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Results for “randomized controlled trial (RCT)”

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PubMed2006

The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: rationale and study design of a randomized controlled pilot study.

BACKGROUND: Nocturnal hemodialysis (NHD) is an alternative to conventional three times per week hemodialysis (CvHD) and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT) has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV) mass, as measured by cardiac magnetic resonance imaging (cMR). METHODOLOGY/DESIGN: All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP) to a goal of <130/80 mmHg post-dialysis using a predefined BP management protocol. The primary outcome is change in LV mass, a surrogate marker for cardiac mortality, measured at baseline and 6 months. The high sensitivity and reproducibility of cMR facilitates reduction of the required sample size and the time needed between measures compared with echocardiography. Secondary outcomes include BP control, anemia, mineral metabolism, health-related quality of life, and costs. DISCUSSION: To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

Female↗

PubMed2003

Critical appraisal skills of family physicians in Ontario, Canada.

BACKGROUND: Our primary objective in this study was to measure family physicians' knowledge of the key elements that go into assessing the validity and interpreting the results in three different types of studies: i) a randomized controlled trial (RCT); ii) a study evaluating a diagnostic test; and iii) a systematic review (SR). Our secondary objectives were to determine the relationship between the above skills and age, gender, and type of practice. METHODS: We obtained a random sample of 1000 family physicians in Ontario from the College of Family Physicians of Canada database. These physicians were sent a questionnaire in the mail with follow-up mailings to non-responders at 3 and 8 weeks. The questionnaire was designed to measure knowledge and understanding of the basic concepts of critical appraisal skills. Based on the responses to the questions an Evidence Based Medicine (EBM) Knowledge Score was determined for each physician. RESULTS: A response rate of 30.2% was achieved. The respondents were younger and more likely to be recent graduates than the population of Ontario Family Physicians as a whole. This was an expected outcome. Just over 50% of respondents were able to answer questions concerning the critical appraisal of methods and the interpretation of results of research articles satisfactorily. The average score on the 12-point EBM Knowledge Scale was 6.4. The younger physicians scored higher than the older physicians, and academic physicians scored higher than community-based physicians. Scores of male and female physicians did not differ. CONCLUSIONS: We have shown that in a population of physicians which is younger than the general population of physicians, about 50% have reasonable knowledge regarding the critical appraisal of the methods and the interpretation of results of a research article. In general, younger physicians were more knowledgeable than were older physicians. EBM principles were felt to be important to the practice of medicine by 95% of respondents.

Adult↗

PubMed2002

Recruiting family physicians and patients for a clinical trial: lessons learned.

BACKGROUND: The randomized controlled trial (RCT) is the most definitive tool for evaluating an intervention. However, methodological deficiencies may limit the internal or external validity of the RCT. OBJECTIVE: Our aim was to describe the tactics used and the resources required randomly to select and recruit family physicians (FPs) and their patients aged 65 and older (seniors) for a community-based cluster RCT in primary care. METHODS: We randomly selected 48 FPs in 24 urban and rural sites in Southern Ontario, and 889 of their community-dwelling seniors (approximately 20 per FP) taking five or more medications daily. To accomplish this, the principal investigator (an FP) contacted the eligible FPs. The participating FPs' office staff then generated and contacted the roster of eligible seniors, with support provided by the research staff. RESULTS: Of the 163 randomly selected FPs telephoned, 94 were ineligible and 48 (69.6%) of the remaining 69 participated. The rosters were generated with the assistance of the research staff (taking 1.5-8.0 hours) in each of the 48 practices, using electronic appointment records (n = 26), electronic billing records (n = 17), electronic medical records (n = 2) or written charts or file cards (n = 3). Of the 2078 seniors approached, 799 were ineligible and 889 (69.5%) of the remaining 1279 participated. Seniors' refusal rates among practices ranged from 4.8 to 62.3%. CONCLUSIONS: Recruitment of a representative sample and generalizability of results are possible in RCTs in primary care. Involvement of an FP in physician recruitment and clinical research nurses who provided assistance to office staff were keys to success.

Aged↗

PubMed2000

[Current status and problem of adjuvant chemotherapy for curatively resected gastric cancer].

