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At least 433 records · Page 24Linked to original sources
PubMed2003

Technical quality of root canal treatment in Taiwan.

AIM: To evaluate the current technical quality of root canal treatment (RCT) in Taiwan. METHODOLOGY: A total of 1085 RCT cases, randomly selected from a large sample and representative of the Taiwanese population from April to September 2000, were evaluated by eight endodontic specialists. The qualitative evaluation of RCT cases was based on two variables: length of the root filling and density of the obturation. A root canal with both adequate filling length (the apical termination of the root filling within 2 mm of the radiographic apex) and complete obturation (no lateral or apical canal lumen visible in the apical one-third of the root canal) was defined as having good-quality endodontic work (GQEW). A tooth was defined as having a GQEW when all its canals were categorized as GQEW. RESULTS: From a total of 1867 root canals, overfilling occurred in 235 (12.6%), adequate filling length in 1152 (61.7%), underfilling in 466 (25.0%) and no filling in 12 (0.6%). Of the 1867 root canals, 710 (38.0%) demonstrated complete obturation and 1157 (62%) demonstrated incomplete obturation. GQEW was found in 650 (34.8%) root canals and 329 (30.3%) teeth. The percentage of teeth with GQEW in hospital cases (38.1%) was significantly greater (P < 0.001) than that in private clinic cases (24.3%). In addition, the frequency of teeth with GQEW in the anterior teeth (40.4%) or in the premolars (33%) was significantly greater (P < 0.001) than that in the molars (18.4%). CONCLUSIONS: Approximately 70% of the teeth receiving RCT in Taiwan were either of inadequate filling length or sealing density.

Bicuspid↗
PubMed2002

Demonstrating the clinical and cost effectiveness of adhesion reduction strategies.

OBJECTIVE: To examine the feasibility of conducting Randomized Controlled Trials (RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related admissions following use of an adhesion reduction product, and to model the cost effectiveness of such products. METHODS: The number of patients in each limb of a RCT comparing an adhesion reduction product to a control has been estimated based on 25% and 50% reductions in adhesion-related readmissions one year after surgery, for P = 0.05 at a power of 80% and P=0.01 at a power of 90%. A cost effectiveness model based on the Surgical and Clinical Adhesions Research Group (SCAR) database has been developed which calculates the percentage reduction in readmissions required of an adhesion reduction product to return the cost of investment. It also estimates the cumulative costs of adhesion-related readmissions for lower abdominal surgery and the cost savings associated with an adhesion reduction policy using a low or high cost product. RESULTS: 7.2% of patients undergoing lower abdominal surgery will readmit due to adhesions in the first year after surgery. To demonstrate a 25% reduction in readmissions one year after surgery, it is calculated that a RCT would require between 5686 (P = 0.05, power=80%) and 7766 (P = 0.01, power = 90%) lower abdominal surgery patients followed-up for one year. A cost effectiveness analysis demonstrates that routine use of adhesion reduction products costing pound 50 per patient will payback the cost of such investment if they reduce adhesion-related readmissions by 16% after 3 years. A product costing pound 200 will need to offer a 64.1% reduction in readmissions after 3 years. For the estimated 158 000 lower abdominal surgery operations conducted in the UK each year, the cumulative costs of adhesion-related readmissions over 10 years are estimated at pound 569 Million. CONCLUSION: Demonstrating the clinical effectiveness of adhesion reduction products in the RCT setting is unlikely to be feasible due to the large number of patients required. Products costing pound 200 or more are unlikely to payback their direct costs.

Journal Article↗
PubMed2001

Basal and postprandial serum-promoted cholesterol efflux in normolipidemic subjects: Importance of fat mass distribution.

