SEARCH · PubMed Health

Results for “randomized controlled trial (RCT)”

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 163 records · Page 9Linked to original sources

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↗

PubMed2002

Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials.

PURPOSE: To review the available evidence of chemoembolization for unresectable hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Computerized bibliographic searches with MEDLINE and CANCERLIT databases from 1980 through 2000 were supplemented with manual searches, with the keywords "hepatocellular carcinoma," "liver cell carcinoma," "randomized controlled trial [RCT]," and "chemoembolization." Studies were included if patients with unresectable HCC were enrolled and if they were RCTs in which chemoembolization was compared with nonactive treatment (five RCTs) or if different transarterial modalities of therapy (13 RCTs) were compared. Data were extracted from each RCT according to the intention-to-treat method. Five of the RCTs with a nonactive treatment arm were combined by using the random-effects model, whereas all 18 RCTs were pooled from meta-regression analysis. RESULTS: Chemoembolization significantly reduced the overall 2-year mortality rate (odds ratio, 0.54; 95% CI: 0.33, 0.89; P =.015) compared with nonactive treatment. Analysis of comparative RCTs helped to predict that overall mortality was significantly lower in patients treated with transarterial embolization (TAE) than in those treated with transarterial chemotherapy (odds ratio, 0.72; 95% CI: 0.53, 0.98; P =.039) and that there is no evidence that transarterial chemoembolization is more effective than TAE (odds ratio, 1.007; 95% CI: 0.79, 1.27; P =.95), which suggests that the addition of an anticancer drug did not improve the therapeutic benefit. CONCLUSION: In patients with unresectable HCC, chemoembolization significantly improved the overall 2-year survival compared with nonactive treatment, but the magnitude of the benefit is relatively small.

Carcinoma, Hepatocellular↗

PubMed2001

Survival on long-term oxygen therapy in chronic airflow limitation: from evidence to outcomes in the routine clinical setting.

BACKGROUND: Two previous randomized controlled trials (RCT) demonstrated that the administration of long-term oxygen therapy (LTOT) improved survival in selected patients with hypoxic chronic obstructive pulmonary disease (COPD) or chronic airflow limitation (CAL). AIMS: The aim of the present study was to investigate whether the survival of CAL patients prescribed LTOT at Flinders Medical Centre (FMC) was gender and age related, and equivalent to that of the previous RCT. METHODS: A list of patients prescribed domiciliary oxygen therapy for CAL at FMC was generated from Respiratory Unit records and hospital financial records for the supply of this therapy. Survival was compared with that reported for the original RCT, and for Swedish and Belgian COPD patients. Factors influencing survival were studied. RESULTS: Five hundred and five (249 males, 256 females) patients were prescribed LTOT for CAL at FMC during the study period and included in the survival analysis. The patients were elderly with multiple comorbidities. Survival was less than for the control arms of the previous RCT (apart from the Medical Research Council Working Party (MRC) female group) but comparable with recent overseas data. Overall crude survival was 75.1%, 51.3%, 18.9% and 1.1% at 1, 2, 5 and 10 years respectively. Females experienced longer survival than males. Multivariate analysis indicated that age, forced expiratory volume in 1 s, body mass index (BMI) and the number of comorbidities were prognostic indicators for females; BMI was a prognostic indicator for males. A survival advantage existed for females using at least 19 h concentrator oxygen per day. CONCLUSIONS: In routine practice, survival of unselected CAL patients with multiple comorbidities is less than that reported in the original RCT.

Age Factors↗

PubMed2005

Exercise research issues in the spinal cord injured population.

Although considered the gold-standard research design, randomized controlled trials (RCT) create a series of methodological, ethical, and practical challenges when applied to exercise training studies of people with spinal cord injury (SCI). These challenges are discussed, and some pragmatic alternatives are suggested to advance SCI research while maintaining scientific integrity.

Exercise↗

PubMed1998

Complementary and alternative medicine: evaluating its effectiveness in inflammatory bowel disease.

