranted to investigate whether the assessment of higher educational value or an increase in response rate to delayed testing is replicable in other RCTs addressing common confounders and if these factors influence future CME participation, changes in physician clinical behavior, or patient health outcomes.

Analysis of Variance↗

PubMed2001

A review of studies on the effect of iron deficiency on cognitive development in children.

Studies on the effect of iron deficiency on children's cognition and behavior are selectively reviewed, looking for evidence of a causal relationship. Most correlational studies have found associations between iron-deficiency anemia and poor cognitive and motor development and behavioral problems. Longitudinal studies consistently indicate that children anemic in infancy continue to have poorer cognition, school achievement, and more behavior problems into middle childhood. However, the possible confounding effects of poor socioeconomic backgrounds prevent causal inferences from being made. In anemic children <2 y old, short-term trials of iron treatment have generally failed to benefit development. Most longer trials lacked randomized placebo groups and failed to produce benefits. Only one small randomized controlled trial (RCT) has shown clear benefits. It therefore remains uncertain whether the poor development of iron-deficient infants is due to poor social backgrounds or irreversible damage or is remediable with iron treatment. Similarly, the few preventive trials have had design problems or produced no or questionable benefits only. For children >2 y old, the evidence from RCT is reasonably convincing but not conclusive. RCT of iron treatment are warranted especially in younger children.

Achievement↗

PubMedDate not supplied

Randomized controlled trials to investigate occupational therapy research questions.

The randomized controlled trial (RCT) has become the most widely accepted research design for testing the efficacy of health care interventions. The purposes of this paper are to (a) introduce the essential elements of RCTs, and (b) discuss some of the special problems faced by occupational therapists in conducting and interpreting RCTs. The CONSORT (Consolidated Standards of Reporting Trials) statement is recommended as an introduction to the components of RCT quality. Problems pertinent to the study of the efficacy of occupational therapy and related interventions include the importance of: theory, background, and rationale; treatment fidelity; theory-based outcomes; management of non-masked (non-blinded) interventionists and participants; and multiplicity of statistical analyses. This paper can help practitioners judge the quality of an RCT, and it can help the profession work toward the development of a cadre of qualified researchers who can adapt the well-established methods of RCTs to the study of occupation-based interventions.

Evidence-Based Medicine↗

PubMed1997

The ethical challenges of a randomized controlled trial of involuntary outpatient commitment.

Involuntary outpatient commitment (OPC) is a civil justice procedure intended to enhance compliance with community mental health treatment, to improve functioning, and to reduce recurrent dangerousness and hospital recidivism. The research literature on OPC indicates that it appears to improve outcomes in rates of rehospitalization and length of stay. However, all studies to date have serious methodological limitations because of selection bias; lack of specification of target populations; unclear operationalization of OPC; unmeasured variability in type, frequency, and intensity of treatment; as well as other confounding factors. To address limitations in these studies, the authors designed a randomized controlled trial (RCT) of OPC, combined with community-based case management, which is now under way in North Carolina. This article describes ethical dilemmas in designing and implementing an RCT of a legally coercive intervention in community-based settings. These ethical dilemmas challenge the experimental validity of an RCT but can be successfully addressed with careful planning and negotiation.

Ambulatory Care↗

PubMed2005

When treatment meets research: clinical perspectives from the CSAT Methamphetamine Treatment Project.

Integrating research-based treatments into clinical settings has become a priority in the substance abuse treatment field. This article examines the introduction of research, via manualized treatment (i.e., the Matrix Model), into community treatment settings that participated in the Center for Substance Abuse Treatment Methamphetamine Treatment Project, a multi-site randomized controlled trial (RCT) that provided free treatment to 1016 methamphetamine-dependent individuals. With both empirical (qualitative) and anecdotal data from those involved clinically in the project, the article utilizes the framework of practitioner concerns set forth by Addis, Wade, and Hatgis (1999) to assess the issues realized during the implementation of this manualized treatment. Despite fairly smooth implementation of the model, the authors conclude that introducing manualized treatment in the context of an RCT may not be the best way to bring research-based treatment into the practice world.

Amphetamine-Related Disorders↗