Sample records for trials group study

  1. ‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

    PubMed Central

    2014-01-01

    Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers. Trial registration ISRCTN28645428. PMID:24758530

  2. Can Research Assessments Themselves Cause Bias in Behaviour Change Trials? A Systematic Review of Evidence from Solomon 4-Group Studies

    PubMed Central

    McCambridge, Jim; Butor-Bhavsar, Kaanan; Witton, John; Elbourne, Diana

    2011-01-01

    Background The possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms: (1) assessed experimental group; (2) unassessed experimental group (3) assessed control group; or (4) unassessed control group. This design provides a test of the internal validity of effect sizes obtained in conventional two-group trials by controlling for the effects of baseline assessment, and assessing interactions between the intervention and baseline assessment. The aim of this systematic review is to evaluate evidence from Solomon 4-group studies with behavioural outcomes that baseline research assessments themselves can introduce bias into trials. Methodology/Principal Findings Electronic databases were searched, supplemented by citation searching. Studies were eligible if they reported appropriately analysed results in peer-reviewed journals and used Solomon 4-group designs in non-laboratory settings with behavioural outcome measures and sample sizes of 20 per group or greater. Ten studies from a range of applied areas were included. There was inconsistent evidence of main effects of assessment, sparse evidence of interactions with behavioural interventions, and a lack of convincing data in relation to the research question for this review. Conclusions/Significance There were too few high quality completed studies to infer conclusively that biases stemming from baseline research assessments do or do not exist. There is, therefore a need for new rigorous Solomon 4-group studies that are purposively designed to evaluate the potential for research assessments to cause bias in behaviour change trials. PMID:22039407

  3. THE AUSTRALIA NEW ZEALAND BREAST CANCER TRIALS GROUP: SOME CONTRIBUTIONS TO BREAST CANCER TRIALS

    Microsoft Academic Search

    John F Forbes

    The Australian New Zealand Breast Cancer Trials Group was formed in 1978 after the first adjuvant therapy trials were published. This commenced a new era of clinical trials and the commencement of substantial global collaboration, particularly with the International Breast Cancer Study Group. The Australia New Zealand Group is currently conducting 46 trials encompassing prevention and early and advanced disease.

  4. Phenome-wide Association Study Relating Pretreatment Laboratory Parameters With Human Genetic Variants in AIDS Clinical Trials Group Protocols

    PubMed Central

    Moore, Carrie B.; Verma, Anurag; Pendergrass, Sarah; Verma, Shefali S.; Johnson, Daniel H.; Daar, Eric S.; Gulick, Roy M.; Haubrich, Richard; Robbins, Gregory K.; Ritchie, Marylyn D.; Haas, David W.

    2015-01-01

    Background.?Phenome-Wide Association Studies (PheWAS) identify genetic associations across multiple phenotypes. Clinical trials offer opportunities for PheWAS to identify pharmacogenomic associations. We describe the first PheWAS to use genome-wide genotypic data and to utilize human immunodeficiency virus (HIV) clinical trials data. As proof-of-concept, we focused on baseline laboratory phenotypes from antiretroviral therapy-naive individuals. Methods.?Data from 4 AIDS Clinical Trials Group (ACTG) studies were split into 2 datasets: Dataset I (1181 individuals from protocol A5202) and Dataset II (1366 from protocols A5095, ACTG 384, and A5142). Final analyses involved 2547 individuals and 5 954 294 imputed polymorphisms. We calculated comprehensive associations between these polymorphisms and 27 baseline laboratory phenotypes. Results.?A total of 10 584 (0.17%) polymorphisms had associations with P < .01 in both datasets and with the same direction of association. Twenty polymorphisms replicated associations with identical or related phenotypes reported in the Catalog of Published Genome-Wide Association Studies, including several not previously reported in HIV-positive cohorts. We also identified several possibly novel associations. Conclusions.?These analyses define PheWAS properties and principles with baseline laboratory data from HIV clinical trials. This approach may be useful for evaluating on-treatment HIV clinical trials data for associations with various clinical phenotypes. PMID:25884002

  5. Phenome-wide Association Study Relating Pretreatment Laboratory Parameters With Human Genetic Variants in AIDS Clinical Trials Group Protocols.

    PubMed

    Moore, Carrie B; Verma, Anurag; Pendergrass, Sarah; Verma, Shefali S; Johnson, Daniel H; Daar, Eric S; Gulick, Roy M; Haubrich, Richard; Robbins, Gregory K; Ritchie, Marylyn D; Haas, David W

    2015-01-01

    Background. ?Phenome-Wide Association Studies (PheWAS) identify genetic associations across multiple phenotypes. Clinical trials offer opportunities for PheWAS to identify pharmacogenomic associations. We describe the first PheWAS to use genome-wide genotypic data and to utilize human immunodeficiency virus (HIV) clinical trials data. As proof-of-concept, we focused on baseline laboratory phenotypes from antiretroviral therapy-naive individuals. Methods. ?Data from 4 AIDS Clinical Trials Group (ACTG) studies were split into 2 datasets: Dataset I (1181 individuals from protocol A5202) and Dataset II (1366 from protocols A5095, ACTG 384, and A5142). Final analyses involved 2547 individuals and 5 954 294 imputed polymorphisms. We calculated comprehensive associations between these polymorphisms and 27 baseline laboratory phenotypes. Results. ?A total of 10 584 (0.17%) polymorphisms had associations with P < .01 in both datasets and with the same direction of association. Twenty polymorphisms replicated associations with identical or related phenotypes reported in the Catalog of Published Genome-Wide Association Studies, including several not previously reported in HIV-positive cohorts. We also identified several possibly novel associations. Conclusions. ?These analyses define PheWAS properties and principles with baseline laboratory data from HIV clinical trials. This approach may be useful for evaluating on-treatment HIV clinical trials data for associations with various clinical phenotypes. PMID:25884002

  6. Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial

    PubMed Central

    Kadimpati, Sandeep; McCormick, Jennifer B; Chiu, Yichen; Parker, Ashley B.; Iftikhar, Aliya Z.; Flick, Randall P.; Warner, David O.

    2014-01-01

    Background In the recent literature, there has been some evidence that exposure of children to anesthetic procedures during the first two years of life may impair cognitive function and learning in later life. We planned a clinical study to quantify this risk, a study involving testing 1,000 children for neurodevelopmental deficits. As a part of this planning, we conducted focus groups involving potential participants and their parents to elicit information regarding three issues: communications with the community and potential participants, recruitment and consent processes, and the return of neurodevelopmental testing results. Methods Three focus groups were conducted with the parents of potential participants and one focus group was conducted with an 18-19 year old group; each group consisted of 6-10 participants. The moderated discussions had questions about recruitment, consenting issues, and expectations from the study about return of both overall trial findings and individual research test results. Results The focus group data gave us an insight on potential participants’ views on recruitment, consenting, communications about the study, and expectations about return of both overall trial findings and individual research test results. The concerns expressed were largely addressable. In addition, the concern we had about some parents enrolling their children in the study solely for the sake of getting their child's cognitive function results was dispelled. Conclusions We found that the individuals participating in our focus groups were generally enthusiastic about the large clinical study and could see the value in answering the study question. The data from the focus groups were used to inform changes to the recruitment and consent process. Focus group input was also instrumental in affirming the study design regarding return of results. Our experience suggests that the approach we used may serve as a model for other investigators to help inform the various elements of clinical study design, in particular the recruitment and consenting processes and expectations of potential participants regarding the return of individual research findings. PMID:24955380

  7. Phase I Trial of Rosiglitazone in FSGS: I. Report of the FONT Study Group

    PubMed Central

    Joy, Melanie S.; Gipson, Debbie S.; Dike, Mary; Powell, Leslie; Thompson, Amber; Vento, Suzanne; Eddy, Allison; Fogo, Agnes B.; Kopp, Jeffrey B.; Cattran, Daniel; Trachtman, Howard

    2009-01-01

    Background and objectives: Patients with primary focal segmental glomerulosclerosis (FSGS) who are resistant to standard therapy are at high risk for progressive chronic kidney disease. Prevention of renal fibrosis represents a promising strategy to slow or halt kidney function decline. This paper presents the results of a Phase I clinical trial of rosiglitazone, a thiazolidinedione, that exerts antifibrotic effects in animal models of FSGS. The primary goal was assessment of safety, tolerability, and pharmacokinetics (PK) of rosiglitazone. Design, setting, participants, & measurements; Eleven patients, including eight boys/men and three girls/women, with mean age 15 ± 6 yr and estimated GFR 131 ± 62 ml/min/1.73 m2, received rosiglitazone, 3 mg/m2/d for 16 wk. PK was assessed twice, after the initial dose and after attaining steady state, in a General Clinical Research Center. Results: There were no serious adverse events or cardiovascular complications. Rosiglitazone was well tolerated by all patients, as judged by the Treatment Satisfaction Questionnaire for Medication. The PK studies indicated that the area under the curve was decreased by 40 to 50% and oral clearance of rosiglitazone was increased by 250 to 300% in patients with resistant FSGS compared with healthy controls and patients with nonproteinuric stage 2 chronic kidney disease. Conclusions: Rosiglitazone therapy was safe and well tolerated. PK assessment of potential novel therapies for resistant FSGS is necessary to define appropriate dosing regimens. There is rationale to evaluate the efficacy of rosiglitazone as an antifibrotic agent for resistant FSGS in Phase II/III clinical trials. PMID:19073787

  8. Factors affecting baseline quality of life in two international adjuvant breast cancer trials. International Breast Cancer Study Group (IBCSG).

    PubMed Central

    Bernhard, J.; Hürny, C.; Coates, A. S.; Peterson, H. F.; Castiglione-Gertsch, M.; Gelber, R. D.; Galligioni, E.; Marini, G.; Thürlimann, B.; Forbes, J. F.; Goldhirsch, A.; Senn, H. J.; Rudenstam, C. M.

    1998-01-01

    Quality of life (QL) is used to assess treatments in clinical trials but may be influenced by other factors. We analysed the impact of biomedical, sociodemographic and cultural factors on baseline QL indicators in two International Breast Cancer Study Group trials. Patients with stage II breast cancer were randomized within 6 weeks of primary surgery to various adjuvant treatments. They were asked to assess five indicators of QL at baseline. QL forms were available for 1231 (83%) of the 1475 premenopausal and 989 (82%) of the 1212 post-menopausal patients, who were from nine countries and spoke seven languages. Culture (defined as language/country groups) had a statistically significant impact on baseline QL measures. Premenopausal patients with poor prognostic factors showed a tendency to report worse QL, with oestrogen receptor status as an independent predictor for mood (P = 0.0005). Older post-menopausal patients reported better emotional wellbeing (P = 0.002), mood (P = 0.002), and less effort to cope (P = 0.0009) compared with younger post-menopausal patients. Co-morbidity, type of surgery, treatment assignment and sociodemographic factors showed a statistically significant impact in post-menopausal patients only. Cultural and biomedical factors influenced baseline QL and should be considered when evaluating the impact of treatment on QL in international breast cancer clinical trials. PMID:9744512

  9. Gall stone recurrence and its prevention: the British/Belgian Gall Stone Study Group's post-dissolution trial.

    PubMed Central

    Hood, K A; Gleeson, D; Ruppin, D C; Dowling, R H

    1993-01-01

    The British/Belgian Gall Stone Study Group (BBGSG) post-dissolution trial was a prospective, multicentre, randomised, double blind trial of: (i) low dose ursodeoxycholic acid, (ii) placebo, and (iii) a high fibre, low refined carbohydrate diet in the prevention of gall stone recurrence in patients with complete gall stone dissolution. Further aims included establishing the timing and frequency of recurrence and its association with biliary symptoms, a comparison of the sensitivity of ultrasonography v oral cholecystectography in detecting recurrent stones, and a search for risk factors predicting recurrence. Ninety three patients entered the study, and 82 were followed up for up to five years (mean (SEM) 28 (1.5) months) with six monthly ultrasonography and yearly oral cholecystectography. There were 21 recurrences (26 by oral cholecystectography or ultrasonography, or both), only two of which were symptomatic, which were detected between 12 and 42 months after trial entry. This corresponded to an actuarial recurrence rate of 33.9 (7.0%) by lifetable analysis at 42 months and subsequently. There were four recurrences in the ursodeoxycholic acid, six in the placebo, and 11 in the diet groups, corresponding to 21.9 (9.9)%, 27.4 (10.1)%, and 45.8 (12.4)% respectively at 42 months by lifetable analysis (NS). Variables including age, obesity, menopausal state, pregnancy, and oestrogen containing drugs were not shown to affect recurrence rate. Men had more frequent recurrence than women (NS). Patients who had had multiple stones experienced more recurrences than did those with single stones (NS). Recurrence did not occur in patients who took non-steroidal anti-inflammatory drugs (NSAIDs) (p < 0.02). The stone free interval between stone dissolution and trial entry proved to be important--those stone free > nine months had a recurrence rate of only 12.7 (6.0)% at 42 months compared with 55.4 (12.5)% in those stone free < nine months (p < 0.01). There was imbalance between the ursodeoxycholic acid and placebo groups for this factor, and after applying a statistical correction, the adjusted recurrence rate in the ursodeoxycholic acid group was 15% compared with 30% in both placebo and diet groups (NS). These data suggest that after medical dissolution, the risk of gall stone recurrence is not reduced by a high fibre, low refined carbohydrate diet: it may be lowered, but not abolished, by low dose ursodeoxycholic acid. PMID:8406169

  10. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

    PubMed Central

    2012-01-01

    MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy regarding vitamin D supplementation in pregnancy. It will also provide a valuable resource in which to study the influence of maternal vitamin D status on other childhood outcomes such as glucose tolerance, blood pressure, cardiovascular function, IQ and immunology. PMID:22314083

  11. A randomised trial of low dose folic acid to prevent neural tube defects. The Irish Vitamin Study Group

    Microsoft Academic Search

    P N Kirke; L E Daly; J H Elwood

    1992-01-01

    A randomised trial was initiated in Ireland in 1981 to determine if periconceptional supplementation with either folic acid alone or a multivitamin preparation alone could reduce the recurrence risk of neural tube defects (NTDs) in women with a previously affected pregnancy from 5.0% to 1.0% or less. The trial was concluded before the initial target number of study subjects was

  12. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials.

    PubMed

    Goede, Valentin; Cramer, Paula; Busch, Raymonde; Bergmann, Manuela; Stauch, Martina; Hopfinger, Georg; Stilgenbauer, Stephan; Döhner, Hartmut; Westermann, Anne; Wendtner, Clemens M; Eichhorst, Barbara; Hallek, Michael

    2014-06-01

    This study investigated the impact of comorbidity in 555 patients with chronic lymphocytic leukemia enrolled in two trials of the German Chronic Lymphocytic Leukemia Study Group on first-line treatment with fludarabine plus cyclophosphamide, fludarabine, or chlorambucil. Patients with two or more comorbidities and patients with less than two comorbidities differed in overall survival (71.7 versus 90.2 months; P<0.001) and progression-free survival (21.0 versus 31.5 months; P<0.01). After adjustment for other prognostic factors and treatment, comorbidity maintained its independent prognostic value in a multivariate Cox regression analysis. Chronic lymphocytic leukemia was the major cause of death in patients with two or more comorbidities. Disease control in patients with two or more comorbidities was better with fludarabine plus cyclophosphamide than with fludarabine treatment, but not with fludarabine compared to chlorambucil treatment. These results give insight into interactions between comorbidity and therapy of chronic lymphocytic leukemia and suggest that durable control of the hematologic disease is most critical to improve overall outcome of patients with increased comorbidity. The registration numbers of the trials reported are NCT00276848 and NCT00262795. PMID:24584349

  13. Outcome of the vaginal infections and prematurity study: Results of a clinical trial of erythromycin among pregnant women colonized with group B streptococci

    Microsoft Academic Search

    Mark A. Klebanoff; Joan A. Regan; A. Vijaya Rao; Robert P. Nugent; William C. Blackwelder; David A. Eschenbach; Joseph G. Pastorek; Sterling Williams; Ronald S. Gibbs; J. Chris Carey

    1995-01-01

    OBJECTIVE: Our purpose was to determine whether erythromycin treatment of pregnant women colonized with group B streptococci would reduce the occurrence of low birth weight (<2500 gm) and preterm (<37 completed weeks) birth.STUDY DESIGN: In a double-blind clinical trial, 938 carriers of group B streptococci were randomized to receive erythromycin base (333 mg three times a day) or matching placebo

  14. Racial Differences in Response to Antiretroviral Therapy for HIV Infection: An AIDS Clinical Trials Group (ACTG) Study Analysis

    PubMed Central

    Ribaudo, Heather J.; Smith, Kimberly Y.; Robbins, Gregory K.; Flexner, Charles; Haubrich, Richard; Chen, Yun; Fischl, Margaret A.; Schackman, Bruce R.; Riddler, Sharon A.; Gulick, Roy M.

    2013-01-01

    Background.?In the United States, black individuals infected with human immunodeficiency virus (HIV) have higher rates of virologic failure on antiretroviral therapy (ART) and of death compared to white individuals. The cause for these disparities is uncertain. We sought to examine differences in virologic outcomes among antiretroviral-naive clinical trial participants starting randomized ART and to investigate factors to explain the differences. Methods.?Individual-level data from participants initiating ART in 5 AIDS Clinical Trials Group studies were analyzed. Included studies were those conducted during 1998–2006 with a primary outcome of virologic failure. The primary outcome measure was time to virologic failure, regardless of ART changes. Results.?A total of 2495 individuals (1151 black; 1344 white) were included with a median follow-up of 129 weeks. Compared to whites, blacks had an increased hazard of virologic failure (hazard ratio [HR]; 1.7; 95% confidence interval [CI], 1.4–1.9; P < .001), with no evidence of heterogeneity across regimens (P = .97); the association remained after adjustment for measured confounders (HR, 1.4; 95% CI, 1.2–1.6; P < .001). Increased hazard of virologic failure was associated with younger age, higher pretreatment HIV type 1 RNA level, lower pretreatment CD4 cell count, hepatitis C antibody, less education, and recent nonadherence to treatment. Sensitivity analyses with different endpoint definitions demonstrated similar results. Conclusions.?In this analysis, blacks had a 40% higher virologic failure risk than whites that was not explained by measured confounders. The observation was consistent over a range of regimens, suggesting that the difference may be driven by social factors; however, biological factors cannot be ruled out. Further research should identify the sources of racial disparities and develop strategies to reduce them. PMID:24046302

  15. Phase II trial of etoposide in leiomyosarcoma of the uterus: a Gynecologic Oncology Group study.

    PubMed

    Thigpen, T; Blessing, J A; Yordan, E; Valea, F; Vaccarello, L

    1996-10-01

    Twenty-eight patients with advanced, persistent or recurrent leiomyosarcoma of the uterus not previously exposed to cytotoxic drugs were entered into a study of single-agent intravenous etoposide 100 mg/m2 daily for 3 days every 3 weeks. No complete or partial responses were observed. Thirteen patients demonstrated stable disease, while 15 exhibited increasing disease. Median progression-free interval was 2.1 months, median survival 9.2+ months. The most frequent and severe adverse effects were the result of myelosuppression and manifested primarily as leukopenia and neutropenia. Based on the absence of activity, no further study of intravenous etoposide in leiomyosarcoma of the uterus at the dose and schedule tested is planned. PMID:8898180

  16. Phase II Trial of Etoposide in Leiomyosarcoma of the Uterus: A Gynecologic Oncology Group Study

    Microsoft Academic Search

    Tate Thigpen; John A. Blessing; Edgardo Yordan; Fidel Valea; Luis Vaccarello

    1996-01-01

    Twenty-eight patients with advanced, persistent or recurrent leiomyosarcoma of the uterus not previously exposed to cytotoxic drugs were entered into a study of single-agent intravenous etoposide 100 mg\\/m2daily for 3 days every 3 weeks. No complete or partial responses were observed. Thirteen patients demonstrated stable disease, while 15 exhibited increasing disease. Median progression-free interval was 2.1 months, median survival 9.2+

  17. Phase II trial with S-1 in chemotherapy-na??ve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)

    Microsoft Academic Search

    P Chollet; P Schöffski; K Weigang-Köhler; J. H. M Schellens; H Cure; N Pavlidis; V Grünwald; R De Boer; J Wanders; P Fumoleau

    2003-01-01

    S-1 is a new oral fluorinated pyrimidine derivate, in which the oral 5-fluorouracil (5-FU) prodrug, tegafur, was combined with two 5-FU-modulating substances, 5-chloro-2,4-dihydroxypyridine (gimeracil), and potassium oxonate (oteracil), at a molar ratio of 1:0.4:1. The final mechanism of action is exerted by 5-FU. The present study is the first European phase II trial of S-1 in gastric cancer. The primary

  18. Phase II Study of Temsirolimus in Women With Recurrent or Metastatic Endometrial Cancer: A Trial of the NCIC Clinical Trials Group

    PubMed Central

    Oza, Amit M.; Elit, Laurie; Tsao, Ming-Sound; Kamel-Reid, Suzanne; Biagi, Jim; Provencher, Diane Michele; Gotlieb, Walter H.; Hoskins, Paul J.; Ghatage, Prafull; Tonkin, Katia S.; Mackay, Helen J.; Mazurka, John; Sederias, Joana; Ivy, Percy; Dancey, Janet E.; Eisenhauer, Elizabeth A.

    2011-01-01

    Purpose Phosphatase and tensin homolog (PTEN) is a tumor suppressor gene, and loss of function mutations are common and appear to be important in the pathogenesis of endometrial carcinomas. Loss of PTEN causes deregulated phosphatidylinositol-3 kinase/serine-threonine kinase/mammalian target of rapamycin (PI3K/Akt/mTOR) signaling which may provide neoplastic cells with a selective survival advantage by enhancing angiogenesis, protein translation, and cell cycle progression. Temsirolimus, an ester derivative of rapamycin that inhibits mTOR, was evaluated in this setting. Patients and Methods Sequential phase II studies evaluated single-agent activity of temsirolimus in women with recurrent or metastatic chemotherapy-naive or chemotherapy-treated endometrial cancer. Temsirolimus 25 mg intravenously was administered weekly in 4-week cycles. Results In the chemotherapy-naive group, 33 patients received a median of four cycles (range, one to 23 cycles). Of the 29 patients evaluable for response, four (14%) had an independently confirmed partial response and 20 (69%) had stable disease as best response, with a median duration of 5.1 months (range, 3.7 to 18.4 months) and 9.7 months (range, 2.1 to 14.6 months). Only five patients (18%) had progressive disease. In the chemotherapy-treated group, 27 patients received a median of three cycles (range, one to six cycles). Of the 25 patients evaluable for response, one (4%) had an independently confirmed partial response, and 12 patients (48%) had stable disease, with a median duration of 4.3 months (range, 3.6 to 4.9 months) and 3.7 months (range, 2.4 to 23.2 months). PTEN loss (immunohistochemistry and mutational analysis) and molecular markers of PI3K/Akt/mTOR pathway did not correlate with the clinical outcome. Conclusion mTOR inhibition with temsirolimus has encouraging single-agent activity in endometrial cancer which is higher in chemotherapy-naive patients than in chemotherapy-treated patients and is independent of PTEN status. The difference in activity according to prior therapy should be factored into future clinical trial designs. PMID:21788564

  19. Quality assurance of HIV prevention counseling in a multi-center randomized controlled trial. Project RESPECT Study Group.

    PubMed Central

    Kamb, M L; Dillon, B A; Fishbein, M; Willis, K L

    1996-01-01

    Current HIV prevention counseling strategies rely largely on interventions aimed at changing behaviors. Among these is HIV prevention counseling and testing, which has been a prominent component in the federally supported strategies for HIV/AIDS prevention in the United States. To assess the efficacy of HIV counseling in reducing risk behaviors and preventing HIV infection and other sexually transmitted diseases, a multicenter, randomized controlled trial is being conducted among sexually transmitted disease clinic patients (Project RESPECT). The trial compares three separate HIV prevention strategies on increasing condom use and decreasing new cases of sexually transmitted diseases. The strategies are (a) Enhanced HIV Prevention Counseling, a 4-session individual counseling intervention based on behavioral and social science theory; (b) HIV Prevention Counseling, a 2-session individual pre- and post test counseling strategy that attempts to increase perception of risk and reduce risk behaviors using small, achievable steps; and (c) HIV Education, a brief 2-session pre- and post-test strategy that is purely informational. One difficulty in conducting randomized trials of behavioral interventions is assuring that the interventions are being conducted both as conceptualized and in a consistent manner by different counselors and, for multicenter studies, at different study sites. This article describes the quality assurance measures that have been used for Project RESPECT. These have included development of standard tools, standard training, frequent observation and feedback to study personnel, and process evaluation. PMID:8862164

  20. A Novel Study Paradigm for Long-term Prevention Trials in Alzheimer Disease: The Placebo Group Simulation Approach (PGSA)

    PubMed Central

    Berres, M.; Kukull, W.A; Miserez, A.R.; Monsch, A.U.; Monsell, S.E; Spiegel, R.

    2014-01-01

    INTRODUCTION The PGSA (Placebo Group Simulation Approach) aims at avoiding problems of sample representativeness and ethical issues typical of placebo-controlled secondary prevention trials with MCI patients. The PGSA uses mathematical modeling to forecast the distribution of quantified outcomes of MCI patient groups based on their own baseline data established at the outset of clinical trials. These forecasted distributions are then compared with the distribution of actual outcomes observed on candidate treatments, thus substituting for a concomitant placebo group. Here we investigate whether a PGSA algorithm that was developed from the MCI population of ADNI 1*, can reliably simulate the distribution of composite neuropsychological outcomes from a larger, independently selected MCI subject sample. METHODS Data available from the National Alzheimer’s Coordinating Center (NACC) were used. We included 1523 patients with single or multiple domain amnestic mild cognitive impairment (aMCI) and at least two follow-ups after baseline. In order to strengthen the analysis and to verify whether there was a drift over time in the neuropsychological outcomes, the NACC subject sample was split into 3 subsamples of similar size. The previously described PGSA algorithm for the trajectory of a composite neuropsychological test battery (NTB) score was adapted to the test battery used in NACC. Nine demographic, clinical, biological and neuropsychological candidate predictors were included in a mixed model; this model and its error terms were used to simulate trajectories of the adapted NTB. RESULTS The distributions of empirically observed and simulated data after 1, 2 and 3 years were very similar, with some over-estimation of decline in all 3 subgroups. The by far most important predictor of the NTB trajectories is the baseline NTB score. Other significant predictors are the MMSE baseline score and the interactions of time with ApoE4 and FAQ (functional abilities). These are essentially the same predictors as determined for the original NTB score. CONCLUSION An algorithm comprising a small number of baseline variables, notably cognitive performance at baseline, forecasts the group trajectory of cognitive decline in subsequent years with high accuracy. The current analysis of 3 independent subgroups of aMCI patients from the NACC database supports the validity of the PGSA longitudinal algorithm for a NTB. Use of the PGSA in long-term secondary AD prevention trials deserves consideration. PMID:25530953

  1. Participants' experiences of care during a randomized controlled trial comparing a lay-facilitated angina management programme with usual care: a qualitative study using focus groups

    PubMed Central

    Nelson, Pauline; Cox, Helen; Furze, Gill; Lewin, Robert JP; Morton, Veronica; Norris, Heather; Patel, Nicky; Elton, Peter; Carty, Richard

    2013-01-01

    Aim This paper is a report of a qualitative study conducted as part of a randomized controlled trial comparing a lay-facilitated angina management programme with usual care. Its aim was to explore participants' beliefs, experiences, and attitudes to the care they had received during the trial, particularly those who had received the angina management intervention. Background Angina affects over 50 million people worldwide. Over half of these people have symptoms that restrict their daily life and would benefit from knowing how to manage their condition. Design A nested qualitative study within a randomized controlled trial of lay-facilitated angina management. Method We conducted four participant focus groups during 2008; three were with people randomized to the intervention and one with those randomized to control. We recruited a total of 14 participants to the focus groups, 10 intervention, and 4 control. Findings Although recruitment to the focus groups was relatively low by comparison to conventional standards, each generated lively discussions and a rich data set. Data analysis demonstrated both similarities and differences between control and intervention groups. Similarities included low levels of prior knowledge about angina, whereas differences included a perception among intervention participants that lifestyle changes were more easily facilitated with the help and support of a lay-worker. Conclusion Lay facilitation with the Angina Plan is perceived by the participants to be beneficial in supporting self-management. However, clinical expertise is still required to meet the more complex information and care needs of people with stable angina. PMID:22738415

  2. A trial of zileuton versus mesalazine or placebo in the maintenance of remission of ulcerative colitis. The European Zileuton Study Group For Ulcerative Colitis

    Microsoft Academic Search

    CJ Hawkey; LM Dube; LV Rountree; PJ Linnen; JF Lancaster

    1997-01-01

    BACKGROUND & AIMS: Leukotriene B4 is a major neutrophil chemoattractant detected during relapse of inflammatory bowel disease and represents a potentional therapeutic target. The aim of this study was to compare the efficacy of zileuton, an active 5-lipoxygenase inhibitor, with mesalazine and placebo in the maintenance of remission in ulcerative colitis.METHODS: A double-blind, parallel-group, multicenter, and multinational trial was conducted

  3. Rituximab in relapsed lymphocyte-predominant Hodgkin lymphoma: long-term results of a phase 2 trial by the German Hodgkin Lymphoma Study Group (GHSG)

    Microsoft Academic Search

    Holger Schulz; Ute Rehwald; Franck Morschhauser; Thomas Elter; Christoph Driessen; Thomas Rudiger; Peter Borchmann; Roland Schnell; Volker Diehl; Andreas Engert; Marcel Reiser

    2007-01-01

    Because nodular lymphocyte-predomi- nant Hodgkin lymphoma (NLPHL) ex- press CD20, rituximab may be used as a nonmutagenic treatment option to avoid late toxicities in this rather indolent en- tity. Between 1999 and 2004, the German Hodgkin Study Group (GHSG) investi- gated the activity of rituximab (375 mg\\/m2 in 4 doses) in a phase 2 trial in 21 relapsed or refractory

  4. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ? 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates. Discussion Several aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic. Trial Registration Number ISRCTN45190901 PMID:21388549

  5. The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

    PubMed Central

    2013-01-01

    Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

  6. Randomized Phase II Trial of Erlotinib Versus Temozolomide or Carmustine in Recurrent Glioblastoma: EORTC Brain Tumor Group Study 26034

    PubMed Central

    van den Bent, Martin J.; Brandes, Alba A.; Rampling, Roy; Kouwenhoven, Mathilde C.M.; Kros, Johan M.; Carpentier, Antoine F.; Clement, Paul M.; Frenay, Marc; Campone, Mario; Baurain, Jean-Francois; Armand, Jean-Paul; Taphoorn, Martin J.B.; Tosoni, Alicia; Kletzl, Heidemarie; Klughammer, Barbara; Lacombe, Denis; Gorlia, Thierry

    2009-01-01

    Purpose Approximately 50% of glioblastomas (GBMs) are characterized by overexpression of the epidermal growth factor receptor (EGFR) and EGFR gene amplification. In approximately 25% of instances, constitutively activated EGFR mutants are present. These observations make EGFR-inhibiting drugs a logical approach for trials in recurrent GBM. Patients and Methods In a randomized, controlled, phase II trial, 110 patients with progressive GBM after prior radiotherapy were randomly assigned to either erlotinib or a control arm that received treatment with either temozolomide or carmustine (BCNU). The primary end point was 6-month progression-free survival (PFS). Tumor specimens obtained at first surgery were investigated for EGFR expression; EGFRvIII mutants; EGFR amplification; EGFR mutations in exons 18, 19, and 21; and pAkt. These results were correlated with outcome. Pharmacokinetic analysis was part of the study. Results Treatment was well tolerated in general; skin toxicity was the most frequent adverse effect of erlotinib. The 6-month PFS rate in the erlotinib arm was 11.4% (95% CI, 4.6% to 21.5%), and it was 24% in the control arm. Of all explored biomarkers, only low pAkt expression appeared to be of borderline significance to an improved outcome. None of the eight patients who had tumors with EGFRvIII mutant presence and PTEN expression had 6-month PFS. The use of enzyme-inducing anticonvulsants significantly increased erlotinib clearance, but pharmacokinetic findings were not related to outcome. Conclusion Erlotinib has insufficient single-agent activity in unselected GBM. No clear biomarker associated with improved outcome to erlotinib was identified. PMID:19204207

  7. Impact of Randomized Antiretroviral Therapy Initiation on Glucose Metabolism: AIDS Clinical Trials Group Study A5224s

    PubMed Central

    ERLANDSON, Kristine Mace; KITCH, Douglas; TIERNEY, Camlin; SAX, Paul E.; DAAR, Eric S.; MELBOURNE, Kathleen M.; HA, Belinda; MCCOMSEY, Grace A.

    2014-01-01

    Objective Prior studies have found that early HIV protease inhibitors (PIs) contribute to glucose dysregulation. Few randomized trials have evaluated glucose indices in antiretroviral-naïve subjects on newer antiretroviral therapy (ART). Methods A5224s was a substudy of A5202, a prospective trial of 1857 ART-naïve participants randomized to blinded abacavir-lamivudine (ABC/3TC) or tenofovir DF-emtricitabine (TDF/FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV/r). Analyses used 2-sample t-tests, Spearman correlation coefficients and linear regression. Results A5224s included 269 non-diabetic subjects: 85% male, 47% white non-Hispanic, baseline median age 38 years, HIV-1 RNA 4.6 log10 copies/mL and CD4 233 cells/?L. Overall, significant 96-week increases occurred in fasting glucose, insulin, and the homeostatic model assessment of insulin resistance (HOMA-IR), p?0.004. Assignment to EFV (vs ATV/r) resulted in significantly greater glucose increase (mean difference 4.4; 95% CI 1.3, 7.5 mg/dL; p=0.006) but not insulin or HOMA-IR (p?0.72). Glucose indices were not significantly different between ABC/3TC or TDF/FTC arms, p?0.18. Significant correlations were detected between changes in glucose indices and changes in body mass index; all r?0.23, p?0.001. In multivariable analyses, in addition to the EFV effect, higher baseline HIV-1 RNA, and greater BMI change were significant independent factors associated with greater glucose increase. Conclusions Changes in glucose metabolism were not significantly different between TDF/FTC- and ABC/3TC-based regimens. A small but significantly greater increase in glucose was observed in those assigned to EFV. As glucose dysregulation may increase with time on ART, longer term studies will be needed to further clarify the clinical significance of these findings. PMID:24637543

  8. The Irish DAFNE Study Protocol: A cluster randomised trial of group versus individual follow-up after structured education for Type 1 diabetes

    PubMed Central

    Dinneen, Seán F; O' Hara, Mary Clare; Byrne, Molly; Newell, John; Daly, Lisa; O' Shea, Donal; Smith, Diarmuid

    2009-01-01

    Background Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA1c and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. Methods Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA1c levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA1c values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA1c were undertaken in a central laboratory. Discussion This pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practice Trial registration Current Controlled Trials ISRCTN79759174 PMID:19775465

  9. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    PubMed

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment. PMID:24378880

  10. A randomized trial of cyclophosphamide and doxorubicin with or without cisplatin in advanced ovarian carcinoma. A Gynecologic Oncology Group Study.

    PubMed

    Omura, G; Blessing, J A; Ehrlich, C E; Miller, A; Yordan, E; Creasman, W T; Homesley, H D

    1986-05-01

    A randomized clinical trial was conducted in women with bulky (suboptimal) Stage III and Stage IV ovarian carcinoma, using doxorubicin (Adriamycin) and cyclophosphamide with or without cisplatin. There were 440 evaluable cases, of which 227 had measurable disease. One hundred twenty of these latter patients were treated with cyclophosphamide and doxorubicin (CA), while 107 received cyclophosphamide, doxorubicin and cisplatin (CAP). The clinical complete response (CR) rate for CA was 26% (31/120) compared with 51% (55/107) for CAP (P = less than 0.0001). Of 23 CRs receiving CA who had a second-look laparotomy, only four were negative; of 39 CRs receiving CAP and a second-look, 13 were negative (not statistically significant). The response duration for patients with measurable disease (median 14.6 versus 8.8 months), progression-free interval for all patients (13.1 versus 7.7 months), and survival for patients with measurable disease (19.7 versus 15.7 months) showed a statistically significant advantage for CAP; however, there was no difference in survival of patients with nonmeasurable disease. Toxicity was more severe with CAP but was tolerable. Thus, the addition of cisplatin improves the chemotherapy of advanced ovarian carcinoma. PMID:3513943

  11. Prostate-Specific Antigen Progression Predicts Overall Survival in Patients With Metastatic Prostate Cancer: Data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916

    PubMed Central

    Hussain, Maha; Goldman, Bryan; Tangen, Cathy; Higano, Celestia S.; Petrylak, Daniel P.; Wilding, George; Akdas, Atif M.; Small, Eric J.; Donnelly, Bryan J.; Sundram, Subramanian Kanaga; Burch, Patrick A.; DiPaola, Robert S.; Crawford, E. David

    2009-01-01

    Purpose Prostate-specific antigen progression (PSA-P) is an indicator of progression in hormone-sensitive (HS) and castration-resistant (CR) prostate cancer (PC). We evaluated different definitions of PSA-P as predictors of overall survival (OS). Patients and Methods A total of 1,078 patients with HSPC who were on hormones (Southwest Oncology Group [SWOG] trial 9346 [S9346]) and 597 patients with CRPC who were treated with chemotherapy (SWOG trial 9916 [S9916]) were eligible for this analysis. PSA-P definitions tested included the following: PSA Working Group, Prostate Cancer Working Group (PCWG 2008), and other definitions. A time-varying approach analyzed associations between PSA-P at any time and OS. A landmark analysis examined the relationship between PSA-P status at 7 months for S9346, or 3 months for S9916, and subsequent OS. Results In the time-varying analysis, both working groups definitions were strongly associated with OS (P < .001) in both study settings. In patients enrolled onto S9346, both definitions predicted a 2.4-fold increased risk of death (ROD) and a greater than four-fold increased ROD if PSA-P occurred in the first 7 months. In S9916, they predicted a 40% increase in ROD and a two-fold increase in ROD if PSA-P occurred at 3 months. In landmark analyses of patients on S9346 by using the PCWG 2008 definition of PSA-P, median subsequent OS was 10 months versus 44 months in patients who did or did not have PSA-P by 7 months, respectively; in S9916, data were 11 months versus 18 months for patients who did or did not have PSA-P by 3 months, respectively. Conclusion PSA-P, defined as an increase of ? 25% greater than the nadir and an absolute increase of at least 2 or 5 ng/mL, predicts OS in HSPC and CRPC and may be a suitable end point for phase II studies in these settings. PMID:19380444

  12. A randomized trial of surgery with and without chemotherapy for localized squamous carcinoma of the thoracic esophagus: The Japan clinical oncology group study

    Microsoft Academic Search

    Nobutoshi Ando; Toshifumi Iizuka; Teruo Kakegawa; Kaichi Isono; Hiroshi Watanabe; Hiroko Ide; Otsuo Tanaka; Masayuki Shinoda; Wataru Takiyama; Masaki Arimori; Kaoru Ishida; Shoichiro Tsugane

    1997-01-01

    Objective: To determine whether postoperative adjuvant chemotherapy confers a survival benefit on patients with esophageal squamous cell carcinoma undergoing radical surgery, we undertook a cooperative, prospective randomized controlled trial. Methods: A total of 205 patients underwent transthoracic esophagectomy with lymphadenectomy at eleven institutions between December 1988 and July 1991. These patients were prospectively randomized into two groups (100 patients underwent

  13. A Phase II Trial of Brivanib in Recurrent or Persistent Endometrial Cancer: An NRG Oncology/Gynecologic Oncology Group Study

    PubMed Central

    Powell, Matthew A.; Sill, Michael W.; Goodfellow, Paul J.; Benbrook, Doris M.; Lankes, Heather A.; Leslie, Kimberly K.; Jeske, Yvette; Mannel, Robert S.; Spillman, Monique A; Lee, Paula S.; Hoffman, James S.; McMeekin, D. Scott; Pollock, Pamela M.

    2014-01-01

    Purpose Brivanib, an oral, multi-targeted tyrosine kinase inhibitor with activity against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR) was investigated as a single agent in a phase II trial to assess the activity and tolerability in recurrent or persistent endometrial cancer (EMC). Patients and Methods Eligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and performance status of ?2. Treatment consisted of brivanib 800 mg orally every day until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) at six months and objective tumor response. Expression of multiple angiogenic proteins and FGFR2 mutation status was assessed. Results Forty-five patients were enrolled. Forty-three patients were eligible and evaluable. Median age was 64 years. Twenty-four patients (55.8%) received prior radiation. Median number of cycles was two (range 1–24). No GI perforations but one rectal fistula were seen. Nine patients had grade 3 hypertension, with one experiencing grade 4 confusion. Eight patients (18.6%; 90% CI 9.6–31.7%) had responses (one CR and seven PRs), and 13 patients (30.2%; 90% CI 18.9–43.9%) were PFS at six months. Median PFS and overall survival (OS) were 3.3 and 10.7 months, respectively. When modeled jointly, VEGF and Angiopoietin-2 expression may diametrically predict PFS. Estrogen receptor-? (ER) expression was positively correlated with OS. Conclusion Brivanib is reasonably well tolerated and worthy of further investigation based on PFS at six months in recurrent or persistent EMC. PMID:25019571

  14. Phase I Three-Dimensional Conformal Radiation Dose Escalation Study in Newly Diagnosed Glioblastoma: Radiation Therapy Oncology Group Trial 98-03

    SciTech Connect

    Tsien, Christina [Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States)], E-mail: ctsien@umich.edu; Moughan, Jennifer [Radiation Therapy Oncology Group, Philadelphia, PA (United States); Michalski, Jeff M. [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Gilbert, Mark R. [Department of Neuro-Oncology, University of Texas M. D. Anderson Cancer Center, Houston, TX (United States); Purdy, James [University of California-Davis Medical Center, Sacramento, CA (United States); Simpson, Joseph [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Kresel, John J. [Arizona Oncology Services and Barrows Neurological Institute, Phoenix, AZ (United States); Curran, Walter J. [Thomas Jefferson University, Philadelphia, PA (United States); Diaz, Aidnag [University of Texas Health Science Center, San Antonio, TX (United States); Mehta, Minesh P. [University of Wisconsin, Madison, WI (United States)

    2009-03-01

    Purpose: To evaluate in a Phase I trial the feasibility and toxicity of dose-escalated three-dimensional conformal radiotherapy (3D-CRT) concurrent with chemotherapy in patients with primary supratentorial glioblastoma (GBM). Methods and Materials: A total of 209 patients were enrolled. All received 46 Gy in 2-Gy fractions to the first planning target volume (PTV{sub 1}), defined as the gross tumor volume (GTV) plus 1.8 cm. A subsequent boost was given to PTV{sub 2}, defined as GTV plus 0.3 cm. Patients were stratified into two groups (Group 1: PTV{sub 2} <75 cm{sup 3}; Group 2: PTV{sub 2} {>=}75 cm{sup 3}). Four RT dose levels were evaluated: 66, 72, 78, and 84 Gy. Carmustine 80 mg/m{sup 2} was given during RT, then every 8 weeks for 6 cycles. Pretreatment characteristics were well balanced. Results: Acute and late Grade 3/4 RT-related toxicities were no more frequent at higher RT dose or with larger tumors. There were no dose-limiting toxicities (acute Grade {>=}3 irreversible central nervous system toxicities) observed on any dose level in either group. On the basis of the absence of dose-limiting toxicities, dose was escalated to 84 Gy in both groups. Late RT necrosis was noted at 66 Gy (1 patient), 72 Gy (2 patients), 78 Gy (2 patients), and 84 Gy (3 patients) in Group 1. In Group 2, late RT necrosis was noted at 78 Gy (1 patient) and 84 Gy (2 patients). Median time to RT necrosis was 8.8 months (range, 5.1-12.5 months). Median survival in Group 1 was 11.6-19.3 months. Median survival in Group 2 was 8.2-13.9 months. Conclusions: Our study shows the feasibility of delivering higher than standard (60 Gy) RT dose with concurrent chemotherapy for primary GBM, with an acceptable risk of late central nervous system toxicity.

  15. Effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care: study protocol of a three-arm parallel-group randomized controlled trial

    PubMed Central

    2014-01-01

    Background Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, aiming to evaluate and, if necessary, adapt treatment. Clients fill out questionnaires and clinicians receive feedback about the results. Studies concerning feedback in youth mental health care are rare. The effects of feedback, the importance of specific aspects of feedback, and the mechanisms underlying the effects of feedback are unknown. In the present study, several potentially effective components of feedback from Routine Outcome Monitoring in youth mental health care in the Netherlands are investigated. Methods/Design We will examine three different forms of feedback through a three-arm parallel-group randomized controlled trial. 432 children and adolescents (aged 4 to 17 years) and their parents, who have been referred to mental health care institution Pro Persona, will be randomly assigned to one of three feedback conditions (144 participants per condition). Randomization will be stratified by age of the child or adolescent and by department. All participants fill out questionnaires at the start of treatment, one and a half months after the start of treatment, every three months during treatment, and at the end of treatment. Participants in the second and third feedback conditions fill out an additional questionnaire. In condition 1, clinicians receive basic feedback regarding clients’ symptoms and quality of life. In condition 2, the feedback of condition 1 is extended with feedback regarding possible obstacles to a good outcome and with practical suggestions. In condition 3, the feedback of condition 2 is discussed with a colleague while following a standardized format for case consultation. The primary outcome measure is symptom severity and secondary outcome measures are quality of life, satisfaction with treatment, number of sessions, length of treatment, and rates of dropout. We will also examine the role of being not on track (not responding to treatment). Discussion This study contributes to the identification of effective components of feedback and a better understanding of how feedback functions in real-world clinical practice. If the different feedback components prove to be effective, this can help to support and improve the care for youth. Trial registration Dutch Trial Register NTR4234 PMID:24393491

  16. [Group meetings for patient recruitment in clinical trial in pediatrics].

    PubMed

    Collet, J P; Floret, D; Cochat, P; Gillet, J; Cogan-Collet, J; David, L; Dauvergne, B; Boissel, J P

    1991-01-01

    Recruitment of patients in a clinical trial is often difficult and probably more difficult in pediatrics where parents are asked to give the informed consent. In order to recruit infants in a randomized clinical trial we organized group meetings with families (4 to 40 at a time) in order to describe the study procedures: random allocation to treatment or placebo and double blind assessment, and ask them to allow their child to participate. All meetings were conducted by both a pediatrician and a RCT specialist. Parents asked questions about the effects of the drug, the evaluation process and the follow-up procedures. Forty nine % of all eligible infants participated in the study. The success rate was related to franc and open communication with the family, provided by highly qualified physicians. PMID:2053092

  17. Efficacy and safety of front-line therapy with fludarabine-cyclophosphamide-rituximab regimen for chronic lymphocytic leukemia outside clinical trials: the Israeli CLL Study Group experience

    PubMed Central

    Herishanu, Yair; Goldschmidt, Neta; Bairey, Osnat; Ruchlemer, Rosa; Fineman, Riva; Rahimi-Levene, Naomi; Shvidel, Lev; Tadmor, Tamar; Ariel, Aviv; Braester, Andrea; Shapiro, Mika; Joffe, Erel; Polliack, Aaron

    2015-01-01

    This study aimed to evaluate the efficacy and safety of the fludarabine-cyclophosphamide-rituximab regimen for young physically fit patients with chronic lymphocytic leukemia in the “real-life” setting. We specifically focused on the impact of dose reduction on patient outcomes. The patient cohort consisted of 128 patients with chronic lymphocytic leukemia (?70 years) treated at 10 Israeli centers with front-line fludarabine-cyclophosphamide-rituximab. We defined reduced chemotherapy as two-thirds or less of the total indicated dose. Patients treated with rituximab were divided into two groups and compared: those who received full dosages of 375 mg/m2 or 500 mg/m2, and patients given less than six cycles with either dose. Overall and clinical complete response rates (92.8% and 70.4%), as well as toxicities and overall survival (median not reached at 6 years), were similar to other reported clinical trials, but progression-free survival was shorter (42.5 months). Almost 50% of patients had some dose reduction of chemotherapy, 21% receiving less than two-thirds of the indicated dose, while close to 30% did not complete six cycles of rituximab. Reduced doses of chemotherapy and rituximab were independently associated with shorter progression-free survival (hazard ratio 3.6, P<0.0001 for reduced chemotherapy; hazard ratio 2.5, P=0.003 for incomplete-treatment with rituximab). Achieving a complete response was associated with longer overall survival but was not linked to the given dose of chemoimmunotherapy. In younger physically fit patients, front-line fludarabine-cyclophosphamide-rituximab therapy in the “real-life” setting achieves long remissions (albeit shorter than in clinical trials) and prolonged overall survival. However, dose reductions are commonly administered and may impact outcome. PMID:25661442

  18. Evaluating the Effect of Early Versus Late ARV Regimen Change if Failure on an Initial Regimen: Results From the AIDS Clinical Trials Group Study A5095.

