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1

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Retreatment Trial (CRRT). AIDS Clinical Trial Group (ACTG) protocol 228.  

National Technical Information Service (NTIS)

This document contains the study data collection forms for the CMV Retinitis Retreatment Trial (CRRT). These forms also serve as dictionary to the data sets for the trial. The trial was a multicenter, unmasked clinical trial conducted by the Studies of th...

1995-01-01

2

Comparison of Immunologic Assays for Detecting Immune Responses in HIV Immunotherapeutic Studies: AIDS Clinical Trials Group Trial A5181?  

PubMed Central

This study was designed to evaluate which of several T-cell-specific, immune response assays are the most relevant in measuring the key characteristics of an effective immune response to HIV-1. Using 5 HIV-1 antigens as stimulants, we assessed lymphocyte proliferation, supernatant gamma interferon (IFN-?) cytokine production (CP), single-cell IFN-? production by enzyme-linked immunospot (ELISPOT) assay, with and without Epstein-Barr virus-transformed B-lymphoblastoid cell lines (B-LCLs), and intracellular cytokine production (ICC) for IFN-? and interleukin 2 (IL-2) by flow cytometry. We used these to compare specimens from HIV-1-infected subjects who were virally suppressed with a stable antiretroviral therapy (ART) regimen (group A) with specimens from subjects not on ART but with HIV-1 viremia of <3,000 copies/ml (group B). The lymphocyte proliferation assay (LPA) did not significantly differentiate between the two groups. Using fresh peripheral blood mononuclear cells (PBMCs), the CP and ELISPOT assays for IFN-? detected the greatest differences between the two groups, specific for three of the five HIV-1 antigens, whereas significant differences were seen only in response to one antigen when cryopreserved cells were used. The strongest correlations were seen between the CP and ELISPOT assays. The ELISPOT B-LCL assay showed a cell concentration-dependent increase in IFN-? production compared to that shown by the standard ELISPOT assay but did not differentiate between the groups. In the ICC assay, greater numbers of IFN-?-producing T cells were seen in group B, and little or no detectable IL-2 production was seen in both groups. These studies highlight complexities of immunologic monitoring of T-cell responses in multisite clinical trials in HIV infection and outline considerations for optimizing these efforts.

Macatangay, Bernard J. C.; Zheng, Lu; Rinaldo, Charles R.; Landay, Alan L.; Pollard, Richard B.; Pahwa, Savita; Lederman, Michael M.; Bucy, R. Pat

2010-01-01

3

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

Microsoft Academic Search

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

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

1993-01-01

4

NCCTG Study N9741: Leveraging Learning from an NCI Cooperative Group Phase III Trial  

Microsoft Academic Search

N9741 is a clinical trial in patients with metastatic colorec- tal cancer that was originally written in 1997 and com- pleted patient accrual in 2004. One thousand seven hundred thirty-one patients were enrolled in the study. During the conduct of the trial, N9741 was repeatedly modified to adapt to toxicity findings, to add evaluation of oxaliplatin to what was originally

RICHARD M. GOLDBERG; DANIEL J. SARGENT; ROSCOE F. MORTON; HANNA K. SANOFF

5

NCCTG Study N9741: Leveraging Learning from an NCI Cooperative Group Phase III Trial  

PubMed Central

N9741 is a clinical trial in patients with metastatic colorectal cancer that was originally written in 1997 and completed patient accrual in 2004. One thousand seven hundred thirty-one patients were enrolled in the study. During the conduct of the trial, N9741 was repeatedly modified to adapt to toxicity findings, to add evaluation of oxaliplatin to what was originally a trial examining various schedules of irinotecan-based therapy, and to ask evolving questions. The trial led to a new U.S. Food and Drug Administration indication for 5-fluorouracil, leucovorin, and oxaliplatin as indicated for the treatment of previously untreated patients with metastatic colorectal cancer and helped to change the standard of care for the disease in the U.S. and worldwide. The data from the trial have been used to study multiple regimens, pharmacogenetics, and quality of life issues, to correlate plasma protein levels with outcomes, to inform trial methodology, and to perform economic analyses. To date nearly 30 papers and an even larger number of abstracts have been based upon data arising from the study. The history of the trial and the major findings are summarized in this review.

Goldberg, Richard M.; Sargent, Daniel J.; Morton, Roscoe F.; Green, Erin; Sanoff, Hanna K.; Mcleod, Howard; Buckner, Jan

2010-01-01

6

[Improving the quality of reports on randomized controlled trials. Recommendations of the CONSORT Study Group].  

PubMed

This summary corresponds to the translation into Spanish of the Special Communication published in the Journal of the American Medical Association in August 1996, along with the editorial published in the same issue "How to report Randomized Controlled Trials. The Consort Statement". It describes the Consolidated Standards for Preparation of Controlled Clinical Trials, prepared by a work group made up of members of the SORT Group and of the Asilomar Work Group, along with the director of a magazine and the author of the report on a clinical trial. The work was carried out by means of a Delphi process and the result was a check list and a process diagram. The check list is made up of 21 items that mainly refer to methods, results and discussions on the report of a controlled clinical trial, identifying the necessary information in order to be able to evaluate the internal and external value of the report, judging the improvement to be positive for the patient, the editors and the reviewers of the magazines. PMID:9477711

Begg, C; Cho, M; Eastwood, S; Horton, R; Moher, D; Olkin, I; Pitkin, R; Rennie, D; Schulz, K F; Simel, D; Stroup, D F

7

The Preventing Australian Football Injuries with Exercise (PAFIX) Study: a group randomised controlled trial  

PubMed Central

Background: Knee injuries are a major injury concern for Australian Football players and participants of many other sports worldwide. There is increasing evidence from laboratory and biomechanically focused studies about the likely benefit of targeted exercise programmes to prevent knee injuries. However, there have been few international studies that have evaluated the effectiveness of such programmes in the real-world context of community sport that have combined epidemiological, behavioural and biomechanical approaches. Objective: To implement a fully piloted and tested exercise training intervention to reduce the number of football-related knee injuries. In so doing, to evaluate the intervention’s effectiveness in the real-world context of community football and to determine if the underlying neural and biomechanical training adaptations are associated with decreased risk of injury. Setting: Adult players from community-level Australian Football clubs in two Australian states over the 2007–08 playing seasons. Methods: A group-clustered randomised controlled trial with teams of players randomly allocated to either a coach-delivered targeted exercise programme or usual behaviour (control). Epidemiological component: field-based injury surveillance and monitoring of training/game exposures. Behavioural component: evaluation of player and coach attitudes, knowledge, behaviours and compliance, both before and after the intervention is implemented. Biomechanical component: biomechanical, game mobility and neuromuscular parameters assessed to determine the fundamental effect of training on these factors and injury risk. Outcome measures: The rate and severity of injury in the intervention group compared with the control group. Changes, if any, in behavioural components. Process evaluation: coach delivery factors and likely sustainability.

Finch, C; Lloyd, D; Elliott, B

2009-01-01

8

Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods  

PubMed Central

Background Group Cognitive Behavioural Therapy (CBT) may provide a means of improving mental health among people with depression but few studies have explored its effectiveness. Our aim was to examine the feasibility and acceptability of a randomised controlled trial of a group intervention based on CBT principles for women with depression in primary care. Methods Women aged 30 to 55 years were recruited and randomly assigned to either 12 weeks of the group intervention or usual care (control). The group intervention was based on a manual and used CBT and problem solving principles with weekly topics including raising activity levels, spotting and catching negative thoughts, problem solving and relaxation. Women were recruited from deprived areas of Bristol. The groups were run by facilitators with some experience and background in group work and one weeks training in use of the course manual. Assessments of mental health were made using measures including the PHQ-9. Follow-up was at 3 and 6 months after the intervention. Qualitative methods were used to support the design of the intervention and to help understand issues of acceptability and feasibility. Interviews were conducted with all participants at baseline and at 3 and 6 months although detailed qualitative analysis was based on a purposive sample of 20 participants at the 3 time points. Results Of the 86 participants assessed for eligibility, 52 were allocated to the intervention arm and 21 to the control group. The intervention was delivered according to the manual despite the limited training of the facilitators. The intervention was received favourably by participants and facilitators, with good attendance at sessions for those who engaged with the intervention. Follow up rates at 3 and 6 months for women in both the intervention and control arms were also good. The trial methodology used was appropriate and feasible. Conclusions This study showed that a randomised controlled trial of group CBT for women with depression is feasible and the intervention is acceptable, and may possibly prove to be effective in a larger trial. The cost effectiveness of group CBT for depression should be explored further in a full trial. Trial registration NCT00663078

2011-01-01

9

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

Microsoft Academic Search

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.

John F Forbes

10

Group versus individual sessions delivered by a physiotherapist for female urinary incontinence: an interview study with women attending group sessions nested within a randomised controlled trial  

PubMed Central

Background The aim was to explore the concerns and expectations of women invited to attend group physiotherapy sessions for the management of female urinary incontinence and whether the experience changed their views; and to gather recommendations from women attending group sessions on the design and delivery of these sessions Methods An interview study nested within a randomised controlled trial in five British NHS physiotherapy departments, including 22 women who had expressed a preference for an individual physiotherapy session but were randomised to, and attended, group sessions. Results Embarrassment was woven throughout women's accounts of experiencing urinary incontinence and seeking health care. Uncertainty about the nature of group sessions was a source of concern. Attending the first session was seen as a big hurdle by many women. However, a sense of relief was common once the session started, with most women describing some benefit from attendance. Recommendations for design and delivery of the sessions from women focused on reducing embarrassment and uncertainty prior to attendance. Conclusion Taking account of women's embarrassment and providing detailed information about the content of group sessions will enable women to benefit from group physiotherapy sessions for the management of female urinary incontinence. Trial Registration Trial registration number: ISRCTN 16772662

Griffiths, Frances; Pepper, Jo; J?rstad-Stein, Ellen C; Smith, Jan Fereday; Hill, Lesley; Lamb, Sarah (Sallie) E

2009-01-01

11

Studies of the Ocular Complications of AIDS (SOCA). CMV Retinitis Retreatment Trial (CRRT) Handbook (Version 1.0). AIDS Clinical Trials Group (ACTG) 228.  

National Technical Information Service (NTIS)

This document is the study handbook for the CMV Retinitis Retreatment Trial (CRRT). The trial was a multicenter, unmasked clinical trial conducted by the Studies of the Ocular Complications of AIDS (SOCA) in collaboration with the ACTG-228. The study was ...

1995-01-01

12

International Prostate Screening Trials Evaluation Group (IPSTEG)  

Cancer.gov

Key Programs International Prostate Screening Trials Evaluation Group (IPSTEG) Background Information The International Prostate Screening Trial Evaluation Group (IPSTEG) is a collaboration between the researchers in Europe and North America conducting

13

Phase II Trial of Bevacizumab in Recurrent or Persistent Endometrial Cancer: A Gynecologic Oncology Group Study  

PubMed Central

Purpose Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor-A (VEGF-A), has clinical activity in multiple tumor types. We conducted a phase II trial to assess the activity and tolerability of single-agent bevacizumab 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 Gynecologic Oncology Group performance status of ? 2. Treatment consisted of bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression or prohibitive toxicity. VEGF-A was assessed by immunohistochemistry in archival tumor and by enzyme-linked immunosorbent assay in pretreatment plasma. Primary end points were progression-free survival (PFS) at 6 months and overall response rate. Results Fifty-six patients were enrolled. Fifty-two patients were eligible and evaluable. Median age was 62 years, and prior treatment consisted of one or two regimens in 33 (63.5%) and 19 (36.5%) patients, respectively. Twenty-nine patients (55.8%) received prior radiation. Adverse events were consistent with those expected with bevacizumab treatment. No GI perforations or fistulae were seen. Seven patients (13.5%) experienced clinical responses (one complete response and six partial responses; median response duration, 6.0 months), and 21 patients (40.4%) survived progression free for at least 6 months. Median PFS and overall survival times were 4.2 and 10.5 months, respectively. Suggested associations were observed between high VEGF-A and adjusted hazard of death or tumor response when evaluated in tumor/plasma or plasma, respectively. Conclusion Bevacizumab is well tolerated and active based on PFS at 6 months in recurrent or persistent EMC and warrants further investigation.

Aghajanian, Carol; Sill, Michael W.; Darcy, Kathleen M.; Greer, Benjamin; McMeekin, D. Scott; Rose, Peter G.; Rotmensch, Jacob; Barnes, Mack N.; Hanjani, Parviz; Leslie, Kimberly K.

2011-01-01

14

The MATISSE study: a randomised trial of group art therapy for people with schizophrenia  

Microsoft Academic Search

BACKGROUND: Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study

Mike J Crawford; Helen Killaspy; Eleftheria Kalaitzaki; Barbara Barrett; Sarah Byford; Sue Patterson; Tony Soteriou; Francis A O'Neill; Katie Clayton; Anna Maratos; Thomas R Barnes; David Osborn; Tony Johnson; Michael King; Peter Tyrer; Diana Waller

2010-01-01

15

Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial  

PubMed Central

The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the ? VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911.

Gimsing, Peter; Hjertner, Oyvind; Lenhoff, Stig; Laane, Edward; Remes, Kari; Steingrimsdottir, Hlif; Abildgaard, Niels; Ahlberg, Lucia; Blimark, Cecilie; Dahl, Inger Marie; Forsberg, Karin; Gedde-Dahl, Tobias; Gregersen, Henrik; Gruber, Astrid; Guldbrandsen, Nina; Haukas, Einar; Carlson, Kristina; Kvam, Ann Kristin; Nahi, Hareth; Lindas, Roald; Andersen, Niels Frost; Turesson, Ingemar; Waage, Anders; Westin, Jan; Gregersen, Henrik; Frost Andersen, Niels; Gimsing, Peter; Toffner-Clausen, Nilsaage; Abildgaard, Niels; Laane, Edward; Silvennoinen, Raija; Remes, Kari; Steingrimsdottir, Hlif; Lindas, Roald; Gedde-Dahl, Tobias; Guldbrandsen, Nina; Kristin Kvam, Ann; Haukas, Einar; Marie Dahl, Inger; Hjertner, Oyvind; Waage, Anders; Blimark, Cecilie; Mellqvist, Ulf-Henrik; Westin, Jan; Ahlberg, Lucia; Lenhoff, Stig; Turesson, Ingemar; Linder, Olle; Gruber, Astrid; Nahi, Hareth; Forsberg, Karin; Carlson, Kristina

2013-01-01

16

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

PubMed Central

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.

2012-01-01

17

A phase II trial of edatrexate in previously treated ovarian cancer. A Gynecologic Oncology Group study.  

PubMed

Twenty-two patients with recurrent ovarian cancer were entered into a Phase II trial of edatrexate at a dose of 80 mg/m2 i.v. weekly for five consecutive weeks. One patient received an inadequate trial, and six did not complete one cycle due to adverse effects. There were 21 patients evaluable for toxicity and 15 for response. There were no objective responses, 10/15 (67%) had stable disease, 5/15 (33%) increasing disease. Toxicity was predominantly stomatitis and hematologic. Two patients developed skin rashes, and one experienced pulmonary toxicity felt to be related to the drug. Edatrexate administered in this dose and schedule has no demonstrated activity, but moderately severe toxicity in patients with previously treated advanced ovarian cancer. PMID:7900709

Broun, E R; Iseminger, K A; Bookman, M

1995-04-01

18

AIDS Clinical Trials Group Study (ACTG 051): A Double-Blind Placebo-Controlled Trial to Evaluate Intravenous Gamma Globulin in Children with Symptomatic HIV Infection Receiving Zidovudine (for Microcomputers).  

National Technical Information Service (NTIS)

The AIDS Clinical Trials Group Study 051 is a randomized, double-blinded, placebo-controlled Phase III study for children (ages 3 months through 12 years) with AIDS or advanced ARC. Patients received either zidovudine plus monthly intravenous immunoglobul...

1997-01-01

19

Use of Brief Instructional Trials to Identify Small Group Reading Strategies: A Two Experiment Study  

Microsoft Academic Search

The Instructional Hierarchy (IH) has proven useful for understanding the functional properties of empirically valid instructional\\u000a strategies. Investigators have relied heavily on the IH as a heuristic in conceptualizing instructional components used in\\u000a brief experimental analyses. To date, only one investigation has applied brief experimental analysis results to small group\\u000a reading interventions. The purpose of this paper is to describe

Merilee McCurdy; Edward Daly; Valerie Gortmaker; Christine Bonfiglio; Michael Persampieri

2007-01-01

20

Incidence of Pancreatitis in HIV-1-Infected Individuals Enrolled in 20 Adult AIDS Clinical Trials Group Studies  

PubMed Central

Objective To report on the incidence of clinical- and laboratory-defined pancreatitis in HIV-1–infected individuals treated with antiretrovirals (ARVs). Methods Pancreatitis incidence rates were calculated based on a Poisson distribution for subjects enrolled in 1 or more of 20 Adult AIDS Clinical Trials Group studies from October 1989 through July 1999. Results A total of 8451 subjects were enrolled. The overall pancreatitis rates were 0.61 per 100 person-years (PYs) clinical and 2.23 per 100 PYs clinical/laboratory. Pancreatitis rates for single, dual, and triple nucleoside reverse transcriptase inhibitors (NRTIs) were similar. Rates of pancreatitis in didanosine (ddI) arms seemed to be dose dependent. Pancreatitis rates in ddI/hydroxyurea (HU) arms were not significantly different from the rates for ddI alone. Overall pancreatitis rates for ddI/stavudine (d4T) trials were high at 4.16 per 100 PYs clinical and 6.25 per 100 PYs clinical/laboratory. The highest rates were seen with the combination of indinavir (IDV)/ddI/d4Twith or without HU. Conclusions The combination of NRTIs and definition has an impact on the incidence of pancreatitis. Standardization of definition and more comprehensive evaluations are needed to determine how much of this pancreatitis is directly caused by ARVs and how much is attributable to preexisting comorbidities and other known risk factors.

Reisler, Ronald B.; Murphy, Robert L.; Redfield, Robert R.; Parker, Robert A.

2005-01-01

21

Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria  

PubMed Central

Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge.

Segal, Brahm H.; Herbrecht, Raoul; Stevens, David A.; Ostrosky-Zeichner, Luis; Sobel, Jack; Viscoli, Claudio; Walsh, Thomas J.; Maertens, Johan; Patterson, Thomas F.; Perfect, John R.; Dupont, Bertrand; Wingard, John R.; Calandra, Thierry; Kauffman, Carol A.; Graybill, John R.; Baden, Lindsey R.; Pappas, Peter G.; Bennett, John E.; Kontoyiannis, Dimitrios P.; Cordonnier, Catherine; Viviani, Maria Anna; Bille, Jacques; Almyroudis, Nikolaos G.; Wheat, L. Joseph; Graninger, Wolfgang; Bow, Eric J.; Holland, Steven M.; Kullberg, Bart-Jan; Dismukes, William E.; De Pauw, Ben E.

2009-01-01

22

Immunogenetics of CD4 lymphocyte count recovery during antiretroviral therapy: An AIDS Clinical Trials Group study.  

PubMed

During antiretroviral therapy, CD4 lymphocyte count increases are modest in some patients despite virologic control. We explored whether polymorphisms in genes important for T cell expansion, survival, and apoptosis are associated with the magnitude of CD4 lymphocyte count recovery during antiretroviral therapy. We studied treatment-naive individuals who achieved sustained control of plasma viremia (<400 HIV-1 RNA copies/mL) for at least 48 weeks after initiation of antiretroviral therapy and compared genotypes among individuals who had an increase of either <200 or > or =200 CD4 cells/mm3 from baseline. A total of 137 single-nucleotide polymorphisms across 17 genes were characterized in 873 study participants. In multivariate analyses that controlled for clinical variables, polymorphisms in genes encoding tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL), TNF- alpha , Bcl-2-interacting molecule (Bim), interleukin (IL)-15, and IL-15 receptor alpha chain (IL-15R alpha ) were associated with the magnitude of the increase in CD4 lymphocyte count, as were haplotypes in genes encoding interferon- alpha , IL-2, and IL-15R alpha (P < .05, for each). Multifactor dimensionality reduction identified a gene-gene interaction between IL-2/IL-15 receptor common beta chain and IL-2/IL-7/IL-15 receptor common gamma chain. Immune recovery during antiretroviral therapy is a complex phenotype that is influenced by multiple genetic variants. Future studies should validate these tentative associations and define underlying mechanisms. PMID:16991084

Haas, David W; Geraghty, Daniel E; Andersen, Janet; Mar, Jessica; Motsinger, Alison A; D'Aquila, Richard T; Unutmaz, Derya; Benson, Constance A; Ritchie, Marylyn D; Landay, Alan

2006-09-06

23

Cooperative study group for childhood acute lymphoblastic leukaemia (COALL): long-term results of trials 82,85,89,92 and 97  

Microsoft Academic Search

In this study, the long-term outcome of 1818 patients treated in five consecutive clinical trials (the cooperative study group for childhood acute lymphoblastic leukaemia (COALL) 82, 85, 89, 92 and 97) from 24 cooperating centres in Germany is reported. The probability of event-free survival (pEFS) improved significantly from the first two trials conducted in the 1980s (COALL 82 and COALL

G Escherich; M A Horstmann; M Zimmermann; G E Janka-Schaub

2010-01-01

24

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

PubMed

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

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

2013-09-17

25

HIV-1 Protease Inhibitors and Clinical Malaria: a Secondary Analysis of the AIDS Clinical Trials Group A5208 Study  

PubMed Central

HIV-1 protease inhibitors (PIs) have antimalarial activity in vitro and in murine models. The potential beneficial effect of HIV-1 PIs on malaria has not been studied in clinical settings. We used data from Adult AIDS Clinical Trials Group A5208 sites where malaria is endemic to compare the incidence of clinically diagnosed malaria among HIV-infected adult women randomized to either lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) or to nevirapine (NVP)-based ART. We calculated hazard ratios and 95% confidence intervals. We conducted a recurrent events analysis that included both first and second clinical malarial episodes and also conducted analyses to assess the sensitivity of results to outcome misclassification. Among the 445 women in this analysis, 137 (31%) received a clinical diagnosis of malaria at least once during follow-up. Of these 137, 72 (53%) were randomized to LPV/r-based ART. Assignment to the LPV/r treatment group (n = 226) was not consistent with a large decrease in the hazard of first clinical malarial episode (hazard ratio = 1.11 [0.79 to 1.56]). The results were similar in the recurrent events analysis. Sensitivity analyses indicated the results were robust to reasonable levels of outcome misclassification. In this study, the treatment with LPV/r compared to NVP had no apparent beneficial effect on the incidence of clinical malaria among HIV-infected adult women. Additional research concerning the effects of PI-based therapy on the incidence of malaria diagnosed by more specific criteria and among groups at a higher risk for severe disease is warranted.

Cole, Stephen R.; Eron, Joseph J.; Zheng, Yu; Hughes, Michael D.; Lockman, Shahin; Poole, Charles; Skinner-Adams, Tina S.; Hosseinipour, Mina; Shaffer, Doug; D'Amico, Ronald; Sawe, Frederick K.; Siika, Abraham; Stringer, Elizabeth; Currier, Judith S.; Chipato, Tsungai; Salata, Robert; McCarthy, James S.; Meshnick, Steven R.

2012-01-01

26

AIDS Clinical Trials Group 002: Analysis Data Set (for Microcomputers).  

National Technical Information Service (NTIS)

The Phase III study, called ACTG 002, was carried out by the AIDS Clinical Trials Group. The aim of the study was to evaluate the efficacy and safety of a reduced dose of AZT compared to the standard dose of AZT. A randomized controlled trial was conducte...

1993-01-01

27

A phase II trial of edatrexate in previously treated squamous cell cervical cancer: a Gynecologic Oncology Group study.  

PubMed

A Phase II trial of edatrexate in patients with recurrent cervical carcinoma was conducted by the Gynecologic Oncology Group (GOG). Twenty patients were treated with edatrexate at a dose of 80 mg/m2 i.v. weekly for 5 consecutive weeks per cycle. Four patients received an inadequate trial and were inevaluable for response. Among the 16 patients evaluable for response, there were no objective responses: 50% had stable disease, 50% had progressive disease. All 20 patients were evaluable for toxicity, predominantly stomatitis and bone marrow suppression were substantial. Grades 3-4 bone marrow toxicity were observed in eight of 20 (40%) patients, and there were two deaths due to neutropenic sepsis. Fanconi's syndrome, possibly treatment related, was seen in two patients. Edatrexate administered in this dose and schedule has no demonstrated activity and has severe toxicity in patients with previously-treated advanced cervical cancer. PMID:9020294

Broun, E R; Iseminger, K A; Rose, P G; Lentz, S L; Malfetano, J H; Lincoln, S; Mannel, R

1997-02-01

28

Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group.  

PubMed

Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance. PMID:10394415

Sauerwein, W; Moss, R; Rassow, J; Stecher-Rasmussen, F; Hideghéty, K; Wolbers, J G; Sack, H

1999-06-01

29

The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial  

PubMed Central

Background Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. Methods A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected through interviews. Trial registration ISRCTN: ISRCTN01805825

2011-01-01

30

The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial  

Microsoft Academic Search

BACKGROUND: Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. METHODS: The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n

Ulla Toft; Lis Kristoffersen; Steen Ladelund; Lars Ovesen; Cathrine Lau; Charlotta Pisinger; Lisa Smith; Knut Borch-Johnsen; Torben Jørgensen

2008-01-01

31

Roadmap for the European Network of Gynaecological Trial groups (ENGOT) Trials.  

PubMed

The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided. PMID:23970159

Vergote, Ignace; Elser, Gabriele; Votan, Benedicte; Farrelly, Laura; De Roover, Joke; Bryce, Jane; du Bois, Andreas

2013-09-01

32

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

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.

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

2013-01-01

33

Phase II trial of vorinostat in combination with bortezomib in recurrent glioblastoma: a north central cancer treatment group study  

PubMed Central

Vorinostat, a histone deacetylase (HDAC) inhibitor, has shown evidence of single-agent activity in glioblastoma (GBM), and in preclinical studies, we have demonstrated significant synergistic cytotoxicity between HDAC inhibitors and proteasome inhibitors in GBM cell lines. We therefore conducted a phase II trial to evaluate the efficacy of vorinostat in combination with the proteasome inhibitor bortezomib in patients with recurrent GBM. Vorinostat was administered at a dose of 400 mg daily for 14 days of a 21-day cycle, and bortezomib was administered at a dose of 1.3 mg/m2 intravenously on days 1, 4, 8, and 11 of the cycle. A total of 37 patients were treated, and treatment was well tolerated: grade 3, 4 nonhematologic toxicity occurred in 30% of patients and consisted mainly of fatigue (14%) and neuropathy (5%); grade 3, 4 hematologic toxicity occurred in 37% of patients and consisted of thrombocytopenia (30%), lymphopenia (4%), and neutropenia (4%). The trial was closed at the predetermined interim analysis, with 0 of 34 patients being progression-free at 6 months. One patient achieved a partial response according to the Macdonald criteria. The median time to progression for all patients was 1.5 months (range, 0.5–5.6 months), and median overall survival (OS) was 3.2 months. Patients who had received prior bevacizumab therapy had a shorter time to progression and OS, compared with those who had not. On the basis of the results of this phase II study, further evaluation of the vorinostat-bortezomib combination in GBM patients in this dose and schedule is not recommended.

Friday, Bret B.; Anderson, S. Keith; Buckner, Jan; Yu, Chunrong; Giannini, Caterina; Geoffroy, Francois; Schwerkoske, John; Mazurczak, Miroslaw; Gross, Howard; Pajon, Eduardo; Jaeckle, Kurt; Galanis, Evanthia

2012-01-01

34

A group-randomized tobacco trial among 30 Pacific Northwest colleges: Results from the Campus Health Action on Tobacco study  

PubMed Central

Introduction: We conducted a group-randomized trial to increase smoking cessation and decrease smoking onset and prevalence in 30 colleges and universities in the Pacific Northwest. Methods: Random samples of students, oversampling for freshmen, were drawn from the participating colleges; students completed a questionnaire that included seven major areas of tobacco policies and behavior. Following this baseline, the colleges were randomized to intervention or control. Three interventionists developed Campus Advisory Boards in the 15 intervention colleges and facilitated intervention activities. The freshmen cohort was resurveyed 1 and 2 years after the baseline. Two-years postrandomization, new cross-sectional samples were drawn, and students were surveyed. Results: At follow-up, we found no significant overall differences between intervention and control schools when examining smoking cessation, prevalence, or onset. There was a significant decrease in prevalence in private independent colleges, a significant increase in cessation among rural schools, and a decrease in smoking onset in urban schools. Discussion: Intervention in this college population had mixed results. More work is needed to determine how best to reach this population of smokers.

McLerran, Dale; Livaudais, Jennifer C.; Coronado, Gloria D.

2010-01-01

35

Phase II study of Triapine in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161).  

PubMed

Triapine is a novel small molecule ribonucleotide reductase inhibitor that showed activity in renal cell carcinoma (RCC) cell lines. Evaluating new agents with novel mechanisms remains of interest for patients with incurable RCC. This was a single-arm, multicentre phase II trial where Triapine was given at a schedule of 96 mg/m2 2-h infusion daily x 4 repeated every 2 weeks in patients with recurrent RCC. A median of four cycles of Triapine was administered to 19 eligible patients. One response was seen (7%.) Median time to progression was 3.6 months. Common adverse events (AEs) were grade 1-2, with fatigue in 74%, nausea in 68% and vomiting in 58%. However grade 3/4 neutropenia was seen in 79% and acute reactions of hypoxia, hypotension, methemoglobinemia were seen. Dose reductions/delays due to AEs were common with only 47% of patients receiving > 90% of planned dose intensity. The study closed, at the end of stage 1 as it did not meet the minimal efficacy criteria to proceed. Further evaluation of Triapine at this dose and schedule in patients with advanced kidney cancer is not recommended. PMID:17393073

Knox, Jennifer J; Hotte, Sebastien J; Kollmannsberger, Christian; Winquist, Eric; Fisher, Bryn; Eisenhauer, Elizabeth A

2007-03-28

36

Is chemotherapy necessary for premenopausal women with lower-risk node-positive, endocrine responsive breast cancer? 10-year update of International Breast Cancer Study Group Trial 11-93  

Microsoft Academic Search

Introduction International Breast Cancer Study Group (IBCSG) Trial 11-93 is the largest trial evaluating the role of the addition of chemotherapy\\u000a to ovarian function suppression\\/ablation (OFS) and tamoxifen in premenopausal patients with endocrine-responsive early breast\\u000a cancer. Methods IBCSG Trial 11-93 is a randomized trial comparing four cycles of adjuvant chemotherapy (AC: doxorubicin or epirubicin, plus\\u000a cyclophosphamide) added to OFS and

Beat Thürlimann; Karen N. Price; Richard D. Gelber; Stig B. Holmberg; Diana Crivellari; Marco Colleoni; John Collins; John F. Forbes; Monica Castiglione-Gertsch; Alan S. Coates; Aron Goldhirsch

2009-01-01

37

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

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

2011-01-01

38

Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the German CLL Study Group CLL3 trial.  

PubMed

The CLL3 trial was designed to study intensive treatment including autologous stem cell transplantation (autoSCT) as part of first-line therapy in patients with chronic lymphocytic leukemia (CLL). Here, we present the long-term outcome of the trial with particular focus on the impact of genomic risk factors, and we provide a retrospective comparison with patients from the fludarabine-cyclophosphamide-rituximab (FCR) arm of the German CLL Study Group (GCLLSG) CLL8 trial. After a median observation time of 8.7 years (0.3-12.3 years), median progression-free survival (PFS), time to retreatment, and overall survival (OS) of 169 evaluable patients, including 38 patients who did not proceed to autoSCT, was 5.7, 7.3, and 11.3 years, respectively. PFS and OS were significantly reduced in the presence of 17p- and of an unfavorable immunoglobulin heavy variable chain mutational status, but not of 11q-. Five-year nonrelapse mortality was 6.5%. When 110 CLL3 patients were compared with 126 matched patients from the FCR arm of the CLL8 trial, 4-year time to retreatment (75% vs 77%) and OS (86% vs 90%) was similar despite a significant benefit for autoSCT in terms of PFS. In summary, early treatment intensification including autoSCT can provide very effective disease control in poor-risk CLL, although its clinical benefit in the FCR era remains uncertain. The trial has been registered with www.clinicaltrials.gov as NCT00275015. PMID:22490331

Dreger, Peter; Döhner, Hartmut; McClanahan, Fabienne; Busch, Raymonde; Ritgen, Matthias; Greinix, Hildegard; Fink, Anna-Maria; Knauf, Wolfgang; Stadler, Michael; Pfreundschuh, Michael; Dührsen, Ulrich; Brittinger, Günter; Hensel, Manfred; Schetelig, Johannes; Winkler, Dirk; Bühler, Andreas; Kneba, Michael; Schmitz, Norbert; Hallek, Michael; Stilgenbauer, Stephan

2012-04-05

39

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

PubMed Central

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

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

2009-01-01

40

Reactogenicity and immunogenicity of a new combined measles-mumps-rubella vaccine: results of a multicentre trial. The Cooperative Group for the Study of MMR vaccines.  