Randomized controlled trials (RCT) on adjuvant chemotherapy for gastric cancer published in the West and Japan were reviewed. Although several small trials showed positive data, adjuvant chemotherapy for curatively resected gastric cancer has been thought to be ineffective in western countries. Results of Japanese RCTs also have not become evidence of its benefit. Despite this, suggestive data by non-predefined subset analyses of old RCTs have been misread as definitive evidence of benefit because of less understanding of clinical statistics in Japan. As a result most Japanese patients have received postoperative adjuvant chemoimmunotherapy. Recently understanding of clinical trial has spread gradually and well designed RCTs with sufficient sample size have been reported. First of all we have to determine the efficacy of adjuvant chemotherapy by carefully designed RCT using surgery alone arm as control.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2026

Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: Prespecified Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Pregnant women with ICD-10 (International Statistical Classification of Diseases, Tenth Revision) affective or stress-related disorders face an elevated risk of perinatal depression and anxiety, yet evidence on digital nonpharmacologic interventions for this population remains limited. OBJECTIVE: This study evaluated the effectiveness of an 8-week digital mindfulness-based intervention (eMBI) compared with treatment as usual (TAU) among pregnant women with ICD-10 affective or stress-related disorders participating in a randomized controlled trial (RCT). METHODS: This prespecified secondary analysis was conducted within a multicenter RCT in Baden-Württemberg, Germany. Pregnant women aged 18 years and older with elevated depressive symptoms (Edinburgh Postnatal Depression Scale [EPDS]>9) and ICD-10-diagnosed affective or stress-related disorders were randomized 1:1 to eMBI or TAU. The intervention consisted of 8 weekly app-based mindfulness sessions (45 min each) delivered during gestational weeks 29-36, with no direct therapist contact. The primary outcome was continuous depressive symptom severity measured with the EPDS at 4-6 weeks post partum. Secondary outcomes included the EPDS at 6 months post partum, generalized anxiety (State-Trait Anxiety Inventory-State [STAI-S], State-Trait Anxiety Inventory-Trait [STAI-T]), and Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R). Analyses followed the intention-to-treat (ITT) principle, using mixed models for repeated measures and multiple imputation. RESULTS: Of the 5299 screened women, 147 met the inclusion criteria for this subgroup analysis (intervention group [IG] had n=73 women and control group had n=74 women). Groups were comparable at baseline. The IG showed significantly greater reductions in EPDS scores at gestational week 34 (Δ=-2.21, P=.01), week 36 (Δ=-3.25, P=.01), and 4-6 weeks post partum (Δ=-4.81, P=.007). Treatment effects remained robust under conservative missing-data assumptions. At 4-6 weeks post partum, a higher proportion of participants in the IG achieved clinically meaningful improvement (31/73, 42.5% vs 21/74, 28.4%; adjusted odds ratio 1.56, 95% CI 1.19-2.05; P=.001). Anxiety outcomes followed a similar pattern, whereas pregnancy-related anxiety did not differ between groups. CONCLUSIONS: In this prespecified subgroup of pregnant women with ICD-10 affective or stress-related disorders, the eMBI was associated with clinically meaningful reductions in depressive symptoms from late pregnancy to 4-6 weeks post partum. Effects at 6 months post partum were attenuated and less stable across missing-data assumptions. These findings support eMBIs as a scalable, nonpharmacological adjunct to perinatal mental health care for women with affective or stress-related disorders, while confirmation in adequately powered trials with strategies to reduce postpartum attrition is warranted.

Humans↗

PubMed2005

Identifying, recruiting, and enrolling adolescent survivors of childhood cancer into a randomized controlled trial of health promotion: preliminary experiences in the Survivor Health and Resilience Education (SHARE) Program.

OBJECTIVE: To report on the identification, recruitment, and enrollment of adolescent survivors of childhood cancer into an ongoing randomized controlled trial (RCT) of health promotion. METHODS: A total of 244 adolescents were contacted by mail and telephone to assess their trial eligibility. Data were collected with respect to each adolescent's demographics and trial recruitment efforts (frequency and intensity of telephone call contact); exclusion and randomization status were tracked throughout. RESULTS: Thirty-one percent of adolescents were ultimately randomized in the trial and 69% were excluded from randomization (13% were ineligible, 33% refused to participate, 22% were unreachable or nonresponsive, that is, did not respond to trial mailings or telephone calls, and less than 1% were withdrawn prior to randomization). Among all eligible adolescents, the trial's consent rate was 49%. Adolescents excluded owing to refusal resided the farthest away from the intervention site and experienced the least amount of telephone call contact time. The primary reasons for trial refusal were lack of interest in health promotion (28%) and lack of time to participate (23%). CONCLUSIONS: Health promotion RCTs among adolescent survivors of childhood cancer may help prevent and control the onset and severity cancer-treatment-related late effects. However, trial success may be contingent upon tracing nonresponsive adolescents and reducing and eliminating barriers to participation.

Adolescent↗

PubMed2001

Domiciliary oxygen for interstitial lung disease.