Excess of adipose tissue may affect the reverse cholesterol transport mediated by high-density lipoprotein (HDL). Impairments in this system may be one possible factor favoring atherosclerosis development in obesity. To investigate if gender and regional fat mass distribution independently influence reverse cholesterol transport (RCT), we studied in vitro the capacity of serum to promote the cell cholesterol efflux. Measurements were performed both in the fasting state and in the postprandial state, a setting known to stimulate cholesterol transport and altered in obesity. Thirteen obese women with an android phenotype, waist-to-hip ratio (WHR): 0.98 to 0.85 and 51 normal-weight subjects: 25 women and 26 men, with a similar WHR range: 0.96 to 0.67, were recruited. All the participants were normolipoproteinemic in the fasting state and were given an oral fat load. Blood samples were taken before giving the oral fat load and after every 2 hours. The measurements of the ability of serum to promote cholesterol efflux from cells were performed using 3H-cholesterol labeled Fu5AH hepatoma cells in the fasting state 6 and 8 hours after the lipid rich meal. Incremental serum triglyceride (TG), area under the curve (iAUC) and AUC of retinyl palmitate (RP) for the obese women and nonobese subjects were similar. Basal cholesterol efflux was reduced in obese women compared with normal-weight women (26.75% +/- 3.1% v 30.81% +/- 4.2%, P =.004). However, the magnitude of cholesterol efflux promoted by whole serum increased similarly in all the groups. In the subjects with similar WHR, no gender difference was observed in the postprandial TG response and in the first step of RCT. Multivariate regression analyses indicated that plasma HDL-cholesterol (HDL-C) concentration is the best predictor of cholesterol efflux in the fasting state with an independent mild additive effect of WHR. Conversely, postprandial efflux appeared to be mostly related to the WHR with a mild additive effect of HDL-C. Our results indicate that alterations in the first step of RCT can occur in normolipidemic obese subjects and are tightly associated with the abdominal distribution of fat mass. Android obesity in women brings them to the level of men with respect to RCT.

Administration, Oral↗
PubMed2004

High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis trial: lessons learned.

OBJECTIVES: To review important findings, or lessons, that were learned about measures of response, design, conduct, and analysis of a randomized, controlled trial (RCT), even though the trial failed to demonstrate efficacy of d-penicillamine. METHODS: One hundred thirty-four patients with early (< or =18 months), diffuse systemic sclerosis (SSc) were entered into an RCT (high-dose [822 mg daily] vs low-dose [120 mg every other day] D-penicillamine) and were followed up regularly for up to 4 years. Because analysis failed to show efficacy for D-penicillamine in early diffuse SSc, all data were pooled for additional secondary analyses. RESULTS: This RCT showed that trials of potential disease-modifying interventions can be completed in SSc using the American College of Rheumatology guidelines. This RCT used an active control. After analysis, we were not able to tell whether either dose was effective or ineffective. That experience argues in favor of using placebo controls until such time as an active control can be found that truly modifies the disease. Skin score and the disability index of the Health Assessment Questionnaire (HAQ-DI) were valid predictors of outcome. Along with the physician global assessment, they also were valid measures of response. CONCLUSIONS: Even in studies that are therapeutically "negative," careful evaluation of the data can examine other hypotheses and thereby provide important insights into other aspects of trial design, outcome measures, patient function, and trial conduct.

Adult↗
PubMed2002

Amifostine in simultaneous radiochemotherapy of advanced head and neck cancer.