PubMed

A large single blind, multi-centre study involving 1779 children was performed in Italy. Infants, aged between 12 and 27 months were divided between two groups: group A received a single dose of a new MMR vaccine, 'Priorix'(3), while group B received a widely used MMR vaccine, Triviraten(4). Solicited local and general symptoms were recorded using diary cards and antibody levels were measured, prior to and 60 days post-vaccination, using ELISA assays. The incidence of solicited symptoms (evaluated in 1754 subjects) was comparable between groups, with the exception of fever which was significantly lower in group B. Immunogenicity was evaluated in 686 subjects. Of note, was the significantly higher anti-mumps seroconversion rate (p<0.001) observed in group A (97.0%) compared to group B (35.4%). However the anti-measles and anti-rubella seroconversion rates were equivalent between groups. Significantly higher (p<0.001) post-vaccination GMTs were in group A vs group B for anti-measles (2830 vs 784 IU/ml) and anti-mumps (1640 vs 469 U/ml), however the anti-rubella GMTs were significantly higher (p<0.001) in group B (117.6 IU/ml) compared to group A (92.6 IU/ml). The persistence of antibodies in 35 subjects was assessed 1 year after vaccination and the results showed no appreciable decline in titres with either vaccine. The trial demonstrates 'Priorix' is well tolerated and highly immunogenic. PMID:10812221

Crovari, P; Gabutti, G; Giammanco, G; Dentico, P; Moiraghi, A R; Ponzio, F; Soncini, R

2000-06-15

41

A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer  

PubMed Central

Background: This multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer. Methods: Eligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy. Patients were randomly assigned at a 1?:?1 ratio to either the gemcitabine group or the surgery-only group. Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000?mg?m?2 over 30?min on days 1, 8 and 15, every 4 weeks for 3 cycles. Results: Between April 2002 and March 2005, 119 patients were enrolled in this study. Among them, 118 were eligible and analysable (58 in the gemcitabine group and 60 in the surgery-only group). Both groups were well balanced in terms of baseline characteristics. Although heamatological toxicity was frequently observed in the gemcitabine group, most toxicities were transient, and grade 3 or 4 non-heamatological toxicity was rare. Patients in the gemcitabine group showed significantly longer disease-free survival (DFS) than those in the surgery-only group (median DFS, 11.4versus 5.0 months; hazard ratio=0.60 (95% confidence interval (CI): 0.40–0.89); P=0.01), although overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 versus 18.4 months; hazard ratio=0.77 (95% CI: 0.51–1.14); P=0.19). Conclusion: The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.

Ueno, H; Kosuge, T; Matsuyama, Y; Yamamoto, J; Nakao, A; Egawa, S; Doi, R; Monden, M; Hatori, T; Tanaka, M; Shimada, M; Kanemitsu, K

2009-01-01

42

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

PubMed Central

Women in drug treatment struggle with co-occurring problems, including trauma and posttraumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA’s Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women’s health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

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

2009-01-01

43

Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)  

PubMed Central

Introduction Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15?h, spread over 3?days, with a –2?h follow-up session 2?weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12?months postrandomisation. Pain self-efficacy is measured at 3?months to assess whether change mediates clinical effect. Ethics/dissemination Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration ISRCTN24426731.

Carnes, Dawn; Taylor, Stephanie JC; Homer, Kate; Eldridge, Sandra; Bremner, Stephen; Pincus, Tamar; Rahman, Anisur; Underwood, Martin

2013-01-01

44

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

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

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

45

Defining the optimal treatment strategy for localized prostate cancer patients: a survey of ongoing studies at the National Cancer Institute of Canada Clinical Trials Group  

PubMed Central

The designation “clinically localized prostate cancer” comprises a group of biologically heterogeneous tumours with different growth rates and risks of relapse. Because prostate cancer is primarily a disease of older men, treatment selection must take into account the prognosis of the tumour, patient age, comorbidities, side effects of treatment, and patient preferences. Clinical trials must identify the various prognostic groups and test the appropriate treatment strategies within these subgroups.

Parulekar, W.R.; McKenzie, M.; Chi, K.N.; Klotz, L.; Catton, C.; Brundage, M.; Ding, K.; Hiltz, A.; Meyer, R.; Saad, F.

2008-01-01

46

A phase II trial of vincristine in advanced or recurrent endometrial carcinoma. A Gynecologic Oncology Group Study.  

PubMed

Thirty-three evaluable patients who had not received prior chemotherapy were entered on a study of vincristine therapy for advanced or recurrent endometrial carcinoma. Vincristine 1.4 mg/m2 was given weekly as an i.v. bolus for 4 weeks and then every other week. There was one complete response (CR) lasting 5 months. Five patients had partial responses (PR) lasting 3-18 months. The CR+PR rate was 18% (95% confidence interval for CR+PR was 7-36%). Thirteen patients (38%) had stable disease from 2-28 months, and 14 had progressive disease. The major toxicity was neurological, with 11 patients having grade 2 or 3 peripheral neuropathy. Vincristine at this dose and schedule has modest activity, but troublesome toxicity in advanced or recurrent endometrial carcinoma. PMID:8424397

Broun, G O; Blessing, J A; Eddy, G L; Adelson, M D

1993-02-01

47

Epirubicin-vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial  

PubMed Central

The aim of the study was to compare our reference adjuvant chemotherapy, FEC100 (fluorouracil 500?mg?m?2, epirubicin 100?mg?m?2 and cyclophosphamide 500?mg?m?2, six cycles every 21 days), to an epirubicin–vinorelbine (Epi-Vnr) combination for early, poor-prognosis breast cancer patients. Patients (482) were randomised to receive FEC100, or Epi-Vnr (epirubicin 50?mg?m?2 day 1 and vinorelbine 25?mg?m?2, days 1 and 8, six cycles every 21 days). The 7-year disease-free survival rates were 59.4 and 58.8%, respectively (P=0.47). The relative dose intensity of planned epirubicin doses was 89.1% with FEC100 and 88.9% with Epi-Vnr. There were significantly more grades 3–4 neutropenia (P=0.009) with Epi-Vnr, and significantly more nausea-vomiting (P<0.0001), stomatitis (P=0.0007) and alopecia (P<0.0001) with FEC100. No cases of congestive heart failure were reported, whereas four decreases in left ventricular ejection fraction occurred after FEC100 and five after Epi-Vnr. One case of acute myeloblastic leukaemia was registered in the FEC100 arm. After 7 years of follow-up, there was no difference between treatment arms. Epi-Vnr regimen provided a good efficacy in such poor-prognosis breast cancer patients, and could be an alternative to FEC100, taking into account respective safety profiles of both regimens.

Kerbrat, P; Roche, H; Bonneterre, J; Veyret, C; Lortholary, A; Monnier, A; Fumoleau, P; Fargeot, P; Namer, M; Chollet, P; Goudier, M-J; Audhuy, B; Simon, H; Montcuquet, P; Eymard, J-C; Walter, S; Clavere, P; Guastalla, J-P

2007-01-01

48

Mitochondrial Genomics and CD4 T-cell Count Recovery after Antiretroviral Therapy Initiation in AIDS Clinical Trials Group Study 384  

PubMed Central

BACKGROUND Mitochondrial DNA (mtDNA) variation has been associated with time to progression to AIDS and adverse effects from antiretroviral therapy (ART). In this study, full mitochondrial DNA (mtDNA) sequence data from U.S.-based adult participants in the AIDS Clinical Trials Group (ACTG) study 384 was used to assess associations between mtDNA variants and CD4 T cell recovery with ART. METHODS Full mtDNA sequence was determined using chip-based array sequencing. Sequence and CD4 cell count data was available at baseline and after ART initiation for 423 subjects with HIV RNA levels <400copies/mL plasma. The primary outcome was change in CD4 count of ?100 cells/mm3 from baseline. Analyses were adjusted for baseline age, CD4 cell count, HIV RNA, and naïve:memory CD4 cell ratio. RESULTS Race-stratified analysis of mtDNA variants with a minor allele frequency >1% revealed multiple mtDNA variants marginally associated (P < 0.05 before Bonferroni correction) with CD4 cell recovery. The most significant SNP associations were those tagging the African L2 haplogroup, which was associated with a decreased likelihood of ?100 cells/mm3 CD4 count increase at week 48 in non-Hispanic blacks (adjusted OR=0.17; 95% CI=0.06–0.53; P=0.002). CONCLUSIONS An African mtDNA haplogroup was associated with CD4 cell recovery after ART in this clinical trial population. These initial findings warrant replication and further investigation in order to confirm the role of mtDNA variation in CD4 cell recovery during ART.

Grady, Benjamin J.; Samuels, David C.; Robbins, Gregory K.; Selph, Doug; Canter, Jeffrey A.; Pollard, Richard B.; Haas, David W.; Shafer, Robert; Kalams, Spyros A.; Murdock, Deborah G.; Ritchie, Marylyn D.; Hulgan, Todd

2011-01-01

49

Dialysis patients treated with Epoetin ? show improved exercise tolerance and physical function: A new analysis of the Canadian Erythropoietin Study Group trial.  

PubMed

The risks/benefits of anemia treatment in dialysis patients have been redefined in the US Epoetin ? label. This analysis was carried out to determine if increasing hemoglobin (Hb) levels improve exercise tolerance and physical function in anemic dialysis patients. This is a new analysis of the Canadian Erythropoietin Study Group trial, a double-blind, randomized, placebo-controlled trial in dialysis patients. Subjects were 18 to 75 years old, on hemodialysis for >3 months, and had a baseline Hb <9.0?g/dL. Patients with a history of diabetes mellitus, ischemic heart disease, or severe/uncontrolled hypertension were excluded. Patients were randomized to receive Epoetin ? to a target Hb of 9.5 to 11.0?g/dL (n=40) or a target of 11.5 to 13.0?g/dL (n=38), or receive placebo (n=40). Results from patients in the Epoetin-?-treated arms were combined for this analysis. Hb level, exercise tolerance (Treadmill Stress Test and 6-Minute Walk Test) and patient-reported physical function measures (Physical Summary domain from the Kidney Disease Questionnaire, and 4 domains from the Sickness Impact Profile) were reported at baseline and months 2, 4, and 6. Differences in measures were statistically significant for exercise tolerance (Treadmill Stress, P=0.0001) and patient-reported physical function (Kidney Disease Questionnaire Physical, P=0.0001; Sickness Impact Profile Physical, P=0.0015) across all time points for Epoetin-?-treated patients compared with placebo. Improvements were seen at 2 months and were maintained through months 4 and 6. Dialysis patients receiving Epoetin ? showed improved exercise tolerance and physical function. These findings should be considered as physicians weigh the risks and benefits of treatment. PMID:21138518

Muirhead, Norman; Keown, Paul A; Churchill, David N; Poulin-Costello, Melanie; Gantotti, Sandeep; Lei, Lei; Gitlin, Matthew; Mayne, Tracy J

2010-12-01

50

Salmeterol compared with slow-release terbutaline in nocturnal asthma. A multicenter, randomized, double-blind, double-dummy, sequential clinical trial. French Multicenter Study Group.  

PubMed

The aim of the multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial with a 2-week treatment period was to compare the efficacy and safety of salmeterol (50 micrograms twice daily) with slow-release (SR) terbutaline (5 mg orally, twice daily) in nocturnal asthma. A total of 159 asthmatic adults (FEV, 50-90% of predicted value; sex ratio: 0.87) with at least two nocturnal awakenings during a 7-d run-in period was included in the study. Patients were centrally randomized with a national computer network (Minitel). The main variable (number of awakening-free nights during the last week of treatment) was analyzed according to a sequential method with the one-sided triangular test. The number of awakening-free nights (+/- SD) was significantly higher in the salmeterol group: 5.3 +/- 2.4 vs 4.6 +/- 2.3 (P = 0.006). Salmeterol was significantly more effective than SR-terbutaline in the following factors: number of patients without any awakening during the last week of treatment (50% vs 27%, P = 0.003), mean morning PEF (351 +/- 109 l/min-1 vs 332 +/- 105 l/min-1, P = 0.04), PEF diurnal variation 6 +/- 10% vs 11 +/- 12%, P = 0.01), overall assessment of efficacy by the patient and the investigator (P = 0.001 and 0.005, respectively), and daily rescue salbutamol intakes (P = 0.004). In the salmeterol group, significantly fewer patients reported adverse events (16% vs 29%, P = 0.04).(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7915501

Brambilla, C; Chastang, C; Georges, D; Bertin, L

1994-07-01

51

Web-Based, Cross-Group Registration for Clinical Trials Piloted for NCI's Cooperative Group Members Cancer Trial Support Unit Could Expand to Other Physicians in 2001  

Cancer.gov

Oncologists who belong to the National Cancer Institute's (NCI's) Cooperative Groups can now register online for selected phase III studies in a pilot project intended to streamline and simplify many of the tasks associated with clinical trials.

52

The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.  

PubMed

PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also significantly improved self-reported productivity. CONCLUSION. An effective intervention can change employee health risk status and activation both at the population level and at the individual high risk level. However, program engagement at the population level was low, indicating that additional promotional strategies, such as greater use of incentives, need to be examined. Less intensive coaching can be as effective as more intensive, albeit both interventions produced modest behavior change and retention in the consumer activation arm was most difficult. Further research is needed concerning recruitment and retention methods that will enable populations to realize the full potential of activated consumerism. PMID:22040398

Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

53

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 Central

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.

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

2012-01-01

54

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

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

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

2012-07-24

55

Design of Group Sequential Clinical Trials with Multiple Endpoints  

Microsoft Academic Search

Group sequential testing for randomized clinical trials designed with multiple endpoints is considered. Previously computed tables for single endpoints are still useful, with a change in interpretation of certain parameters. The advantage in setting sample size based on multiple endpoints is that the sample size required when a trial is designed using more than one endpoint is smaller than the

Dei-In Tang; Clare Gnecco; Nancy L. Geller

1989-01-01

56

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

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.

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

57

Are Randomized Control Trial Outcomes Influenced by the Inclusion of a Placebo Group?  

Microsoft Academic Search

Placebo groups are often included in randomized control trials evaluating drug therapy, yet we know little about the placebo effect. The purpose of our study was to evaluate how the presence of a placebo group in a randomized control trial (RCT) influences the patients’ ratings of the efficacy of an active drug therapy and their reporting of its adverse effects.

Paula A. Rochon; Malcolm A. Binns; Jason A. Litner; Geoffrey M. Litner; Michelle S. Fischbach; David Eisenberg; Ted J. Kaptchuk; William B. Stason; Thomas C. Chalmers

1999-01-01

58

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial  

PubMed Central

Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

2013-01-01

59

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

PubMed

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

Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

2013-01-07

60

A phase I/II study of sorafenib in combination with low dose cytarabine in elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome from the National Cancer Institute of Canada Clinical Trials Group: trial IND.186.  

PubMed

Sorafenib is active in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The National Cancer Institute of Canada (NCIC) Clinical Trials Group initiated a phase I/II study of the combination of sorafenib with cytarabine in older patients with AML or high-risk MDS who were unsuitable for intensive chemotherapy. FLT3 mutational status was determined in all patients. Twenty-one patients were enrolled (four MDS, 17 AML) with a median age of 77 years. The recommended phase II dose (RP2D) was cytarabine 10 mg bid days 1-10 and sorafenib 600 mg/day days 2-28. Dose-limiting toxicities were fatigue, sepsis and skin rash. Of 15 evaluable patients treated at the RP2D, two patients responded. The overall response rate for eligible patients was 10%. FLT3 mutations were found in only three patients. We conclude that this combination of sorafenib and cytarabine has limited activity in this unselected cohort of elderly patients with AML/MDS in which FLT3 mutations seemed underrepresented. PMID:23061485

Macdonald, David A; Assouline, Sarit E; Brandwein, Joseph; Kamel-Reid, Suzanne; Eisenhauer, Elizabeth A; Couban, Stephen; Caplan, Stephen; Foo, Alison; Walsh, Wendy; Leber, Brian

2012-11-15

61

Spherical and aspherical photorefractive keratectomy and laser in-situ keratomileusis for moderate to high myopia: two prospective, randomized clinical trials. Summit technology PRK-LASIK study group.  

PubMed Central

OBJECTIVE: Determine the outcomes of single-zone photorefractive keratectomy (SZPRK), aspherical photorefractive keratectomy (ASPRK), and laser in-situ keratomileusis (LASIK) for the correction of myopia between -6 and -12 diopters. DESIGN: Two simultaneous prospective, randomized, multi-center clinical trials. PARTICIPANTS: 286 first-treated eyes of 286 patients enrolled in one of two studies. In Study I, 134 eyes were randomized to SZPRK (58 eyes) or ASPRK (76 eyes). In Study II, 152 eyes were randomized to ASPRK (76 eyes) or to LASIK (76 eyes). INTERVENTION: All eyes received spherical one-pass excimer laser ablation as part of PRK or LASIK performed with the Summit Technologies Apex laser under an investigational device exemption, with attempted corrections between -6 and -12 diopters. MAIN OUTCOME MEASURES: Data on uncorrected and best spectacle-corrected visual acuity, predictability and stability of refraction, and complications were analyzed. Follow-up was 12 months. RESULTS: At 1 month postoperatively, more eyes in the LASIK group achieved 20/20 and 20/25 or better uncorrected visual acuity than PRK-treated eyes; at the 20/25 or better level, the difference was significant for LASIK (29/76 eyes, 38%) over SZPRK (10/58 eyes, 17%) (P = .0064). At all subsequent postoperative intervals, no difference was seen between treatment groups. Similarly, best corrected visual acuities were better for LASIK than all PRK eyes at 1 month postoperatively, and LASIK was better than SZPRK at 3 months follow-up (e.g., for 20/20 or better at 1 month, LASIK 50/76 eyes (66%) versus SZPRK 24/57 eyes (42%), P = .0066). PRK eyes had a mean loss of BCVA through 6 months, while LASIK eyes had a slight gain of mean BCVA through month 6; at 12 months, both ASPRK groups but not SZPRK continued to have a small mean loss of BCVA (e.g., compared to preoperative, mean BCVA at 12 months for SZPRK was + 0.3, LASIK was +.21, ASPRK I was -0.11, and ASPRK II -0.31 (SZPRK versus ASPRK II, P = .0116). Predictability was better for PRK than LASIK at all follow-up intervals (e.g., for manifest refraction spherical equivalent +/- 1.0 diopters at 6 months, ASPRK I 42/62 eyes (68%) versus LASIK 29/72 eyes (40%), P = .0014%). Stability was slightly but insignificantly less in the LASIK eyes compared to PRK eyes. All visual outcome measures were better for eyes with preoperative myopia between -6 and -8.9 D compared with eyes with myopia between -9 and -12 D. No consistent differences in refractive outcomes or postoperative corneal haze were seen between aspherical and single-zone ablations; haze diminished over 12 months and was judged to be vision-impairing in only one ASPRK eye. Microkeratome and flap complications occurred in 4 eyes, resulting in delay of completion of the procedure in 3 eyes but not causing long-term impairment. CONCLUSIONS: Improvement in uncorrected visual acuity and return of best corrected visual acuity was more rapid for LASIK than PRK, but efficacy outcomes in the longer term through 12 months were similar for all treatment groups. LASIK eyes tended toward undercorrection with the nomogram employed in this study compared to PRK, but the scatter was similar, suggesting little difference between these procedures for most patients by 6 months and thereafter. No consistent advantage was demonstrated between aspherical and single-zone ablation patterns. Predictability was much better for all procedures for corrections of -6 to -8.9 D compared with -9 to -12 D. Sporadic loss of best corrected vision in the PRK eyes not found in the LASIK eyes and other measures of visual function require further study.

Steinert, R F; Hersh, P S

1998-01-01

62

Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group  

PubMed Central

Background The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.” Purpose We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. Methods The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. Results The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. Limitations The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols. Conclusions The POWER Trials Collaborative Research Group is a case study of an alternative organizational model to conduct independent, yet coordinated trials. Such a model is increasingly being used in NHLBI supported trials , especially given the interest in comparative effectiveness research. Nevertheless, the ultimate utility of this model will not be fully understood until the trials are completed.

Yeh, Hsin-Chieh; Clark, Jeanne M.; Emmons, Karen M.; Moore, Renee H.; Bennett, Gary G; Warner, Erica T.; Sarwer, Davis B.; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A.; Wells, Barbara; Wadden, Thomas A.; Colditz, Graham A.; Appel, Lawrence J.

2011-01-01

63

Randomised, double blind, multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: results of the HANE study. HANE Trial Research Group.  

PubMed Central

OBJECTIVE: To compare the effectiveness and tolerability of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in patients with mild to moderate hypertension. DESIGN: Randomised multicentre trial over 48 weeks with double blind comparison of treatments. SETTING: 48 centres in four countries. PATIENTS: 868 patients with essential hypertension (diastolic blood pressure 95-120 mm Hg) INTERVENTIONS: Initial treatment (step 1) consisted of 12.5 mg hydrochlorothiazide (n = 215), 25 mg atenolol (n = 215), 10 mg nitrendipine (n = 218), or 5 mg enalapril (n = 220) once daily. If diastolic blood pressure was not reduced to < 90 mm Hg within four weeks, doses were increased to 25 mg, 50 mg, 20 mg, 10 mg, respectively, once daily (step 2) and after two more weeks to twice daily (step 3). The eight week titration phase was followed by an additional 40 weeks for patients who had reached the target diastolic pressure. MAIN OUTCOME MEASURES: Blood pressure by means of an automatic device with repeated measurements. RESULTS: After eight weeks the response rate for atenolol (63.7%) was significantly higher than for enalapril (50.0%), hydrochlorothiazide (44.7%), or nitrendipine (44.5%). After one year atenolol was still more effective (48.0%) than hydrochlorothiazide (35.4%) and nitrendipine (32.9%), but not significantly better than enalapril (42.7%). The treatment related dropout rate was higher (P < 0.001) in the nitrendipine group (n = 28). CONCLUSIONS: There is no evidence of superiority for antihypertensive effectiveness or tolerability of the "new" classes of antihypertensives (calcium channel blockers and angiotensin converting enzyme inhibitors). As these drugs are now widely used as treatment of first choice, our results further emphasise the need for studies confirming that they also reduce morbidity and mortality, as has been shown for diuretics and beta blockers.

Philipp, T.; Anlauf, M.; Distler, A.; Holzgreve, H.; Michaelis, J.; Wellek, S.

1997-01-01

64

Estimating Statistical Power for Open Enrollment Group Treatment Trials  

PubMed Central

Modeling turnover in group membership has been identified as a key barrier contributing to a disconnect between the manner in which behavioral treatment is conducted (open enrollment groups) and the designs of substance abuse treatment trials (closed enrollment groups, individual therapy). Latent class pattern mixture models (LCPMM) are an emerging tool for modeling data from open enrollment groups with membership turnover in recently proposed treatment trials. The current article illustrates an approach to conducting power analyses for open enrollment designs based on Monte Carlo simulation of LCPMM models using parameters derived from published data from an RCT comparing Seeking Safety to a Community Care condition for women presenting with comorbid PTSD and substance use disorders. The example addresses discrepancies between the analysis framework assumed in power analyses of many recently-proposed open enrollment trials and the proposed use of LCPMM for data analysis.

Morgan-Lopez, Antonio A.; Saavedra, Lissette M.; Hien, Denise A.; Fals-Stewart, William

2010-01-01

65

Prognostic and predictive impact of central necrosis and fibrosis in early breast cancer: Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy  

Microsoft Academic Search

A minority of early invasive breast cancers show a pattern of central necrosis and fibrosis (CNF). Previous studies have documented\\u000a an adverse prognostic impact and association with other adverse pathological features, but its predictive importance for therapy\\u000a selection is unknown. We examined the prognostic and predictive value of CNF in two randomized clinical trials comparing chemoendocrine\\u000a therapy with endocrine therapy

Eugenio Maiorano; Meredith M. Regan; Giuseppe Viale; Mauro G. Mastropasqua; Marco Colleoni; Monica Castiglione-Gertsch; Karen N. Price; Richard D. Gelber; Aron Goldhirsch; Alan S. Coates

2010-01-01

66

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research  

Microsoft Academic Search

BACKGROUND: While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program

Jeanne Poduska; Sheppard Kellam; C. Hendricks Brown; Carla Ford; Amy Windham; Natalie Keegan; Wei Wang

2009-01-01

67

United States Critical Illness and Injury Trials Group.  

PubMed

The United States Critical Illness and Injury Trials (USCIIT) Group is an inclusive, grassroots "network of networks" with the dual missions of fostering investigator-initiated hypothesis testing and developing recommendations for strategic plans at a national level. The USCIIT Group's transformational approach enlists multidisciplinary investigative teams across institutions, critical illness and injury professional organizations, federal agencies that fund clinical and translational research, and industry partners. The USCIIT Group is endorsed by all major critical illness and injury professional organizations spanning the specialties of anesthesiology, emergency medicine, internal medicine, neurology, nursing, pediatrics, pharmacy and nutrition, surgery and trauma, and respiratory and physical therapy. Recent successes provide the opportunity to significantly increase the dialogue necessary to advance clinical and translational research on behalf of our community. More than 200 investigators are now involved across > 30 academic and community hospitals. Collectively, USCIIT Group investigators have enrolled > 10,000 patients from academic and community hospitals in studies during the last 3 years. To keep our readership "ahead of the curve," this article provides a vision for critical illness and injury research based on (1) programmatic organization of large-scale, multicentered collaborative studies and (2) annual strategic planning at a national scale across disciplines and stakeholders. PMID:23460158

Blum, James M; Morris, Peter E; Martin, Greg S; Gong, Michelle N; Bhagwanjee, Satish; Cairns, Charles B; Cobb, J Perren

2013-03-01

68

Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non Hodgkin's lymphoma: a Pediatric Oncology Group study.  

PubMed

The Pediatric Oncology Group (POG) adopted a histology-based approach to the management of pediatric non-Hodgkin's lymphomas (NHL) utilizing the National Cancer Institute Working Formulation for Clinical Usage. Patients with diffuse large cell lymphoma (DLCL) were treated on a separate protocol from small cell diffuse undifferentiated or lymphoblastic lymphomas. This study assessed the overall and event free survival of children with DLCL and determined the effects of cyclophosphamide upon these end-points in a prospective randomized trial. One hundred and twenty eligible stage III or IV NHL patients with the confirmed diagnosis of diffuse large cell or immunoblastic histology were enrolled on study between October 1986 and November 1991. Patients were randomized to receive or not receive cyclophosphamide; 58 received cyclophosphamide, doxorubicin, vincristine, 6-mercaptopurine (6-MP), and prednisone (ACOP+) and 62 were treated with doxorubicin, vincristine, 6-MP, and prednisone (APO). In both treatment programs methotrexate was substituted when the doxorubicin cumulative dose reached 450 mg/m2. Radiation was administered to bulky disease if progression or no response were observed after induction therapy. Planned duration of therapy was 12 months. The 5-year event free survival (EFS) rates of patients treated with ACOP+ versus APO were 62% +/- 7% and 72% +/- 6%, respectively. While there was no statistically significant difference between the two treatment arms (p = 0.28), we can only say that we are 95% confident that the difference in 5-year EFS falls in the wide range from 28% in favor of APO to 8% favoring ACOP+. Marrow suppression was the main toxicity with one fatal infection. There were three other deaths on study due to respiratory failure in patients with mediastinal masses. Only one patient experienced cardiotoxicity requiring discontinuation of doxorubicin. Ten patients received radiation therapy to achieve. In conclusion the efficacy of elimination of cyclophosphamide from the treatment program of children and adolescents with advanced stage diffuse large cell lymphoma was inconclusive as to its effect on EFS. Furthermore, the majority of the patients (92%) did not require any radiation therapy to bulky disease indicating that the chemotherapy regimens are quite efficient for achievement of complete remission. PMID:11699405

Laver, J H; Mahmoud, H; Pick, T E; Hutchinson, R E; Weinstein, H J; Schwenn, M; Weitzman, S; Murphy, S B; Ochoa, S; Shuster, J J

2001-07-01

69

Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol  

PubMed Central

Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence) to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+) who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility, operationalized as the Short Physical Performance Battery at 12 months. Secondary outcomes include frailty, rehospitalizations, falls risk factors, quality of life, as well as physical activity and sedentary behaviour. We will conduct an economic evaluation to determine health related costs in the first year, and a process evaluation to ascertain the acceptance of the program by older adults, as well as clinicians and staff within the clinic. Trial registration number ClinicalTrials.gov: NCT01254942

2011-01-01

70

A Phase I/II trial of radiotherapy concurrent with TS-1 plus cisplatin in patients with clinically resectable type 4 or large type 3 gastric cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1205.  

PubMed

A Phase I/II trial of radiotherapy administered concurrently with TS-1 plus cisplatin has been initiated in Japanese patients with clinical resectable type 4 or large type 3 gastric cancer. The aim of this trial is to determine the recommended dose of TS-1 and cisplatin combined with radiotherapy at a fixed dose in the Phase I study, and to evaluate the efficacy and safety in the Phase II study. The primary endpoint for Phase II is the pathological complete response rate, assessed using surgically resected specimens. Secondary endpoints are the response rate, progression-free survival, overall survival, operation transitional rate, R0 resection rate, rate of treatment completion, rate of down-staging and rates of postoperative complications and adverse events. In Phase II, a total of 30 patients will be enrolled in the Osaka Gastrointestinal Cancer Chemotherapy Study Group trial over a period of 6 years. PMID:23447812

Imano, Motohiro; Furukawa, Hiroshi; Yokokawa, Masaki; Nishimura, Yasumasa; Kurokawa, Yukinori; Satoh, Taroh; Sakai, Daisuke; Yasuda, Takushi; Imamoto, Haruhiko; Tujinaka, Toshimasa; Shimokawa, Toshio; Shiozaki, Hitoshi

2013-02-26

71

Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer  

PubMed Central

Background: Peritumoral vascular invasion (PVI) may assist in assigning optimal adjuvant systemic therapy for women with early breast cancer. Patients and methods: Patients participated in two International Breast Cancer Study Group randomized trials testing chemoendocrine adjuvant therapies in premenopausal (trial VIII) or postmenopausal (trial IX) node-negative breast cancer. PVI was assessed by institutional pathologists and/or central review on hematoxylin–eosin-stained slides in 99% of patients (analysis cohort 2754 patients, median follow-up >9 years). Results: PVI, present in 23% of the tumors, was associated with higher grade tumors and larger tumor size (trial IX only). Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival. The adverse prognostic impact of PVI in trial VIII was limited to premenopausal patients with endocrine-responsive tumors randomized to therapies not containing goserelin, and conversely the beneficial effect of goserelin was limited to patients whose tumors showed PVI. In trial IX, all patients received tamoxifen: the adverse prognostic impact of PVI was limited to patients with receptor-negative tumors regardless of chemotherapy. Conclusion: Adequate endocrine adjuvant therapy appears to abrogate the adverse impact of PVI in node-negative disease, while PVI may identify patients who will benefit particularly from adjuvant therapy.

Viale, G.; Giobbie-Hurder, A.; Gusterson, B. A.; Maiorano, E.; Mastropasqua, M. G.; Sonzogni, A.; Mallon, E.; Colleoni, M.; Castiglione-Gertsch, M.; Regan, M. M.; Brown, R. W.; Golouh, R.; Crivellari, D.; Karlsson, P.; Ohlschlegel, C.; Gelber, R. D.; Goldhirsch, A.; Coates, A. S.