BACKGROUND: Retrospective survival data have suggested poor effectiveness of oxygen therapy in patients with interstitial lung disease (ILD). OBJECTIVES: To determine the effect of domiciliary oxygen therapy on survival and quality of life in patients with a diagnosis of ILD and hypoxaemia. SEARCH STRATEGY: Randomized Controlled Trials (RCTs) were identified using the Cochrane Airways Group register and the search terms: (home OR domiciliary AND oxygen AND (Interstitial lung disease OR ILD OR pulmonary fibrosis OR IPF)). SELECTION CRITERIA: Any randomized controlled trial (RCT) in adult patients with hypoxaemia and ILD that compared long term domiciliary or home oxygen therapy with a control group. DATA COLLECTION AND ANALYSIS: Only one unpublished RCT was identified. MAIN RESULTS: Only one trial was identified. Mortality for both the oxygen treated and control groups was approximately 91% after 3 years (Peto odds ratio 0.99, 95% confidence intervals 0.16,6.26). The effect of oxygen therapy on quality of life and physiological parameters was not reported. REVIEWER'S CONCLUSIONS: The assumption that home oxygen therapy has a beneficial survival effect in patients with ILD has not been demonstrated in the single RCT identified.

Confidence Intervals↗

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↗

PubMed2006

Online randomized controlled trial of brief and full cognitive behaviour therapy for depression.

BACKGROUND: Effective internet-based programs for depression usually incorporate a component that provides telephone or email contact. Open access websites, without such contact, show high rates of attrition and poorer outcomes. The present study was designed as an exploratory investigation of the parameters that influence the effectiveness and retention of users on open access websites. We investigated whether brief cognitive behaviour therapy (CBT) was as effective as an extended version, whether add-on components of behaviour therapy or stress management contributed to positive outcomes, and whether longer programs were associated with greater attrition. METHOD: An online randomized controlled trial (RCT) was conducted between 13 January 2005 and 26 May 2005 (19 weeks). A total of 2794 registrants (1846 women and 948 men; median age category 35-44 years) with elevated scores on the Goldberg Depression Scale of 5.96 (S.D.=2.09) elected online to be randomized to one of six versions of a CBT website. The versions were compiled consisting of various components of brief CBT, extended CBT, behaviour strategies, stress management and problem solving. RESULTS: A total of 20.4% of participants completed the assigned intervention. The interaction of measurement occasion and treatment version was significant [F(13,131)=2.20, p=0.01]. A single module of brief introductory CBT was not effective in reducing depression symptoms. However, extended CBT with or without the addition of behaviour strategies resulted in the reduction of depression. CONCLUSIONS: Brief CBT-based interventions are not as effective as extended interventions. However, longer programs are associated with higher rates of dropout.

Adult↗

PubMed2005

Effects of the search technique on the measurement of the change in quality of randomized controlled trials over time in the field of brain injury.

BACKGROUND: To determine if the search technique that is used to sample randomized controlled trial (RCT) manuscripts from a field of medical science can influence the measurement of the change in quality over time in that field. METHODS: RCT manuscripts in the field of brain injury were identified using two readily-available search techniques: (1) a PubMed MEDLINE search, and (2) the Cochrane Injuries Group (CIG) trials registry. Seven criteria of quality were assessed in each manuscript and related to the year-of-publication of the RCT manuscripts by regression analysis. RESULTS: No change in the frequency of reporting of any individual quality criterion was found in the sample of RCT manuscripts identified by the PubMed MEDLINE search. In the RCT manuscripts of the CIG trials registry, three of the seven criteria showed significant or near-significant increases over time. CONCLUSIONS: We demonstrated that measuring the change in quality over time of a sample of RCT manuscripts from the field of brain injury can be greatly affected by the search technique. This poorly recognized factor may make measurements of the change in RCT quality over time within a given field of medical science unreliable.

Bias↗

PubMed1996

Utility of the National Cooperative Growth Study database for safety reporting.

The National Cooperative Growth Study (NCGS) maintains the largest database in the world, collecting information on patients with growth disorders treated with growth hormone (GH). More than 24,000 children have been monitored during its first decade (1985 through 1995). The database provides unique opportunities to learn about effectiveness of GH therapy in a real-world context. Its size also makes it possible to investigate rare adverse reactions, which is not reasonable in a randomized controlled trial (RCT). The frequency of adverse experiences reported in an observational study like the NCGS is lower than in an RCT, because the investigators in an observational study typically do not report events that they believe are clearly unrelated to the study drug. Nevertheless the NCGS has greatly facilitated collecting adverse-event data; approximately 75% of all adverse-event reports for GH received by the manufacturer are through NCGS data-collection forms. The NCGS has thus amassed a repository of GH safety data that is unparalleled. Furthermore, in contrast to an RCT, the NCGS database reflects real-world experience with long-term GH therapy in North America. Although the advantages of an observational study such as the NCGS must be recognized, such a study does differ from an RCT in important ways. For example, because the NCGS protocol allows customized patient treatment and individualization of GH therapy, it may be difficult to use the database to address questions (e. g., estimation of dose-response relationships, true incidence of adverse events) that require RCT designs.