The authors discuss the results of 3 studies of their group reflecting the possible role of amifostine in simultaneous radiochemotherapy (RCT) of advanced head and neck cancer. In a controlled phase II trial (1995 through 1996), 39 patients were included in this pilot investigation. A control group (n = 14) received simultaneous RCT of the head and neck region with an irradiation dose of 60 Gy and 2 cycles of carboplatin (700 mg/m(2) cumulative dose). Twenty-five patients received the same basic therapy and an additional 500-mg dose of amifostine before each chemotherapy. Amifostine was administered less than 45 minutes before the end of radiotherapy. The authors observed a dramatic reduction of typical radiotherapy-associated toxicities (mucositis, xerostomia, loss of taste, dysphagia). The hematologic side effects (leukocytopenia, anemia, thrombocytopenia) also were decreased significantly. The overall survival rate and locoregional control of both groups were comparable after 12 months. In a controlled intensification trial (1997 through 1999), the authors included 76 consecutive patients (69 men, 7 women) with pharyngeal cancer (oropharynx, n = 33; hypopharynx, n = 43). The tumors were characterized as unresectable and locally advanced without distant metastasis. All patients received a conventional radiotherapy (2-Gy single dose, daily fractionation) up to doses of 60 Gy and an additional 10 Gy as a boost in the tumor-infiltrated region. A dose of carboplatin, 70 mg/m(2), was given to a group of 45 patients on days 1 through 5 and 29 through 33 of radiotherapy (RCT arm). The resulting cumulative dose was 700 mg/m(2). A group of 31 patients (RCTintens arm) received the same dose of carboplatin on days 1 through 5, 22 through 26, and 43 through 47 or 1 through 5, 15 through 19, 29 through 33, and 43 through 47 of radiotherapy (cumulative dose 1.05 to 1.40 mg/m(2)). All patients received 500 mg of amifostine before each carboplatin administration. If the tumor volume was less than 20 cm(3), we observed an increased 1-year overall survival rate (91% v 71%) and time to progression (17 months v 10 months). If the tumor volume was greater than 20 cm(3), we observed comparable treatment results in both groups (1-year survival rate, 60% v 61%; time to progression, 13 months v 12 months). In a long-term follow-up investigation (1999 through 2000), 531 patients (89 women, 442 men) were analyzed according to their toxicities during regular follow-up investigations at our outpatient facility. All patients were treated by surgery or radio(chemo)therapy because of an advanced head and neck cancer. A total of 218 of 531 patients received the antineoplastic therapy without cytoprotection. An additional 313 patients received their RCT combined with amifostine administration before administration of the radiosensitizer. A significant influence of cytoprotection was registered in the following toxicities: xerostomia, fibrosis, loss of taste, and dysphagia. No impact was seen on the development of interstitial lymph edema and esophageal stenosis. Amifostine could be integrated in simultaneous radiochemotherapy of advanced head and neck cancer patients. The authors favor the administration of amifostine before chemotherapeutics alone. Selective cytoprotection could decrease the main acute toxicities (mucositis, xerostomia, dysphagia) as well as late side effects (xerostomia, loss of taste, fibrosis) of this form of combined treatment. The enhanced therapeutic index may be changed into a prognostic benefit for selected patients with unresectable tumors, if the volume is smaller than 20 cm(3).

Adolescent↗
PubMed2001

An investigation into the feasibility of comparing three management options (augmentation, conservative and water) for nulliparae with dystocia in the first stage of labour.

OBJECTIVE: to evaluate the feasibility of a randomised controlled trial (RCT) examining the effect of three options (augmentation, conservative and water) for the management of dystocia in nulliparae. The main objectives were to explore the feasibility of trial procedures in the clinical environment, consent rates and acceptability of the management options to women, local incidence of dystocia in nulliparae and the size of the subsequent study. DESIGN: a two part study: a pilot, RCT with follow-up through to delivery with postnatal maternal surveys, and a case review of nulliparae with dystocia. SETTING: a large maternity unit in the South of England in May-July 1997 inclusive. PARTICIPANTS: nulliparae with dystocia in the first stage of labour who had an otherwise uncomplicated obstetric background. INTERVENTIONS: women in the pilot RCT received one of three management options: labouring in a waterbirth pool, conservative management or augmentation of labour, which is the standard management of women with dystocia condition in the Unit. FINDINGS: it is feasible to conduct an RCT of management of dystocia in the Unit. Seventy per cent (95% confidence interval 47% to 87%) of women approached agreed to participate. Conservative management was the least acceptable option to women and has been dropped from the subsequent trial. The audit provided some idea of possible differences in operative delivery and epidural rates depending on augmentation or not. A sample of 220 women should be large enough to detect moderate changes and will require a 2-year recruitment period. CONCLUSIONS: a subsequent trial is feasible and is now underway. It has the potential to provide information enabling women and practitioners to have a greater choice of care options in the presence of dystocia, or provide a good basis for an even larger trial.

Baths↗
PubMed2001

A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies.