The use of complementary and alternative medicine (CAM) by patients with inflammatory bowel disease (IBD) is common. Physicians and scientists believe that the randomized controlled trial (RCT) provides the best evidence of an intervention's efficacy. However, there are only a few controlled trials that have assessed these therapies in IBD and all contain methodological problems. The RCT does not always fit well with the underlying principles of disease causation and treatment of CAM. Many forms of CAM take a holistic approach to the diagnosis and treatment of disease, where the patient plays an active and key role in healing and treatments are often highly individualized. Therefore, the use of placebos, blinding, and random allocation to structured treatment protocols in an RCT setting is often contradictory to the principles of CAM. We still know relatively little about the use of CAM in IBD. Prior to embarking upon a program of clinical trials to evaluate these therapies, a better understanding of the specific therapies being used, reasons for their use, and their potential side effects is required. We also need to understand how the CAM practitioners use their therapies, what they view as the appropriate indications, and how treatments are best administered.

Clinical Protocols↗

PubMed2004

Endoscopic retrograde cholangiopancreatography in gallstone-associated acute pancreatitis.

BACKGROUND: Early endoscopic retrograde cholangio-pancreatography with or without endoscopic sphincterotomy (ERCP+/-ES) has been advocated to reduce complications in patients presenting with a severe attack of gallstone-associated acute pancreatitis (GAP). However, a recent trial has reported contradictory results. Importantly, patients with acute cholangitis were excluded suggesting it may be a major confounding factor affecting previous studies. OBJECTIVES: To assess the effectiveness of early ERCP+/-ES compared to conservative management stratified according to severity of disease, concealment of randomisation, acute cholangitis and bilirubin level in the reduction of mortality, morbidity, length of hospitalisation and cost in adults suspected of having GAP. SEARCH STRATEGY: We searched - Cochrane Library (Issue 4 2003), Medline (1966-2004), EMBASE (1980-2004) and LILACS. 'Grey literature' was sought by looking at cited references and hand searched to identify further relevant trials. Conference proceedings of United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were also hand searched. SELECTION CRITERIA: Randomized controlled trials (RCT) of adult patients, from 15 years old or greater, presenting with gallstone-associated acute pancreatitis (GAP) comparing ERCP +/- ES versus Conservative management within 72 hours of admission. DATA COLLECTION AND ANALYSIS: Data were assessed for quality independently by two reviewers. Wherever appropriate, results were pooled together and sub-grouped by predicted severity of disease. Fixed and random effects models were applied. Sensitivity analysis was performed to test the fragility of results. MAIN RESULTS: Three trials, involving 511 patients, met inclusion criteria. The test for heterogeneity yielded statistically non-significant results (p-value 0.1 to 0.63) suggesting all comparisons were above the established threshold for combinability (p<0.1). Fixed effect and random effect meta-analyses gave identical results. Early ERCP +/- ES was associated with non-significant effect on reduction of mortality in predicted mild (OR = 0.62, 95% CI = 0.27 to 1.41) and severe GAP (OR = 0.62, 95% CI = 0.27 to 1.41). Reduction in complications was non-significant in predicted mild (OR = 0.89, 95% CI = 0.53 to 1.49), but significant in severe GAP (OR = 0.27, 95% CI = 0.14 to 0.53). There was insufficient evidence to draw any conclusions about hospital stay and cost. REVIEWERS' CONCLUSIONS: Odds of having complications are reduced in predicted severe disease by early ERCP +/- ES. This effect was however, non-significant in predicted mild disease and for reduction of mortality in either predicted mild or severe disease. These results are controlled for confounding due to associated acute cholangitis and are robust for clinical and statistical heterogeneity.

Acute Disease↗

PubMed2006

[Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers.

Acupuncture Therapy↗

PubMed2006

Treating asthma with omega-3 fatty acids: where is the evidence? A systematic review.