2010-01-01

72

Outcomes Research in Cancer Clinical Trial Cooperative Groups: The RTOG Model  

Microsoft Academic Search

Background: The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. Methods: To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess

D. W. Bruner; B. Movsas; A. Konski; M. Roach; M. Bondy; C. Scarintino; C. Scott; W. Curran

2004-01-01

73

A phase III randomized trial of postoperative pelvic irradiation in stage IB cervical carcinoma with poor prognostic features: Follow-up of a gynecologic oncology group study  

SciTech Connect

Purpose: To investigate, in a phase III randomized trial, whether postoperative external-beam irradiation to the standard pelvic field improves the recurrence-free interval and overall survival (OS) in women with Stage IB cervical cancers with negative lymph nodes and certain poor prognostic features treated by radical hysterectomy and pelvic lymphadenectomy. Methods and Materials: Eligible patients had Stage IB cervical cancer with negative lymph nodes but with 2 or more of the following features: more than one third (deep) stromal invasion, capillary lymphatic space involvement, and tumor diameter of 4 cm or more. The study group included 277 patients: 137 randomized to pelvic irradiation (RT) and 140 randomized to observation (OBS). The planned pelvic dose was from 46 Gy in 23 fractions to 50.4 Gy in 28 fractions. Results: Of the 67 recurrences, 24 were in the RT arm and 43 were in the OBS arm. The RT arm showed a statistically significant (46%) reduction in risk of recurrence (hazard ratio [HR] = 0.54, 90% confidence interval [CI] = 0.35 to 0.81, p = 0.007) and a statistically significant reduction in risk of progression or death (HR = 0.58, 90% CI = 0.40 to 0.85, p = 0.009). With RT, 8.8% of patients (3 of 34) with adenosquamous or adenocarcinoma tumors recurred vs. 44.0% (11 of 25) in OBS. Fewer recurrences were seen with RT in patients with adenocarcinoma or adenosquamous histologies relative to others (HR for RT by histology interaction = 0.23, 90% CI = 0.07 to 0.74, p = 0.019). After an extensive follow-up period, 67 deaths have occurred: 27 RT patients and 40 OBS patients. The improvement in overall survival (HR = 0.70, 90% CI = 0.45 to 1.05, p = 0.074) with RT did not reach statistical significance. Conclusions: Pelvic radiotherapy after radical surgery significantly reduces the risk of recurrence and prolongs progression-free survival in women with Stage IB cervical cancer. RT appears to be particularly beneficial for patients with adenocarcinoma or adenosquamous histologies. Circumstances that may have influenced the overall survival differences are considered.

Rotman, Marvin [Department of Radiation Oncology, SUNY Downstate Medical Center, Brooklyn, NY (United States)]. E-mail: mrotman@downstate.edu; Sedlis, Alexander [Department of Obstetrics and Gynecology, SUNY Downstate Medical Center, Brooklyn, NY (United States); Piedmonte, Marion R. [Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY (United States); Bundy, Brian [Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY (United States); Lentz, Samuel S. [Section on Gynecologic Oncology, Wake Forest University School of Medicine, Winston-Salem, NC (United States); Muderspach, Laila I. [Women's and Children's Hospital, Keck School of Medicine, University of Southern California, Los Angeles, CA (United States); Zaino, Richard J. [Department of Pathology, Milton S. Hershey Medical Center of Pennsylvania State University, Hershey, PA (United States)

2006-05-01

74

Facilitating Teacher Study Groups  

ERIC Educational Resources Information Center

|Although literacy coaching means many different things, all coaching initiatives have one common commitment: the goal of building teacher expertise. In the authors' work as coaches and with coaches, they have relied on teacher study groups as a main strategy for accomplishing this task. Their understanding of the potential for study groups has…

Walpole, Sharon; Beauchat, Katherine A.

2008-01-01

75

Effect of CYP2B6, ABCB1, and CYP3A5 polymorphisms on efavirenz pharmacokinetics and treatment response: an AIDS Clinical Trials Group study.  

PubMed

In AIDS Clinical Trials Group protocols 384, A5095, and A5097s, we characterized relationships between 22 polymorphisms in CYP2B6, ABCB1, and CYP3A5; plasma efavirenz exposure; and/or treatment responses. A stepwise logistic regression procedure selected polymorphisms associated with reduced drug clearance adjusted for body mass index and the composite CYP2B6 516/983 genotype. Relationships between selected polymorphisms and treatment responses were characterized by competing risk methodology. Association analyses involved 821 individuals (317 for pharmacokinetics and 643 for treatment response). Models that included CYP2B6 516/983 genotype best predicted pharmacokinetics. Slow-metabolizer genotypes were associated with increased central nervous system events among white participants and decreased virologic failure among black participants. PMID:20662624

Ribaudo, Heather J; Liu, Huan; Schwab, Matthias; Schaeffeler, Elke; Eichelbaum, Michel; Motsinger-Reif, Alison A; Ritchie, Marylyn D; Zanger, Ulrich M; Acosta, Edward P; Morse, Gene D; Gulick, Roy M; Robbins, Gregory K; Clifford, David; Haas, David W

2010-09-01

76

Impact of CYP2B6, ABCB1 and CYP3A5 Polymorphisms on Efavirenz Pharmacokinetics and Treatment Response: An AIDS Clinical Trials Group Study  

PubMed Central

We characterized relationships between 22 polymorphisms in CYP2B6, ABCB1 and CYP3A5, plasma efavirenz exposure, and/or treatment responses in AIDS Clinical Trials Group protocols 384, A5095, and A5097s. A stepwise logistic regression procedure selected polymorphisms associated with reduced drug clearance adjusted for body mass index and composite CYP2B6 516/983 genotype. Competing risk methodology characterized relationships between selected polymorphisms and treatment responses. Association analyses involved 821 individuals (317 for pharmacokinetics, 643 for treatment response). Models that included CYP2B6 516/983 genotype best predicted pharmacokinetics. Slow metabolizer genotypes were associated with increased central nervous system events among whites, and decreased virologic failure among blacks.

Ribaudo, Heather J.; Liu, Huan; Schwab, Matthias; Schaeffeler, Elke; Eichelbaum, Michel; Motsinger-Reif, Alison A.; Ritchie, Marylyn D.; Zanger, Ulrich M; Acosta, Edward P.; Morse, Gene D.; Gulick, Roy M.; Robbins, Gregory K.; Clifford, David; Haas, David W.

2010-01-01

77

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder  

PubMed Central

Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years), and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

2011-01-01

78

Efficacy of test of memory malingering Trial 1, Trial 2, the Retention Trial, and the Albany Consistency Index in a criterion group forensic neuropsychological sample.  

PubMed

The Test of Memory Malingering is one of the most popular and heavily researched validity tests available for use in neuropsychological evaluations. Recent research has suggested, however, that the original indices and cutoffs may require modifications to increase sensitivity rates. Some of these modifications lack cross-validation and no study has examined all indices in a single sample. This study compares Trial 1, Trial 2, the Retention Trial, and the newly created Albany Consistency Index in a criterion group forensic neuropsychological sample. Findings lend support for the newly created indices and cutoff scores. Implications and cautionary statements are provided and discussed. PMID:23079153

Schroeder, R W; Buddin, W H; Hargrave, D D; VonDran, E J; Campbell, E B; Brockman, C J; Heinrichs, R J; Baade, L E

2012-10-18

79

Group Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial  

Microsoft Academic Search

OBJECTIVE: To determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences. METHODS: A multisite randomized controlled trial was conducted at two university-affiliated hospital prenatal clinics. Pregnant women aged 14-25 years (n1,047) were randomly assigned to either standard or group care. Women with medical conditions requiring individualized care were excluded from

Jeannette R. Ickovics; Trace S. Kershaw; Claire Westdahl; Urania Magriples; Zohar Massey; Heather Reynolds

2007-01-01

80

Conclusions from clinical trials of the Southwest Oncology Group.  

PubMed

Mature data from four clinical trials conducted by the Southwest Oncology Group from 1971 to 1978 for patients with all stages of Hodgkin's disease (HD) are reviewed in this paper. In the RAC #1 trial of stage I and II HD we demonstrated that involved-field radiotherapy plus six courses of MOPP chemotherapy improved relapse-free survival compared to standard radiotherapy alone (P = 0.12), especially in patients with B symptoms (P less than 0.03) or mediastinal disease (P = 0.08). However, at present, there is no significant difference in overall survival. In the CAR #1 study for patients with pathologic stage IIB, IIIA, and IIIB HD, we demonstrated that three or four courses of MOPP before radiotherapy produced a 90% complete remission (CR) rate, with 70% of the patients remaining free of disease at 5 years. In the CAR #2 study for patients with pathologic stage IIIA or IIIB disease, we demonstrated that chemotherapy alone (MOPP-bleomycin) was as effective as combined modality treatment (MOPP-bleomycin plus radiotherapy) in terms of CR rate (85% versus 89%, respectively), relapse-free survival, and survival. For advanced stages of HD we added doxorubicin to our MOPP-bleomycin schedule and demonstrated that MOP-BAP produced a 77% CR rate compared to 67% for MOPP-bleomycin (P = 0.10). Moreover, MOP-BAP produced consistently superior CR rates and survival in patients with more prognostically favorable presentations of HD. Our new ongoing study (MOPP #6) incorporates many of the concepts derived from these earlier clinical investigations. PMID:6176321

Jones, S E; Coltman, C A; Grozea, P N; DePersio, E J; Dixon, D O

1982-04-01

81

AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT): Rationale, Design, and Baseline Characteristics  

PubMed Central

Purpose ALLRT is a longitudinal cohort study of HIV-infected subjects prospectively randomized into selected clinical trials for antiretroviral (ARV) treatment-naïve and ARV treatment-experienced individuals conducted by the AIDS Clinical Trials Group (ACTG). We describe the rationale, design, and baseline characteristics of the ALLRT cohort and its potential to address important research questions related to ARV therapy. Method Standardized visits occur every 16 weeks to evaluate long-term clinical, virologic, and immunologic outcomes associated with ARV treatment. Results A total of 4,371 subjects enrolled in ALLRT from January 2000 through June 2007. Of these, 3,146 (72%) were ARV naïve at parent study entry (18% female, 44% white, 32% black, 21% Hispanic; median age 37 years, CD4 count 218 cells/?L, follow-up 3.6 years; 343 [11%] followed ?8 years) and 1,225 (28%) were treatment experienced (13% female, 59% white, 20% black, 17% Hispanic; median age 42 years, CD4 count 325 cells/?L, follow-up 5.7 years). Conclusions ALLRT provides the opportunity to understand long-term ramifications of therapeutic ARV choices and determine whether these vary by treatment regimen, timing of treatment initiation, or treatment changes over long-term follow-up. Investigations based on uniform data and specimen collection in the context of randomized ARV treatments will be critical to developing more successful long-term therapeutic strategies for HIV treatment.

Smurzynski, Marlene; Collier, Ann C.; Koletar, Susan L.; Bosch, Ronald J.; Wu, Kunling; Bastow, Barbara; Benson, Constance A.

2009-01-01

82

Sunitinib in relapsed or refractory diffuse large B-cell lymphoma: a clinical and pharmacodynamic phase II multicenter study of the NCIC Clinical Trials Group  

PubMed Central

There are limited effective therapies for most patients with relapsed diffuse large B-cell lymphoma (DLBCL). We conducted a phase II trial of the multi-targeted vascular endothelial growth factor receptor (VEGFR) kinase inhibitor, sunitinib, 37.5 mg given orally once daily in adult patients with relapsed or refractory DLBCL. Of 19 enrolled patients, 17 eligible patients were evaluable for toxicity and 15 for response. No objective responses were seen and nine patients achieved stable disease (median duration 3.4 months). As a result, the study was closed at the end of the first stage. Grades 3—4 neutropenia and thrombocytopenia were observed in 29% and 35%, respectively. There was no relationship between change in circulating endothelial cell numbers (CECs) and bidimensional tumor burden over time. Despite some activity in solid tumors, sunitinib showed no evidence of response in relapsed/refractory DLBCL and had greater than expected hematologic toxicity.

Buckstein, Rena; Kuruvilla, John; Chua, Neil; Lee, Christina; Macdonald, David A; Al-Tourah, Abdulwahab J; Foo, Alison H; Walsh, Wendy; Ivy, S Percy; Crump, Michael; Eisenhauer, Elizabeth A

2011-01-01

83

Erectile dysfunction is frequent in systemic sclerosis and associated with severe disease: a study of the EULAR Scleroderma Trial and Research group  

PubMed Central

Introduction Erectile dysfunction (ED) is common in men with systemic sclerosis (SSc) but the demographics, risk factors and treatment coverage for ED are not well known. Method This study was carried out prospectively in the multinational EULAR Scleroderma Trial and Research database by amending the electronic data-entry system with the International Index of Erectile Function-5 and items related to ED risk factors and treatment. Centres participating in this EULAR Scleroderma Trial and Research substudy were asked to recruit patients consecutively. Results Of the 130 men studied, only 23 (17.7%) had a normal International Index of Erectile Function-5 score. Thirty-eight per cent of all participants had severe ED (International Index of Erectile Function-5 score ? 7). Men with ED were significantly older than subjects without ED (54.8 years vs. 43.3 years, P < 0.001) and more frequently had simultaneous non-SSc-related risk factors such as alcohol consumption. In 82% of SSc patients, the onset of ED was after the manifestation of the first non-Raynaud's symptom (median delay 4.1 years). ED was associated with severe cutaneous, muscular or renal involvement of SSc, elevated pulmonary pressures and restrictive lung disease. ED was treated in only 27.8% of men. The most common treatment was sildenafil, whose efficacy is not established in ED of SSc patients. Conclusions Severe ED is a common and early problem in men with SSc. Physicians should address modifiable risk factors actively. More research into the pathophysiology, longitudinal development, treatment and psychosocial impact of ED is needed.

2012-01-01

84

Controlled trial of a single dose of synthetic surfactant at birth in premature infants weighing 500 to 699 grams. The American Exosurf Neonatal Study Group I.  

PubMed

In a multicenter, double-blind, placebo-controlled trial conducted at 23 hospitals in the United States, a single prophylactic 5 ml/kg dose of a synthetic surfactant (Exosurf Neonatal) or air placebo was administered shortly after birth to 215 infants with birth weights of 500 to 699 gm. Despite stratification at entry by birth weight and gender, by chance female infants predominated in the air placebo group and male infants predominated in the surfactant group. Among infants receiving synthetic surfactant, improvements in oxygen requirements were significant at 2 hours after birth (p = 0.014) and persisted for 3 days (p = 0.001); improvements in the alveolar-arterial partial pressure of oxygen gradient were significant at 6 hours after birth (p = 0.01) and persisted for 3 days (p = 0.008). Improvements in mean airway pressure were not significant at 2 or at 6 hours after birth (p = 0.622 and 0.083, respectively), but became significant thereafter and persisted for 3 days (p = 0.002). Pneumothorax was reduced by slightly more than half (25 vs 11; p = 0.014); death from respiratory distress syndrome (RDS) was also reduced (26 vs 15; p = 0.046). Overall neonatal mortality, however, was not significantly reduced (58 vs 46; p = 0.102). Other complications of RDS and prematurity were not altered, except that pulmonary hemorrhage occurred significantly more frequently in infants receiving synthetic surfactant (2 vs 12; p = 0.006). These findings indicate that a single prophylactic dose of synthetic surfactant in infants weighing 500 to 699 gm at birth improves lung function, incidence of air leak, and death from RDS but not overall mortality. The only safety problem identified was an increase in pulmonary hemorrhage. PMID:1735849

Stevenson, D; Walther, F; Long, W; Sell, M; Pauly, T; Gong, A; Easa, D; Pramanik, A; LeBlanc, M; Anday, E

1992-02-01

85

Phase II Trial of Hydroxyurea, Dacarbazine (DTIC), and Etoposide (VP-16) in Mixed Mesodermal Tumors of the Uterus: A Gynecologic Oncology Group Study  

Microsoft Academic Search

Objective: The purpose of this study was to evaluate the efficacy of this three-drug regimen—hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16)—in patients with advanced or recurrent mixed mesodermal tumors (MMT) of the uterus who had not undergone previous chemotherapy. The study was performed as a groupwide phase II study of the Gynecologic Oncology Group. Study Design: Thirty-three evaluable patients received hydroxyurea

John L. Currie; John A. Blessing; Ramon McGehee; John T. Soper; Michael Berman

1996-01-01

86

Phase III Trial of Weekly Methotrexate or Pulsed Dactinomycin for Low-Risk Gestational Trophoblastic Neoplasia: A Gynecologic Oncology Group Study  

PubMed Central

Purpose There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN). Patients and Methods Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma. Results Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m2 was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m2 (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated. Conclusion The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.

Osborne, Raymond J.; Filiaci, Virginia; Schink, Julian C.; Mannel, Robert S.; Alvarez Secord, Angeles; Kelley, Joseph L.; Provencher, Diane; Scott Miller, David; Covens, Allan L.; Lage, Janice M.

2011-01-01

87

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

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.

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

88

A phase II trial of olanzapine for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier Oncology Group study.  

PubMed

In a previous phase I study, olanzapine was demonstrated to be a safe and effective agent for the prevention of delayed emesis in chemotherapy-naïve cancer patients receiving cyclophosphamide, doxorubicin, and/or cisplatin. Using the maximum tolerated dose of olanzapine in the phase I trial, a phase II trial was performed for the prevention of chemotherapy-induced nausea and vomiting in chemotherapy-naïve patients. The regimen was 5 mg/day of oral olanzapine on the 2 days prior to chemotherapy, 10 mg on the day of chemotherapy, day 1, (added to intravenous granisetron, 10 mcg/kg and dexamethasone 20 mg), and 10 mg/day on days 2-4 after chemotherapy (added to dexamethasone, 8 mg p.o. BID days 2 and 3, and 4 mg p.o. BID day 4). Thirty patients (median age 58.5 years, range 25-84; 23 women; ECOG PS 0, 1) consented to the protocol, and all were evaluable. Complete response (CR) (no emesis, no rescue) was 100% for the acute period (24 h postchemotherapy), 80% for the delayed period (days 2-5 postchemotherapy), and 80% for the overall period (0-120 h postchemotherapy) in ten patients receiving highly emetogenic chemotherapy (cisplatin > or =70 mg/m(2)). CR was also 100% for the acute period, 85% for the delayed period, and 85% for the overall period in 20 patients receiving moderately emetogenic chemotherapy (doxorubicin > or =50 mg/m(2)). Nausea was very well controlled in the patients receiving highly emetogenic chemotherapy, with no patient having nausea [0 on scale of 0-10, M.D. Anderson Symptom Inventory (MDASI)] in the acute or delayed periods. Nausea was also well controlled in patients receiving moderately emetogenic chemotherapy, with no nausea in 85% of patients in the acute period and 65% in the delayed and overall periods. There were no grade 3 or 4 toxicities and no significant pain, fatigue, disturbed sleep, memory changes, dyspnea, lack of appetite, drowsiness, dry mouth, mood changes, or restlessness experienced by the patients. Complete response and control of nausea in subsequent cycles of chemotherapy (25 patients, cycle 2; 25 patients, cycle 3; 21 patients, cycle 4) were equal to or greater than cycle 1. Olanzapine is safe and highly effective in controlling acute and delayed chemotherapy-induced nausea and vomiting in patients receiving highly and moderately emetogenic chemotherapy. PMID:15700131

Navari, Rudolph M; Einhorn, Lawrence H; Passik, Steven D; Loehrer, Patrick J; Johnson, Cynthia; Mayer, M L; McClean, J; Vinson, Jake; Pletcher, W

2005-02-08

89

Phase III Study Comparing Gemcitabine Plus Cetuximab Versus Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma: Southwest Oncology Group-Directed Intergroup Trial S0205  

PubMed Central

Purpose Patients with advanced pancreas cancer present with disease that is poorly responsive to conventional therapies. Preclinical and early clinical evidence has supported targeting the epidermal growth factor receptor (EGFR) signaling pathway in patients with pancreas cancer. This trial was conducted to evaluate the contribution of an EGFR-targeted agent to standard gemcitabine therapy. Cetuximab is a monoclonal antibody against the ligand-binding domain of the receptor. Patients and Methods Patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma were randomly assigned to receive gemcitabine alone or gemcitabine plus cetuximab. The primary end point was overall survival. Secondary end points included progression-free survival, time to treatment failure, objective response, and toxicity. Results A total of 745 eligible patients were accrued. No significant difference was seen between the two arms of the study with respect to the median survival time (6.3 months for the gemcitabine plus cetuximab arm v 5.9 months for the gemcitabine alone arm; hazard ratio = 1.06; 95% CI, 0.91 to 1.23; P = .23, one-sided). Objective responses and progression-free survival were similar in both arms of the study. Although time to treatment failure was longer in patients on gemcitabine plus cetuximab (P = .006), the difference in length of treatment was only 2 weeks longer in the combination arm. Among patients who were studied for tumoral EGFR expression, 90% were positive, with no treatment benefit detected in this patient subset. Conclusion In patients with advanced pancreas cancer, the anti-EGFR monoclonal antibody cetuximab did not improve the outcome compared with patients treated with gemcitabine alone. Alternate targets other than EGFR should be evaluated for new drug development.

Philip, Philip A.; Benedetti, Jacqueline; Corless, Christopher L.; Wong, Ralph; O'Reilly, Eileen M.; Flynn, Patrick J.; Rowland, Kendrith M.; Atkins, James N.; Mirtsching, Barry C.; Rivkin, Saul E.; Khorana, Alok A.; Goldman, Bryan; Fenoglio-Preiser, Cecilia M.; Abbruzzese, James L.; Blanke, Charles D.

2010-01-01

90

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

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

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

91

A phase I trial of olanzapine (Zyprexa) for the prevention of delayed emesis in cancer patients: a Hoosier Oncology Group study.  

PubMed

Chemotherapy-induced delayed emesis (DE) can affect up to 50% to 70% of patients receiving moderately and highly emetogenic chemotherapy, although rates are improving. DE most commonly occurs within the first 24 to 48 hours of chemotherapy administration and can persist for 2 to 5 days. Olanzapine, due to its activity at multiple dopaminergic, serotonergic, muscarinic, and histaminic receptor sites, has potential as antiemetic therapy. A phase I study was designed with olanzapine, using a four-cohort dose escalation of 3 to 6 patients per cohort, for the prevention of DE in cancer patients receiving their first cycle of chemotherapy consisting of cyclophosphamide, doxorubicin, platinum, and/or irinotecan. All patients received standard premedication. Olanzapine was administered on days -2 and -1 prior to chemotherapy and continued for 8 days (days 0-7). Episodes of vomiting as well as daily measurements of nausea, sedation, and toxicity were monitored at each dose level. Fifteen patients completed the protocol. No grade 4 toxicities were seen, and three patients experienced a dose-limiting toxicity (grade 3) of a depressed level of consciousness during the study. The maximum tolerated dose appeared to be 5 mg (for days -2 and -1) and 10 mg (for days 0-7). Four of six patients receiving highly emetogenic chemotherapy (cisplatin, > or = 70 mg/m2) and nine of nine patients receiving moderately emetogenic chemotherapy (doxorubicin, > or = 50 mg/m2) had complete control (no vomiting episodes) of DE. Therefore, olanzapine may be an effective agent for the prevention of chemotherapy-induced DE. A phase II trial is underway. PMID:15493359

Passik, Steven D; Navari, Rudolph M; Jung, Sin-Ho; Nagy, Cindy; Vinson, Jake; Kirsh, Kenneth L; Loehrer, Patrick

2004-01-01

92

Safety, tolerability, and pharmacokinetic interactions of the antituberculous agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS Clinical Trials Group study A5267  

PubMed Central

Background Drug-drug interactions complicate management of co-infection with HIV-1 and Mycobacterium tuberculosis. Bedaquiline (formerly TMC207), an investigational agent for the treatment of tuberculosis, is metabolized by cytochrome P450 (CYP) 3A which may be induced by the antiretroviral drug efavirenz. Methods This was a Phase I pharmacokinetic drug interaction trial. Each healthy volunteer received two 400 mg doses of bedaquiline, the first alone, and the second with concomitant steady-state efavirenz. Plasma pharmacokinetic sampling for bedaquiline and its N-monodesmethyl metabolite (M2) was performed over 14 days after each bedaquiline dose. Steady-state efavirenz pharmacokinetics were also determined. Efavirenz metabolizer status was based on CYP2B6 composite 516/983 genotype. Results Thirty-three of 37 enrolled subjects completed the study. Geometric mean ratios (GMR) for bedaquiline with efavirenz versus bedaquiline alone were 0.82 (90% CI 0.75 to 0.89) for the 14-day area under the concentration-time curve (AUC0-336h) and 1.00 (90% CI 0.88 to 1.13) for the maximum concentration (Cmax). For M2, the GMR was 1.07 (90% CI 0.97 to 1.19) for AUC0-336h and 1.89 (90% CI 1.66 to 2.15) for Cmax. There were no Grade 3 or 4 clinical adverse events. One subject developed asymptomatic Grade 3 serum transaminase elevation, prompting study drug discontinuation. Efavirenz concentrations stratified by CYP2B6 genotype were similar to historical data. Conclusions Single-dose bedaquiline was well-tolerated alone and with steady-state efavirenz. The effect of efavirenz on bedaquiline concentrations is unlikely to be clinically significant.

Dooley, Kelly E; Park, Jeong-Gun; Swindells, Susan; Allen, Reena; Haas, David W.; Cramer, Yoninah; Aweeka, Francesca; Wiggins, Ilene; Gupta, Amita; Lizak, Patricia; Qasba, Sonia; van Heeswijk, Rolf; Flexner, Charles

2012-01-01

93

Outcome after relapse of acute lymphoblastic leukemia in adult patients included in four consecutive risk-adapted trials by the PETHEMA Study Group  

PubMed Central

Background About one half of adults with acute lymphoblastic leukemia are not cured of the disease and ultimately die. The objective of this study was to explore the factors influencing the outcome of adult patients with relapsed acute lymphoblastic leukemia. Design and Methods We analyzed the characteristics, the outcome and the prognostic factors for survival after first relapse in a series of 263 adult patients with acute lymphoblastic leukemia (excluding those with mature B-cell acute lymphoblastic leukemia) prospectively enrolled in four consecutive risk-adapted PETHEMA trials. Results The median overall survival after relapse was 4.5 months (95% CI, 4–5 months) with a 5-year overall survival of 10% (95% CI, 8%–12%); 45% of patients receiving intensive second-line treatment achieved a second complete remission and 22% (95% CI, 14%–30%) of them remained disease free at 5 years. Factors predicting a good outcome after rescue therapy were age less than 30 years (2-year overall survival of 21% versus 10% for those over 30 years old; P<0.022) and a first remission lasting more than 2 years (2-year overall survival of 36% versus 17% among those with a shorter first remission; P<0.001). Patients under 30 years old whose first complete remission lasted longer than 2 years had a 5-year overall survival of 38% (95% CI, 23%–53%) and a 5-year disease-free survival of 53% (95% CI, 34%–72%). Conclusions The prognosis of adult patients with acute lymphoblastic leukemia who relapse is poor. Those aged less than 30 years with a first complete remission lasting longer than 2 years have reasonable possibilities of becoming long-term survivors while patients over this age or those who relapse early cannot be successfully rescued using the therapies currently available.

Oriol, Albert; Vives, Susana; Hernandez-Rivas, Jesus-Maria; Tormo, Mar; Heras, Inmaculada; Rivas, Concepcion; Bethencourt, Concepcion; Moscardo, Federico; Bueno, Javier; Grande, Carlos; del Potro, Eloy; Guardia, Ramon; Brunet, Salut; Bergua, Juan; Bernal, Teresa; Moreno, Maria-Jose; Calvo, Carlota; Bastida, Pilar; Feliu, Evarist; Ribera, Josep-Maria

2010-01-01

94

Endothelial Function in HIV-Infected Antiretroviral Na?ve Subjects Before and After Starting Potent Antiretroviral Therapy: AIDS Clinical Trials Group Study 5152s  

PubMed Central

Objectives This study evaluated the effects of three class-sparing antiretroviral therapy (ART) regimens on endothelial function in HIV-infected subjects participating in a randomized trial. Background Endothelial dysfunction has been observed in patients receiving ART for human immunodeficiency virus (HIV) infection. Methods This was a prospective, multicenter study of treatment-naïve subjects who were randomly assigned to receive a protease inhibitor-sparing regimen of nucleoside reverse transcriptase inhibitors (NRTIs) + efavirenz, a non-nucleoside reverse transcriptase inhibitor-sparing regimen of NRTIs + lopinavir/ritonavir, or a NRTI-sparing regimen of efavirenz + lopinavir/ritonavir. NRTIs were lamivudine + stavudine, zidovudine, or tenofovir. Brachial artery flow-mediated dilation (FMD) was determined by B-mode ultrasound before starting on ART, then after 4 and 24 weeks. Results There were 82 subjects (median age 35 years, 91% men, 54% white). Baseline CD4 cell counts and plasma HIV RNA values were 245 cells/mm3 and 4.8 log10 copies/ml, respectively. At baseline, FMD was 3.68% (interquartile range 1.98 – 5.51%). After 4 and 24 weeks of ART, plasma HIV RNA decreased by 2.1 and 3.0 log10 copies/mL, respectively. FMD increased by 0.74% (?0.62 – +2.74, p=0.003) and 1.48% (?0.20 – +4.30%, p< 0.001), respectively, with similar changes in each arm (pKW>0.600). The decrease in plasma HIV RNA at 24 weeks was associated with greater FMD (rs=? 0.30, p=0.017). Conclusions Among treatment-naïve individuals with HIV, three different ART regimens rapidly improved endothelial function. Benefits were similar for all ART regimens, appeared quickly, and persisted at 24 weeks. Condensed Abstract Among 82 treatment-naïve HIV-infected subjects participating in a prospective, multicenter study of three class-sparing antiretroviral therapy regimens, flow-mediated dilation of the brachial artery improved after 4 (+0.74%, p=0.003) and 24 weeks (+1.48%, p< 0.001), with similar changes in each arm (pKW>0.600).

Torriani, Francesca J.; Komarow, Lauren; Parker, Robert A.; Cotter, Bruno R.; Currier, Judith S.; Dube, Michael P.; Fichtenbaum, Carl J.; Gerschenson, Mariana; Mitchell, Carol K.C.; Murphy, Robert L.; Squires, Kathleen; Stein, James H.

2008-01-01

95

Clinical Trial to Evaluate Omega3 Fatty Acids and Alternate Day Prednisone in Patients with IgA Nephropathy: Report from the Southwest Pediatric Nephrology Study Group  

Microsoft Academic Search

This randomized, placebo-controlled, double-blind trial evaluated the role of prednisone and omega 3 fatty acids (O3FA) in patients with IgA nephropathy. Entry criteria were (1) biopsy-proven IgA nephropathy, (2) estimated GFR >50 ml\\/min per 1.73 m 2 , and (3) moderate to severe proteinuria. Thirty-three patients were randomly assigned to receive prednisone 60 mg\\/m 2 every other day for 3

Ronald J. Hogg; Jeannette Lee; Nancy Nardelli; Bruce A. Julian; Daniel Cattran; Bryson Waldo; Robert Wyatt; J. Charles Jennette; Richard Sibley; Keith Hyland; Lisa Fitzgibbons; Gladys Hirschman; James V. Donadio; Bruce J. Holub

96

Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study  

Microsoft Academic Search

Purpose To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease. Patients and Methods Four hundred twenty-two patients were entered onto this trial. Of 396 assessable patients, 202 were randomly allocated to receive WAI, and 194 were allocated to receive AP. Irradiation

Marcus E. Randall; Virginia L. Filiaci; Hyman Muss; Nick M. Spirtos; Robert S. Mannel; Jeffrey Fowler; J. Tate Thigpen; Jo Ann Benda

2006-01-01

97

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

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)

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

2008-01-01

98

Effect of Omacor on HRV parameters in patients with recent uncomplicated myocardial infarction - A randomized, parallel group, double-blind, placebo-controlled trial: study design [ISRCTN75358739  

PubMed Central

Background A large body of data derived from animal, epidemiological and clinical studies indicate that n-3 polyunsaturated fatty acids have a favourable effect on the prognosis of patients with cardiovascular disease in general, and on reducing sudden death in particular. Depressed heart rate variability (HRV), an indicator of impairment of the autonomic nervous system, has been shown to be a powerful predictor of subsequent mortality in patients surviving an acute myocardial infarction. A multitude of studies have demonstrated this strong association, suggesting that the imbalance in the sympathic/parasympathetic system may facilitate emergence of ventricular arrhythmias. Heart rate variability parameters will be assessed in the present study, with the primary objective of evaluating the possible superiority of Omacor (a highly refined, concentrated omega-3 fatty acid) versus placebo in improving HRV from baseline to endpoint in patients with recent uncomplicated myocardial infarction. Both groups will receive optimal conventional treatment. The study will also explore and quantify improvement in time domain HRV indices and will assess the safety of administering Omacor to optimally treated post-infarction patients (conventional treatment). Methods This multi-centre study will evaluate the effect of Omacor 1 g, o.d. on time-domain HRV parameters in comparison to placebo o.d. in patients with recent uncomplicated transmural myocardial infarction. Patients will be screened during the first few days after the acute event as appropriate for the patient's condition, and after obtaining informed consent. Based on inclusion/exclusion criteria, a first 24-hour Holter recording will be performed. Two to five days later, screened patients still eligible for the study will undergo a second 24-hour Holter recording. After the second Holter recording, all patients will be randomly allocated to treatment with Omacor 1 g, o.d. or placebo o.d. One hundred patients will be followed in double-blind fashion for a six-month period after randomization. Visits, including 24-hour Holter recording and assessment of adverse events, will take place at one-month intervals ± five days after randomization, i.e., six times in all.