    PubMed

    Li, Li; Eron, Joseph J; Ribaudo, Heather; Gulick, Roy M; Johnson, Brent A

    2012-01-01

    The current goal of initial antiretroviral (ARV) therapy is suppression of plasma human immunodeficiency virus (HIV)-1 RNA levels to below 200 copies per milliliter. A proportion of HIV-infected patients who initiate antiretroviral therapy in clinical practice or antiretroviral clinical trials either fail to suppress HIV-1 RNA or have HIV-1 RNA levels rebound on therapy. Frequently, these patients have sustained CD4 cell counts responses and limited or no clinical symptoms and, therefore, have potentially limited indications for altering therapy which they may be tolerating well despite increased viral replication. On the other hand, increased viral replication on therapy leads to selection of resistance mutations to the antiretroviral agents comprising their therapy and potentially cross-resistance to other agents in the same class decreasing the likelihood of response to subsequent antiretroviral therapy. The optimal time to switch antiretroviral therapy to ensure sustained virologic suppression and prevent clinical events in patients who have rebound in their HIV-1 RNA, yet are stable, is not known. Randomized clinical trials to compare early versus delayed switching have been difficult to design and more difficult to enroll. In some clinical trials, such as the AIDS Clinical Trials Group (ACTG) Study A5095, patients randomized to initial antiretroviral treatment combinations, who fail to suppress HIV-1 RNA or have a rebound of HIV-1 RNA on therapy are allowed to switch from the initial ARV regimen to a new regimen, based on clinician and patient decisions. We delineate a statistical framework to estimate the effect of early versus late regimen change using data from ACTG A5095 in the context of two-stage designs.In causal inference, a large class of doubly robust estimators are derived through semiparametric theory with applications to missing data problems. This class of estimators is motivated through geometric arguments and relies on large samples for good performance. By now, several authors have noted that a doubly robust estimator may be suboptimal when the outcome model is misspecified even if it is semiparametric efficient when the outcome regression model is correctly specified. Through auxiliary variables, two-stage designs, and within the contextual backdrop of our scientific problem and clinical study, we propose improved doubly robust, locally efficient estimators of a population mean and average causal effect for early versus delayed switching to second-line ARV treatment regimens. Our analysis of the ACTG A5095 data further demonstrates how methods that use auxiliary variables can improve over methods that ignore them. Using the methods developed here, we conclude that patients who switch within 8 weeks of virologic failure have better clinical outcomes, on average, than patients who delay switching to a new second-line ARV regimen after failing on the initial regimen. Ordinary statistical methods fail to find such differences. This article has online supplementary material. PMID:23329858

  19. Pediatric Oncology Group (POG) studies of acute myeloid leukemia (AML): a review of four consecutive childhood AML trials conducted between 1981 and 2000

    Microsoft Academic Search

    Y Ravindranath; M Chang; C P Steuber; D Becton; G Dahl; C Civin; B Camitta; A Carroll; S C Raimondi; H J Weinstein

    2005-01-01

    From 1981 to 2000, a total of 1823 children with acute myeloid leukemia (AML) enrolled on four consecutive Pediatric Oncology Group (POG) clinical trials. POG 8101 demonstrated that the induction rate associated with the 3+7+7 combination of daunorubicin, Ara-C, and 6-thioguanine (DAT) was greater than that associated with an induction regimen used to treat acute lymphoblastic leukemia (82 vs 61%;

  20. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    PubMed

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. PMID:24033239

  1. Phase II trial of Cetuximab in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

    PubMed Central

    Santin, Alessandro D.; Sill, Michael W.; McMeekin, D. Scott; Leitao, Mario M.; Brown, Jubilee; Sutton, Gregory P.; Van Le, Linda; Griffin, Patricia; Boardman, Cecelia H.

    2011-01-01

    Purpose The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix. Patients and Methods Eligible patients had cervical cancer, measurable disease, and GOG performance status ?2. Treatment consisted of cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and response. The study used a 2-stage group sequential design. Results Thirty-eight patients were entered with 3 exclusions, leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n = 25, 71.4%) or 2 (n = 10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n = 5), GI (n = 4), anemia (n = 2), constitutional (n = 3), infection (n = 2), vascular (n = 2), pain (n = 2), and pulmonary, neurological, vomiting and metabolic (n = 1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology. Conclusion Cetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology. PMID:21684583

  2. Measuring Group Dynamics: An Exploratory Trial

    ERIC Educational Resources Information Center

    Phan, Loan T.; Rivera, Edil Torres; Volker, Martin A.; Garrett, Michael T.

    2004-01-01

    This article reports on the development of a scale used to assess and measure group dynamics during group supervision counselling courses (practicum and internship). A 20-item Likert-type scale was administered to 200 counsellors-in-training master's students. Reliability and validity data are described. An exploratory factor analysis yielded…

  3. A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Depression is a mental health condition which affects millions of people each year, with worldwide rates increasing. Cognitive behavioral therapy (CBT) is recommended in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of depression. However, waiting lists can cause delays for face-to-face therapy. Also a proportion of people decline to present for help through the health service – the so-called treatment gap. Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem. The aim of this randomized controlled trial (RCT) is to determine the efficacy of such a guided CBT self-help course, the ‘Living Life to the Full’ (LLTTF) classes delivered by the charity Action on Depression (AOD). The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 (PHQ9) depression scale. Secondary measures include levels of anxiety and social functioning. Methods/design Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website. Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course. The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention. Levels of depression, anxiety and social functioning will be assessed and an economic analysis will be carried out. Discussion This RCT will test whether the LLTTF intervention is effective and/or cost-effective. If the LLTTF community-based classes are found to be cost effective, they may be helpful as both an intervention for those already seeking care in the health service, as well as those seeking help outside that setting, widening access to psychological therapy. Trial registration Current Controlled Trials ISRCTN86292664 PMID:24252475

  4. Phase II Trial of Depsipeptide (NSC-630176) in Previously Treated Colorectal Cancer Patients with Advanced Disease: A Southwest Oncology Group Study (S0336)

    PubMed Central

    Whitehead, Robert P.; Rankin, Cathryn; Hoff, Paulo M.G.; Gold, Philip J.; Billingsley, Kevin G.; Chapman, Robert A.; Wong, Lucas; Ward, John H.; Blanke, Charles D.

    2010-01-01

    Introduction Patients with metastatic colorectal cancer who progress on standard chemotherapy have limited treatment options. New and effective drugs are needed for these patients. Depsipeptide is a histone deacetylase inhibitor that can alter chromatin structure and gene transcription leading to multiple changes in cellular protein production. This may result in cell cycle arrest and tumor growth inhibition. Depsipeptide has shown anti-proliferative activity in vitro against multiple mouse and human tumor cell lines and in vivo in human tumor xenograft models. Patients and Methods Patients were required to have pathologically verified, measurable, metastatic or locally advanced colorectal cancer that was surgically unresectable. They must have failed either one or two prior chemotherapy regimens, had performance status of 0–1, adequate bone marrow, renal and hepatic function, and no significant cardiac disease. Patients were treated with depsipeptide at a dose of 13 mg/m2 as a 4 hour iv infusion on days 1, 8, and 15 of a 28 day cycle. The study had a two stage design. The primary objective of the study was to determine the confirmed response probability in this group of patients treated with depsipeptide. Results Twenty-eight patients were registered to the study, two of whom were ineligible. One eligible patient refused all treatment and was not analyzed. For the 25 remaining patients, performance status was 0 in 16 patients and 1 in 9 patients. Ten patients had received one prior chemotherapy regimen and fifteen 2 prior regimens. Out of the 25 eligible and analyzable patients accrued in the first stage of the protocol, no objective responses were observed and the study was permanently closed. Four patients had stable disease as the best response. Twenty-five patients were assessed for toxicity. No grade 4 or greater toxicities were seen. Fourteen of the 25 patients experienced grade 3 toxicities the most common of which were fatigue or anorexia. Conclusion Depsipeptide at this dose and schedule is ineffective in the treatment of patients with metastatic colorectal cancer after prior chemotherapy. Future trials might evaluate combinations of depsipeptide with chemotherapeutic or other agents. PMID:18941712

  5. A multicenter trial of the efficacy of nimodipine on outcome after severe head injury. The European Study Group on Nimodipine in Severe Head Injury.

    PubMed

    1994-05-01

    Between January 1, 1989, and June 30, 1991, 852 severely head-injured patients were entered into a prospective placebo-controlled trial of the efficacy of nimodipine administration. The patients could not obey commands at the time of entry into the trial, which was within 12 hours after the start of the inability to obey commands and within 24 hours of injury. The main hypothesis that nimodipine would increase the percentage of patients with a favorable outcome (moderate disability or good recovery) from 50% to 60% was rejected. A trend toward a favorable effect was seen in patients who exhibited traumatic subarachnoid hemorrhage (SAH) on the computerized tomography (CT) scan obtained prior to entry into the study. The effect was statistically significant in those patients who complied with all protocol requirements. This finding is consistent with the effect of nimodipine on secondary ischemia following spontaneous SAH. The results of the study warrant a clinical trial of the efficacy of nimodipine in severely head-injured patients who show traumatic SAH on the initial CT scan. PMID:8169617

  6. Teachable Trials in the Social Studies Classroom

    ERIC Educational Resources Information Center

    Weiner, Mark S.

    2010-01-01

    At the heart of the Western intellectual tradition, particularly the value it places on the critical analysis of civic life, or social studies, lies the story of a trial. If the story of a trial lies at the root of social studies, then it comes as no surprise that many teachers find that trials can serve as excellent teaching tools, especially for…

  7. GRIN: “GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: an assessor-masked randomised comparison trial”: study protocol

    PubMed Central

    2014-01-01

    Background Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years. Methods/Design An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child’s occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health. Discussion This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy. Trial registration ACTRN12611000454976 PMID:24502231

  8. Structure, process and annual intensive care unit mortality across 69 centers: United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS)

    PubMed Central

    Checkley, William; Martin, Greg S; Brown, Samuel M; Chang, Steven Y; Dabbagh, Ousama; Fremont, Richard D; Girard, Timothy D; Rice, Todd W; Howell, Michael D; Johnson, Steven B; O'Brien, James; Park, Pauline K; Pastores, Stephen M; Patil, Namrata T; Pietropaoli, Anthony P; Putman, Maryann; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Sevransky, Jonathan E

    2014-01-01

    Objective Hospital-level variations in structure and process may affect clinical outcomes in intensive care units (ICUs). We sought to characterize the organizational structure, processes of care, use of protocols and standardized outcomes in a large sample of U.S. ICUs. Design We surveyed 69 ICUs about organization, size, volume, staffing, processes of care, use of protocols, and annual ICU mortality. Setting ICUs participating in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS). Measurements and Main Results We characterized structure and process variables across ICUs, investigated relationships between these variables and annual ICU mortality, and adjusted for illness severity using APACHE II. Ninety-four ICU directors were invited to participate in the study and 69 ICUs (73%) were enrolled, of which 25 (36%) were medical, 24 were surgical (35%) and 20 (29%) were of mixed type, and 64 (93%) were located in teaching hospitals with a median number of 5 trainees per ICU. Average annual ICU mortality was 10.8%, average APACHE II score was 19.3, 58% were closed units and 41% had a 24-hour in-house intensivist. In multivariable linear regression adjusted for APACHE II and multiple ICU structure and process factors, annual ICU mortality was lower in surgical ICUs than in medical ICUs (5.6% lower, 95% CI 2.4%–8.8%) or mixed ICUs (4.5% lower, 95% CI 0.4%–8.7%). We also found a lower annual ICU mortality among ICUs that had a daily plan of care review (5.8% lower, 95% CI 1.6%–10.0%) and a lower bed-to-nurse ratio (1.8% lower when the ratio decreased from 2:1 to 1.5:1; 95% CI 0.25%–3.4%). In contrast, 24-hour intensivist coverage (p=0.89) and closed ICU status (p=0.16) were not associated with a lower annual ICU mortality. Conclusions In a sample of 69 ICUs, a daily plan of care review and a lower bed-to-nurse ratio were both associated with a lower annual ICU mortality. In contrast to 24-hour intensivist staffing, improvement in team communication is a low-cost, process-targeted intervention strategy that may improve clinical outcomes in ICU patients. PMID:24145833

  9. Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials

    PubMed Central

    Peters, Erica N.; Torres, Essie; Toll, Benjamin A.; Cummings, K. Michael; Gritz, Ellen R.; Hyland, Andrew; Herbst, Roy S.; Marshall, James R.; Warren, Graham W.

    2012-01-01

    Purpose Substantial evidence suggests that tobacco use has adverse effects on cancer treatment outcomes; however, routine assessment of tobacco use has not been fully incorporated into standard clinical oncology practice. The purpose of this study was to evaluate tobacco use assessment in patients enrolled onto actively accruing cancer clinical trials. Methods Protocols and forms for 155 actively accruing trials in the National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program were evaluated for tobacco use assessment at enrollment and follow-up by using a structured coding instrument. Results Of the 155 clinical trials reviewed, 45 (29%) assessed any form of tobacco use at enrollment, but only 34 (21.9%) assessed current cigarette use. Only seven trials (4.5%) assessed any form of tobacco use during follow-up. Secondhand smoke exposure was captured in 2.6% of trials at enrollment and 0.6% during follow-up. None of the trials assessed nicotine dependence or interest in quitting at any point during enrollment or treatment. Tobacco status assessment was higher in lung/head and neck trials as well as phase III trials, but there was no difference according to year of starting accrual or cooperative group. Conclusion Most actively accruing cooperative group clinical trials do not assess tobacco use, and there is no observable trend in improvement over the past 8 years. Failure to incorporate standardized tobacco assessments into NCI-funded Cooperative Group Clinical Trials will limit the ability to provide evidence-based cessation support and will limit the ability to accurately understand the precise effect of tobacco use on cancer treatment outcomes. PMID:22689794

  10. Genome-wide Association Study of Virologic Response with Efavirenz- or Abacavir-containing Regimens in AIDS Clinical Trials Group Protocols

    PubMed Central

    Lehmann, David S.; Ribaudo, Heather J.; Daar, Eric S.; Gulick, Roy M.; Haubrich, Richard H.; Robbins, Gregory K.; de Bakker, Paul I.W.; Haas, David W.; McLaren, Paul J.

    2015-01-01

    Background Efavirenz and abacavir are components of recommended first-line regimens for human immunodeficiency virus (HIV)-1 infection. We used genome-wide genotyping and clinical data to explore genetic associations with virologic failure among subjects randomized to efavirenz- or abacavir-containing regimens in AIDS Clinical Trials Group (ACTG) protocols. Methods Virologic response and genome-wide genotype data were available from treatment-naive subjects randomized to efavirenz-containing (n=1,596) or abacavir-containing (n=786) regimens in ACTG protocols 384, A5142, A5095, and A5202. Results Meta-analysis of association results across race/ethnic groups showed no genome-wide significant associations (p<5×10?8) with virologic response for either efavirenz or abacavir. Our sample size provided 80% power to detect a genotype relative risk of 1.8 for efavirenz, and 2.4 for abacavir. Analyses focused on CYP2B genotypes that define the lowest plasma efavirenz exposure stratum did not reveal associations, nor did analysis limited to gene sets predicted to be relevant to efavirenz and abacavir disposition. Conclusions No single polymorphism is strongly associated with virologic failure with efavirenz- or abacavir-containing regimens. Analyses to better consider context, and that minimize confounding by non-genetic factors, may reveal associations not apparent herein. PMID:25461247

  11. Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study)

    PubMed Central

    Zaitsu, Masayoshi; Mikami, Koji; Ishida, Noriko; Takeuchi, Takumi

    2011-01-01

    Objectives. Overactive bladder (OAB) is a chronic disease, but comparative trials of anticholinergics, which are commonly used for treatment of OAB, have generally been performed for up to 12 weeks only. There is no comparative study of a long-term intervention. Methods. We conducted a 52-week prospective randomized comparative study to evaluate the efficacy and tolerability of two anticholinergics. Results. Forty-one Japanese patients with untreated OAB were randomly assigned to imidafenacin and solifenacin groups. There was no difference in OABSS and KHQ scores between the two groups, but the severity and incidence of adverse events caused by the anticholinergics showed increased differences between the groups with time. The severity of dry mouth and the incidence of constipation were significantly lower in the imidafenacin group (P = 0.0092 and P = 0.0013, resp.). Conclusions. This study is the first long-term trial to show differences in the properties of anticholinergics that were not detected in short-term studies. Since OAB is a chronic disease, we conclude that imidafenacin is preferable to solifenacin from a perspective of safety. PMID:22046182

  12. CLINICAL TRIALS OFFICE The principal charge of this focus group was to identify the key elements of a Clinical Trials

    E-print Network

    of a Clinical Trials Office at the LSUHSC-NO Campus. We propose that the mission of the Clinical Trials OfficeCLINICAL TRIALS OFFICE The principal charge of this focus group was to identify the key elements is to organize and enhance operational processes that support clinical research and facilitate the timely

  13. Maximizing statistical power in group-randomized vaccine trials.

    PubMed

    Riggs, T; Koopman, J S

    2005-12-01

    Statistical power in group-randomized vaccine trials is complex: group randomization may increase power by capturing more transmission effects but may decrease power as more individuals are affected by a common source of variance. The former effect dominates when most infections arise from within the group and the latter when most arise outside. This process is complicated further when individuals possess partial natural immunity. Vaccine trials typically compare infection frequency (as measured by agent or antibody detection) in vaccinated vs. unvaccinated groups. To assess the relative contributions to statistical power by direct agent detection vs. serological detection of recent infection, we constructed stochastic compartmental models using differential equations describing all possible discrete states of the group. We contrasted models where natural immunity was absent, altered only the susceptible state, or altered both the susceptible and infected states. We observed the effects of endemic infection levels, the fraction of infection arising from outside the group, infectiousness vs. susceptibility vaccine effects and waning rates. There was significant enhancement of statistical power when serological testing separated infected and susceptible classes into subsets by natural immunity status. PMID:16274496

  14. Genome-wide association study of peripheral neuropathy with D-drug-containing regimens in AIDS Clinical Trials Group protocol 384

    PubMed Central

    Leger, Paul D.; Johnson, Daniel H.; Robbins, Gregory K.; Shafer, Robert W.; Clifford, David B.; Li, Jun; McLaren, Paul J.; Haas, David W.

    2014-01-01

    Stavudine (d4T) was, until recently, one of the most widely prescribed antiretroviral drugs worldwide. While there has been a major shift away from d4T use in resource-limited countries, a large number of patients have previously received (or continue to receive) d4T, and many have developed peripheral neuropathy. The identification of genetic predictors of increased risk might suggest novel therapeutic targets for such patients. In AIDS Clinical Trials Group protocol 384, antiretroviral-naïve patients were randomized to d4T/didanosine (ddI)- or zidovudine/lamivudine-containing regimens. Data from d4T/ddI recipients were analyzed for genome-wide associations (approximately 1 million genetic loci) with new onset distal sensory peripheral neuropathy. Analyses involved 254 patients (49 % White, 34 % Black, 17 % Hispanic), comprising 90 peripheral neuropathy cases (32 grade 1, 35 grade 2, 23 grade 3) and 164 controls. After correcting for multiple comparisons, no polymorphism was consistently associated with neuropathy among all patients, among White, Black, and Hispanic patients analyzed separately, both in genome-wide analyses (threshold, P<5.0×10?8) and focused on 46 neuropathy-associated genes (threshold, P<3.5×10?5). In the latter analyses, the lowest P values were in KIF1A among Whites (rs10199388, P=8.4×10?4), in LITAF among Blacks (rs13333308, P=6.0×10?6), and in NEFL among Hispanics (rs17763685, P=5.6×10?6). Susceptibility to d4T/ddI-associated neuropathy is not explained by a single genetic variant with a marked effect. PMID:24554482

  15. Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group.

    PubMed Central

    Fink, M P; Snydman, D R; Niederman, M S; Leeper, K V; Johnson, R H; Heard, S O; Wunderink, R G; Caldwell, J W; Schentag, J J; Siami, G A

    1994-01-01

    Intravenously administered ciprofloxacin was compared with imipenem for the treatment of severe pneumonia. In this prospective, randomized, double-blind, multicenter trial, which included an intent-to-treat analysis, a total of 405 patients with severe pneumonia were enrolled. The mean APACHE II score was 17.6, 79% of the patients required mechanical ventilation, and 78% had nosocomial pneumonia. A subgroup of 205 patients (98 ciprofloxacin-treated patients and 107 imipenem-treated patients) were evaluable for the major efficacy endpoints. Patients were randomized to receive intravenous treatment with either ciprofloxacin (400 mg every 8 h) or imipenem (1,000 mg every 8 h), and doses were adjusted for renal function. The primary and secondary efficacy endpoints were bacteriological and clinical responses at 3 to 7 days after completion of therapy. Ciprofloxacin-treated patients had a higher bacteriological eradication rate than did imipenem-treated patients (69 versus 59%; 95% confidence interval of -0.6%, 26.2%; P = 0.069) and also a significantly higher clinical response rate (69 versus 56%; 95% confidence interval of 3.5%, 28.5%; P = 0.021). The greatest difference between ciprofloxacin and imipenem was in eradication of members of the family Enterobacteriaceae (93 versus 65%; P = 0.009). Stepwise logistic regression analysis demonstrated the following factors to be associated with bacteriological eradication: absence of Pseudomonas aeruginosa (P < 0.01), higher weight (P < 0.01), a low APACHE II score (P = 0.03), and treatment with ciprofloxacin (P = 0.04). When P. aeruginosa was recovered from initial respiratory tract cultures, failure to achieve bacteriological eradication and development of resistance during therapy were common in both treatment groups (67 and 33% for ciprofloxacin and 59 and 53% for imipenem, respectively). Seizures were observed more frequently with imipenem than with ciprofloxacin (6 versus 1%; P = 0.028). These results demonstrate that in patients with severe pneumonia, monotherapy with ciprofloxacin is at least equivalent to monotherapy with imipenem in terms of bacteriological eradication and clinical response. For both treatment groups, the presence of P. aeruginosa had a negative impact on treatment success. Seizures were more common with imipenem than with ciprofloxacin. Monotherapy for severe pneumonia is a safe and effective initial strategy but may need to be modified if P. aeruginosa is suspected or recovered from patients. PMID:8203853

  16. A simple and flexible graphical approach for adaptive group-sequential clinical trials.

    PubMed

    Sugitani, Toshifumi; Bretz, Frank; Maurer, Willi

    2014-11-01

    Abstract Adaptive clinical trial designs incorporating treatment selection at pre-specified interim analyses have recently attracted considerable attention. In this paper, we introduce a graphical approach to testing multiple hypotheses in group-sequential clinical trials allowing for mid-term design modifications. It is intended for structured study objectives in adaptive clinical trials and extends the graphical group-sequential designs from Maurer and Bretz (Statistics in Biopharmaceutical Research 2013; 5: 311-320) to adaptive trial designs. The resulting test strategies can be visualized graphically and performed iteratively. We illustrate the methodology with two examples from our clinical trial practice. First, we consider a three-armed gold-standard trial with the option to reallocate patients to either the test drug or the active control group, while stopping the recruitment of patients to placebo, after having demonstrated superiority of the test drug over placebo at an interim analysis. Second, we consider a confirmatory two-stage adaptive design with treatment selection at interim. PMID:25372071

  17. A three-group study, internet-based, face-to-face based and standard- management after acute whiplash associated disorders (WAD) – choosing the most efficient and cost-effective treatment: study protocol of a randomized controlled trial

    PubMed Central

    Söderlund, Anne; Bring, Annika; Åsenlöf, Pernilla

    2009-01-01

    Background The management of Whiplash Associated Disorders is one of the most complicated challenges with high expenses for the health care system and society. There are still no general guidelines or scientific documentation to unequivocally support any single treatment for acute care following whiplash injury. The main purpose of this study is to try a new behavioural medicine intervention strategy at acute phase aimed to reduce the number of patients who have persistent problems after the whiplash injury. The goal is also to identify which of three different interventions that is most cost-effective for patients with Whiplash Associated Disorders. In this study we are controlling for two factors. First, the effect of behavioural medicine approach is compared with standard care. Second, the manner in which the behavioural medicine treatment is administered, Internet or face-to-face, is evaluated in it's effectiveness and cost-effectiveness. Methods/Design The study is a randomized, prospective, experimental three-group study with analyses of cost-effectiveness up to two-years follow-up. Internet – based programme and face-to-face group treatment programme are compared to standard-treatment only. Patient follow-ups take place three, six, twelve and 24 months, that is, short-term as well as long-term effects are evaluated. Patients will be enrolled via the emergency ward during the first week after the accident. Discussion This new self-help management will concentrate to those psychosocial factors that are shown to be predictive in long-term problems in Whiplash Associated Disorders, i.e. the importance of self-efficacy, fear of movement, and the significance of catastrophizing as a coping strategy for restoring and sustaining activities of daily life. Within the framework of this project, we will develop, broaden and evaluate current physical therapy treatment methods for acute Whiplash Associated Disorders. The project will contribute to the creation of a cost-effective behavioural medicine approach to management of acute Whiplash Associated Disorders. The results of this study will answer an important question; on what extent and how should these patients be treated at acute stage and how much does the best management cost. Trial registration number Current Controlled Trials ISRCTN61531337 PMID:19624833

  18. A phase II study of the HDAC inhibitor SB939 in patients with castration resistant prostate cancer: NCIC clinical trials group study IND195.

    PubMed

    Eigl, B J; North, S; Winquist, E; Finch, D; Wood, L; Sridhar, S S; Powers, J; Good, J; Sharma, M; Squire, J A; Bazov, J; Jamaspishvili, T; Cox, M E; Bradbury, P A; Eisenhauer, E A; Chi, K N

    2015-08-01

    Background SB939 is a potent oral inhibitor of class 1, 2, and 4 histone deacetylases (HDACs). These three HDAC classes are highly expressed in castration resistant prostate cancer (CRPC) and associated with poor clinical outcomes. We designed a phase II study of SB939 in men with metastatic CRPC. Methods Patients received SB939 60 mg on alternate days three times per week for 3 weeks on a 4-week cycle. Primary endpoints were PSA response rate (RR) and progression-free survival (PFS). Secondary endpoints included objective response rate and duration; overall survival; circulating tumor cell (CTC) enumeration and safety. Exploratory correlative studies of the TMPRSS2-ERG fusion and PTEN biomarkers were also performed. Results Thirty-two patients were enrolled of whom 88 % had received no prior chemotherapy. The median number of SB939 cycles administered was three (range 1-8). Adverse events were generally grade 1-2, with five pts experiencing one or more grade three event. One patient died due to myocardial infarction. A confirmed PSA response was noted in two pts (6 %), lasting 3.0 and 21.6 months. In patients with measurable disease there were no objective responses. Six patients had stable disease lasting 1.7 to 8.0 months. CTC response (from ?5 at baseline to <5 at 6 or 12 weeks) occurred in 9/14 evaluable patients (64 %). Conclusion Although SB939 was tolerable at the dose/schedule given, and showed declines in CTC in the majority of evaluable patients, it did not show sufficient activity based on PSA RR to warrant further study as a single agent in unselected patients with CRPC. PMID:25983041

  19. [Controlled, clinical trial of isoprinosine administration to HIV-infected patients. Results of a Danish/Swedish multicenter study. The Scandinavian Isoprinosine Study Group].

    PubMed

    Thorsen, S; Pedersen, C; Sandström, E; Petersen, C S; Norkrans, G; Gerstoft, J; Karlsson, A; Christensen, K C; Håkansson, C; Pehrson, P O

    1994-05-30

    The safety and efficacy of isoprinosine in HIV-infected individuals were assessed in a multicentre, randomized, double-blind, 24-week study phase, followed by an optional 24-week open treatment phase. The results of the double-blind phase have been reported separately. Of 866 HIV-seropositive individuals randomized, 832 were eligible for efficacy analysis. On completion of the double-blind phase, 596 patients started open treatment. All patients were evaluated with regard to progression to AIDS. Within 48 weeks, 10/412 patients (2.4%) assigned isoprinosine and 27/420 (6.4%) assigned placebo progressed to AIDS (p = 0.005; odds ratio: 2.8, 95% CI: 1.3-6.2). Intention-to-treat analysis showed identical results. No severe adverse reactions or toxicities were observed. We conclude that HIV-infected individuals without AIDS may be safely and effectively treated with isoprinosine. PMID:7520643

  20. The Impact of Trauma-Focused Group Therapy upon HIV Sexual Risk Behaviors in the NIDA Clinical Trials Network “Women and Trauma” Multi-Site Study

    Microsoft Academic Search

    Denise A. Hien; Aimee N. C. Campbell; Therese Killeen; Mei-Chen Hu; Cheri Hansen; Huiping Jiang; Mary Hatch-Maillette; Gloria M. Miele; Lisa R. Cohen; Weijin Gan; Stella M. Resko; Michele DiBono; Elizabeth A. Wells; Edward V. Nunes

    2010-01-01

    Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which\\u000a can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual\\u000a occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving\\u000a treatment at six community-based drug treatment

  1. Weight and Lean Body Mass Change with Antiretroviral Initiation and Impact on Bone Mineral Density: AIDS Clinical Trials Group Study A5224s

    PubMed Central

    Erlandson, Kristine Mace; Kitch, Douglas; Tierney, Camlin; Sax, Paul E.; Daar, Eric S.; Tebas, Pablo; Melbourne, Kathleen; Ha, Belinda; Jahed, Nasreen C.; Mccomsey, Grace A.

    2014-01-01

    Objective To compare the effect initiating different antiretroviral therapy (ART) regimens have on weight, body mass index (BMI), and lean body mass (LBM) and explore how changes in body composition are associated with bone mineral density (BMD). Methods A5224s was a substudy of A5202, a prospective trial of 1857 ART-naïve participants randomized to blinded abacavir-lamivudine (ABC/3TC) or tenofovir DF-emtricitabine (TDF/FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV/r). All subjects underwent dual-energy absorptiometry (DXA) and abdominal CT for body composition. Analyses used 2-sample t-tests and linear regression. Results A5224s included 269 subjects: 85% male, 47% white non-Hispanic, median age 38 years, HIV-1 RNA 4.6 log10 copies/mL, and CD4 233 cells/µL. Overall, significant gains occurred in weight, BMI, and LBM at 96 weeks post randomization (all p<0.001). Assignment to ATV/r (vs EFV) resulted in significantly greater weight (mean difference 3.35 kg) and BMI gain (0.88 kg/m2; both p=0.02), but not LBM (0.67 kg; p=0.15), while ABC/3TC and TDF/FTC were not significantly different (p?0.10). In multivariable analysis, only lower baseline CD4 count and higher HIV-1 RNA were associated with greater increase in weight, BMI, or LBM. In multivariable analyses, increased LBM was associated with an increased hip BMD. Conclusions ABC/3TC vs. TDF/FTC did not differ in change in weight, BMI, or LBM; ATV/r vs. EFV resulted in greater weight and BMI gain but not LBM. A positive association between increased LBM and increased hip BMD should be further investigated through prospective interventional studies to verify the impact of increased LBM on hip BMD. PMID:24384588

  2. Allogeneic stem cell transplantation for mantle cell lymphoma--final report from the prospective trials of the East German Study Group Haematology/Oncology (OSHO).

    PubMed

    Krüger, William H; Hirt, Carsten; Basara, Nadezda; Sayer, Herbert G; Behre, Gerhard; Fischer, Thomas; Grobe, Norbert; Maschmeyer, Georg; Niederwieser, Dietger; Dölken, Gottfried

    2014-09-01

    This study was conducted in order to evaluate allogeneic stem cell transplantation (alloSCT) as consolidation for patients with mantle cell lymphoma (MCL). Patients with MCL were included into two prospective trials OSHO #060 (refractory/relapsed) and #074 (de novo). Induction was rituximab and chemotherapy. Responding patients proceeded to alloSCT. Minimal residual disease was monitored by quantitative RT-PCR detecting either t(11;14) or clonospecific CDR-III regions. In case of circulating lymphoma cells, immunomodulation (cyclosporine A withdrawal, rituximab, donor lymphocyte infusion) was initiated. Thirty-three of 39 patients underwent alloSCT after myeloablative (n?=?7) or toxicity-reduced (n?=?26) conditioning. Leukocytes engrafted at day +16 (median, range 0-101) and platelets at day +14 (0-142). Acute graft-versus-host disease stages I-II occurred in 42 % and stages III-IV in 15 %. Five patients have relapsed after SCT. The overall mortality after SCT was 24 % (n?=?8). Median follow-up after SCT was 2.8 years (range 0.0-10.9). Five-year progression-free survival was 67 %, and overall survival 73 % after SCT. The results were comparable for primary MCL and refractory/relapsed disease as well as for related vs. unrelated SCT. Younger patients had a significantly better outcome than the elderly. AlloSCT is a feasible and promising consolidation therapy for relapsed and refractory disease and an attractive option for young patients with de novo MCL of high risk. PMID:24782119

  3. Using Multilevel Mixtures to Evaluate Intervention Effects in Group Randomized Trials

    ERIC Educational Resources Information Center

    Van Horn, M. Lee; Fagan, Abigail A.; Jaki, Thomas; Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Abbott, Robert D.; Catalano, Richard F.

    2008-01-01

    There is evidence to suggest that the effects of behavioral interventions may be limited to specific types of individuals, but methods for evaluating such outcomes have not been fully developed. This study proposes the use of finite mixture models to evaluate whether interventions, and, specifically, group randomized trials, impact participants…

  4. Increasing the Degrees of Freedom in Future Group Randomized Trials: The "df*" Method Revisited

    ERIC Educational Resources Information Center

    Murray, David M.; Blitstein, Jonathan L.; Hannan, Peter J.; Shadish, William R.

    2012-01-01

    Background: This article revisits an article published in Evaluation Review in 2005 on sample size estimation and power analysis for group-randomized trials. With help from a careful reader, we learned of an important error in the spreadsheet used to perform the calculations and generate the results presented in that article. As we studied the…

  5. An analysis of group size models for optimal group sequential clinical trials

    E-print Network

    Barber, Stuart

    properties of the optimal designs and comparable error spending tests. Some key words: Error spending tests for group sequential clinical trials is the error spending method due to Lan & DeMets (1983 we compare our optimal tests to the error spending tests using the -family and -family error spending

  6. Hyperbaric Oxygen Therapy for Radionecrosis of the Jaw: A Randomized, Placebo-Controlled, Double-Blind Trial From the ORN96 Study Group

    Microsoft Academic Search

    Djillali Annane; Joel Depondt; Philippe Aubert; Maryvonne Villart; Philippe Gajdos; Sylvie Chevret

    2004-01-01

    Purpose To determine the efficacy and safety of hyperbaric oxygen therapy (HBO) for overt mandibular osteoradionecrosis. Patients and Methods This prospective, multicenter, randomized, double-blind, placebo-controlled trial was con- ducted at 12 university hospitals. Ambulatory adults with overt osteoradionecrosis of the mandible were assigned to receive 30 HBO exposures preoperatively at 2.4 absolute atmosphere for 90 minutes or a placebo, and

  7. Multicenter phase II trial of neoadjuvant exemestane for postmenopausal patients with hormone receptor-positive, operable breast cancer: Saitama Breast Cancer Clinical Study Group (SBCCSG-03)

    Microsoft Academic Search

    Hiroyuki Takei; Kimito Suemasu; Kenichi Inoue; Tsuyoshi Saito; Katsuhiko Okubo; Junichi Koh; Kazuhiko Sato; Hitoshi Tsuda; Masafumi Kurosumi; Toshio Tabei

    2008-01-01

    This multicenter phase II trial evaluated the efficacy and tolerability of 4 months of neoadjuvant exemestane in 44 postmenopausal\\u000a patients with estrogen receptor (ER)-positive and\\/or progesterone receptor-positive, stage II to IIIB breast cancer measuring\\u000a ?3 cm. Pathological response was assessed by a central review board using response criteria proposed by the Japanese Breast\\u000a Cancer Society. Clinical response [complete or partial response (PR)

  8. First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse

    PubMed Central

    2013-01-01

    Background Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness. Methods/Design The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. ‘Low educational qualifications’ is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment. The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services. Discussion This is the first study of the effectiveness of gFNP in the UK. Results should inform decision-making about its delivery alongside universal services, potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting. Trial registration ISRCTN78814904. PMID:24011061

  9. Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated. Methods/Design We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome. Discussion Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients’ partners in effective diabetes care is also acknowledged in the study. Trial registration Netherlands National Trial Register (NTR) NTR3302. PMID:24690511

  10. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    SciTech Connect

    Gaze, Mark N., E-mail: mark.gaze@uclh.nhs.uk [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium)] [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Dieckmann, Karin; Hoermann, Marcus [General Hospital Vienna, Medical University Vienna (Austria)] [General Hospital Vienna, Medical University Vienna (Austria); Gains, Jennifer E.; Sullivan, Kevin P. [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom)] [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Ladenstein, Ruth [Children's Cancer Research Institute, St. Anna Children's Hospital, Vienna (Austria)] [Children's Cancer Research Institute, St. Anna Children's Hospital, Vienna (Austria)

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  11. Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

    PubMed Central

    2012-01-01

    Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The findings from the study may be used to guide teacher pre-service education, professional learning and school policy in primary schools. Trial registration Australian New Zealand Clinical Trials Registry No: ACTRN12611001080910 PMID:22691451

  12. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    SciTech Connect

    Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  13. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study

    PubMed Central

    Alberts, David S.; Blessing, John A.; Landrum, Lisa M.; Warshal, David P.; Martin, Lainie P.; Rose, Stephen L.; Bonebrake, Albert J.; Ramondetta, Lois M.

    2013-01-01

    Background Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied >20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m2 IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1–15). Ten (28.6%; CI 14.6%–46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation. Conclusions Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer. PMID:22986144

  14. Phase III Randomized Trial of Weekly Cisplatin and Irradiation Versus Cisplatin and Tirapazamine and Irradiation in Stages IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis: A Gynecologic Oncology Group Study

    PubMed Central

    DiSilvestro, Paul A.; Ali, Shamshad; Craighead, Peter S.; Lucci, Joseph A.; Lee, Yi-Chun; Cohn, David E.; Spirtos, Nicola M.; Tewari, Krishnasu S.; Muller, Carolyn; Gajewski, Walter H.; Steinhoff, Margaret M.; Monk, Bradley J.

    2014-01-01

    Purpose This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. Patients and Methods Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. Results PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. Conclusion TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose. PMID:24395863

  15. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial

    Microsoft Academic Search

    Selwyn C M Richards; David L Scott

    2002-01-01

    Objectives To evaluate cardiovascular fitness exercise in people with fibromyalgia. Design Randomised controlled trial. Setting Hospital rheumatology outpatients. Group based classes took place at a \\

  16. Community-Based Colorectal Cancer Screening Trials with MultiEthnic Groups: A Systematic Review

    Microsoft Academic Search

    Jay B. MorrowFlorence; Florence J. Dallo; Manjula Julka

    2010-01-01

    The objective of this review was to summarize the current literature of community-based colorectal cancer screening randomized\\u000a controlled trials with multi-ethnic groups. The CDC reports 40% of adults do not receive time-appropriate colorectal cancer\\u000a screening. Although overall screening rates have improved since 2000, disparities remain. Studies examining community characteristics\\u000a may offer insight into improving screening rates and eliminating disparities. We

  17. Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group.

    PubMed

    MacKinnon, Christopher J; Smith, Nathan Grant; Henry, Melissa; Milman, Evgenia; Chochinov, Harvey M; Körner, Annette; Berish, Mel; Farrace, Amanda Jessica; Liarikos, Nikoleta; Cohen, S Robin

    2015-08-01

    More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC. PMID:25674830

  18. Clinical Trial Registries: A Survey of Patient Advocate Group Perceptions

    Microsoft Academic Search

    Jacqueline Sayers

    2009-01-01

    There has long been a recognized need to provide the public in general, and specifically patients and physicians, with quality information about clinical trials—what diseases are being investigated, with what products, in what countries, and so on—and also to ensure that trial results are made publicly available.In 2005 Roche launched its own clinical trial protocol registry and results database designed

  19. Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

    SciTech Connect

    Tokumaru, Sunao, E-mail: tokumaru@cc.saga-u.ac.jp [Department of Heavy Particle Therapy and Radiation Oncology, Saga University, Saga (Japan)] [Department of Heavy Particle Therapy and Radiation Oncology, Saga University, Saga (Japan); Toita, Takafumi [Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa (Japan)] [Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa (Japan); Oguchi, Masahiko [Radiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (Japan)] [Radiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (Japan); Ohno, Tatsuya [Gunma University Heavy Ion Medical Center, Maebashi (Japan)] [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Kato, Shingo [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan)] [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Niibe, Yuzuru [Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan)] [Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan); Kazumoto, Tomoko [Department of Radiology, Saitama Cancer Center, Saitama (Japan)] [Department of Radiology, Saitama Cancer Center, Saitama (Japan); Kodaira, Takeshi [Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan)] [Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan); Kataoka, Masaaki [Department of Radiology, National Shikoku Cancer Center, Matsuyama (Japan)] [Department of Radiology, National Shikoku Cancer Center, Matsuyama (Japan); Shikama, Naoto [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan)] [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Kenjo, Masahiro [Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan)] [Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan); Yamauchi, Chikako [Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan)] [Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan); Suzuki, Osamu [Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan)] [Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan); Sakurai, Hideyuki [Proton Medical Research Center and Tsukuba University, Tuskuba (Japan)] [Proton Medical Research Center and Tsukuba University, Tuskuba (Japan); Teshima, Teruki [Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita (Japan)] [Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita (Japan); Kagami, Yoshikazu [Department of Radiology, Showa University School of Medicine, Tokyo (Japan)] [Department of Radiology, Showa University School of Medicine, Tokyo (Japan); Nakano, Takashi [Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan)] [Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan); Hiraoka, Masahiro [Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan)] [Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan); and others

    2012-10-01

    Purpose: To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Materials and Methods: Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, which consisted of whole-pelvic external-beam radiation therapy of 50 Gy/25 fractions and high-dose-rate intracavitary brachytherapy of 24 Gy/4 fractions without chemotherapy. After radiation therapy the patients were evaluated by both pelvic CT and pelvic MRI at 3, 6, 12, 18, and 24 months. Diagnosis of IF was made when the patients had both CT and MRI findings, neither recurrent tumor lesions nor traumatic histories. The CT findings of IF were defined as fracture lines or sclerotic linear changes in the bones, and MRI findings of IF were defined as signal intensity changes in the bones, both on T1- and T2-weighted images. Results: The median follow-up was 24 months. The 2-year pelvic IF cumulative occurrence rate was 36.9% (21 patients). Using Common Terminology Criteria for Adverse Events version 3.0, grade 1, 2, and 3 IF were seen in 12 (21%), 6 (10%), and 3 patients (5%), respectively. Sixteen patients had multiple fractures, so IF were identified at 44 sites. The pelvic IF were frequently seen at the sacroileal joints (32 sites, 72%). Nine patients complained of pain. All patients' pains were palliated by rest or non-narcotic analgesic drugs. Higher age (>70 years) and low body weight (<50 kg) were thought to be risk factors for pelvic IF (P=.007 and P=.013, Cox hazard test). Conclusions: Cervical cancer patients with higher age and low body weight may be at some risk for the development of pelvic IF after pelvic radiation therapy.

  20. A randomized trial of three cisplatin-containing regimens in advanced non-small-cell lung cancer (NSCLC): a study of the Umbrian Lung Cancer Group

    Microsoft Academic Search

    Lucio Crino; Maurizio Tonato; Samir Darwishl; Maria L. Meaccil; Enrichetta Corgna; Francesco Di Costanzo; Franco Buzzi; Giovanni Fornari; Emilio Santi; Enzo Ballatori; Carla Santucci; Stephen Davis

    1990-01-01

    Summary  Survival in patients with locally advanced (stage III Mo) and metastatic (M1) non-small-cell lung cancer (NSCLC) is short.\\u000a Phase II studies have reported objective responses ranging from 20% to 60% using cisplatin-based chemotherapeutic regimens,\\u000a yet few have shown improvement in median survival. In our phase II pilot studies with cisplatin (CDDP) and etoposide (VP-16),\\u000a we observed a 26% response rate;

  1. A hhase I\\/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I\\/II breast carcinoma: Initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Study 0319

    Microsoft Academic Search

    Frank. Vicini; Kathryn M. S. Winter; William Straube; John Wong; Helen Pass; Rachel Rabinovitch; Susan Chafe; Douglas Arthur; Ivy Petersen; Beryl McCormick

    2005-01-01

    Background: This prospective study (Radiation Therapy Oncology Group Study 0319) examines the use of three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Reproducibility, as measured by technical feasibility, was the primary end point with the goal of demonstrating whether the technique is widely applicable in a multicenter setting before a Phase III trial is undertaken. Methods

  2. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study

    Microsoft Academic Search

    Henry M Keys; James A Roberts; Virginia L Brunetto; Richard J Zaino; Nick M Spirtos; Jeffrey D Bloss; Andrew Pearlman; Mitchell A Maiman; Jeffrey G Bell

    2004-01-01

    Background. Despite their low risk for recurrence, many women with endometrial adenocarcinoma receive postoperative radiation therapy (RT). This study was developed to determine if adjunctive external beam irradiation lowers the risk of recurrence and death in women with endometrial cancer International Federation of Gynaecology and Obstetrics (FIGO) stages IB, IC, and II (occult disease).Methods. Four hundred forty-eight consenting patients with

  3. Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial

    Microsoft Academic Search

    C. Camps; B. Massuti; A. Jimenez; I. Maestu; R. Garcõ ´ aG omez; D. Isla; J. L. Gonzalez; D. Almenar; A. Blasco; R. Rosell; A. Carrato; N. Vinolas; N. Batista; C. Garcõ ´; A. Galan; M. Lopez; R. Blanco; M. Provencio; P. Diz; E. Felip

    2006-01-01

    Background: Docetaxel is a widely accepted second-line treatment in advanced non-small-cell lung cancer (NSCLC) with a risk of myelotoxicity. This study evaluated the efficacy and toxicity profile of two docetaxel regimens in NSCLC patients who had failed first-line non-docetaxel-based chemotherapy. Patients and methods: A total of 259 patients from 33 Spanish centers were randomized to receive either docetaxel 75 mg\\/m2

  4. Lobaplatin (D-19466) in Patients with Advanced Non-Small-Cell Lung Cancer: A Trial of the Association for Medical Oncology (AIO) Phase II Study Group

    Microsoft Academic Search

    C. Manegold; P. Drings; U. Gatzemeier; J. v. Pawel; H. H. Fiebig; W. Queißer; L. Edler

    1996-01-01

    Summary Background: Lobaplatin, D-19466, 1,2-diaminomethyl cyclo-butane ?latinum(II)lactate, is a new, water-soluble platinum complex which we expected would have a better therapeutic index than either cisplatin or carboplatin, since various murine and human tumor models had previously indicated effectiveness. Furthermore, a phase I study demonstrated that Lobaplatin was successful in the treatment of bronchogenic carcinomas. Patients and Methods: A total of

  5. A Randomized Phase II Trial of Preoperative Exercise to Reduce Operative Risk in Gastric Cancer Patients with Metabolic Syndrome: Adjuvant Exercise for General Elective Surgery (AEGES) Study Group

    Microsoft Academic Search

    Haruhiko Cho; Akira Tsuburaya; Junichi Sakamoto; Satoshi Morita; Koji Ob; Takaki Yoshikawa; Naomi Miyajima

    This study is conducted to evaluate the efficacy and safety of preoperative exercise in patients with T1N0\\/T1N1\\/T2N0 gastric cancer and metabolic syndrome, which has emerged as a global health care issue. The primary endpoint is an incidence of perioperative compli- cations and the secondary endpoints are weight change, change in high density lipoprotein cholesterol, operation time, intraoperative blood loss, number

  6. A phase I II trial of etoposide and cisplatin in extensive small cell lung cancer: A cancer and Leukemia Group B study

    Microsoft Academic Search

    Edith P. Mitchell; Michael C. Perry; Sharon D. Luikart; Constance T. Cirrincione; David A. Van Echo; James E. Herndon; L. Herbert Maurer; Gerald Clamon; Mark R. Green

    1996-01-01

    Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0–2 were treated with etoposide 200 mg\\/m2\\/day on days 1–3 and cisplatin doses of 20, 30, or 35 mg\\/m2\\/day days 1–3 in a Phase III format. Of the nine patients treated at the 35 mg\\/m2\\/day cisplatin dose in the Phase I portion of the study, Grade 4

  7. A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study

    Microsoft Academic Search

    Rudolph M. Navari; Lawrence H. Einhorn; Patrick J. Loehrer Sr; Steven D. Passik; Jake Vinson; John McClean; Naveed Chowhan; Nasser H. Hanna; Cynthia S. Johnson

    2007-01-01

    Objective  The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV)\\u000a in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined\\u000a use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only.\\u000a \\u000a \\u000a \\u000a Materials and methods  Forty chemotherapy-naive patients received on the day of chemotherapy, day 1,

  8. Phase I trial of cisplatin and razoxane (ICRF-159) (NSC #119875) in advanced squamous cell carcinoma of the cervix. A Gynecologic Oncology Group Pilot Study.