OBJECTIVES: to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic. DESIGN AND METHOD: small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed. SETTING: a special care baby unit in a District General Hospital in the UK. PARTICIPANTS: over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14). PROCEDURE: the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted. FINDINGS: the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis. CONCLUSIONS: if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.

Bottle Feeding↗
PubMed2001

Effect of up-regulating individual steps in the reverse cholesterol transport pathway on reverse cholesterol transport in normolipidemic mice.

Cholesterol acquired by extrahepatic tissues (from de novo synthesis or lipoproteins) is returned to the liver for excretion in a process called reverse cholesterol transport (RCT). We undertook studies to determine if RCT could be enhanced by up-regulating individual steps in the RCT pathway. Overexpression of 7alpha-hydroxylase, Scavenger receptor B1, lecithin:cholesterol acyltransferase (LCAT), or apoA-I in the liver did not stimulate cholesterol efflux from any extrahepatic tissue. In contrast, infusion of apoA-I.phospholipid complexes (rHDL) that resemble nascent HDL markedly stimulated cholesterol efflux from tissues into plasma. Cholesterol effluxed to rHDL was initially unesterified but by 24 h this cholesterol was largely esterified and had shifted to normal HDL (in mice lacking cholesteryl ester transfer protein) or to apoB containing lipoproteins (in cholesteryl ester transfer protein transgenic mice). Most of the cholesterol effluxed into plasma in response to rHDL came from the liver. However, an even greater proportion of effluxed cholesterol was cleared by the liver resulting in a transient increase in liver cholesterol concentrations. Fecal sterol excretion was not increased by rHDL. Thus, although rHDL stimulated cholesterol efflux from most tissues and increased net cholesterol movement from extrahepatic tissues to the liver, cholesterol flux through the entire RCT pathway was not increased.

Animals↗
PubMed2002

Assessing effectiveness of home care for persons with AIDS: analysis of methodological problems.

The aim of this paper is to assess the methodological problems of an unsuccessful randomized controlled trial (RCT) conducted to evaluate the effectiveness, in terms of survival and quality of life, of the early offer of home care (HC) to persons with AIDS (PWA). The study carried out was an intention-to-treat RCT. Persons in the treatment group (TG) received the offer of HC at the moment of AIDS diagnosis; those in the control group (CG) received it six months from diagnosis. Many problems have hindered the progress of the study: particularly, the low compliance to the offer and the failure to enroll the required sample size have made the results unreliable. Analogous problems have been reported within other trials evaluating HC in different fields. The present study thoroughly evaluates the specific ethical and methodological problems encountered in designing and conducting a RCT on HC for PWA. We conclude that, before designing and conducting a RCT in this field, it is advisable to examine some main issues carefully, such as the acceptability of the offer of treatment, the expected compliance and the required size of the study population. If one or more of these elements prove to be problematic, the results of the trial risk being seriously compromised, and alternative approaches should be considered.

Acquired Immunodeficiency Syndrome↗
PubMed1991

Development of a field method for determining the service lives of respirator cartridges--Part IV: Results of field validation trials.

Results of a fourth study on the use of small, carbon-filled glass tubes, referred to as respirator carbon tubes (RCTs), for predicting the service lives of organic vapor respirator cartridges are presented. Organic vapors are drawn through the RCT by using a personal sampling pump until breakthrough is detected. This breakthrough time is then used in conjunction with a bed-residence adsorption model to predict the breakthrough time of a cartridge containing carbon identical to that in the RCT. Previous laboratory work demonstrated that accurate prediction of cartridge breakthrough time was possible for exposure to carbon tetrachloride in atmospheres containing 5-94% relative humidity (RH) with both dry and prehumidified carbon beds and with n-hexane, pyridine, and binary mixtures of each with carbon tetrachloride. This report examines the performance of the RCT method in a workplace environment where carbon tetrachloride concentrations varied from 101 to 855 ppm, pyridine levels varied from 0 to 29 ppm, temperatures ranged from 28 to 39 degrees C, and RH varied from 19% to 49%. The RCT method predicted cartridge breakthrough times to an accuracy of +/- 8 at the 95% confidence level, which equaled or exceeded results of previously reported laboratory studies. Actual breakthrough times averaged within +/- 5% of times predicted with previous laboratory data. A plot of bed-residence time versus breakthrough time yielded a coefficient of determination of 0.71 when ambient concentrations were standardized.