Pater, Cornel; Compagnone, Daniele; Luszick, Joachim; Verboom, Cees-Nico

2003-01-01

99

Effect of Omacor on HRV parameters in patients with recent uncomplicated myocardial infarction - A randomized, parallel group, double-blind, placebo-controlled trial: study design [ISRCTN75358739].  

PubMed

BACKGROUND: A large body of data derived from animal, epidemiological and clinical studies indicate that n-3 polyunsaturated fatty acids have a favourable effect on the prognosis of patients with cardiovascular disease in general, and on reducing sudden death in particular.Depressed heart rate variability (HRV), an indicator of impairment of the autonomic nervous system, has been shown to be a powerful predictor of subsequent mortality in patients surviving an acute myocardial infarction. A multitude of studies have demonstrated this strong association, suggesting that the imbalance in the sympathic/parasympathetic system may facilitate emergence of ventricular arrhythmias.Heart rate variability parameters will be assessed in the present study, with the primary objective of evaluating the possible superiority of Omacor (a highly refined, concentrated omega-3 fatty acid) versus placebo in improving HRV from baseline to endpoint in patients with recent uncomplicated myocardial infarction. Both groups will receive optimal conventional treatment.The study will also explore and quantify improvement in time domain HRV indices and will assess the safety of administering Omacor to optimally treated post-infarction patients (conventional treatment). METHODS: This multi-centre study will evaluate the effect of Omacor 1 g, o.d. on time-domain HRV parameters in comparison to placebo o.d. in patients with recent uncomplicated transmural myocardial infarction.Patients will be screened during the first few days after the acute event as appropriate for the patient's condition, and after obtaining informed consent. Based on inclusion/exclusion criteria, a first 24-hour Holter recording will be performed. Two to five days later, screened patients still eligible for the study will undergo a second 24-hour Holter recording. After the second Holter recording, all patients will be randomly allocated to treatment with Omacor 1 g, o.d. or placebo o.d.One hundred patients will be followed in double-blind fashion for a six-month period after randomization. Visits, including 24-hour Holter recording and assessment of adverse events, will take place at one-month intervals +/- five days after randomization, i.e., six times in all. PMID:14613518

Pater, Cornel; Compagnone, Daniele; Luszick, Joachim; Verboom, Cees-Nico

2003-10-15

100

Phase II Study of Ifosfamide+Doxorubicin in Patients With Advanced Synovial Sarcomas (E1793): A Trial of the Eastern Cooperative Oncology Group  

PubMed Central

Purpose Because we had observed in the synovial sarcoma subgroup of a broad phase III advanced soft tissue sarcoma study a significantly greater objective regression rate from ifosfamide+doxorubicin (88%) than from doxorubicin alone (20%) (P = 0.02), the Eastern Cooperative Oncology Group (ECOG) decided to further assess this two drug combination in a subsequent Phase II study. Patients Between 1994 and 1999, twelve adult patients with advanced synovial sarcomas were enrolled to receive, as their initial chemotherapy, ifosfamide 7.5 gm/m2 plus doxorubicin 60 mg/m2, given intravenously over two consecutive days every 3 weeks. Methods Each day for 2 days doxorubicin 30 mg/m2 was infused over 5 min through a running i.v., followed by ifosfamide 3750 mg/m2 over 4 h. Continuous i.v. fluid was infused at 300 mL/h for 3 h on day 1, before chemotherapy was begun; then the infusion was continued at 100 mL/h for a total of 3 days. Mesna 750 mg/m2 was given 15 min before ifosfamide and at 4 and 8 h after ifosfamide on days 1 and 2 of each treatment cycle. Filgrastim (G-CSF) 5 ?g/kg was given subcutaneously each day for 14 days beginning on day 3 of each treatment cycle to limit the severity of neutropenia. Results Five of our 12 patients (42%) experienced partial regression of their advanced synovial sarcomas; however, this first stage result was borderline for proceeding to the second planned stage of accrual and our case accrual was quite poor. Thus, the study was closed after stage one accrual. Our patients received a median of four cycles of chemotherapy (range: 1 to 6). All patients experienced at least grade 3 neutropenia (grade 4 in nine of them), and one patient died of treatment-related sepsis following the initial cycle of chemotherapy. Median survival was 11 months.

Ryan, Louise M.; Falkson, Carla I.; Hicks, David G.; Blum, Ronald H.

2003-01-01

101

Vinorelbine and gemcitabine vs vinorelbine and carboplatin as first-line treatment of advanced NSCLC. A phase III randomised controlled trial by the Norwegian Lung Cancer Study Group  

PubMed Central

Background: Platinum-based doublet chemotherapy is the standard first-line treatment for advanced non-small cell lung cancer (NSCLC), but earlier studies have suggested that non-platinum combinations are equally effective and better tolerated. We conducted a national, randomised study to compare a non-platinum with a platinum combination. Methods: Eligible patients had stage IIIB/IV NSCLC and performance status (PS) 0–2. Patients received up to three cycles of vinorelbine 60?mg?m?2 p.o.+gemcitabine 1000?mg?m?2 i.v. day 1 and 8 (VG) or vinorelbine 60?mg?m?2 p.o. day 1 and 8+carboplatin area under the curve=5 (Calvert's formula) i.v. day 1 (VC). Patients ?75 years received 75% of the dose. Endpoints were overall survival, health-related quality of life (HRQoL), toxicity, and the use of radiotherapy. Results: We randomised 444 patients from September 2007 to April 2009. The median age was 65 years, 58% were men and 25% had PS 2. Median survival was VG: 6.3 months; VC: 7.0 months, P=0.802. Vinorelbine plus carboplatin patients had more grade III/IV nausea/vomiting (VG: 4%, VC: 12%, P=0.008) and grade IV neutropenia (VG: 7%, VC: 19%, P<0.001). Infections, HRQoL and the use of radiotherapy did not differ significantly between the treatment groups. Conclusion: The two regimens yielded similar overall survival. The VG combination had only a slightly better toxicity profile.

Fl?tten, ?; Gr?nberg, B H; Bremnes, R; Amundsen, T; Sundstr?m, S; Rolke, H; Hornslien, K; Wentzel-Larsen, T; Aaseb?, U; von Plessen, C

2012-01-01

102

BICULTURAL RESYNTHESIS: TAILORING AN EFFECTIVENESS TRIAL FOR A GROUP OF URBAN AMERICAN INDIAN WOMEN  

Microsoft Academic Search

The purpose of this qualitative study of a 6 week effectiveness trial was to describe among a group of urban American Indian women, the process of successful traditionalism in the form of bicultural resynthesis. Bicultural resynthesis represents a major current attempt on the part of the participants to integrate traditional and contemporary demands in a positive, culturally-consistent manner. The themes

Linda Napholz

103

Using Multilevel Mixtures to Evaluate Intervention Effects in Group Randomized Trials  

ERIC Educational Resources Information Center

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…

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

104

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

ERIC Educational Resources Information Center

|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…

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

2012-01-01

105

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

ERIC Educational Resources Information Center

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…

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

2012-01-01

106

A Randomized Controlled Trial of Cognitive Behavioral Group Therapy for Bipolar Disorder  

Microsoft Academic Search

Background: This study evaluated the effectiveness of adjunctive cognitive behavioral group therapy (CBGT) to prevent recurrence of episodes in euthymic patients with bipolar disorder. Methods: A randomized controlled single-blind trial was conducted with 50 patients with bipolar disorder types I and II followed up for at least 12 months in an outpatient service and whose disease was in remission. An

B. C. Gomes; L. N. Abreu; E. Brietzke; S. C. Caetano; A. Kleinman; F. G. Nery; B. Lafer

2011-01-01

107

SEQPWR and SEQOPR: computer programs for design of maximum information trials based on group sequential logrank tests.  

PubMed

The maximum information trial paradigm for clinical trials with failure time data was recognized and has been investigated. With the maximum information trial paradigm, a study is concluded when a prespecified maximum number of events of interest, thus maximum information, has been accrued if there was no early stopping due to treatment difference or lack thereof. We present two interactive FORTRAN programs for use in designing maximum information trials based on group sequential logrank tests. The program SEQPWR computes the attainable power of group sequential logrank tests given the combinations of the accrual and follow-up durations. The program SEQOPR allows the users to investigate the operating characteristics of the maximum information trial given the information fractions of interim analyses. A clinical trial from the Eastern Cooperative Oncology Group is provided to illustrate the usage and features of the programs. PMID:7796583

Kim, K

1995-02-01

108

Selegiline in the treatment of Alzheimer's disease: a long-term randomized placebo-controlled trial. Czech and Slovak Senile Dementia of Alzheimer Type Study Group.  

PubMed Central

OBJECTIVE: To evaluate the efficacy and adverse effects of the type B monoamine oxidase inhibitor selegiline (also known as I-deprenyl) in the treatment of Alzheimer's disease. DESIGN: Long-term, double-blind, placebo-controlled trial. SETTING: Seven cities (1 or 2 nursing homes in each city) in the Czech and Slovak Republics. PATIENTS: A total of 173 nursing-home residents fulfilling the DSM-III criteria for mild to moderate Alzheimer's disease. INTERVENTIONS: Selegiline (10 mg per day) or placebo (both including 50 mg ascorbic acid) administered for 24 weeks. OUTCOME MEASURES: Clinical Global Impressions scale and Nurses Observation Scale for Inpatient Evaluation at baseline and at weeks 6, 12 and 24; Clock Drawing Test at baseline and 24 weeks, results of which were evaluated as normal or pathologic, and quantitatively on a modified 6-point scale; Sternberg's Memory Scanning test at baseline and at weeks 6, 12 and 24; Mini Mental State Examination, and electroencephalogram at baseline and 24 weeks; Structured Adverse Effects Rating Scale; physical, laboratory, hematological and electrocardiographic examinations at baseline and weeks 12 and 24. RESULTS: A total of 143 subjects completed enough of the trial to be entered in the analysis. Subjects were analyzed by 2 subgroups depending on whether they had a normal or pathologic result of the Clock Drawing Test. Analysis of variance showed significant improvement with selegiline versus placebo among those with a normal result of the Clock Drawing Test on the Mini Mental Status Examination (total score and orientation-place subscale) and among those with a pathologic result of the Clock Drawing Test of Sternberg's Memory Scanning test (for both speed and accuracy), on the Clinical Global Impressions scale as well as in terms of the dominant frequency on electroencephalograms. CONCLUSION: Selegiline has a long-term beneficial effect in Alzheimer's disease on memory modalities that reflect the function of the prefrontal areas of the brain, which are rich in dopamine receptors. The delayed appearance of differences between selegiline and placebo supports the notion that the mechanism of action is through neuronal rescue or neuroprotection. The differential response of patients with normal and pathologic results of the Clock Drawing Test may reflect the fact that the evaluation methods' sensitivity to change depends on the severity of dementia.

Filip, V; Kolibas, E

1999-01-01

109

Efficacy of rifaximin on symptoms of uncomplicated diverticular disease of the colon. A pilot multicentre open trial. Diverticular Disease Study Group.  

PubMed

Diverticular disease of the colon is a common health problem in western societies. Most patients with colonic diverticula are asymptomatic; it has been estimated that only 20% of individuals harboring diverticula will develop symptoms and signs of illness and a minority will develop major complications. Although the efficacy of a high fiber diet in the management of symptomatic uncomplicated diverticular disease is still controversial, bran and bulking agents are commonly used. Antibiotics are used to treat major inflammatory complications of diverticular disease but apparently there is no rationale for the use of antibiotics in uncomplicated disease where an inflammatory component is by definition excluded. In a multicenter open trial, 217 patients with symptomatic uncomplicated diverticular disease were treated with glucomannan (110 pts) or with glucomannan plus a poorly absorbable antibiotic (rifaximin 400 mg bid for 7 days each month) (107 pts). Clinical evaluation was performed bimonthly for 12 months using a global score system for 8 clinical variables. After 12 months, patients treated with glucomannan plus rifaximin showed a 63.9% reduction of the score as compared to 47.6% in patients treated with glucomannan only (p < 0.001). Cyclic administration of rifaximin appears to be of some advantage in obtaining symptomatic relief in uncomplicated diverticular disease. PMID:1330083

Papi, C; Ciaco, A; Koch, M; Capurso, L

1992-10-01

110

The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group  

PubMed Central

Background Observational studies indicate that physical activity (pa) is strongly associated with improved disease outcomes in colon cancer survivors, but a randomized controlled trial is needed to determine whether the association is causal and whether new policies to promote exercise are justified. Purpose The co.21 Colon Health and Life-Long Exercise Change (challenge) trial undertaken by the National Cancer Institute of Canada Clinical Trials Group (ncic ctg) is designed to determine the effects of a structured pa intervention on outcomes for survivors of high-risk stage ii or iii colon cancer who have completed adjuvant therapy within the previous 2–6 months. Methods Trial participants (n = 962) will be stratified by centre, disease stage, body mass index, and performance status, and will be randomly assigned to a structured pa intervention or to general health education materials. The pa intervention will consist of a behavioural support program and supervised pa sessions delivered over a 3-year period, beginning with regular face-to-face sessions and tapering to less frequent face-to-face or telephone sessions. The primary endpoint is disease-free survival. Important secondary endpoints include multiple patient-reported outcomes, objective physical functioning, biologic correlative markers, and an economic analysis. Summary Cancer survivors and cancer care professionals are interested in the potential role of PA to improve multiple disease-related outcomes, but a randomized controlled trial is needed to provide compelling evidence to justify changes in health care policies and practice.

Courneya, K.S.; Booth, C.M.; Gill, S.; O'Brien, P.; Vardy, J.; Friedenreich, C.M.; Au, H.J.; Brundage, M.D.; Tu, D.; Dhillon, H.; Meyer, R.M.

2008-01-01

111

Placebo-group responders in methamphetamine pharmacotherapy trials: the role of immediate establishment of abstinence.  

PubMed

Treatment responses of placebo groups in addiction medicine trials have important implications for research methodology and clinical practice, however studies examining placebo group responses in addiction medicine are scarce. Extant data suggest the importance of early treatment responsiveness for long-term outcomes. Among methamphetamine-(MA) dependent individuals randomized to placebo pill plus behavioral support conditions in pharmacotherapy development trials, we hypothesized that immediate abstinence would be a necessary but insufficient predictor for end-of-trial (EOT) abstinence. The study is a secondary analysis of participants (n = 184; 36% female) in the placebo condition of three randomized, placebo-controlled methamphetamine dependence pharmacotherapy trials. Receiver operating characteristic (ROC) curve analyses assessed the predictive power of initial abstinence, assessed by thrice weekly urine samples, for EOT abstinence. Sixty percent of individuals with complete abstinence in the first two weeks of treatment were abstinent at EOT, while 18% of people who failed to meet this standard were abstinent at EOT. Early response was related to retention at EOT and 12-month follow-up. Findings suggest that the inability to achieve at least three MA negative screenings in the first two weeks is associated with greater than 90% likelihood of treatment failure. A third week of screening added minimally to the prediction of EOT outcomes. The prediction of treatment failure was more precise than the prediction of treatment success. The absence of a clinical response in the first two weeks of treatment among participants in the placebo group signals high risk of treatment failure. The majority of information regarding response in the placebo group from a 12-week trial is obtained early in the trial. PMID:22867036

Brensilver, Matthew; Heinzerling, Keith G; Swanson, Aimee-Noelle; Shoptaw, Steven J

2012-08-06

112

A Phase I Trial and Pharmacokinetic Study of Aflibercept (VEGF Trap) in Children with Refractory Solid Tumors: A Children's Oncology Group Phase I Consortium Report  

PubMed Central

Background Aflibercept is a novel decoy receptor that efficiently neutralizes circulating vascular endothelial growth factor (VEGF). A pediatric phase 1 trial was performed to define the dose limiting toxicities (DLT), maximum tolerated dose (MTD) and pharmacokinetics (PK) of aflibercept. Methods Cohorts of 3–6 children with refractory solid tumors received aflibercept intravenously over 60 minutes every 14 days, at 2.0, 2.5 or 3.0 mg/kg/dose. PK sampling and analysis of peripheral blood biomarkers were performed with the initial dose. Results 21 eligible patients were enrolled; 18 were fully evaluable for toxicity. One of 6 patients receiving 2.0 mg/kg/dose developed dose-limiting intra-tumoral hemorrhage and 2 of 6 receiving 3.0 mg/kg/dose developed either dose-limiting tumor pain or tissue necrosis. None of the 6 patients receiving 2.5 mg/kg/dose developed DLT, defining this as the MTD. The most common non-dose limiting toxicities were hypertension and fatigue. Three patients with hepatocellular carcinoma, hepatoblastoma and clear cell sarcoma had stable disease for >13 weeks. At the MTD, the ratio of free to bound aflibercept serum concentration was 2.10 on day 8, but only 0.44 by day 15. A rapid decrease in VEGF (p<0.05) and increase in PlGF (p<0.05) from baseline was observed in response to aflibercept by day 2. Conclusion The aflibercept MTD in children of 2.5 mg/kg/dose every 14 days is lower that the adult recommended dose of 4.0 mg/kg. This dose achieves, but does not sustain, free aflibercept concentrations in excess of bound. Tumor pain and hemorrhage may be evidence of anti-tumor activity, but were dose-limiting.

Bender, Julia Glade; Blaney, Susan M.; Borinstein, Scott; Reid, Joel M.; Baruchel, Sylvain; Ahern, Charlotte; Ingle, Ashish M.; Yamashiro, Darrell J.; Chen, Alice; Weigel, Brenda; Adamson, Peter C.; Park, Julie R.

2012-01-01

113

Dose selection trial of metronomic oral vinorelbine monotherapy in patients with metastatic cancer: a hellenic cooperative oncology group clinical translational study.  

PubMed

BACKGROUND: Metronomic chemotherapy is considered an anti-angiogenic therapy that involves chronic administration of low-dose chemotherapy at regular short intervals. We investigated the optimal metronomic dose of oral vinorelbine when given as monotherapy in patients with metastatic cancer. METHODS: Patients with recurrent metastatic breast (BC), prostate (PC) or non-small cell lung cancer (NSCLC) and adequate organ functions were randomly assigned to 30, 40 or 50 mg vinorelbine, taken orally three times a week. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or maximum 24 months. Primary endpoint was time-to-treatment failure (TTF) and secondary were progression-free survival (PFS), toxicity, changes in blood concentrations of angiogenesis-associated biomarkers and pharmacokinetics. RESULTS: Seventy-three patients were enrolled. Four-month TTF rate did not differ between the three arms: 25.9% (11.1%-46.2% 95% Confidence Interval), 33.3% (15.6%-55.3%) and 18.2% (5.2%-40.3%) for the 30 mg, 40 mg and 50 mg arms (p-value = 0.56). Objective response was seen in 2 patients with NSCLC (treated at 30 and 50 mg respectively), one with BC (at 40 m g) and one with PC (at 50 mg) and lasted from 4 to 100 weeks, with maximum response duration achieved at 50 mg. Adverse events were mild and negligible and did not differ between the three arms. Blood levels of vinorelbine reached steady state from the second week of treatment and mean values for the 30, 40 and 50 mg were respectively 1.8 ng/ml (SD 1.10), 2.2 ng/ml (SD 1.87) and 2.6 ng/ml (SD 0.69). Low pre-treatment blood concentrations of FGF2 and IL8 predicted favorable response to therapy (p values 0.02 and 0.006, respectively), while high levels of TEK gene transcript predicted treatment resistance. CONCLUSIONS: Considering the antitumor activity and response duration, the negligible toxicity of the highest dose investigated and the lack of drug accumulation over time, we suggest that 50 mg given three times a week is the optimal dose for metronomic oral vinorelbine. Further investigation of metronomic oral vinorelbine (MOVIN) at this dose is warranted in combination with conventional chemotherapy regimens and targeted therapies.Trial registration: Clinicaltrials.gov NCT00278070. PMID:23718900

Briasoulis, Evangelos; Aravantinos, Gerasimos; Kouvatseas, George; Pappas, Periklis; Biziota, Eirini; Sainis, Ioannis; Makatsoris, Thomas; Varthalitis, Ioannis; Xanthakis, Ioannis; Vassias, Antonios; Klouvas, George; Boukovinas, Ioannis; Fountzilas, George; Syrigos, Kostantinos N; Kalofonos, Haralambos; Samantas, Epaminontas

2013-05-29

114

The selection of cases for randomised trials: a registry survey of concurrent trial and non-trial patients. The British Stomach Cancer Group.  

PubMed Central

A randomised trial of adjuvant chemotherapy vs placebo in operable stomach cancer recruited 249 patients from the West Midlands Region between 1976-1980. A Cancer Registry survey identified a further 1261 suitable concurrent cases. Trial patients were compared with the 960 non-trial cases from participating Districts. Only 493 (51%) non-trial cases passed all of the prospective trial selection criteria for entry. Stage and fitness caused the majority of exclusions and were also highly prognostic. A univariate analysis comparing eligible patients with the trial showed the two groups to be balanced for the significant independent prognostic factors of the trial. However, differences in patient age and the surgery performed indicate that recruitment may have been influenced by unknown selection factors. This survey highlights the difficulty of retrospective selection and confirms the need for randomised controls. Data available from specialist Registries may be used to help develop new protocols and to verify and extend trial results.

Ward, L. C.; Fielding, J. W.; Dunn, J. A.; Kelly, K. A.

1992-01-01

115

Phase II Clinical Trial of Ixabepilone in Patients With Recurrent or Persistent Platinum- and Taxane-Resistant Ovarian or Primary Peritoneal Cancer: A Gynecologic Oncology Group Study  

PubMed Central

Purpose Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma. Patients and Methods Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m2 administered over 1 hour on days 1, 8, and 15 of a 28-day cycle. Results Of 51 patients entered, 49 were eligible. The objective response rate was 14.3% (95% CI, 5.9% to 27.2%), with three complete and four partial responses. Twenty patients (40.8%) had stable disease, whereas sixteen (32.7%) had increasing disease. The median time to progression was 4.4 months (95% CI, 0.8 to 32.6+ months); median survival was 14.8 months (95% CI, 0.8 to 50.0) months. Patients received a median of two treatment cycles (range, 1 to 29 cycles), and 18.4% of patients received ? six cycles. Adverse effects included peripheral grade 2 (28.5%) and grade 3 (6.1%) neuropathy, grades 3 to 4 neutropenia (20.4%), grade 3 fatigue (14.3%), grade 3 nausea/emesis (22%), grade 3 diarrhea (10%), and grade 3 mucositis (4%). Conclusion Ixabepilone 20 mg/m2 over 1 hour on days 1, 8, and 15 of a 28-day cycle demonstrates antitumor activity and acceptable safety in patients with platinum- and taxane-resistant recurrent or persistent ovarian or primary peritoneal carcinoma.

De Geest, Koen; Blessing, John A.; Morris, Robert T.; Yamada, S. Diane; Monk, Bradley J.; Zweizig, Susan L.; Matei, Daniela; Muller, Carolyn Y.; Richards, William E.

2010-01-01

116

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

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

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

117

Safety and acceptability of vaginal disinfection with benzalkonium chloride in HIV infected pregnant women in west Africa: ANRS 049b phase II randomized, double blinded placebo controlled trial. DITRAME Study Group  

PubMed Central

OBJECTIVES: To study the tolerance and acceptability in Africa of a perinatal intervention to prevent vertical HIV transmission using benzalkonium chloride disinfection. DESIGN: A randomized, double blinded phase II trial. SETTING: Prenatal care units in Abidjan (Cote d'Ivoire) and Bobo-Dioulasso (Burkina Faso). PATIENTS: Women accepting testing and counselling who were seropositive for HIV-1 and under 37 weeks of pregnancy were eligible. A total of 108 women (54 in each group) enrolled from November 1996 to April 1997, with their informed consent. INTERVENTION: Women self administered daily a vaginal suppository of 1% benzalkonium chloride or matched placebo from 36 weeks of pregnancy, and a single intrapartum dose. The neonate was bathed with 1% benzalkonium chloride solution or placebo within 30 minutes after birth. MAIN OUTCOME MEASURES: Adverse events were recorded weekly, with a questionnaire and speculum examination in women through delivery, and examination of the neonate through day 30. The incidence of genital signs and symptoms in the women and cutaneous or ophthalmological events in newborns were compared between groups on an intent to treat basis. RESULTS: The median duration of prepartum treatment was 21 days (range 0-87 days). Compliance was 87% for prepartum and 69% for intrapartum treatment, and 88% for the neonatal bath, without differences between the two groups. In women, the most frequent event was leucorrhoea; the incidence of adverse events did not differ between treatment groups. In children, the incidence of dermatitis and conjunctivitis did not differ between the benzalkonium chloride and placebo groups (p = 0.16 and p = 0.29, respectively). CONCLUSION: Vaginal disinfection with benzalkonium chloride is a feasible and well tolerated intervention in west Africa. Its efficacy in preventing vertical HIV transmission remains to be demonstrated. ???

Msellati, P.; Meda, N.; Leroy, V.; Likikouet, R.; Van de Perre, P.; Cartoux, M.; Bonard, D.; Ouangre, A.; Combe, P.; Gautier-Charpenti..., L.; Sylla-Koko, F.; Lassalle, R.; Dosso, M.; Welffens-Ekra, C.; Dabis, F.; Mandelbrot, L.

1999-01-01

118

Exploring mediators of accelerometer assessed physical activity in young adolescents in the HEalth In Adolescents study - a group randomized controlled trial  

PubMed Central

Background There is a shortage of information about the factors that mediate physical activity intervention effects which involve youth. The purpose of this study was to examine whether personal, social and physical-environmental factors mediated the intervention effect on physical activity and whether gender and weight status moderated mediated effects in the Health In Adolescents Study – a school-based intervention to promote healthy weight development among young adolescents. Methods Participating schools were randomized to Control (n?=?25) and Intervention (n?=?12). The intervention components to enhance physical activity targeted change through theoretically informed mediators embedded in a social-ecological framework. Accelerometer assessed physical activity (mean count per minute) and self-efficacy, enjoyment, perceived social support from parents, teachers and friends and perceived environmental opportunities were measured by questionnaires at baseline and post-intervention after 20?months among 700 11–13?year-old adolescents (Intervention?=?485; Control?=?215). The product-of-coefficient test was used to examine mediation. Results No mediating effect of any of the hypothesized mediators was identified and gender and weight status did not moderate any mediated effects with the exception of weight status that moderated the mediated effect of enjoyment. Few intervention effects were seen on the mediators, except for a positive change in social support from teachers among girls and the normal weight, and a negative effect on enjoyment and self-efficacy among the overweight. However, change in enjoyment, self-efficacy, perceived social support from friends and environmental opportunities were associated with change in mean count per minute with some variation across the investigated subgroups, and thus show evidence of being potential mediators of physical activity change in adolescents. Conclusions While no mediation effects were observed, change in both personal and social-environmental factors predicted change in physical activity behavior. Hence, a social- ecological approach targeting a wide range of determinants to promote change in physical activity holds promise. Overweight and normal weight adolescents may not respond in the same way to school-based physical activity interventions. Therefore, strategies to better reach the overweight seem needed. Future studies should continue to identify mediating and moderation mechanisms in physical activity change in adolescents.

2012-01-01

119

A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial  

PubMed Central

High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.

Jacob, Shevin T.; Baeten, Jared M.; Hughes, James P.; Peinado, Jesus; Wang, Jing; Sanchez, Jorge; Reid, Stewart E.; Delany-Moretlwe, Sinead; Cowan, Frances; Fuchs, Jonathan; Koblin, Beryl; Griffith, Sam; Wald, Anna; Celum, Connie

2010-01-01

120

T Cell Activation Markers and African Mitochondrial DNA Haplogroups among Non-Hispanic Black Participants in AIDS Clinical Trials Group Study 384  

PubMed Central

Introduction Mitochondrial function influences T cell dynamics and is affected by mitochondrial DNA (mtDNA) variation. We previously reported an association between African mtDNA haplogroup L2 and less robust CD4 cell recovery on antiretroviral therapy (ART) in non-Hispanic black ACTG 384 subjects. We explored whether additional T cell parameters in this cohort differed by mtDNA haplogroup. Methods ACTG 384 randomized ART-naïve subjects to two different nucleoside regimens with efavirenz, nelfinavir, or both. CD4 and CD8 memory and activation markers were available at baseline and week 48 on most subjects. mtDNA sequencing was performed on whole blood DNA, and haplogroups were determined. We studied non-Hispanic black subjects with HIV RNA <400 copies/mL at week 48. Analyses included Wilcoxon ranksum test and linear regression. Results Data from 104 subjects were included. Major African mtDNA haplogroups included L1 (N?=?25), L2 (N?=?31), and L3 (N?=?32). Baseline age, HIV RNA, and CD4 cells did not differ between L2 and non-L2 haplogroups. Compared to non-L2 haplogroups, L2 subjects had lower baseline activated CD4 cells (median 12% vs. 17%; p?=?0.03) and tended toward lower activated CD8 cells (41% vs. 47%; p?=?0.06). At 48 weeks of ART, L2 subjects had smaller decreases in activated CD4 cells (?4% vs. ?11%; p?=?0.01), and smaller CD4 cell increases (+95 vs. +178; p?=?0.002). In models adjusting for baseline age, CD4 cells, HIV RNA, and naïve-to-memory CD4 cell ratio, haplogroup L2 was associated with lower baseline (p?=?0.04) and 48-week change in (p?=?0.01) activated CD4 cells. Conclusions Among ART-naïve non-Hispanic blacks, mtDNA haplogroup L2 was associated with baseline and 48-week change in T cell activation, and poorer CD4 cell recovery. These data suggest mtDNA variation may influence CD4 T cell dynamics by modulating T cell activation. Further study is needed to replicate these associations and identify mechanisms.

Hulgan, Todd; Robbins, Gregory K.; Kalams, Spyros A.; Samuels, David C.; Grady, Benjamin; Shafer, Robert; Murdock, Deborah G.; Selph, Doug; Haas, David W.; Pollard, Richard B.; De Gruttola, Victor; Snyder, Sally; Nevin, Thomas; Pettinelli, Carla; Dube, Michael; Fischl, Margaret; Delaphna, Robert; Gideon, Linda; D’Aquila, Richard; Vella, Stefano; Merigan, Thomas; Hirsch, Martin

2012-01-01

121

Southwest Oncology Group Study S0530: A Phase 2 Trial of Clofarabine and Cytarabine for Relapsed or Refractory Acute Lymphocytic Leukemia  

PubMed Central

SUMMARY Clofarabine and cytarabine target different steps in DNA synthesis and replication, are synergistic in vivo, and have non-overlapping toxicities making this combination a potentially promising treatment for acute lymphocytic leukemia (ALL). Study goals were to: (1) evaluate the complete remission (CR) rate with Clo/Cy in patients with relapsed/refractory ALL; and (2) assess expression of connective tissue growth factor (CTGF) and nucleoside transporters in leukemic blasts. Associated with poor outcome in newly diagnosed ALL, CTGF is over-expressed in both pediatric and adult ALL. Transport of nucleoside analogs, such as clofarabine, may determine their cytotoxicity, therefore, nucleoside transporter expression may affect response. Thirty-seven patients were treated and evaluated for response. Median age was 41 years, and 44% of patients were either refractory or in ? 2nd relapse. Fifty-nine percent of evaluable patients had poor risk cytogenetics. CR/CRi rate was 17% (95% CI 6–33%) and median overall survival 3 months. Elevated levels of hENT1, hCNT3, and dCK were seen in 54%, 33% and 44% of patients, respectively, but were not significantly correlated with outcome. Higher expression CTGF patients showed a trend for shorter overall survival. This regimen is without sufficient activity to warrant further testing. CTGF expression may predict response and overall survival.