    PubMed

    Bonomi, P; Yordan, E; Blessing, J A

    1988-02-01

    Both cisplatin and razoxane have shown activity in squamous carcinoma of the cervix. Cisplatin at a dose of 50 mg/m2 intravenously every 21 days was combined with razoxane at two dose levels--750 mg/m2 weekly and 1150 mg/m2 weekly. Three patients were treated at the first dose level and six patients were treated at the second dose level of razoxane. No objective regressions were observed, and three patients refused to continue therapy at the higher dose of razoxane because of nausea and vomiting. Further study of this regimen in cervical cancer is not recommended. PMID:3277372

  9. Anemia during adjuvant non-taxane chemotherapy for early breast cancer: Incidence and risk factors from two trials of the International Breast Cancer Study Group

    Microsoft Academic Search

    Lorenzo Gianni; Bernard F. Cole; Ilaria Panzini; Raymond Snyder; Stig B. Holmberg; Michael Byrne; Diana Crivellari; Marco Colleoni; Stefan Aebi; Edda Simoncini; Olivia Pagani; Monica Castiglione-Gertsch; Karen N. Price; Aron Goldhirsch; Alan S. Coates; Alberto Ravaioli

    2008-01-01

    Goal of the work  Anemia is a common side effect of chemotherapy. Limited information exists about its incidence and risk factors. The objective\\u000a of this study was to evaluate the incidence of anemia and risk factors for anemia occurrence in patients with early breast\\u000a cancer who received adjuvant chemotherapy.\\u000a \\u000a \\u000a \\u000a Materials and methods  We evaluated risk factors for anemia in pre- and post\\/perimenopausal

  10. Phase I/II Trial and Pharmacokinetic Study of Cixutumumab in Pediatric Patients With Refractory Solid Tumors and Ewing Sarcoma: A Report From the Children's Oncology Group

    PubMed Central

    Malempati, Suman; Weigel, Brenda; Ingle, Ashish M.; Ahern, Charlotte H.; Carroll, Julie M.; Roberts, Charles T.; Reid, Joel M.; Schmechel, Stephen; Voss, Stephan D.; Cho, Steven Y.; Chen, Helen X.; Krailo, Mark D.; Adamson, Peter C.; Blaney, Susan M.

    2012-01-01

    Purpose A phase I/II study of cixutumumab (IMC-A12) in children with refractory solid tumors was conducted. This study was designed to assess the toxicities, pharmacokinetics, and pharmacodynamics of cixutumumab in children to determine a recommended phase II dose and to assess antitumor activity in Ewing sarcoma (ES). Patients and Methods Pediatric patients with relapsed or refractory solid tumors were treated with cixutumumab as a 1-hour intravenous infusion once per week. Two dose levels—6 and 9 mg/kg—were evaluated using a standard three-plus-three cohort design. Patients with refractory ES were treated in an expanded phase II cohort at each dose level. Results Forty-seven eligible patients with a median age of 15 years (range, 4 to 28 years) were enrolled. Twelve patients were treated in the dose-finding phase. Hematologic and nonhematologic toxicities were generally mild and infrequent. Dose-limiting toxicities included grade 4 thrombocytopenia at 6 mg/kg and grade 3 dehydration at 9 mg/kg. Mean trough concentration (± standard deviation) at 9 mg/kg was 106 ± 57 ?g/mL, which exceeded the effective trough concentration of 60 ?g/mL observed in xenograft models. Three patients with ES had confirmed partial responses: one of 10 at 6 mg/kg and two of 20 at 9 mg/kg. Serum insulin-like growth factor I (IGF-I) levels consistently increased after one dose of cixutumumab. Tumor IGF-I receptor expression by immunohistochemistry did not correlate with response in patients with ES. Conclusion Cixutumumab is well tolerated in children with refractory solid tumors. The recommended phase II dose is 9 mg/kg. Limited single-agent activity of cixutumumab was seen in ES. PMID:22184397

  11. A clustering method to identify who benefits most from the treatment group in clinical trials

    PubMed Central

    Lee, Beom S.; Sen, Pranab K.; Park, Nan S.; Boothroyd, Roger A.; Peters, Roger H.; Chiriboga, David A.

    2014-01-01

    In randomized controlled trials (RCTs), the most compelling need is to determine whether the treatment condition was more effective than control. However, it is generally recognized that not all participants in the treatment group of most clinical trials benefit equally. While subgroup analyses are often used to compare treatment effectiveness across pre-determined subgroups categorized by patient characteristics, methods to empirically identify naturally occurring clusters of persons who benefit most from the treatment group have rarely been implemented. This article provides a modeling framework to accomplish this important task. Utilizing information about individuals from the treatment group who had poor outcomes, the present study proposes an a priori clustering strategy that classifies the individuals with initially good outcomes in the treatment group into: (a) group GE (good outcome, effective), the latent subgroup of individuals for whom the treatment is likely to be effective and (b) group GI (good outcome, ineffective), the latent subgroup of individuals for whom the treatment is not likely to be effective. The method is illustrated through a re-analysis of a publically available data set from the National Institute on Drug Abuse. The RCT examines the effectiveness of motivational enhancement therapy from 461 outpatients with substance abuse problems. The proposed method identified latent subgroups GE and GI, and the comparison between the two groups revealed several significantly different and informative characteristics even though both subgroups had good outcomes during the immediate post-therapy period. As a diagnostic means utilizing out-of-sample forecasting performance, the present study compared the relapse rates during the long-term follow-up period for the two subgroups. As expected, group GI, composed of individuals for whom the treatment was hypothesized to be ineffective, had a significantly higher relapse rate than group GE (63% vs. 27%; ? 2?=?9.99, p-value?=?.002). PMID:25750814

  12. Associative tolerance to nicotine's analgesic effects: studies on number of conditioning trials and corticosterone 

    E-print Network

    Davis, Kristina

    2004-09-30

    This study examined the number of conditioning trials necessary to produce associative nicotine tolerance and the changes in corticosterone levels during the procedures. Six independent groups of rats (N = 355) were run through tolerance...

  13. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group.

    PubMed

    Lambert, J S; Mofenson, L M; Fletcher, C V; Moye, J; Stiehm, E R; Meyer, W A; Nemo, G J; Mathieson, B J; Hirsch, G; Sapan, C V; Cummins, L M; Jimenez, E; O'Neill, E; Kovacs, A; Stek, A

    1997-02-01

    The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (Vd) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, Vd, and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations. PMID:9203648

  14. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    PubMed Central

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally effective sexual assault resistance education program that can be adopted by universities, to assess whether aspects of the program need to be strengthened, and also to indicate how long the effects of the program last and at which point in time refresher sessions may be necessary. Trial registration ClinicalTrials.gov NCT01338428 PMID:23702221

  15. German Acupuncture Trials (GERAC) for Chronic Low Back Pain Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups

    Microsoft Academic Search

    Michael Haake; Hans-Helge Muller; Carmen Schade-Brittinger; Heinz D. Basler; Helmut Schafer; Christoph Maier; Heinz G. Endres; Hans J. Trampisch; Albrecht Molsberger

    2007-01-01

    Methods A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean ± SD age, 50 ± 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n =

  16. Phase 1 trial of gemtuzumab ozogamicin in combination with enocitabine and daunorubicin for elderly patients with relapsed or refractory acute myeloid leukemia: Japan Adult Leukemia Study Group (JALSG)-GML208 study.

    PubMed

    Ito, Yoshikazu; Wakita, Atsushi; Takada, Satoru; Mihara, Masahiro; Gotoh, Moritaka; Ohyashiki, Kazuma; Ohtake, Shigeki; Miyawaki, Shuichi; Ohnishi, Kazunori; Naoe, Tomoki

    2012-10-01

    We conducted a phase 1 study of a combination of gemtuzumab ozogamicin (GO) plus conventional chemotherapy in elderly patients (? 65 years old) with relapsed or refractory CD33-positive acute myeloid leukemia (AML). Patients received a standard dose of enocitabine (200 mg/m² × 8 days) and daunorubicin (30 mg/m² × days 1-3) plus an escalating dose of GO (1.5-5 mg/m² on day 4). The dose escalation of GO was done according to a standard 3 + 3 design following a modified Fibonacci sequence. No dose-limiting toxicities were observed in three patients (median age, 71) at level 1 (1.5 mg/m²) or in three patients (median age, 73) at level 2 (3 mg/m²). Neither veno-occlusive diseases nor sinusoidal obstructive syndromes were noted at either level. However, as GO was withdrawn from the US market in June 2010, based on a randomized study in newly diagnosed AML, we decided not to proceed to the level 3 (5 mg/m²) in order to avoid possibly more severe adverse effects, and also because all six patients experienced grade 4 myelosuppression, with complete remission in three. This study showed that 3 mg/m² of GO in combination with enocitabine and daunorubicin may be a recommendable dose for a phase 2 study in Japanese elderly patients with CD33-positive AML. The study was registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ ) as UMIN000002603. PMID:22956429

  17. Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions

    PubMed Central

    2013-01-01

    Background Trial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available. Methods The ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register. Results The search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database. Conclusions Although still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor. PMID:24289719

  18. Cancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues

    PubMed Central

    Rimm, David L.; Nielsen, Torsten O.; Jewell, Scott D.; Rohrer, Daniel C.; Broadwater, Gloria; Waldman, Frederic; Mitchell, Kisha A.; Singh, Baljit; Tsongalis, Gregory J.; Frankel, Wendy L.; Magliocco, Anthony M.; Lara, Jonathan F.; Hsi, Eric D.; Bleiweiss, Ira J.; Badve, Sunil S.; Chen, Beiyun; Ravdin, Peter M.; Schilsky, Richard L.; Thor, Ann; Berry, Donald A.

    2011-01-01

    Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population. PMID:21519016

  19. Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial

    Microsoft Academic Search

    Nanette Mutrie; Anna M Campbell; Fiona Whyte; Alex McConnachie; Carol Emslie; Laura Lee; Nora Kearney; Andrew Walker; Diana Ritchie

    2007-01-01

    Objectives To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer, with six month follow-up.Design Pragmatic randomised controlled prospective open trial.Setting Three National Health Service oncology clinics in Scotland and community exercise facilities.Participants 203 women entered the study; 177 completed the six month follow-up. Interventions Supervised 12 week group

  20. Effects of group prenatal care on psychosocial risk in pregnancy: Results from a randomised controlled trial

    PubMed Central

    Ickovics, Jeannette R.; Reed, Elizabeth; Magriples, Urania; Westdahl, Claire; Rising, Sharon Schindler; Kershaw, Trace S.

    2012-01-01

    Few interventions have succeeded in reducing psychosocial risk among pregnant women. The objective of this study was to determine whether an integrated group prenatal care intervention already shown to improve perinatal and sexual risk outcomes can also improve psychosocial outcomes compared to standard individual care. This randomised controlled trial included pregnant women ages 14–25 from two public hospitals (N = 1047) who were randomly assigned to standard individual care, group prenatal care or integrated group prenatal care intervention (CenteringPregnancy Plus, CP+). Timing and content of visits followed obstetrical guidelines, from 18-week gestation through birth. Each 2-h group prenatal care session included physical assessment, education/skills building and support via facilitated discussion. Using intention-to-treat models, there were no significant differences in psychosocial function; yet, women in the top tertile of psychosocial stress at study entry did benefit from integrated group care. High-stress women randomly assigned to CP+ reported significantly increased self-esteem, decreased stress and social conflict in the third trimester of pregnancy; social conflict and depression were significantly lower 1-year postpartum (all p-values <0.02). CP+ improved psychosocial outcomes for high-stress women. This ‘bundled’ intervention has promise for improving psychosocial outcomes, especially for young pregnant women who are traditionally more vulnerable and underserved. PMID:21318932

  1. Clinical Trials

    MedlinePLUS

    ... existing treatments. Some may study new forms of psychotherapy (talk therapy). Others may study a combination of ... period. In trials that test new forms of psychotherapy, one group may be randomly assigned to a ...

  2. First-line treatment of pancreatic cancer patients with the combination of 5-fluorouracil\\/folinic acid plus gemcitabine: a multicenter phase II trial by the CONKO-study group

    Microsoft Academic Search

    Uwe PelzerDirk; Dirk Arnold; Peter Reitzig; Julia Herrenberger; Friedrich Wilhelm Korsten; Manfred Kindler; Jens Stieler; Bernd Dörken; Hanno Riess; Helmut Oettle

    Purpose  This open-label, multi-center phase II study investigated the efficacy and safety of the combination of 5-fluorouracil (5-FU)\\/folinic\\u000a acid (FA) plus gemcitabine (GFF) in patients with advanced pancreatic cancer. The study is based on our completed dose finding\\u000a phase I trial.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  A total of 90 patients (pts) were recruited between 02\\/2000 and 04\\/2002 to receive 5-FU 750 mg\\/m2 (24 h, i.v.), FA 500 mg\\/m2

  3. Group therapy for adolescents with repeated self harm: randomised controlled trial with economic evaluation

    Microsoft Academic Search

    J M Green; A J Wood; M J Kerfoot; G Trainor; C Roberts; J Rothwell; A Woodham; E Ayodeji; B Barrett; S Byford; R Harrington

    2011-01-01

    Objective To examine the effectiveness and cost-effectiveness of group therapy for self harm in young people.Design Two arm, single (assessor) blinded parallel randomised allocation trial of a group therapy intervention in addition to routine care, compared with routine care alone. Randomisation was by minimisation controlling for baseline frequency of self harm, presence of conduct disorder, depressive disorder, and severity of

  4. The development and description of the comparison group in the Look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Despite more lifestyle intervention trials, there is little published information on the development of the comparison group intervention. This article describes the comparison group intervention, termed Diabetes Support and Education Intervention and its development for the Action for HEAlth in Dia...

  5. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  6. Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial. | accrualnet.cancer.gov

    Cancer.gov

    Some patients assigned to clinical trial control groups are disappointed at not participating in the intervention group. This disappointment is often given as the reason patients withdraw from trials. In this study, patients who said they were very disappointed also said that they had not received understandable information provided during the consent process. The authors provide suggestions for addressing patients’ needs to lower drop-out rates. It is especially important to make sure that patients understand randomization prior to enrollment.

  7. Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics

    PubMed Central

    2009-01-01

    Background Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. Methods Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. Discussion A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms. Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication. Trial Registration NCT00260663 PMID:20003515

  8. p-adic Groups Seminar / Study group

    E-print Network

    Carbone, Lisa

    , and accounts of it have been written by Tits and Satake. Tits compiled tables of `admissible indices' from which groups can be constructed. We describe Tits' tables for groups of relative rank 1 over non in pure and applied mathematics ; v. 3. [Ti1] Tits, J, Reductive groups over local fields, Automorphic

  9. Generation of "virtual" control groups for single arm prostate cancer adjuvant trials.

    PubMed

    Jia, Zhenyu; Lilly, Michael B; Koziol, James A; Chen, Xin; Xia, Xiao-Qin; Wang, Yipeng; Skarecky, Douglas; Sutton, Manuel; Sawyers, Anne; Ruckle, Herbert; Carpenter, Philip M; Wang-Rodriguez, Jessica; Jiang, Jun; Deng, Mingsen; Pan, Cong; Zhu, Jian-Guo; McLaren, Christine E; Gurley, Michael J; Lee, Chung; McClelland, Michael; Ahlering, Thomas; Kattan, Michael W; Mercola, Dan

    2014-01-01

    It is difficult to construct a control group for trials of adjuvant therapy (Rx) of prostate cancer after radical prostatectomy (RP) due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS) based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets) whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies. PMID:24465467

  10. Hanford Waste Tank Grouping Study

    SciTech Connect

    Remund, K.M.; Simpson, B.C.

    1996-09-30

    This letter report discusses the progress and accomplishments of the Tank Grouping Study in FY96. Forty-one single-shell tanks (SSTs) were included in the FY95. In FY96, technical enhancements were also made to data transformations and tank grouping methods. The first focus of the FY96 effort was a general tank grouping study in which the 41 SSTs were grouped into classes with similar waste properties. The second FY96 focus was a demonstration of how multivariate statistical methods can be used to help resolve tank safety issues.

  11. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A. [Department of Psychosocial Resources, Tom Baker Cancer Centre, Calgary, Alberta (Canada); Calgary Health Region Chronic Pain Centre, Calgary, Alberta (Canada); Robinson, John W. [Department of Psychosocial Resources, Tom Baker Cancer Centre, Calgary, Alberta (Canada) and Program in Clinical Psychology, University of Calgary, Calgary, Alberta (Canada) and Faculty of Medicine, Department of Oncology, University of Calgary, Calgary, Alberta (Canada)]. E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S. [Faculty of Medicine, Department of Oncology, University of Calgary, Calgary, Alberta (Canada); Department of Radiation Oncology, Tom Baker Cancer Centre, Calgary, Alberta (Canada); Keats, Melanie R. [Faculty of Kinesiology, University of Calgary, Calgary, Alberta (Canada)

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  12. Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial

    Microsoft Academic Search

    Pat Hoddinott; Jane Britten; Gordon J Prescott; David Tappin; Anne Ludbrook; David J Godden

    2009-01-01

    Objective To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women.Design Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes.Setting Primary care in Scotland.Participants Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that

  13. Development of Grid Frameworks for Clinical Trials and Epidemiological Studies

    E-print Network

    Glasgow, University of

    Development of Grid Frameworks for Clinical Trials and Epidemiological Studies Richard SINNOTT many heterogeneous domains where a plethora of often legacy based or in-house/bespoke IT solutions and trials hence the development of a re-usable framework for creation and subsequent management

  14. "Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

    ERIC Educational Resources Information Center

    Niccols, Alison

    2008-01-01

    Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

  15. PHASE III STUDY OF RADIATION THERAPY WITH OR WITHOUT CIS-PLATINUM IN PATIENTS WITH UNRESECTABLE SQUAMOUS OR UNDIFFERENTIATED CARCINOMA OF THE HEAD AND NECK: AN INTERGROUP TRIAL OF THE EASTERN COOPERATIVE ONCOLOGY GROUP (E2382)

    PubMed Central

    Quon, Harry; Leong, Traci; Haselow, Robert; Leipzig, Bruce; Cooper, Jay; Forastiere, Arlene

    2013-01-01

    Purpose The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials Eligible patients were randomized to RT (70 Gy at 1.8–2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion The addition of concurrent weekly cisplatin at 20 mg/m2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications. PMID:20888709

  16. Phase III Study of Radiation Therapy With or Without Cis-Platinum in Patients With Unresectable Squamous or Undifferentiated Carcinoma of the Head and Neck: An Intergroup Trial of the Eastern Cooperative Oncology Group (E2382)

    SciTech Connect

    Quon, Harry, E-mail: quon@xrt.upenn.edu [University of Pennsylvania, Philadelphia, PA (United States); Leong, Traci [Emory University, Atlanta, GA (United States); Haselow, Robert [Metro Minnesota CCOP, St. Louis Park, MN (United States); Leipzig, Bruce [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Cooper, Jay [Maimonides Cancer Center, Brooklyn, NY (United States); Forastiere, Arlene [Johns Hopkins University, Baltimore, MD (United States)

    2011-11-01

    Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m{sup 2}. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m{sup 2} to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

  17. Attitudes of primary care physicians toward cancer-prevention trials: a focus group analysis.

    PubMed Central

    Frayne, S. M.; Mancuso, M.; Prout, M. N.; Freund, K. M.

    2001-01-01

    PURPOSE: Recruitment of low-income and minority women to cancer-prevention trials requires a joint effort from specialists and primary care providers. We sought to assess primary care providers' attitudes toward participating in cancer-prevention trial recruitment. PROCEDURES: We conducted a focus group with seven Boston-based primary care providers serving low-income and minority women. Providers discussed knowledge, attitudes, and beliefs regarding their role in recruitment to prevention trials. FINDINGS: A qualitative analysis of the focus group transcript revealed nine categories. Three categories related specifically to the primary care physician: 1) the dual role physicians play as advocates for both patient and research; 2) threats to maintaining the primary care relationship; and 3) general philosophy toward prevention. An additional six categories could be subdivided as they apply to the primary care physician, the patient, and the community: 4) trust/commitment; 5) benefits of the research; 6) access to the research; 7) knowledge and recall of the research; 8) influences of media coverage about the research; and 9) cultural sensitivity. CONCLUSIONS: Investigators conducting cancer-prevention trials must address the concerns of primary care physicians to optimize recruitment of subjects- especially low-income and minority women-into trials. PMID:11730121

  18. Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: Report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group

    Microsoft Academic Search

    L Fern; S Davies; T Eden; R Feltbower; R Grant; M Hawkins; I Lewis; E Loucaides; C Rowntree; S Stenning; J Whelan

    2008-01-01

    Poor inclusion rates into clinical trials for teenagers and young adults (TYA; aged 13–24 years) have been assumed but not systematically investigated in England. We analysed accrual rates (AR) from 1 April 2005 up to 31 March 2007 to National Cancer Research Network (NCRN) Phase III trials for the commonest tumour types occurring in TYA and children: leukaemia, lymphoma, brain

  19. Multicenter phase II clinical trial of nilotinib for patients with imatinib-resistant or -intolerant chronic myeloid leukemia from the East Japan CML study group evaluation of molecular response and the efficacy and safety of nilotinib

    PubMed Central

    2014-01-01

    Background Nilotinib is a second-generation tyrosine kinase inhibitor that exhibits significant efficacy as first- or second-line treatment in patients with chronic myeloid leukemia (CML). We conducted a multicenter Phase II Clinical Trial to evaluate the safety and efficacy of nilotinib among Japanese patients with imatinib-resistant or -intolerant CML-chronic phase (CP) or accelerated phase (AP). Results We analyzed 49 patients (33 imatinib-resistant and 16 imatinib-intolerant) treated with nilotinib 400 mg twice daily. The major molecular response (MMR) rate was 47.8% at 12 months among 35 patients who did not demonstrate an MMR at study entry. Somatic BCR-ABL1 mutations (Y253H, I418V, and exon 8/9 35-bp insertion [35INS]) were detected in 3 patients at 12 months or upon discontinuation of nilotinib. Although 75.5% of patients were still being treated at 12 months, nilotinib treatment was discontinued because of progressing disease in 1 patient, insufficient effect in 2, and adverse events in 9. There was no statistically significant correlation between MMR and trough concentrations of nilotinib. Similarly, no correlation was observed between trough concentrations and adverse events, except for pruritus and hypokalemia. Hyperbilirubinemia was frequently observed (all grades, 51.0%; grades 2–4, 29%; grades 3–4, 4.1%). Hyperbilirubinemia higher than grade 2 was significantly associated with the uridine diphosphate glucuronosyltransferase (UGT)1A9 I399C/C genotype (P?=?0.0086; Odds Ratio, 21.2; 95% Confidence Interval 2.2–208.0). Conclusions Nilotinib was efficacious and well tolerated by patients with imatinib-resistant or -intolerant CML-CP/AP. Hyperbilirubinemia may be predicted before nilotinib treatment, and may be controlled by reducing the daily dose of nilotinib in patients with UGT1A9 polymorphisms. Trial registration clinicaltrials.gov: UMIN000002201 PMID:24650752

  20. Results of a randomized trial comparing sequential intravenous/oral treatment with ciprofloxacin plus metronidazole to imipenem/cilastatin for intra-abdominal infections. The Intra-Abdominal Infection Study Group.

    PubMed Central

    Solomkin, J S; Reinhart, H H; Dellinger, E P; Bohnen, J M; Rotstein, O D; Vogel, S B; Simms, H H; Hill, C S; Bjornson, H S; Haverstock, D C; Coulter, H O; Echols, R M

    1996-01-01

    OBJECTIVE: In a randomized, double-blind, multicenter trial, ciprofloxacin/metronidazole was compared with imipenem/cilastatin for treatment of complicated intra-abdominal infections. A secondary objective was to demonstrate the ability to switch responding patients from intravenous (IV) to oral (PO) therapy. SUMMARY BACKGROUND DATA: Intra-abdominal infections result in substantial morbidity, mortality, and cost. Antimicrobial therapy often includes a 7- to 10-day intravenous course. The use of oral antimicrobials is a recent advance due to the availability of agents with good tissue pharmacokinetics and potent aerobic gram-negative activity. METHODS: Patients were randomized to either ciprofloxacin plus metronidazole intravenously (CIP/MTZ IV) or imipenem intravenously (IMI IV) throughout their treatment course, or ciprofloxacin plus metronidazole intravenously and treatment with oral ciprofloxacin plus metronidazole when oral feeding was resumed (CIP/MTZ IV/PO). RESULTS: Among 671 patients who constituted the intent-to-treat population, overall success rates were as follows: 82% for the group treated with CIP/MTZ IV; 84% for the CIP/MTZ IV/PO group; and 82% for the IMI IV group. For 330 valid patients, treatment success occurred in 84% of patients treated with CIP/MTZ IV, 86% of those treated with CIP/MTZ IV/PO, and 81% of the patients treated with IMI IV. Analysis of microbiology in the 30 patients undergoing intervention after treatment failure suggested that persistence of gram-negative organisms was more common in the IMI IV-treated patients who subsequently failed. Of 46 CIP/MTZ IV/PO patients (active oral arm), treatment success occurred in 96%, compared with 89% for those treated with CIP/MTZ IV and 89% for those receiving IMI IV. Patients who received intravenous/oral therapy were treated, overall, for an average of 8.6 +/- 3.6 days, with an average of 4.0 +/- 3.0 days of oral treatment. CONCLUSIONS: These results demonstrate statistical equivalence between CIP/MTZ IV and IMI IV in both the intent-to-treat and valid populations. Conversion to oral therapy with CIP/MTZ appears as effective as continued intravenous therapy in patients able to tolerate oral feedings. PMID:8604912

  1. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial

    PubMed Central

    Zheng, Hui; Xu, Jing; Li, Juan; Li, Xiang; Zhao, Ling; Chang, Xiaorong; Liu, Mi; Gong, Biao; Li, Xuezhi; Liang, Fanrong

    2013-01-01

    Introduction Whether acupuncture is efficacious for patients with functional dyspepsia is still controversial. So we designed a randomised controlled trial to settle the problem. Methods and analysis We designed a multicentre, two-arm, sham-controlled clinical trial. 200 participants with functional dyspepsia will be randomly assigned to the true acupuncture (TA) group and sham acupuncture (SA) group in a 1:1 ratio. Participants in the TA group will receive acupuncture at points selected according to syndrome differentiation. Participants in the sham acupuncture group will receive penetrations at sham points. Participants in both groups will receive 20 sessions of electroacupuncture in 4?weeks, five times continuously with a 2?day rest in a week. The primary outcome is the proportion of patients reporting the absence of dyspeptic symptoms at 16?weeks after inclusion. The secondary outcome includes a Short-Form Leeds Dyspepsia Questionnaire, the Chinese version of the 36-Item Short Form Survey, the Chinese version of the Nepean dyspepsia index, etc. Ethics and dissemination The study protocol has been approved by the institutional review boards and ethics committees of the first affiliated hospital of Chengdu University of TCM, the first affiliated hospital of Hunan University of TCM and Chongqing Medical University, respectively (from April to August 2012). The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses. Trials registration ClinicalTrials.gov NCT01671670. PMID:23901030

  2. “Entering a Clinical Trial: Is it Right For You?"-- A Randomized Study of The Clinical Trials Video and Its Impact on the Informed Consent Process

    PubMed Central

    Hoffner, Brianna; Bauer-Wu, Susan; Hitchcock-Bryan, Suzanne; Powell, Mark; Wolanski, Andrew; Joffe, Steven

    2011-01-01

    PURPOSE This randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients’ understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients’ satisfaction with the video. METHODS Ninety adults considering cancer clinical trials were randomized to receive (n=45) or not receive (n=45) the video. Using the validated Quality of Informed Consent (QuIC), respondents’ knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model and descriptive statistics. RESULTS Although intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation. CONCLUSIONS Although the video did not measurably improve patients’ knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers. PMID:22009665

  3. Study protocol for the nutritional route in oesophageal resection trial: a single-arm feasibility trial (NUTRIENT trial)

    PubMed Central

    Weijs, Teus J; Nieuwenhuijzen, Grard A P; Ruurda, Jelle P; Kouwenhoven, Ewout A; Rosman, Camiel; Sosef, Meindert; v Hillegersberg, Richard; Luyer, Misha D P

    2014-01-01

    Introduction The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy. Methods and analysis This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered. Ethics and dissemination Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the study has been registered at the Dutch Trial Register, NTR4136. Results will be published and presented at international congresses. Discussion We hypothesise that the oral route of feeding is safe and feasible following oesophagectomy, as has been shown previously for other types of gastrointestinal surgery. It is expected that early oral nutrition will result in enhanced recovery. Furthermore, complications related to artificial feeding, such as jejunostomy tube feeding, are believed to be reduced. However, (aspiration) pneumonia and anastomotic leakage are potential risks that are carefully monitored. Trial registration number NTR4136. PMID:24907243

  4. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

    PubMed Central

    2013-01-01

    Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size =?11). Participants were 223 smokers consuming???5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M =?37.5 years [SD =?11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p =?.73) or on the number of cigarettes smoked per day (p =?.56). Smoking abstinence self-efficacy did not differ between the interventions (p =?.14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p =?.02). Both interventions produced few adverse reactions (p =?.81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

  5. Personalised Normative Feedback for Preventing Alcohol Misuse in University Students: Solomon Three-Group Randomised Controlled Trial

    PubMed Central

    Moreira, Maria T.; Oskrochi, Reza; Foxcroft, David R.

    2012-01-01

    Background Young people tend to over-estimate peer group drinking levels. Personalised normative feedback (PNF) aims to correct this misperception by providing information about personal drinking levels and patterns compared with norms in similar aged peer groups. PNF is intended to raise motivation for behaviour change and has been highlighted for alcohol misuse prevention by the British Government Behavioural Insight Team. The objective of the trial was to assess the effectiveness of PNF with college students for the prevention of alcohol misuse. Methodology Solomon three-group randomised controlled trial. 1751 students, from 22 British Universities, allocated to a PNF group, a normal control group, or a delayed measurement control group to allow assessment of any measurement effects. PNF was provided by email. Participants completed online questionnaires at baseline, 6- and 12-months (only 12-months for the delayed measurement controls). Drinking behaviour measures were (i) alcohol disorders; (ii) frequency; (iii) typical quantity, (iv) weekly consumption; (v) alcohol-related problems; (vi) perceived drinking norms; and (vii) positive alcohol expectancies. Analyses focused on high-risk drinkers, as well as all students, because of research evidence for the prevention paradox in student drinkers. Principal Findings Follow-up rates were low, with only 50% and 40% responding at 6- and 12-months, respectively, though comparable to similar European studies. We found no evidence for any systematic attrition bias. Overall, statistical analyses with the high risk sub-sample, and for all students, showed no significant effects of the intervention, at either time-point, in a completed case analysis and a multiple imputation analysis. Conclusions We found no evidence for the effectiveness of PNF for the prevention of alcohol misuse and alcohol-related problems in a UK student population. Registration Controlled-Trials.com ISRCTN30784467 PMID:22984466

  6. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Microsoft Academic Search

    Konrad Streitberger; Steffen Witte; Ulrich Mansmann; Christine Knauer; Jürgen Krämer; Hanns-Peter Scharf; Norbert Victor

    2004-01-01

    BACKGROUND: Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. METHODS: 900 patients will be randomised to three treatment arms. One group

  7. Return of individual research results and incidental findings in the clinical trials cooperative group setting.

    PubMed

    Ferriere, Michael; Van Ness, Brian

    2012-04-01

    The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation. PMID:22382800

  8. Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study

    Microsoft Academic Search

    Usha Menon; Aleksandra Gentry-Maharaj; Andy Ryan; Aarti Sharma; Matthew Burnell; Rachel Hallett; Sara Lewis; Alberto Lopez; Keith Godfrey; David Oram; Jonathan Herod; Karin Williamson; Mourad Seif; Ian Scott; Tim Mould; Robert Woolas; John Murdoch; Stephen Dobbs; Nazar Amso; Simon Leeson; Derek Cruickshank; Ali McGuire; Stuart Campbell; Lesley Fallowfield; Steve Skates; Mahesh Parmar; Ian Jacobs

    2008-01-01

    Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials.Design Descriptive study.Setting 13 NHS trusts in England, Wales, and Northern Ireland.Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian

  9. Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Traumatic brain injury (TBI) is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP) add to the morbidity and mortality of traumatic brain-injured patients. In one study, hydrocortisone for treatment of traumatic-induced corticosteroid insufficiency (CI) in multiple injured patients has prevented HAP, particularly in the sub-group of patients with severe TBI. Fludrocortisone is recommended in severe brain-injured patients suffering from acute subarachnoid hemorrhage. Whether an association of hydrocortisone with fludrocortisone protects from HAP and improves neurological recovery is uncertain. The aim of the current study is to compare corticotherapy to placebo for TBI patients with CI. Methods The CORTI-TC (Corticotherapy in traumatic brain-injured patients) trial is a multicenter, randomized, placebo controlled, double-blind, two-arms study. Three hundred and seventy six patients hospitalized in Intensive Care Unit with a severe traumatic brain injury (Glasgow Coma Scale ? 8) are randomized in the first 24 hours following trauma to hydrocortisone (200 mg.day-1 for 7 days, 100 mg on days 8-9 and 50 mg on day-10) with fludrocortisone (50 ?g for 10 days) or double placebo. The treatment is stopped if patients have an appropriate adrenal response. The primary endpoint is HAP on day-28. The endpoint of the ancillary study is the neurological status on 6 and 12 months. Discussion The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery. Trial registration NCT01093261 PMID:21999663

  10. Conducting randomised controlled trials across countries with disparate levels of socio-economic development: the experience of the Asia-Pacific Hepatocellular Carcinoma Trials Group.

    PubMed

    Kong, Nicole H Y; Chow, Pierce K H

    2013-11-01

    Hepatocellular carcinoma (HCC), which constitutes over 85-90% of all primary liver cancers, is the most predominant type of liver cancer, and the third leading cause of cancer related deaths in the world. While the Asia-Pacific is a highly heterogeneous region in geography, ethnicity and in the level of socio-economic development, the main burden of HCC falls in this region and there are compelling reasons and advantages to conduct definitive clinical trials in HCC where it is endemic. The Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group was established in 1997 and has faced and overcome challenges that are inherent in conducting clinical trials in a disparate region. Clinical trial infrastructure is rudimentary at many sites and requires significant effort to be expended on training and monitoring to ensure production of definitive data. The benefits of industrial support of Investigator-Initiated Trials are discussed in the context of the Asia-Pacific. The positive experience of the AHCC trials group would be valuable to any collaborative trials in countries with disparate levels of socio-economic development. PMID:23587539

  11. An open trial investigation of a transdiagnostic group treatment for children with anxiety and depressive symptoms.

    PubMed

    Bilek, Emily L; Ehrenreich-May, Jill

    2012-12-01

    The current study investigates the feasibility and preliminary outcomes associated with a transdiagnostic emotion-focused group protocol for the treatment of anxiety disorders and depressive symptoms in youth. Twenty-two children (ages 7 to 12; M=9.79) with a principal anxiety disorder and varying levels of comorbid depressive symptoms were enrolled in an open trial of the Emotion Detectives Treatment Protocol (EDTP; Ehrenreich-May & Bilek, 2009), an intervention adapted from existent unified protocols for the treatment of emotional disorders among adults and adolescents. Results indicate that participants experienced significant improvements in clinician-rated severity of principal anxiety disorder diagnoses (d=1.38), the sum of all anxiety and depressive disorder severity ratings (d=1.07), and child-reported anxiety (d=0.47) and parent-reported depressive symptoms (d=0.54) at the posttreatment assessment. EDTP had good retention rates and reports of high satisfaction. Thus, preliminary evidence suggests that EDTP is a feasible and potentially efficacious treatment of youth anxiety disorders and co-occurring depressive symptoms. Children experiencing a range of internalizing symptoms may benefit from this more generalized, emotion-focused treatment modality, as it offers flexibility to families and the mental health clinician, while maintaining a concurrent focus on the provision of cognitive-behavioral treatment skills vital to the amelioration of anxiety and depressive disorder symptoms in youth. PMID:23046789

  12. Radiotherapy in pediatric medulloblastoma: Quality assessment of Pediatric Oncology Group Trial 9031

    SciTech Connect

    Miralbell, Raymond [Quality Assurance Review Committee, Providence, RI (United States) and Department of Radiation Oncology, University Hospital, Geneva (Switzerland)]. E-mail: Raymond.Miralbell@hcuge.ch; Fitzgerald, T.J. [Quality Assurance Review Committee, Providence, RI (United States); Laurie, Fran [Quality Assurance Review Committee, Providence, RI (United States); Kessel, Sandy [Quality Assurance Review Committee, Providence, RI (United States); Glicksman, Arvin [Quality Assurance Review Committee, Providence, RI (United States); Friedman, Henry S. [Pediatric Neuro-Oncology Division, Duke South Hospital, Durham, NC (United States); Urie, Marcia [Quality Assurance Review Committee, Providence, RI (United States); Kepner, James L. [Roswell Park Cancer Institute, Buffalo, NY (United States); Zhou Tianni [Operations Center, Children's Oncology Group, Arcadia, CA (United States); Chen Zhengjia [Operations Center, Children's Oncology Group, Arcadia, CA (United States); Barnes, Pat [Department of Radiology, Stanford University, Stanford, CA (United States); Kun, Larry [Department of Radiation Oncology, St. Jude Children's Research Hospital, Memphis, TN (United States); Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States)

    2006-04-01

    Purpose: To evaluate the potential influence of radiotherapy quality on survival in high-risk pediatric medulloblastoma patients. Methods and Materials: Trial 9031 of the Pediatric Oncology Group (POG) aimed to study the relative benefit of cisplatin and etoposide randomization of high-risk patients with medulloblastoma to preradiotherapy vs. postradiotherapy treatment. Two-hundred and ten patients were treated according to protocol guidelines and were eligible for the present analysis. Treatment volume (whole brain, spine, posterior fossa, and primary tumor bed) and dose prescription deviations were assessed for each patient. An analysis of first site of failure was undertaken. Event-free and overall survival rates were calculated. A log-rank test was used to determine the significance of potential survival differences between patients with and without major deviations in the radiotherapy procedure. Results: Of 160 patients who were fully evaluable for all treatment quality parameters, 91 (57%) had 1 or more major deviations in their treatment schedule. Major deviations by treatment site were brain (26%), spinal (7%), posterior fossa (40%), and primary tumor bed (17%). Major treatment volume or total dose deviations did not significantly influence overall and event-free survival. Conclusions: Despite major treatment deviations in more than half of fully evaluable patients, underdosage or treatment volume misses were not associated with a worse event-free or overall survival.

  13. The Effect of Spiritual and Religious Group Psychotherapy on Suicidal Ideation in Depressed Patients: A Randomized Clinical Trial

    PubMed Central

    Ebrahimi, Hossein; Kazemi, Abdul Hassan; Fallahi Khoshknab, Masoud; Modabber, Raheleh

    2014-01-01

    Introduction: Suicide is a great economical, social and public health problem. It is prevalent worldwide and has a lot of negative effects on individuals, families and society. Depression is often prelude to Suicide. An important part of the treatment of the mentally ill patients is spiritual-religious psychotherapy which should be done after physical treatment. The aim of this study was to determine the effect of spiritual and religious group psychotherapy on suicidal ideation in depressed patients. Methods: 51 depressed patients with suicidal ideation from Razi hospital (Tabriz, Iran) participated in this clinical trial. To collect Data questionnaire was used which included demographic and Beck Suicide Scale Ideation. Experimental group participated in 10 sessions of group psychotherapy. Each section lasted 1 hour. Two weeks after the last section post test was done. Statistical software SPSS ver 13 was used for data analysis. Results: Results of independent t-test revealed no difference between two groups in terms of suicidal ideation before intervention but after study there is a statistical difference. Also the results of ANCOVA test showed a significant relationship between spiritual group therapy and decrease in suicidal ideation, so that this intervention can make 57% of variance in suicidal ideation of experimental group. Conclusion: Regarding positive effect of spiritual and religious group psychotherapy on decreasing suicidal ideation of depressed patients, we suggest this intervention to be held in Psychiatric Wards and also more study on depression and other psychiatric patients with greater sample size would be helpful. PMID:25276756

  14. Factors Associated with Lack of Viral Suppression at Delivery among HAART-Naïve HIV-Positive Women in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study

    PubMed Central

    Katz, Ingrid T.; Leister, Erin; Kacanek, Deborah; Hughes, Michael D.; Bardeguez, Arlene; Livingston, Elizabeth; Stek, Alice; Shapiro, David E.; Tuomala, Ruth

    2014-01-01

    Background High delivery maternal plasma HIV-1 RNA level (viral load, VL) is a risk factor for mother to child transmission and poor maternal health. Objective To identify factors associated with detectable VL at delivery despite initiation of highly active antiretroviral therapy (HAART) during pregnancy. Design Multicenter observational study. Setting 67 US AIDS clinical research sites. Patients HIV-1-positive pregnant women who initiated HAART during pregnancy. Measurements Descriptive summaries and associations between socio-demographic, HIV disease, treatment and pregnancy-related risk factors and detectable VL (>400copies/mL) at delivery. Results Between October 2002 and December 2011, 671 women met inclusion criteria and 13% had detectable VL at delivery. Factors associated with detectable VL included multiparity (16.4% vs 8% nulliparous, p=0.002), black non-Hispanic ethnicity (17.6% vs 6.6% Hispanic and 6.6% white/non-Hispanic, p<0.001), 11th grade or less education (17.6% vs.12.1% high school graduate and 6.7% some college or higher, p=0.013), and initiation of HAART in third trimester (23.9% vs 12.3% second and 8.6% first, p=0.002), timing of HIV diagnosis prior to current pregnancy (16.1% vs 11% during current pregnancy, p=0.051), and timing of first prenatal visit in 3rd trimester (33.3% vs 14.3% second and 10.5% first, p=0.002). Women who experienced treatment interruptions or reported poor medication adherence during pregnancy were more likely to have detectable VL at delivery than women with no interruptions or who reported better adherence. Limitations Women entered the study at varying times during pregnancy and for this and other reasons there was incomplete data on many covariates. Conclusions In this large U.S.-based cohort of HIV-1 positive women, 13% of women who initiated HAART during pregnancy had detectable VL at delivery. The timing of HAART initiation and prenatal care along with medication adherence during pregnancy appear to be modifiable factors associated with detectable VL at delivery. Social factors such as Black/non-Hispanic ethnicity and less than high school education may help to identify women at highest risk who may benefit from focused efforts to promote early treatment initiation and adherence to HAART. Clinical Trial Registration Number NCT00028145 PMID:25599347

  15. Immune Response Gene Expression in Colorectal Cancer Carries Distinct Prognostic Implications According to Tissue, Stage and Site: A Prospective Retrospective Translational Study in the Context of a Hellenic Cooperative Oncology Group Randomised Trial

    PubMed Central

    Pentheroudakis, George; Raptou, Georgia; Kotoula, Vassiliki; Wirtz, Ralph M.; Vrettou, Eleni; Karavasilis, Vasilios; Gourgioti, Georgia; Gakou, Chryssa; Syrigos, Konstantinos N.; Bournakis, Evangelos; Rallis, Grigorios; Varthalitis, Ioannis; Galani, Eleni; Lazaridis, Georgios; Papaxoinis, George; Pectasides, Dimitrios; Aravantinos, Gerasimos; Makatsoris, Thomas; Kalogeras, Konstantine T.; Fountzilas, George

    2015-01-01

    Background Although host immune response is an emerging prognostic factor for colorectal cancer, there is no consensus on the optimal methodology, surrogate markers or tissue for study. Patients and Methods Tumour blocks were prospectively collected from 344 patients with stage II/III colorectal cancer (CRC) treated with adjuvant chemotherapy. Whole section lymphocytic infiltration was studied along with mRNA expression of CD3Z, CD8, CD4, CXCL9, CXCL13, IGHM, FOXP3, SNAI2 and ESR1 by qRT-qPCR in tissue microarray (TMA) cores from the centre of tumour, invasive margin and adjacent normal mucosa. Results Lymphocytic infiltration, deficient MMR (10.9%), KRAS (40.7%) and BRAF (4.9%) mutations or single mRNA gene expression were not prognostic. Tumour ESR1 gene expression (Hazard Ratio [HR] for relapse 2.33, 95% CI 1.35-4.02; HR for death 1.74, 95% CI 1.02-2.97) and absence of necrosis (HR for relapse 1.71, 95% CI 1.05-2.71; HR for death 1.98, 95% CI 1.14-3.43) were adverse prognostic features. We used CD3Z and CD8 expression in order to devise the mRNA-based Immune Score (mIS) and proceeded to partitioning analysis in 267 patients, with age, stage, tumour site (Right vs Left CRC), KRAS mutation and tumour mIS as input factors. Only in patients with stage III right-sided colon cancer, a low immune response was associated with inferior disease-free survival (mIS-low, HR for relapse 2.28, 95% CI 1.05-8.02). No prognostic significance was seen for tumour mIS in any other stage or site of CRC, or for a similar mIS score derived from adjacent normal mucosa. Independent adverse prognostic significance was retained in multivariable analysis for absence of necrosis, tumour ESR1 expression in all patients and low tumour mIS in stage III right-sided CRC. Conclusions In localised CRC, mRNA-based CD3Z/CD8 profiling of tumour immune response may have stage, site and tissue-specific prognostic significance, along with ESR1 expression. Trial Registration ANZCTR.org.au ACTRN12610000509066 PMID:25970543

  16. Treatment Group Measure Study Comparator pvalue

    E-print Network

    Alemayehu, Demissie

    ),. ``Meta­analysis of drug safety data,'' In: Drug Safety Assessment in Clinical Tri­ als, Marcel Dekker test, p = 0:018 (Table 1). The differ­ ence between the groups was significant and the analysis­146. 2. DerSimonian R, Laird NM. (1986) ``Meta­ analysis in clinical trials,'' Controlled Clin­ ical

  17. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study)

    PubMed Central

    Gehring, Marta; Taylor, Rod S; Mellody, Marie; Casteels, Brigitte; Piazzi, Angela; Gensini, Gianfranco; Ambrosio, Giuseppe

    2013-01-01

    Objectives Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. Design The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Setting and participants Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. Outcome measures Primary outcome: weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Results Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). Conclusions Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of ‘hidden’ indirect costs, may bring significantly more clinical trials to Europe. PMID:24240138

  18. A Randomized Controlled Trial of the Conventional Technique Versus the No-touch Isolation Technique for Primary Tumor Resection in Patients with Colorectal Cancer: Japan Clinical Oncology Group Study JCOG1006

    PubMed Central

    Takii, Yasumasa; Shimada, Yasuhiro; Moriya, Yoshihiro; Nakamura, Kenichi; Katayama, Hiroshi; Kimura, Aya; Shibata, Taro; Fukuda, Haruhiko

    2014-01-01

    A randomized controlled trial is currently being conducted in Japan to demonstrate the superiority of the no-touch isolation technique over the conventional technique for patients with potentially curative colon and rectosigmoid cancer. The conventional technique procedure gives first priority to mobilization of the tumor-bearing segment of the colon, which is followed by central vascular ligation and ligation of other vasculature. Conversely, the no-touch isolation technique gives first priority to central vascular ligation, which is followed by mobilization of the tumor-bearing segment of the colon. A total of 850 patients will be enrolled in this trial. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, liver metastasis-free survival, mode of recurrence, surgical morbidity, adverse events due to postoperative chemotherapy, serious adverse events and short-term clinical outcomes. PMID:24211857

  19. Phase II trial with ISIS 5132 in patients with small-cell (SCLC) and non-small cell (NSCLC) lung cancer. A European Organization for Research and Treatment of Cancer (EORTC) Early Clinical Studies Group report

    Microsoft Academic Search

    B Coudert; A Anthoney; W Fiedler; J. P Droz; V Dieras; M Borner; J. F Smyth; R Morant; M. J de Vries; M Roelvink; P Fumoleau

    2001-01-01

    Two multicentre phase II trials were designed to determine if tumour responses can be achieved in progressive small-cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC) patients treated with ISIS 5132, an inhibitor of C-raf kinase mRNA expression (CGP 69846A; ISIS Pharmaceuticals Inc, Carlsbad, CA), and to further characterise the safety of the compound. Between August 1998 and November

  20. The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT): Study protocol

    Microsoft Academic Search

    Stefan H. Hohnloser; Stuart J. Connolly; Karl Heinz Kuck; Paul Dorian; Eric Fain; John R. Hampton; Robert Hatala; Andreas C. Pauly; Robin S. Roberts; Ellison Themeles; Michael Gent

    2000-01-01

    Background The implantable cardioverter\\/defibrillator (ICD) has been shown to be superior to antiarrhythmic drug therapy for the secondary prevention of sudden cardiac death. Its role in the primary prevention of sudden death after myocardial infarction is unknown. Methods and Results The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) is a randomized, open-label, parallel-group comparison of ICD therapy versus no ICD

  1. Group interpersonal psychotherapy for postnatal depression: a pilot study

    Microsoft Academic Search

    R. Reay; Y. Fisher; M. Robertson; E. Adams; C. Owen

    2006-01-01

    Summary  We conducted a pilot study to assess the potential effectiveness of group interpersonal psychotherapy (IPT-G) as a treatment\\u000a for postnatal depression (PND). The study was also established to test a treatment manual for IPT-G, assess the acceptability\\u000a of this format for participants and test a recruitment strategy for a randomised controlled trial. 18 mothers diagnosed with\\u000a PND participated in 2

  2. Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism

    PubMed Central

    2014-01-01

    Background Serotonin reuptake inhibitors (SSRIs) are commonly prescribed off-label for children with autism. To date, clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice. The aim of the Fluoxetine for Autistic Behaviors (FAB) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo, for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder (ASD). The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored. Methods/Design The FAB study is a multicenter, double-blinded, randomized controlled trial, funded by the Australian Government’s National Health and Medical Research Council (NHMRC) grant. Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD. Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period. Medication will be titrated over the first four weeks. Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale (CGI). The primary outcome measure is the Children’s Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders (CYBOCS-PDD), administered at baseline and 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), the Spence Children’s Anxiety Scale Parent Report (SCAS-P), and the Repetitive Behaviors Scale (RBS-R), measured at baseline and 16 weeks. Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab. Continuous outcomes, including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression. Binary outcomes will be compared using unadjusted logistic regression. Discussion The FAB study is a large clinical trial to specifically investigate the efficacy of low dose fluoxetine for restricted, repetitive, and stereotyped behaviors in ASD. The outcomes of this study will contribute to evidence-based interventions used in clinical practice to assist children with ASD. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12608000173392; registered on 9 April, 2008. PMID:24934401

  3. Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology. The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis. Methods/Design The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ. We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data. Trial registration Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247 PMID:24028414

  4. Reference datasets for bioequivalence trials in a two-group parallel design.

    PubMed

    Fuglsang, Anders; Schütz, Helmut; Labes, Detlew

    2015-03-01

    In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. This paper puts a total 11 datasets into the public domain along with proposed consensus obtained via evaluations from six different software packages (R, SAS, WinNonlin, OpenOffice Calc, Kinetica, EquivTest). Insofar as possible, datasets were evaluated with and without the assumption of equal variances for the construction of a 90% confidence interval. Not all software packages provide functionality for the assumption of unequal variances (EquivTest, Kinetica), and not all packages can handle datasets with more than 1000 subjects per group (WinNonlin). Where results could be obtained across all packages, one showed questionable results when datasets contained unequal group sizes (Kinetica). A proposal is made for the results that should be used as validation targets. PMID:25488055

  5. The digestibility study (trial A) was made on 20 castrated male pigs (5 groups) placed in individual pens with total collection of the excreta for 10 consecutive days. The energy

    E-print Network

    Boyer, Edmond

    of cassava was assessed by the substitution method using diets including 25 or 50 p. 100 cassava (1 or 2) in the place of a diet containing maize-soybean meal (control group). The digestible energy values of cassava 1 : the control diet maize- soybean meal (group 1), a diet with 15 p. 100 cassava 1 (group 2), a diet with 30 p

  6. Literature Study Groups: Literacy Learning "With Legs"

    NSDL National Science Digital Library

    Sue Christian Parsons

    Literature study groups help promote critical thinking and improve reading skills. This article describes research-based approaches to literacy study groups and provides suggestions for implementation.