Air Pollutants, Occupational↗
PubMed2005

A lesson learnt: the importance of modelling in randomized controlled trials for complex interventions in primary care.

BACKGROUND: The Randomised Controlled Trial (RCT) is recognised as the 'gold standard' in quantitative research. However RCTs testing health care interventions can be difficult to design and implement. Health care interventions are often complex in themselves and are always applied in complex settings. Such interventions require a process of careful 'modelling' to maximize the chances of successful trials that will add to knowledge. OBJECTIVES: To describe the terms 'complex' and 'modelling' as used in the setting of randomised controlled trials of complex interventions. To give a practical example of an RCT involving a complex intervention applied in a health care setting to illustrate how this might take place in practice. METHODS: We describe an RCT designed and conducted by the authors. We then use our trial as an example to illustrate how complex interventions such as ours might benefit from modelling during the design of the intervention and the setting within which the intervention is to be tested. RESULTS: Our project was designed and tested before current guidance on complex interventions was published; our RCT was therefore not 'modelled' but was based on the outcome of a single quantitative pilot study. As part of our study we ran a parallel qualitative study, which highlighted several areas of complexity both in our intervention, and in the setting within which we applied it. In this paper we show how modelling might have allowed us to recognise these complexities at an early stage and might therefore have resulted in a study more likely to have demonstrated useful outcomes. CONCLUSION: Careful modelling of complex interventions is an essential step in designing trials of innovations in health care and health care services. Such a process ensures that interventions fit with and reflect the complexities of the settings within which interventions will be applied, and should ensure that the outcomes chosen are those most appropriate to demonstrate any benefits or risks.

Algorithms↗
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↗
PubMed2006

The effect of statins on urinary albumin excretion and glomerular filtration rate: results from both a randomized clinical trial and an observational cohort study.

BACKGROUND: Statins improve cardiovascular outcome, but less is known on the renal outcome. We, therefore, studied the relationship between the use of statins and urinary albumin excretion (UAE) and glomerular filtration rate (GFR) in two settings: a randomized controlled trial (RCT) and an observational cohort study, in which patients were included to study the impact of an elevated UAE on renal and cardiovascular prognosis. METHODS: We used data from the Prevention of REnal and Vascular ENd-stage Disease Intervention trial (PREVEND-IT) and the PREVEND cohort study. The PREVEND-IT subjects (788 with a UAE 15-300 mg/day) received pravastatin 40 mg/day vs placebo and/or fosinopril 20 mg/day vs placebo in a 2x2 factorial-RCT design. Of the 3440 cohort subjects, 469 used statins during the 4-year follow-up period. Multivariate-regression adjusted for confounding factors and the propensity score was used to estimate the relation between statin use and UAE and GFR. RESULTS: In the RCT, pravastatin did not change UAE or GFR, neither in fosinopril yes/no subgroups. In the observational cohort, statin use was associated with a rise in UAE (+12.1%), compared with statin non-use (+3.6%, P<0.001). This rise was most pronounced in those on statins prior to the first screening [+24.8% (95% CI: 11.9-39.2)], those using statins>3 years [+18.5% (7.3-30.8)] and those with >1 or >2 defined daily doses (+15.7 and +17.3%, respectively). These differences remained significant after adjustment for relevant variables and propensity score. The rise in UAE could not be attributed to a higher dose or a specific statin. GFR fell in 4 years in both statin users and non-users (4.6+/-13.5 and 2.4+/-11.2, respectively). The fall in GFR between groups was not different after adjustment (P=0.11). CONCLUSIONS: We conclude from the RCT data that statins do not lower UAE in subjects selected because of an elevated UAE instead of hyperlipidaemia. In the observational cohort study, the use of statins similarly was not associated with a fall in UAE; UAE instead increased. Statin treatment was not associated with a significant change in GFR in these subjects with only modestly impaired GFR.