Advani, Anjali S.; Gundacker, Holly M.; Sala-Torra, Olga; Radich, Jerald P.; Lai, Raymond; Slovak, Marilyn L.; Lancet, Jeffrey E.; Coutre, Steve E.; Stuart, Robert K.; Mims, Martha P.; Stiff, Patrick J.; Appelbaum, Frederick R.

2010-01-01

122

Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes  

Microsoft Academic Search

OBJECTIVE: To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials METHODS: A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: \\

Howard Vernon; Aaron Puhl; Christine Reinhart

2011-01-01

123

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

Microsoft Academic Search

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 \\

Selwyn C M Richards; David L Scott

2002-01-01

124

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

Microsoft Academic Search

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

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

2010-01-01

125

Effectiveness of an Online Group Course for Depression in Adolescents and Young Adults: A Randomized Trial  

PubMed Central

Background Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course. Objective To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group. Methods We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed. Results The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t 187 = 6.62, P < .001), with a large between-group effect size of d = 0.94 (95% confidence interval [CI] 0.64–1.23). The MYM group also showed greater improvement in anxiety (t 187 = 3.80, P < .001, d = 0.49, 95% CI 0.24–0.75) and mastery (t 187 = 3.36, P = .001, d = 0.44, 95% CI 0.19–0.70). At 12 weeks, 56% (68/121) of the participants in the MYM group and 20% (24/123) in the control group showed reliable and clinically significant change. This between-group difference was significant (?2 1 = 35.0, P < .001) and yielded a number needed to treat of 2.7. Improvements in the MYM group were maintained at 6 months. A limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months. Conclusions The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months. Trial Registration Nederlands Trial Register: NTR1694; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1694 (Archived by WebCite at http://www.webcitation.org/683SBoeGV)

Kramer, Jeannet; Gerrits, Rob; Cuijpers, Pim

2012-01-01

126

TrialNet Information for Study Participants  

MedlinePLUS

... Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes. Learn More > Visit us on Facebook Follow us on Twitter TrialNet YouTube Channel TrialNet is funded by: Department of Health and ...

127

Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions  

PubMed Central

Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

2011-01-01

128

Marketing and clinical trials: a case study  

PubMed Central

Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-01-01

129

Three-Armed Trials Including Placebo and No-Treatment Groups May Be Subject to Publication Bias: Systematic Review  

PubMed Central

Background It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with active treatment, placebo, and no-treatment groups. Methods Three-armed randomized trials of acupuncture, acupoint stimulation, and transcutaneous electrical stimulation were obtained from electronic databases. Effect sizes between treatment and placebo groups were calculated for treatment effect, and effect sizes between placebo and no-treatment groups were calculated for placebo effect. All data were then analyzed for publication bias. Results For the treatment effect, small trials with fewer than 100 patients per arm showed more benefits than large trials with at least 100 patients per arm in acupuncture and acupoint stimulation. For the placebo effect, no differences were found between large and small trials. Further analyses showed that the treatment effect in acupuncture and acupoint stimulation may be subject to publication bias because study design and any known factors of heterogeneity were not associated with the small study effects. In the simulation, the magnitude of the placebo effect was smaller than that calculated after considering publication bias. Conclusions Randomized three-armed trials, which are necessary for estimating the placebo effect, may be subject to publication bias. If the magnitude of the placebo effect is assessed in an intervention, the potential for publication bias should be investigated using data related to the treatment effect.

Koog, Yun Hyung; We, Seo Ryang; Min, Byung-Il

2011-01-01

130

Results from the Scandinavian Prostate Cancer Group Trial Number 4: a randomized controlled trial of radical prostatectomy versus watchful waiting.  

PubMed

In the Scandinavian Prostate Cancer Group Trial Number 4 (SPCG-4), 347 men were randomly assigned to radical prostatectomy and 348 to watchful waiting. In the most recent analysis (median follow-up time = 12.8 years), the cumulative mortality curves had been stable over the follow-up. At 15 years, the absolute risk reduction of dying from prostate cancer was 6.1% following randomization to radical prostatectomy, compared with watchful waiting. Hence, 17 need to be randomized to operation to avert one death. Data on self-reported symptoms, stress from symptoms, and quality of life were collected at 4 and 12.2 years of median follow-up. These questionnaire studies show an intricate pattern of symptoms evolving after surgery, hormonal treatments, signs of tumor progression, and also from natural aging. This article discusses some of the main findings of the SPCG-4 study. PMID:23271778

Holmberg, Lars; Bill-Axelson, Anna; Steineck, Gunnar; Garmo, Hans; Palmgren, Juni; Johansson, Eva; Adami, Hans-Olov; Johansson, Jan-Erik

2012-12-01

131

Quality Assessment for Therapeutic Drug Monitoring in AIDS Clinical Trials Group (ACTG 5146): A Multicenter Clinical Trial  

PubMed Central

In a randomized trial, AIDS Clinical Trials Group (ACTG) protocol 5146 (A5146) investigated the use of TDM to adjust doses of HIV-1 protease inhibitors (PIs) in patients with prior virologic failure on PI-based therapy who were starting a new PI-based regimen. The overall percentage of “PI trough repeats”, such as rescheduled visits or redrawn PI trough specimens, increased from 2% to 5% to 10% as the process progressed from the clinical sites, the PSL, and the study team, respectively. Cumulatively, this represents a 17% rate of failure to obtain adequate PI trough sample. While targeting a turn-around of ? 7 days from sample receipt to a drug concentration report, 12% of the received specimens required a longer period to report concentrations. The implementation of dosing changes in the TDM arm were achieved within ?7 days for 56% of the dose change events, and within ?14 days for 77% of dose change events. This quality assurance analysis provides a valuable summary of the specific points in the TDM process that could be improved during a multicenter clinical trial including: [1] shortening the timeline of sample shipment from clinical site to the lab, [2] performing the collection of PI trough specimen within the targeted sampling window by careful monitoring of the last dose times and collection times by the clinicians [3] increasing patient adherence counseling to reduce the number of samples that are redrawn due to suspecting inconsistent adherence, and [4] decreasing the time to successful TDM-based dose adjustment. The application of some of these findings may also be relevant to single center studies or clinical TDM programs within a hospital.

DiFrancesco, Robin; Rosenkranz, Susan; Mukherjee, A. Lisa; Demeter, Lisa M.; Jiang, Hongyu; DiCenzo, Robert; Dykes, Carrie; Rinehart, Alex; Albrecht, Mary; Morse, Gene D.

2010-01-01

132

Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer  

PubMed Central

Background: The International Breast Cancer Study Group Trial VIII compared long-term efficacy of endocrine therapy (goserelin), chemotherapy [cyclophosphamide, methotrexate and fluorouracil (CMF)], and chemoendocrine therapy (CMF followed by goserelin) for pre/perimenopausal women with lymph-node-negative breast cancer. Patients and methods: From 1990 to 1999, 1063 patients were randomized to receive (i) goserelin for 24 months (n = 346), (ii) six courses of ‘classical’ CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF? goserelin; n = 357). Tumors were classified as estrogen receptor (ER) negative (19%), ER positive (80%), or ER unknown (1%); 19% of patients were younger than 40. Median follow-up was 12.1 years. Results: For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%) (P = 0.04 for each comparison), due largely to the effect in younger patients. Patients with ER-negative tumors whose treatment included CMF had similar DFS (12-year DFS CMF = 67%; 12-year DFS CMF? goserelin = 69%) compared with goserelin alone (12-year DFS = 61%, P= NS). Conclusions: For pre/perimenopausal women with lymph-node-negative ER-positive breast cancer, CMF followed by goserelin improved DFS in comparison with either modality alone. The improvement was the most pronounced in those aged below 40, suggesting an endocrine effect of prolonged CMF-induced amenorrhea.

Karlsson, P.; Sun, Z.; Braun, D.; Price, K. N.; Castiglione-Gertsch, M.; Rabaglio, M.; Gelber, R. D.; Crivellari, D.; Collins, J.; Murray, E.; Zaman, K.; Colleoni, M.; Gusterson, B. A.; Viale, G.; Regan, M. M.; Coates, A. S.; Goldhirsch, A.

2011-01-01

133

Correlation of Kinase Genotype and Clinical Outcome in the North American Intergroup Phase III Trial of Imatinib Mesylate for Treatment of Advanced Gastrointestinal Stromal Tumor: CALGB 150105 Study by Cancer and Leukemia Group B and Southwest Oncology Group  

PubMed Central

Purpose Imatinib mesylate is standard treatment for patients who have advanced gastrointestinal stromal tumor (GIST), but not all patients benefit equally. In previous studies, GIST genotype correlated with treatment outcome and optimal imatinib dosing. Patients and Methods We examined the relationship between kinase genotype and treatment outcome for 428 patients enrolled on the North American phase III study SWOG S0033/CALGB 150105 and treated with either 400 mg or 800 mg daily doses of imatinib. Results The presence of KIT exon 11–mutant genotype (n = 283) correlated with improved treatment outcome when compared with KIT exon 9–mutant (n = 32) and wild-type (WT; n = 67) genotypes for objective response (complete response [CR]/partial response [PR], 71.7% v 44.4% [P = .007]; and 44.6% [P = .0002], respectively); time to tumor progression (TTP; median 24.7 months v 16.7 and 12.8 months, respectively); and overall survival (OS; median 60.0 months v 38.4 and 49.0 months, respectively). The survival outcomes for patients with exon 9–mutant, exon 11–mutant or WT GIST were not affected by imatinib dose. However, there was evidence of improved response rates for patients with exon 9–mutant tumors treated with imatinib 800 mg versus 400 mg (CR/PR, 67% v 17%; P = .02). Patients who had CD117-negative GIST had similar TTP but inferior OS compared with patients who had CD117-positive disease, which suggests that patients who have CD117-negative GIST may benefit from imatinib treatment. In addition, we identified novel but rare mutations of the KIT extracellular domain (exons 8 and 9). Conclusion We confirmed the favorable impact of KIT exon 11 genotype when compared with KIT exon 9 and wild-type genotype for patients with advanced GIST who are treated with imatinib.

Heinrich, Michael C.; Owzar, Kouros; Corless, Christopher L.; Hollis, Donna; Borden, Ernest C.; Fletcher, Christopher D.M.; Ryan, Christopher W.; von Mehren, Margaret; Blanke, Charles D.; Rankin, Cathryn; Benjamin, Robert S.; Bramwell, Vivien H.; Demetri, George D.; Bertagnolli, Monica M.; Fletcher, Jonathan A.

2008-01-01

134

Accrual and drop out in a primary prevention randomised controlled trial: qualitative study  

PubMed Central

Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

2011-01-01

135

A prospectively randomized trial carried out by the German Hodgkin Study Group (GHSG) for elderly patients with advanced Hodgkin's disease comparing BEACOPP baseline and COPP-ABVD (study HD9elderly).  

PubMed

In contrast to younger patients, the prognosis of elderly patients with advanced Hodgkin's disease (HD) has not improved substantially over the last 20 years. We thus carried out a prospectively randomized study (HD9(elderly)) to compare the BEACOPP regimen in this setting against standard COPP-ABVD. Between February 1993 and 1998, 75 patients aged 66-75 years with newly diagnosed HD in advanced stages were recruited into the HD9 trial as a separate stratum (HD9(elderly)). Patients were assigned to eight alternating cycles of COPP and ABVD or eight cycles of BEACOPP in baseline doses. Radiotherapy was given to initial bulky or residual disease. In total, 68 of 75 registered patients were assessable: 26 were treated with COPP-ABVD and 42 with BEACOPP baseline. There were no significant differences between COPP-ABVD and BEACOPP in terms of complete remission (76%), overall survival (50%) and freedom from treatment failure (FFTF) (46%) at 5 years. At a median follow-up of 80 months, a total of 37 patients died: 14/26 patients (54%) treated with COPP-ABVD and 23/42 patients (55%) with BEACOPP. Two patients (8%) treated with COPP-ABVD and nine patients (21%) treated with BEACOPP died of acute toxicity. Hodgkin-specific FFTF at 5 years was 55% after COPP-ABVD and 74% after BEACOPP (P=0.13). Thus, there are no differences in survival between these regimens in elderly patients. PMID:15598949

Ballova, V; Rüffer, J-U; Haverkamp, H; Pfistner, B; Müller-Hermelink, H K; Dühmke, E; Worst, P; Wilhelmy, M; Naumann, R; Hentrich, M; Eich, H T; Josting, A; Löffler, M; Diehl, V; Engert, A

2005-01-01

136

What to Do When Data Are Missing in Group Randomized Controlled Trials.  

National Technical Information Service (NTIS)

This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups...

C. Price M. J. Puma R. B. Olsen S. H. Bell

2009-01-01

137

The Essence Trial: Efficacy and Safety of Subcutaneous Enoxaparin in Unstable Angina and Non-Q-Wave MI: A Double-Blind, Randomized, Parallel-Group, Multicenter Study Comparing Enoxaparin and Intravenous Unfractionated Heparin: Methods and Design  

Microsoft Academic Search

Antithrombotic therapy reduces the risk of recurrent ischemic events in patients with unstable angina. The primary aim of the ESSENCE trial is to evaluate the efficacy of enoxaparin (low molecular weight heparin) versus unfractionated heparin, plus aspirin, in patients with rest angina or non-Q-wave infarction. This is a randomized, double-blind, placebo-controlled study of 3180 patients comparing enoxaparin, 1 mg\\/kg sc

Marc Cohen; Reginald Blaber; Christine Demers; Enrique P. Gurfinkel; Anatoly Langer; Gregg Fromell; Jerome Premmereur; Alexander G. G. Turpie

1997-01-01

138

Phase II study of S-1 monotherapy as a first-line treatment for elderly patients with advanced nonsmall-cell lung cancer: the Central Japan Lung Study Group trial 0404.  

PubMed

Although S-1 has been shown to have activity against advanced nonsmall-cell lung cancer (NSCLC), its efficacy for elderly patients remains unclear. This phase II study evaluated the efficacy and safety of S-1 as a first-line treatment for elderly patients. Chemotherapy-naïve patients aged 70 years or older with stages IIIB to IV or postoperative NSCLC and performance status 1 or lower were eligible. Patients received S-1 approximately equivalent to 80 mg/m/day for 2 weeks followed by a 1-week rest period every 3 weeks. The primary end point was the response rate. Secondary end points were toxicity, disease control rate, progression-free survival, and overall survival. Twenty-nine patients were eligible. The median age was 78 years (range, 70-85 years). The overall response rate and the disease control rate were 27.6 [95% confidence interval (CI), 11.3-43.9%] and 65.5% (95% CI: 48.2-82.8%), respectively. The median progression-free survival time was 4.0 months (95% CI: 4.0-9.8 months). The median overall survival was 12.1 months (95% CI: 13.8-25.5 months) and the 1-year survival rate was 53.6%. No grade 4 toxicities were observed. The only hematological toxicity of grade 3 was anemia in 6.9% of patients. The grade 3 nonhematological toxicities included hyponatremia, anorexia, nausea, oral mucositis, and diarrhea in 3.4% of patients and infection in 6.9% of patients. S-1 monotherapy was effective and well tolerated as a first-line treatment for elderly patients with advanced NSCLC. The results of this study warrant further investigations of this regimen, including a randomized controlled trial. PMID:21317767

Nishiyama, Osamu; Taniguchi, Hiroyuki; Kondoh, Yasuhiro; Takada, Kazuto; Baba, Kenji; Saito, Hiroshi; Sugino, Yasuteru; Yamamoto, Masashi; Ogasawara, Toshihiko; Kondo, Masashi; Imaizumi, Kazuyoshi; Hasegawa, Yoshinori; Suzuki, Ryujiro; Shimokata, Kaoru

2011-09-01

139

CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.  

PubMed

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials. PMID:22036893

Moher, David; Hopewell, Sally; Schulz, Kenneth F; Montori, Victor; Gøtzsche, Peter C; Devereaux, P J; Elbourne, Diana; Egger, Matthias; Altman, Douglas G

2011-10-12

140

The Buried in Treasures Workshop: waitlist control trial of facilitated support groups for hoarding.  

PubMed

Hoarding is a serious form of psychopathology that has been associated with significant health and safety concerns, as well as the source of social and economic burden (Tolin, Frost, Steketee, & Fitch, 2008; Tolin, Frost, Steketee, Gray, & Fitch, 2008). Recent developments in the treatment of hoarding have met with some success for both individual and group treatments. Nevertheless, the cost and limited accessibility of these treatments leave many hoarding sufferers without options for help. One alternative is support groups that require relatively few resources. Frost, Pekareva-Kochergina, and Maxner (2011) reported significant declines in hoarding symptoms following a non-professionally run 13-week support group (The Buried in Treasures [BIT] Workshop). The BIT Workshop is a highly structured and short term support group. The present study extended these findings by reporting on the results of a waitlist control trial of the BIT Workshop. Significant declines in all hoarding symptom measures were observed compared to a waitlist control. The treatment response rate for the BIT Workshop was similar to that obtained by previous individual and group treatment studies, despite its shorter length and lack of a trained therapist. The BIT Workshop may be an effective adjunct to cognitive behavior therapy for hoarding disorder, or an alternative when cognitive behavior therapy is inaccessible. PMID:22982080

Frost, Randy O; Ruby, Dylan; Shuer, Lee J

2012-08-24

141

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

PubMed Central

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.

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

2012-01-01

142

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

ERIC Educational Resources Information Center

|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.…

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

2011-01-01

143

JCOG Radiation Therapy Study Group: history and achievements.  

PubMed

The Radiation Therapy Study Group (RTSG) of the Japan Clinical Oncology Group (JCOG) was established in 2003. The missions of this group are to develop new standards of care with innovative, advanced technology radiation therapy, both for single- and multi-modality cancer treatment, and to improve radiation therapy quality and outcomes of JCOG trials conducted by other organ-oriented groups. In 2004, the first RTSG trial, a Phase II study of stereotactic body radiation therapy for Stage IA non-small cell lung cancer (JCOG 0403), was initiated. Four other trials are currently open for accrual. JCOG 0702 is a Phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer. JCOG 0701 is a Phase III study comparing accelerated fractionation with conventional fractionation radiation therapy for T1-2N0M0 glottic cancer. JCOG 0906 is a multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery in patients with margin-negative invasive breast cancer. JCOG 1015 is a Phase II study of intensity-modulated radiation therapy with chemotherapy for loco-regionally advanced nasopharyngeal cancer. Other RTSG activities include a medical physics working group responsible for dosimetry audits; a genetic analysis working group involved in accompanying research to analyze single-nucleotide polymorphisms to identify predictors of radiation toxicities; a working group that has developed atlases of clinical target volumes for uterine cervical cancer; and participation in the Harmonisation Group to promote global harmonization of radiotherapy and radiotherapy quality assurance among trial groups. Further efforts to improve radiation therapy quality and outcomes of cancer treatment are necessary. PMID:21980050

Ishikura, Satoshi; Ito, Yoshinori; Hiraoka, Masahiro

2011-10-06

144

Addressing Challenges in Adolescent Smoking Cessation: Design and Baseline Characteristics of the HS Group-Randomized Trial  

PubMed Central

Objective Well-documented challenges have hampered both intervention development and research in teen smoking cessation. Addressing these challenges, the Hutchinson Study of High School Smoking (HS Study), the largest group-randomized trial in adolescent smoking cessation to date, incorporates several design innovations to investigate the effect of a counselor-initiated, individually tailored telephone counseling smoking cessation intervention for older adolescents. This paper presents and discusses these innovative design features, and baseline findings on the resulting study population. Method The trial used a population-based survey to proactively identify and recruit all high school juniors who had smoked in the past month—potentially expanding intervention reach to all smokers, even those who smoked less than daily and those not motivated to quit. For ethical and intervention reasons, some nonsmokers were enrolled in the intervention, also. Other important design features included the random allocation of schools into experimental conditions (intervention vs. no-intervention control) and a multi-wave design. Results & Conclusion The design innovations address problems and challenges identified in adolescent smoking cessation literature. The heterogeneous baseline characteristics of the study population, well-balanced between the two arms, have three significant implications: They (1) demonstrate the effectiveness of the trial’s design features, (2) highlight several intervention-related issues, and (3) provide assurance that the trial’s evaluation of intervention effectiveness will be unbiased.

Liu, Jingmin; Peterson, Arthur V.; Kealey, Kathleen A.; Mann, Sue L.; Bricker, Jonathan B.; Marek, Patrick M.

2007-01-01

145

Extraovarian peritoneal serous papillary carcinoma: a phase II trial of cisplatin and cyclophosphamide with comparison to a cohort with papillary serous ovarian carcinoma—a Gynecologic Oncology Group Study  

Microsoft Academic Search

ObjectivesThe goals of this study were first, to assess the clinical effectiveness of cisplatin and cyclophosphamide in a phase II study involving a well-defined group of women with extraovarian peritoneal serous papillary carcinoma (EPSPC); and second, to compare these results with those of a group of patients with papillary serous ovarian carcinoma (PSOC) who received identical therapy.

Jeffrey D Bloss; Mark F Brady; Shu Yuan Liao; Thomas Rocereto; Edward E Partridge; Daniel L Clarke-Pearson

2003-01-01

146

Statistical analysis of group-administered intervention data: Reanalysis of two randomized trials  

Microsoft Academic Search

Group-administered interventions often create statistical dependencies, which, if ignored, increase the rate of Type I errors. The authors analyzed data from two randomized trials involving group interventions to document the impact of statistical dependency on tests of intervention effects and to provide estimates of statistical dependency. Intraclass correlations ranged from .02 to .12. Adjusting for dependencies increased p values for

Scott A. Baldwin; Eric Stice; Paul Rohde

2008-01-01

147

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

Microsoft Academic Search

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

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

148

Recruiting ethnic minority participants to a clinical trial: a qualitative study  

PubMed Central

Objectives To compare the motives and experiences of different ethnic groups participating in a randomised double blind placebo-controlled trial of montelukast in preschool wheeze, and to assess parents’ or guardians’ understanding of trial procedures and their implications, including the collection of genetic material. Design Qualitative interviews with parents or guardians. Setting Interviews occurred in the homes of London children recruited to a national multicentre clinical trial following primary and secondary care attendance with wheeze. Participants 42 parents (20 of Bangladeshi origin, 10 white UK, 12 other ethnicities) of preschool children enrolled in a clinical trial. Results Bangladeshi families were relatively reluctant to participate in the qualitative study, despite strong engagement with the parent study. Anxiety related to wheezing was a common primary motive for trial enrolment. Parents viewed the trial as a route to improved treatment. Verbal delivery of trial information appeared more effective than study literature, especially for Bangladeshi families, with low parental literacy and high levels of trust in medical professionals potential contributors to this effect. All ethnic groups expressed a low understanding and/or retention of essential study concepts such as randomisation and genetic testing. Conclusions Bangladeshi families are particularly motivated to participate in clinical trials despite variable comprehension of study concepts. This motivation is more strongly contingent on strong researcher-subject rapport than on the quality of study literature. Trial teams seeking to recruit from South Asian populations should emphasise face-to-face verbal explanation of trial concepts and procedures and consider modified trial literature.

MacNeill, Virginia; Nwokoro, Chinedu; Griffiths, Chris; Grigg, Jonathan; Seale, Clive

2013-01-01

149

Randomized Controlled Trial of Acitretin Versus Placebo in Patients at High Risk for Basal Cell or Squamous Cell Carcinoma of the Skin (North Central Cancer Treatment Group Study 969251)  

PubMed Central

BACKGROUND Chemoprevention with systemic retinoids has demonstrated promise in decreasing the incidence of new primary nonmelanoma skin cancers (NMSCs) in immunocompromised post-transplantation recipients. There is limited evidence for the use of systemic retinoids in the nontransplantation patient. To the authors’ knowledge, this is the first randomized controlled trial to assess the efficacy of acitretin as a chemopreventive agent in nontransplantation patients at high risk for NMSC. METHODS The study was designed as a prospective, randomized, double-blind, placebo-controlled clinical trial. To test the possible skin cancer-preventing effect of a 2-year treatment with acitretin, 70 nontransplantation patients aged ?18 years who had a history of ?2 NMSCs within 5 years of trial onset were randomized to receive either placebo or acitretin 25 mg orally 5 days per week. The primary outcome measure was the rate of new NMSC development. RESULTS Seventy patients were randomized to receive either acitretin alone (N = 35) or placebo (N = 35). During the 2-year treatment period, the patients who received acitretin did not have a statistically significant reduction in the rate of new primary NMSCs (odds ratio, 0.41; 95% confidence interval, 0.15–1.13; 54% vs 74%; P = .13). However, using the incidence of new NMSC, the time to new NMSC, and total NMSC counts, an umbrella test indicated a significant trend that favored the use of acitretin (chi-square statistic, 3.94; P = .047). The patients who received acitretin reported significantly more mucositis and skin toxicities compared with the patients who received placebo. CONCLUSIONS Although there was not a statistically significant benefit observed with the use of acitretin, this may have been the result of low statistical power.

Kadakia, Kunal C.; Barton, Debra L.; Loprinzi, Charles L.; Sloan, Jeff A.; Otley, Clark C.; Diekmann, Brent B.; Novotny, Paul J.; Alberts, Steven R.; Limburg, Paul J.; Pittelkow, Mark R.

2012-01-01

150

Combined Treatment with Dif1stat ® and Diet Reduce Plasma Lipid Indicators of Moderate Hypercholesterolemia More Effectively than Diet Alone: A Randomized Trial in Parallel Groups  

Microsoft Academic Search

An open-labeled randomized trial with parallel groups was carried out to study the effects of Dif1stat® (Monascus purpureus–Linear aliphatic alcohols–Niacin) in the treatment of primary moderate hypercholesterolemia. The trial lasted 8 months. The\\u000a patients, males and females, were assigned to two groups: A (#130), treated with diet, and B (#110) submitted to diet + Dif1stat®. After 4 months, group A did not show significant

Claudia Stefanutti; Fabio Mazza; Antonio Vivenzio; Serafina Di Giacomo; Giuseppina Perrone; Mariarosaria Serra; Antonello Bucci

2009-01-01

151

Recommendations for collection and handling of specimens from group breast cancer clinical trials.  

PubMed

Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue. PMID:18955459

Leyland-Jones, Brian R; Ambrosone, Christine B; Bartlett, John; Ellis, Matthew J C; Enos, Rebecca A; Raji, Adekunle; Pins, Michael R; Zujewski, Jo Anne; Hewitt, Stephen M; Forbes, John F; Abramovitz, Mark; Braga, Sofia; Cardoso, Fatima; Harbeck, Nadia; Denkert, Carsten; Jewell, Scott D

2008-10-27

152

Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials  

PubMed Central

Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue.

Leyland-Jones, Brian R.; Ambrosone, Christine B.; Bartlett, John; Ellis, Matthew J.C.; Enos, Rebecca A.; Raji, Adekunle; Pins, Michael R.; Zujewski, Jo Anne; Hewitt, Stephen M.; Forbes, John F.; Abramovitz, Mark; Braga, Sofia; Cardoso, Fatima; Harbeck, Nadia; Denkert, Carsten; Jewell, Scott D.

2008-01-01

153

The United States critical illness and injury trials group: an introduction.  

PubMed

The US Critical Illness and Injury Trials Group is funded to engage the relevant scientific communities and federal agencies to jointly advocate for clinical research. An inclusive, nationwide network of experts has been created to establish national priorities and pursue a strategic plan in conjunction with professional societies and existing research networks. Investigator-initiated clinical proposals will be presented and discussed at the inaugural National Institutes of Health meeting to promote collaboration and establish working groups to develop projects and core resources. Future US Critical Illness and Injury Trials Group meetings will convene triannually, providing a venue to gauge progress on strategic deliverables, foster development of the clinical projects, discuss education and training in clinical trial design, and address the ethical, legal, and social implications of research in the critically ill or injured patients. PMID:19667851

Cobb, J Perren; Cairns, Charles B; Bulger, Eileen; Wong, Hector R; Parsons, Polly E; Angus, Derek C; Gentile, Nina T; Hoyt, David B; Schwinn, Debra A; Wiener-Kronish, Jeanine P; Upperman, Jeffrey S

2009-08-01

154

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

PubMed Central

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

2009-01-01

155

Critical trial-related criteria in acute schizophrenia studies  

Microsoft Academic Search

The Trial Criteria in Schizophrenia Working Group was convened in November 2007 to define consensus criteria for clinical\\u000a trials in patients suffering from acute schizophrenia with special focus on placebo-controlled trials and withdrawal conditions.\\u000a Clinical trials involving patients give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially\\u000a expose patients to ineffective treatment regimens or placebo.

Stefan Leucht; Eckart Rüther; Max Schmauß; Hans-Jürgen Möller

156

Evaluation of an adjustment group for people with multiple sclerosis: a pilot randomized controlled trial  

Microsoft Academic Search

Objective: The aim was to evaluate a group treatment for people with multiple sclerosis and low mood.Design: Randomized controlled trial.Setting: Community.Participants: Patients with multiple sclerosis and low mood, scoring >7 on the Hospital Anxiety and Depression Scales or >2 on the General Health Questionnaire 12.Interventions: Participants either attended an adjustment group for six, 2-hour group treatment sessions or were on

AC Forman; NB Lincoln

2010-01-01

157

Video-Assisted Thoracic Surgery Study Group.  

PubMed

Both patients and the medical profession are quick to embrace new technology, particularly when it may replace an existing surgical procedure. Unfortunately, the rapidity of acceptance is rarely associated with careful evaluation. Laparoscopy is a recent example of such widely embraced technology. Studies of laparoscopy that yielded good comparative data to more traditional methods were slow to accrue. This led to the exposure of its shortcomings through governmental reports and the lay press. To prevent this from happening in thoracoscopy, two types of studies are required so that valid conclusions about the new technology can be drawn. The first is an accounting of the new technology as procedures evolve around it. The data collected in such a study should contain basic information, including the indications for the procedure, how it was performed, procedure length, associated complications, and patient outcome. Such information provides a broad profile of the technology, emphasizing from the outset its potential strengths and weaknesses. The second type of study involves a more detailed concurrent comparison of the specific procedures utilizing this technology to the established traditional methods. Such randomized studies help to firmly establish through scientific process the place of the new technology. The Video-Assisted Thoracic Surgery Study Group was organized in early 1992 to address these concerns. From an initial four surgeons the group has grown to include more than 41 institutions. Currently the group is collecting data in a registry and has established three clinical trials to evaluate video-assisted thoracic surgery.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8379782

LoCicero, J

1993-09-01

158

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder  

Microsoft Academic Search

Background  Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support\\u000a in a specialist mood disorder centre in Spain (with effects lasting up to five years), and treatment as usual in Australia.\\u000a It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively

Richard K Morriss; Fiona Lobban; Steven Jones; Lisa Riste; Sarah Peters; Christopher Roberts; Linda Davies; Debbie Mayes

2011-01-01

159

A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial.  

PubMed

High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials. PMID:21104007

Jacob, Shevin T; Baeten, Jared M; Hughes, James P; Peinado, Jesús; Wang, Jing; Sanchez, Jorge; Reid, Stewart E; Delany-Moretlwe, Sinead; Cowan, Frances; Fuchs, Jonathan D; Koblin, Beryl; Griffith, Sam; Wald, Anna; Celum, Connie

2011-07-01

160

An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group  

PubMed Central

Background Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group. Methods and Findings Participants (n?=?1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio?=?1.14, confidence interval?=?0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons. Conclusions These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups. Trial Registration ClinicalTrials.gov NCT00153361 Please see later in the article for the Editors' Summary

Mansergh, Gordon; Koblin, Beryl A.; McKirnan, David J.; Hudson, Sharon M.; Flores, Stephen A.; Wiegand, Ryan E.; Purcell, David W.; Colfax, Grant N.