  7. Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation

    Microsoft Academic Search

    Suchitra Rath; Nirmala Nair; Prasanta K Tripathy; Sarah Barnett; Shibanand Rath; Rajendra Mahapatra; Rajkumar Gope; Aparna Bajpai; Rajesh Sinha; Anthony Costello; Audrey Prost

    2010-01-01

    BACKGROUND: Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008).

  8. Are Power Analyses Reported with Adequate Detail? Evidence from the First Wave of Group Randomized Trials Funded by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca

    2008-01-01

    This study examines the reporting of power analyses in the group randomized trials funded by the Institute of Education Sciences from 2002 to 2006. A detailed power analysis provides critical information that allows reviewers to (a) replicate the power analysis and (b) assess whether the parameters used in the power analysis are reasonable.…

  9. Longitudinal Effects of Coping on Outcome in a Randomized Controlled Trial of a Group Intervention for HIV-Positive Adults with AIDS-Related Bereavement

    ERIC Educational Resources Information Center

    Hansen, Nathan B.; Tarakeshwar, Nalini; Ghebremichael, Musie; Zhang, Heping; Kochman, Arlene; Sikkema, Kathleen J.

    2006-01-01

    This study examined the longitudinal effects of coping on outcome one year following completion of a randomized, controlled trial of a group coping intervention for AIDS-related bereavement. Bereaved HIV-positive participants (N = 267) were administered measures of grief, psychiatric distress, quality of life, and coping at baseline,…

  10. Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy

    PubMed Central

    Bakermans-Kranenburg, M J; van IJzendoorn, M H

    2013-01-01

    The popularity of oxytocin (OT) has grown exponentially during the past decade, and so has the number of OT trials in healthy and clinical groups. We take stock of the evidence from these studies to explore potentials and limitations of pharmacotherapeutic applications. In healthy participants, intranasally administered OT leads to better emotion recognition and more trust in conspecifics, but the effects appear to be moderated by context (perceived threat of the ‘out-group'), personality and childhood experiences. In individuals with untoward childhood experiences, positive behavioral or neurobiological effects seem lowered or absent. In 19 clinical trials, covering autism, social anxiety, postnatal depression, obsessive-compulsive problems, schizophrenia, borderline personality disorder and post-traumatic stress, the effects of OT administration were tested, with doses ranging from 15?IU to more than 7000?IU. The combined effect size was d=0.32 (N=304; 95% confidence interval (CI): 0.18–0.47; P<0.01). However, of all disorders, only studies on autism spectrum disorder showed a significant combined effect size (d=0.57; N=68; 95% CI: 0.15–0.99; P<0.01). We hypothesize that for some of the other disorders, etiological factors rooted in negative childhood experiences may also have a role in the diminished effectiveness of treatment with OT. PMID:23695233

  11. A Phase Ii Trial Of Selumetinib (Azd6244) In Women With Recurrent Low-Grade Serous Carcinoma Of The Ovary Or Peritoneum: A Gynecologic Oncology Group Trial

    PubMed Central

    Farley, John; Brady, William E.; Vathipadiekal, Vinod; Lankes, Heather A.; Coleman, Robert; Morgan, Mark A.; Mannel, Robert; Yamada, S. Diane; Mutch, David; Rodgers, William H.; Birrer, Michael; Gershenson, David M.

    2013-01-01

    BACKGROUND Because low grade serous carcinoma of the ovary is relatively chemo resistant disease, this study evaluated Selumetinib (AZD6244), an inhibitor of mitogen-activated protein kinase kinase (MEK-1/2), and explored associations between RAS, and RAF family mutations with clinical outcome. METHODS Women with recurrent low-grade serous ovarian or peritoneal carcinoma were eligible and received Selumetinib at 100 mg. orally b.i.d. until progression or toxicity were enrolled in Gynecologic Oncology protocol 239(NCT00551070). This trial has been completed and we are reporting the results. The primary endpoint of this trial was to examine tumor response rate to Selumetinib. The study used all-treated patients to determine response rate and overall survival. FINDINGS Fifty-two patients were enrolled over two years. Eight patients (15.4%) had complete (1) or partial (7) responses, and 34 (65%) had stable disease. There were no treatment-related deaths. There were three observed grade 4 toxicities and 46 grade 3 toxicities that occurred in more than one patient. Observed grade 4 toxicities were cardiac (1), pain (1), and pulmonary (1). Grade 3 toxicities that occurred included gastrointestinal (13), dermatologic (9), and metabolic (7). CONCLUSIONS Selumetinib is well tolerated, and is active in the treatment of recurrent low-grade serous carcinoma. In exploratory analyses, response to Selumetinib did not appear to be related to RAS/RAF mutational status. The 63% disease control is encouraging and worthy of further evaluation of MEK inhibitors in this population. This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group. PMID:23261356

  12. The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.

    PubMed

    Hamilton, D W; de Salis, I; Donovan, J L; Birchall, M

    2013-08-01

    We aimed to investigate the factors contributing to poor recruitment to the EaStER trial "Early Stage glottic cancer: Endoscopic excision or Radiotherapy" feasibility study. We performed a prospective qualitative assessment of the EaStER trial at three centres to investigate barriers to recruitment and implement changes. Methods used included semi-structured interviews, focus groups and audio-recordings of recruitment encounters. First, surgeons and recruiters did not all accept the primary outcome as the rationale for the trial. Surgeons did not always adhere to the trial eligibility criteria leading to variations between centres in the numbers of "eligible" patients. Second, as both treatments were considered equally successful, recruiters and patients focused on the pragmatics of the different trial arms, favouring surgery over radiotherapy. The lack of equipoise was reflected in the way recruiters presented trial information. Third, patient views, beliefs and preferences were not fully elicited or addressed by recruiters. Fourth, in some centres, logistical issues made trial participation difficult. This qualitative research identified several major issues that explained recruitment difficulties. While there was insufficient time to address these in the EaStER trial, several factors would need to be addressed to launch further RCTs in head and neck cancer. These include the need for clear ongoing agreement among recruiting clinicians regarding details in the study protocol; an understanding of the logistical issues hindering recruitment at individual centres; and training recruiters to enable them to explain the need for randomisation and the rationale for the RCT to patients. PMID:23334205

  13. Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors

    PubMed Central

    Maercker, Andreas; Zöllner, Tanja; Menning, Hans; Rabe, Sirko; Karl, Anke

    2006-01-01

    Background We translated, modified, and extended a cognitive behavioral treatment (CBT) protocol by Blanchard and Hickling (2003) for the purpose of treating survivors of MVA with full or subsyndromal posttraumatic stress disorder (PTSD) whose native language is German. The treatment manual included some additional elements, e. g. cognitive procedures, imaginal reliving, and facilitating of posttraumatic growth. The current study was conducted in order to test the efficacy of the modified manual by administering randomized controlled trial in which a CBT was compared to a wait-list control condition. Methods Forty-two motor vehicle accident survivors with chronic or severe subsyndromal posttraumatic stress disorder (PTSD) completed the treatment trial with two or three detailed assessments (pre, post, and 3-month follow-up). Results CAPS-scores showed significantly greater improvement in the CBT condition as compared to the wait list condition (group × time interaction effect size d = 1.61). Intent-to-treat analysis supported the outcome (d = 1.34). Categorical diagnostic data indicated clinical recovery of 67% (post-treatment) and 76% (3 months FU) in the treatment group. Additionally, patients of the CBT condition showed significantly greater reductions in co-morbid major depression than the control condition. At follow-up the improvements were stable in the active treatment condition. Conclusion The degree of improvement in our treatment group was comparable to that in previously reported treatment trials of PTSD with cognitive behavioral therapy. Trial registration ISRCTN66456536 PMID:16824221

  14. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    PubMed Central

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  15. Phase 1 Trial of Temsirolimus in Combination with Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors: A Children’s Oncology Group Study

    PubMed Central

    Bagatell, R; Norris, RE; Ingle, AM; Ahern, CH; Voss, S; Fox, E; Little, A; Weigel, B; Adamson, PC; Blaney, SM

    2014-01-01

    Background mTOR inhibitors have activity in pediatric tumor models. A phase I trial of the mTOR inhibitor temsirolimus (TEM) with irinotecan (IRN) and temozolomide (TMZ) was conducted in children with recurrent/refractory solid tumors, including central nervous system (CNS) tumors. Methods Escalating doses of intravenous TEM were administered on days 1 and 8 of 21-day cycles. IRN (50 mg/m2/dose escalated to a maximum of 90 mg/m2/dose) and TMZ (100 mg/m2/dose escalated to a maximum of 150 mg/m2/dose) were administered orally on days 1–5. When maximum tolerated doses (MTD) were identified, TEM frequency was increased to weekly. Results Seventy-one eligible pts (median age 10.9 years, range 1.0–21.5) with neuroblastoma (16), osteosarcoma (7), Ewing sarcoma (7), rhabdomyosarcoma (4), CNS (22) or other (15) tumors were enrolled. Dose-limiting hyperlipidemia occurred in 2 patients receiving oral corticosteroids. The protocol was subsequently amended to preclude chronic steroid use. The MTD was identified as TEM 35 mg/m2weekly, with IRN 90 mg/m2and TMZ 125 mg/m2on days 1–5. At higher dose levels, elevated serum alanine aminotransferase and triglycerides, anorexia, and thrombocytopenia were dose limiting. Additional ? grade 3 regimen-related toxicities included leukopenia, neutropenia, lymphopenia, anemia, and nausea/vomiting. Six patients had objective responses confirmed by central review; 3 of these had sustained responses through ? 14 cycles of therapy. Conclusion The combination of TEM (35 mg/m2/dose weekly), IRN (90 mg/m2/dose days 1–5) and TMZ (125 mg/m2/dose days 1–5) administered every 21 days is well tolerated in children. Phase 2 trials of this combination are ongoing. PMID:24249672

  16. Doing Anger Differently: Two Controlled Trials of Percussion Group Psychotherapy for Adolescent Reactive Aggression

    ERIC Educational Resources Information Center

    Currie, Michael; Startup, Mike

    2012-01-01

    This study evaluates efficacy and effectiveness of "Doing Anger Differently" (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1,…

  17. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Methods/Design Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Discussion Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Trial registration Netherlands Trial Register, NTR3571 PMID:24467861

  18. A trial studying approach to predict college achievement

    PubMed Central

    Meijer, Rob R.; Niessen, A. Susan M.

    2015-01-01

    We argue that using trial studying is a reliable and valid way to select students for higher education. This method is based on a work sample approach often used in personnel selection contexts. We discuss that this method has predictive validity for study success, has high acceptance by stakeholders, and measures self-regulation in a high-stakes testing context that cannot be measured through self-report questionnaires. We suggest further research to implement this method to select students. PMID:26175704

  19. Clinical Trial Adaptation by Matching Evidence in Complementary Patient Sub-groups of Auxiliary Blinding Questionnaire Responses

    PubMed Central

    Arandjelovi?, Ognjen

    2015-01-01

    Clinical trial adaptation refers to any adjustment of the trial protocol after the onset of the trial. Such adjustment may take on various forms, including the change in the dose of administered medicines, the frequency of administering an intervention, the number of trial participants, or the duration of the trial, to name just some possibilities. The main goal is to make the process of introducing new medical interventions to patients more efficient, either by reducing the cost or the time associated with evaluating their safety and efficacy. The principal challenge, which is an outstanding research problem, is to be found in the question of how adaptation should be performed so as to minimize the chance of distorting the outcome of the trial. In this paper we propose a novel method for achieving this. Unlike most of the previously published work, our approach focuses on trial adaptation by sample size adjustment i.e. by reducing the number of trial participants in a statistically informed manner. We adopt a stratification framework recently proposed for the analysis of trial outcomes in the presence of imperfect blinding and based on the administration of a generic auxiliary questionnaire that allows the participants to express their belief concerning the assigned intervention (treatment or control). We show that this data, together with the primary measured variables, can be used to make the probabilistically optimal choice of the particular sub-group a participant should be removed from if trial size reduction is desired. Extensive experiments on a series of simulated trials are used to illustrate the effectiveness of our method. PMID:26161797

  20. The Joys of Clinical Trials: A Case Study of a Multicenter Pharmaceutical Trial.

    ERIC Educational Resources Information Center

    Soronson, Bryan M.; Shaw, Diana V.

    1994-01-01

    A discussion of clinical trials in the pharmaceutical industry describes typical processes and administrative issues, then presents a case in which a foreign pharmaceutical company negotiated with a university for sponsorship of a multicenter clinical trial of a new drug therapy. Problems and important considerations in clinical trials are…

  1. A traditional Chinese medicine versus Western combination therapy in the treatment of rheumatoid arthritis: two-stage study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background The common randomized controlled trial design has distinct limitations when applied to Chinese medicine, because Chinese medicine identifies and treats 'Chinese medicine patterns' rather than diagnosed diseases. Chinese medicine patterns are a group of associated symptoms, tongue appearances and pulse characteristics. These limitations could be overcome by developing new strategies to evaluate the effect of Chinese medicine. The idea behind pattern-based efficacy evaluations may optimize clinical trial design by identifying the responsiveness-related Chinese medicine patterns. Methods/Design This is a two-stage multi-center trial of Chinese herbal medicine for the management of rheumatoid arthritis. The stage one trial is an open-label trial and aims to explore what groups of Chinese medicine information (such as symptoms) correlates with better efficacy, and the stage two trial is a randomized, controlled, double-blind, double-dummy clinical trial that incorporates the efficacy-related information identified in the stage-one trial into the inclusion criteria. Discussion The indication of a Chinese herbal formula is a specific Chinese medicine pattern and not a single disease and stratifying a disease into several patterns with a group of symptoms is a feasible procedure in clinical trials. This study is the first to investigate whether this approach in the design of Chinese herbal medicine trials can improve responses. Trial registration ChiCTR-TRC-10000989 PMID:21639923

  2. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power

    PubMed Central

    Hox, Joop J.; Moerbeek, Mirjam; Kluytmans, Anouck; van de Schoot, Rens

    2013-01-01

    Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen's theory of planned behavior is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioral intention. Structural equation modeling (SEM) is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g., much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5–10 clusters are available per treatment condition even with Bayesian estimation problems occur. PMID:24550881

  3. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999.

    PubMed Central

    Evelyn, B.; Toigo, T.; Banks, D.; Pohl, D.; Gray, K.; Robins, B.; Ernat, J.

    2001-01-01

    Few recent data are available from formal evaluations of approved new drug applications to address perceptions that racial and ethnic groups are under-represented in clinical trials of new drugs. This study reviews racial and ethnic group participation in clinical trials and race-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This was a retrospective review of FDA medical officers' reviews of clinical trial protocols and product labeling for 185 new molecular entities (NME's) approved by CDER between January 1,1995, and December 31, 1999. Enrollment data were obtained from the reviews and tabulated according to race/ethnicity. The approved product labeling was searched for statements related to product testing in various racial/ethnic groups. All data were compiled and analyzed using Microsoft Access. This study quantifies the participation of racial/ethnic groups in clinical trials by year and therapeutic category. Additionally, the study categorizes labeling based on the types of effects described as related to race/ethnicity. Racial and ethnic groups appear to participate in clinical trials to varying degrees. African Americans participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. Among trials known to be conducted only in the U.S., African-American participation is comparable to their representation in the U.S. population. In all cases, participants designated as Hispanic appear to be far below their representation in the population. Some differences in participation for all racial and ethnic groups are seen when comparisons from year-to-year or among drug classes are made. Labeling for 45% (84/185) of the products contained some statement about race, although in only 8% (15/185) were differences related to race described. Fifty percent (50%) of the effects were pharmacokinetic, 39% were efficacy, and 11% were safety. One product label recommended a change in dosage based on racial differences. Images Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 7 PMID:11798060

  4. Canadian-led capacity-building in biostatistics and methodology in cardiovascular and diabetes trials: the CANNeCTIN Biostatistics and Methodological Innovation Working Group

    PubMed Central

    2011-01-01

    The Biostatistics and Methodological Innovation Working (BMIW) Group is one of several working groups within the CANadian Network and Centre for Trials INternationally (CANNeCTIN). This programme received funding from the Canadian Institutes of Health Research and the Canada Foundation for Innovation beginning in 2008, to enhance the infrastructure and build capacity for large Canadian-led clinical trials in cardiovascular diseases (CVD) and diabetes mellitus (DM). The overall aims of the BMIW Group's programme within CANNeCTIN, are to advance biostatistical and methodological research, and to build biostatistical capacity in CVD and DM. Our program of research and training includes: monthly videoconferences on topical biostatistical and methodological issues in CVD/DM clinical studies; providing presentations on methods issues at the annual CANNeCTIN meetings; collaborating with clinician investigators on their studies; training young statisticians in biostatistics and methods in CVD/DM trials and organizing annual symposiums on topical methodological issues. We are focused on the development of new biostatistical methods and the recruitment and training of highly qualified personnel - who will become leaders in the design and analysis of CVD/DM trials. The ultimate goal is to enhance global health by contributing to efforts to reduce the burden of CVD and DM. PMID:21332987

  5. Altering school climate through school-wide Positive Behavioral Interventions and Supports: findings from a group-randomized effectiveness trial.

    PubMed

    Bradshaw, Catherine P; Koth, Christine W; Thornton, Leslie A; Leaf, Philip J

    2009-06-01

    Positive Behavioral Interventions and Supports (PBIS) is a universal, school-wide prevention strategy that is currently implemented in over 7,500 schools to reduce disruptive behavior problems. The present study examines the impact of PBIS on staff reports of school organizational health using data from a group-randomized controlled effectiveness trial of PBIS conducted in 37 elementary schools. Longitudinal multilevel analyses on data from 2,596 staff revealed a significant effect of PBIS on the schools' overall organizational health, resource influence, staff affiliation, and academic emphasis over the 5-year trial; the effects on collegial leadership and institutional integrity were significant when implementation fidelity was included in the model. Trained schools that adopted PBIS the fastest tended to have higher levels of organizational health at baseline, but the later-implementing schools tended to experience the greatest improvements in organizational health after implementing PBIS. This study indicated that changes in school organizational health are important consequences of the PBIS whole-school prevention model, and may in turn be a potential contextual mediator of the effect of PBIS on student performance. PMID:19011963

  6. Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Attention-deficit/hyperactivity disorder (ADHD) is a common neuro-psychiatric problem, affecting 7-9% of children. Pharmacological interventions are widely used with behavioral treatments in ADHD. Still, the origin of ADHD is unclear, limiting pharmacological effectiveness and making adverse effects common. The use of complementary and alternative medicine (CAM) has increased, especially for developmental and behavioral disorders, such as ADHD. CAM is used by 60-65% of parents of children with ADHD to relieve ADHD-associated symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with ADHD, but the available evidence of its effectiveness is insufficient. Our aim was to evaluate the effectiveness and safety of acupuncture in patients (both and each treatment naive and conventional therapy children) with ADHD (any subtype) compared to the waitlist control. Methods/Design This study is a waitlist controlled open trial. We used a computer generated randomization scheme. This randomised, controlled trial had two parallel arms (acupuncture, and waitlist group). Each arm consisted of 40 participants. The acupuncture group received acupuncture treatment two times per week for a total of 12 sessions over 6 weeks. Post-treatment follow-up was performed 3 weeks later to complement the 12 acupuncture sessions. Participants in the waitlist group did not receive acupuncture treatments during the first six weeks but were only required to be assessed. After 6 weeks, the same treatments given to the acupuncture group were provided to the waitlist group. The primary outcome of this trial included differences in Korean version of ADHD-Rating Scale (K-ADHD-RS) before randomization, 3 weeks and 6 weeks after randomization, and 3 weeks after completing the treatment. Discussion Subjective measurements, like K-ADHD-RS, are commonly used in ADHD. Although these measurements have adequate reliability and validity, lack of objective assessment in ADHD may lead to some disputes, like parental placebo effects. More objective measurements, like Computerized Neurocognitive function Test (CNT) in this study, are needed in ADHD trials. Furthermore, this trial will provide evidence for the effectiveness of acupuncture as a treatment for ADHD. Trial Registration Clinical Research Information Service (CRiS) KCT0000019 PMID:21745388

  7. Studying a disease with no home - lessons in trial recruitment from the PATCH II study

    Microsoft Academic Search

    Kim S Thomas

    2010-01-01

    BACKGROUND: Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that

  8. Group-Sequential Methods for Adaptive Seamless Phase II\\/III Clinical Trials

    Microsoft Academic Search

    Nigel Stallard

    2011-01-01

    The last 10 years have seen considerable interest in clinical trial designs that allow the seamless combination of Phases II and III in a single clinical trial. Such designs bring together the selection of the most promising of a number of treatments, as usually performed in a Phase II clinical trial, with the rigorous analysis and control of type I

  9. Trial participants' understanding of randomization, double-blinding, and placebo use in low literacy populations: findings from a study conducted within a microbicide trial in Malawi.

    PubMed

    Ndebele, Paul; Wassenaar, Douglas; Masiye, Francis; Munalula-Nkandu, Esther

    2014-07-01

    Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants' understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualitative methods, including structured questionnaire interviews with a random sample of 203 individual participants, four in-depth interviews with research nurses, and two focus group discussions with 18 study participants. Most respondents earned high scores on questions related to randomization (85%) and placebo use (72%), while a greater proportion of the same respondents obtained low scores on questions related to double-blinding (68%) and personal implications of the study procedures (63%). Overall, most respondents (61%; n = 124) obtained low scores on combined understanding of all the three concepts under study. PMID:25746781

  10. Southeastern Cancer Study Group: breast cancer studies

    SciTech Connect

    Smalley, R.V.; Bartolucci, A.A.; Moore, M.

    1983-12-01

    During the past 10 years, the Southeastern Cancer Study Group (SECSG) has been engaged in one major adjuvant study and three major advanced disease studies for patients with adenocarcinoma of the breast. The adjuvant study is demonstrating that six months of adjuvant CMF is the therapeutic equivalent of 12 months and that post-operative irradiation is of no added therapeutic benefit. In patients with advanced disease, a low dose 5 drug combination of CMFVP induces more objective responses than single agent 5FU, but improves survival only for those patients with liver metastases when compared to the sequential use of the same 5 single agents. The three drug combination, CAF, utilizing doxorubicin, induces more objective responses than low dose CMFVP, but it does not improve overall survival. The addition of a phase active combination, CAMELEON, (i.e., sequentially alternating therapy) of CAF has not improved the duration of disease control and survival for patients with liver metastases, lymphangitic and nodular lung metastases compared to CAF. Aggressive combination chemotherapeutic approaches to patients with advanced disease provide better and longer disease and tumor control but only marginal improvements in overall survival. Adding additional agents to a maximally tolerable regimen has not improved the therapeutic outcome.

  11. Current status and future perspectives of cooperative study groups for lung cancer in Japan.

    PubMed

    Kawano, Yuko; Okamoto, Isamu; Fukuda, Haruhiko; Ohe, Yuichiro; Nakamura, Shinichiro; Nakagawa, Kazuhiko; Hotta, Katsuyuki; Kiura, Katsuyuki; Takiguchi, Yuichi; Saka, Hideo; Okamoto, Hiroaki; Takayama, Koichi; Semba, Hiroshi; Kobayashi, Kunihiko; Kenmotsu, Hirotsugu; Tsuboi, Masahiro; Yamamoto, Nobuyuki; Nukiwa, Toshihiro; Nakanishi, Yoichi

    2014-11-01

    The performance of scientifically and ethically valid prospective clinical trials is the only means by which to obtain reliable clinical evidence that can improve clinical practice and thus the outcome of patients with lung cancer. The efficacy of treatment for advanced lung cancer remains limited; many cooperative study groups for lung cancer have been established in Japan since 1990s, and they have completed several landmark investigator-initiated clinical trials. This review highlights eight active Japanese cooperative study groups for lung cancer and summarizes their achievements made through clinical trials. In addition to their benefits, the existence of multiple study groups for a single disease such as lung cancer presents several challenges including the provision of infrastructure to ensure the scientific integrity of trial results, the unnecessary duplication of effort and the wasting of limited resources, and the accrual and completion of large-scale phase III trials in the shortest possible time. Collaboration among Japanese cooperative groups has recently increased in order to overcome these challenges. Although institutional barriers to the performance of such large intergroup trials remain, further harmonization and collaboration among cooperative groups will be vital in allowing Japanese investigators to make further important contributions for the development of new lung cancer therapies. PMID:25453377

  12. Community-based group exercise for persons with Parkinson disease: a randomized controlled trial.

    PubMed

    Combs, Stephanie A; Diehl, M Dyer; Chrzastowski, Casey; Didrick, Nora; McCoin, Brittany; Mox, Nicholas; Staples, William H; Wayman, Jessica

    2013-01-01

    The purpose of this study was to compare group boxing training to traditional group exercise on function and quality of life in persons with Parkinson disease (PD). A convenience sample of adults with PD (n = 31) were randomly assigned to boxing training or traditional exercise for 24-36 sessions, each lasting 90 minutes, over 12 weeks. Boxing training included: stretching, boxing (e.g. lateral foot work, punching bags), resistance exercises, and aerobic training. Traditional exercise included: stretching, resistance exercises, aerobic training, and balance activities. Participants were tested before and after completion of training on balance, balance confidence, mobility, gait velocity, gait endurance, and quality of life. The traditional exercise group demonstrated significantly greater gains in balance confidence than the boxing group (p < 0.025). Only the boxing group demonstrated significant improvements in gait velocity and endurance over time with a medium between-group effect size for the gait endurance (d = 0.65). Both groups demonstrated significant improvements with the balance, mobility, and quality of life with large within-group effect sizes (d ? 0.80). While groups significantly differed in balance confidence after training, both groups demonstrated improvements in most outcome measures. Supporting options for long-term community-based group exercise for persons with PD will be an important future consideration for rehabilitation professionals. PMID:23422464

  13. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    PubMed Central

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ?18?years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16?mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21?mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12?weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p?=?0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products. Trial registration Australian NZ Clinical Trials Registry (ACTRN12610000866000). PMID:23496861

  14. Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

    PubMed Central

    Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

  15. Group-Based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients

    ERIC Educational Resources Information Center

    Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.; Lewis, Marilyn W.; Dieckhaus, Kevin

    2010-01-01

    Objective: Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. Method: HIV-positive patients with cocaine or opioid use…

  16. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

    PubMed Central

    Dobkin, Bruce H.

    2014-01-01

    Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

  17. The Trial of Napoleon: A Case Study for Using Mock Trials.

    ERIC Educational Resources Information Center

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  18. A Randomized Trial of Pelvic Radiation Therapy versus No Further Therapy in Selected Patients with Stage IB Carcinoma of the Cervix after Radical Hysterectomy and Pelvic Lymphadenectomy: A Gynecologic Oncology Group Study

    Microsoft Academic Search

    Alexander Sedlis; Brian N. Bundy; Marvin Z. Rotman; Samuel S. Lentz; Laila I. Muderspach; Richard J. Zaino

    1999-01-01

    Objective.The objective of this study was to evaluate the benefits and risk of adjuvant pelvic radiotherapy aimed at reducing recurrence in women with Stage IB cervical cancer treated by radical hysterectomy and pelvic lymphadenectomy.Methods.Two hundred seventy-seven eligible patients were entered with at least two of the following risk factors: >1\\/3 stromal invasion, capillary lymphatic space involvement, and large clinical tumor

  19. Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial;Bone; Lymphoma; Radiotherapy; Chemotherapy; Clinical trial

    SciTech Connect

    Christie, David, E-mail: david.christie@premion.com.au [Premion and Bond University, Gold Coast, Queensland (Australia); Dear, Keith [Department of Epidemiology and Population Studies, Australian National University, Canberra, New South Wales (Australia); Le, Thai [BHB, Premion, Brisbane, Queensland (Australia); Barton, Michael [Collaboration for Cancer Outcomes and Research (CCORE) and University of NSW, Sydney, New South Wales (Australia); Wirth, Andrew [Peter MacCallum Cancer Institute, Melbourne, Victoria (Australia); Porter, David [Auckland Hospital, Auckland (New Zealand); Roos, Daniel [Royal Adelaide Hospital, Adelaide, South Australia (Australia); Pratt, Gary [Royal Brisbane Hospital, Brisbane, Queensland (Australia)

    2011-07-15

    Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

  20. Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. | accrualnet.cancer.gov

    Cancer.gov

    This paper may be useful for researchers interested in enhancing their interactions with community physicians and increasing the number of minority patients referred to clinical trials. It describes a study conducted by the Eastern Cooperative Oncology Group (ECOG) in collaboration with the National Medical Association (NMA) to better understand barriers and solutions to African-American (AA) accrual and to test several recommended low-cost strategies.

  1. Phase II Study of Intravesical Therapy with AD32 in Patients with Papillary Urothelial Carcinoma or Carcinoma in situ (CIS) Refractory to Prior Therapy with Bacillus Calmette-Guerin (E3897): A Trial of the Eastern Cooperative Oncology Group

    PubMed Central

    Ignatoff, Jeffrey M.; Chen, Yu-Hui; Evan Greenberg, Richard; Pow-Sang, Julio M.; Messing, Edward M.; Wilding, George

    2009-01-01

    SUMMARY Objectives Assess the safety and effectiveness of AD32, a doxorubicin analogue with little systemic exposure when administered intravesically, in patients with recurrent or refractory superficial urothelial carcinoma (formerly called transitional cell carcinoma [TCC]), or carcinoma in situ (CIS), who have failed prior BCG-based immunotherapy. Methods Eligible patients received 6 weekly doses (800mg) of intravesical AD32 and were evaluated at 12-week intervals for 24 months or until date of worsening disease. Primary analysis was the proportion of all patients recurrence-free at 12 months. Treatment-related and GU-specific toxicities were also examined. All participating institutions submitted the protocol for Institutional Review Board (IRB) approval. Results The study was halted due to unavailability of study drug after accrual of 48 of a planned 64 patients; 42 were included in the analysis. Of these, 28 (67%) were still alive after median follow-up of 61.1 months. Of 21 TCC patients, 18 (85.7%) experienced disease recurrence (median time to recurrence, 5.3 months). Of the 5 CIS patients with complete response (CR), 3 (60%) experienced disease recurrence; (median time to recurrence, 37.3 months). Recurrence-free rates at 12 and 24 months were 20% (90% CI, 7.8%, 36.1%) and 15% (90 CI, 4.9%, 30.2%), respectively, for patients with TCC and 80% (90% CI, 31.4%, 95.8%) at both intervals for CIS patients with CR. Infection was the most common treatment-related toxicity; no grade 4 or higher toxicity was observed. The most common GU-specific toxicity was increased frequency/urgency. Conclusions AD32 is safe and active for treatment of recurrent or refractory superficial bladder carcinoma. The agent awaits more complete characterization when drug production problems can be solved. PMID:18639470

  2. Phase I Trial of Two Schedules of Vincristine, Oral Irinotecan, and Temozolomide (VOIT) for Children with Relapsed or Refractory Solid Tumors: A Children's Oncology Group Phase I Consortium Study

    PubMed Central

    Wagner, Lars M.; Perentesis, John P.; Reid, Joel M.; Ames, Matthew M.; Safgren, Stephanie L.; Nelson, Marvin D.; Ingle, Ashish M.; Blaney, Susan M.; Adamson, Peter C.

    2011-01-01

    Background In pre-clinical models, temozolomide and vincristine are additive or synergistic with irinotecan. We examined this 3-drug combination in children with relapsed solid tumors. Patients received orally administered irinotecan together with temozolomide and vincristine on two different schedules, using cefixime to reduce irinotecan-associated diarrhea. Methods Oral irinotecan was given daily on days 1-5 and 8-12 (Schedule A), or on days 1-5 (Schedule B). Temozolomide was given on days 1-5, with vincristine 1.5 mg/m2 administered on days 1 and 8 (Schedule A) or day 1 (Schedule B) in 21-day courses. Results On Schedule A, the maximum tolerated dose of oral irinotecan was 35 mg/m2/day combined with temozolomide 100 mg/m2/day and vincristine on days 1 and 8. Dose-limiting toxicities in 4 of 12 patients included hepatotoxicity, abdominal pain, anorexia, hypokalemia and thrombocytopenia at 50 mg/m2/day. Using Schedule B, 0 of 6 patients experienced dose-limiting toxicity at the highest doses studied of oral irinotecan 90 mg/m2/day, temozolomide 150 mg/m2/day × 5, and vincristine on day 1. First-course and cumulative toxicity was greater with Schedule A. UGT1A1*28 genotype did not correlate with dose-limiting toxicity. At the irinotecan dose of 90 mg/m2/day, the mean SN-38 AUCinf was 63 ng/ml*h. Activity was seen in sarcoma patients, and overall 8 patients received ? 6 courses. Conclusions The 5-day schedule of VOIT was well tolerated and provided SN-38 exposures similar to those achieved with intravenous IRN. Activity on this and prior studies suggests a potential role for VOIT in a spectrum of childhood solid tumors. PMID:20049936

  3. Phase II Trial of Sorafenib (BAY43-9006) in Patients with Advanced Urothelial Cancer (E1804): A Trial of the Eastern Cooperative Oncology Group

    PubMed Central

    Dreicer, Robert; Li, Hailun; Stein, Mark; DiPaola, Robert; Eleff, Michael; Roth, Bruce J.; Wilding, George

    2009-01-01

    Background There is no effective second line systemic chemotherapy for patients with disease progression following cisplatin-based chemotherapy. A phase II trial of sorafenib was performed to determine the activity and toxicity of this agent in a multiinstitutional setting in patients previously treated with 1 prior chemotherapy regimen. Methods 27 patients with advanced urothelial carcinoma were treated with sorafenib 400 mg orally twice daily continuously until progression or unacceptable toxicity. Results There were no objective responses observed. The 4-month progression free survival (PFS) rate was 9.5% , median overall survival of the group was 6.8 months. There were no therapy related deaths, and common grade 3 toxicities included fatigue and hand-foot syndrome Conclusions Although sorafenib as a single agent has minimal activity in patients with advanced urothelial cancer in the second line setting, further investigation of tyrosine kinase inhibitors using different trial designs with PFS endpoints is warranted. PMID:19536901

  4. Patient advocates' role in clinical trials: Perspectives from Cancer and Leukemia Group B investigators and advocates. | accrualnet.cancer.gov

    Cancer.gov

    Although there is a call for increased involvement of patient advocates in the design of clinical trials and patient recruitment and awareness efforts, little is known about the role and impact of patient advocates. A cooperative group survey of advocates and investigators forms the basis for recommendations.

  5. Feasibility trial for adjuvant chemotherapy with docetaxel plus cisplatin followed by single agent long-term administration of S-1 chemotherapy in patients with completely resected non-small cell lung cancer: Thoracic Oncology Research Group Study 0809

    PubMed Central

    Niho, S; Ikeda, N; Michimae, H; Suzuki, K; Sakai, H; Kaburagi, T; Minato, K; Kato, T; Okamoto, H; Seto, T; Hosomi, Y; Shimizu, K; Oshita, F; Kunitoh, H; Tsuboi, M; Takeuchi, M; Watanabe, K

    2013-01-01

    Background: We conducted a multicentre feasibility study for single agent long-term S-1 chemotherapy following docetaxel plus cisplatin in patients with curatively resected stage II–IIIA non-small cell lung cancer. Methods: Patients received three cycles of docetaxel (60?mg?m?2) plus cisplatin (80?mg?m?2) and then received S-1 (40?mg?m?2 twice daily) for 14 consecutive days with a 1-week rest for >6 months (maximum, 1 year). The primary end point was feasibility, which was defined as the proportion of patients who completed eight or more cycles of S-1 chemotherapy. If the lower 95% confidence interval (CI) of this proportion was 50% or more, then the treatment was considered as feasible. The sample size was set at 125 patients. Results: One hundred and thirty-one patients were enrolled, of whom 129 patients were eligible and assessable. In all, 109 patients (84.5%) completed 3 cycles of docetaxel plus cisplatin and 66 patients (51.2%, 95% CI: 42.5–59.8) completed 8 or more cycles of S-1 treatment. Grade 3/4 toxicities during the S-1 chemotherapy included anaemia (7.3%), neutropaenia (3.7%), and anorexia (3.7%). Conclusion: The toxicity level was acceptable, although the results did not meet our criterion for feasibility. Modification of the treatment schedule for S-1 chemotherapy might improve the treatment compliance. PMID:23868010

  6. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods

    PubMed Central

    2012-01-01

    Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our understanding of whether and how to use pet dogs to promote physical activity and/or to reduce sedentary behaviour in children and adults. The trial is intended to lead to a subsequent more definitive randomised controlled trial, and the work should inform future dog-based public health interventions such as secondary prevention interventions in children or adults. Trial registration number ISRCTN85939423 PMID:22429665

  7. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial

    PubMed Central

    2014-01-01

    Background Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. Methods/design A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck’s depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers’ Institutional Review Boards. Discussion Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. Trial registration ClinicalTrials.gov Identifier: NCT01921504. PMID:24655542

  8. Evaluation of support group interventions for children in troubled families: study protocol for a quasi-experimental control group study

    PubMed Central

    2014-01-01

    Background Support groups for children in troubled families are available in a majority of Swedish municipalities. They are used as a preventive effort for children in families with different parental problems such as addiction to alcohol/other drugs, mental illness, domestic violence, divorce situations, or even imprisonment. Children from families with these problems are a well-known at-risk group for various mental health and social problems. Support groups aim at strengthening children’s coping behaviour, to improve their mental health and to prevent a negative psycho-social development. To date, evaluations using a control-group study design are scarce. The aim of the current study is to evaluate the effects of support groups. This paper describes the design of an effectiveness study, initially intended as a randomized controlled trial, but instead is pursued as a quasi-experimental study using a non-randomized control group. Methods/design The aim is to include 116 children, aged 7–13 years and one parent/another closely related adult, in the study. Participants are recruited via existing support groups in the Stockholm county district and are allocated either into an intervention group or a waiting list control group, representing care as usual. The assessment consists of questionnaires that are to be filled in at baseline and at four months following the baseline. Additionally, the intervention group completes a 12-month follow-up. The outcomes include the Strength and Difficulties Questionnaire (SDQ S11-16), the Kids Coping Scale, the “Ladder of life” which measures overall life satisfaction, and “Jag tycker jag är” (I think I am) which measures self-perception and self-esteem. The parents complete the SDQ P4-16 (parent-report version) and the Swedish scale “Familjeklimat” (Family Climate), which measures the emotional climate in the family. Discussion There is a need for evaluating the effects of support groups targeted to children from troubled families. This quasi-experimental study therefore makes an important contribution to this novel field of research. In the article various problems related to pursuing a study with children at risk are discussed. Trial registration ISRCTN52310507 PMID:24460905

  9. National Lung Screening Trial: Questions and Answers

    Cancer.gov

    The National Lung Screening Trial (NLST) is a lung cancer screening trial sponsored by the National Cancer Institute (NCI) and conducted by the American College of Radiology Imaging Network (ACRIN) and the Lung Screening Study group.

  10. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. Methods/Design In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. Discussion The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics. Trial registration This trial is registered on ClinicalTrials.gov under the identifier NCT01790529. PMID:24885132

  11. Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based Acceptance and Commitment Therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. Methods/design We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (Acceptance and Commitment Therapy, Cognitive Behavior Therapy or waitlist control). Those in the Acceptance and Commitment Therapy and Cognitive Behavior Therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the Cognitive Behavior Therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. Discussion To the best of our knowledge, this study will be the largest trial of Acceptance and Commitment Therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of Acceptance and Commitment Therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of Cognitive Behavior Therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently implemented widely in contemporary clinical practice. Anticipated difficulties for the trial are the recruitment and retention of participants, particularly adolescents. To avert these concerns and maximize recruitment, several strategies will be adopted to optimize referral rates as well as reduce participant drop-outs. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry, registration number: ACTRN12611001280998 PMID:23672442

  12. LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ?34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. Methods/design This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ?34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. Trial registration ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). PMID:25027230

  13. Determination of Prognostic Factors in Japanese Patients With Advanced Gastric Cancer Using the Data From a Randomized Controlled Trial, Japan Clinical Oncology Group 9912

    PubMed Central

    Boku, Narikazu; Mizusawa, Junki; Takashima, Atsuo; Yamada, Yasuhide; Yoshino, Takayuki; Yamazaki, Kentaro; Koizumi, Wasaburo; Fukase, Kazutoshi; Yamaguchi, Kensei; Goto, Masahiro; Nishina, Tomohiro; Tamura, Takao; Tsuji, Akihito; Ohtsu, Atsushi

    2014-01-01

    Background. In advanced gastric cancer (AGC), no globally accepted prognostic scoring system has been developed. Therefore, we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial, Japan Clinical Oncology Group (JCOG) 9912, which investigated the efficacy of systemic chemotherapy as a first-line treatment. Patients and Methods. Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG9912 using the Cox proportional hazard model. The Royal Marsden Hospital prognostic model was also applied to the JCOG9912 trial. Results. A total of 650 (92.3%) of the 704 patients randomized in the JCOG9912 trial, for whom complete data were available for multivariate analyses, was included in the present study (5-fluorouracil arm, n = 215; irinotecan plus cisplatin arm, n = 216; S-1 arm, n = 219). The median survival time (MST) for all patients was 11.8 months. To construct a prognostic index, we selected four risk factors by multivariate analysis: performance status ? 1, number of metastatic sites ? 2, no prior gastrectomy, and elevated alkaline phosphatase. MSTs were 17.0 months for patients categorized into the low-risk group, who had zero or one risk factor (n = 225); 10.4 months for patients in the moderate-risk group, who had two or three risk factors (n = 368); and 5.0 months for patients in the high-risk group, who had all four risk factors (n = 57). Conclusion. In the present study, we propose a new prognostic index for patients with AGC. This can be used for more appropriate patient stratification in future clinical trials. PMID:24668328

  14. Who Enrolls Onto Clinical Oncology Trials? A Radiation Patterns of Care Study Analysis

    SciTech Connect

    Movsas, Benjamin [Department of Radiation Oncology, Henry Ford Health System, Detroit, MI (United States)]. E-mail: bmovsas1@hfhs.org; Moughan, Jennifer [American College of Radiology, Philadelphia, PA (United States); Owen, Jean [American College of Radiology, Philadelphia, PA (United States); Coia, Lawrence R. [Department of Radiation Oncology, Community Medical Center, Toms River, NJ (United States); Zelefsky, Michael J. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY (United States); Hanks, Gerald [Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA (United States); Wilson, J. Frank [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States)

    2007-07-15

    Purpose: To identify factors significantly influencing accrual to clinical protocols by analyzing radiation Patterns of Care Study (PCS) surveys of 3,047 randomly selected radiotherapy (RT) patients. Methods and Materials: Patterns of Care Study surveys from disease sites studied for the periods 1992-1994 and 1996-1999 (breast cancer, n = 1,080; prostate cancer, n = 1,149; esophageal cancer, n = 818) were analyzed. The PCS is a National Cancer Institute-funded national survey of randomly selected RT institutions in the United States. Patients with nonmetastatic disease who received RT as definitive or adjuvant therapy were randomly selected from eligible patients at each institution. To determine national estimates, individual patient records were weighted by the relative contribution of each institution and patients within each institution. Data regarding participation in clinical trials were recorded. The factors age, gender, race, type of insurance, and practice type of treating institution (academic or not) were studied by univariate and multivariate analyses. Results: Overall, only 2.7% of all patients were accrued to clinical protocols. Of these, 57% were enrolled on institutional review board-approved institutional trials, and 43% on National Cancer Institute collaborative group studies. On multivariate analysis, patients treated at academic facilities (p = 0.0001) and white patients (vs. African Americans, p = 0.0002) were significantly more likely to participate in clinical oncology trials. Age, gender, type of cancer, and type of insurance were not predictive. Conclusions: Practice type and race significantly influence enrollment onto clinical oncology trials. This suggests that increased communication and education regarding protocols, particularly focusing on physicians in nonacademic settings and minority patients, will be essential to enhance accrual.