BACKGROUND: Considerable interest exists in the potential therapeutic value of dietary supplementation with the omega-3 fatty acids. Given the interplay between pro-inflammatory omega-6 fatty acids, and the less pro-inflammatory omega-3 fatty acids, it has been thought that the latter could play a key role in treating or preventing asthma. The purpose was to systematically review the scientific-medical literature in order to identify, appraise, and synthesize the evidence for possible treatment effects of omega-3 fatty acids in asthma. METHODS: Medline, Premedline, Embase, Cochrane Central Register of Controlled Trials, CAB Health, and, Dissertation Abstracts were searched to April 2003. We included randomized controlled trials (RCT's) of subjects of any age that used any foods or extracts containing omega-3 fatty acids as treatment or prevention for asthma. Data included all asthma related outcomes, potential covariates, characteristics of the study, design, population, intervention/exposure, comparators, and co interventions. RESULTS: Ten RCT's were found pertinent to the present report. CONCLUSION: Given the largely inconsistent picture within and across respiratory outcomes, it is impossible to determine whether or not omega-3 fatty acids are an efficacious adjuvant or monotherapy for children or adults. Based on this systematic review we recommend a large randomized controlled study of the effects of high-dose encapsulated omega-3 fatty acids on ventilatory and inflammatory measures of asthma controlling diet and other asthma risk factors. This review was limited because Meta-analysis was considered inappropriate due to missing data; poorly or heterogeneously defined populations, interventions, intervention-comparator combinations, and outcomes. In addition, small sample sizes made it impossible to meaningfully assess the impact on clinical outcomes of co-variables. Last, few significant effects were found.

Adult↗

PubMed1999

Might stopping smoking reduce injury death risks? A meta-analysis of randomized, controlled trials.

BACKGROUND: Smokers have excesses of injuries. Randomized, controlled trials (RCT) could assess whether cigarette smoking (smoking) causes (and smoking cessation (cessation) prevents) those injuries. We analyzed injury, accident, suicide, and homicide deaths as secondary endpoints in RCT that induced cessation. METHODS: RCT were sought via MEDLINE, bibliographies, the CDC Smoking and Health database, and the GLOBALink Tobacco listserver. RCT were included if (1) net (intervention minus control) cessation totaled over 10% of all intervention smokers and (2) injury data were available. Relative risks (RR) were summarized by fixed effects modeling. RESULTS: Three trials were located (the Lung Health Study, MRFIT, and Whitehall RCT). In-trial annual point prevalence cessation averaged 41, 46, and 59% in the intervention group smokers versus 17, 22, and 28% in the respective controls. Intervention (cessation) was associated with pooled injury RR of 0.65 within the trials (95% confidence interval (CI) 0.36-1.19) and 0.68 (95% CI 0.43-1.09) with additional follow-up in the Lung Health and MRFIT populations. CONCLUSIONS: The smoking/injury death association is of borderline statistical significance in currently available RCT data. It modestly supports the significant forensic, cohort, case-control, cross-sectional, challenge-rechallenge, in vitro, and animal data suggesting that smoking may cause injury. Direct tests of the hypothesis could strengthen this inference.

Accidents↗

PubMed1994

Can quality care be planned?

Planning quality care can begin with planning a randomized controlled trial (RCT). Given that health-care services must compete for scarce resources, it is important that RCTs collect data to support an economic evaluation when the RCT ends. Economic data can be collected after an RCT ends; however, translating the clinical findings into clinical practice and health-care policy may be less efficient and less effective. Three types of data--economic, behavioral, and biological outcomes--should be collected during an RCT to conduct an economic evaluation at the end of an RCT. Economic outcomes represent the actual resources consumed by a health service, i.e., economic costs; behavioral outcomes include measures of longevity and health-related quality of life; and biological outcomes measure physiological state, e.g., retinopathy level.

Delivery of Health Care↗

PubMed1989

Stage-shift cancer screening model.

A stage-shift cancer screening model is developed in the context of a randomized controlled trial (RCT) of cancer screening. In the model, detection by screening causes the time of diagnosis of the cancer to be advanced so that either the stage at diagnosis is shifted from one stage to the next lower one or the stage of diagnosis is unchanged but the cancer is diagnosed earlier in the stage. These are called external and internal stage shifts, respectively. At each stage the extent of the external and internal shifts and any associated mortality benefits are estimated. Further, the model allows the interrelationships of these benefits within and between stages to be delineated. This then allows us to better understand the results of the RCT. Data from a completed breast cancer screening RCT are used to illustrate the application of the model and its value in improving our understanding of the trial's results.