2010-01-01

161

Racial Disparities in Cancer Survival Among Randomized Clinical Trials Patients of the Southwest Oncology Group  

PubMed Central

Background Racial disparities in cancer outcomes have been observed in several malignancies. However, it is unclear if survival differences persist after adjusting for clinical, demographic, and treatment variables. Our objective was to determine whether racial disparities in survival exist among patients enrolled in consecutive trials conducted by the Southwest Oncology Group (SWOG). Methods We identified 19?457 adult cancer patients (6676 with breast, 2699 with lung, 1244 with colon, 1429 with ovarian, and 1843 with prostate cancers; 1291 with lymphoma; 2067 with leukemia; and 2208 with multiple myeloma) who were treated on 35 SWOG randomized phase III clinical trials from October 1, 1974, through November 29, 2001. Patients were grouped according to studies of diseases with similar histology and stage. Cox regression was used to evaluate the association between race and overall survival within each disease site grouping, controlling for available prognostic factors plus education and income, which are surrogates for socioeconomic status. Median and ten-year overall survival estimates were derived by the Kaplan–Meier method. All statistical tests were two-sided. Results Of 19?457 patients registered, 2308 (11.9%, range = 3.9%–21.6%) were African American. After adjustment for prognostic factors, African American race was associated with increased mortality in patients with early-stage premenopausal breast cancer (hazard ratio [HR] for death = 1.41, 95% confidence interval [CI] = 1.10 to 1.82; P = .007), early-stage postmenopausal breast cancer (HR for death = 1.49, 95% CI = 1.28 to 1.73; P < .001), advanced-stage ovarian cancer (HR for death = 1.61, 95% CI = 1.18 to 2.18; P = .002), and advanced-stage prostate cancer (HR for death = 1.21, 95% CI = 1.08 to 1.37; P = .001). No statistically significant association between race and survival for lung cancer, colon cancer, lymphoma, leukemia, or myeloma was observed. Additional adjustments for socioeconomic status did not substantially change these observations. Ten-year (and median) overall survival rates for African American vs all other patients were 68% (not reached) vs 77% (not reached), respectively, for early-stage, premenopausal breast cancer; 52% (10.2 years) vs 62% (13.5 years) for early-stage, postmenopausal breast cancer; 13% (1.3 years) vs 17% (2.3 years) for advanced ovarian cancer; and 6% (2.2 years) vs 9% (2.7 years) for advanced prostate cancer. Conclusions African American patients with sex-specific cancers had worse survival than white patients, despite enrollment on phase III SWOG trials with uniform stage, treatment, and follow-up.

Unger, Joseph M.; Crowley, John J.; Coltman, Charles A.; Hershman, Dawn L.

2009-01-01

162

Academic detailing and adherence to guidelines for Group B streptococci prenatal screening: a randomized controlled trial  

PubMed Central

Background Clinical practice guidelines (CPGs) recommend universal prenatal screening for Group B Streptococcus (GBS) to identify candidates for intrapartum antibiotic prophylaxis to prevent early onset neonatal GBS infection. Interventions to promote physician adherence to these guidelines are imperative. This study examined the effectiveness of academic detailing (AD) of obstetricians, compared with CPG mailshot and no intervention, on the screening of pregnant women for GBS. Methods A randomized controlled clinical trial was conducted in the medical cooperative of Porto Alegre, Brazil. All obstetricians who assisted in a delivery covered by private health insurance managed by the cooperative in the 3 months preceding the study (n = 241) were invited to participate. The obstetricians were randomized to three groups: direct mail (DM, n = 76), AD (n = 76) and control (C, n = 89, no intervention). Those in the DM group were sent guidelines on GBS. The AD group received the guidelines and an educational visit detailing the guidelines, which was conducted by a trained physician. Data on obstetrician age, gender, time since graduation, whether patients received GBS screening during pregnancy, and obstetricians who requested screening were collected for all participant obstetricians for 3 months before and after the intervention, using database from the private health insurance information system. Results Three months post-intervention, the data showed that the proportion of pregnant women screened for GBS was higher in the AD group (25.4%) than in the DM (15.9%) and C (17.7%) groups (P = 0.023). Similar results emerged when the three groups were taken as a cluster (pregnant women and their obstetricians), but the difference was not statistically significant (Poisson regression, P = 0.108). Additionally, when vaginal deliveries were analyzed separately, the proportion screened was higher in the AD group (75%) than in the DM group (41.9%) and the C group (30.4%) (chi-square, P < 0.001). Conclusions The results suggest that AD increased the prevalence of GBS screening in pregnant women in this population.

2013-01-01

163

Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes  

PubMed Central

Background Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. Objective To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. Materials and methods This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Results Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months’ postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. Conclusion The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the effect of a goal-oriented physical training program toward NH residents UI complaints.

Vinsnes, Anne G; Helbostad, Jorunn L; Nyr?nning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn

2012-01-01

164

The Inclusion of Minority Groups in Clinical Trials: Problems of Under Representation and Under Reporting of Data  

Microsoft Academic Search

Objective: To evaluate the representation of minority groups in randomized control trials (RCTs), and the frequency with which this information is reported.Study Design: Reviewers collected data on the racial\\/ethnic composition of study samples from all RCTs published in six leading medical journals in 1999.Results: Of the 280 RCTs, most (204, 71.3%) provided no information on the race\\/ethnicity of participants. Of

Paula A. Rochon; Azad Mashari; Ariel Cohen; Anjali Misra; Dara Laxer; David L. Streiner; Jocalyn P. Clark; Julie M. Dergal; Jennifer Gold

2004-01-01

165

Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903.  

PubMed

A multicenter Eastern Cooperative Group (ECOG) phase 2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). Forty-eight subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3-month low-dose prednisone taper. Ten subjects received 3 months, and 25 received 6 months of therapy. Myelosuppression was the main toxicity with 88% with ? grade 3 hematologic toxicity and 45% ? grade 3 nonhematologic toxicity. There were responses in 10 subjects (23%) using the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)-defined clinical improvement of anemia in 8 (19%) and/or decreased spleen size in 4 (10%). Serial bone marrow analysis showed no resolution of disease-related fibrosis or angiogenesis. With a median follow-up of 2.3 years, 23 subjects are alive. Lenali-domide and prednisone for myelofibro-sis evaluated through a multicentered-cooperative group mechanism is only modestly active and myelosuppre-sive. This study was registered at http://clinicaltrials.gov as NCT00227591. PMID:20651074

Mesa, Ruben A; Yao, Xiaopan; Cripe, Larry D; Li, Chin Yang; Litzow, Mark; Paietta, Elisabeth; Rowe, Jacob M; Tefferi, Ayalew; Tallman, Martin S

2010-07-22

166

Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903  

PubMed Central

A multicenter Eastern Cooperative Group (ECOG) phase 2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). Forty-eight subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3-month low-dose prednisone taper. Ten subjects received 3 months, and 25 received 6 months of therapy. Myelosuppression was the main toxicity with 88% with ? grade 3 hematologic toxicity and 45% ? grade 3 nonhematologic toxicity. There were responses in 10 subjects (23%) using the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)–defined clinical improvement of anemia in 8 (19%) and/or decreased spleen size in 4 (10%). Serial bone marrow analysis showed no resolution of disease-related fibrosis or angiogenesis. With a median follow-up of 2.3 years, 23 subjects are alive. Lenali-domide and prednisone for myelofibro-sis evaluated through a multicentered-cooperative group mechanism is only modestly active and myelosuppre-sive. This study was registered at http://clinicaltrials.gov as NCT00227591.

Yao, Xiaopan; Cripe, Larry D.; Li, Chin Yang; Litzow, Mark; Paietta, Elisabeth; Rowe, Jacob M.; Tefferi, Ayalew; Tallman, Martin S.

2010-01-01

167

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

PubMed Central

Background 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 Diabetes (Look AHEAD) trial. Look AHEAD, a randomized, controlled, multicenter trial, was designed to determine whether an Intensive Lifestyle Intervention to reduce weight and increase physical activity reduces cardiovascular morbidity and mortality in overweight volunteers with type 2 diabetes compared to the Diabetes Support and Education Intervention. The Diabetes Support and Education Committee was charged with developing the Diabetes Support and Education Intervention with the primary aim of participant retention. Purpose The objectives were to design the Diabetes Support and Education Intervention sessions, standardize delivery across the 16 clinics, review quality and protocol adherence and advise on staffing and funding. Methods Following a mandatory session on basic diabetes education, three optional sessions were offered on nutrition, physical activity, and support yearly for 4 years. For each session, guidelines, objectives, activities, and a resource list were created. Conclusions Participant evaluations were very positive with hands on experiences being the most valuable. Retention so far at years 1 and 4 has been excellent and only slightly lower in the Diabetes Support and Education Intervention arm. The comparison group plays an important role in the success of a clinical trial. Understanding the effort needed to develop and implement the comparison group intervention will facilitate its implementation in future lifestyle intervention trials, particularly multicenter trials. Retention rates may improve by developing the comparison intervention simultaneously with the lifestyle intervention.

2011-01-01

168

Pain and Emotional Well-Being Outcomes in Southwest Oncology Group-Directed Intergroup Trial S0205: A Phase III Study Comparing Gemcitabine Plus Cetuximab Versus Gemcitabine As First-Line Therapy in Patients With Advanced Pancreas Cancer  

PubMed Central

Purpose S0205 was a randomized clinical trial that compared the therapeutic impact of gemcitabine versus gemcitabine plus cetuximab. Study results for patient-reported health-related quality of life (HRQL) outcomes are reported. Patients and Methods Patients completed the Brief Pain Inventory and a measure of emotional well-being (each measured on a 0 to 10 scale) at baseline and at weeks 5, 9, 13, and 17 postrandom assignment. Worst pain status was classified as palliated (worst pain scores < 5 maintained for 2 consecutive cycles) or not palliated (remaining patients) and tested with a ?2 test. Change in emotional well-being and worst pain (exploratory analysis) were assessed over 17 weeks using generalized estimating equations with inverse probability of censoring weights. Results Seven hundred twenty of 766 enrolled patients contributed baseline HRQL data. The two treatment arms did not differ statistically in the percentage of patients with successful worst pain palliation. Longitudinal analyses showed significantly improved emotional well-being for patients on both arms by weeks 13 and 17 (P < .01 and P < .001). An exploratory longitudinal analysis of worst pain showed significant decreases at all time points for both arms (P < .01 and P < .001). Significant treatment arm differences for either worst pain or emotional well-being were not observed at any of the assessment times. Conclusion We observed palliated pain and improved well-being for patients on this trial. However, these improvements were similar in both treatment arms, suggesting that the addition of cetuximab did not contribute to improvement in these HRQL outcomes.

Moinpour, Carol M.; Vaught, Nancy L.; Goldman, Bryan; Redman, Mary W.; Philip, Philip A.; Millwood, Barbara; Lippman, Scott M.; Seay, Thomas E.; Flynn, Patrick J.; O'Reilly, Eileen M.; Rowland, Kendrith M.; Wong, Ralph P.; Benedetti, Jacqueline; Blanke, Charles D.

2010-01-01

169

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

SciTech Connect

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.

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

170

What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049  

ERIC Educational Resources Information Center

|This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

2009-01-01

171

Literature Study Groups: Literacy Learning "With Legs"  

NSDL National Science Digital Library

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.

Parsons, Sue C.; Mokhtari, Kouider; Yellin, David; Orwig, Ryan

2011-05-01

172

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

PubMed Central

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.

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

2001-01-01

173

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial  

PubMed Central

Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390).

2011-01-01

174

Group Performance in Information Systems Project Groups: An Empirical Study  

ERIC Educational Resources Information Center

|The importance of teamwork in Information Systems Development (ISD) practice and education has been acknowledged but not studied extensively to date. This paper tests a model of how groups participating in ISD projects perform and examines the relationships between some antecedents of this performance based on group research theory well…

Bahli, Bouchaib; Buyukkurt, Meral Demirbag

2005-01-01

175

Trial Sample Size, but not trial Quality is Associated with Positive Study Outcome  

PubMed Central

Objective To assess whether reported trial quality or trial characteristics are associated with trial outcome. Study Design and Setting We identified all eligible randomized controlled trials (RCTs) of arthroplasty from 1997 and 2006. Trials were classified based on whether the main trial outcome was reported to be positive (n=90) or negative (n=94). Multivariable logistic regression analyses studied the association of reporting of trial quality measures (blinding, placebo use, allocation procedure; overall quality) and trial characteristics (intervention type, number of patients/centers, funding) with positive trial outcome. Results RCTs that used placebo or blinded care providers, used pharmacological interventions, had higher Jadad quality scores or sample size >100 patients were significantly more likely to report positive result in univariate analyses. Multivariable regression did not identify methodological quality of RCTs, but rather that sample size, was associated with trial outcome. Studies with >100 patients were 2.2 times more likely to report a positive result than smaller studies (p=0.04). Conclusions Lack of association of reported trial quality with positive outcome in multivariable analyses suggests that previously observed association of reported study quality with study outcome in univariate analyses may be mediated by other study characteristics, such as study sample size. What's New? Arthroplasty RCTs with sample size of 100 patients or more are significantly more likely to report a positive rather than a negative outcome.RCT quality was not associated with study outcome (positive vs. negative) in multivariable analyses, in contrast to previous studies that found an association of quality with outcomes in univariate analyses that did not adjust for sample size or type of intervention.Previously reported associations of study quality and outcomes may have been mediated by these characteristics.Future studies examining correlates of study outcomes should control for sample size, study quality and type of intervention.

Singh, Jasvinder A; Murphy, Stephen; Bhandari, Mohit

2009-01-01

176

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial  

PubMed Central

Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Trial register Pan African Clinical Trial Registry PACTR201205000380384

2012-01-01

177

Altering School Climate through School-Wide Positive Behavioral Interventions and Supports: Findings from a Group-Randomized Effectiveness Trial  

Microsoft Academic Search

Positive Behavioral Interventions and Supports (PBIS) is a universal, school-wide prevention strategy that is currently implemented\\u000a in over 7,500 schools to reduce disruptive behavior problems. The present study examines the impact of PBIS on staff reports\\u000a of school organizational health using data from a group-randomized controlled effectiveness trial of PBIS conducted in 37\\u000a elementary schools. Longitudinal multilevel analyses on data

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

2009-01-01

178

Dosimetric verification in participating institutions in a stereotactic body radiotherapy trial for stage I non-small cell lung cancer: Japan clinical oncology group trial (JCOG0403)  

Microsoft Academic Search

A multicentre phase II trial of stereotactic body radiotherapy for T1N0M0 non-small cell lung cancer was initiated in Japan as the Japan Clinical Oncology Group trial (JCOG0403). Before starting the trial, a decision was made to evaluate the treatment machine and treatment planning in participating institutions to minimize the variations of the prescription dose between the institutions. We visited the

Teiji Nishio; Etsuo Kunieda; Hiroki Shirato; Satoshi Ishikura; Hiroshi Onishi; Kunihiko Tateoka; Masahiro Hiraoka; Yuichirou Narita; Masataka Ikeda; Tomonori Goka

2006-01-01

179

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

PubMed Central

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

2013-01-01

180

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  

Microsoft Academic Search

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

Anne Söderlund; Annika Bring; Pernilla Åsenlöf

2009-01-01

181

Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial  

Microsoft Academic Search

Background  The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent\\u000a need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the\\u000a Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in\\u000a this protocol will test the effectiveness of

Carmen V Voogt; Evelien AP Poelen; Marloes Kleinjan; Lex ACJ Lemmers; Rutger CME Engels

2011-01-01

182

Transfusion of fresh frozen plasma in non-bleeding ICU patients -TOPIC TRIAL: study protocol for a randomized controlled trial  

PubMed Central

Background Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients. With the aim to investigate whether prophylactic FFP transfusions to critically ill patients can be safely omitted, a multi-center randomized clinical trial is conducted in ICU patients with a coagulopathy undergoing an invasive procedure. Methods A non-inferiority, prospective, multicenter randomized open-label, blinded end point evaluation (PROBE) trial. In the intervention group, a prophylactic transfusion of FFP prior to an invasive procedure is omitted compared to transfusion of a fixed dose of 12 ml/kg in the control group. Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of International Normalized Ratio, onset of acute lung injury, length of ventilation days and length of Intensive Care Unit stay. Discussion The Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure. Trial Registration Trial registration: Dutch Trial Register NTR2262 and ClinicalTrials.gov: NCT01143909

2011-01-01

183

Intervention with PTCA and CABG following thrombolysis for acute myocardial infarction. Australian data from GUSTO 1 (1991-3) and International Study Group r-TPA-Streptokinase Mortality (1989) trials. Global Utilisation of Streptokinase and Tissue.  

PubMed

The patterns of revascularisation with percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in the GUSTO 1 trial patients in Australia are described. In comparison with rates documented in earlier trials of thrombolytic therapy in Australia, the rates of revascularisation post-thrombolysis increased by 50%, primarily due to a doubling in the rate of use of PTCA. However, the rates were low by international comparisons. There were marked variations in the rates of revascularisation between States, but no correlation with differences in mortality between States. The main predictors of post thrombolysis PTCA were prior angina, mild infarction and access to PTCA facilities. PMID:9777135

Tideman, P A; Fabri, J K; Aylward, P E; Simes, R J

1998-08-01

184

The Thrombolysis in Myocardial Infarction (TIMI) Study Group experience.  

PubMed

The Thrombolysis in Myocardial Infarction (TIMI) study group, an academic research organization, was formed in 1984 with initial support from the National Heart, Lung, and Blood Institute. Its initial goal was to compare the effects of the then-new thrombolytic agent, recombinant tissue plasminogen activator, with streptokinase. The TIMI study group has remained active since then and has completed 50 multicenter clinical trials. The TIMI network now collaborates with more than 1000 separate sites in 45 countries on 5 continents. In addition to thrombolytic agents, TIMI has studied antithrombotic, antiplatelet, anti-ischemic, lipid lowering, and anti-inflammatory drugs. TIMI has also established robust biomarker and pharmacogenetics programs, and has devised a panel of risk assessment scores that are widely used. TIMI is currently conducting 7 large trials worldwide on novel agents designed to reduce the morbidity and mortality of a variety of cardiovascular disorders. PMID:22901500

Braunwald, Eugene; Sabatine, Marc S

2012-08-15

185

Group Mentoring: A Study of Mentoring Groups in Three Programs.  

ERIC Educational Resources Information Center

This study investigated three innovative group mentoring programs and examined findings from data collected in two earlier studies of mentoring programs. The three programs were YouthFriends, which provided technical assistance to school districts establishing school-based mentoring programs; TEAMWORKS, which organized teams of mentors to meet…

Herrera, Carla; Vang, Zoua; Gale, Lisa Y.

186

A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial  

PubMed Central

Background Coping with a chronic illness (CI) challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers') [1] for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age) with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program) and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed. Trial registration Current Controlled Trials ISRCTN60919570

2011-01-01

187

Recruiting a Diverse Group of Middle School Girls into the Trial of Activity for Adolescent Girls  

ERIC Educational Resources Information Center

|Background: School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among…

Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

2008-01-01

188

A Phase I Clinical Trial of the hu14.18-IL2 (EMD 273063) as a Treatment for Children with Refractory or Recurrent Neuroblastoma and Melanoma: a Study of the Children's Oncology Group  

PubMed Central

Purpose Evaluate the clinical safety, toxicity, immune activation/modulation, and maximal tolerated dose of hu14.18-IL2 (EMD 273063) in pediatric patients with recurrent/refractory neuroblastoma and other GD2-positive solid tumors. Experimental Design Twenty-seven pediatric patients with recurrent/refractory neuroblastoma and one with melanoma were treated with a humanized anti-GD2 monoclonal antibody linked to human interleukin 2 (IL-2). Cohorts of patients received hu14.18-IL2, administered i.v. over 4 hours for three consecutive days, at varying doses. Patients with stable disease, partial, or complete responses were eligible to receive up to three additional courses of therapy. Results Most of the clinical toxicities were anticipated and similar to those reported with IL-2 and anti-GD2 monoclonal antibody therapy and to those noted in the initial phase I study of hu14.18-IL2 in adults with metastatic melanoma. The maximal tolerated dose was determined to be 12 mg/m2/d, with agent-related dose-limiting toxicities of hypotension, allergic reaction, blurred vision, neutropenia, thrombocytopenia, and leukopenia. Three patients developed dose-limiting toxicity during course 1; seven patients in courses 2 to 4. Two patients required dopamine for hypotension. There were no treatment-related deaths, and all toxicity was reversible. Treatment with hu14.18-IL2 led to immune activation/modulation as evidenced by elevated serum levels of soluble IL-2 receptor ? (sIL2R?) and lymphocytosis. The median half-life of hu14.18-IL2 was 3.1 hours. There were no measurable complete or partial responses to hu14.18-IL2 in this study; however, three patients did show evidence of antitumor activity. Conclusion Hu14.18-IL2 (EMD 273063) can be administered safely with reversible toxicities in pediatric patients at doses that induce immune activation. A phase II clinical trial of hu14.18-IL2, administered at a dose of 12 mg/m2/d × 3 days repeated every 28 days, will be done in pediatric patients with recurrent/refractory neuroblastoma.

Osenga, Kaci L.; Hank, Jacquelyn A.; Albertini, Mark R.; Gan, Jacek; Sternberg, Adam G.; Eickhoff, Jens; Seeger, Robert C.; Matthay, Katherine K.; Reynolds, C. Patrick; Twist, Clare; Krailo, Mark; Adamson, Peter C.; Reisfeld, Ralph A.; Gillies, Stephen D.; Sondel, Paul M.

2008-01-01

189

Phase 2 trial design in neuro-oncology revisited: a report from the RANO group.  

PubMed

Advances in the management of gliomas, including the approval of agents such as temozolomide and bevacizumab, have created an evolving therapeutic landscape in glioma treatment, thus affecting our ability to reliably use historical controls to comparatively assess the activity of new therapies. Furthermore, the increasing availability of novel, targeted agents--which are competing for a small patient population, in view of the low incidence of primary brain tumours--draws attention to the need to improve the efficiency of phase 2 clinical testing in neuro-oncology to expeditiously transition the most promising of these drugs or combinations to potentially practice-changing phase 3 trials. In this report from the Response Assessment in Neurooncology (RANO) group, we review phase 2 trial designs that can address these challenges and capitalise on scientific and clinical advances in brain tumour treatment in neuro-oncology to accelerate and optimise the selection of drugs deserving further testing in phase 3 trials. Although there is still a small role for single-arm and non-comparative phase 2 designs, emphasis is placed on the potential role that comparative randomised phase 2 designs--such as screening designs, selection designs, discontinuation designs, and adaptive designs, including seamless phase 2/3 designs--can have. The rational incorporation of these designs, as determined by the specific clinical setting and the trial's endpoints or goals, has the potential to substantially advance new drug development in neuro-oncology. PMID:22554547

Galanis, Evanthia; Wu, Wenting; Cloughesy, Timothy; Lamborn, Kathleen; Mann, Bhupinder; Wen, Patrick Y; Reardon, David A; Wick, Wolfgang; Macdonald, David; Armstrong, Terri S; Weller, Michael; Vogelbaum, Michael; Colman, Howard; Sargent, Daniel J; van den Bent, Martin J; Gilbert, Mark; Chang, Susan

2012-05-01

190

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

PubMed

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

Bilek, Emily L; Ehrenreich-May, Jill

2012-05-01

191

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

SciTech Connect

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.

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

192

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

PubMed Central

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

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

2012-01-01

193

IMMUNOCHEMICAL STUDIES ON BLOOD GROUPS  

PubMed Central

The immunochemical properties of purified A1 and A2 glycoproteins have been compared to ascertain whether their antigenic determinants differ. Quantitative precipitin and complement-fixation studies using several anti-A sera as well as purified ?G anti-A antibodies clearly showed a specificity difference. This was also supported by absorption studies: A2 substance specifically removed antibodies reacting with A2 substance leaving anti-A1 activity. A1 substance was more effective than A2 substance in dissolving an A1 anti-A1-specific precipitate. Purified ?M anti-A hemolyzed A1 cells more readily than A2 cells. Inhibition studies using mono- and difucosyl type 2 A-active oligosaccharides showed that type 2 difucosyl receptors are present in A2 substance. The structural basis for the specificity difference between A1 and A2 would appear to be that A2 substances lack type 1 A determinants; this would account for the observed higher H and Leb activity in A2 substances.

Moreno, Carlos; Lundblad, Arne; Kabat, Elvin A.

1971-01-01

194

The NSABP Study of Tamoxifen and Raloxifene (STAR) trial  

PubMed Central

In the Study of Tamoxifen and Raloxifene (STAR) trial, postmenopausal women at increased risk of breast cancer received either oral tamoxifen (20 mg/day) or raloxifene (60 mg/day) over 5 years. There were an equal number of cases of invasive breast cancer in women assigned to tamoxifen and raloxifene. There were fewer cases of noninvasive breast cancer in the tamoxifen group than in the raloxifene group (risk ratio [RR]: 1.40; 95% confidence interval [CI]: 0.98–2.02). There were more cases of uterine cancer with tamoxifen than with raloxifene (RR: 0.62; 95% CI: 0.35–1.08). Thromboembolic events occurred less often in the raloxifene group (RR: 0.70; 95% CI: 0.54–0.91) and there were fewer cataracts and cataract surgeries in the women taking raloxifene (RR: 0.79; 95% CI: 0.68–0.92). The STAR trial has shown that raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of adverse events but a nonstatistically significant higher risk of noninvasive breast cancer. The risk of other cancers, fractures, ischemic heart disease and stroke is similar for both drugs.

Vogel, Victor G

2009-01-01

195

Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6–12 months after completion of primary chemotherapy with exploratory TS DPD and TP correlates: a Gynecologic Oncology Group study  

Microsoft Academic Search

Abstract Purpose. A phase II trial was conducted to evaluate the anti-tumor activity and adverse effects of capecitabine in women,with measurable platinum-sensitive ovarian cancer or platinum-sensitive primary peritoneal cancer and to explore the ability of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) to predict response and toxicities. Experimental design. Patients were treated with a daily starting dose

Agustin A. Garcia; John A. Blessing; Heinz-josef Lenz; Kathleen M. Darcy; Robert S. Mannel; David Scott Miller; Nader Husseinzadeh

196

Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study  

Microsoft Academic Search

Purpose. A phase II trial was conducted to evaluate the anti-tumor activity and adverse effects of capecitabine in women with measurable platinum-sensitive ovarian cancer or platinum-sensitive primary peritoneal cancer and to explore the ability of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) to predict response and toxicities. Experimental design. Patients were treated with a daily starting dose

Agustin A. Garciaa; John A. Blessingb; Heinz-Josef Lenzc; Kathleen M. Darcyd; Robert S. Mannele; David Scott Millerf; Nader Husseinzadehg

197

Group and Individual Treatment of Obsessive-Compulsive Disorder Using Cognitive Therapy and Exposure Plus Response Prevention: A 2-Year Follow-Up of Two Randomized Trials  

ERIC Educational Resources Information Center

|Relatively little is known about the long-term durability of group treatments for obsessive-compulsive disorder (OCD) and contemporary cognitive treatments. The current study investigated the 2-year follow-up results for participants who completed randomized trials of group or individual treatment and received either cognitive therapy (CT) or…

Whittal, Maureen L.; Robichaud, Melisa; Thordarson, Dana S.; McLean, Peter D.

2008-01-01

198

The National Lung Screening Trial: overview and study design.  

PubMed

The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented. PMID:21045183

Aberle, Denise R; Berg, Christine D; Black, William C; Church, Timothy R; Fagerstrom, Richard M; Galen, Barbara; Gareen, Ilana F; Gatsonis, Constantine; Goldin, Jonathan; Gohagan, John K; Hillman, Bruce; Jaffe, Carl; Kramer, Barnett S; Lynch, David; Marcus, Pamela M; Schnall, Mitchell; Sullivan, Daniel C; Sullivan, Dorothy; Zylak, Carl J

2010-11-02

199

After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children  

ERIC Educational Resources Information Center

|This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

2006-01-01

200

Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors  

Microsoft Academic Search

Background Insufficient blinding of persons involved in randomized clinical trials is associated with bias. The appraisal of the risk of bias is difficult without adequate information in trial reports.Purpose We wanted to study how blinding is reported in clinical trials and how lack of reporting relate to lack of blinding.Methods A cohort study of 200 blinded randomized clinical trials published

Mette Thorlund Haahr; Asbjørn Hróbjartsson

2006-01-01

201

Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial  

PubMed Central

Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild depression symptoms. It results in a high remission rate, is recommended in PC and can be carried out by nurses with previous training. In moderate patients, group psychoeducation is effective in the short-term. Trial registration Clinical Trials.gov identifier NCT00841737

2012-01-01

202

Phase II Selection Design Trial of Concurrent Chemotherapy and Cetuximab Versus Chemotherapy Followed by Cetuximab in Advanced-Stage Non-Small-Cell Lung Cancer: Southwest Oncology Group Study S0342  

PubMed Central

Purpose Randomized clinical trials failed to show a survival benefit for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors plus concurrent chemotherapy in patients with metastatic non–small-cell lung cancer (NSCLC), with preclinical data suggesting potential negative interactions. In contrast, pilot trials of the EGFR-targeted antibody, cetuximab, plus chemotherapy suggested enhanced antitumor activity. This randomized phase II trial was designed to select a cetuximab plus chemotherapy regimen for phase III evaluation. Patients and Methods Treatment-naive patients with advanced-stage NSCLC were randomly assigned to receive paclitaxel (225 mg/m2) and carboplatin (area under the curve, 6) every 3 weeks plus concurrent cetuximab (400 mg/m2 loading dose followed by 250 mg/m2 weekly) for four cycles followed by maintenance cetuximab or sequential paclitaxel-carboplatin for four cycles followed by cetuximab. Results Of 242 patients enrolled, 224 were eligible and assessable for response (106 and 118 patients in the concurrent and sequential arms, respectively). With a median follow-up time of 32 months, the median overall survival was 10.9 months (95% CI, 9.2 to 13.0 months) for patients receiving concurrent therapy and 10.7 months (95% CI, 8.5 to 12.8 months) for patients receiving sequential therapy (P = .57); 1-year survival rates were 45% (95% CI, 36% to 54%) and 44% (95% CI, 35% to 53%), respectively. Response rates and progression-free survival times were similar in both arms, as was grade 3 rash, whereas sensory neuropathy was higher in the concurrent arm (15% v 5% in the sequential arm; P = .036). Conclusion Although both regimens met the efficacy criterion for continued evaluation, the concurrent regimen of paclitaxel/carboplatin plus cetuximab was chosen.

Herbst, Roy S.; Kelly, Karen; Chansky, Kari; Mack, Philip C.; Franklin, Wilbur A.; Hirsch, Fred R.; Atkins, James N.; Dakhil, Shaker R.; Albain, Kathy S.; Kim, Edward S.; Redman, Mary; Crowley, John J.; Gandara, David R.

2010-01-01

203

Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study.  

PubMed

The optimal schedule and regimen of chemotherapy (CT) in association with chemoradiation has not been established in stage III non-small-cell lung cancer (NSCLC). We have compared three schedules of non-platinum-based CT plus either radiotherapy or chemoradiation. From May 2001 to June 2006, 158 patients with unresectable stage III NSCLC were enrolled in a randomized phase II trial with overall response rate (ORR) as the primary endpoint. The initial design included three arms: sequential CT followed by thoracic radiation (TRT); concurrent CT/TRT followed by consolidation CT; and induction CT followed by concurrent CT/TRT. However, based on the preliminary results of the RTOG 9410 trial, the sequential arm was closed when 19 patients had been enrolled. All patients received two cycles of docetaxel 40 mg/m(2) days 1 and 8 plus gemcitabine 1200 mg/m(2) days 1 and 8, as either induction or consolidation therapy. Concurrent CT/TRT consisted of docetaxel 20 mg/m(2) and carboplatin AUC 2 weekly plus 60 Gy TRT. No differences were found in ORR between the two arms (56% and 57%). Hematological toxicity was mild but significantly superior with consolidation CT; the esophagitis rate was similar in both arms (16% and 15%). With a median follow-up of 57 months, no differences were found in median survival (13.07 and 13.8 months) or 5-year survival (16.4% and 22%). This regimen cannot be recommended as an alternative to platinum-based CT/TRT although it has an acceptable toxicity profile and encouraging long-term survival data (ClinicalTrials.gov NCT01652820). PMID:23611405

Garrido, Pilar; Rosell, Rafael; Arellano, Antonio; Andreu, Francisco; Dómine, Manuel; Perez-Casas, Ana; Cardenal, Felipe; Arnaiz, María Del Mar; Morán, Teresa; Morera, Rosa; Isla, Dolores; Valencia, Javier; Cobo, Manuel; Delgado, Raquel; García-Gómez, Ramón; Calvo, Felipe; Zamora, Javier; Ramos, Alfredo; Massutí, Bartomeu

2013-04-21

204

Are Observational Studies ‘Just as Effective’ as Randomized Clinical Trials?  