  15. Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

    SciTech Connect

    Rodrigues, George, E-mail: george.rodrigues@lhsc.on.c [Department of Oncology, University of Western Ontario, London, Ontario (Canada); Bae, Kyounghwa [Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, Pennsylvania (United States); Roach, Mack [Department of Radiation Oncology, University of California San Francisco, San Francisco, California (United States); Lawton, Colleen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Donnelly, Bryan [Department of Surgical Oncology, University of Calgary, Calgary, Alberta (Canada); Grignon, David [Department of Pathology, Indiana Pathology Institute, Indianapolis, Indiana (United States); Hanks, Gerald [Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Porter, Arthur [Department of Oncology, McGill University Health Centre, Montreal, Quebec (Canada); Lepor, Herbert [Department of Urology, NY University Langone Medical Center, New York, New York (United States); Sandler, Howard [Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California (United States)

    2011-06-01

    Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

  16. Parent Training With High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

    PubMed Central

    Lau, Anna S.; Fung, Joey J.; Ho, Lori Y.; Liu, Lisa L.; Gudiño, Omar G.

    2013-01-01

    We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families. Parents were eligible for intervention if they were Chinese-speaking immigrants referred from schools, community clinics, or child protective services with concerns about parenting or child behavior problems. Retention and engagement were high with 83% of families attending 10 or more sessions. Results revealed that the treatment was efficacious in reducing negative discipline, increasing positive parenting, and decreasing child externalizing and internalizing problems. Treatment effects were larger among families with higher levels of baseline behavior problems and lower levels of parenting stress. Further augmentation of PT to address immigrant parent stress may be warranted. Qualitative impressions from group leaders suggested that slower pacing and increased rehearsal of skills may improve efficacy for immigrant parents unfamiliar with skills introduced in PT. PMID:21658524

  17. Doing Anger Differently: two controlled trials of percussion group psychotherapy for adolescent reactive aggression.

    PubMed

    Currie, Michael; Startup, Mike

    2012-08-01

    This study evaluates efficacy and effectiveness of 'Doing Anger Differently' (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1, but also followed up controls at 6 months. In study 1 (N = 54) the treatment resulted in lowered trait anger (Cohen's d = -1.3), aggression-reports (d = -1.0) and depression (d = -0.6), and increased self-esteem (d = 0.6), all maintained at six months. In study 2 (N = 65), aggression-reports fell to one fifth of pre-treatment levels at nine months follow-up (d = -1.2), with lowered trait anger (d = -0.4) and anger expression (d = -0.3) post-treatment. PMID:22245455

  18. Effect of Silymarin in the Prevention of Cisplatin Nephrotoxicity, a Clinical Trial Study

    PubMed Central

    Momeni, Ali; Geshnizjani, Shohreh; Kheiri, Soleiman

    2015-01-01

    Background Reno-protective effect of Silymarin was studied in some studies mainly on rats. In some of these studies, Silymarin was shown to have positive effects on preventing or decreasing severity of Cisplatin nephrotoxicity. Objective The aim of this study was to evaluate the protective effect of Silymarin on Cisplatin nephrotoxicity in adult patients with malignancy. Materials and Methods In this clinical trial study, 60 patients with malignancy, candidate of Cisplatin treatment were randomly enrolled in two equal groups. In patients of case group, Silymarin tablet 140 mg/bid was administrated seven days before Cisplatin administration together with Cisplatin, and in control group, Cisplatin was prescribed. Blood Urea Nitrogen (BUN) and serum Creatinine (Cr) were checked at the same day and 3 and 7 days after administration of Cisplatin. Results Mean age of the patients in case and control groups were 51.1±14.3 y and 51.1±13.7 y respectively (p=0.99). There was no significant difference based on BUN and serum Cr in the beginning of study and three days after administration of Cisplatin in two groups of patients; however, after two weeks, BUN and serum Cr were significantly lower in the case group compared to the control group. Also, in the case group, BUN and serum Cr decreased and in the control group, they increased after two weeks after Cisplatin administration. Conclusion This study showed that Silymarin can decrease Cisplatin nephrotoxicity, so because of safety profile and minor adverse effect of Silymarin, we can use it as prophylaxis against Cisplatin nephrotoxicity in various Cisplatin-contained chemotherapy regimens. PMID:26046020

  19. Back massage intervention for relieving lower back pain in puerperal women: A randomized control trial study.

    PubMed

    Lee, Hsiu-Jung; Ko, Yi-Li

    2015-05-01

    This study evaluates the effectiveness of a back massage (BM) intervention in relieving lower back pain (LBP) in post-partum women.This is a randomized controlled trial study. Sixty normal spontaneous delivery women (response rate: 96.7%), who gave birth at our hospital, participated in this study from February to May of 2012. We randomly assigned 30 women to the experimental group and 30 women to the control group. During the 1 month post-partum period, the women in the experimental group received a BM for 5 consecutive days, whereas the women in the control group received routine care only. The LBP score was assessed according to a pain visual analog scale. After 5 days of intervention, the experimental group (n?=?30) experienced significantly less LBP than did the control group (n?=?30) (2.97?±?1.71 vs. 4.43?±?1.77, t?=?3.26, P?=?0.002). BM therapy can effectively reduce LBP during the first post-partum month. Additional studies are required to confirm the effects of BM therapy during extended post-partum periods. PMID:26125572

  20. Two randomized controlled clinical trials to study the effectiveness of prednisolone treatment in preventing and restoring clinical nerve function loss in leprosy: the TENLEP study protocols

    PubMed Central

    2012-01-01

    Background Nerve damage in leprosy often causes disabilities and deformities. Prednisolone is used to treat nerve function impairment (NFI). However, optimal dose and duration of prednisolone treatment has not been established yet. Besides treating existing NFI it would be desirable to prevent NFI. Studies show that before NFI is clinically detectable, nerves often show subclinical damage. Within the ‘Treatment of Early Neuropathy in LEProsy’ (TENLEP) study two double blind randomized controlled trials (RCT) will be carried out: a trial to establish whether prednisolone treatment of 32 weeks duration is more effective than 20 weeks in restoring nerve function in leprosy patients with clinical NFI (Clinical trial) and a trial to determine whether prednisolone treatment of early sub-clinical NFI can prevent clinical NFI (Subclinical trial). Methods Two RCTs with a follow up of 18 months will be conducted in six centers in Asia. In the Clinical trial leprosy patients with recent (< 6 months) clinical NFI, as determined by Monofilament Test and Voluntary Muscle Test, are included. The primary outcomes are the proportion of patients with restored or improved nerve function. In the Subclinical trial leprosy patients with subclinical neuropathy, as determined by Nerve Conduction Studies (NCS) and/or Warm Detection Threshold (WDT), and without any clinical signs of NFI are randomly allocated to a placebo group or treatment group receiving 20 weeks prednisolone. The primary outcome is the proportion of patients developing clinical NFI. Reliability and normative studies are carried out before the start of the trial. Discussion This study is the first RCT testing a prednisolone regimen with a duration longer than 24 weeks. Also it is the first RCT assessing the effect of prednisolone in the prevention of clinical NFI in patients with established subclinical neuropathy. The TENLEP study will add to the current understanding of neuropathy due to leprosy and provide insight in the effectiveness of prednisolone on the prevention and recovery of NFI in leprosy patients. In this paper we present the research protocols for both Clinical and Subclinical trials and discuss the possible findings and implications. Trial registration Netherlands Trial Register: NTR2300 Clinical Trial Registry India: CTRI/2011/09/002022 PMID:23249098

  1. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Pregnant women are the highest priority group for annual influenza vaccination. Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women. This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong. Methods A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong. Participants will be randomly assigned to either one of the two treatment groups: standard care (control) or standard care plus brief education (intervention). Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention. Content of the education session will cover four core components recommended in the research literature. The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy. A total of 184 pregnant women (92 per group) will be required to give an 80% power to detect a treatment effect of 15%. Discussion Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting. The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake. Trial registration This trial is registered with the Clinical Trials Registry at www.clinicaltrials.gov(NCT01772901). PMID:24423245

  2. Effectiveness of Healthy Relationships Video-Group—A Videoconferencing Group Intervention for Women Living with HIV: Preliminary Findings from a Randomized Controlled Trial

    PubMed Central

    Buhi, Eric R.; Baldwin, Julie; Chen, Henian; Johnson, Ayesha; Lynn, Vickie; Glueckauf, Robert

    2014-01-01

    Abstract Introduction: Expanded access to efficacious interventions is needed for women living with human immunodeficiency virus (WLH) in the United States. Availability of “prevention with (human immunodeficiency virus [HIV)] positives” interventions in rural/remote and low HIV prevalence areas remains limited, leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships (HR). Offering such programs via videoconferencing groups (VGs) may expand access. This analysis tests the effectiveness of HR-VG (versus wait-list control) for reducing sexual risk behavior among WLH and explores intervention satisfaction. Subjects and Methods: In this randomized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across randomization groups through zero-inflated Poisson regression modeling, controlling for unprotected sex at baseline. Seventy-one WLH were randomized and completed the baseline assessment (n=36 intervention and n=35 control); 59 (83% in each group) had follow-up data. Results: Among those who engaged in unprotected sex at 6-month follow-up, intervention participants had approximately seven fewer unprotected occasions than control participants (95% confidence interval 5.43–7.43). Intervention participants reported high levels of satisfaction with HR-VG; 84% reported being “very satisfied” overall. Conclusions: This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs. Important next steps will be to determine whether VGs are effective with other subpopulations of people living with HIV (i.e., men and non-English speakers) and to assess cost-effectiveness. Possibilities for using VGs to expand access to other psychosocial and behavioral interventions and reduce stigma are discussed. PMID:24237482

  3. A Study of Bion's Basic Assumption Groups

    Microsoft Academic Search

    Sigmund Karterud

    1989-01-01

    Bion's group dynamic theory can be divided into a general group dynamic part, a description of the basic assumptions fight\\/flight, dependency and pairing, and a metapsychological explanation of the basic assumption phenomena. Previous studies with somewhat questionable methodology have found that the basic assumption pairing seems more closely associated with fight\\/flight than dependency. This study replicates these findings. Seventyfive inpatient

  4. Reverse Auction Bidding - Multiple Group Study 

    E-print Network

    Zhou, Xun

    2012-10-19

    is the second multi-group study in the research. In this study, a multiple group comparison was made between different numbers of bidders, with Games One, Two and Three having three, four and ten bidders respectively. All participants were faculty and students...

  5. Reverse Auction Bidding - Multiple Group Study

    E-print Network

    Zhou, Xun

    2012-10-19

    is the second multi-group study in the research. In this study, a multiple group comparison was made between different numbers of bidders, with Games One, Two and Three having three, four and ten bidders respectively. All participants were faculty and students...

  6. An Open Trial Investigation of a Transdiagnostic Group Treatment for Children with Anxiety and Depressive Symptoms

    ERIC Educational Resources Information Center

    Bilek, Emily L.; Ehrenreich-May, Jill

    2012-01-01

    The current study investigates the feasibility and preliminary outcomes associated with a transdiagnostic emotion-focused group protocol for the treatment of anxiety disorders and depressive symptoms in youth. Twenty-two children (ages 7 to 12; M = 9.79) with a principal anxiety disorder and varying levels of comorbid depressive symptoms were…

  7. Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

    2005-01-01

    This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

  8. No Differences between Group versus Individual Treatment of Childhood Anxiety Disorders in a Randomised Clinical Trial

    ERIC Educational Resources Information Center

    Liber, Juliette M.; Van Widenfelt, Brigit M.; Utens, Elisabeth M. W. J.; Ferdinand, Robert F.; Van Der Leeden, Adelinde J. M.; Van Gastel, Willemijn; Treffers, Philip D. A.

    2008-01-01

    Background: The present study compares an individual versus a group format in the delivery of manualised cognitive-behavioural therapy (FRIENDS) for children with anxiety disorders. Clinically referred children (aged 8 to 12) diagnosed with Separation Anxiety Disorder (n = 52), Generalised Anxiety Disorder (n = 37), Social Phobia (n = 22) or…

  9. New Empirical Evidence for the Design of Group Randomized Trials in Education

    ERIC Educational Resources Information Center

    Jacob, Robin; Zhu, Pei; Bloom, Howard

    2010-01-01

    This article provides practical guidance for researchers who are designing studies that randomize groups to measure the impacts of educational interventions. The article (a) provides new empirical information about the values of parameters that influence the precision of impact estimates (intraclass correlations and R[superscript 2] values) and…

  10. No differences between group versus individual treatment of childhood anxiety disorders in a randomised clinical trial

    Microsoft Academic Search

    Juliette M. Liber; Brigit M. Van Widenfelt; Elisabeth M. W. J. Utens; Robert F. Ferdinand; Willemijn Van Gastel; Philip D. A. Treffers

    2008-01-01

    Background: The present study compares an individual versus a group format in the delivery of manualised cognitive-behavioural therapy (FRIENDS) for children with anxiety disorders. Clinically referred children (aged 8 to 12) diagnosed with Separation Anxiety Disorder (n ¼ 52), Generalised Anxiety Disorder (n ¼ 37), Social Phobia (n ¼ 22) or Specific Phobia (n ¼ 16) were randomly assigned to

  11. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563)

    PubMed Central

    2014-01-01

    Background Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients’ short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. Methods/design Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. Discussion This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. Trial registration ISRCTN: ISRCTN93634563. PMID:25064573

  12. Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background Tuberculosis is an infectious disease that continues to cause considerable morbidity and mortality globally. Only 65% of patients worldwide are currently diagnosed. Contact investigation is a strategy that aims to increase case detection and reduce transmission of tuberculosis, yet there is little evidence to show its effectiveness. Methods/Design We will conduct a cluster randomized controlled trial of contact investigation within the national tuberculosis control program of Vietnam. Household contacts of patients with smear-positive pulmonary tuberculosis will be invited to attend district tuberculosis units for symptom screening, examination, and chest radiography on four occasions over a two-year period. The primary endpoint is clinically confirmed tuberculosis among contacts during the 24 months of follow-up, ascertained using capture-recapture analysis. Microbiologically proven tuberculosis and treatment completion rates among contacts diagnosed with tuberculosis will be secondary endpoints. The incremental cost-effectiveness ratio will be estimated. The study will have 80% power to detect a 50% increase in the primary endpoint in the active intervention arm compared with the control arm. The study will include 8,829 contacts in each of the active screening and control groups, within 70 districts in 8 provinces in Vietnam, in both rural and urban settings. Discussion The effectiveness of contact investigation as a tool for improved tuberculosis case finding has not been established. This cluster randomized trial will provide valuable operational information for national tuberculosis programs in high-prevalence countries, in order to select the most cost-effective strategies to improve tuberculosis case detection. Trial registration The ACT2 study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12610000600044). PMID:24138766

  13. ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

    PubMed Central

    van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

    2014-01-01

    SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

  14. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    PubMed Central

    Streitberger, Konrad; Witte, Steffen; Mansmann, Ulrich; Knauer, Christine; Krämer, Jürgen; Scharf, Hanns-Peter; Victor, Norbert

    2004-01-01

    Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers. PMID:15040805

  15. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102)

    PubMed Central

    Katsumata, N; Yoshikawa, H; Kobayashi, H; Saito, T; Kuzuya, K; Nakanishi, T; Yasugi, T; Yaegashi, N; Yokota, H; Kodama, S; Mizunoe, T; Hiura, M; Kasamatsu, T; Shibata, T; Kamura, T

    2013-01-01

    Background: A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival. Methods: Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7?mg days 1–5, vincristine 0.7?mg?m?2 day 5, mitomycin 7?mg?m?2 day 5, cisplatin 14?mg?m?2 days 1–5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival. Results: A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80% P=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (P=0.85). Conclusion: Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT. PMID:23640393

  16. The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP - a non randomised controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain (LBP) is costly to society and improving patient outcomes is a priority. Stratifying LBP patients into more homogenous groups is advocated to improve patient outcome. The STarT Back tool, a prognostic screening tool has demonstrated efficacy and greater cost effectiveness in physiotherapy settings. The management of LBP patients in groups is common but to date the utility of the STarT Back tool in group settings has not been explored. The aim of this study is to determine if the implementation of ‘stratified care’ when delivered in a group setting will lead to significantly better physical and psychological outcomes and greater cost effectiveness in LBP patients compared to a bestcare historical control group. Methods/Design This study is a non randomised controlled trial. Low back pain patients recruited from the Waterford Primary Care area (population = 47,000) will be stratified into low, medium or high risk of persisting symptoms using the STarT Back Tool. Low risk patients will be offered a single one off education/exercise class offering positive messages on LBP management in line with recommended guidelines. Medium risk patients will be offered a 12 week group exercise/education intervention addressing their dominant physical obstacles to recovery. A 12 week group cognitive behavioural approach will be delivered to the high risk patients, characterised by the presence of high levels of psychosocial prognostic factors. These patients will be compared with a historical control group where therapists were blinded as to the risk stratification of patients and a generic group intervention was delivered to all patients, irrespective of their initial risk stratification. The primary outcome measure will be disability (Roland Morris Disability Questionnaire). Secondary outcomes will include back pain intensity (Visual Analogue Scale), distress (Distress and Risk Assessment Method), back beliefs (Back Beliefs Questionnaire), health status (Euroqol), global benefit (7 point likert scale), satisfaction (7 point likert scale), cost effectiveness and functional status. Outcome will be measured at baseline, 12 weeks and 6 months. Discussion This paper details the rationale, design, methods, planned analysis and operational aspects of a study examining the utility of the STarT Back Tool as a ‘stratification tool for targeted treatment’ in a group intervention. Trial registration Current controlled trials: ACTRN12613000431729. PMID:24308746

  17. Harnessing Technology to Enhance Delivery of Clinical Trials Education for Nurses: A Report From the Children's Oncology Group.

    PubMed

    Haugen, Maureen; Gasber, Eric; Leonard, Marcia; Landier, Wendy

    2015-03-01

    The challenge of providing high-quality, relevant, time-sensitive continuing nursing education is particularly salient in pediatric oncology, where nurses commonly deliver complex protocol-based care to children enrolled on clinical trials. The Children's Oncology Group Nursing Discipline developed Portable Document Format multimedia modules to make a broad range of educational content regarding pediatric oncology clinical trials available to its membership. This time-sensitive educational content is accessible to nurses via asynchronous online education. To assess awareness of and user experience with the multimedia modules, a survey was conducted of nurses attending a Children's Oncology Group meeting. Over half (57%) of nurses were aware of the modules and half of those (51%) had viewed at least 1 module. Over 90% of nurses who viewed the modules were satisfied or very satisfied with the viewing experience; nurses younger than age 40 were 4 times more likely to be unaware of the modules than were older nurses (P = .007). PMID:25612836

  18. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    ERIC Educational Resources Information Center

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  19. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

    PubMed Central

    2014-01-01

    Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months (pre-intervention), 9, 15, and 21 months. Discussion We know of no previous study that has evaluated an intervention that combines the capacity of nurse and internet-based services to improve outcomes for mothers and infants. The knowledge gained from this study will inform the design and conduct of community-based postnatal mother and child support programs. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000204741 PMID:24886238

  20. Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Occupational therapists may have an added value in the care of patients with Parkinson’s disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson’s disease. Methods/Design A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson’s disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation. Discussion This is the first large-scale trial specifically evaluating occupational therapy in Parkinson’s disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson’s disease. Trial registration Clinicaltrials.gov: NCT01336127. PMID:23374761

  1. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    PubMed Central

    2011-01-01

    Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic). Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT); referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide), will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration Australian and New Zealand Clinical Trials Registry ANZTCN: ACTRN12609000465257 PMID:21762532

  2. Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial

    Microsoft Academic Search

    Marie-Germaine Bousser; Pierre Amarenco; Angel Chamorro; Marc Fisher; Ian Ford; Kim M Fox; Michael G Hennerici; Heinrich P Mattle; Peter M Rothwell; Agnès de Cordoüe; Marie-Dominique Fratacci; H. F. de Leeuw

    2011-01-01

    BACKGROUND: Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event. METHODS: This randomised, double-blind, parallel-group trial was undertaken in 802 centres

  3. Eastern Cooperative Oncology Group Phase II Trial of Lapatinib in Men with Biochemically Relapsed, Androgen Dependent Prostate Cancer

    PubMed Central

    Liu, Glenn; Chen, Yu-Hui; Kolesar, Jill; Huang, Wei; DiPaola, Robert; Pins, Michael; Carducci, Michael; Stein, Mark; Bubley, Glenn J.; Wilding, George

    2011-01-01

    Purpose Activation of the epidermal growth factor pathway is important in prostate cancer development and the transcription of androgen receptor regulated genes. This study evaluated the potential activity of lapatinib in men with biochemically-relapsed androgen-dependent (stage D0) prostate cancer. Experimental Design Patients with a rising PSA after primary therapy for prostate cancer were enrolled. A PSA doubling time (PSADT) <12 months was required. Lapatinib was administered at 1,500 mg orally daily. Outcome measures were changes in PSA kinetics. Primary tumor blocks were obtained and assessed for EGFR expression, EGFR Q787Q polymorphism, and Kras 38 mutational status. Results 49 patients were enrolled (14 ineligible), resulting in 35 pts for analysis. No PSA response was observed; best response was stable disease (n=28, 80.0%). Pre-treatment average slope was 0.19 log (PSA)/month (PSADT=3.70 months), in contrast to on-treatment average slope of 0.13 log (PSA)/month (PSADT=5.44 months) using linear mixed effects models (p=0.006). Median progression-free survival (PFS) was 17.4 months for the high EGFR group and 6.0 months for the low EGFR group (p=0.50). Patients with Kras 38 mutation had shorter PFS than those without Kras 38 mutation (p=0.09). Conclusion Although no PSA responses (primary endpoint) was observed, lapatinib may have biologic activity in men with stage D0 prostate cancer as evidenced by a decrease in PSA slope in this non-randomized study. Additional trials assessing the role of EGFR overexpression and Kras wild type status in prostate cancer should be investigated. PMID:21784672

  4. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia

    PubMed Central

    Franzen, Samuel R P; Chandler, Clare; Enquselassie, Fikre; Siribaddana, Sisira; Atashili, Julius; Angus, Brian; Lang, Trudie

    2013-01-01

    Objectives Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Design Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Setting Fieldwork took place in Ethiopia during March 2011. Participants Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Outcome measures Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. Results All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Conclusions Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely. PMID:24285629

  5. Congestive heart failure adherence redesign trial: a pilot study

    PubMed Central

    Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

    2014-01-01

    Objective Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. Setting A large tertiary care medical centre in Chicago. Participants Low-income patients (study. Interventions Physicians received HF guidelines and periodic individualised feedback on their adherence to EBT. Patients received HF education, support and self-management training for diet and medication adherence by a trained nurse through 11 interactive sessions over a 4-month period. Evaluations were conducted pre-enrolment and 1?month postintervention completion. Outcome measures Feasibility was assessed by the ability to deliver intervention to patients and physicians. Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians. Results Eighty-seven per cent and 82% of patients received >80% of interventions at 1?month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0?g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. Conclusions This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. PMID:25475245

  6. Study protocol: home-based telehealth stroke care: a randomized trial for veterans

    PubMed Central

    2010-01-01

    Background Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. Methods We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. Discussion For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans. Trial Registration Clinical Trials.gov Identifier: NCT00384748 PMID:20591171

  7. Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of platelet-rich plasma (PRP) in painful tendons is widespread but its efficacy remains controversial. Methods/Design This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have ultrasound (US)-guided needling combined with a leukocyte-depleted (that is, pure) PRP or lidocaine each alternate week for a total of two interventions. Outcome data will be collected before intervention, and at 6 weeks, 3, 6, and 12 months after intervention. Main outcome measure: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH-E, Spanish version) score, at 6 months. We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least 25% in the DASH-E score. Secondary outcome measures include changes in DASH-E at 3 and 12 months, changes in pain as assessed by the visual analogue scale (VAS) at the 6-week, 3-, 6-, and 12-month follow-up, changes in sonographic features and neovascularity, and percentage of patients in each group with adverse reactions at 3, 6, and 12 months. Discussion The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies. Trial registration ClinicalTrials.gov: NCT01945528. PMID:24289799

  8. Induction chemotherapy and radiotherapy of advanced cancer of the cervix: A pilot study and phase III randomized trial

    Microsoft Academic Search

    Felix Leborgne; José H. Leborgne; Raquel Doldán; Eduardo Zubizarreta; Bettys Ortega; Juan Maisonneuve; Eduardo Musetti; Luciano Hekimian; Julieta Mezzera

    1997-01-01

    Purpose: This study assessed the effectiveness and toxicity of induction chemotherapy (CT) and radiation therapy (RT) in the treatment of locally advanced carcinoma of the cervix with data provided by a pilot study and a randomized trial.Methods and Materials: Eighty-six patients with International Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA (Stage B > 4-cm tumor diameter) (Group A) were

  9. Therapeutic research in low-income countries: studying trial communities.

    PubMed

    Whyte, Susan Reynolds

    2014-11-01

    Social scientists undertaking studies of transnational medical research in developing countries focus on 'trial communities': networks of funders, institutions, researchers, clinical staff, fieldworkers and study participants. They relate these to the political economy that brings powerful research resources to poor settings. Whereas bioethicists tend to consider universal ethical requirements, social scientists examine how ethics are practiced in given situations in the light of the concerns and interests held by different parties involved in medical research. In conditions of poverty, high morbidity and weak public health services, research subjects are heavily induced by the prospect of high quality medical care and other benefits that researchers seem to offer. Studies of medical research undertaken by well-established internationally funded institutions in Africa show that parents are keen to have their children 'join' projects at these organisations. They assess benefits and risks less in terms of specific research projects and more in terms of their overall trust in the care these institutions are known to have provided previously for others in the community. Bioethics should widen its scope beyond concern with protecting individual subjects from the risks of specific research projects. It should recognise that clinical and research functions are indistinguishable for many participants, who want information on results of clinical investigations and sustained support for improving the health of their children. PMID:24748638

  10. Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis—the PMEP trial: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) respiratory infection in cystic fibrosis (CF) has increased dramatically over the last decade, and is now affecting approximately 25% of patients. Epidemiologic evidence suggests that persistent infection with MRSA results in an increased rate of decline in FEV1 and shortened survival. Currently, there are no conclusive studies demonstrating an effective and safe treatment protocol for persistent MRSA respiratory infection in CF. Methods/Design The primary objective of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation in combination with oral antibiotics in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. This is a two-center, randomized, double-blind, comparator-controlled, parallel-group study with 1:1 assignment to either vancomycin for inhalation (250 mg twice a day) or taste-matched placebo for 28 days in individuals with cystic fibrosis. In addition, both groups will receive oral rifampin, a second oral antibiotic – trimethoprim/sulfamethoxazole (TMP/SMX) or doxycycline, protocol determined – mupirocin intranasal cream, and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled: 20 will be randomized to vancomycin for inhalation and 20 to a taste-matched placebo. The primary outcome will be the presence of MRSA in sputum respiratory tract cultures 1 month after the conclusion of treatment. Secondary outcomes include the efficacy of the intervention on: FEV1% predicted, patient reported outcomes, pulmonary exacerbations, and MRSA colony-forming units found in respiratory tract sample culture. Discussion Results of this study will provide guidance to clinicians regarding the safety and effectiveness of a targeted eradication strategy for persistent MRSA infection in CF. Trial registration This trial is registered at ClinicalTrials.gov (NCT01594827, received 05/07/2012) and is funded by the Cystic Fibrosis Foundation (Grants: PMEP10K1 and PMEP11K1). PMID:24925006

  11. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups

    Microsoft Academic Search

    Matias Vested Madsen; P. C Gotzsche; A. Hrobjartsson

    2009-01-01

    Objectives To study the analgesic effect of acupuncture andplaceboacupunctureandtoexplorewhetherthetype of the placebo acupuncture is associated with the estimated effect of acupuncture. Design Systematic review and meta-analysis of three armed randomised clinical trials. Data sources Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT. Data extraction and analysis Standardised mean differencesfromeachtrialwereusedtoestimatetheeffect of acupuncture and placebo acupuncture. The different types of placebo acupuncture

  12. Challenges in Obtaining Adequate Genetic Sample Sets in Clinical Trials: The Perspective of the Industry Pharmacogenomics Working Group

    Microsoft Academic Search

    A W Warner; A Bhathena; S Gilardi; D Mohr; D Leong; K L Bienfait; J Sarang; S Duprey; M A Franc; A Nelsen; A Snapir

    2011-01-01

    Collection of DNA samples from subjects participating in clinical trials is vital to understanding variability in drug response. The purpose of this study was to assess pharmacogenetic sample-collection practices in the industry and to gather information on issues affecting collection. A survey questionnaire was developed and distributed to 20 pharmaceutical companies; 15 provided responses. Assessments included rate of DNA sample

  13. Clinical predictors of spontaneous acute urinary retention in men with LUTS and clinical BPH: a comprehensive analysis of the pooled placebo groups of several large clinical trials

    Microsoft Academic Search

    Claus G Roehrborn; Marie-Pierre Malice; Thomas J Cook; Cynthia J Girman

    2001-01-01

    Objectives. To comprehensively evaluate clinical predictors of spontaneous acute urinary retention (AUR) across pooled data of placebo-treated patients from clinical trials conducted in men with lower urinary tract symptoms and clinically diagnosed benign prostatic hyperplasia.Methods. Data from the placebo-treatment groups of several prospective, randomized clinical trials conducted in the United States (n = 3040), Scandinavia, Canada, and worldwide (n =

  14. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions

    PubMed Central

    2014-01-01

    Background The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. Methods In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n?=?300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. Discussion This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness. Trial registration Clinicaltrials.gov: NCT01978392 (Issued November 6, 2013) PMID:24885844

  15. Does telecare prolong community living in dementia? A study protocol for a pragmatic, randomised controlled trial

    PubMed Central

    2013-01-01

    Background Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current economic situation in England has renewed interest in ATT instead of community care packages. However, at present, the evidence base to support claims about the impact and effectiveness of ATT is limited, despite its potential to mitigate the high financial cost of caring for people with dementia and the social and psychological cost to unpaid carers. Method/design ATTILA (Assistive Technology and Telecare to maintain Independent Living At Home for People with Dementia) is a pragmatic, multi-centre, randomised controlled trial over 104 weeks that compares outcomes for people with dementia who receive ATT and those who receive equivalent community services but not ATT. The study hypothesis is that fewer people in the ATT group will go into institutional care over the 4-year period for which the study is funded. The study aims to recruit 500 participants, living in community settings, with dementia or significant cognitive impairment, who have recently been referred to social services. Primary outcome measures are time in days from randomisation to institutionalisation and cost effectiveness. Secondary outcomes are caregiver burden, health-related quality of life in carers, number and severity of serious adverse events, and data on acceptability, applicability and reliability of ATT intervention packages. Assessments will be undertaken in weeks 0 (baseline), 12, 24, 52 and 104 or until institutionalisation or withdrawal of the participant from the trial. Discussion In a time of financial austerity, CASSRs in England are increasingly turning to ATT in the belief that it will deliver good outcomes for less money. There is an absence of robust evidence for the cost-effectiveness and benefit of using assistive technology and telecare. The ATTILA trial meets a pressing need for robust, generalisable evidence to either justify continuing investment or reappraise the appropriate scale of ATT use. Trial registration Current Controlled Trials ISRCTN86537017 PMID:24152600

  16. A Controlled Trial of Active versus Passive Learning Strategies in a Large Group Setting

    ERIC Educational Resources Information Center

    Haidet, Paul; Morgan, Robert O.; O'Malley, Kimberly; Moran, Betty Jeanne; Richards, Boyd F.

    2004-01-01

    Objective: To compare the effects of active and didactic teaching strategies on learning- and process-oriented outcomes. Design: Controlled trial. Setting: After-hours residents' teaching session. Participants: Family and Community Medicine, Internal Medicine, and Pediatrics residents at two academic medical institutions. Interventions: We…

  17. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (?7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012. Trial registration [ClinicalTrials.gov: Identifier NCT00945204] PMID:22971356

  18. Phase II trial of bortezomib plus doxorubicin in hepatocellular carcinoma (E6202): a trial of the Eastern Cooperative Oncology Group

    PubMed Central

    Feng, Yang; Benson, Al Bowen; Su, Yingjun; Horton, Linda; Short, Sarah P.; Kauh, John Sae Wook; Staley, Charles; Mulcahy, Mary; Powell, Mark; Amiri, Katayoun I.; Richmond, Ann; Berlin, Jordan

    2014-01-01

    Summary Purpose To evaluate the efficacy and tolerability of bortezomib in combination with doxorubicin in patients with advanced hepatocellular carcinoma, and to correlate pharmaco-dynamic markers of proteasome inhibition with response and survival. Experimental Design This phase II, open-label, multi-center study examined the efficacy of bortezomib (1.3 mg/m2 IV on d1, 4, 8, 11) and doxorubicin (15 mg/m2 IV on d1, 8) in 21-day cycles. The primary endpoint was objective response rate. Results Best responses in 38 treated patients were 1 partial response (2.6 %), 10 (26.3 %) stable disease, and 17 (44.7 %) progressive disease; 10 patients were unevaluable. Median PFS was 2.2 months. Median OS was 6.1 months. The most common grade 3 to 4 toxicities were hypertension, glucose intolerance, ascites, ALT elevation, hyperglycemia and thrombosis/ embolism. Worse PFS was seen in patients with elevated IL-6, IL-8, MIP-1? and EMSA for NF-?B at the start of treatment. Worse OS was seen in patients with elevated IL-8 and VEGF at the start of treatment. Patients had improved OS if a change in the natural log of serum MIP-1?/CCL3 was seen after treatment. RANTES/CCL5 levels decreased significantly with treatment. Conclusions The combination of doxorubicin and bortezomib was well-tolerated in patients with hepatocellular carcinoma, but the primary endpoint was not met. Exploratory analyses of markers of proteasome inhibition suggest a possible prognostic and predictive role and should be explored further in tumor types for which bortezomib is efficacious. PMID:24890858

  19. Generalizing from Clinical Trial Data: A Case Study. The Risk of Suicidality Among Pediatric Antidepressant Users

    E-print Network

    Generalizing from Clinical Trial Data: A Case Study. The Risk of Suicidality Among Pediatric Antidepressant Users Running Title: Generalizing from Clinical Trial Data: A Case Study Authors: Joel B Department of Statistics, Carnegie Mellon University, Pittsburgh, PA 2 Department of Statistics, Ohio State

  20. Studying a disease with no home - lessons in trial recruitment from the PATCH II study

    PubMed Central

    2010-01-01

    Background Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients. Methods A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V) with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis. Results The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i) changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii) those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii) funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success. Discussion The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment took place prior to research support being available through the Comprehensive Clinical Research Network (CCRN). There is a balance to be struck between asking a lot of centres to recruit just a few patients, and asking a few centres to recruit a lot of patients. Giving modest funds to principal investigators to buy local research nurse time did not work well, probably because too little research time was bought, and it was difficult to separate research tasks from the nurses existing clinical duties. National research infrastructure networks such as the Comprehensive Clinical Research Network will overcome many of the problems encountered in the PATCH II trial. Trial Registration The trial registration number is ISRCTN03813200. PMID:20196846

  1. Continuous infusion of bupivacaine following total knee arthroplasty: a randomized control trial pilot study.

    PubMed

    Williams, Dale; Petruccelli, Danielle; Paul, James; Piccirillo, Liz; Winemaker, Mitch; de Beer, Justin

    2013-03-01

    An RCT pilot-study was conducted to assess efficacy of a 48-h continuous local infiltration of intra-articular bupivacaine (0.5% at 2 cc/h) versus placebo (0.5% saline at 2 cc/h) in decreasing PCA morphine consumption following TKA. Secondary outcomes included 48-h VAS pain, opioid side effects, length of stay, and knee function scores up to 1-year postoperatively. Of 67 randomized patients, 49 completed the trial including 24 bupivacaine, and 25 placebo patients. Mean 48-h PCA morphine consumption did not differ significantly between treatment (39 mg ± 27.1) and placebo groups (53 mg ± 30.4) (P = .137). The intervention did not improve pain scores, or any other outcome studied. Given study results we would conclude that analgesia outcomes with a multimodal analgesia regimen are not significantly improved by adding 48 h of 0.5% bupivacaine infiltration at 2 cc/h. PMID:23123039

  2. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    Microsoft Academic Search

    Andrew Clegg; Sally Barber; John Young; Anne Forster; Steve Iliffe

    2011-01-01

    Background  Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability\\u000a and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the\\u000a risk of these adverse outcomes by increasing muscle strength and improving mobility.\\u000a \\u000a \\u000a \\u000a \\u000a Methods\\/Design  The Home-Based Older People's Exercise (HOPE) trial is a two

  3. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system. Trial Registration Clinicaltrials.gov NCT01039298 PMID:22026481

  4. Group Music Intervention Reduces Aggression and Improves Self-esteem in Children with Highly Aggressive Behavior: A Pilot Controlled Trial.

    PubMed

    Choi, Ae-Na; Lee, Myeong Soo; Lee, Jung-Sook

    2010-06-01

    We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents), Child Aggression Assessment Inventory (Teachers) and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control. PMID:18955314

  5. A minimally invasive technique for decompression of Chiari malformation type I (DECMI study): study protocol for a randomised controlled trial

    PubMed Central

    Hu, Yu; Liu, Jiagang; Chen, Haifeng; Jiang, Shu; Li, Qiang; Fang, Yuan; Gong, Shuhui; Wang, Yuelong; Huang, Siqing

    2015-01-01

    Introduction Chiari malformation type I (CM-I) is a congenital hindbrain anomaly that requires surgical decompression in symptomatic patients. Posterior fossa decompression with duraplasty (PFDD) has been widely practiced in Chiari decompression, but dural opening carries a high risk of surgical complications. A minimally invasive technique, dural splitting decompression (DSD), preserves the inner layer of the dura without dural opening and duraplasty, potentially reducing surgical complications, length of operative time and hospital stay, and cost. If DSD is non-inferior to PFDD in terms of clinical improvement, DSD could be an alternative treatment modality for CM-I. So far, no randomised study of surgical treatment of CM-I has been reported. This study aims to evaluate if DSD is an effective, safe and cost-saving treatment modality for adult CM-I patients, and may provide evidence for using the minimally invasive procedure extensively. Methods and analysis DECMI is a randomised controlled, single-masked, non-inferiority, single centre clinical trial. Participants meeting the criteria will be randomised to the DSD group and the PFDD group in a 1:1 ratio. The primary outcome is the rate of clinical improvement, which is defined as the complete resolution or partial improvement of the presenting symptoms/signs. The secondary outcomes consist of the incidence of syrinx reduction, postoperative morbidity rates, reoperation rate, quality of life (QoL) and healthcare resource utilisation. A total of 160 patients will be included and followed up at 3 and 12?months postoperatively. Ethics and dissemination The study protocol was approved by the Biological and Medical Ethics Committee of West China Hospital. The findings of this trial will be published in a peer-reviewed scientific journal and presented at scientific conferences. Trial registration number ChiCTR-TRC-14004099. PMID:25926152

  6. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    PubMed Central

    2012-01-01

    Background Neck pain is one of the chief symptoms of cervical spondylosis (CS). Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture versus placebo or non-classic acupuncture treatment and evaluate whether classic Chinese medical acupuncture is effective on CS neck pain. This study will provide evidence for the effects of acupuncture on CS neck pain. Trial Registration Chinese Clinical Trial Registry: ChiCTR-TRC-00000184. PMID:22776567

  7. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    PubMed Central

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  8. [Phase I trials--clinical studies of antineoplastic agents].

    PubMed

    Takahashi, H; Wakui, A; Yokoyama, M; Oikawa, H; Yoshioka, T; Matsuoka, S

    1991-07-01

    The establishment of the starting dose and the dose escalation are the principal issues of the Phase I trials of anticancer agents. We report the procedures and results of the Phase I studies we participated in Japan in the 1980's concerning 17 intravenous anticancer agents. The drugs indicated a correlation between the mouse LD10 and the man MTD (maximum tolerated dose) in mg/m2. Median mouse LD10 (135 mg/m2) approximated to median man MTD (137 mg/m2) in mg/m2. One fifth of the mouse LD10 was lower than the man MTD. Therefore, as recognized at the 23rd Annual Congress, Japan Society for Cancer Therapy, the lower one of either 1/5 the mouse LD10 or 1/3 the dog TDL (toxic dose low) in mg/m2 has to be determined as safe starting dose. The modified Fibonacci search scheme has been generally adopted for the dose escalation. 14 applicable drugs were examined including 7 drugs in the early 1980's and 7 drugs in the late 1980's. The real number of steps that reached the man MTD was compared to the number of the steps taken in the dose escalation by the Fibonacci's method. The real steps were more than the Fibonacci's ones in the late 1980's. It showed the tendency of a more careful and safer dose escalation, however, to put it critically, the dose escalation was not efficient enough. It is expected that the contradictory problem between safety and efficacy in the Phase I studies will be solved by developing methods like pharmacokinetic study in animals and man. PMID:1854218

  9. The effectiveness of integrated treatment in patients with substance use disorders co-occurring with anxiety and/or depression - a group randomized trial

    PubMed Central

    2014-01-01

    Background Integrated Treatment (IT) has proved effective in treating patients with Substance Use Disorders (SUD) co-occurring with severe Mental Disorders (MD), less is known about the effectiveness of IT for patients with SUD co-occurring with less severe MD. The aim of this study was to investigate the effectiveness of IT for patients with SUD co-occurring with anxiety and/or depression on the following parameters: 1. The use of substances, as measured by the Alcohol Use Identification Test (AUDIT), the Drug Use Identification Test (DUDIT), and the Addiction Severity Index (EuropASI). 2. The severity of psychiatric symptoms, as measured by the Symptom Check List 90 r (SCL 90R). 3. The client’s motivation for changing his/her substance use behaviour, as measured by the Substance Abuse Treatment Scale (SATSr). Methods This is a group randomized clinical trial comparing the effectiveness of IT to treatment as usual in Community Mental Health Centres (CMHCs). Five CMHCs were drawn to the Intervention Group (IG) and four CMHCs to the Control Group (CG). The allocation to treatment conditions was not blinded. New referrals were screened with the AUDIT and the DUDIT. Those who scored above the cut-off level of these instruments were assessed with the Structured Clinical Interview for DSM-IV 1 and 2. We included patients with anxiety and/or depression together with one or more SUDs. Results We included 55 patients in the IG and 21 in the CG. A linear multilevel model was used. Both groups reduced their alcohol and substance use during the trial, while there was no change in psychiatric symptoms in either group. However, the IG had a greater increase in motivation for substance use treatment after 12 months than had the CG with an estimate of 1.76, p = 0.043, CI95% (0.08; 3.44) (adjusted analyses). There were no adverse events. Conclusions Integrated treatment is effective in increasing the motivation for treatment amongst patients with anxiety and/or depression together with SUD in outpatient clinics. Trial registration ClinicalTrials.gov: NCT00447733. PMID:24597469

  10. Internal Versus External Motivation in Referral of Primary Care Patients with Depression to an Internet Support Group: Randomized Controlled Trial

    PubMed Central

    Houston, Thomas K; Fogel, Joshua; Lee, Royce; Ford, Daniel E

    2013-01-01

    Background Depressive disorders and symptoms affect more than one-third of primary care patients, many of whom do not receive or do not complete treatment. Internet-based social support from peers could sustain depression treatment engagement and adherence. We do not know whether primary care patients will accept referral to such websites nor do we know which methods of referral would be most effective. Objective We conducted a randomized clinical trial to determine whether (1) a simple generic referral card (control), (2) a patient-oriented brochure that provided examples of online postings and experience (internal motivation), or (3) a physician letter of recommendation (external motivation) would generate the greatest participation in a primary care Internet depression treatment support portal focused around an Internet support group (ISG). Methods We used 3 offline methods to identify potential participants who had not used an ISG in the past 6 months. Eligibility was determined in part by a brief structured psychiatric interview based on the Patient Health Questionnaire-9 (PHQ-9). After consent and enrollment, participants were randomly assigned to 1 of 3 groups (control, internal motivation, or external motivation). We constructed a portal to connect primary care patients to both fact-based information and an established ISG (Psycho-Babble). The ISG allowed participants to view messages and then decide if they actually wished to register there. Participation in the portal and the ISG was assessed via automated activity tracking. Results Fifty participants were assigned to the 3 groups: a motivation-neutral control group (n=18), an internal motivation group (n=19), and an external motivation group (n=13). Of these participants, 31 (62%) visited the portal; 27 (54%) visited the ISG itself. The internal motivation group showed significantly greater participation than the control group on several measures. The external motivation group spent significantly less time logged onto the portal than the control group. The internal motivation group showed significantly greater participation than the external motivation group on several measures. Conclusions Referral of primary care patients with depressive disorders and symptoms to an ISG is feasible even if they have never previously used one. This may best be accomplished by enhancing their internal motivation. Trial Registration Clinicaltrials.gov: NCT00886730; http://clinicaltrials.gov/show/NCT00886730 (Archived by WebCite at http://www.webcitation.org/6F4981fDN) PMID:23482332

  11. Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group.

    PubMed

    Lin, Nancy U; Lee, Eudocia Q; Aoyama, Hidefumi; Barani, Igor J; Baumert, Brigitta G; Brown, Paul D; Camidge, D Ross; Chang, Susan M; Dancey, Janet; Gaspar, Laurie E; Harris, Gordon J; Hodi, F Stephen; Kalkanis, Steven N; Lamborn, Kathleen R; Linskey, Mark E; Macdonald, David R; Margolin, Kim; Mehta, Minesh P; Schiff, David; Soffietti, Riccardo; Suh, John H; van den Bent, Martin J; Vogelbaum, Michael A; Wefel, Jeffrey S; Wen, Patrick Y

    2013-09-01

    Therapeutic outcomes for patients with brain metastases need to improve. A critical review of trials specifically addressing brain metastases shows key issues that could prevent acceptance of results by regulatory agencies, including enrolment of heterogeneous groups of patients and varying definitions of clinical endpoints. Considerations specific to disease, modality, and treatment are not consistently addressed. Additionally, the schedule of CNS imaging and consequences of detection of new or progressive brain metastases in trials mainly exploring the extra-CNS activity of systemic drugs are highly variable. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, collaborative effort to improve the design of trials in patients with brain tumours. In this two-part series, we review the state of clinical trials of brain metastases and suggest a consensus recommendation for the development of criteria for future clinical trials. PMID:23993384

  12. Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial

    PubMed Central

    2012-01-01

    Background Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD) is far from satisfactory. Vagus nerve stimulation (VNS) is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response. This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention. Design One hundred twenty cases (60 males) of volunteer patients with mild and moderate depression will be randomly divided into transcutaneous vagus nerve stimulation group (tVNS) and sham tVNS group. The treatment period lasts 4 months and all clinical and physiological measurements are acquired at the beginning and the end of the treatment period. Discussion This study has the potential to significantly extend the application of VNS treatment for MDD and other disorders (including epilepsy, bipolar disorder, and morbid obesity), resulting in direct benefit to the patients suffering from these highly prevalent disorders. In addition, the results of this double-blinded clinical trial will shed new light on our understanding of acupuncture point specificity, and development of methodologies in clinical trials of acupuncture treatment. Trials registration Clinical Trials. ChiCTR-TRC-11001201 http://www.chictr.org/cn/ PMID:23241431

  13. Exploring the role of the radioprotector amifostine in locally advanced non-small cell lung cancer: Radiation Therapy Oncology Group trial 98-01.