Adult↗
PubMed2002

Randomized clinical trials in pediatric critical care: Rarely done but desperately needed.

OBJECTIVE: To review the benefits and challenges of using the randomized, controlled trial (RCT) study design to evaluate preventive and therapeutic interventions in pediatric critical care medicine. CONCLUSIONS: The RCT design is able to control for many sources of potential bias that other types of study designs cannot. The findings of RCTs often contradict the findings of less rigorous study designs. Before performing an RCT, there must exist a state of clinical equipoise, a sufficient number of eligible patients must be available, and the epidemiology of the disorder in question must be well studied. There are many challenges to performing high-quality RCTs. Studying multiple element support strategies in the critically ill patient population is more complex than studying a single drug therapy. High patient and practice variability and hazy diagnostic definitions can dilute the signal-to-noise ratio. Most interventions in critical care are expected to have a modest or small effect. This markedly increases the requisite sample size. There is a paucity of accepted clinically important measurements of the outcome of critical care, making mortality a common outcome to evaluate with a not-so-common incidence. Developmental issues, the inability to give informed consent, and the failure to perform the appropriate pharmacokinetic and safety studies are additional challenges facing pediatric investigators. Despite these limitations, a good RCT remains the best way to prove that an intervention is working or not. Indeed, RCTs are and will remain the "gold standard" method to estimate the efficacy of a therapeutic or prophylactic intervention.

Journal Article↗
PubMed2005

Fluoxetine for the treatment of childhood anxiety disorders: open-label, long-term extension to a controlled trial.

OBJECTIVE: To assess the efficacy of fluoxetine for the long-term treatment of children and adolescents with anxiety disorders, including generalized anxiety disorder, separation anxiety disorder, and/or social phobia. METHOD: Children and adolescents (7-17 years old) with anxiety disorders were studied in open treatment for 1 year after they completed a randomized, controlled trial (RCT) comparing fluoxetine and placebo. The follow-up phase assessments included clinician, parent, and child ratings with measures of global severity, global improvement, and anxiety symptoms. RESULTS: Subjects taking fluoxetine (n = 42) were compared with those taking no medication (n = 10) during follow-up on anxiety changes from the end of the RCT through the follow-up period. Statistical models included RCT assignment and follow-up psychological treatment. Excluded subjects took other medications (n = 4) or did not complete follow-up (n = 18). Compared with subjects taking no medication, subjects taking fluoxetine showed significantly superior follow-up outcomes on most measures, including clinician, parent, and child ratings. CONCLUSIONS: The results suggest that fluoxetine is clinically effective for the maintenance treatment of anxiety disorders in children and adolescents. A major limitation, however, was the lack of RCT methodology in the follow-up phase. RCTs are needed to determine the long-term risks and benefits of fluoxetine for this group.

Adolescent↗
PubMed1996

A pilot study for a randomized controlled trial to prevent gastric cancer in high-risk Japanese population: study design and feasibility evaluation.

Observational epidemiological studies suggest that some nutrients reduce the risk of gastric cancer and that individuals with atrophic gastritis are at high risk of developing gastric cancer. One possible measure for gastric cancer prevention is therefore nutritional supplementation for the high risk group. Before recommending this strategy for the general public, however, a randomized controlled trial (RCT) is necessary. To evaluate the feasibility of an RCT, the authors conducted a pilot study using recipients of a health check-up program in a general hospital in Japan. The subjects who were asked to participate in the trial had been diagnosed as having atrophic gastritis on the basis of serum pepsinogen I < 70 ng/ml and the ratio of pepsinogen I to II < 3.0. They were requested to ingest double-blinded capsules containing different levels of vitamin C and beta-carotene every day. Out of the 219 subjects (118 males, 101 females) who were eligible for the study and had the required pepsinogen measurement, 90 (41%) met the criteria for atrophic gastritis. Among them, 55 (61%) (35 males, 20 females) gave their informed consent to participate in the RCT. Fifty-four participants completed a 3-month course of supplementation, and all of them agreed to a 5-year supplementation period. The authors concluded that an RCT using double-blinded nutritional supplements and targeting apparently healthy individuals is feasible in an intervention study for cancer prevention in Japan.