Adverse Drug Reaction Reporting Systems↗

PubMed2002

Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review.

BACKGROUND: The effectiveness of human albumin administration in prevention of severe ovarian hyperstimulation syndrome (OHSS) was reviewed using the Cochrane Menstrual Disorders and Subfertility Group literature search strategy. METHODS: Only randomized controlled trials (RCT) comparing the effect of human albumin with placebo or no treatment were included in this review. Seven RCT were identified, five of which met our inclusion criteria and enrolled 378 women (193 in the albumin-treated group and 185 in the control group). Trials under consideration were evaluated for methodological quality and appropriateness for inclusion without consideration of their results. The five included trials were single-centre parallel RCT. Relevant data were extracted independently by two reviewers using the standardized data extraction sheet. Validity was assessed in terms of method of randomization, completeness of follow-up, presence or absence of crossover and co-intervention. RESULTS: There was significant reduction in severe OHSS on administration of human albumin [odds ratio (OR): 0.28; 95% confidence interval (95% CI) 0.11-0.73]. Relative risk was 0.35 (95% CI 0.14-0.87) and absolute risk reduction was 5.5. For every 18 women at risk of severe OHSS, albumin infusion will save one more case. There was no evidence of an increase in the pregnancy rate [OR 1.09 (95% CI 0.65-1.83)]. CONCLUSIONS: This Cochrane review shows a clear benefit from administration of i.v. albumin at the time of oocyte retrieval in prevention of severe OHSS in high-risk cases. Whether the number needed to treat would justify the routine use of albumin infusion in cases at risk of severe OHSS needs to be judged by clinical decision-makers.

Adult↗

PubMed2004

Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence?

BACKGROUND: The need to administer antibiotic prophylaxis (ABP) during laparoscopic cholecystectomy (LC) is still a matter of significant controversy. The purpose of this study was to resolve this issue by performing a meta-analysis of the available randomized controlled trials (RCT) on this topic. METHODS: Papers identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. The outcome measures were the rates of all perioperative infections, the rates of surgical site infections, and the rates of infections at other sites. Results were examined for 974 patients randomized to ABP or placebo prior to LC in six RCT published from 1997 to 2001. RESULTS: The cumulative rates of all infections were 2.8% in the ABP group and 4.4% in the placebo group. The pooled odds ratio (OR) (95% confidence interval [CI]) was 0.69 (0.34-1.43; p = 0.32). The cumulative rates of surgical site infections were 2.1% in the ABP group and 2.9% in the placebo group. The pooled OR (95% CI) was 0.82 (0.36-1.86; p = 0.63). The cumulative rates of infections at other sites were 0.7% in the ABP group and 1.5% in the placebo group. Pooled OR (95% CI) was 0.82 (0.18-1.90; p = 0.37). No significant heterogeneity was found in any data pooling. CONCLUSIONS: Based on the available evidence, there appears to be no need to administer routine ABP to low-risk patients during LC. However, the number of patients enrolled to date into RCT is insufficient to avoid a type II error. A large and well-designed trial is urgently needed to find a conclusive answer to this question.

Antibiotic Prophylaxis↗

PubMed1998

[Is the randomized controlled trial overvalued as a basis for clinical decision-making? A review with comments].

The randomized controlled trial (RCT) may have considerable limitations in clinical research. Lacking the possibility of blinding impairs the internal validity of the trials. The external validity is often impaired, as results of RCTs obtained in an ideal situation, may be difficult to generalize to a clinical routine situation. Pragmatic randomized trials move from ideal situations towards routine situations, and by modifying the design it is possible to reduce selection bias due to patient and physician preferences. Quasi-experimental studies have varying degrees of problems with internal validity but are necessary contributions to our knowledge of the effect of treatment in clinical routine situations. Limitations of the usefulness of RCTs as well as pragmatic and quasi-experimental studies in clinical research make it necessary to recognise that different methods complement one another. Research in development of RCTs and new methods in clinical research should be encouraged.

Decision Making↗

PubMed1998

Trials and tribulations. Emerging issues in designing economic evaluations alongside clinical trials.

Decisions relating to designing and implementing economic evaluations alongside clinical trials are dependent on a number of issues initial consideration should focus on whether an economic evaluation is appropriate, whether a randomized controlled trial (RCT) is a suitable vehicle, and whether the design of the specific RCT is appropriate for integration of economic evaluation. If an economic evaluation is appropriate, decisions are required on how economic data are to be collected and analyzed. This paper discusses these and other issues and, where appropriate, provides recommendations for future studies.

Costs and Cost Analysis↗

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↗