    PubMed

    Movsas, Benjamin

    2002-01-01

    The ultimate goal of any strategy in oncology is to enhance the therapeutic ratio, defined as tumor cell kill divided by normal tissue injury. Whereas most trials focus on intensifying therapy, this often increases toxicity so that there is no overall gain in the therapeutic ratio. Radiation Therapy Oncology Group (RTOG) trial 98-01, a phase III study testing the ability of a radioprotector (Amifostine [Ethyol, WR-2721]) to reduce the toxicity of an intensive chemoradiation regimen for locally advanced non-small cell lung cancer (NSCLC), is unique in that it addresses both "sides" of this equation. During the 1990s, thoracic radiotherapy (RT) combined with chemotherapy was accepted as a "new" gold standard for patients with good performance status locally advanced/inoperable NSCLC. This paradigm shift away from RT alone has raised several key questions: What is the optimal method of integrating chemotherapy and RT? Equally importantly, how can the toxicity of combined modality strategies be reduced? This article will review the background underlying RTOG 98-01, a trial exploring the potential role of amifostine in NSCLC. PMID:11917283

  14. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    PubMed Central

    2011-01-01

    Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

  15. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up. Discussion This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group. Trial registration ISRCTN58561170 PMID:23866771

  16. [How to share results of clinical trials with study participants?].

    PubMed

    Sarradon-Eck, Aline; Mancini, Julien; Genre, Dominique; Sakoyan, Juliette; Desclaux, Alice; Julian-Reynier, Claire

    2012-03-01

    Informing research participants of the results of clinical trials in which they were enrolled is in agreement with patients' rights and human dignity; such feedback is considered an ethical standard applied to clinical research. Cancer patients who participate in a clinical trial usually want to know the results. Here we analysed the literature about the different ways of disclosure of clinical trial results to participants, questioning their expectations and the meanings they give to the results. We describe some of the dilemma and intertwining between clinical care and clinical research. We highlight how the standardisation of sharing such results to participants could raise difficulties particularly for the relationship between doctor and patients. PMID:22494655

  17. Workflow to improve patient recruitment for clinical trials within hospital information systems – a case-study

    Microsoft Academic Search

    Martin Dugas; Matthias Lange; Wolfgang E Berdel; Carsten Müller-Tidow

    2008-01-01

    BACKGROUND: The identification of suitable patients is a common problem in clinical trials that is especially evident in tertiary care hospitals. METHODS: We developed and analysed a workflow, which uses routine data captured during patient care in a hospital information system (HIS), to identify potential trial subjects. Study nurses or physicians are notified automatically by email and verify eligibility. RESULTS:

  18. Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study

    Microsoft Academic Search

    Ivan Pavlovi?; Tomaž Kern; Damijan Miklav?i?

    2009-01-01

    An alternative to clinical trial paper-based data collection (PDC) is internet based electronic data collection (EDC), where the investigators over the internet enter data directly in the electronic database by themselves. In our study we considered clinical trial as a business process. Our objective was to model PDC and EDC process and to estimate the difference of the costs of

  19. TrialDB: A web-based Clinical Study Data Management System.

    PubMed

    Brandt, C A; Deshpande, A M; Lu, C; Ananth, G; Sun, K; Gadagkar, R; Morse, R; Rodriguez, C; Miller, P L; Nadkarni, P M

    2003-01-01

    Clinical Study Data Management Systems (CSDMSs) are a class of software that support centralized management of data generated during the conduct of clinical studies. Commercial CSDMSs include Oracle Clinical, ClinTrial and MetaTrial. Such systems, which are typically deployed at an institutional or organizational level, must accommodate diverse types of data from different clinical domains that is generated by different groups of clinical investigators. Large-scale CSDMSs typically employ a high-end database engine that is usually accessed over an intranet or the Internet using Web-based technologies. CSDMSs in institution-wide use for a variety of clinical domains are best served by entity-attribute-value (EAV) modeling for the clinical data: all the commercial CSDMSs that we are aware of use EAV design. However, de novo development of EAV databases for data management is a challenging task. A large body of generic metadata-driven code must be developed before a basic EAV application can be written. Clearly, the availability of pre-existing software with the requisite functionality would be very valuable. We will discuss the benefits of such software being in open-source form. PMID:14728299

  20. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial

    PubMed Central

    2014-01-01

    Background Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. Methods/Design We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Discussion Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-13003708. PMID:24693945

  1. Tobacco Cessation Treatment for Alaska Native Adolescents: Group Randomized Pilot Trial

    PubMed Central

    2014-01-01

    Introduction: Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design. Methods: Eight villages in western Alaska were randomly assigned to receive the intervention (n = 4 villages) or a delayed treatment control condition (written materials only; n = 4 villages). Ten adolescents aged 12–17 years were targeted from each village with a planned enrollment of 80. The intervention was held over a weekend, and youth traveled from their villages to quit tobacco use with other teens. The intervention comprised 8hr of group-based counseling. Talking circles, personal stories from elders, and recreational activities were included to enhance cultural acceptability and participation. Newsletters were mailed weekly for 5-weeks postprogram. Assessments were conducted at baseline, week 6 (end-of-treatment), and 6 months. Self-reported tobacco abstinence was confirmed with salivary cotinine. Results: Recruitment targets were met in the intervention (41 enrolled) but not in control villages (27 enrolled). All intervention participants attended the weekend program. Retention was high; 98% of intervention and 86% of control participants completed 6-month follow-up. The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10% (4/41) and 0% (0/27) at both week 6 and 6 months (p = .15). Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months. Conclusion: The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth. Alternative approaches are warranted. PMID:24532352

  2. Intraclass Correlation Values for Planning Group-Randomized Trials in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2007-01-01

    Experiments that assign intact groups to treatment conditions are increasingly common in social research. In educational research, the groups assigned are often schools. The design of group-randomized experiments requires knowledge of the intraclass correlation structure to compute statistical power and sample sizes required to achieve adequate…

  3. A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway

    PubMed Central

    2012-01-01

    Background Late-life depression is a common condition and a challenging public health problem. A lack of social support is strongly associated with psychological distress. Senior centres seem to be suitable arenas for community-based health promotion interventions, although few studies have addressed this subject. The objectives were to examine the effect of a preventive senior centre group programme consisting of weekly meetings, on social support, depression and quality of life. Methods A questionnaire was sent to a random sample of 4,000 persons over 65 in Oslo, and a total of 2,387 completed questionnaires were obtained. These subjects served as a basis for recruitment of participants for a trial, with scores on HSCL-10 being used as a main inclusion criterion. A total of 138 persons were randomized into an intervention group (N?=?77) and control group (N?=?61). Final analyses included 92 persons. Social support (OSS-3), depression (BDI), life satisfaction and health were measured in interviews at baseline and after 12?months (at the end of the intervention programme). Perceptions of benefits from the intervention were also measured. Mean scores, SD, SE and CI were used to describe the changes in outcomes. Effect sizes were calculated based on the original scales and as Cohen’s d. Paired sample tests and ANOVA were used to test group differences. Results There was an increase in social support in both groups, but greatest in the intervention group. The level of depression increased for both groups, but more so in the control than the intervention group. There was a decrease in life satisfaction, although the decrease was largest among controls. There were almost no differences in reported health between groups. However, effect sizes were small and differences were not statistically significant. In contrast, most of the participants said the intervention meant much to them and led to increased use of the centre. Conclusions In all probability, the intervention failed to meet optimistic targets, but possibly met quite modest ones. Since intention-to-treat analysis was not possible, we do not know the effect on the intervention group as a whole. A further evaluation of these programmes is necessary to expand the group programme. For the depressed, more specialized programmes to cope with depression may be a more appropriate intervention. Trial Registration DRKS00003120 on DRKS PMID:22607553

  4. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9?weeks after randomization. The acupuncture groups are: (1) Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group); (2) He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group); (3) Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group). The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS). The first two of second outcomes are measured 1?week before randomization and 2, 4, and 8?weeks after randomization. Other second outcomes are measured 1?week before randomization and 2 and 4?weeks after randomization, but SF-36 is measured at randomization and 4?weeks after randomization. Discussion The result of this trial (which will be available in 2012) will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501 PMID:22759406

  5. Report of the Public Cryptography Study Group.

    ERIC Educational Resources Information Center

    American Council on Education, Washington, DC.

    Concerns of the National Security Agency (NSA) that information contained in some articles about cryptography in learned and professional journals and in monographs might be inimical to the national security are addressed. The Public Cryptography Study Group, with one dissenting opinion, recommends that a voluntary system of prior review of…

  6. Initial experience with a group presentation of study results to research participants

    PubMed Central

    Avins, Andrew L; Bent, Stephen; Padula, Amy; Staccone, Suzanne; Badua, Evelyn; Goldberg, Harley

    2008-01-01

    Background Despite ethical imperatives, informing research participants about the results of the studies in which they take part is not often performed. This is due, in part, to the costs and burdens of communicating with each participant after publication of the results. Methods Following the closeout and publication of a randomized clinical trial of saw palmetto for treatment of symptoms of benign prostatic hyperplasia, patients were invited back to the research center to participate in a group presentation of the study results. Results Approximately 10% of participants attended one of two presentation sessions. Reaction to the experience of the group presentation was very positive among the attendees. Conclusion A group presentation to research participants is an efficient method of communicating study results to those who desire to be informed and was highly valued by those who attended. Prospectively planning for such presentations and greater scheduling flexibility may result in higher attendance rates. Trial Registration Number Clinicaltrials.gov #NCT00037154 PMID:18355417

  7. Enhancing ventilation in homes of children with asthma: cost-effectiveness study alongside randomised controlled trial

    PubMed Central

    Edwards, Rhiannon T; Neal, Richard D; Linck, Pat; Bruce, Nigel; Mullock, Linda; Nelhans, Nick; Pasterfield, Diana; Russell, Daphne; Russell, Ian; Woodfine, Louise

    2011-01-01

    Background There has been little rigorous economic analysis of the relationship between asthma and improved housing. Aim To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with ‘moderate’ or ‘severe’ asthma. Design and setting An incremental cost-effectiveness analysis alongside a pragmatic randomised controlled trial of a tailored package of housing modifications designed to improve ventilation and household heating in homes within Wrexham County Borough, Wales, UK. Method A total of 177 children aged between 5 and 14 years, identified from general practice registers, were studied. Parents reported on the quality of life of their children over a 12-month period. General practices reported on health-service resources used by those children, and their asthma-related prescriptions, over the same period. Results The tailored package shifted 17% of children in the intervention group from ‘severe’ to ‘moderate’ asthma, compared with a 3% shift in the control group. The mean cost of these modifications was £1718 per child treated or £12300 per child shifted from ‘severe’ to ‘moderate’. Healthcare costs over 12 months following randomisation did not differ significantly between intervention and control groups. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £234 per point improvement on the 100-point PedsQL™ asthma-specific scale, with 95% confidence interval (CI) = £140 to £590. The ICER fell to £165 (95% CI = £84 to £424) for children with ‘severe’ asthma. Conclusion This novel and pragmatic trial, with integrated economic evaluation, reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public resources. This is a rare example of evidence for collaboration between local government and the NHS. PMID:22054337

  8. WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

    PubMed Central

    2014-01-01

    Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. Trial registration Current Controlled Trials ISRCTN04199273 – WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013. PMID:24888479

  9. A cluster randomised trial of a school-based intervention to prevent decline in adolescent physical activity levels: study protocol for the ‘Physical Activity 4 Everyone’ trial

    PubMed Central

    2013-01-01

    Background Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents’ physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12–13 years) and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA), will be objectively assessed using accelerometers (Actigraph GT3x+). Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. Discussion The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000382875. PMID:23336603

  10. Cognitive behavioral group therapy for social phobia with or without attention training: a controlled trial.

    PubMed

    McEvoy, Peter M; Perini, Sarah J

    2009-05-01

    The Self-Regulatory Executive Function model [S-REF; Wells, A., & Matthews, G. (1996). Modelling cognition in emotional disorder: the S-REF model. Behaviour Research and Therapy, 34, 881-888] proposes that metacognitive beliefs, inflexible self-focused attention, and perseverative thinking (rumination and worry) play an important role in maintaining emotional dysfunction. Attention training [ATT; Wells, A. (1990). Panic disorder in association with relaxation induced anxiety: an attentional training approach to treatment. Behavior Therapy, 21, 273-280] is a technique designed to increase attentional control and flexibility, and thereby lessen the impact of these maintaining factors. The main aim of this study was to determine whether or not supplementing cognitive behavioral group therapy (CBGT) with ATT could potentiate greater changes in social anxiety, depression, attentional control, metacognitive beliefs, and anticipatory and post-event processing in a clinical sample with social phobia. Patients (N=81) were allocated to CBGT with ATT or relaxation training (RT). ATT did not potentiate greater change on any outcome variable, with both groups achieving significant improvements on all measures. Exploratory correlational analyses (pre-treatment and changes scores) showed that some metacognitive beliefs were associated with attentional control, anticipatory processing, and symptoms of social anxiety and depression. However, attentional control was more consistently associated with anticipatory processing, post-event processing, and symptoms of social anxiety and depression, than with metacognitive beliefs. Results are discussed with reference to cognitive behavioral models of social phobia. It is tentatively concluded that while supplementing CBGT with ATT does not improve outcomes, increasing attentional control during CBGT is associated with symptom relief. PMID:19059753

  11. Electromagnetic source reconstruction for group studies

    PubMed Central

    Litvak, Vladimir; Friston, Karl

    2008-01-01

    The aim of this paper is to describe a simple procedure for electromagnetic (EEG or MEG) source reconstruction, in the context of group studies. This entails a simple extension of existing source reconstiruction techniques based upon the inversion of hierarchical models. The extension ensures that evoked or induced responses are reconstructed in the same subset of sources, over subjects. Effectively, the procedure aligns the deployment of reconstructed activity over subjects and increases, substantially, the detection of differences between evoked or induced responses at the group or between-subject level. PMID:18639641

  12. Incomplete Reconstitution of T Cell Subsets on Combination Antiretroviral Therapy in the AIDS Clinical Trials Group Protocol 384

    PubMed Central

    Robbins, Gregory K.; Spritzler, John G.; Chan, Ellen S.; Asmuth, David M.; Gandhi, Rajesh T.; Rodriguez, Benigno A.; Skowron, Gail; Skolnik, Paul R.; Shafer, Robert W.; Pollard, Richard B.

    2009-01-01

    Background Initiation of combination antiretroviral therapy (ART) results in higher total CD4 cell counts, a surrogate for immune reconstitution. Whether the baseline CD4 cell count affects reconstitution of immune cell subsets has not been well characterized. Methods Using data from 978 patients (621 with comprehensive immunological assessments) from the AIDS [Acquired Immunodeficiency Syndrome] Clinical Trials Group protocol 384, a randomized trial of initial ART, we compared reconstitution of CD4+, CD4+ naive and memory, CD4+ activation, CD8+, CD8+ activation, B, and natural killer cells among patients in different baseline CD4+ strata. Reference ranges for T cell populations in control patients negative for human immunodeficiency virus (HIV) infection were calculated using data from AIDS Clinical Trials Group protocol A5113. Results Patients in the lower baseline CD4+ strata did not achieve total CD4+ cell counts similar to those of patients in the higher strata during 144 weeks of ART, although CD4+ cell count increases were similar. Ratios of CD4+ naive-memory cell counts and CD4+:CD8+ cell counts remained significantly reduced in patients with lower baseline CD4+ cell counts (?350 cells/mm3). These immune imbalances were most notable for those initiating ART with a baseline CD4+ cell count ?200 cells/mm3, even after adjustment for baseline plasma HIV RNA levels. Conclusions After nearly 3 years of ART, T cell subsets in patients with baseline CD4+ cell counts >350 cells/mm3 achieved or approached the reference range those of control individuals without HIV infection. In contrast, patients who began ART with ?350 CD4+ cells/mm3 generally did not regain normal CD4+ naive-memory cell ratios. These results support current guidelines to start ART at a threshold of 350 cells/mm3 and suggest that there may be immunological benefits associated with initiating therapy at even higher CD4+ cell counts. PMID:19123865

  13. Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

    PubMed

    Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

    2014-03-01

    This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p?=?0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials. PMID:24127249

  14. Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov

    PubMed Central

    Stockmann, Chris; Sherwin, Catherine M.T.; Ampofo, Krow; Hersh, Adam L.; Pavia, Andrew T.; Byington, Carrie L.; Ward, Robert M.; Spigarelli, Michael G.

    2013-01-01

    Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come. PMID:23726436

  15. FALL 2009 GROUP STUDY ART 496H Art History Group Study: Collections Research

    E-print Network

    FALL 2009 GROUP STUDY ART 496H Art History Group Study: Collections Research TR 2:00-3:15 UCA 240 3 credits (upper division art history) Museum, gallery and private collections are maintained through further experience in art history research, museology, or the connoisseurship of collecting. Enrollment

  16. Cognitive-Behavioral Group Therapy as an Early Intervention for Insomnia: A Randomized Controlled Trial

    Microsoft Academic Search

    Markus Jansson; Steven J. Linton

    2005-01-01

    A randomized controlled design was used with a 1-yr follow-up. The purpose was to compare the effects of two early interventions, a cognitive-behavioral group intervention and a self-help information package, in patients with insomnia. In sum, 165 individuals seeking care for insomnia of 3–12 months duration were randomized to either a group receiving a CBT intervention or a group receiving

  17. Influence of Control Group on Effect Size in Trials of Acupuncture for Chronic Pain: A Secondary Analysis of an Individual Patient Data Meta-Analysis

    PubMed Central

    MacPherson, Hugh; Vertosick, Emily; Lewith, George; Linde, Klaus; Sherman, Karen J.; Witt, Claudia M.; Vickers, Andrew J.

    2014-01-01

    Background In a recent individual patient data meta-analysis, acupuncture was found to be superior to both sham and non-sham controls in patients with chronic pain. In this paper we identify variations in types of sham and non-sham controls used and analyze their impact on the effect size of acupuncture. Methods Based on literature searches of acupuncture trials involving patients with headache and migraine, osteoarthritis, and back, neck and shoulder pain, 29 trials met inclusion criteria, 20 involving sham controls (n?=?5,230) and 18 non-sham controls (n?=?14,597). For sham controls, we analysed non-needle sham, penetrating sham needles and non-penetrating sham needles. For non-sham controls, we analysed non-specified routine care and protocol-guided care. Using meta-regression we explored impact of choice of control on effect of acupuncture. Findings Acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles. The difference in effect size was ?0.45 (95% C.I. ?0.78, ?0.12; p?=?0.007), or ?0.19 (95% C.I. ?0.39, 0.01; p?=?0.058) after exclusion of outlying studies showing very large effects of acupuncture. In trials with non-sham controls, larger effect sizes associated with acupuncture vs. non-specified routine care than vs. protocol-guided care. Although the difference in effect size was large (0.26), it was not significant with a wide confidence interval (95% C.I. ?0.05, 0.57, p?=?0.1). Conclusion Acupuncture is significantly superior to control irrespective of the subtype of control. While the choice of control should be driven by the study question, our findings can help inform study design in acupuncture, particularly with respect to sample size. Penetrating needles appear to have important physiologic activity. We recommend that this type of sham be avoided. PMID:24705624

  18. Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic stable angina pectoris (CSAP) is a common cardiovascular condition that endangers a patient’s life quality and longevity. As demonstrated in several clinical trials, acupuncture is attested to be effective for CSAP. Current trials are not adequate enough to provide high-quality evidence for clinical decision making, as a result of inadequate methodology design and small sample size. Notably, stark controversy toward acupoint specificity also exists in the clinical acupuncture trials for CSAP. Therefore, we designed the present study as a randomized controlled trial primarily to investigate the effectiveness of acupuncture in addition to routine care among patients with CSAP. Meanwhile, we examined whether acupoint on the disease-affected meridian (DAM) is superior to either acupoint on the non-affected meridian (NAM) or non-acupoint (NA), to further investigate the meridian-based characteristics of acupoint specificity. Methods/Design This study was a multicenter, assessor and statistician blinded, randomized controlled trial in China. In this study, 404 participants in sum will be randomly assigned to four groups through central randomization in a 1:1:1:1 ratio. The whole study period is 20 weeks including a 4-week baseline period, a 4-week treatment period and a 12-week follow-up. Participants in the DAM group receive acupuncture stimulation at acupoints on the disease-affected meridian, and three different control groups will undergo acupuncture stimulation at the NAM, the non-acupoint and no intervention respectively, in addition to basic treatment. Participants in the acupuncture groups will receive 12 sessions of acupuncture treatment over 4 weeks, while the wait-listed (WL) group would receive free acupuncture treatment after the completion of the study. The outcome measures in this trial include the frequency of angina attack during 4 weeks as the primary outcome and eight other secondary outcomes. Discussion This trial will provide new and relatively high-quality evidence in acupuncture treatment for CSAP. Moreover, this trial may further validate the meridian-based characteristics of acupoint specificity by comparing the strength of acupoints on the disease-affected meridian versus that of the non-affected meridian, to further inspire optimization of acupuncture therapy for CSAP. Trial registration Clinical Trials.gov NCT01686230 PMID:24499445

  19. PEDro or Cochrane to Assess the Quality of Clinical Trials? A Meta-Epidemiological Study

    PubMed Central

    Armijo-Olivo, Susan; da Costa, Bruno R.; Cummings, Greta G.; Ha, Christine; Fuentes, Jorge; Saltaji, Humam; Egger, Matthias

    2015-01-01

    Objective There is debate on how the methodological quality of clinical trials should be assessed. We compared trials of physical therapy (PT) judged to be of adequate quality based on summary scores from the Physiotherapy Evidence Database (PEDro) scale with trials judged to be of adequate quality by Cochrane Risk of Bias criteria. Design Meta-epidemiological study within Cochrane Database of Systematic Reviews. Methods Meta-analyses of PT trials were identified in the Cochrane Database of Systematic Reviews. For each trial PeDro and Cochrane assessments were extracted from the PeDro and Cochrane databases. Adequate quality was defined as adequate generation of random sequence, concealment of allocation, and blinding of outcome assessors (Cochrane criteria) or as trials with a PEDro summary score ?5 or ?6 points. We combined trials of adequate quality using random-effects meta-analysis. Results Forty-one Cochrane reviews and 353 PT trials were included. All meta-analyses included trials with PEDro scores ?5, 37 (90.2%) included trials with PEDro scores ?6 and only 22 (53.7%) meta-analyses included trials of adequate quality according to the Cochrane criteria. Agreement between PeDro and Cochrane was poor for PeDro scores of ?5 points (kappa = 0.12; 95% CI 0.07 to 0.16) and slight for ?6 points (kappa 0.24; 95% CI 0.16-0.32). When combining effect sizes of trials deemed to be of adequate quality according to PEDro or Cochrane criteria, we found that a substantial difference in the combined effect size (?0.15) was evident in 9 (22%) out of the 41 meta-analyses for PEDro cutoff ?5 and 10 (24%) for cutoff ?6. Conclusions The PeDro and Cochrane approaches lead to different sets of trials of adequate quality, and different combined treatment estimates from meta-analyses of these trials. A consistent approach to assessing RoB in trials of physical therapy should be adopted. PMID:26161653

  20. Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol

    PubMed Central

    2014-01-01

    Background New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration Clinical Trials.gov Identifier: NCT02016014 PMID:24628961

  1. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

    PubMed Central

    2013-01-01

    Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half the time (88/154, 56%). We found no contact information for study investigators in the abstract, but this information was available in less than one quarter of ClinicalTrial.gov records (17%; 26/154). Conclusion RCT design information not reported in conference abstracts is often available in the corresponding ClinicalTrials.gov registration record. Sometimes there is conflicting information reported in the two sources and further contact with the trial investigators may still be required. PMID:23773868

  2. Predictors of Study Completion and Withdrawal in a Randomized Clinical Trial of a Pediatric Diabetes Adherence Intervention

    PubMed Central

    Driscoll, Kimberly A.; Killian, Michael; Johnson, Suzanne Bennett; Silverstein, Janet H.; Deeb, Larry C.

    2010-01-01

    Purpose Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study withdrawal throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. Methods An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child’s regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n = 41) and Late Completers (n = 39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants’ completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). Results Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. Conclusions Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group. PMID:19470311

  3. Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. Methods/Design Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles. Discussion To address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects. Trial registration Chinese Clinical Trial Registry (http://cwww.chictr.org): ChiCTR-TRC-13003233, registered 26 May 2013. PMID:25052161

  4. Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Community-acquired pneumonia (CAP) is the third-leading infectious cause of death worldwide. The standard treatment of CAP has not changed for the past fifty years and its mortality and morbidity remain high despite adequate antimicrobial treatment. Systemic corticosteroids have anti-inflammatory effects and are therefore discussed as adjunct treatment for CAP. Available studies show controversial results, and the question about benefits and harms of adjunct corticosteroid therapy has not been conclusively resolved, particularly in the non-critical care setting. Methods/Design This randomized multicenter study compares a treatment with 7 days of prednisone 50 mg with placebo in adult patients hospitalized with CAP independent of severity. Patients are screened and enrolled within the first 36 hours of presentation after written informed consent is obtained. The primary endpoint will be time to clinical stability, which is assessed every 12 hours during hospitalization. Secondary endpoints will be, among others, all-cause mortality within 30 and 180 days, ICU stay, duration of antibiotic treatment, disease activity scores, side effects and complications, value of adrenal function testing and prognostic hormonal and inflammatory biomarkers to predict outcome and treatment response to corticosteroids. Eight hundred included patients will provide an 85% power for the intention-to-treat analysis of the primary endpoint. Discussion This largest to date double-blind placebo-controlled multicenter trial investigates the effect of adjunct glucocorticoids in 800 patients with CAP requiring hospitalization. It aims to give conclusive answers about benefits and risks of corticosteroid treatment in CAP. The inclusion of less severe CAP patients will be expected to lead to a relatively low mortality rate and survival benefit might not be shown. However, our study has adequate power for the clinically relevant endpoint of clinical stability. Due to discontinuing glucocorticoids without tapering after seven days, we limit duration of glucocorticoid exposition, which may reduce possible side effects. Trial registration 7 September 2009 on ClinicalTrials.gov: NCT00973154. PMID:24974155

  5. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial

    PubMed Central

    2013-01-01

    Background Mild to moderate cognitive impairment is common amongst long-term survivors of cardiac arrest. In the Target Temperature Management trial (TTM-trial) comatose survivors were randomized to 33°C or 36°C temperature control for 24 hours after cardiac arrest and the effects on survival and neurological outcome assessed. This protocol describes a sub-study of the TTM-trial investigating cognitive dysfunction and its consequences for patients’ and relatives’ daily life. Methods/Design Sub-study sites in five European countries included surviving TTM patients 180 days after cardiac arrest. In addition to the instruments for neurological function used in the main trial, sub-study patients were specifically tested for difficulties with memory (Rivermead Behavioural Memory Test), attention (Symbol Digit Modalities Test) and executive function (Frontal Assessment Battery). Cognitive impairments will be related to the patients’ degree of participation in society (Mayo-Portland Adaptability Inventory-4), health related quality of life (Short Form Questionnaire–36v2©), and the caregivers’ situation (Zarit Burden Interview©). The two intervention groups (33°C and 36°C) will be compared with a group of myocardial infarction controls. Discussion This large international sub-study of a randomized controlled trial will focus on mild to moderate cognitive impairment and its consequences for cardiac arrest survivors and their caregivers. By using an additional battery of tests we may be able to detect more subtle differences in cognitive function between the two intervention groups than identified in the main study. The results of the study could be used to develop a relevant screening model for cognitive dysfunction after cardiac arrest. Trial registration ClinicalTrials.gov: NCT01946932. PMID:24118853

  6. A Comparative Study of Family Bereavement Groups.

    ERIC Educational Resources Information Center

    Hopmeyer, Estelle; Werk, Annette

    1994-01-01

    Examined five bereavement support groups, three of which focused on widows, family survivors of suicide, and family survivors of death of family member by cancer. Members of three groups tended to report strong satisfaction with group experience. Reasons for joining group and most valuable aspects of group experience varied as function of group

  7. Population-based tobacco treatment: study design of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention. Methods/Design This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology. Discussion This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs. Clinical trials registration ClinicalTrials.gov: NCT00608426. PMID:22394386

  8. Combination of Trabectedin and Gemcitabine for Advanced Soft Tissue Sarcomas: Results of a Phase I Dose Escalating Trial of the German Interdisciplinary Sarcoma Group (GISG)

    PubMed Central

    Kasper, Bernd; Reichardt, Peter; Pink, Daniel; Sommer, Michaela; Mathew, Monika; Rauch, Geraldine; Hohenberger, Peter

    2015-01-01

    Background: Evaluation of the potential efficacy and safety of combination therapies for advanced soft tissue sarcomas (STS) has increased substantially after approval of trabectedin and pazopanib. Trabectedin’s introduction in Europe in 2007 depended mainly on its activity in so-called L-sarcomas (liposarcoma and leiomyosarcoma); combination of trabectedin with other chemotherapies used in STS seems of particular interest. Methods: We initiated within the German Interdisciplinary Sarcoma Group (GISG) a phase I dose escalating trial evaluating the combination of trabectedin and gemcitabine in patients with advanced and/or metastatic L-sarcomas (GISG-02; ClinicalTrials.gov NCT01426633). Patients were treated with increasing doses of trabectedin and gemcitabine. The primary endpoint was to determine the maximum tolerated dose. Results: Five patients were included in the study. Two patients were treated on dose level 1 comprising trabectedin 0.9 mg/m2 on day 1 and gemcitabine 700 mg/m2 on days 1 + 8, every 3 weeks. Due to dose-limiting toxicity (DLT) in both patients (elevated transaminases and thrombocytopenia), an additional three patients were treated on dose level ?1 with trabectedin 0.7 mg/m2 plus gemcitabine 700 mg/m2. Of these three patients, two demonstrated another DLT; therefore, the trial was stopped and none of the dose levels could be recommended for phase II testing. Conclusion: The GISG-02 phase I study was stopped with the conclusion that the combination of gemcitabine and trabectedin is generally not recommended for the treatment of patients with advanced and/or metastatic leiomyosarcoma or liposarcoma. Also, this phase I study strongly supports the necessity for careful evaluation of combination therapies. PMID:25591040

  9. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

    PubMed Central

    2013-01-01

    Background Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which >250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP. Methods The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions. Results A total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale). Conclusions Conducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention. Trial registration Feasibility study first randomization: 29 September 2010. Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012). Full trial first randomization: 19 September 2012. PMID:24304689

  10. Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT. PMID:22998983

  11. Nursing Leadership of Successful Clinical Trial Recruitment Strategies to an NCCCP endorsed Study | accrualnet.cancer.gov

    Cancer.gov

    This study explores nursing leadership interventions for efficient trial accrual. The identified interventions resulted in successful screening and enrollment of appropriate patients to a chronic lymphocytic leukemia trial within a limited two-month enrollment timeframe.

  12. Group and Individual Cognitive-Behavioral Treatments for Youth with Anxiety Disorders: A Randomized Clinical Trial

    Microsoft Academic Search

    Ellen C. Flannery-Schroeder; Philip C. Kendall

    2000-01-01

    Children (aged 8–14 years) with anxiety disorders were randomly assigned to cognitive-behavioral individual treatment, cognitive-behavioral group treatment, or a wait-list control. Treatment outcome was evaluated using diagnostic status, child self-reports, and parent- and teacher-reports. Analyses of diagnostic status revealed that significantly more treated children (73% individual, 50% group) than wait-list children (8%) did not meet diagnostic criteria for their primary

  13. Childhood non-Hodgkin lymphomas in the United Kingdom: findings from the UK Children's Cancer Study Group

    Microsoft Academic Search

    D Wright; P McKeever; R Carter

    1997-01-01

    AIM: To review the presenting clinical features and the histology of cases of non-Hodgkin lymphoma (NHL) entered into the United Kingdom Children's Cancer Study Group NHL Trial. METHODS: Sections of biopsy specimens from all cases entered into the trial were stained with Giemsa and haematoxylin and eosin. All cases were stained immunohistochemically for CD45, CD3, CD45RO, CD20, and CD30. Sections

  14. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

    Microsoft Academic Search

    Lisa Hartling; Maria Ospina; Yuanyuan Liang; Donna M Dryden; Nicola Hooton; Jennifer Krebs Seida; Terry P Klassen

    2009-01-01

    Objectives To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates.Design Cross sectional study.Study sample 163 trials in children.Main outcome measures Inter-rater agreement between

  15. An analysis of two island groups as potential sites for trials of transgenic mosquitoes for malaria control

    PubMed Central

    Marsden, Clare D; Cornel, Anthony; Lee, Yoosook; Sanford, Michelle R; Norris, Laura C; Goodell, Parker B; Nieman, Catelyn C; Han, Sarah; Rodrigues, Amabelia; Denis, Joao; Ouledi, Ahmed; Lanzaro, Gregory C

    2013-01-01

    Considerable technological advances have been made towards the generation of genetically modified mosquitoes for vector control. In contrast, less progress has been made towards field evaluations of transformed mosquitoes which are critical for evaluating the success of, and hazards associated with, genetic modification. Oceanic islands have been highlighted as potentially the best locations for such trials. However, population genetic studies are necessary to verify isolation. Here, we used a panel of genetic markers to assess for evidence of genetic isolation of two oceanic island populations of the African malaria vector, Anopheles gambiae s.s. We found no evidence of isolation between the Bijagós archipelago and mainland Guinea-Bissau, despite separation by distances beyond the known dispersal capabilities of this taxon. Conversely, the Comoros Islands appear to be genetically isolated from the East African mainland, and thus represent a location worthy of further investigation for field trials. Based on assessments of gene flow within and between the Comoros islands, the island of Grande Comore was found to be genetically isolated from adjacent islands and also exhibited local population structure, indicating that it may be the most suitable site for trials with existing genetic modification technologies. PMID:23789035

  16. Informing relatives about their hereditary or familial cancer risk: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Genetic counseling for hereditary breast or colon cancer has implications for both counselees and their relatives. Although counselees are encouraged by genetic counselors to disclose genetic cancer risk information, they do not always share this information with their at-risk relatives. Reasons for not informing relatives may be generally categorized as a lack of knowledge, motivation and/or self-efficacy. Presented here is the protocol of a randomized controlled trial that aims to establish the effectiveness of an intervention focused on supporting counselees in their disclosure of genetic cancer information to their relatives. Methods/Design A multicenter randomized controlled trial with parallel group design will be used to compare the effects of an additional telephone counseling session performed by psychosocial workers to enhance the disclosure of genetic cancer information to at-risk relatives (intervention group) with a control group of standard care. Consecutive index patients with relatives at risk for hereditary or familial breast and/or ovarian cancer or colon cancer, are randomly assigned (block size: 8; 1:1 allocation ratio) to the intervention (n?=?132) or control group (n?=?132, standard care). Primary outcomes are counselees’ knowledge, motivation and self-efficacy regarding informing their relatives. Discussion This intervention may prove important in supporting counselees to disclose hereditary and/or familial cancer risk information to at-risk relatives and may enable more at-risk relatives to make a well-informed decision regarding genetic services and/or screening. Trial registration This trial is registered in the Netherlands National Trial Register (NTR) with trial ID number NTR3745. PMID:24649895

  17. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    SciTech Connect

    Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States)] [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States) [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada)] [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada)] [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States)] [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States)] [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States)] [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States)] [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States)] [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: ying.xiao@jefferson.edu [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA for RTOG clinical trials is feasible and effective. The magnitude of registration discrepancy between institution and reviewer was presented, and the major issues were investigated to further improve this remote evaluation process.

  18. Guest Expert: Monica Bertagnolli, MD - Thoughts from the Group Chair of the Alliance for Clinical Trials in Oncology | accrualnet.cancer.gov

    Cancer.gov

    We are fortunate this month to have Dr. Monica Bertagnolli as our Guest Expert. Dr. Bertagnolli, the Group Chair of the Alliance for Clinical Trials in Oncology, has long been an unwavering advocate for clinical trial teamwork. Despite her official position as leader or chair of many national efforts, she seems to always know what’s going on in the trenches and to be willing to pitch in at any level. After reading Dr.

  19. The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home

    PubMed Central

    2014-01-01

    Background The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention. Methods/Design DOMUS is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options. Discussion Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can be a powerful tool to improve patients’ quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient’s preferred place of care and attempt to clarify challenges. Trial registration Clinicaltrials.gov Identifier: NCT01885637 PMID:25242890

  20. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

    PubMed Central

    2010-01-01

    Background The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed. Methods/Design A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks). A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual. Discussion This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry. Trial registration NCT00664976 PMID:20178636

  1. Body Mass Index and its Association with Clinical Outcomes for Advanced Non-Small Cell Lung Cancer Patients Enrolled on Eastern Cooperative Oncology Group Clinical Trials

    PubMed Central

    Dahlberg, Suzanne E.; Schiller, Joan H.; Bonomi, Philip B.; Sandler, Alan B.; Brahmer, Julie R.; Ramalingam, Suresh S.; Johnson, David H.

    2013-01-01

    Introduction Obesity increases the risk of death from many adverse health outcomes and has also been linked with cancer outcomes. The impact of obesity on outcomes of advanced non-small cell lung cancer patients is unclear. Methods The authors evaluated the association of body mass index and outcomes in 2585 eligible patients enrolled to three consecutive first-line trials conducted by the Eastern Cooperative Oncology Group. Body mass index was categorized as underweight (BMI < 18.5 kg/m2), normal weight (BMI: 18.5 to < 25 kg/m2), overweight (BMI: 25 to < 30 kg/m2) and obese (BMI ? 30 kg/m2). In addition to analyzing overall and progression-free survival, reasons for treatment discontinuation were also assessed by BMI group. Results 4.6% of patients were underweight, 44.1% were normal weight, 34.3% of patients were classified as overweight, and 16.9% were obese. Non-proportional hazards existed for obese patients relative to the other three groups of patients, with a change in OS hazard occurring at approximately 16 months. In multivariable Cox models, obese patients had superior outcomes earlier on study compared to normal/overweight patients 0.86 (p=0.04, 95% CI: 0.75–0.99), but later experienced increased hazard 1.54 (p<0.001, 95% CI: 1.22–1.94), indicating a time effect while undergoing treatment. Conclusion Data from these three trials suggest differential outcomes associated with body mass index, and additional studies of the mechanisms underlying this observation, as well as dietary and lifestyle interventions, are warranted to help optimize therapy. PMID:23887169

  2. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial

    PubMed Central

    Charususin, Noppawan; Gosselink, Rik; Decramer, Marc; McConnell, Alison; Saey, Didier; Maltais, Francois; Derom, Eric; Vermeersch, Stefanie; van Helvoort, Hanneke; Heijdra, Yvonne; Klaassen, Mariska; Glöckl, Rainer; Kenn, Klaus; Langer, Daniel

    2013-01-01

    Introduction Inspiratory muscle training (IMT) has been applied during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). However, it remains unclear if the addition of IMT to a general exercise training programme leads to additional clinically relevant improvements in patients with COPD. In this study, we will investigate whether the addition of IMT to a general exercise training programme improves 6?min walking distance, health-related quality of life, daily physical activity and inspiratory muscle function in patients with COPD with inspiratory muscle weakness. Methods and analysis Patients with COPD (n=170) with inspiratory muscle weakness (Pi,max <60?cm?H2O or <50%pred) will be recruited to a multicentre randomised placebo controlled trial of IMT and allocated into one of the two groups. Patients in both groups will follow a 3?month general exercise training programme, in combination with home-based IMT. IMT will be performed with a recently developed device (POWERbreathe KH1). This device applies an inspiratory load that is provided by an electronically controlled valve (variable flow resistive load). The intervention group (n=85) will undertake an IMT programme at a high intensity (?50% of their Pi,max), whereas the placebo group (n=85) will undertake IMT at a low training intensity (?10% of Pi,max). Total daily IMT time for both groups will be 21?min (6 cycles of 30 breaths). Improvement in the 6?min walking distance will be the primary outcome. Inspiratory muscle function, health-related quality of life and daily physical activity will be assessed as secondary outcomes. Ethics and dissemination Ethics approval has been obtained from relevant centre committees and the study has been registered in a publicly accessible clinical trial database. The results will be easily interpretable and should immediately be communicated to healthcare providers, patients and the general public. Results This can be incorporated into evidence-based treatment recommendations for clinical practice. ClinicalTrials.gov NCT01397396. PMID:23921069

  3. Couples groups for parents of preschoolers: ten-year outcomes of a randomized trial*

    PubMed Central

    Cowan, Carolyn Pape; Cowan, Philip A.; Barry, Jason

    2011-01-01

    This paper reports the results of a 10-year follow-up of two variations of a couples group preventive intervention offered to couples in the year before their oldest child made the transition to kindergarten. 100 couples were randomly assigned to (1) a low-dose control condition, (2) a couples group meeting for 16 weeks that focused more on couple relationship issues among other family topics, or (3) a couples group meeting for 16 weeks that focused more on parenting issues among other family issues, with an identical curriculum to condition (2). Earlier papers reported that both variations of the intervention produced positive results on parent-child relationships and on the children’s adaptation to kindergarten and 1st grade, and that the groups emphasizing couple relationships also had additional positive effects on couple interaction quality. The present paper uses growth curve analyses to examine intervention effects extending from the children’s transition to kindergarten to the transition to high school – ten years after the couples groups ended. There were 6-year positive effects of the pre-kindergarten interventions on observed couple interaction and 10-year positive effects on both parents’ marital satisfaction and the children’s adaptation (hyperactivity and aggression). Discussion includes a focus on the implications of these results for family policy, clinical practice, and the need to include a couples focus in preventive interventions to strengthen family relationships and enhance children’s adaptation to school. PMID:21480703

  4. Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block. Methods/Design This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay. Discussion Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients. Trial registration Clinicaltrials.gov NCT01398982 PMID:24325953

  5. A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. Methods/Design The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. Discussion This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. Trial registration This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236. PMID:23880333

  6. The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial

    PubMed Central

    White, David; Waugh, Norman; Elliott, Jackie; Lawton, Julia; Barnard, Katharine; Campbell, Michael J; Dixon, Simon; Heller, Simon

    2014-01-01

    Introduction People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education. Methods and analysis A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2?years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24?months in those participants whose baseline HbA1c is at or above 7.5% (58?mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58?mmol/mol) or less at 24?months. Ethics and dissemination The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups. Trial registration number ISRCTN 61215213. PMID:25186159

  7. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol

    PubMed Central

    Holt, Anne-Marie; Jancey, Jonine; Lee, Andy H; Kerr, Deborah A; Hills, Andrew P; Anderson, Annie S; Howat, Peter A

    2014-01-01

    Introduction Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars. The RV provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight. Method and analysis This cluster-randomised controlled trial will evaluate a physical activity, nutrition and healthy weight management intervention for insufficiently active (‘not achieving 150?min of moderate-intensity physical activity per week’) adults aged 60–75 residing in RV's. A total of 400 participants will be recruited from 20 randomly selected RV's in Perth, Western Australia. Villages will be assigned to either the intervention group (n=10) or the control group (n=10) each containing 200 participants. The Retirement Village Physical Activity and Nutrition for Seniors (RVPANS) programme is a home-based physical activity and nutrition programme that includes educational resources, along with facilitators who will motivate and guide the participants during the 6-month intervention. Descriptive statistics and mixed regression models will be performed to assess the intervention effects. This trial will evaluate an intervention for the modification of health risk factors in the RV setting. Such research conducted in RV's has been limited. Ethics and dissemination Curtin University Human Research Ethics Committee (approval number: HR128/2012). Dissemination of the study results will occur through publications, reports, conference presentations and community seminars. Trial registration number Australia and New Zealand Clinical Trial Registry (ACTRN12612001168842) PMID:25256185

  8. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol. PMID:24888266

  9. Evaluating holistic needs assessment in outpatient cancer care—a randomised controlled trial: the study protocol

    PubMed Central

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-01-01

    Introduction People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients’ needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. Methods and analysis The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care—routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. Ethics and dissemination This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Trail registration number Clinical Trials.gov NCT02274701. PMID:25967990

  10. What Are the Health Benefits of Active Travel? A Systematic Review of Trials and Cohort Studies

    PubMed Central

    Saunders, Lucinda E.; Green, Judith M.; Petticrew, Mark P.; Steinbach, Rebecca; Roberts, Helen

    2013-01-01

    Background Increasing active travel (primarily walking and cycling) has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. Methods The study design was a systematic review of (i) non-randomised and randomised controlled trials, and (ii) prospective observational studies examining either (a) the effects of interventions to promote active travel or (b) the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. Results Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. Conclusions Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes. PMID:23967064

  11. Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase. The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes. Methods/Design The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly. We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either ‘intensive’ involving both hospital and home-based functional exercise rehabilitation, or ‘standard of care’ consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness. Trial registration Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445. PMID:24484541

  12. Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial

    PubMed Central

    Vederhus, John-Kåre; Timko, Christine; Kristensen, Øistein; Hjemdahl, Bente; Clausen, Thomas

    2014-01-01

    Aims To compare a motivational intervention (MI) focused on increasing involvement in 12-Step groups (TSGs; e.g. Alcoholics Anonymous) versus brief advice (BA) to attend TSGs. Design Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge. Setting and participants One hundred and forty substance use disorder (SUD) patients undergoing in-patient detoxification (detox) in Norway. Measurements The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale (AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured. Findings At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval (CI)?=?0.04 to 1.78; P?=?0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI?=??6.5 to ?0.6; P?=?0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI?=??7.5 to ?0.4; P?=?0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results. Conclusions A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox. PMID:24400937

  13. Randomised controlled trial of the effects of physical activity feedback on awareness and behaviour in UK adults: the FAB study protocol [ISRCTN92551397

    Microsoft Academic Search

    Clare Watkinson; Esther MF van Sluijs; Stephen Sutton; Theresa Marteau; Simon J Griffin

    2010-01-01

    BACKGROUND: While there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promote physical activity is uncertain. Using a randomised controlled trial nested within a population-based cohort study, we plan to test three variations of physical activity feedback against a control group. Our primary objective is to

  14. Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

    PubMed

    Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

    2011-11-01

    The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study. PMID:22059309

  15. The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT) designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children. Methods/design The Active for Life Year 5 (AFLY5) study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years). All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012) and control arm (receive the intervention after the final follow-up assessment, 2013-2014). The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4), at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity. Discussion The results of the trial will provide information about the public health effectiveness of a school-based intervention aimed at improving levels of physical activity, sedentary behaviour and diet in children. Trial registration ISRCTN50133740 PMID:21781344

  16. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials

    Microsoft Academic Search

    Dean Fergusson; Steve Doucette; Kathleen Cranley Glass; Stan Shapiro; David Healy; Paul Hebert; Brian Hutton

    2005-01-01

    Objective To establish whether an association exists between use of selective serotonin reuptake inhibitors (SSRIs) and suicide attempts. Design Systematic review of randomised controlled trials. Data sources Medline and the Cochrane Collaboration's register of controlled trials (November 2004) for trials produced by the Cochrane depression, anxiety, and neurosis group. Selection of studies Studies had to be randomised controlled trials comparing

  17. Evaluation of the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation

    PubMed Central

    2014-01-01

    Background In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials. Methods To assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool. Results The survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway. Conclusions Overall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation. PMID:24731537

  18. Does Adding Dexamethasone to Clomiphene Citrate Improve Ovulation in PCOS Patients? A Triple - Blind Randomized Clinical Trial Study

    PubMed Central

    Esmaeilzadeh, Seddigheh; Amiri, Masoumeh Golsorkhtabar; Basirat, Zahra; Shirazi, Mahin

    2011-01-01

    Background A common cause of anovulation is polycystic ovarian syndrome (PCOS). Clomiphene citrate (CC) is the first line of treatment in PCOS patients however approximately 25% of patients may be CC-resistant. This study aimed to evaluate the efficacy of adding dexamethasone (dex) to CC in CC-resistant PCOS patients with the intent to improve ovulation. Materials and Methods This randomized controlled trial study was performed on 60 infertile PCOS patients referred to our infertility research center from 2007 to 2009. Patients were randomly divided in two groups and stimulation performed with dex+CC or CC+placebo. Rates of ovulation, pregnancy and number of mature follicles were evaluated. Results Ovulation rate in the dex+CC group was 21 out of 30 (70%) and in the CC+placebo group it was 17 out of 30 (56.7%). The pregnancy rate was 5 (16.7%) in the dex+CC group and 3 (10%) in the CC+placebo group. There was no significant difference between rates of ovulation and pregnancy in both groups, but the number of follicles ?18 mm were significant in the dex+CC group (p<0.05). Conclusion Our results showed that addition of dex to CC significantly increased the number of matured follicles, however the ovulation and pregnancy rates were comparable between the two groups (Registeration Number: IRCT 138807041760 N2). PMID:24917918

  19. Environmental studies group. Annual report for 1978

    SciTech Connect

    Hunt, D. C.; Hurley, J. D. [eds.] [eds.