Adult↗

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 be achieved only 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 article 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 Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because 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 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to 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.

Publishing↗

PubMed2005

A comparison of buprenorphine and lofexidine for community opiate detoxification: results from a randomized controlled trial.

OBJECTIVE: To investigate whether a buprenorphine opiate detoxification regimen can be considered to be at least as clinically effective as a lofexidine regimen. DESIGN: An open-label randomized controlled trial (RCT) using a non-inferiority approach. Non-inferiority is demonstrated if, within a 95% confidence interval, buprenorphine performs within a preset tolerance limit of clinically acceptable difference in outcomes and completion rates between the two treatments. METHODS: Individuals ready for heroin detoxification were given information about the trial and invited to participate. Consenting participants (n = 210) were then randomized to one of the two treatments. Detoxification was undertaken in a specialist out-patient clinic according to predefined protocols. The primary outcome was whether or not an individual completed the detoxification. Abstinence at 1-month follow-up was used as a secondary outcome measure. Additional secondary outcome measures were substance use, dependence, psychological health, social satisfaction, and treatment satisfaction. Data were also collected for individuals who declined randomization and instead chose their treatment (n = 271). RESULTS: A total of 46% of those on lofexidine and 65% of those on buprenorphine completed detoxification. Of these, 35.7% of the lofexidine and 45.9% of the buprenorphine groups reported abstinence at 1 month. Of those not completing detoxification abstinence was reported at 27.5% and 29.0%, respectively; 271 individuals who opted not to be allocated randomly and instead chose one of the two treatments produced similar results CONCLUSIONS: Buprenorphine is at least as effective as lofexidine detoxification treatment. Whether or not individuals were randomized to, or chose, a treatment appeared not to affect the study's outcome.

Adolescent↗

PubMed2002

[Analysis of randomized controlled trials on otorhinolaryngological diseases in China].

OBJECTIVE: To evaluate the quality of randomized controlled trials (RCT) in otorhinolaryngology in China and offer evidence for the improvement of RCT. METHODS: Five kinds of Chinese journals of clinical otorhinolaryngology were searched, and RCTs were identified and analyzed according to the standards of Evidence Based Medicine. RESULTS: Two hundred and eighty seven issues were referred to, and eighty-one RCTs were finally identified and analyzed. Of these RCTs, 34.57% (28/81) had definite diagnostic standards, 38.27% (31/81) had including standards and 33.33% (27/81) had excluding standards; only 1.23% (1/81) got the approval of the participants; 40.74% (33/81) had moderate sample size, 3.70% (3/81) had large sample size and non of them mentioned sample size estimation; 81.48% (66/81) didn't report the method of randomization and 38.27% (31/81) had baseline comparison; 18.52% (15/81) didn't define the control interventions and 8.64% (7/81) even didn't explicate the experimental intervention; 32.10% (26/81) used blank comparison; 86.42% (70/81) didn't use blindness; 37.04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of following-up and only 1.23% (1/81) treated the loss with statistics methods. CONCLUSION: The quantity and quality of otorhinolaryngological RCTs couldn't meet the clinical need. More high quality RCTs are required to improve the level of prevention and cure of otorhinolaryngologic diseases.

China↗

PubMed2026

Anti-inflammatory agents after hip and shoulder arthroplasty: A systematic review and meta-analysis.