Adult↗
PubMed1993

Reverse cholesterol transport: relationship between free cholesterol uptake and HDL3 in normolipidaemic and hyperlipidaemic subjects.

High density lipoproteins (HDL) are responsible for the Reverse Cholesterol Transport (RCT). The role of the composition of the HDL particle in RCT, involving free cholesterol (chol) uptake from cell membranes, is not completely understood. We have therefore studied the uptake capacity from subjects with a wide variety of plasma HDL cholesterol concentrations in an HDL-receptor free model consisting of bovine heart mitochondrial membranes labeled with [14C]cholesterol. HDL were isolated by molecular sieve chromatography from fresh plasma samples of eight subjects with low plasma HDL chol concentrations (< or equal to 1.0 mmol L-1) and 15 subjects with normal HDL chol concentrations. The latter were subdivided into an intermediate (HDL chol: 1.0-1.4 mmol L-1; n =9) and a high HDL chol group (> or equal to 1.4 mmol L-1; n = 6). In the HDL fractions isolated by chromatography (cHDL), total chol and apolipoprotein (apo) AI were measured. Free chol uptake was significantly decreased by 32% in the tertile with the lowest plasma HDL chol (49.1 +/- 15.8 arbitrary units; mean +/- SD), compared to the tertile with high HDL chol (72.1 +/- 16.6 au). Linear regression analysis showed a positive correlation between the free chol uptake and plasma HDL3 concentrations (r = 0.61; P < 0.01), HDL chol (r = 0.56; P < 0.01), HDL associated apo AI (R = 0.46; P < 0.05), cHDL apo AI (r = 0.56; P < 0.05) and cHDL chol (r = 0.46; P < 0.05) in all subjects combined. Stepwise multiple-regression analysis confirmed the association of [14C] cholesterol uptake with plasma HDL3 concentrations (beta, 0.61; P = 0.004). No correlations were found between free chol uptake and total plasma apo AI (r = 0.26. ns) or HDL2 (r = 0.27; ns). After an oral fat load in four FCH patients, free chol uptake paralleled the changes in plasma HDL 3 chol concentrations. We conclude that HDL3 is involved in the early steps of RCT and low HDL 3 levels may result in less efficient RCT in hypertriglyceridemia.

Adult↗
PubMed2006

A comparison between integrating clinical practice setting and randomized controlled trial setting into economic evaluation models of therapeutics.

BACKGROUND: Cost-effectiveness analyses generated from randomized controlled trials (RCTs) represent results obtained under ideal experimental conditions (efficacy) and the applicability of these data to real-world settings (effectiveness) may be questionable. OBJECTIVE: To compare cost-effectiveness results obtained from a RCT setting with the results derived from community-based clinical practice. METHODS: Using data from a community-based cohort study and from a RCT, two cost-effectiveness analyses were performed and the incremental cost-effectiveness ratios (ICERs) were calculated for the use of etanercept in the treatment of patients with rheumatoid arthritis. RESULTS: Using an effectiveness-based analysis, the mean quality-adjusted life years (QALYs) gained during the 12-month monitoring period were 0.45 and 0.35 for the treatment and control groups respectively. The ICER for etanercept treatment was 174,200 dollars (CDN) per QALY (95% confidence limits between 119,500 dollars and 285,000 dollars). Incorporating efficacy data obtained from the RCT into the analysis, the mean QALYs gained were 0.56 and 0.35 for the treatment and control groups respectively. This resulted in a substantially lower ICER for etanercept treatment of 82,952 dollars per QALY (95% confidence limits between 66,500 dollars and 103,430 dollars). CONCLUSION: Depending on the type of clinical setting used for the analysis, the resulting ICER for etanercept treatment was very different. These results help to explain the difference in cost-effectiveness reported in previous modeling studies, some based on RCT assumptions and some based on effectiveness setting.

Anti-Inflammatory Agents, Non-Steroidal↗