    1980-08-21

    Group projects included radioecological studies of aquatic and terrestrial systems, land management activities, foodstuff monitoring, dust transport studies including fugitive dust measurements and modeling, and several support programs involving evaluation of the plant's ambient air samplers and airborne tritium monitoring techniques. Some salient results from the several project reports include determination of an appropriate model for mechanically generated fugitive dust dispersion, a radionuclide inventory of Smart Ditch Pond (Pond D-1), a coefficient of community determination for two terrestrial sample plots on the plant site buffer zone, a natality and mortality rate determination for fawns in the plant deer herd (including one positive coyote-kill determination), inlet loss and filter paper collection efficiencies for the plant ambient air samplers, and differential tritium sampling measurements of the vapor in Building 771 stack effluent.

  20. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be analyzed. Discussion Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients. Trial registration This study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466. PMID:24746224

  1. Promoting Professional Student Learning Through Study Groups: A Case Study

    E-print Network

    Shaw, Donita J.

    2011-01-01

    styles and perspectives to be read and discussed. Further, providing students’ some choice promotes internal motivation, and motivation is critical for learning (Pintrich, 2003). Providing multiple books for small group discussion is one option...: A guide to design and implementation. San Francisco: Jossey Bass. STUDY GROUP LEARNING 23 Miller, D. 2002. Reading with meaning. Portland, ME: Stenhouse Publishers. Pintrich, P.R. 2003. A motivational science perspective on the role...

  2. Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study

    PubMed Central

    van den Bogert, Cornelis A; Souverein, Patrick C; Brekelmans, Cecile T M; Janssen, Susan W J; van Hunnik, Manon; Koëter, Gerard H; Leufkens, Hubertus G M; Bouter, Lex M

    2015-01-01

    Introduction Responsible conduct of research implies that results of clinical trials should be completely and adequately reported. This article describes the design of a cohort study that aims to investigate the occurrence and the determinants of selective reporting in an inception cohort of all clinical drug trials that were reviewed by the Dutch Institutional Review Boards (IRBs) in 2007. It also describes the characteristics of the study cohort. Methods and analysis In 2007, Dutch IRBs reviewed 622 clinical drug trials. For each trial, we assessed the stages of progress. We discriminated five intermediate stages and five definite stages. Intermediate stages of progress are: approved by an IRB; started inclusion; completed as planned; terminated early; published as article. The definite stages of progress are: rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported. We will use univariate and multivariate Cox regression models to identify trial characteristics associated with non-publication. We will identify seven trial-specific discrepancy items, including the objectives, inclusion and exclusion criteria, end points, sample size, additional analyses, type of population analysis and sponsor acknowledgement. The percentage of trials with discrepancies between the protocol and the publication will be scored. We will investigate the association between trial characteristics and the occurrence of discrepancies. Ethics and dissemination No IRB-approval is required for this study. Access to confidential research protocols was provided by the Central Committee on Research Involving Human Subjects. We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3?months. Hence, a first draft of an article containing the results is expected before the end of October 2015. PMID:26152325

  3. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background In the paediatric population, pain and distress associated with burn injuries during wound care procedures remain a constant challenge. Although silver dressings are the gold standard for burn care in Australasia, very few high-level trials have been conducted that compare silver dressings to determine which will provide the best level of care clinically. Therefore, for paediatric patients in particular, identifying silver dressings that are associated with lower levels of pain and rapid wound re-epithelialisation is imperative. This study will determine whether there is a difference in time to re-epithelialisation and pain and distress experienced during wound care procedures among Acticoat™, Acticoat™ combined with Mepitel™ and Mepilex Ag™ dressings for acute, paediatric partial thickness burns. Methods/Design Children aged 0 to 15 years with an acute partial thickness (superficial partial to deep partial thickness inclusive) burn injury and a burn total body surface area of ?10% will be eligible for the trial. Patients will be randomised to one of the three dressing groups: (1) Acticoat™ or (2) Acticoat™ combined with Mepitel™ or (3) Mepilex Ag™. A minimum of 28 participants will be recruited for each treatment group. Primary measures of pain, distress and healing will be repeated at each dressing change until complete wound re-epithelialisation occurs or skin grafting is required. Additional data collected will include infection status at each dressing change, physical function, scar outcome and scar management requirements, cost effectiveness of each dressing and staff perspectives of the dressings. Discussion The results of this study will determine the effects of three commonly used silver and silicone burn dressing combinations on the rate of wound re-epithelialisation and pain experienced during dressing procedures in acute, paediatric partial thickness burn injuries. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000105741 PMID:24274190

  4. Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group. Methods and design This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur. Discussion This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000084785. PMID:24143890

  5. Clinical Trial Study in the Treatment of Nail Psoriasis with Pulsed Dye Laser.

    PubMed

    Goldust, Mohamad; Raghifar, Ramin

    2013-10-16

    Abstract Objective: The treatment options for nail psoriasis have been limited, and the management of nail psoriasis has been challenging for physicians. This study aimed at evaluating the effect of different pulse durations in the treatment of nail psoriasis with the 595-nm PDL to determine the optimal pulse duration. Methods: Forty patients with bilateral fingernail psoriasis were recruited and completed a 6-month trial. PDL was applied on the proximal and lateral nailfolds based on random assignment. Eghity nails were treated with 6-millisecond pulse duration and 9 J/cm(2) whereas 80 nails were treated with 0.45-millisecond pulse duration and 6 J/cm(2). Nail Psoriasis Severity Index (NAPSI) was used to assess the clinical outcome from pretreatment and posttreatment photographs. Results: After 6 months of first treatment, there was a significant reduction in overall NAPSI, nail matrix NAPSI, and nail bed NAPSI scores from baseline in both groups; however, no significant difference was found between the two pulse duration groups. Side effects were mild including transient petechiae and hyperpigmentation. Conclusion: Both the longer 6-millisecond and shorter 0.45-millisecond pulses of PDL (595 nm) have been clinically proven to be effective for the treatment of nail matrix and nail bed psoriasis. PMID:24131073

  6. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    PubMed Central

    2012-01-01

    Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob) PMID:23130754

  7. Participating in Clinical Trials

    MedlinePLUS Videos and Cool Tools

    ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... for more information Scientists usually do years of experiments in the laboratory and in animals before they ...

  8. Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial

    E-print Network

    Cooper, Sue; Foster, Katharine; Naughton, Felix; Leonardi-Bee, Jo; Sutton, Stephen; Ussher, Michael; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

    2015-01-27

    controlled trial, Protocol * Correspondence: sue.cooper@nottingham.ac.uk 1Division of Primary Care, University of Nottingham, University Park,Sue Cooper1*, Katharine Foster1, Felix Naughton2, Jo Leonardi-Bee3, Stephen Sutton2, Michael Ussher4, Matthew... outcomes between the trial treatment groups. Logistic regression models will then be used to compare the outcomes between the two trial groups with adjustment for factors used to stratify the randomisation (centre and gestation at ran- domisation; <16 weeks...

  9. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial

    PubMed Central

    2014-01-01

    Background Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating disorders at Stolpegaard Psychotherapy Centre, aims to investigate the impact of continuous feedback on attendance and outcome in group psychotherapy. Methods/design The hypothesis is that continuous feedback to both patient and therapist on treatment progress and alliance will increase attendance and treatment outcome. The trial is set up using a randomized design with a minimum of 128 patients allocated to either an experimental or control group at a ratio of 1:1. The experimental group will receive standard treatment (systemic and narrative group psychotherapy) with feedback intervention, whereas the control group will receive standard treatment only. The participants are diagnosed with bulimia nervosa, binge eating disorder, or an eating disorder not otherwise specified, according to the DSM-IV. In the experimental group feedback to the participants, based on the Outcome Rating Scale (ORS) and the Group Session Rating Scale (GSRS), is actively added to standard treatment. The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships. In the control group, the patients fill out the Outcome Rating Scale only, and feedback is not provided. The primary outcome is the rate of attendance to treatment sessions. The secondary outcome is the severity of eating disorder symptoms. Exploratory outcomes are the level of psychological and social functioning, and suicide or self-harm. This is measured with the ORS, Symptom Check List, WHO-Five Wellbeing Index, Sheehan Disability Scale and a modified version of the Self-Harm Inventory. Discussion If the results will confirm the hypothesis, this trial will support feedback as a way to improve group treatment attendance for outpatients with eating disorders. Trial registration ClinicalTrials.gov identifier: NCT01693237 PMID:24754974

  10. Group heterogeneity increases the risks of large group size: a longitudinal study of productivity in research groups.

    PubMed

    Cummings, Jonathon N; Kiesler, Sara; Bosagh Zadeh, Reza; Balakrishnan, Aruna D

    2013-06-01

    Heterogeneous groups are valuable, but differences among members can weaken group identification. Weak group identification may be especially problematic in larger groups, which, in contrast with smaller groups, require more attention to motivating members and coordinating their tasks. We hypothesized that as groups increase in size, productivity would decrease with greater heterogeneity. We studied the longitudinal productivity of 549 research groups varying in disciplinary heterogeneity, institutional heterogeneity, and size. We examined their publication and citation productivity before their projects started and 5 to 9 years later. Larger groups were more productive than smaller groups, but their marginal productivity declined as their heterogeneity increased, either because their members belonged to more disciplines or to more institutions. These results provide evidence that group heterogeneity moderates the effects of group size, and they suggest that desirable diversity in groups may be better leveraged in smaller, more cohesive units. PMID:23575599

  11. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002–2012

    PubMed Central

    Hwang, Jenny; Ciolino, Joseph B

    2015-01-01

    Objectives Novel therapeutics are an important part of ophthalmologists’ armamentarium, and the risks and benefits of these therapies must be carefully evaluated. We sought to quantify the characteristics of the pivotal clinical trials supporting the regulatory approval of new ophthalmic drugs and medical devices. Design Retrospective observational study. Setting and data source Medical review dossiers for new ophthalmic drug and high-risk device approvals released publicly by the US Food and Drug Administration (FDA). Main outcome measures Proportion of pivotal trials with randomisation, masking, active or placebo controls and subgroup analyses; total and median number of trial enrollees; and the number of drugs and devices approved with required postapproval studies. Results From 2002 to 2012, the FDA approved 11 ophthalmic drugs and 25 devices. The pivotal trials underlying the approvals of ophthalmic drugs in our study cohort enrolled a median of 809 patients. Virtually all drug trials were randomised and masked (91%), of which 7 (70%) used a placebo control. Pivotal trials for ophthalmic devices enrolled 324 patients on average, and significantly fewer trials for ophthalmic devices versus drugs were randomised (16% vs 91%; p<0.001) or masked (12% vs 91%; p<0.001). 8 (32%) ophthalmic devices and 6 (55%) ophthalmic drugs were approved with required postapproval studies. Conclusions Ophthalmic therapeutics were approved based on varying levels of evidence. Postapproval studies could be used to confirm or refute early indications of safety and effectiveness of these therapeutics, with the study results accessible to patients and clinicians who need to make informed treatment decisions. PMID:26044760

  12. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial

    PubMed Central

    Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

    2015-01-01

    Introduction Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. Methods and analysis This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ?50?mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100?mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8?weeks after treatment. Ethics and dissemination Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. PMID:25652804

  13. Effectiveness and efficiency of integrated mental health care programmes in Germany: study protocol of an observational controlled trial

    PubMed Central

    2014-01-01

    Background Since 2009 some German health insurance companies have implemented integrated mental health care services along the principles of assertive community treatment in collaboration with local mental health service providers across Germany. Focus of this study is the analysis of effectiveness and cost-effectiveness of this integrated care programme compared to care as usual in routine care surroundings in five regions in Germany. Methods In this 18-month multi-centre observational trial 250 patients enrolled in an integrated mental health care programme and 250 patients who receive treatment as usual from five catchment areas will be included. In addition, in each group about 125 relatives of the participating patients will be included. The primary outcome criterion is the improvement of empowerment; secondary outcomes are subjective quality of life, functional impairment and costs of illness. Data will be collected at baseline and three follow-ups after 6, 12 and 18 months. Data will be analysed by means of mixed effects regression models. Propensity score methods are used for selection bias control. Discussion Study results are expected to provide information about how integrated care programmes in their present form contribute to the improvement of mental health care. In addition, the study will provide hints to weaknesses of the current integrated care programme and options to overcome them. The major strengths of this study are the real-world character of the study intervention with a simultaneous high level of academic rigour. However, the fact that patients are not randomised to study groups and that there is no blinding might limit the study. Trial registration German Clinical Trial Register DRKS00005111. PMID:24894310

  14. Consent for Genetics Studies Among Clinical Trial Participants: Findings from Action for Health in Diabetes (Look AHEAD)

    PubMed Central

    Espeland, Mark A.; Dotson, Kathy; Jaramillo, Sarah A.; Kahn, Steven E.; Harrison, Barbara; Montez, Maria; Foreyt, John P.; Montgomery, Brenda; Knowler, William C.

    2008-01-01

    Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression, or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated, or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes, and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships. PMID:17060218

  15. Strategies to Improve Success of Pediatric Cancer Co-operative Group Quality of Life Studies: A Report from the Children’s Oncology Group

    PubMed Central

    Whitlow, Puja G.; Caparas, Mae; Cullen, Patricia; Trask, Christine; Schulte, Fiona; Embry, Leanne; Nagarajan, Rajaram; Johnston, Donna L.; Sung, Lillian

    2015-01-01

    Purpose Quality of life (QoL) has been increasingly emphasized in National Cancer Institute (NCI) sponsored multi-site clinical trials. Little is known about the outcomes of these trials in pediatric cancer. Objectives were to describe the proportion of Children’s Oncology Group (COG) QoL studies that successfully accrued subjects and were analyzed, presented or published. Methods We conducted a survey to describe outcomes of COG QoL studies. We included studies that contained at least one QoL assessment and were closed to patient accrual at the time of survey dissemination. Respondents were the investigators most responsible for the QoL aim. Results Sixteen studies were included; response rate was 100%. Nine (56%) studies were embedded into a cancer treatment trial. Only 3 (19%) studies accrued their intended sample size. Seven (44%) studies were analyzed, 9 (56%) were presented and 6 (38%) were published. Conclusions NCI-sponsored pediatric QoL studies have high rates of failure to accrue. Many were not analyzed or disseminated. Using this data, strategies have been implemented to improve conduct in future trials. Monitoring of QoL studies is important to maximize the chances of study success. PMID:25429821

  16. The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial

    PubMed Central

    2013-01-01

    Background Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses’ stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. Methods This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ? two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants’ perceptions of the intervention. Results The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial ?2=0.22) and anxiety (p= 0.02, partial ?2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift. Conclusions This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings. Trial registration ACTRN: ACTRN12612000659808. PMID:23414448

  17. Factors that Contribute in the First Hookah Smoking Trial by Women: A Qualitative Study from Iran

    PubMed Central

    BAHEIRAEI, Azam; SHAHBAZI SIGHALDEH, Shirin; EBADI, Abbas; KELISHADI, Roya; MAJDZADEH, Reza

    2015-01-01

    Abstract Background Hookah smoking is growing in popularity especially among women but little is known about the determinants influencing on hookah smoking initiation. In order to address this emerging health risk, a qualitative study was conducted to explore the factors that contribute in the first hookah smoking trial by women. Methods This qualitative study was conducted during 2012 to 2013 in Tehran, Iran. Participants were recruited to represent diversity in smoking status, ethnicity, age groups and residence. Data was collected through in-depth individual interviews and was analyzed through content analysis. Results Four main themes were identified from the qualitative data including: Positive attitude toward hookah smoking; Social and family facilitators; Psychosocial needs and gaps and Sensory characteristic of hookah. Conclusion From this study, a variety of factors which contribute to the initiation of hookah smoking among women have been identified. Since one of the major causes of increased hookah smoking may be its ordinary use, all factors causing the ordinary use should be eliminated, and efforts should be made in opposition to hookah smoking promotions. PMID:26060781

  18. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia. Methods/Design A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio. The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support. We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching. Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period. Risk ratios will be used as the measure of effect of the intervention on the outcomes, and these will be estimated with 95% confidence intervals. All analyses will be based on the ‘intention to treat’ principle. Discussion This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy. Findings could be generalisable to similar populations in different settings. Trial registration ClinicalTrials.gov Identifier: NCT01823861 PMID:24330763

  19. Looking for the new preparations for antibacterial therapy III. New antimicrobial agents from the quinolones group in clinical trials.

    PubMed

    Karpiuk, Izabela; Tyski, Stefan

    2013-01-01

    There is an essential need for searching for the new compounds effective in the treatment of infections caused by multidrug-resistant bacteria. This paper is the third part of a series associated with the exploration of new antibacterial agents and it discusses the compounds belonging to the group of quinolones and substances possessing a hybrid structure composed of the quinolone molecule and other compounds. Eleven new substances at the stage of clinical trials are presented. Three of them belong to the group of non-fluorinated quinolone (nemonoxacin, ozenoxacin and KRP-AM 1977X), while six are the quinolones containing fluorine atom at 6 position of the carbon atom in the quinoline ring (zabofloxacin, finafloxacin, delafloxacin, JNJ-Q2, WCK771 and KPI-10). The remaining two compounds possess a hybrid construction composed of the quinolone structure and other molecules (cadazolid and CBR-2092). There is a chance in the near future, that the presented compounds can extend the range of existing antibacterial drugs and provide an alternative to currently available medicinal products. PMID:24340560

  20. Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)

    PubMed Central

    2014-01-01

    Background About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. Methods/Design This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children’s Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children’s Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. Discussion The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD. Trial Registration Current Controlled Trials ISRCTN88136485. PMID:24670079

  1. Reflections One Year into the 22 Center NIH-funded WRIST Study. A Primer on Conducting a Multicenter Clinical Trial

    PubMed Central

    2013-01-01

    The Wrist and Radius Surgery Trial (WRIST) study group is a collaboration of 22 hand surgery centers in the US, Canada, and Singapore to showcase the interest and capability of hand surgeons to conduct a multicenter clinical trial. The WRIST study group was formed in response to the seminal systematic review by Margaliot et al. and the Cochrane report that indicated marked deficiency in the quality of evidence in the distal radius fracture literature. Since the initial description of this fracture by Colles in 1814, over 2,000 studies have been published on this subject, yet high level studies based on the principles of evidence-based medicine are lacking. As we continue to embrace evidence-based medicine to raise the quality of research, the lessons learned during the organization and conduct of WRIST can serve as a template for others contemplating similar efforts. This paper will trace the course of WRIST by sharing the triumphs, and more importantly the struggles, faced in the first year of this study. PMID:23608306

  2. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee. Methods/Design A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program?+?phototherapy, or exercise program?+?placebo phototherapy, all of which will last for eight weeks. Discussion The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed. Trial registration The protocol for this study has been submitted to Clinical Trials, registration number NCT02102347, on 29 March 2014. PMID:24919587

  3. A cluster randomised controlled trial of the Climate Schools: Ecstasy and Emerging Drugs Module in Australian secondary schools: study protocol

    PubMed Central

    2013-01-01

    Background The use of ecstasy is a public health problem and is associated with a range of social costs and harms. In recent years, there has been growing concern about the availability and misuse of new and emerging drugs designed to mimic the effects of illicit drugs, including ecstasy. This, coupled with the fact that the age of use and the risk factors for using ecstasy and emerging drugs are similar, provides a compelling argument to implement prevention for these substances simultaneously. The proposed study will evaluate whether a universal Internet-based prevention program, known as the Climate Schools: Ecstasy and Emerging Drugs Module, can address and prevent the use of ecstasy and emerging drugs among adolescents. Methods A cluster randomised controlled trial will be conducted among Year 10 students (aged 15–16 years) from 12 secondary schools in Sydney, Australia. Schools will be randomly assigned to either the Climate Schools intervention group or the control group. All students will complete a self-report questionnaire at baseline, immediately post-intervention, and 6-, 12- and 24-months post-baseline. The primary outcome measures will include ecstasy and emerging drug-related knowledge, intentions to use these substances in the future, and the patterns of use of ecstasy and emerging drugs. A range of secondary outcomes will also be assessed, including beliefs and attitudes about ecstasy and emerging drugs, peer pressure resistance, other substance use and mental health outcomes. Discussion To our knowledge, this will be the first evaluation of an Internet-based program designed to specifically target ecstasy and NED use among adolescents. If deemed effective, the Climate Schools: Ecstasy and Emerging Drugs Module will provide schools with an interactive and novel prevention program for ecstasy and emerging drugs that can be readily implemented by teachers. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000708752. PMID:24330505

  4. A geometric study of Fibonacci groups

    Microsoft Academic Search

    H. Helling; A. C. Kim; J. L. Mennicke

    1998-01-01

    . Fibonacci groups are recovered as fundamental groups of certain closed hyperbolic 3-manifolds. This is achieved by constructing compact hyperbolic polyhedra in dimension3 which are fundamental domains of torsion free lattices in SL 2 (C) . Their presentation can beread off by classical methods. This presentation can easily be given standard Fibonacci form.IntroductionIf a group G is only given by

  5. Cognitive Distance, Absorptive Capacity and Group Rationality: A Simulation Study

    PubMed Central

    Cur?eu, Petru Lucian; Krehel, Oleh; Evers, Joep H. M.; Muntean, Adrian

    2014-01-01

    We report the results of a simulation study in which we explore the joint effect of group absorptive capacity (as the average individual rationality of the group members) and cognitive distance (as the distance between the most rational group member and the rest of the group) on the emergence of collective rationality in groups. We start from empirical results reported in the literature on group rationality as collective group level competence and use data on real-life groups of four and five to validate a mathematical model. We then use this mathematical model to predict group level scores from a variety of possible group configurations (varying both in cognitive distance and average individual rationality). Our results show that both group competence and cognitive distance are necessary conditions for emergent group rationality. Group configurations, in which the groups become more rational than the most rational group member, are groups scoring low on cognitive distance and scoring high on absorptive capacity. PMID:25314132

  6. PROSPECTIV—a pilot trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors: study protocol for a randomised controlled trial

    PubMed Central

    Watson, Eila; Rose, Peter; Frith, Emma; Hamdy, Freddie; Neal, David; Kastner, Christof; Russell, Simon; Walter, Fiona M; Faithfull, Sara; Wolstenholme, Jane; Perera, Rafael; Weller, David; Campbell, Christine; Wilkinson, Clare; Neal, Richard; Sooriakumaran, Prasanna; Butcher, Hugh; Matthews, Mike

    2014-01-01

    Background Prostate cancer survivors can experience physical, sexual, psychological and emotional problems, and there is evidence that current follow-up practices fail to meet these men's needs. Studies show that secondary and primary care physicians see a greater role for primary care in delivering follow-up, and that primary care-led follow-up is acceptable to men with prostate cancer. Methods and analysis A two-phase study with target population being men who are 9–24?months from diagnosis. Phase 1 questionnaire aims to recruit 300 men and measure prostate-related quality of life and unmet needs. Men experiencing problems with urinary, bowel, sexual or hormonal function will be eligible for phase 2, a pilot trial of a primary care nurse-led psychoeducational intervention. Consenting eligible participants will be randomised either to intervention plus usual care, or usual care alone (40 men in each arm). The intervention, based on a self-management approach, underpinned by Bandura's Social Cognitive Theory, will provide advice and support tailored to these men's needs and address any problems they are experiencing. Telephone follow-up will take place at 6?months. Study outcomes will be measured by a questionnaire at 7?months. Phase 1 will allow us to estimate the prevalence of urinary, sexual, bowel and hormone-related problems in prostate cancer survivors and the level of unmet needs. ‘Usual care’ will also be documented. Phase 2 will provide information on recruitment and retention, acceptability of the intervention/outcome measures, effect sizes of the intervention and cost-effectiveness data, which is required to inform development of a larger, phase 3 randomised controlled trial. The main outcome of interest is change in prostate-cancer-related quality of life. Methodological issues will also be addressed. Ethics and dissemination Ethics approval has been gained (Oxford REC A 12/SC/0500). Findings will be disseminated in peer-reviewed journals, at conferences, through user networks and relevant clinical groups. Trial registration number ISRCTN 97242511. PMID:24852301

  7. Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

    PubMed Central

    2013-01-01

    Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

  8. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial

    PubMed Central

    2013-01-01

    Background Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. Methods/designs This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. Discussion This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care. Trial registration Clinical Research Information Service: KCT0000169 PMID:24053577

  9. Comparative Trial to Study the Effectiveness of Clonidine Hydrochloride and Buprenorphine-Naloxone in Opioid Withdrawal – A Hospital Based Study

    PubMed Central

    Farhat, Samina; Rather, Yasir Hassan; Abbas, Zaffar

    2015-01-01

    Objectives: Prevalence of opioid addiction has alarmingly increased over the recent years. In South Asian region alone there are more than 10 million opioid abusers amounting to 2% of world population. Detoxification remains to be the first step for the successful treatment of opioid addiction. The present study was carried out to compare the relative efficacy and safety of buprenorphine –naloxone and clonidine hydrochloride in the detoxification of opioid-dependents. Materials and Methods: Present trial was conducted at De- addiction centre of Institute of Mental and Neurosciences (IMNS), GMC Srinagar. Fifty four (54) treatment seeking subjects, 15-50 years of age, fulfilling DSM-1V TR (American Psychiatric association`s Mental Disorders-1V text revision) criteria for opioid dependence were included and randomized into two groups. The groups received either clonidine hydrochloride (Group A) or buprenorphine- naloxone (Bup-Nax) (Group B) for the duration of 10 days. The efficacy of the two drugs in controlling the opioid withdrawal was evaluated by Clinical Opioid Withdrawal Scale (COWS) and their effect on the desire for the abused substance was measured by Visual Analogue Scale (VAS). The safety of the two drugs was measured by taking the side effect profile of the two compared drugs into consideration. Results: There was significant difference of COWS-score between the two groups which was evident from day 3 (14.85 ± 3.43 vs. 11.67 ± 2.40, p<0.005) and continued till day 6 (2.56 ± 1.40 vs. 0.30 ± 0.61, p<0.005), for Group A and group B respectively. The effect of two drugs in controlling the craving for the abused substance also showed significant difference from day 2 (66.30 ± 10.80 vs. 47.40 ± 12.90, p<0.005) till day 5 (7.78 ± 6.41 vs. 1.85 ± 6.22, p<0.005), for Group A and Group B respectively. Conclusion: Administration of buprenorphine-naloxone was more efficient in reducing the signs and symptoms of opioid withdrawal and in controlling the craving for the abused substance during the first few days of detoxification. PMID:25738001

  10. A randomized clinical trial to study the effect of silicone gel dressing and pressure therapy on posttraumatic hypertrophic scars.

    PubMed

    Li-Tsang, Cecilia Wai Ping; Zheng, Yong Ping; Lau, Joy C M

    2010-01-01

    To investigate the effect of pressure therapy (PG), silicone gel sheeting (SGS), and combined therapy on the management of posttraumatic hypertrophic scar (HS) using a randomized controlled clinical trial. A total of 104 subjects with HS mostly resulting from burns and scald injuries (63 men and 41 women; average age: 21.8 +/- 18.7 years) were recruited from Jiangsu People's First Affiliated Hospital in Nanjing, China. The mean scar formation period was 14.9 +/- 30.8 months. All subjects were randomly allocated into four groups, namely the PG, SGS, combined PG and SGS groups, and single-blinded control group for the treatment of 6 months. Standardized scar assessments (pigmentation, vascularity, thickness, pain, and itchiness) were conducted before the intervention, 2, 4, and 6 months of the intervention, and 1 month after completion of the program, respectively, to observe the progress of the treatments. The results showed that the combined therapy seemed to be more effective in improving the thickness of scar after 2 months of intervention (P < .001). After 6 months of intervention, both the combined therapy group and the PG group showed significant improvement in scar thickness. The improvement in scar thickness was most significant in the combined therapy group. SGS was found to be more effective in alleviating the pain and pruritus rather than the scar thickness. This randomized clinical trial has demonstrated the evidence of the effect of combined PG and gel intervention on posttraumatic HS. The PG group showed an improvement in scar thickness too. Further studies are needed to investigate the biomechanical and physiological effect that PG and gel sheeting would exert on the scar tissues. PMID:20375696

  11. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial

    PubMed Central

    2013-01-01

    Background Insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome (PCOS), which is characterized by hyperandrogenism, ovulatory dysfunction, and presence of polycystic ovaries on pelvic scanning. Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Berberine has effects on insulin resistance but its use in women with PCOS has not been fully investigated. In this paper, we present a research design evaluating the effects of berberine on insulin resistance in women with PCOS. Methods/design This is a multicenter, randomized, placebo-controlled and double-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. Berberine or placebo will be taken orally for 12 weeks. The primary outcome is the whole body insulin action assessed with the hyperinsulinemic-euglycemic clamp. Discussion We postulate that women with PCOS will have improved insulin resistance following berberine administration. Trial registration This study is registered at ClinicalTrials.gov, NCT01138930. PMID:23866924

  12. Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the ‘conscious target’: patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. Methods/Design A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. Discussion This ‘educational research’ project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake. Trial registration number Clinicaltrials.gov #NCT01360346 PMID:23551983

  13. Gemcitabine Plus Bevacizumab Compared With Gemcitabine Plus Placebo in Patients With Advanced Pancreatic Cancer: Phase III Trial of the Cancer and Leukemia Group B (CALGB 80303)

    PubMed Central

    Kindler, Hedy Lee; Niedzwiecki, Donna; Hollis, Donna; Sutherland, Susan; Schrag, Deborah; Hurwitz, Herbert; Innocenti, Federico; Mulcahy, Mary Frances; O'Reilly, Eileen; Wozniak, Timothy F.; Picus, Joel; Bhargava, Pankaj; Mayer, Robert J.; Schilsky, Richard L.; Goldberg, Richard M.

    2010-01-01

    Purpose The combination of gemcitabine plus bevacizumab produced a 21% response rate and a median survival of 8.8 months in a multicenter phase II trial in patients with metastatic pancreatic cancer. These encouraging data led Cancer and Leukemia Group B (CALGB) to conduct a double-blind, placebo-controlled, randomized phase III trial of gemcitabine/bevacizumab versus gemcitabine/placebo in advanced pancreatic cancer patients. Patients and Methods Eligible patients had no prior therapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, no tumor invasion of adjacent organs, and no increased bleeding risk. The primary end point was overall survival. Patients were stratified by performance status, extent of disease, and prior radiotherapy. Patients received gemcitabine at 1,000 mg/m2 over 30 minutes on days 1, 8, and 15 every 28 days and bevacizumab at 10 mg/kg or placebo on days 1 and 15 every 28 days. Results Between June 2004 and April 2006, 602 patients were enrolled onto the study and 535 were treated. Median overall survival was 5.8 months for gemcitabine/bevacizumab and 5.9 months for gemcitabine/placebo (P = .95). Median progression-free survival was 3.8 and 2.9 months, respectively (P = .07). Overall response rates were 13% and 10%, respectively. Patients with a performance status of 0, 1, and 2 survived a median of 7.9, 4.8, and 2.4 months, respectively. The only statistically significant differences in grades 3 and 4 toxicity occurred for hypertension (10% v 3%; P < .001) and proteinuria (5% v 1%; P = .002); venous thrombosis grade ? 3 was equivalent in both arms (14% and 15%, respectively). Conclusion The addition of bevacizumab to gemcitabine does not improve survival in advanced pancreatic cancer patients. PMID:20606091

  14. Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial

    PubMed Central

    2013-01-01

    Background Recruiting participants to multicentre, community-based trials is a challenge. This case study describes how this challenge was met for the BeWEL trial, which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps. Methods The BeWEL trial was a community-based trial, involving centres linked to the Scottish National Health Service (NHS) colorectal cancer screening programme. BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme. Results BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this. The major causes of delay were lower consent rates (49% as opposed to 70% estimated from earlier work), the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment, for which there were substantial bureaucratic delays. A range of specific interventions to increase recruitment, for example, telephone reminders and a shorter participant information leaflet, helped to increase the proportion of eligible individuals consenting and being randomized. Conclusions Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team. In a UK context, NHS research and development approval can be a substantial source of delay. Investigators should be cautious when estimating consent rates. If consent rates are less than expected, qualitative analysis might be beneficial, to try and identify the reason. Finally, investigators should select trial sites on the basis of a formal assessment of a site’s past performance and the likelihood of success in the trial being planned. Trial registration Current Controlled Trials ISRCTN53033856 PMID:24351063

  15. A parallel-group, randomised controlled trial of a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners: design and rationale

    PubMed Central

    Lambert, Sylvie D; Girgis, Afaf; McElduff, Patrick; Turner, Jane; Levesque, Janelle V; Kayser, Karen; Mihalopoulos, Cathrine; Shih, Sophy T F; Barker, Daniel

    2013-01-01

    Introduction Coping skills training interventions have been found to be efficacious in helping both patients and their partners manage the physical and emotional challenges they face following a cancer diagnosis. However, many of these interventions are costly and not sustainable. To overcome these issues, a self-directed format is increasingly used. The efficacy of self-directed interventions for patients has been supported; however, no study has reported on the outcomes for their partners. This study will test the efficacy of Coping-Together—a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners. Methods and analysis The proposed three-group, parallel, randomised controlled trial will recruit patients diagnosed in the past 4?months with breast, prostate, colorectal cancer or melanoma through their treating clinician. Patients and their partners will be randomised to (1) a minimal ethical care (MEC) condition—selected Cancer Council New South Wales booklets and a brochure for the Cancer Council Helpline, (2) Coping-Together generic—MEC materials, the six Coping-Together booklets and DVD, the Cancer Council Queensland relaxation audio CD and login to the Coping-Together website or (3) Coping-Together tailored—MEC materials, the Coping-Together DVD, the login to the website and only those Coping-Together booklet sections that pertain to their direct concerns. Anxiety (primary outcome), distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy and dyadic and individual coping will be assessed before receiving the study material (ie, baseline) and again at 3, 6 and 12?months postbaseline. Intention-to-treat and per protocol analysis will be conducted. Ethics and dissemination This study has been approved by the relevant local area health and University ethics committees. Study findings will be disseminated not only through peer-reviewed publications and conference presentations but also through educational outreach visits, publication of lay research summaries in consumer newsletters and publications targeting clinicians. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000491763 (03/05/2013) PMID:23883890

  16. CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption – study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age. Methods A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhône - Alpes), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30% of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk ??=?5%; power?=?90%; intra-cluster correlation coefficient ??=?0.2; Hawthorne effect?=?15%; lost to follow-up rates for GPs?=?10% and for patients?=?20%). This plan is replicated for the three areas, and therefore a total of 750 patients are expected. The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption. Discussion Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training. Trial registration CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental Fund, Health Ministry). Date first patient randomized: March 2012. PMID:24479702

  17. The Effect of Exercise on Prevention of the Common Cold: A Meta-Analysis of Randomized Controlled Trial Studies

    PubMed Central

    Lee, Hyun Kun; Hwang, In Hong; Pyo, Se Young

    2014-01-01

    Background Because there is no specific treatment for the common cold, many previous studies have focused on prevention of the common cold. There were some studies reporting that regular, moderate-intensity exercise increases immunity and prevents the common cold. We conducted a meta-analysis to determine the effects of exercise on prevention of the common cold. Methods We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL for studies released through June 2013. We manually searched the references. Two authors independently extracted the data. To assess the risk of bias of included literature, Cochrane Collaboration's tool for assessing risk of bias was used. Review Manager ver. 5.2 (RevMan, Cochrane Collaboration) was used for statistical analysis. Results Four randomized controlled trials were identified. A total of 281 participants, 134 in the exercise group and 147 in the control group, were included. The effect of exercise on the prevention of the common cold had a relative risk (RR) of 0.73 (95% confidence interval [CI], 0.56 to 0.95; I2 = 7%). The mean difference of mean illness days between exercise group and control group was -3.50 (95% CI, -6.06 to -0.94; I2 = 93%). In the subgroup analysis, the RR of under 16 weeks exercise was 0.79 (95% CI, 0.58 to 1.08). Conclusion In this meta-analysis, regular, moderate-intensity exercise may have an effect on the prevention of the common cold. But numbers of included studies and participants were too small and quality of included studies was relatively poor. Subsequent well-designed studies with larger sample size are needed to clarify the association. PMID:24921030

  18. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial

    PubMed Central

    Trudel, Suzanne; Bahlis, Nizar J.; White, Darrell; Sabry, Waleed; Belch, Andrew; Reiman, Tony; Roy, Jean; Shustik, Chaim; Kovacs, Michael J.; Rubinger, Morel; Cantin, Guy; Song, Kevin; Tompkins, Kirsty A.; Marcellus, Deb C.; Lacy, Martha Q.; Sussman, Jonathan; Reece, Donna; Brundage, Michael; Harnett, Erica L.; Shepherd, Lois; Chapman, Judy-Anne W.; Meyer, Ralph M.

    2013-01-01

    We conducted a randomized, controlled trial comparing thalidomide-prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival, progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide-prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomide-prednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit. PMID:23297129

  19. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial.

    PubMed

    Stewart, A Keith; Trudel, Suzanne; Bahlis, Nizar J; White, Darrell; Sabry, Waleed; Belch, Andrew; Reiman, Tony; Roy, Jean; Shustik, Chaim; Kovacs, Michael J; Rubinger, Morel; Cantin, Guy; Song, Kevin; Tompkins, Kirsty A; Marcellus, Deb C; Lacy, Martha Q; Sussman, Jonathan; Reece, Donna; Brundage, Michael; Harnett, Erica L; Shepherd, Lois; Chapman, Judy-Anne W; Meyer, Ralph M

    2013-02-28

    We conducted a randomized, controlled trial comparing thalidomide-prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival,progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide-prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomide-prednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit. PMID:23297129

  20. A multicentre, randomised controlled, non-inferiority trial, comparing high flow therapy with nasal continuous positive airway pressure as primary support for preterm infants with respiratory distress (the HIPSTER trial): study protocol

    PubMed Central

    Roberts, Calum T; Owen, Louise S; Manley, Brett J; Donath, Susan M; Davis, Peter G

    2015-01-01

    Introduction High flow (HF) therapy is an increasingly popular mode of non-invasive respiratory support for preterm infants. While there is now evidence to support the use of HF to reduce extubation failure, there have been no appropriately designed and powered studies to assess the use of HF as primary respiratory support soon after birth. Our hypothesis is that HF is non-inferior to the standard treatment—nasal continuous positive airway pressure (NCPAP)— as primary respiratory support for preterm infants. Methods and analysis The HIPSTER trial is an unblinded, international, multicentre, randomised, non-inferiority trial. Eligible infants are preterm infants of 28–36+6 weeks’ gestational age (GA) who require primary non-invasive respiratory support for respiratory distress in the first 24?h of life. Infants are randomised to treatment with either HF or NCPAP. The primary outcome is treatment failure within 72?h after randomisation, as determined by objective oxygenation, blood gas, and apnoea criteria, or the need for urgent intubation and mechanical ventilation. Secondary outcomes include the incidence of intubation, pneumothorax, bronchopulmonary dysplasia, nasal trauma, costs associated with hospital care and parental stress. With a specified non-inferiority margin of 10%, using a two-sided 95% CI and 90% power, the study requires 375 infants per group (total 750 infants). Ethics and dissemination Ethical approval has been granted by the relevant human research ethics committees at The Royal Women's Hospital (13/12), The Royal Children's Hospital (33144A), The Mercy Hospital for Women (R13/34), and the South-Eastern Norway Regional Health Authority (2013/1657). The trial is currently recruiting at 9 centres in Australia and Norway. The trial results will be published in peer-reviewed international journals, and presented at national and international conferences. Trial registration number Australian New Zealand Clinical Trials Registry ID: ACTRN12613000303741. PMID:26109120

  1. Discontinuing Inappropriate Medication in Nursing Home Residents (DIM-NHR Study): protocol of a cluster randomised controlled trial

    PubMed Central

    Wouters, Hans; Quik, Elise H; Boersma, Froukje; Nygård, Peder; Bosman, Judith; Böttger, Wendelien M; Mulder, Hans; Maring, Jan-Gerard; Wijma-Vos, Linda; Beerden, Tim; van Doormaal, Jasperien; Postma, Maarten J; Zuidema, Sytse U; Taxis, Katja

    2014-01-01

    Introduction Nursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents’ quality of life. The objective of the ‘Discontinuing Inappropriate Medication in Nursing Home Residents’ (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication. Methods A cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4?months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient’s elderly care physician in collaboration with a pharmacist. Analysis Primary outcomes—the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes—undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness. Ethics and dissemination Participant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed. Trial registration number This study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095) PMID:25296655

  2. Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

    PubMed Central

    Woolfall, Kerry; Young, Bridget; Frith, Lucy; Appleton, Richard; Iyer, Anand; Messahel, Shrouk; Hickey, Helen; Gamble, Carrol

    2014-01-01

    Objective To inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process. Design Qualitative interview and focus group study. Setting 8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care. Participants 17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE. Results Most parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information. Conclusions Our study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making. PMID:24833694

  3. Weight loss in a UK commercial all meal provision study: a randomised controlled trial

    PubMed Central

    Mellor, D D; Whitham, C; Goodwin, S; Morris, M; Reid, M; Atkin, S L

    2014-01-01

    Background Effective approaches are needed to address the increasing prevalence of overweight and obesity. The present study investigated whether all meal provision was a more effective and acceptable method for weight loss than a self-directed diet. Methods This randomised controlled trial recruited 112 men and women with a body mass index in the range 27–35 kg m–2, who had no comorbidities, from the local area of Hull. Participants were randomised to receive either meal provision or follow a self-directed diet for a 12-week period that resulted in an estimated 2928 kJ day?1 (700 kcal day?1) deficit. A dietitian supervised both dietary interventions. Results At 12 weeks [mean (SEM)], percentage weight loss in the meal provision group was 6.6% (0.5%) compared to 4.3% (0.6%) for those on the self-directed diet. In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the self-directed diet (P < 0.001). Weight loss was associated with wellbeing in both groups. Attrition was less apparent with 7% of those participants receiving meal provision withdrawing from the study compared to 41% of those following the self-directed diet (P < 0.001). Conclusions Meal provision was a more effective and accepted method for weight loss over a 12-week period compared to a self-directed diet. This may in part represent the difference between being given the meal provision food free of charge. However, longer-term maintenance studies need to be undertaken to ascertain their effects on the maintenance of weight loss. PMID:24147918

  4. Australasian Gastrointestinal Trials Group (AGITG) Contouring Atlas and Planning Guidelines for Intensity-Modulated Radiotherapy in Anal Cancer

    SciTech Connect

    Ng, Michael, E-mail: mng@radoncvic.com.au [Radiation Oncology Victoria, Victoria (Australia)] [Radiation Oncology Victoria, Victoria (Australia); Leong, Trevor [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia) [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia); University of Melbourne (Australia); Chander, Sarat; Chu, Julie [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia)] [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia); Kneebone, Andrew [Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, NSW (Australia) [Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, NSW (Australia); University of Sydney (Australia); Carroll, Susan [Department of Radiation Oncology, Sydney Cancer Centre, Royal Prince Alfred Hospital, NSW (Australia) [Department of Radiation Oncology, Sydney Cancer Centre, Royal Prince Alfred Hospital, NSW (Australia); University of Sydney (Australia); Wiltshire, Kirsty [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia)] [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia); Ngan, Samuel [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia) [Department of Radiation Oncology, Peter MacCallum Cancer Centre, Victoria (Australia); University of Melbourne (Australia); Kachnic, Lisa [Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, Boston, MA (United States)] [Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, Boston, MA (United States)

    2012-08-01

    Purpose: To develop a high-resolution target volume atlas with intensity-modulated radiotherapy (IMRT) planning guidelines for the conformal treatment of anal cancer. Methods and Materials: A draft contouring atlas and planning guidelines for anal cancer IMRT were prepared at the Australasian Gastrointestinal Trials Group (AGITG) annual meeting in September 2010. An expert panel of radiation oncologists contoured an anal cancer case to generate discussion on recommendations regarding target definition for gross disease, elective nodal volumes, and organs at risk (OARs). Clinical target volume (CTV) and planning target volume (PTV) margins, dose fractionation, and other IMRT-specific issues were also addressed. A steering committee produced the final consensus guidelines. Results: Detailed contouring and planning guidelines and a high-resolution atlas are provided. Gross tumor and elective target volumes are described and pictorially depicted. All elective regions should be routinely contoured for all disease stages, with the possible exception of the inguinal and high pelvic nodes for select, early-stage T1N0. A 20-mm CTV margin for the primary, 10- to 20-mm CTV margin for involved nodes and a 7-mm CTV margin for the elective pelvic nodal groups are recommended, while respecting anatomical boundaries. A 5- to 10-mm PTV margin is suggested. When using a simultaneous integrated boost technique, a dose of 54 Gy in 30 fractions to gross disease and 45 Gy to elective nodes with chemotherapy is appropriate. Guidelines are provided for OAR delineation. Conclusion: These consensus planning guidelines and high-resolution atlas complement the existing Radiation Therapy Oncology Group (RTOG) elective nodal ano-rectal atlas and provide additional anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of IMRT for anal cancer.

  5. Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial

    PubMed Central

    2010-01-01

    Background The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents. Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. Methods/Design In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. Discussion This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. Trial Registration UMIN000004049 PMID:21118514

  6. Pathogen group-specific risk factors for intramammary infection in treated and untreated dairy heifers participating in a prepartum antimicrobial treatment trial.

    PubMed

    Passchyn, P; Piepers, S; De Vliegher, S

    2014-10-01

    Heifer mastitis is a well-known problem, with several pathogens being involved. Several generic risk factors associated with the likelihood of intramammary infections (IMI) in fresh dairy heifers have been identified before. Yet, a need exists to identify pathogen group-specific factors, as the effect of (groups of) pathogens on udder health and milk yield is different. The aim of the present study was to identify pathogen group-specific risk factors for IMI in heifers participating in a prepartum antimicrobial treatment trial, allowing us to test the hypothesis that different factors are of importance between treated and untreated control heifers as well. Data from a clinical trial in which end-term heifers were treated systemically (over 3 consecutive days) 2 wk before calving with penethamate hydriodide (n=76) or remained untreated (n=73), were available. Several potential risk factors at the herd, heifer, and quarter level were recorded in the first 3 d in milk. Quarters from untreated heifers supplemented with ?4 mg of selenium/d prepartum were significantly less likely to be infected with coagulase-negative staphylococci (CNS), whereas quarters were more likely to be infected with CNS when assistance during calving was needed. Udder edema before calving significantly decreased the odds of IMI with major pathogens. In treated heifers, no factors were detected that were associated with the likelihood of CNS IMI, whereas quarters from heifers were significantly more likely to be infected with major pathogens when they were housed in the calving pen more than 1 d and when they had been in contact with the lactating cows before calving. The risk factors for IMI that were identified in treated heifers were different than those in untreated heifers, independent of the pathogen group that was considered. It looks as if prepartum treatment not only changed the likelihood of infection, but also the factors that were associated with infection. However, except for treated heifers with an IMI with major pathogens, only a small proportion of the variation could be explained in the final models. Therefore, factors other than those that were studied could explain the likelihood of infection. PMID:25108863

  7. Biomarkers of sarcopenia in clincal trials recommendations from the international working group on sarcopenia

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the r...