BACKGROUND: Postoperative inflammation after arthroplasty contributes to pain, delayed mobilization and prolonged hospitalization. Recent randomized trials have evaluated pharmacological anti-inflammatory strategies within contemporary enhanced recovery pathways, but evidence after hip and shoulder arthroplasty remains scattered across different drug classes and perioperative regimens. OBJECTIVES: To synthesize recent randomized controlled trial (RCT) evidence on perioperative anti-inflammatory agents after hip and shoulder arthroplasty. METHODS: PubMed, Embase, Cochrane Library and Web of Science were searched for English-language RCTs published from January 2020 to March 2026. The 2020-2026 window was selected to update evidence generated under modern arthroplasty, anesthesia, multimodal analgesia and enhanced recovery after surgery (ERAS) pathways. Eligible trials included adults undergoing hip or shoulder arthroplasty and compared corticosteroids, cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drug (NSAID)-based/local anti-inflammatory regimens, or related anti-inflammatory interventions with placebo, saline, no treatment, or the same regimen without the target component. Weighted mean differences (WMDs) were pooled using random-effects models. RESULTS: Nine RCTs involving 800 patients were included. Anti-inflammatory interventions significantly reduced postoperative C-reactive protein (CRP) [WMD=-32.18, 95% confidence interval (CI) (-41.16, -23.21), P<0.001], interleukin-6 (IL-6) [WMD=-31.25, 95% CI (-41.79, -20.77), P<0.001], rest pain [WMD=-0.41, 95% CI (-0.58, -0.23), P<0.001], activity pain [WMD=-0.56, 95% CI (-0.83, -0.29), P<0.001] and hospital stay [WMD=-0.54, 95% CI (-0.92, -0.15), P=0.006]. CONCLUSION: Recent RCT evidence suggests that perioperative anti-inflammatory interventions can attenuate early inflammatory responses and improve short-term pain and recovery after hip and shoulder arthroplasty. Because data were limited and clinically heterogeneous, the findings should not be interpreted as evidence favoring a specific drug class, dose, route, or timing.

Humans↗

PubMed2005

The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.

To comprehend the result of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can be achieved only 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 article incorporates new evidence and addresses some criticism of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage or participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up and analysis). The diagram explicitly includes the number of participants, according to 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 or an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Guidelines as Topic↗

PubMed2004

Back schools in occupational health care: design of a randomized controlled trial and cost-effectiveness study.

OBJECTIVE: To describe the design of a randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing high-intensity and low-intensity back schools with usual care in occupational health care. DESIGN: RCT and cost-effectiveness analysis. STUDY POPULATION: Employees sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain. Interventions High-intensity back school treatment consists of a training program based on the principles of cognitive-behavioral therapy. Low-intensity back school treatment is comparable to the original Swedish Back School. Usual care is provided by the occupational physician according to the Dutch guidelines for the occupational health treatment of patients with low back pain. OUTCOME MEASURES: Primary outcome measures are return to work, pain intensity, functional status, and general improvement. Secondary outcome measures are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs. The outcome measures are assessed before randomization and 3, 6, and 12 months after randomization. CONCLUSION: RCTs of different methodological quality have been conducted to examine the effectiveness of back schools in occupational health care. The large variation in type, content, and intensity of back schools has led to conflicting evidence. Therefore, 2 different forms of back schools are compared. Moreover, this is the first RCT to include a cost-effectiveness analysis comparing low-intensity and high-intensity back schools with usual care in occupational health care.

Adolescent↗

PubMed2003

Design and quality control issues related to dietary assessment, randomized clinical trials and meta-analysis of field-based studies in developing countries.

The essential design and quality control aspects of dietary assessment, randomized controlled trials (RCT) in developing countries and their subsequent meta-analysis are reviewed. Dietary assessment protocols consist of three stages: measurement of food intakes using a method appropriate for the study objectives, calculation of nutrient intakes and finally an evaluation of their nutrient adequacy. The latter may involve: 1) assessment of dietary diversity (average number of different foods consumed per day) and selected indices of dietary quality such as intakes of animal source foods (g/d); 2) percentage of energy from protein, fat and animal protein; 3) selected nutrient densities; and 4) dietary phytate:zinc molar ratio, as well as the prevalence of inadequate nutrient intakes calculated using a probability approach. To establish causality between the nutrient inadequacies identified and adverse health outcomes, RCT must be undertaken. A prerequisite of RCT is double-blind randomization, a procedure designed to eliminate biases arising from baseline confounding variables, unintended interventions and ascertainment bias. Results from existing RCT can be summarized via meta-analysis to gain a better understanding of the population relationship. Meta-analysis is a statistical technique involving linear models or generalized linear models, which can be performed after locating the individual studies, and selecting and abstracting all the necessary data.

Developing Countries↗