  8. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

    PubMed Central

    2013-01-01

    Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ? six month history of PDN and a mean weekly pain score of ? 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. Discussion The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Trial registration Clinical Research information Service. Unique identifier: KCT0000466. PMID:23866906

  9. Phase I trial of erlotinib with radiation therapy in patients with glioblastoma multiforme: Results of North Central Cancer Treatment Group protocol N0177

    SciTech Connect

    Krishnan, Sunil [Department of Radiation Oncology, Mayo Clinic College of Medicine, Rochester, MN (United States)]. E-mail: skrishnan@mdanderson.org; Brown, Paul D. [Department of Radiation Oncology, Mayo Clinic College of Medicine, Rochester, MN (United States); Ballman, Karla V. [Division of Biostatistics, Mayo Clinic College of Medicine, Rochester, MN (United States); Fiveash, John B. [Department of Neurology, University of Alabama, Birmingham, AL (United States); Uhm, Joon H. [Department of Neurology, Mayo Clinic College of Medicine, Rochester, MN (United States); Giannini, Caterina [Department of Pathology, Mayo Clinic College of Medicine, Rochester, MN (United States); Jaeckle, Kurt A. [Department of Neurology, Mayo Clinic College of Medicine, Jacksonville, FL (United States); Geoffroy, Francois J. [Oncology Hematology Associates of Central Illinois, Peoria, IL (United States); Nabors, L. Burt [Department of Neurology, Mayo Clinic College of Medicine, Rochester, MN (United States); Buckner, Jan C. [Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN (United States)

    2006-07-15

    Purpose: To evaluate the toxicity and maximum tolerated dose (MTD) of erlotinib plus radiation therapy (RT) in patients with glioblastoma multiforme (GBM) in a multicenter phase I trial. Methods and Materials: Patients were stratified on the basis of the use of enzyme-inducing anticonvulsants (EIACs). After resection or biopsy, patients were treated with erlotinib for 1 week before concurrent erlotinib and 6 weeks (60 Gy) of RT and maintained on erlotinib until progression. The erlotinib dose was escalated in cohorts of 3 starting at 100 mg/day. Results: Twenty patients were enrolled and 19 were evaluable for the MTD and efficacy endpoints. Of these patients, 14 were males and 5 were females, with a median age of 54 years. Seven had undergone biopsy only, 5 had subtotal resections, and 7 had gross total resections. The highest dose level was 150 mg/day erlotinib for patients not on EIACs (Group 1) and 200 mg/day for patients on EIACs (Group 2). MTD was not reached in either group. In Group 1 at 100 mg (n = 6) and at 150 mg (n = 4), only 1 dose-limiting toxicity (DLT) occurred (stomatitis at 100 mg). No DLTs have occurred in Group 2 at 100 mg (n = 3), 150 mg (n = 3), and 200 mg (n = 3). With a median follow-up of 52 weeks, progression was documented in 16 patients and 13 deaths occurred. Median time to progression was 26 weeks, and median survival was 55 weeks. Conclusion: Toxicity is acceptable at the current doses of erlotinib plus RT. The study was modified to include concurrent and adjuvant temozolomide, and accrual is in progress.

  10. Augmented visual feedback of movement performance to enhance walking recovery after stroke: study protocol for a pilot randomised controlled trial

    PubMed Central

    2012-01-01

    Background Increasing evidence suggests that use of augmented visual feedback could be a useful approach to stroke rehabilitation. In current clinical practice, visual feedback of movement performance is often limited to the use of mirrors or video. However, neither approach is optimal since cognitive and self-image issues can distract or distress patients and their movement can be obscured by clothing or limited viewpoints. Three-dimensional motion capture has the potential to provide accurate kinematic data required for objective assessment and feedback in the clinical environment. However, such data are currently presented in numerical or graphical format, which is often impractical in a clinical setting. Our hypothesis is that presenting this kinematic data using bespoke visualisation software, which is tailored for gait rehabilitation after stroke, will provide a means whereby feedback of movement performance can be communicated in a more meaningful way to patients. This will result in increased patient understanding of their rehabilitation and will enable progress to be tracked in a more accessible way. Methods The hypothesis will be assessed using an exploratory (phase II) randomised controlled trial. Stroke survivors eligible for this trial will be in the subacute stage of stroke and have impaired walking ability (Functional Ambulation Classification of 1 or more). Participants (n?=?45) will be randomised into three groups to compare the use of the visualisation software during overground physical therapy gait training against an intensity-matched and attention-matched placebo group and a usual care control group. The primary outcome measure will be walking speed. Secondary measures will be Functional Ambulation Category, Timed Up and Go, Rivermead Visual Gait Assessment, Stroke Impact Scale-16 and spatiotemporal parameters associated with walking. Additional qualitative measures will be used to assess the participant’s experience of the visual feedback provided in the study. Discussion Results from the trial will explore whether the early provision of visual feedback of biomechanical movement performance during gait rehabilitation demonstrates improved mobility outcomes after stroke and increased patient understanding of their rehabilitation. Trial registration Current Controlled Trials ISRCTN79005974 PMID:22967674

  11. Randomized study of mammography screening — preliminary report on mortality in the stockholm trial

    Microsoft Academic Search

    J. Frisell; G. Eklund; L. Hellström; E. Lidbrink; L.-E. Rutqvist; A. Somell

    1991-01-01

    Summary In March 1981, 40,318 women in Stockholm, aged 40–64, entered a randomized trial of breast cancer screening by single-view mammography alone versus no intervention in a control group of 20,000 women. The attendance rate during the first screening round was 81 per cent and the cancer detection rate was 4.0 per 1000 women. The detection the rate fell to

  12. A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study

    Microsoft Academic Search

    N. K. Arden; C. Price; I. Reading; J. Stubbing; J. Hazelgrove; C. Dunne; M. Michel; P. Rogers; C. Cooper

    2005-01-01

    Objective. To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections (ESI) in patients with sciatica. We performed a 12-month, multicentre, double-blind, randomized, placebo-controlled, parallel-group trial in four secondary pain-care clinics in the Wessex Region. Methods. Two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of 1-18 months' duration were randomized to either three

  13. Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials

    Microsoft Academic Search

    Andrew Vickers; Niraj Goyal; Robert Harland; Rebecca Rees

    1998-01-01

    Objective: To determine whether clinical trials originating in certain countries always have positive results. Data sources: Abstracts of trials from Medline (January 1966–June 1995). Study selection: Two separate studies were conducted. The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo, no treatment, or a

  14. Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial

    PubMed Central

    2014-01-01

    Background About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care. Methods and design This study will be a four-parallel-arm, multicentre, randomised, placebo-controlled trial. A total of 212 pregnant women (24 to 36 weeks’ gestation), aged at least 17 years, with LBPGP, will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group (VAAc), to the non-specific auricular acupuncture plus standard obstetric care group (NSAAc), to the non-specific placebo auricular acupuncture plus standard obstetric care group (PAAc), or the standard obstetric care group (SOC). The VAAc, NSAAc, and PAAc groups will receive treatment at three auricular acupuncture points (specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups), once a week for 2 weeks; the SOC group will receive only standard obstetric care during the same period. The primary outcome will be the reduction in pain intensity, according to the visual analogue scale (iVAS), at 2 weeks after the start of treatment. The secondary outcomes will be functional status with respect to LBPGP (according to the Roland-Morris disability questionnaire), health-related quality of life (SF12) at 2 weeks after the start of treatment, and iVAS at 12 and 48 weeks postpartum. Discussion This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP. Trial registration Current Controlled Trials ISRCTN41033073 (date 20/03/2014). PMID:25027493

  15. What Leads Indians to Participate in Clinical Trials? A Meta-Analysis of Qualitative Studies

    Microsoft Academic Search

    Jatin Y. Shah; Amruta Phadtare; Dimple Rajgor; Meenakshi Vaghasia; Shreyasee Pradhan; Hilary Zelko; Ricardo Pietrobon; Peter McCulloch

    2010-01-01

    BackgroundWith the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of

  16. NETWORK META ANALYSIS MWD & PFWD Not all trials were included due to incompatibility of study

    E-print Network

    Oakley, Jeremy

    characteristics and availability of data. In most trials, the comparator was placebo. No studies of inositol, and palpitations with cilostazol vs placebo. RESULTS ·Not all studies reported all outcomes ·Follow up times varied of treadmill tests Pentoxi- fylline Naftidrofuryl Cilostazol 1 3 66 Placebo Cilostazol 200mg vs placebo: 11

  17. Group Processes and EFL Learners' Motivation: A Study of Group Dynamics in EFL Classrooms

    ERIC Educational Resources Information Center

    Chang, Lilian Ya-Hui

    2010-01-01

    This study explores how group processes, such as group cohesiveness and group norms, influence an individual EFL learner's motivation. The uniqueness of this research lies in shifting the focus from an analysis of the individual's experience being seen as apart from the group to considering the individual's experience in relation to the social…

  18. Children's Learning Groups: A Study of Emergent Leadership, Dominance, and Group Effectiveness.

    ERIC Educational Resources Information Center

    Yamaguchi, Ryoko

    This study explores the importance of the group context in the emergence of leadership, dominance, and group effectiveness in children's collaborative learning groups. Ten 3-person work groups performed a collaborative math activity. Using achievement goal orientation (Ames, 1992; Maehr and Midgley, 1996; Pintrich and Schunk, 1996) as a framework,…

  19. Trial Watch

    PubMed Central

    Vacchelli, Erika; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    During the past two decades, the notion that cancer would merely constitute a cell-intrinsic disease has gradually been complemented by a model postulating that the immune system plays a relevant role during all stages of oncogenesis and tumor progression. Along with this conceptual shift, several strategies have been devised to stimulate tumor-specific immune responses, including relatively unselective approaches such as the systemic administration of adjuvants or immunomodulatory cytokines. One year ago, in the July issue of OncoImmunology, we described the main biological features of this large group of proteins and discussed the progress of ongoing clinical studies evaluating their safety and therapeutic potential in cancer patients. Here, we summarize the latest developments in this area of clinical research, focusing on high impact studies that have been published during the last 13 mo and clinical trials launched in the same period to investigate which cytokines can be employed as safe and efficient immunostimulatory interventions against cancer. PMID:24073369

  20. Case Study: The Wisdom of Groups

    NSDL National Science Digital Library

    Clyde Freeman Herreid

    2009-11-01

    What is it about small groups that make them so powerful? The answer is straightforward: Groups tend to solve problems better than even the brightest individuals because "many hands make light work," and "two heads are better than one." This is especially

  1. Group Cognitive Behavior Therapy for Children with High-Functioning Autism Spectrum Disorders and Anxiety: A Randomized Trial

    PubMed Central

    Reaven, Judy; Blakeley-Smith, Audrey; Culhane-Shelburne, Kathy; Hepburn, Susan

    2015-01-01

    Background Children with high-functioning autism spectrum disorders (ASD) are at high risk for developing significant anxiety. Anxiety can adversely impact functioning across school, home and community environments. Cognitive behavior therapies (CBT) are frequently used with success for children with anxiety symptoms. Modified CBT interventions for anxiety in children with ASD have also yielded promising results. Methods Fifty children with high-functioning ASD and anxiety were randomized to group CBT or Treatment as Usual (TAU) for 12 weeks. Independent Clinical Evaluators, blind to condition, completed structured interviews (Anxiety Disorders Interview Schedule – Parent Version; ADIS-P) pre- and post-intervention condition. Results Forty-seven children completed either the CBT or TAU condition. Results indicated markedly better outcomes for the CBT group. Significant differences by group were noted in Clinician Severity Ratings, diagnostic status, and clinician ratings of global improvement. In the intent-to-treat sample, ten of 20 children (50%) in the CBT group had a clinically meaningful positive treatment response, compared to 2 of 23 children (8.7%) in the TAU group. Conclusions Initial results from this rigorously designed treatment study suggest that a group CBT intervention specifically developed for children with ASD may be effective in decreasing anxiety. Limitations of this study include small sample size, lack of an attention control group, and use of outcome measures normed with typically developing children. PMID:22435114

  2. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

    PubMed Central

    2012-01-01

    Background A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. Methods/Design This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, “ReCaPTure LiFe” will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15–25 years who have completed cancer treatment in the past 1–6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. Discussion This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. Trial Registration ACTRN12610000717055 PMID:22862906

  3. Recruitment of minority ethnic groups into clinical cancer research trials to assess adherence to the principles of the Department of Health Research Governance Framework: national sources of data and general issues arising from a study in one hospital trust in England

    Microsoft Academic Search

    Sylvia Godden; Gareth Ambler; Allyson M Pollock

    2010-01-01

    BackgroundThis article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England.Methods(i) A review of routine data sources to determine whether their usefulness as a source of data on

  4. A Randomized Trial of Long-term Multivitamin Supplementation and Cognitive Function in Men: The Physicians’ Health Study II

    PubMed Central

    Grodstein, Francine; O’Brien, Jacqueline; Kang, Jae Hee; Dushkes, Rimma; Cook, Nancy R.; Okereke, Olivia; Manson, JoAnn E.; Glynn, Robert J.; Buring, Julie E.; Gaziano, J. Michael; Sesso, Howard D.

    2013-01-01

    Background Despite widespread use of multivitamin supplements, their effect on cognitive health – a critical issue with aging – remains inconclusive. To date, there have been no long-term clinical trials to study multivitamin use and cognitive decline in older persons. Objective To evaluate whether long-term multivitamin supplementation affects cognitive health in later-life. Design Randomized, double-blind, placebo-controlled trial of a multivitamin from 1997 to June 1, 2011. The cognitive function sub-study began in 1998; we completed up to four repeated cognitive assessments by telephone interview over 12 years. Setting The Physicians’ Health Study II. Patients 5,947 male physicians aged ? 65 years. Intervention Daily multivitamin, or placebo. Measurements A global composite score averaging 5 tests of global cognition, verbal memory, and category fluency. The secondary endpoint was a verbal memory score combining 4 tests of verbal memory, a strong predictor of Alzheimer disease. Results There was no difference in the mean cognitive change over time between the multivitamin and placebo groups, or in the mean level of cognition at any of the four assessments. Specifically, for the global composite score, the mean difference in cognitive change over follow-up was ?0.01 (95% confidence interval [CI] ?0.04, 0.02) standard units, comparing treatment versus placebo. Similarly, there was no difference in cognitive performance between the treated and placebo groups on the secondary outcome, verbal memory (e.g., mean difference in cognitive change over follow-up=?0.005, 95% CI ?0.04, 0.03). Limitations Doses of vitamins may be too low, or population may be too well-nourished to benefit from multivitamin. Conclusions In male physicians aged ? 65 years, long-term use of a daily multivitamin did not provide cognitive benefits. Trial Registration http://www.clinicaltrials.gov identifier: NCT00270647 PMID:24490265

  5. Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Severe TBI, defined as a Glasgow Coma Scale???8, increases intracranial pressure and activates the sympathetic nervous system. Sympathetic hyperactivity after TBI manifests as catecholamine excess, hypertension, abnormal heart rate variability, and agitation, and is associated with poor neuropsychological outcome. Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow, brain edema, and agitation. However, there is no prospective randomized evidence available demonstrating the feasibility, outcome benefits, and safety for adrenergic blockade after TBI. Methods/Design The DASH after TBI study is an actively accruing, single-center, randomized, double-blinded, placebo-controlled, two-arm trial, where one group receives centrally acting sympatholytic drugs, propranolol (1?mg intravenously every 6?h for 7?days) and clonidine (0.1?mg per tube every 12?h for 7?days), and the other group, double placebo, within 48?h of severe TBI. The study uses a weighted adaptive minimization randomization with categories of age and Marshall head CT classification. Feasibility will be assessed by ability to provide a neuroradiology read for randomization, by treatment contamination, and by treatment compliance. The primary endpoint is reduction in plasma norepinephrine level as measured on day 8. Secondary endpoints include comprehensive plasma and urine catecholamine levels, heart rate variability, arrhythmia occurrence, infections, agitation measures using the Richmond Agitation-Sedation Scale and Agitated Behavior scale, medication use (anti-hypertensive, sedative, analgesic, and antipsychotic), coma-free days, ventilator-free days, length of stay, and mortality. Neuropsychological outcomes will be measured at hospital discharge and at 3 and 12?months. The domains tested will include global executive function, memory, processing speed, visual-spatial, and behavior. Other assessments include the Extended Glasgow Outcome Scale and Quality of Life after Brain Injury scale. Safety parameters evaluated will include cardiac complications. Discussion The DASH After TBI Study is the first randomized, double-blinded, placebo-controlled trial powered to determine feasibility and investigate safety and outcomes associated with adrenergic blockade in patients with severe TBI. If the study results in positive trends, this could provide pilot evidence for a larger multicenter randomized clinical trial. If there is no effect of therapy, this trial would still provide a robust prospective description of sympathetic hyperactivity after TBI. Trial registration ClinicalTrials.gov NCT01322048 PMID:23013802

  6. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

    Microsoft Academic Search

    Nicole van der Roer; Maurits van Tulder; Johanna Barendse; Dirk Knol; Willem van Mechelen; Henrica de Vet

    2008-01-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers\\u000a with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed\\u000a at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low\\u000a back pain. The

  7. Which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies?

    PubMed

    Hug, Kristina; Hermerén, Göran

    2012-01-01

    The aims of this article are to consider (1) whether there are medical and societal differences among diseases regarding which patient groups should be asked to participate in first-in-human (FIH) trials of stem-cell-based therapies; (2) any differences in the light of values generally endorsed by different types of ethical theories, since the question in the title of this article is value laden, and its answer depends on which values one wants to promote and protect, and how they are ranked in importance; (3) whether the answer to that question is disease-specific, or whether it depends on factors common to several diseases. To illustrate these problems, we use Parkinson's disease (PD) and Huntington's disease (HD), between which there are important medical and societal differences. Moreover, research on stem-cell-based therapies for these diseases is being translated from research to practice. This approach to the problem can be applied to decision making about similar problems raised by other diseases that exhibit the same types of differences. PMID:23256407

  8. Neurotrauma and mesenchymal stem cells treatment: From experimental studies to clinical trials

    PubMed Central

    Martinez, Ana Maria Blanco; Goulart, Camila de Oliveira; Ramalho, Bruna dos Santos; Oliveira, Júlia Teixeira; Almeida, Fernanda Martins

    2014-01-01

    Mesenchymal stem cell (MSC) therapy has attracted the attention of scientists and clinicians around the world. Basic and pre-clinical experimental studies have highlighted the positive effects of MSC treatment after spinal cord and peripheral nerve injury. These effects are believed to be due to their ability to differentiate into other cell lineages, modulate inflammatory and immunomodulatory responses, reduce cell apoptosis, secrete several neurotrophic factors and respond to tissue injury, among others. There are many pre-clinical studies on MSC treatment for spinal cord injury (SCI) and peripheral nerve injuries. However, the same is not true for clinical trials, particularly those concerned with nerve trauma, indicating the necessity of more well-constructed studies showing the benefits that cell therapy can provide for individuals suffering the consequences of nerve lesions. As for clinical trials for SCI treatment the results obtained so far are not as beneficial as those described in experimental studies. For these reasons basic and pre-clinical studies dealing with MSC therapy should emphasize the standardization of protocols that could be translated to the clinical set with consistent and positive outcomes. This review is based on pre-clinical studies and clinical trials available in the literature from 2010 until now. At the time of writing this article there were 43 and 36 pre-clinical and 19 and 1 clinical trials on injured spinal cord and peripheral nerves, respectively. PMID:24772245

  9. Quality of life in advanced non-small-cell lung cancer: Results of a Southwest Oncology Group randomized trial

    Microsoft Academic Search

    C. M. Moinpour; B. Lyons; P. K. Grevstad; L. C. Lovato; J. Crowley; K. Czaplicki; Z. M. Buckner; P. A. Ganz; K. Kelly; D. R. Gandara

    2002-01-01

    Purpose: The main purpose of this paper is to present the results of a randomized trial comparing the effects of two chemotherapy regimens on the Quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC). Trials in advanced stage disease represent an important treatment context for QOL assessment. A second purpose of this paper is to examine methods

  10. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials

    Microsoft Academic Search

    David Moher; Kenneth F. Schulz; Douglas G. Altman

    2003-01-01

    To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total 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

  11. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials

    Microsoft Academic Search

    David Moher MSc; Kenneth F Schulz; Douglas G Altman DSc

    2001-01-01

    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 improve- ment. Investigators and editors developed the original CONSORT (Consoli- dated Standards of Reporting Trials) statement to help authors

  12. Advice to use topical or oral ibuprofen for chronic knee pain in older people: randomised controlled trial and patient preference study

    PubMed Central

    2008-01-01

    Objective To determine whether older patients with chronic knee pain should be advised to use topical or oral non-steroidal anti-inflammatory drugs (NSAIDs). Design Randomised controlled trial and patient preference study. Setting 26 general practices. Participants People aged ?50 with knee pain: 282 in randomised trial and 303 in preference study. Interventions Advice to use topical or oral ibuprofen. Primary outcome measures WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, major and minor adverse effects. Results Changes in global WOMAC scores at 12 months were equivalent. In the randomised trial the difference (topical minus oral) was two points (95% confidence interval ?2 to 6); in the preference study, it was one point (?4 to 6). There were no differences in major adverse effects in the trial or study. The only significant differences in secondary outcomes were in the randomised trial. The oral group had more respiratory adverse effects (17% v 7%,95% confidence interval for difference ?17% to ?2%), the change in serum creatinine was 3.7 mmol/l less favourable (0.9 µmol/l to 6.5 µmol/l); and more participants changed treatments because of adverse effects (16% v 1%, ?16% to ?5%). In the topical group more participants had chronic pain grade III or IV at three months, and more participants changed treatment because of ineffectiveness. Conclusions Advice to use oral or topical preparations has an equivalent effect on knee pain over one year, and there are more minor side effects with oral NSAIDs. Topical NSAIDs may be a useful alternative to oral NSAIDs. Trial registration ISRCTN 79353052. PMID:18056743

  13. Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Use of inappropriate drugs is common among institutionalized older people. Rigorous trials investigating the effect of the education of staff in institutionalized settings on the harm related to older people’s drug treatment are still scarce. The aim of this trial is to investigate whether training professionals in assisted living facilities reduces the use of inappropriate drugs among residents and has an effect on residents’ quality of life and use of health services. Methods and design During years 2011 and 2012, a sample of residents in assisted living facilities in Helsinki (approximately?212) will be recruited, having offered to participate in a trial aiming to reduce their harmful drugs. Their wards will be randomized into two arms: one, those in which staff will be trained in two half-day sessions, including case studies to identify inappropriate, anticholinergic and psychotropic drugs among their residents, and two, a control group with usual care procedures and delayed training. The intervention wards will have an appointed nurse who will be responsible for taking care of the medication of the residents on her ward, and taking any problems to the consulting doctor, who will be responsible for the overall care of the patient. The trial will last for twelve months, the assessment time points will be zero, six and twelve months. The primary outcomes will be the proportion of persons using inappropriate, anticholinergic, or more than two psychotropic drugs, and the change in the mean number of inappropriate, anticholinergic and psychotropic drugs among residents. Secondary endpoints will be, for example, the change in the mean number of drugs, the proportion of residents having significant drug-drug interactions, residents' health-related quality of life (HRQOL) according to the 15D instrument, cognition according to verbal fluency and clock-drawing tests and the use and cost of health services, especially hospitalizations. Discussion To our knowledge, this is the first large-scale randomized trial exploring whether relatively light intervention, that is, staff training, will have an effect on reducing harmful drugs and improving QOL among institutionalized older people. Trial registration ACTRN12611001078943 PMID:22709731

  14. Protocol and Recruitment Results from a Randomized Controlled Trial Comparing Group Phone-Based versus Newsletter Interventions for Weight Loss Maintenance among Rural Breast Cancer Survivors

    PubMed Central

    Befort, Christie A.; Klemp, Jennifer R.; Fabian, Carol; Perri, Michael G.; Sullivan, Debra K.; Schmitz, Kathryn H.; Diaz, Francisco J.; Shireman, Theresa

    2014-01-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n = 210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ? 3 months out from initial cancer treatments, have a BMI 27–45 kg/m2, and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information in how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. PMID:24486636

  15. Platelet Aggregation Unchanged by Lipoprotein-Associated Phospholipase A2 Inhibition: Results from an In Vitro Study and Two Randomized Phase I Trials

    PubMed Central

    Shaddinger, Bonnie C.; Xu, Yanmei; Roger, James H.; Macphee, Colin H.; Handel, Malcolm; Baidoo, Charlotte A.; Magee, Mindy; Lepore, John J.; Sprecher, Dennis L.

    2014-01-01

    Background We explored the theorized upregulation of platelet-activating factor (PAF)– mediated biologic responses following lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials. Methods and Results Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib (selective Lp-PLA2 inhibitor) or vehicle. This was followed by a randomized, double-blind crossover study in healthy adult men (n?=?26) employing a single-agonist dose assay of platelet aggregation, after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days. This study was followed by a second randomized, double-blind parallel-group trial in healthy adult men (n?=?58) also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations (0–10 µg/ml) for characterizing EC50 values for platelet aggregation for each subject. Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital, Sydney, Australia. EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies, despite Lp-PLA2 inhibition exceeding 90%. An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study (15.4% vs baseline; 95% confidence interval [CI], 3.9–27.0), which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination. Conclusions Lp-PLA2 inhibition does not enhance platelet aggregation. Trial Registration 1) Study 1: ClinicalTrials.gov NCT01745458 2) Study 2: ClinicalTrials.gov NCT00387257 PMID:24475026

  16. Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study

    PubMed Central

    Fransen, Gerdine AJ; van Marrewijk, Corine J; Mujakovic, Suhreta; Muris, Jean WM; Laheij, Robert JF; Numans, Mattijs E; de Wit, Niek J; Samsom, Melvin; Jansen, Jan BMJ; Knottnerus, J André

    2007-01-01

    Background Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the successes as well as the problems we experienced the quality of future pragmatic trials may benefit. Discussion The first challenge concerned choosing the clinically most relevant interventions to compare and enable blinded comparison, since two interventions had very different appearances. By adding treatment steps to one treatment arm and adding placebo to both treatment arms both internal and external validity were optimized. Nevertheless, although blinding is essential for a high internal validity, it should be warily considered in a pragmatic trial because it decreases external validity. Choosing and recruiting a representative selection of participants was the second challenge. We succeeded in retrieving a representative relatively large patient sample by carefully choosing (few) inclusion and exclusion criteria, by random selection, by paying much attention to participant recruitment and taking the participant's reasons to participate into account. Good and regular contact with the GPs and patients was to our opinion essential. The third challenge was to choose the primary outcome, which needed to reflect effectiveness of the treatment in every day practice. We also designed our protocol to follow every day practice as much as possible, although standardized treatment is usually preferred in trials. The aim of this was our fourth challenge: to limit the number of protocol deviations and increase external validity. Summary It is challenging to design and conduct a pragmatic trial. Thanks to thorough preparation, we were able to collect highly valid data. To our opinion, a critical deliberation of where on the pragmatic – explanatory spectrum you want your trial to be on forehand, in combination with consulting publications especially on patient recruitment procedures, has been helpful in conducting a successful trial. PMID:17451599

  17. HomeversusoutpatientultravioletBphototherapyformild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study)

    Microsoft Academic Search

    Erik Buskens; Paul H A Steegmans; Carla A F M Bruijnzeel; Vigfus Sigurdsson; M B G Koek

    2009-01-01

    Objective To determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis. Design Pragmatic multicentre single blind randomised clinical trial (PLUTO study). Setting Dermatology departments of 14 hospitals in the Netherlands. Participants 196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B

  18. Teenage pregnancy and social disadvantage: systematic review integrating controlled trials and qualitative studies

    Microsoft Academic Search

    Angela Harden; Ginny Brunton; Adam Fletcher; Ann Oakley

    2009-01-01

    Objectives To determine the impact on teenage pregnancy of interventions that address the social disadvantage associated with early parenthood and to assess the appropriateness of such interventions for young people in the United Kingdom.Design Systematic review, including a statistical meta-analysis of controlled trials on interventions for early parenthood and a thematic synthesis of qualitative studies that investigated the views on

  19. U.S. Virtual School Trial Period and Course Completion Policy Study

    ERIC Educational Resources Information Center

    Hawkins, Abigail; Barbour, Michael K.

    2010-01-01

    Variation in policies virtual schools use to calculate course completion and retention rates impacts the comparability of these quality metrics. This study surveyed 159 U.S. virtual schools examining the variability in trial period and course completion policies--two policies that affect course completion rates. Of the 86 respondents, almost 70%…

  20. Proceedings of the Fifty-Eighth European Study Group

    E-print Network

    Bisseling, Rob

    Proceedings of the Fifty-Eighth European Study Group Mathematics with Industry Utrecht de Leur Paul A. Zegeling #12;2 Proceedings of the 58th European Study Group Mathematics with Industry #12;Preface This book presents the scientific proceedings of the 58th European Study Group Mathematics

  1. Participants' recommendations for the ideal grief group: a qualitative study.

    PubMed

    Dyregrov, Kari; Dyregrov, Atle; Johnsen, Iren

    2013-01-01

    Based on the results from the qualitative part of the study "Grief Groups in Norway" conducted in 2009-2011, this article focuses on grief group participants' recommendations for good or ideal grief groups. Participants have insightful observations about grief groups and how they can be improved, and taking their point of view seriously is one important way of ensuring that users of such group get an optimal experience from joining such groups. Using their experiences to adjust the structure and function of the groups, one can allow for practical solutions for organizations that have difficulties starting up grief support groups, for example, in areas where the population density is low. A major finding in this study was that grief group participants stressed the importance of thorough information before and at the start of grief groups. This concerned information about the aim, structure, organization, and possible effects and limitations of group participation. PMID:24416876

  2. Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

    Microsoft Academic Search

    Xin Sun; Matthias Briel; Jason W Busse; Elie A Akl; John J You; Filip Mejza; Malgorzata Bala; Natalia Diaz-Granados; Dirk Bassler; Dominik Mertz; Sadeesh K Srinathan; Per Olav Vandvik; German Malaga; Mohamed Alshurafa; Philipp Dahm; Pablo Alonso-Coello; Diane M Heels-Ansdell; Neera Bhatnagar; Bradley C Johnston; Li Wang; Stephen D Walter; Douglas G Altman; Gordon H Guyatt

    2009-01-01

    BACKGROUND: Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered.

  3. Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1.

    PubMed

    Elm, Jordan J

    2012-10-01

    Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double-blind, parallel-group, placebo-controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long-term Study-1 (LS-1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS-1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS-1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5-year follow-up visit against the background of dopaminergic therapy and best PD care. PMID:23079770

  4. Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial

    PubMed Central

    Khunti, Kamlesh; Stone, Margaret; Farooqi, Azhar; Carr, Sue

    2011-01-01

    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0.034). Conclusion The findings suggest that delivering and evaluating an effective structured group educational intervention to promote better blood pressure control in patients with CKD would be challenging in the current context of kidney care. PMID:22184589

  5. First metatarsophalangeal joint arthrodesis versus proximal phalanx hemiarthroplasty for hallux rigidus: feasibility study for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis of the first metatarsophalangeal joint (hallux rigidus) leads to pain and poor function and mobility. Arthrodesis is the gold standard treatment for end-stage disease. Total joint arthroplasties have been attempted, but early loosening has been attributed to dorsally directed shear forces on the metatarsal component. Metallic proximal phalangeal hemiarthroplasty theoretically avoids this. Whilst early results are promising, no comparative trials exist comparing this to arthrodesis. Methods/Design The primary objectives are to determine the range of outcome scores between the two treatment arms (to inform a power calculation). Outcome measures will include the MOXFQ, AOFAS-Hallux and EuroQol EQ-5D-5 L. Secondary objectives are to determine the accrual rate, dropout rate and trial acceptability to both patients and surgeons. These data will allow the development of a larger trial with longer follow-up. This is a prospective randomised controlled single-centre study comparing proximal phalanx hemiarthroplasty (AnaToemic, Arthrex Ltd., Sheffield, UK) with arthrodesis (15 patients in each arm). Randomisation will be performed using a 1:1 allocation ratio in blocks of six. Patients meeting the eligibility criteria will be recruited from three foot and ankle consultant surgeon’s clinics (East Lancashire Hospitals NHS Trust). If agreeable, informed consent will be obtained before patients are randomised. The outcome measure scores will be completed pre-operatively and repeated at 6 weeks, 3 months and 12 months. A radiological review will be performed at 6 weeks and 12 months to determine rates of loosening (hemiarthroplasty) and union (arthrodesis). Data on length of stay, return to work, complications and re-operation rates will also be collected. The analysis will compare the change in outcome scores between treatment groups at all follow-up time points. Scores will be compared using a Student t-test, adjusting for scores at baseline. This study will be conducted in accordance with the current revision of the Declaration of Helsinki (1996) and the ICH-GCP Guideline (International Conference on Harmonisation, Good Clinical Practice, E6(R1), 1996). This study has been approved by the sponsor, the Trust Research & Development office. Ethical approval has been received from the National Research Ethics Service (North East: 12/NE/0385 for protocol version 5.3 dated 3 June 2013). Trial registration Current Controlled Trials ISRCTN88273654 PMID:24625034

  6. The Experiences of Expert Group Work Supervisors: An Exploratory Study

    ERIC Educational Resources Information Center

    Atieno Okech, Jane E.; Rubel, Deborah

    2009-01-01

    Evaluation of group work supervision literature suggests that description of expert group work supervisors' experiences could be useful for expanding existing group work supervision practices and models. This study provided a systematic exploration of the experiences of expert group work supervisors during the supervision process. Results indicate…

  7. Cultural Diversity and Work Group EffectivenessAn Experimental Study

    Microsoft Academic Search

    David C. Thomas

    1999-01-01

    Changes in workforce demographics resulting from globalization, combined with the rising popularity of team-based management techniques, has resulted in a practical concern with the management of multicultural groups. In this experimental study, three mechanisms that are proposed to influence group effectiveness are examined. Results supported the notion that the cultural diversity of the group, the sociocultural norms of group members,

  8. Evaluation of a Group Cognitive-Behavioral Depression Prevention Program for Young Adolescents: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Kash-MacDonald, V. Megan; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E. P.

    2012-01-01

    Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We…

  9. A Multi-centre Randomized Control Group Trial on the Use of Art Therapy for Older People with Dementia

    Microsoft Academic Search

    Jennifer Rusted; Linda Sheppard; Diane Waller

    2006-01-01

    The principal aim of this study is to evaluate the immediate and long-term effects of art therapy for older people with dementia, specifically to test the premise that participation in art therapy groups effects significant positive changes in mood and cognition both immediately within sessions and later outside the sessions to impact behaviour in the day care\\/residential care setting. The

  10. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

    PubMed

    Lanini, Simone; Zumla, Alimuddin; Ioannidis, John P A; Caro, Antonino Di; Krishna, Sanjeev; Gostin, Lawrence; Girardi, Enrico; Pletschette, Michel; Strada, Gino; Baritussio, Aldo; Portella, Gina; Apolone, Giovanni; Cavuto, Silvio; Satolli, Roberto; Kremsner, Peter; Vairo, Francesco; Ippolito, Giuseppe

    2015-06-01

    The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24?900 cases and about 10?300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use. However, non-randomised studies might not yield valid conclusions, leading to large residual uncertainty about how to interpret the results, and can also waste scarce intervention-related resources, making them profoundly unethical. Scientifically sound and rigorous study designs, such as adaptive RCTs, could provide the best way to reduce the time needed to develop new interventions and to obtain valid results on their efficacy and safety while preserving the application of ethical precepts. We present an overview of clinical studies registered at present at the four main international trial registries and provide a simulation on how adaptive RCTs can behave in this context, when mortality varies simultaneously in either the control or the experimental group. PMID:25881871

  11. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Septic shock is common and has unacceptably high morbidity, mortality, and associated cost with numerous failed attempts at developing effective therapies. Endotoxin, one of the most potent mediators of sepsis, is found in high levels in approximately 50% of patients with septic shock. Polymyxin B (PMX) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes. EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) is a theragnostic trial (matching blood measurement to treatment capability) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay (EAA). Methods EUPHRATES is a pivotal regulatory trial that is multi-centered, placebo-controlled and blinded. The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients. Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA. Those with EAA ?0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart. The primary endpoint for the trial is 28-day all-cause mortality. Discussion Unique features of the trial include absence of systemic inflammatory response (SIRS) criteria as a requirement for inclusion, use of the EAA to confirm endotoxemia as a requisite for treatment, and use of a detailed “façade” hemoperfusion event as a blinding mechanism. The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score (MODS)???9. Results are anticipated in 2016. Trial registration Clinicaltrials.gov identifier: NCT01046669. Registered: January 8, 2010. PMID:24916483

  12. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. The 2014 Clinical Trial Design Working Group Report.

    PubMed

    Martin, Paul J; Lee, Stephanie J; Przepiorka, Donna; Horowitz, Mary M; Koreth, John; Vogelsang, Georgia B; Walker, Irwin; Carpenter, Paul A; Griffith, Linda M; Akpek, Gorgun; Mohty, Mohamad; Wolff, Daniel; Pavletic, Steven Z; Cutler, Corey S

    2015-08-01

    Treatment of chronic graft-versus-host disease is intended to produce a sustainable benefit by reducing symptom burden, controlling objective manifestations of disease activity, preventing damage and impairment, and improving overall survival without causing disproportionate harms related to the treatment itself. Successful management can control the disease until systemic treatment is no longer needed. The complexity of the disease, the extended duration of follow-up needed to observe disease resolution and withdrawal of immunosuppressive treatment, and the lack of fully developed shorter term endpoints impede progress in the field. Identification and characterization of primary endpoints demonstrating clinical benefit without requiring years of follow-up is urgently needed, with the understanding that clinical benefit encompasses not only the self-evident benefit of the primary endpoint but also any other associated benefits. This report discusses regulatory considerations, eligibility criteria, the value of controlled trial designs, the merits of proposed primary endpoints, and key considerations elaborated from experience and progress during the past decade. The report concludes by mapping an overall approach that could support and lead to maximally informative clinical trials, especially those that seek to demonstrate clinical benefit along a pathway to regulatory review and approval. PMID:25985921

  13. Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22)

    Microsoft Academic Search

    Donna Sepulveda Conwell; Ann Mosher; Awal Khan; Jan Tapy; Laurie Sandman; Andrew Vernon; C. Robert Horsburgh

    2007-01-01

    IntroductionLoss to follow-up in clinical trials compromises achievement of study goals. We evaluated factors associated with loss to follow-up after completion of treatment phase in a large tuberculosis treatment trial (TBTC\\/USPHS Study 22) in the U.S. and Canada.

  14. Science Sampler: Validating assessment--Teacher study groups

    NSDL National Science Digital Library

    Erin Peters

    2008-01-01

    Teacher study groups are a valuable method of examining the validity of classroom assessments and determining how well the assessments align with student learning goals. The implementation of teacher study groups is based on a model from the Schools Around the World Academy for Teaching Excellence (Council for Basic Education 2000). The teacher study groups are composed of four to six teachers. Often a teacher solicits group members by sending out flyers to the faculty to find interested volunteers.

  15. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

    PubMed Central

    2011-01-01

    Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

  16. A Study of Group Dynamics in Educational Leadership Cohort and Non-Cohort Groups

    ERIC Educational Resources Information Center

    Greenlee, Bobbie J.; Karanxha, Zorka

    2010-01-01

    The purpose of this study was to examine group dynamics of educational leadership students in cohorts and make comparisons with the group dynamics characteristics of non-cohort students. Cohorts have emerged as dynamic and adaptive entities with attendant group dynamic processes that shape collective learning and action. Cohort (n=42) and…

  17. Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial

    PubMed Central

    2012-01-01

    Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836 PMID:22985134

  18. Randomized clinical trials as reflexive-interpretative process in patients with rheumatoid arthritis: a qualitative study.

    PubMed

    de Jorge, Mercedes; Parra, Sonia; de la Torre-Aboki, Jenny; Herrero-Beaumont, Gabriel

    2015-08-01

    Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category "Interactional Empowerment" emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: "weight of systematisation", "working together", and the significance of the experience: "the duties". Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive-interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved. PMID:25636236

  19. The effectiveness of antioxidant vitamins C and E in reducing myocardial infarct size in patients subjected to percutaneous coronary angioplasty (PREVEC Trial): study protocol for a pilot randomized double-blind controlled trial

    PubMed Central

    2014-01-01

    Background Acute myocardial infarction (AMI) is the leading cause of mortality worldwide. Oxidative stress has been involved in the ischemia-reperfusion injury in AMI. It has been suggested that reperfusion accounts for up to 50% of the final size of a myocardial infarct, a part of the damage likely to be prevented.Therefore, we propose that antioxidant reinforcement through vitamins C and E supplementation should protect against the ischemia-reperfusion damage, thus decreasing infarct size. The PREVEC Trial (Prevention of reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction) seeks to evaluate whether antioxidant vitamins C and E reduce infarct size in patients subjected to percutaneous coronary angioplasty after AMI. Methods/Design This is a randomized, 1:1, double-blind, placebo-controlled clinical trial. The study takes place at two centers in Chile: University of Chile Clinical Hospital and San Borja Arriarán Clinical Hospital. The subjects will be 134 adults with acute myocardial infarction with indication for percutaneous coronary angioplasty. This intervention is being performed as a pilot study, involving high-dose vitamin C infusion plus oral administration of vitamin E (Vitamin-treatment group) or placebo (Control group) during the angioplasty procedure. Afterward, the Vitamin-treatment group receives oral doses of vitamins C and E, and the Control group receives placebo for 84 days after coronary angioplasty. Primary outcome is infarct size, assessed by cardiac magnetic resonance (CMR), measured 6 and 84 days after coronary angioplasty. Secondary outcomes are ejection fraction, measured 6 and 84 days after coronary angioplasty with CMR, and biomarkers for oxidative stress, antioxidant status, heart damage, and inflammation, which will be measured at baseline, at the onset of reperfusion, 6 to 8 hours after revascularization, and at hospital discharge. Discussion The ischemia-reperfusion event occurring during angioplasty is known to increase myocardial infarct size. The cardioprotective benefits of high doses of vitamin C combined with vitamin E have not been fully explored. The PREVEC Trial seeks to determine the suitability of the therapeutic use of vitamins C and E against the reperfusion damage produced during angioplasty. Patient recruitment opened in February 2013. The trial is scheduled to end in March 2016. Trial registration ISRCTN56034553 PMID:24885600

  20. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial

    Microsoft Academic Search

    H. H. Hartgrink; Velde van de C. J. H; H. Putter; J. J. Bonenkamp; E. Meershoek-Klein Kranenbarg; I. Songun; K. Welvaart; S. Meijer; J. T. M. Plukker; P. J. van Elk; H. Obertop; D. J. Gouma; J. J. B. van Lanschot; C. W. Taat; P. W. de Graaf; M. F. von Meyenfeldt; H. W. Tilanus; M. Sasako

    2004-01-01

    PURPOSE: The extent of lymph node dissection appropriate for gastric cancer is still under debate. We have conducted a randomized trial to compare the results of a limited (D1) and extended (D2) lymph node dissection in terms of morbidity, mortality, long-term survival and cumulative risk of relapse. We have reviewed the results of our trial after follow-up of more than

  1. Barriers and Facilitators to Enrollment in Cancer Clinical Trials: Qualitative Study of the Perspectives of Clinical Research Associates | accrualnet.cancer.gov

    Cancer.gov

    The authors conducted focus groups of Clinical Research Associates (CRAs) to explore their views on barriers and facilitators to clinical trials accrual. CRAs considered “system-related factors” to have the greatest impact on clinical trials accrual as compared to patient- or physician-related factors. They pointed to increasing trial demands with tight timelines as a major impediment.

  2. Differential recruitment in a cluster randomized trial in primary care: the experience of the UK Back pain, Exercise, Active management and Manipulation (UK BEAM) feasibility study

    Microsoft Academic Search

    Amanda Farrin; Ian Russell; David Torgerson; Martin Underwood

    2005-01-01

    Background Cluster randomized trials, which randomize groups of patients rather than individuals, are commonly used to evaluate healthcare interventions such as training programmes targeted at health professionals. This article reports the dangers of randomizing entire primary care practices when participants cannot be identified before randomization, as shown by a UK national trial.Method The UK BEAM trial, a national cluster randomized

  3. Group Therapy for Eating Disorders: A Retrospective Case Study

    Microsoft Academic Search

    Janine Wanlass; J. Kelly Moreno; Hannah M. Thomson

    2005-01-01

    An increasing amount of research supports group therapy as an effective treatment option for eating disorders (Moreno, 1994). In an attempt to further delineate therapeutic factors associated with productive group work, this study represents an exploratory, descriptive analysis of client and therapist perspectives on group process and outcome. Specifically, this retrospective study investigated what clients and their therapist considered important,

  4. Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials

    PubMed Central

    Dwan, Kerry; Altman, Douglas G.; Clarke, Mike; Gamble, Carrol; Higgins, Julian P. T.; Sterne, Jonathan A. C.; Williamson, Paula R.; Kirkham, Jamie J.

    2014-01-01

    Background Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs). Methods and Findings A systematic review was conducted and included cohort studies that assessed any aspect of the reporting of analyses of RCTs by comparing different trial documents, e.g., protocol compared to trial report, or different sections within a trial publication. The Cochrane Methodology Register, Medline (Ovid), PsycInfo (Ovid), and PubMed were searched on 5 February 2014. Two authors independently selected studies, performed data extraction, and assessed the methodological quality of the eligible studies. Twenty-two studies (containing 3,140 RCTs) published between 2000 and 2013 were included. Twenty-two studies reported on discrepancies between information given in different sources. Discrepancies were found in statistical analyses (eight studies), composite outcomes (one study), the handling of missing data (three studies), unadjusted versus adjusted analyses (three studies), handling of continuous data (three studies), and subgroup analyses (12 studies). Discrepancy rates varied, ranging from 7% (3/42) to 88% (7/8) in statistical analyses, 46% (36/79) to 82% (23/28) in adjusted versus unadjusted analyses, and 61% (11/18) to 100% (25/25) in subgroup analyses. This review is limited in that none of the included studies investigated the evidence for bias resulting from selective reporting of analyses. It was not possible to combine studies to provide overall summary estimates, and so the results of studies are discussed narratively. Conclusions Discrepancies in analyses between publications and other study documentation were common, but reasons for these discrepancies were not discussed in the trial reports. To ensure transparency, protocols and statistical analysis plans need to be published, and investigators should adhere to these or explain discrepancies. Please see later in the article for the Editors' Summary PMID:24959719

  5. To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial

    PubMed Central

    Jayaram, Mahesh; Bodart, Angelique Y M; Sampson, Stephanie; Zhao, Sai; Montgomery, Alan A; Adams, Clive E

    2015-01-01

    Introduction The Cochrane Schizophrenia Group (CSzG) has produced and maintained systematic reviews of effects of interventions for schizophrenia and related illness. Each review has a Plain Language Summary (PLS), for those without specialised knowledge, and an abstract, which are freely available from The Cochrane Library (https://summaries.cochrane.org). Increasingly, evidence is being distributed using social media such as Twitter and Weibo (in China) alongside traditional publications. Methods and analysis In a prospective two-arm, parallel, open randomised controlled trial with a 1:1 allocation ratio, we will allocate 170 published systematic reviews into the intervention group (tweeting arm/Weibo arm) versus the control group (non-tweeting arm). Reviews will be stratified by baseline access activity, defined as high (?19 views per week, n=14), medium (4.3 to 18.99 views per week, n=72) or low (<4.3 views per week, n=84), based on Google Analytics, which will also be used for evaluating outcomes. The intervention group will have three tweets daily using Hootsuite with a slightly different accompanying text (written by CEA and AB) and a shortened Uniform Resource Locator (URL) to the PLS: a) The review title as it appears in summaries.cochrane.org, b) A pertinent extract from results or discussion sections of the abstract and c) An intriguing question or pithy statement related to the evidence in the abstract. The primary outcome will be: total number of visits to a PLS in 7?days following the tweet. Secondary outcomes will include % new visits, bounce rate, pages per visit, visit duration, page views, unique page views, time on page, entrances, exiting behaviour and country distribution. Ethics and dissemination This study does not involve living participants, and uses information available in the public domain. Participants are published systematic reviews, hence, no ethical approval is required. Dissemination will be via Twitter, Weibo and traditional academic means. Trial registration number ISRCTN84658943. PMID:26159452