Microsoft Academic Search

The question of whether observational studies are ‘just as effective’ as randomized clinical trials appears to presume a competition between the two. However, from a methodological perspective, the two types of studies are complementary. Observational studies and randomized clinical trials can be viewed as expressions in the setting of modern clinical research of the steps of observation and experimentation that

Tom Greene

2000-01-01

205

Effect of a school-based oral health-education program on Iranian children: results from a group randomized trial.  

PubMed

Parents and school staff play important roles in promoting children's oral health. Our study goals were to investigate whether an intervention targeting parents and school staff can improve the oral-health behavior and oral-health status of schoolchildren. Three-hundred and ninety-two schoolchildren in six schools in Tehran participated in a group randomized trial from September 2010 to March 2011. Schools were randomly allocated into three groups: comprehensive, student, and control. Intervention in the comprehensive group consisted of strategies to encourage children, their parents, and school staff to increase the frequency of toothbrushing and flossing. In the student group, the intervention targeted only children. The control group received no intervention. The primary outcome was change in oral-health behaviors (brushing and flossing), while the secondary outcomes were changes in oral hygiene and Community Periodontal indices and in Health Belief Model components. Multilevel modeling was employed for data analyses. Students who were in the comprehensive intervention group brushed and flossed significantly more frequently compared with those in the student intervention group. Although students' gingival health improved significantly in the comprehensive intervention group, such significant improvement was not seen in the student group. In conclusion, promising results are seen when the oral-health education targets both school and home settings. PMID:22985001

Yekaninejad, Mir S; Eshraghian, Mohammad R; Nourijelyani, Keramat; Mohammad, Kazem; Foroushani, Abbas R; Zayeri, Farid; Pakpour, Amir H; Moscowchi, Anahita; Tarashi, Mahsa

2012-08-24

206

Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: a qualitative study exploring HVTN staff perspectives.  

PubMed

In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has proven difficult. The HVTN conducted an internal landscape analysis to: (1) evaluate the challenges of behavioral risk assessment in HIV vaccine trials and observational studies; (2) explore the impact of the Step Study on behavioral risk assessment measures; and (3) identify strategies to overcome existing challenges and improve the quality of data resulting from behavioral risk analysis. These analyses of behavioral risk within the HVTN revealed several challenges and recommendations for improved behavioral risk data collection in future protocols. The recommendations for improvement include: (1) establishment of protocol-specific behavioral risk working groups that include social and behavioral experts; (2) provision of behavioral rationale and objectives to the development team; (3) creation of a template for geographic- and population-specific assessment of low and high risk behaviors; and (4) pilot testing of behavioral risk assessments. Results also underscored the need for routinely conducted analyses of behavioral data. PMID:23859840

Andrasik, Michele Peake; Karuna, Shelly T; Nebergall, Michelle; Koblin, Beryl A; Kublin, Jim G

2013-07-13

207

Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial  

Microsoft Academic Search

BACKGROUND: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. METHODS\\/DESIGN: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up

Kypros Kypri; Jim McCambridge; Amanda Wilson; John Attia; Paschal Sheeran; Steve Bowe; Tina Vater

2011-01-01

208

The effect of Buserelin versus conventional antiandrogenic treatment in patients with T2-4NXM1 prostatic cancer. A prospective, randomized multicentre phase III trial. The "Danish Buserelin Study Group".  

PubMed

A prospective, randomized multicentre phase III trial was undertaken to compare the effectiveness and safety of Buserelin, a gonadotropin-releasing hormone analogue (GnRHa), with conventional antiandrogenic treatment in patients with painful metastases from T2-4NXM1 prostatic cancer. Seventy-two patients received Buserelin, 22 received estrogens and 46 were subjected to orchiectomy. The trial was completed one year after allocation of the patients. No significant differences as regards suppression of testosterone or survival were found in favour of one of the three treatment modalities. The performance index improved significantly both during the first months of treatment with Buserelin and following orchiectomy. No detectable improvement of performance index was seen during treatment with estrogens. Treatment with estrogens also failed to alleviate pain or general symptoms of cancer. Tolerability, safety and compliance of Buserelin was although administered intranasally clearly evidenced as palliation of advanced symptomatic cancer and the efficacy and sideeffects were fully comparable to those following orchiectomy. PMID:8908651

Bruun, E; Frimodt-Møller, C

1996-08-01

209

The Effectiveness of an Online Support Group for Members of the Community with Depression: A Randomised Controlled Trial  

PubMed Central

Background Internet support groups (ISGs) are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. Aim The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. Method Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG), automated depression Internet Training Program (ITP), combination of the two (ITP+ISG), or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. Results There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. Conclusions ISGs for depression are promising and warrant further empirical investigation. Trial Registration Controlled-Trials.com ISRCTN65657330

Griffiths, Kathleen M.; Mackinnon, Andrew J.; Crisp, Dimity A.; Christensen, Helen; Bennett, Kylie; Farrer, Louise

2012-01-01

210

Community Group Involvement in a Fund Raising Project for a University Library: Examples from "A Trial for the Books".  

ERIC Educational Resources Information Center

|This paper describes a unique library fund raiser at California State University (Northridge). "A Trial for the Books" was a dog agility trial held on April 26-27, 1996 as a benefit for the university's Oviatt Library. The event was hosted by West Valley DogSports, a community group. The event raised approximately $2,500 for the library's…

Finley, Mary M.

211

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

PubMed Central

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 psychosocial stress. Participants Adolescents aged 12-17 years with at least two past episodes of self harm within the previous 12 months. Exclusion criteria were: not speaking English, low weight anorexia nervosa, acute psychosis, substantial learning difficulties (defined by need for specialist school), current containment in secure care. Setting Eight child and adolescent mental health services in the northwest UK. Interventions Manual based developmental group therapy programme specifically designed for adolescents who harm themselves, with an acute phase over six weekly sessions followed by a booster phase of weekly groups as long as needed. Details of routine care were gathered from participating centres. Main outcome measures Primary outcome was frequency of subsequent repeated episodes of self harm. Secondary outcomes were severity of subsequent self harm, mood disorder, suicidal ideation, and global functioning. Total costs of health, social care, education, and criminal justice sector services, plus family related costs and productivity losses, were recorded. Results 183 adolescents were allocated to each arm (total n=366). Loss to follow-up was low (<4%). On all outcomes the trial cohort as a whole showed significant improvement from baseline to follow-up. On the primary outcome of frequency of self harm, proportional odds ratio of group therapy versus routine care adjusting for relevant baseline variables was 0.99 (95% confidence interval 0.68 to 1.44, P=0.95) at 6 months and 0.88 (0.59 to 1.33, P=0.52) at 1 year. For severity of subsequent self harm the equivalent odds ratios were 0.81 (0.54 to1.20, P=0.29) at 6 months and 0.94 (0.63 to 1.40, P=0.75) at 1 year. Total 1 year costs were higher in the group therapy arm (£21?781) than for routine care (£15?372) but the difference was not significant (95% CI ?1416 to 10782, P=0.132). Conclusions The addition of this targeted group therapy programme did not improve self harm outcomes for adolescents who repeatedly self harmed, nor was there evidence of cost effectiveness. The outcomes to end point for the cohort as a whole were better than current clinical expectations. Trial registration ISRCTN 20496110

2011-01-01

212

Design of tumor biomarker-monitoring trials: a proposal by the European Group on Tumor Markers.  

PubMed

A major application of tumor biomarkers is in serial monitoring of cancer patients, but there are no published guidelines on how to evaluate biomarkers for this purpose. The European Group on Tumor Markers has convened a multidisciplinary panel of scientists to develop guidance on the design of such monitoring trials. The panel proposes a 4-phase model for biomarker-monitoring trials analogous to that in use for the investigation of new drugs. In phase I, biomarker kinetics and correlation with tumor burden are assessed. Phase II evaluates the ability of the biomarker to identify, exclude, and/or predict a change in disease status. In phase III, the effectiveness of tumor biomarker-guided intervention is assessed by measuring patient outcome in randomized trials. Phase IV consists of an audit of the long-term effects after biomarker monitoring has been included into standard patient care. Systematic well-designed evaluations of biomarkers for monitoring may provide a stronger evidence base that might enable their earlier use in evaluating responses to cancer therapy. PMID:23034139

Sölétormos, György; Duffy, Michael J; Hayes, Daniel F; Sturgeon, Catharine M; Barak, Vivian; Bossuyt, Patrick M; Diamandis, Eleftherios P; Gion, Massimo; Hyltoft-Petersen, Per; Lamerz, Rolf M; Nielsen, Dorte L; Sibley, Paul; Tholander, Bengt; Tuxen, Malgorzata K; Bonfrer, Johannes M G

2012-10-03

213

A group randomized trial of critical incident stress debriefing provided to U.S. peacekeepers.  

PubMed

In a group randomized trial of critical incident stress debriefing (CISD) with platoons of 952 peacekeepers, CISD was compared with a stress management class (SMC) and survey-only (SO) condition. Multilevel growth curve modeling found that CISD did not differentially hasten recovery compared to the other two conditions. For those soldiers reporting the highest degree of exposure to mission stressors, CISD was minimally associated with lower reports of posttraumatic stress and aggression (vs. SMC), higher perceived organizational support (vs. SO), and more alcohol problems than SMC and SO. Soldiers reported that they liked CISD more than the SMC, and CISD did not cause undue distress. PMID:18553407

Adler, Amy B; Litz, Brett T; Castro, Carl Andrew; Suvak, Michael; Thomas, Jeffrey L; Burrell, Lolita; McGurk, Dennis; Wright, Kathleen M; Bliese, Paul D

2008-06-01

214

Surgical Complications Associated With Sentinel Lymph Node Biopsy: Results From a Prospective International Cooperative Group Trial  

Microsoft Academic Search

Background  American College of Surgeons Oncology Group Z0010 is a prospective multicenter trial designed to evaluate the prognostic significance\\u000a of micrometastases in the sentinel lymph nodes and bone marrow aspirates of women with early-stage breast cancer. Surgical\\u000a complications associated with the sentinel lymph node biopsy surgical procedure are reported.\\u000a \\u000a \\u000a \\u000a Methods  Eligible patients included women with clinical T1\\/2N0M0 breast cancer. Surgical outcomes were

Lee Gravatt Wilke; Linda M. McCall; Katherine E. Posther; Pat W. Whitworth; Douglas S. Reintgen; A. Marilyn Leitch; Sheryl G. A. Gabram; Anthony Lucci; Charles E. Cox; Kelly K. Hunt; James E. Herndon II; Armando E. Giuliano

2006-01-01

215

Allogeneic stem cell transplantation provides durable disease control in poor-risk chronic lymphocytic leukemia: long-term clinical and MRD results of the German CLL Study Group CLL3X trial.  

PubMed

The purpose of this prospective multicenter phase 2 trial was to investigate the long-term outcome of reduced-intensity conditioning allogeneic stem cell transplantation (alloSCT) in patients with poor-risk chronic lymphocytic leukemia. Conditioning was fludarabine/ cyclophosphamide-based. Longitudinal quantitative monitoring of minimal residual disease (MRD) was performed centrally by MRD-flow or real-time quantitative polymerase chain reaction. One hundred eligible patients were enrolled, and 90 patients proceeded to alloSCT. With a median follow-up of 46 months (7-102 months), 4-year nonrelapse mortality, event-free survival (EFS) and overall survival (OS) were 23%, 42%, and 65%, respectively. Of 52 patients with MRD monitoring available, 27 (52%) were alive and MRD negative at 12 months after transplant. Four-year EFS of this subset was 89% with all event-free patients except for 2 being MRD negative at the most recent assessment. EFS was similar for all genetic subsets, including 17p deletion (17p-). In multivariate analyses, uncontrolled disease at alloSCT and in vivo T-cell depletion with alemtuzumab, but not 17p-, previous purine analogue refractoriness, or donor source (human leukocyte antigen-identical siblings or unrelated donors) had an adverse impact on EFS and OS. In conclusion, alloSCT for poor-risk chronic lymphocytic leukemia can result in long-term MRD-negative survival in up to one-half of the patients independent of the underlying genomic risk profile. This trial is registered at http://clinicaltrials.gov as NCT00281983. PMID:20595516

Dreger, Peter; Döhner, Hartmut; Ritgen, Matthias; Böttcher, Sebastian; Busch, Raymonde; Dietrich, Sascha; Bunjes, Donald; Cohen, Sandra; Schubert, Jörg; Hegenbart, Ute; Beelen, Dietrich; Zeis, Matthias; Stadler, Michael; Hasenkamp, Justin; Uharek, Lutz; Scheid, Christof; Humpe, Andreas; Zenz, Thorsten; Winkler, Dirk; Hallek, Michael; Kneba, Michael; Schmitz, Norbert; Stilgenbauer, Stephan

2010-07-01

216

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Long-Acting Methylphenidate for Cancer-Related Fatigue: North Central Cancer Treatment Group NCCTG-N05C7 Trial  

PubMed Central

Purpose Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

Moraska, Amanda R.; Sood, Amit; Dakhil, Shaker R.; Sloan, Jeff A.; Barton, Debra; Atherton, Pamela J.; Suh, Jason J.; Griffin, Patricia C.; Johnson, David B.; Ali, Aneela; Silberstein, Peter T.; Duane, Steven F.; Loprinzi, Charles L.

2010-01-01

217

Future oriented group training for suicidal patients: a randomized clinical trial  

PubMed Central

Background In routine psychiatric treatment most clinicians inquire about indicators of suicide risk, but once the risk is assessed not many clinicians systematically focus on suicidal thoughts. This may reflect a commonly held opinion that once the depressive or anxious symptoms are effectively treated the suicidal symptoms will wane. Consequently, many clients with suicidal thoughts do not receive systematic treatment of their suicidal thinking. There are many indications that specific attention to suicidal thinking is necessary to effectively decrease the intensity and recurrence of suicidal thinking. We therefore developed a group training for patients with suicidal thoughts that is easy to apply in clinical settings as an addition to regular treatment and that explicitly focuses on suicidal thinking. We hypothesize that such an additional training will decrease the frequency and intensity of suicidal thinking. We based the training on cognitive behavioural approaches of hopelessness, worrying, and future perspectives, given the theories of Beck, McLeod and others, concerning the lack of positive expectations characteristic for many suicidal patients. In collaboration with each participant in the training individual positive future possibilities and goals were challenged. Methods/Design We evaluate the effects of our program on suicide ideation (primary outcome measure). The study is conducted in a regular treatment setting with regular inpatients and outpatients representative for Dutch psychiatric treatment settings. The design is a RCT with two arms: TAU (Treatment as Usual) versus TAU plus the training. Follow up measurements are taken 12 months after the first assessment. Discussion There is a need for research on the effectiveness of interventions in suicidology, especially RCT's. In our treatment program we combine aspects and interventions that have been proven to be useful in the treatment of suicidal thinking and behavior. Trial registration ISRCTN56421759

van Beek, Wessel; Kerkhof, Ad; Beekman, Aartjan

2009-01-01

218

Relationship between baseline risk factors and coronary heart disease and total mortality in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group  

Microsoft Academic Search

The relationship between selected baseline risk factors and subsequent coronary heart disease (CHD) death and total mortality among participants in the Multiple Risk Factor Intervention Trial (MRFIT) was studied in order to determine whether the three risk factors used to identify high-risk men for the trial were associated with CHD death; whether other risk factors measured at baseline, especially lipoprotein

Judith K. Ockene

1986-01-01

219

Interactional group discussion: Results of a controlled trial using a behavioral intervention to reduce the use of injections in public health facilities  

Microsoft Academic Search

Injections are commonly overused in Indonesia. More than 60% of patients attending public health facilities receive at least one injection, which increases clinical risk and has adverse economic impact. This study assesses the efficacy of an innovative behavioral intervention, the Interactional Group Discussion (IGD), for reducing the overuse of injections. This study was a controlled trial in a single district

Johana E. Prawitasari Hadiyono; Sri Suryawati; Sulanto S. Danu; Sunartono; Budiono Santoso

1996-01-01

220

Group medical visits in the follow-up of women with a BRCA mutation: design of a randomized controlled trial  

PubMed Central

Background BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs). A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making. Methods/design In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit) or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90). Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires. Discussion The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared to individual visits. If GMCs prove to be effective and efficient, implementation of GMCs in regular care for BRCA mutation carriers will be recommended. Trial registration The study is registered at ClinicalTrials.gov (NCT01329068)

2011-01-01

221

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

ERIC Educational Resources Information Center

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,…

Currie, Michael; Startup, Mike

2012-01-01

222

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

ERIC Educational Resources Information Center

|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,…

Currie, Michael; Startup, Mike

2012-01-01

223

Recruitment for phase II of the Trials of Hypertension Prevention. Effective strategies and predictors of randomization. Trials of Hypertension Prevention (TOHP) Collaborative Research Group.  

PubMed

Phase II of the Trials of Hypertension Prevention is a multicenter, randomized, controlled trial designed to determine the efficacy of weight loss and reduction of sodium intake for lowering blood pressure and incidence of hypertension among persons with high-normal levels of blood pressure. The 2 x 2 factorial study design includes weight loss alone, restricted sodium intake alone, the combination of weight loss and sodium restriction, and a control group. Nine clinical centers used a variety of recruitment strategies to enroll 2382 participants over 17 months, which exceeded the sample size goal of 2250. Among randomized participants, 21% were minorities and 34% were women. Overall, direct mail generated the most randomized participants (73%), followed by community screening (12%) and media advertisement (11%). Referrals from community health care providers yielded few participants. Prescreening improved overall efficiency and reduced costs. Participants who were more likely to drop out voluntarily during the three-visit screening regimen tended to be younger, single, male, smokers, and less educated. PMID:7795832

Hollis, J F; Satterfield, S; Smith, F; Fouad, M; Allender, P S; Borhani, N; Charleston, J; Hirlinger, M; King, N; Schultz, R

1995-03-01

224

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

PubMed

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

Bakermans-Kranenburg, M J; van I Jzendoorn, M H

2013-05-21

225

HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention  

PubMed Central

Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1) measured height and weight; 2) online surveys of individual dietary intake and physical activity behaviors; and 3) detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75), 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2). A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36). Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461

2012-01-01

226

Stopping or Reporting Early for Positive Results in Randomized Clinical Trials: The National Cancer Institute Cooperative Group Experience From 1990 to 2005  

PubMed Central

Randomized clinical trials are designed with stopping boundaries to guide data monitoring committees with their decision making concerning ongoing trials. In particular, when extremely positive results are seen and a boundary is crossed, the data monitoring committee may recommend releasing the results earlier to the public than at the definitive final analysis time specified in the protocol. For trials that are still accruing, this also means stopping accrual. Because the information about treatment efficacy is more limited in an early analysis than in a final analysis, questions have been raised about the appropriateness of incorporating early stopping for positive results in trial designs. In particular, there are concerns that treatment effects seen early may not be real or may be overly optimistic. To examine this issue, we collected information about treatment efficacy on National Cancer Institute Cooperative Group trials that were stopped early for positive results (information both at the time the trial was stopped/released and at times of further follow-up). Twenty-seven such trials were located. For 17 of 18 of these trials with sufficient follow-up information, the treatment effect was similar or only slightly smaller at last follow-up compared with the stopping/release time. We critically evaluate reasons why one might be concerned about early stopping for positive results. We conclude that for trials with well-designed interim monitoring plans, the ability to stop early for positive results is an important component of the trial design, allowing the public to benefit as soon as possible from the study conclusions.

Korn, Edward L.; Freidlin, Boris; Mooney, Margaret

2009-01-01

227

chemoprevention trials  

Cancer.gov

In agent prevention or chemoprevention trials, people take medicines, vitamins, minerals or other supplements that researchers believe may lower the risk of a certain type of cancer. Many prevention trials are designed to compare a promising new agent with a standard one, or to no agent at all. Participants are randomly assigned to the study or control group.

228

Power for Studies with Random Group Sizes  

PubMed Central

Summary In any study it is essential to select the sample size carefully to ensure adequate power. For many studies this is simple: recruit a desired number of subjects within each group, conduct measurements, and perform the statistical test. In some studies (e.g., observational studies), however, the group membership is unknown at recruitment. In this paper we examine the effect of random group sizes on power. Additionally, we consider the situation when the group proportions are unknown and specified by a prior distribution. The problem that initially motivated this research is presented (power for a 2-by-2 table), as are examples using continuous outcomes. We find that standard estimates of power using expected group sizes can over- or under-estimate power. SAS macros are available at http://www.phs.wfubmc.edu/public/wambrosi/RandomPower.

Ambrosius, Walter T.; Mahnken, Jonathan D.

2010-01-01

229

Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17.  

PubMed

In recent years, several major trials have studied aromatase inhibitors (AIs)/inactivators as adjuvant therapy for postmenopausal women with early-stage breast cancer. The AIs have demonstrated improved efficacy compared with 5 years of tamoxifen when used as initial therapy or when used sequentially after 2-3 years. They also improve outcomes when used after 5 years of adjuvant tamoxifen in this patient population. In all cases, AIs improve disease-free survival compared with the standard 5 years of adjuvant tamoxifen, leading to a reassessment of the optimal adjuvant endocrine therapy for postmenopausal patients with breast cancer. The American Society of Clinical Oncology now recommends the inclusion of an AI into the adjuvant regimen at some point for most postmenopausal patients with hormone receptor-positive early-stage breast cancer. However, the optimal duration of AI therapy and the comparative efficacy and safety of the alternative strategies for their incorporation remain matters of debate. In addition, the long-term impact of AIs on other organs, such as the bone and cardiovascular systems, is not completely understood, and longer follow-up of patients from these original trials as well as carefully planned future trials with appropriate substudies are essential to determine the optimal endocrine treatment strategy. PMID:16595026

Wardley, Andrew M

2006-02-01

230

Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials: The PeriOperative Epidural Trial (POET) Pilot Study  

PubMed Central

Background Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada. Methodology/Principal Findings After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were ?45 years old, had an expected hospital stay ?48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group) and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group) and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5±0.3 (mean±SEM) subjects per week per centre; 112/494 (22.7%) eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5%) of 49 subjects in the epidural group crossed over to the IV group; seven (14.3%) were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8%) of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0%) of 101 subjects were successfully followed up until 30 days after their surgery. Conclusion/Significance Of the criteria we defined for the feasibility of a full-scale trial, only the follow-up target was met. The other feasibility outcomes did not meet our preset criteria for success. The results suggest that a large multicentre trial may not be a feasible design to study the perioperative effects of neuraxial blockade. Trial Registration ClinicalTrials.gov NCT 0221260 Controlled-Trials.com ISRCTN 35629817

Choi, Peter T.; Beattie, W. Scott; Bryson, Gregory L.; Paul, James E.; Yang, Homer

2009-01-01

231

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

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.…

Spybrook, Jessaca

2008-01-01

232

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

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).

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

233

Time-Limited Group Psychotherapy for Moderately Alcohol Dependent Patients: A Randomized Controlled Clinical Trial  

Microsoft Academic Search

In recent reviews of treatment of alcohol dependence, psychodynamic group psychotherapy has been evaluated as being comparatively less effective than other methods. Some North American studies have, however, demonstrated differential treatment effects for subgroups of alcohol dependent patients. The focus of the present study was on the evaluation, in a different cultural setting, of psychodynamically oriented time-limited group psychotherapy for

Christer Sandahl; Kristina Herlitz; Göran Ahlin; Sten Rönnberg

1998-01-01

234

A randomized, placebo-controlled, double-blind trial of mesalamine in the maintenance of remission of Crohn's disease. The Canadian Mesalamine for Remission of Crohn's Disease Study Group  

Microsoft Academic Search

BACKGROUND & AIMS: The efficacy of mesalamine for the maintenance of remission in patients with Crohn's disease is controversial. The aim of this study was to conduct a double-blind, placebo-controlled study of mesalamine (750 mg four times a day for 48 weeks) in maintaining remission in 293 patients with Crohn's disease. Patients were stratified according to the method of induction

LR Sutherland; F Martin; RJ Bailey; RN Fedorak; M Poleski; C Dallaire; R Rossman; F Saibil; L Lariviere

1997-01-01

235

Randomized trials versus observational studies in adolescent pregnancy prevention.  

PubMed

The objective of this study is to compare the results of randomized trials and observational studies of interventions to prevent adolescent pregnancy. We identified published and unpublished reports through computerized searches of CATLINE, CINAHL, CONFERENCE PAPERS INDEX, DISSERTATION ABSTRACTS ONLINE, EMBASE, ERIC, MEDLINE, NTIS, POPLINE, PsycINFO, and SOCIOLOGICAL ABSTRACTS; manual searches of eight relevant journals; reference lists from primary articles; and contact with content experts. We included randomized trials and observational studies that evaluated the impact of primary prevention interventions including sex education classes, school-based clinics, free-standing clinics, physician/nurse practitioner practice-based service, improved access, and community-based programs on four outcomes: sexual intercourse, birth control use, responsible sexual behavior, or pregnancy in adolescents. One investigator abstracted the data and a second conducted a detailed review of the abstraction. We identified 13 randomized trials and 17 observational studies. We generated estimates of the impact of the interventions separately for males and females for all four outcomes for both observational studies and randomized trials. For six of the eight outcomes the summary odds ratios for the observational studies showed a significant intervention benefit (P<0.05) while the randomized trials did not show a benefit for any outcome in either females or males. The difference between the results of the observational studies and randomized trials was statistically significant in two of the eight outcomes (P<0.05 for initiation of intercourse and pregnancy in females). Observational studies yield systematically greater estimates of treatment effects than randomized trials of adolescent pregnancy prevention interventions. Public policy or individual patient treatment decisions should be based on observational studies only when randomized trials are unavailable and only with careful consideration of possible biases. PMID:10729689

Guyatt, G H; DiCenso, A; Farewell, V; Willan, A; Griffith, L

2000-02-01

236

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

PubMed Central

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.

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

2013-01-01

237

Effectiveness of intensive group and individual interventions for smoking cessation in primary health care settings: a randomized trial  

PubMed Central

Objectives Primary: To compare the effectiveness of intensive group and individual interventions for smoking cessation in a primary health care setting; secondary: to identify the variables associated with smoking cessation. Methods Three-pronged clinical trial with randomisation at the individual level. We performed the following: an intensive individual intervention (III), an intensive group intervention (IGI) and a minimal intervention (MI). Included in the study were smokers who were prepared to quit smoking. Excluded from the study were individuals aged less than 18 years or with severe mental conditions or terminal illnesses. The outcome measure was continued abstinence at 12 months confirmed through CO-oximetry (CO). The analysis was based on intention to treat. Results In total, 287 smokers were recruited: 81 in the III, 111 in the IGI, and 95 in the MI. Continued abstinence at 12 months confirmed through CO was 7.4% in the III, 5.4% in the IGI, and 1% in the MI. No significant differences were noted between III and MI on the one hand, and between IGI and MI on the other [RR 7.04 (0.9-7.2) and RR 5.1 (0.6-41.9), respectively]. No differences were noted between IGI and III [RR 0.7 (0.2-2.2)]. In multivariate analysis, only overall visit length showed a statistically significant association with smoking cessation. Conclusions The effectiveness of intensive smoking interventions in this study was lower than expected. No statistically significant differences were found between the results of individual and group interventions. Trial registration number ISRCTN32323770

2010-01-01

238

Emotional and Social Mind Training: A Randomised Controlled Trial of a New Group-Based Treatment for Bulimia Nervosa  

PubMed Central

Objective There is a need to improve treatment for individuals with bulimic disorders. It was hypothesised that a focus in treatment on broader emotional and social/interpersonal issues underlying eating disorders would increase treatment efficacy. This study tested a novel treatment based on the above hypothesis, an Emotional and Social Mind Training Group (ESM), against a Cognitive Behavioural Therapy Group (CBT) treatment. Method 74 participants were randomised to either ESM or CBT Group treatment programmes. All participants were offered 13 group and 4 individual sessions. The primary outcome measure was the Eating Disorder Examination (EDE) Global score. Assessments were carried out at baseline, end of treatment (four months) and follow-up (six months). Results There were no differences in outcome between the two treatments. No moderators of treatment outcome were identified. Adherence rates were higher for participants in the ESM group. Discussion This suggests that ESM may be a viable alternative to CBT for some individuals. Further research will be required to identify and preferentially allocate suitable individuals accordingly. Trial Registration ISRCTN61115988

Lavender, Anna; Startup, Helen; Naumann, Ulrike; Samarawickrema, Nelum; DeJong, Hannah; Kenyon, Martha; van den Eynde, Frederique; Schmidt, Ulrike

2012-01-01

239

Partner randomized controlled trial: study protocol and coaching intervention  

PubMed Central

Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured. Discussion Twenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented. Trial registration ClinicalTrials.gov identifier NCT00860834.

2012-01-01

240

The effectiveness of a Group Triple P with Chinese parents who have a child with developmental disabilities: a randomized controlled trial.  

PubMed

The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on child behaviour, parental stress, dysfunctional discipline styles and parental conflict before and after program completion by the Intervention group. Intervention group participants also completed these same measures six months after program completion. Compared to the Waitlist Control group, parents receiving Group Triple P reported significantly lower levels of child behaviour problems, parental stress, dysfunctional discipline style and parental conflict scores. The Intervention group participants maintained their gains six months after program completion. The results provided promising evidence for the Level 4 Group Triple P as an effective intervention program for Chinese parents who have preschool aged children with developmental disabilities. PMID:23291515

Leung, Cynthia; Fan, Angel; Sanders, Matthew R

2013-01-03

241

"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

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.

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

2011-01-01

242

Docetaxel and carboplatin as first-line chemotherapy in patients with advanced gynecological tumors. A phase I\\/II trial of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO-OVAR) Ovarian Cancer Study Group  

Microsoft Academic Search

Objectives. We performed a phase I–II study in patients with ovarian and other gynecological cancers to determine the dose-limiting toxicities, maximum tolerated dose (MTD) and efficacy of docetaxel\\/carboplatin.Methods. Thirty patients were treated in three cohorts with carboplatin (AUC 5) and escalating docetaxel (60, 75 and 90 mg\\/m2), administered intravenously on day 1, repeated every 3 weeks. Premedication consisted of 16

J Pfisterer; A du Bois; U Wagner; J Quaas; J. U Blohmer; D Wallwiener; F Hilpert

2004-01-01

243

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

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

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

1999-01-01

244

Desvenlafaxine 50 and 100 mg\\/d in the treatment of major depressive disorder: An 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies  

Microsoft Academic Search

Background: Major depressive disorder (MDD) is a common, chronic illness associated with substantial disability and economic burden. Although a number of effective antidepressants are available, the need for new medications that are effective and well tolerated remains.Objective: The aim of this study was to compare the efficacy and tolerability of fixed-dose desvenlafaxine 50 and 100 mg\\/d with placebo for MDD.

Karen A. Tourian; S. Krishna Padmanabhan; James Groark; Claudine Brisard; Deborah Farrington

2009-01-01

245

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

PubMed

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

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

2013-01-01

246

Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): Lessons learned  

PubMed Central

Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated “help-desk” team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support.

Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

2013-01-01

247

Effectiveness of heat-sensitive moxibustion in the treatment of lumbar disc herniation: study protocol for a randomized controlled trial  

PubMed Central

Background Lumbar disc herniation is a common and costly problem. Moxibustion is employed to relieve symptoms and might therefore act as a therapeutic alternative. Many studies have already reported encouraging results in heat-sensitive moxibustion for lumbar disc herniation. Hence, we designed a randomized controlled clinical trial to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion. Methods This trial is a multicenter, prospective, randomized controlled clinical trial. The 316 eligible patients are randomly allocated to two different groups. The experimental group is treated with heat-sensitive moxibustion (n = 158); while the control group (n = 158) is treated with conventional moxibustion. The moxibustion locations are different for the groups. The experimental group selects heat-sensitization acupoints from the region which consists of bilateral Da Changshu (BL25) and Yao Shu (Du2). Meanwhile, fixed acupoints are used in control group; patients in both groups receive 18 sessions in 2 weeks. Discussion The study design guarantees a high internal validity for the results. It is one large-scale randomized controlled trial to evaluate the efficacy of heat-sensitive moxibustion compared to conventional moxibustion and may provide evidence for this therapy as a treatment for moderate and severe lumbar disc herniation. Moreover, the result may uncover the inherent laws to improve the therapeutic effect with suspended moxibustion. Trial Registration The trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000604. The application date was 27 November 2009. The first patient was randomized on the 16 June 2011.

2011-01-01

248

Hanford single-shell tank grouping study  

SciTech Connect

A tank grouping study has been conducted to find Hanford single-shell tanks with similar waste properties. The limited sampling resources of the characterization program could be allocated more effectively by having a better understanding of the groups of tanks that have similar waste types. If meaningful groups of tanks can be identified, tank sampling requirements may be reduced, and the uncertainty of the characterization estimates may be narrowed. This tank grouping study considers the analytical sampling information and the historical information that is available for all single-shell tanks. The two primary sources of historical characterization estimates and information come from the Historical Tank Content Estimate (HTCE) Model and the Sort on Radioactive Waste Tanks (SORWT) Model. The sampling and historical information are used together to come up with meaningful groups of similar tanks. Based on the results of analyses presented in this report, credible tank grouping looks very promising. Some groups defined using historical information (HTCE and SORWT) correspond well with those based on analytical data alone.

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

1995-10-01

249

Quality of Life with Gefitinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial  

PubMed Central

Background. For non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, first-line gefitinib produced a longer progression-free survival interval than first-line carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study. Methods. Chemotherapy-naïve patients with sensitive EGFR-mutated, advanced NSCLC were randomized to receive gefitinib or chemotherapy (carboplatin and paclitaxel). Patient QoL was assessed weekly using the Care Notebook, and the primary endpoint of the QoL analysis was time to deterioration from baseline on each of the physical, mental, and life well-being QoL scales. Kaplan–Meier probability curves and log-rank tests were employed to clarify differences. Results. QoL data from 148 patients (72 in the gefitinib arm and 76 in the carboplatin plus paclitaxel arm) were analyzed. Time to defined deterioration in physical and life well-being significantly favored gefitinib over chemotherapy (hazard ratio [HR] of time to deterioration, 0.34; 95% confidence interval [CI], 0.23–0.50; p < .0001 and HR, 0.43; 95% CI, 0.28–0.65; p < .0001, respectively). Conclusion. QoL was maintained much longer in patients treated with gefitinib than in patients treated with standard chemotherapy, indicating that gefitinib should be considered as the standard first-line therapy for advanced EGFR-mutated NSCLC in spite of no survival advantage.

Oizumi, Satoshi; Inoue, Akira; Maemondo, Makoto; Sugawara, Shunichi; Yoshizawa, Hirohisa; Isobe, Hiroshi; Harada, Masao; Kinoshita, Ichiro; Okinaga, Shoji; Kato, Terufumi; Harada, Toshiyuki; Gemma, Akihiko; Saijo, Yasuo; Yokomizo, Yuki; Morita, Satoshi; Hagiwara, Koichi; Nukiwa, Toshihiro

2012-01-01

250

A Randomized, Controlled Trial of a Neurological and Psychoeducational Group Appointment Model for Pediatric Headaches  

Microsoft Academic Search

This study evaluated the effectiveness of a multidisciplinary group appointment model for pediatric headaches. Eighty-one patients ages 10 to 18 were randomly assigned to a Traditional Clinic Model (TCM) or a Headache Clinic (HCM) Model for the initial neurological appointment. In addition to a neurological evaluation, the HCM included a group educational session describing stressors contributing to pain, pharmaceutical and

Harry S. Abram; Lisa M. Buckloh; Lisa M. Schilling; Stacey Armatti Wiltrout; Gabriela Ramírez-Garnica; William R. Turk

2007-01-01

251

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

ERIC Educational Resources Information Center

|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…

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

2010-01-01

252

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

PubMed Central

Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess the effectiveness of a 12 week exercise intervention (the HOPE programme) designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT), measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL), EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life measure and the geriatric depression scale (GDS), measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS), record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

2011-01-01

253

Self-management of fatigue in rheumatoid arthritis: a randomised controlled trial of group cognitive-behavioural therapy  

Microsoft Academic Search

ObjectivesTo investigate the effect of group cognitive behavioural therapy (CBT) for fatigue self-management, compared with groups receiving fatigue information alone, on fatigue impact among people with rheumatoid arthritis (RA).MethodsTwo-arm, parallel randomised controlled trial in adults with RA, fatigue ?6\\/10 (Visual Analogue Scale (VAS) 0–10, high bad) and no recent change in RA medication. Group CBT for fatigue self-management comprised six

Sarah Hewlett; Nick Ambler; Celia Almeida; Alena Cliss; Alison Hammond; Karen Kitchen; Bev Knops; Denise Pope; Melissa Spears; Annette Swinkels; Jon Pollock

2011-01-01

254

A group sequential adaptive treatment assignment design for proof of concept and dose selection in headache trials.  

PubMed

The trial objective was to test whether a new mechanism of action would effectively treat migraine headaches and to select a dose range for further investigation. The motivation for a group sequential, adaptive, placebo-controlled trial design was (1) limited information about where across the range of seven doses to focus attention, (2) a need to limit sample size for a complicated inpatient treatment and (3) a desire to reduce exposure of patients to ineffective treatment. A design based on group sequential and up and down designs was developed and operational characteristics were explored by trial simulation. The primary outcome was headache response at 2 h after treatment. Groups of four treated and two placebo patients were assigned to one dose. Adaptive dose selection was based on response rates of 60% seen with other migraine treatments. If more than 60% of treated patients responded, then the next dose was the next lower dose; otherwise, the dose was increased. A stopping rule of at least five groups at the target dose and at least four groups at that dose with more than 60% response was developed to ensure that a selected dose would be statistically significantly (p=0.05) superior to placebo. Simulations indicated good characteristics in terms of control of type 1 error, sufficient power, modest expected sample size and modest bias in estimation. The trial design is attractive for phase 2 clinical trials when response is acute and simple, ideally binary, placebo comparator is required, and patient accrual is relatively slow allowing for the collection and processing of results as a basis for the adaptive assignment of patients to dose groups. The acute migraine trial based on this design was successful in both proof of concept and dose range selection. PMID:15911469

Hall, David B; Meier, Ulrich; Diener, Hans-Cristoph

2005-03-28

255

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial  

PubMed Central

Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis. Trial registration Current Controlled Trials: ISRCTN72764151

2012-01-01

256

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

PubMed Central

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

2011-01-01

257

Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial  

PubMed Central

Background Alcoholic hepatitis is the most florid presentation of alcohol-related liver disease. In its severe form, defined by a Maddrey’s discriminant function (DF) ?32, the 28-day mortality rate is approximately 35%. A number of potential treatments have been subjected to clinical trials, of which two, corticosteroids and pentoxifylline, may have therapeutic benefit. The role of corticosteroids is controversial as trial results have been inconsistent, whereas the role of pentoxifylline requires confirmation as only one previous placebo-controlled trial has been published. Methods/design STOPAH is a multicentre, double-blind, factorial (2 × 2) trial in which patients are randomised to one of four groups: 1. Group A: placebo / placebo 2. Group B: placebo / prednisolone 3. Group C: pentoxifylline / placebo 4. Group D: pentoxifylline / prednisolone The trial aims to randomise 1,200 patients with severe alcoholic hepatitis, in order to provide sufficient power to determine whether either of the two interventions is effective. The primary endpoint of the study is mortality at 28 days, with secondary endpoints being mortality at 90 days and 1 year. Discussion STOPAH aims to be a definitive study to resolve controversy around the existing treatments for alcoholic hepatitis. Eligibility criteria are based on clinical parameters rather than liver biopsy, which are aligned with standard clinical practice in most hospitals. The use of a factorial design will allow two treatments to be evaluated in parallel, with efficient use of patient numbers to achieve high statistical power. Trial registration EudraCT reference number: 2009-013897-42 ISRCTN reference number: ISRCTN88782125

2013-01-01

258

Feasibility of Feature-based Indexing, Clustering, and Search of Clinical Trials. A Case Study of Breast Cancer Trials from ClinicalTrials.gov.  

PubMed

Background: When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. Objectives: This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. Methods: We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. Results: We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. Conclusions: It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency. PMID:23666475

Boland, M R; Miotto, R; Gao, J; Weng, C

2013-05-13

259

Feasibility of feature-based indexing, clustering, and search of clinical trials: A case study of breast cancer trials from ClinicalTrials.gov  

PubMed Central

Summary Background When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. Objectives This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. Methods We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. Results We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. Conclusions It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.

Boland, Mary Regina; Miotto, Riccardo; Gao, Junfeng; Weng, Chunhua

2013-01-01

260

Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial  

PubMed Central

Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N = 18). The EFT group (n = 9) had significantly more depression at baseline than the control group (n = 9) (EFT BDI mean = 23.44, SD = 2.1 versus control BDI mean = 20.33, SD = 2.1). After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P = .001; EFT BDI mean = 6.08, SE = 1.8 versus control BDI mean = 18.04, SE = 1.8). Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.

Church, Dawson; De Asis, Midanelle A.; Brooks, Audrey J.

2012-01-01

261

Postscript Adoption and Foster Care Study Group  

Microsoft Academic Search

A postconference study group on adoption and foster care was established as a follow-up to the Institute for Psychoanalytic Training and Research (IPTAR) Conference on Adoption and Foster Care. Professionals meet monthly to review literature, present case material, hear speakers, and attempt to formulate new ideas and solutions to the problems faced by members of the adoption triad.

Sally Moskowitz; Corliss Parker

2004-01-01

262

Report of the Public Cryptography Study Group.  

ERIC Educational Resources Information Center

|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…

American Council on Education, Washington, DC.

263

Maximising recruitment and retention of general practices in clinical trials: a case study  

PubMed Central

Background There is limited evidence regarding the factors that facilitate recruitment and retention of general practices in clinical trials. It is therefore pertinent to consider the factors that facilitate research in primary care. Aim To formulate hypotheses about effective ways of recruiting and retaining practices to clinical trials, based on a case study. Design of study Case study of practice recruitment and retention to a trial of delivering antenatal sickle cell and thalassaemia screening. Setting Two UK primary care trusts with 123 practices, with a high incidence of sickle cell and thalassaemia, and high levels of social deprivation. Method Practices were invited to take part in the trial using a research information sheet for practices. Invitations were sent to all practice managers, GPs, practice nurses, and nurse practitioners. Expenses of approximately £3000 per practice were available. Practices and the research team signed research activity agreements, detailing a payment schedule based on deliverables. Semi-structured interviews were completed with 20 GPs who participated in the trial. Outcome measures were the number of practices recruited to, and completing, the trial. Results Four practices did not agree to randomisation and were excluded. Of 119 eligible practices, 29 expressed an interest in participation. Two practices withdrew from the trial and 27 participated (two hosted pilot studies and 25 completed the trial), giving a retention rate of 93% (27/29). The 27 participating practices did not differ from non-participating practices in list size, number of GPs, social deprivation, or minority ethnic group composition of the practice population. Conclusion Three factors appeared important in recruiting practices: research topic, invitation method, and interest in research. Three factors appeared important in retaining practices: good communication, easy data-collection methods, and payment upon meeting pre-agreed targets. The effectiveness of these factors at facilitating recruitment and retention requires assessment in experimental studies.

Dormandy, Elizabeth; Kavalier, Fred; Logan, Jane; Harris, Hilary; Ishmael, Nola; Marteau, Theresa M

2008-01-01

264

Cognitive-Behavioral Group Therapy in Obsessive-Compulsive Disorder: A Randomized Clinical Trial  

Microsoft Academic Search

Background: The present study was designed to verify the efficacy of cognitive-behavioral group therapy (CBGT) in reducing obsessive-compulsive symptoms and the intensity of overvalued ideas, as well as in improving the patient’s quality of life. Methods: Forty-seven patients meeting DSM-IV criteria for obsessive-compulsive disorder (OCD) were randomly assigned to either 12 weekly CBGT sessions or a waiting list (control group).

Aristides Volpato Cordioli; Elizeth Heldt; Daniela Braga Bochi; Regina Margis; Marcelo Basso de Sousa; Juliano Fonseca Tonello; Gisele Gus Manfro; Flavio Kapczinski

2003-01-01

265

A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers  

PubMed Central

Background More than half of persons living with HIV (PLWH) in the US smoke cigarettes, and tobacco use is responsible for considerable morbidity and mortality in this group. Little is known about the efficacy of tobacco treatment strategies in PLWH. Design Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group therapy intervention targeting HIV-infected smokers, to standard care. Methods A cohort of 145 PLWH smokers, recruited from an HIV-care center in the Bronx, New York, were randomized 1:1 into the PSF program or standard care. All were offered a 3-month supply of nicotine replacement therapy. PSF is an eight session program tailored to address the needs and concerns of HIV-infected smokers. Sessions were co-facilitated by a graduate student and an HIV-infected peer. The primary outcome was biochemically-confirmed, seven-day point-prevalence abstinence at three months. Results In the intention to treat analysis, PSF condition subjects had nearly double the quit rate of controls (19.2% vs 9.7%, P=0.11). In the complete case, as-treated analysis, assignment to PSF was associated with increased odds of quitting (ORadj 3.55, 95% CI: 1.04– 12.0). Latino ethnicity and lower loneliness score were predictive of abstinence. Subjects in the PSF condition exhibited significant decreases in daily cigarette consumption and significant increases in self-efficacy and in motivation to quit. Attendance of ?7 sessions was associated with higher quit rates. Conclusions These findings suggest a positive effect of PSF on cessation rates in PLWH smokers. Loneliness and self-efficacy are influential factors in the smoking behaviors of PLWH.

Moadel, Alyson B.; Bernstein, Steven L.; Mermelstein, Robin J.; Arnsten, Julia H.; Dolce, Eileen H.; Shuter, Jonathan

2013-01-01

266

An Examination of the Precision and Technical Accuracy of the First Wave of Group-Randomized Trials Funded by the Institute of Education Sciences  

Microsoft Academic Search

This article examines the power analyses for the first wave of group-randomized trials funded by the Institute of Education Sciences. Specifically, it assesses the precision and technical accuracy of the studies. The authors identified the appropriate experimental design and estimated the minimum detectable standardized effect size (MDES) for each study under plausible assumptions about intra-class correlations, covariate-outcome correlations, and explanatory

Jessaca Spybrook; Stephen W. Raudenbush

2009-01-01

267

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

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.

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

268

Supportive-Expressive and Coping Group Teletherapies for HIV-Infected Older Adults: A Randomized Clinical Trial.  

PubMed

This clinical trial tested whether telephone-administered supportive-expressive group therapy or coping effectiveness training reduce depressive symptoms in HIV-infected older adults. Participants from 24 states (N = 361) completed the Geriatric Depression Scale at pre-intervention, post-intervention, and 4- and 8-month follow-up and were randomized to one of three study arms: (1) 12 weekly sessions of telephone-administered, supportive-expressive group therapy (tele-SEGT; n = 122); (2) 12 weekly sessions of telephone-administered, coping effectiveness training (tele-CET; n = 118); or (3) a standard of care (SOC) control group (n = 121). Tele-SEGT participants reported fewer depressive symptoms than SOC controls at post-intervention (MSEGT = 11.9, MSOC = 14.3) and 4- (MSEGT = 12.5, MSOC = 14.4) and 8-month follow-up (MSEGT = 12.7, MSOC = 14.5) and fewer depressive symptoms than tele-CET participants at post-intervention (MSEGT = 12.4, MCET = 13.6) and 8-month follow-up (MSEGT = 12.7, MCET = 14.1). Tele-CET participants reported no statistically significant differences from SOC controls in GDS values at any assessment period. Tele-SEGT constitutes an efficacious treatment to reduce depressive symptoms in HIV-infected older adults. PMID:23474642

Heckman, Timothy G; Heckman, Bernadette D; Anderson, Timothy; Lovejoy, Travis I; Mohr, David; Sutton, Mark; Bianco, Joseph A; Gau, Jen-Tzer

2013-11-01

269

Receiving group clinical supervision: a phenomenological study.  

PubMed

This study examined the process of group supervision as experienced by one team of biofeedback therapists working in the south of England. A phenomenological study was undertaken to examine the team's perceptions of attending group supervision over time. Ten one-to-one in-depth interviews were conducted, six of which were with biofeedback therapists currently receiving supervision, three with nurses who used to receive this supervision and one interview with the supervisor. A four-stage model detailing how supervisees' experiences changed as a consequence of continued group supervision was developed. Study data revealed how this process allowed the biofeedback therapists to examine their clinical interventions and align their approach and perspective alongside other team members. This was a valuable and safe way of learning 'on the job' for the newer members of the team. The opportunity for free-thinking and reflection on practice supported clinical decision-making and therapeutic nursing. The more experienced supervisees demonstrated how their continued attendance of the group supervision sessions not only confirmed their expertise in role, but also facilitated their colleagues' development, which enhanced role satisfaction. The data also indicated some of the essential supervisory features of this process. PMID:24005656

Taylor, Claire

2013-08-01

270

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial  

PubMed Central

Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998

2011-01-01

271

A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1  

Microsoft Academic Search

This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http:\\/\\/grover.concordia.ca\\/abra\\/version1\\/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental groups), or to balanced literacy approaches delivered by their classroom teachers (control group). Two computer-based interventions—a phoneme-based synthetic phonics method

Robert S. Savage; Philip Abrami; Geoffrey Hipps; Louise Deault

2009-01-01

272

Can historical controls be used in current clinical trials in osteosarcoma. Metastases and survival in a historical and a concurrent group  

SciTech Connect

A historical group consisting of 35 patients with osteosarcoma was compared to a concurrent group of 23 patients. The treatment for the primary tumors differed only slghtly in the two groups. A more active approach was adopted for treatment of pulmonary metastases in the concurrent group. The percentage of patients not developing metastases and the survival rate in the historical group were approximately one half those for the concurrent group. An analysis of prognostic factors disclosed differences between the two groups as regards the size and histological type of the tumor. The results of the study cast doubt on the suitability of historical controls in current clinical trials conducted to ascertain the effectiveness of adjuvant therapy for osteosarcoma.

Brostroem, L.A. (Karolinska Hospital, Stockholm, Sweden); Aparisi, T.; Ingimarsson, S.; Lagergren, C.; Nilsonne, U.; Strander, H.; Soederberg, G.

1980-12-01

273

Non-pharmacological, multicomponent group therapy in patients with degenerative dementia: a 12-month randomzied, controlled trial  

PubMed Central

Background Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia. Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care. Methods A randomized, controlled, single-blind longitudinal trial was conducted with 98 patients (follow-up: n = 61) with primary degenerative dementia in five nursing homes in Bavaria, Germany. The highly standardized intervention consisted of motor stimulation, practice in activities of daily living, and cognitive stimulation (acronym MAKS). It was conducted in groups of ten patients led by two therapists for 2 hours, 6 days a week for 12 months. Control patients received treatment as usual. Cognitive function was assessed using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living (E-ADL test) at baseline and after 12 months. Results Of the 553 individuals screened, 119 (21.5%) were eligible and 98 (17.7%) were ultimately included in the study. At 12 months, the results of the per protocol analysis (n = 61) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients (ADAS-Cog: adjusted mean difference: -7.7, 95% CI -14.0 to -1.4, P = 0.018, Cohen's d = 0.45; E-ADL test: adjusted mean difference: 3.6, 95% CI 0.7 to 6.4, P = 0.015, Cohen's d = 0.50). The effect sizes for the intervention were greater in the subgroup of patients (n = 50) with mild to moderate disease (ADAS-Cog: Cohen's d = 0.67; E-ADL test: Cohen's d = 0.69). Conclusions A highly standardized, non-pharmacological, multicomponent group intervention conducted in a nursing-home setting was able to postpone a decline in cognitive function in dementia patients and in their ability to carry out activities of daily living for at least 12 months. Trial Registration http://www.isrctn.com Identifier: ISRCTN87391496

2011-01-01

274

Trial designs used to study neuroprotective therapy in Parkinson's disease.  

PubMed

There have been numerous trials conducted to evaluate putative disease-modifying or neuroprotective treatments in Parkinson's disease. These trials have used several different study designs and outcome measures. Each of these has its own strengths and weaknesses. Confounding all studies is the potential symptomatic benefit that the treatment might have on the features of Parkinson's disease. In addition, patient-related factors such as age of onset and the nature of the dominant symptoms may have important impacts that are often not addressed. Here we provide an overview of the various trial designs that have been used and emphasize the challenges faced in attempting to study neuroprotection in Parkinson's disease and the advances needed before this goal can be successfully achieved. PMID:22927060

Lang, Anthony E; Melamed, Eldad; Poewe, Werner; Rascol, Olivier

2012-08-23

275

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

Microsoft Academic Search

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

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

276

Effects of Digoxin on Morbidity and Mortality in Diastolic Heart Failure The Ancillary Digitalis Investigation Group Trial  

Microsoft Academic Search

Background—About half of the 5 million heart failure patients in the United States have diastolic heart failure (clinical heart failure with normal or near-normal ejection fraction). Except for candesartan, no drugs have been tested in randomized clinical trials in these patients. Although digoxin was tested in an appreciable number of diastolic heart failure patients in the Digitalis Investigation Group ancillary

Ali Ahmed; Michael W. Rich; Jerome L. Fleg; Michael R. Zile; James B. Young; Dalane W. Kitzman; Thomas E. Love; Wilbert S. Aronow; Kirkwood F. Adams; Mihai Gheorghiade

277

Short-Term Group Psychotherapy: A Clinical Trial of a New Combination of Pretreatment and Treatment Strategies.  

ERIC Educational Resources Information Center

|The paper discusses a clinical trial of pretreatment and treatment strategies to enhance the effectiveness of short-term groups. Pretreatment strategies included preparing patients and increasing the perceived authority of the therapists. Treatment strategies include delineation of a specific treatment focus and a directive approach by the…

Merkel, William T.; Willis, Stephen L.

1985-01-01

278

Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial  

PubMed Central

Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456

2011-01-01

279

Randomized trials versus observational studies in adolescent pregnancy prevention  

Microsoft Academic Search

The objective of this study is to compare the results of randomized trials and observational studies of interventions to prevent adolescent pregnancy. We identified published and unpublished reports through computerized searches of CATLINE, CINAHL, CONFERENCE PAPERS INDEX, DISSERTATION ABSTRACTS ONLINE, EMBASE, ERIC, MEDLINE, NTIS, POPLINE, PsycINFO, and SOCIOLOGICAL ABSTRACTS; manual searches of eight relevant journals; reference lists from primary articles;

Gordon H. Guyatt; Alba DiCenso; Vern Farewell; Andrew Willan; Lauren Griffith

2000-01-01

280

A Comparative Study of Family Bereavement Groups.  

ERIC Educational Resources Information Center

|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

Hopmeyer, Estelle; Werk, Annette

1994-01-01

281

Center for Polymer Studies Education Group  

NSDL National Science Digital Library

Since 1989 we at the education group in Boston University's Center for Polymer Studies have worked to incorporate the methods and findings of the cutting edge of scientific discovery into educational settings. Our work focuses on using technology to visualize and analyze complicated phenomena, engaging students, and enabling the grasping of traditionally difficult topics. We use these tools to connect the teaching and research communities, bringing educators and talented students into our laboratories, and sending scientists and graduate students directly to local classrooms.

Studies, Center F.

282

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial  

PubMed Central

Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/?2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911

2012-01-01

283

Coronary heart disease death, nonfatal acute myocardial infarction and other clinical outcomes in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group  

Microsoft Academic Search

The Multiple Risk Factor Intervention Trial was a randomized clinical study to test whether a special-intervention (SI) program aimed at reducing serum cholesterol levels, blood pressure and cigarette smoking would prevent coronary heart disease (CHD) in middle-aged men. The main endpoint reported here is the percentage of participants experiencing first major CHD events (either nonfatal acute myocardial infarction [AMI] or

Judith K. Ockene

1986-01-01

284

An effectiveness trial of group cognitive behavioral therapy for patients with persistent depressive symptoms in substance abuse treatment  

PubMed Central

Context Although depression frequently co-occurs with substance abuse, few individuals entering substance abuse treatment have access to effective depression treatment. Objective The Building Recovery by Improving Goals, Habits and Thoughts (BRIGHT) study is a community-based effectiveness trial that compared residential substance abuse treatment to residential treatment plus group cognitive behavioral therapy (CBT) for depression delivered by substance abuse treatment counselors. The authors hypothesized that intervention clients would have improved depression and substance use outcomes as compared to clients receiving usual care. Design A nonrandomized controlled trial using a quasi-experimental intent-to-treat design in which four sites were assigned to alternate between the intervention and usual care conditions every four months over a two-and-a-half-year period. Setting Four treatment programs in Los Angeles County Participants 1,262 clients were screened for persistent depressive symptoms (Beck Depression Inventory-II (BDI-II) >17). 299 clients were assigned to receive either usual care (N=159) or usual care plus the intervention (N=140). Follow-up rates at three and six months after the baseline interview were 88.1% and 86.2% for usual care and 85.7% and 85.0% for the intervention group. Intervention Sixteen two-hour group sessions of CBT for depression Main Outcome Measures Change in depression symptoms, mental health functioning, and days of alcohol and substance use. Results BRIGHT clients reported significantly fewer depressive symptoms (p<0.001 at three and six months) and had improved mental health functioning (p<0.001 at three-months and p<0.01 at six months). At six months, BRIGHT clients reported fewer drinking days (p<0.05) and fewer days of problem substance use (p<0.05) on days available. Conclusions Providing group CBT for depression to clients with persistent depressive symptoms receiving residential substance abuse treatment is associated with improved depression and substance use outcomes. These results provide support for a new model of integrated care.

Watkins, Katherine E.; Hunter, Sarah B.; Hepner, Kimberly A.; Paddock, Susan M.; de la Cruz, Erin; Zhou, Annie J.; Gilmore, Jim

2011-01-01

285

Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial  

PubMed Central

Background Extraction of lower first permanent molars in children is common. There is uncertainty among clinicians as to whether a ‘compensating extraction’ (removal of the upper first permanent molar to prevent it over erupting) is necessary despite current guidelines recommending this. As a result, unnecessary dental extractions may be carried out or children may be failing to receive extractions required to achieve optimal long-term oral health. In addition, the decision to extract fewer or more teeth affects management options (local anesthetic injections alone, inhalation sedation or general anesthesia) needed to support the child with the surgical procedure(s). The SIXES (Should I eXtract Every Six) dental trial investigates clinical effectiveness and quality of life for conventional treatment (following the guideline of compensation extraction of the upper first permanent molar) compared with the alternative intervention (removal of lower first permanent molars but no extraction of the upper). Methods/Design This is a multicenter, two-arm parallel group randomized clinical trial. Allocation will be web-based randomization. Practitioners in primary and secondary care settings, reflecting the points of presentation and treatment of eligible patients, will recruit 400 children, aged 7 to 11 years requiring extraction of lower first permanent molars but who have upper first permanent molars of good prognosis. Baseline measures (prior to treatment) and outcome data (at one and five years, or when the patient reaches 14 years of age) will be assessed through study models and child/parent questionnaires. The primary outcome measure is degree of tipping of the lower second permanent molar, (favorable outcome is tipping less than 15°). The secondary outcomes are type of anesthetic/sedation used, residual spacing (between lower second premolar and second permanent molar), orthodontic treatment requirement, quality of life, and over-eruption in the intervention group. Assessors will be blinded where possible. Discussion SIXES dental trial investigates whether compensating extraction of upper first permanent molars should be carried out following loss of lower first permanent molars. Currently dentists and orthodontists face a dilemma in clinical decision-making, relying on the lowest level of evidence - expert opinion. SIXES will provide evidence to support decision-making and inform practices and may result in reduced tooth extractions. Trial registration Clinical Trials.gov Identifier: NCT01591265

2013-01-01

286

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

ERIC Educational Resources Information Center

|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…

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

287

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

ERIC Educational Resources Information Center

|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…

Bilek, Emily L.; Ehrenreich-May, Jill

2012-01-01

288

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

Microsoft Academic Search

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

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

289

Demographic and behavioral contextual risk groups among men who have sex with men participating in a phase 3 HIV vaccine efficacy trial: implications for HIV prevention and behavioral/biomedical intervention trials.  

PubMed

Recent outbreaks of syphilis and gonorrhea coupled with reported increases in HIV-risk behavior among men who have sex with men (MSM) have raised concerns about a potential resurgence of HIV among MSM. These concerns have led some to suggest the need for a paradigm shift in how HIV-prevention programs are designed and implemented. In this analysis, baseline demographic, sexual partnership, and substance use information was used to identify contextual-risk groups among 5,095 HIV-seronegative MSM enrolled in a 36-month phase 3 HIV vaccine efficacy trial across 61 sites primarily in North America. Eight demographic and behavioral contextual risk groups were identified, with annualized HIV seroincidence ranging from 1.8% to 6.3% across groups. Men in primary HIV-serodiscordant relationships had the lowest HIV seroincidence (1.8%), while an older group of men with many sex partners had the highest (6.3%). Visit-schedule compliance and study retention were lowest among younger non-White men and highest among older popper users, with annualized HIV seroincidence of 2.9% and 3.5%, respectively. Differences in HIV incidence, study compliance, and retention observed among contextual-risk groups suggest that responsiveness to heterogeneity within risk group (eg, MSM) could benefit screening, enrollment, and retention of HIV-prevention programs and intervention trials, reducing the time and cost related to their design, implementation, and conclusion. PMID:17003693

Bartholow, Bradford N; Goli, Vamshidar; Ackers, Marta; McLellan, Eleanor; Gurwith, Marc; Durham, Marcus; Greenberg, Alan E

2006-12-15

290

Colchicine for Primary Biliary Cirrhosis: A Cochrane Hepatobiliary Group Systematic Review of Randomized Clinical Trials  

Microsoft Academic Search

OBJECTIVES:Colchicine is used for patients with primary biliary cirrhosis due to its immunomodulatory and antifibrotic potential. The results from randomized clinical trials have, however, been inconsistent. We conducted a systematical review to evaluate the effect of colchicine for primary biliary cirrhosis.METHODS:We identified randomized clinical trials comparing colchicine with placebo\\/no intervention. We analyzed effects by fixed and random effects model. We

Yan Gong; Christian Gluud

2005-01-01

291

Randomized controlled GH trial: effects on anthropometry, body composition and body proportions in a large group of children with Prader-Willi syndrome  

Microsoft Academic Search

BACKGROUND: Prader-Willi syndrome (PWS) children have impaired growth, and abnormal body composition. Previous 1-year controlled studies showed improvement of height and body composition during GH-treatment. OBJECTIVE: To evaluate growth, body composition and body proportions during GH-treatment in a large group of PWS children. DESIGN\\/PATIENTS: We performed a randomized controlled GH trial in 91 prepubertal PWS children (42 infants, 49 children,

Dederieke A. M. Festen; Roderick de Lind van Wijngaarden; Marielle van Eekelen; Barto J. Otten; Jan M. Wit; Hugo J. Duivenvoorden; Anita C. S. Hokken-Koelega

2008-01-01

292

The activity of the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group.  

PubMed

The Bone and Soft Tissue Tumor Study Group (BSTTSG) of the Japan Clinical Oncology Group (JCOG) was established in 2002. At present, 26 institutions are participating as active members of the BSTTSG of the JCOG. In 2004, the first BSTTSG trial, JCOG 0304, was initiated. JCOG 0304 was a Phase II study of perioperative chemotherapy with doxorubicin and ifosfamide for patients with operable, high-grade, non-round cell soft tissue sarcomas (T2bN0M0) arising in the extremities. The results of JCOG 0304 suggested the efficacy of the perioperative chemotherapy on operable soft tissue sarcoma in the extremities and led to planning of the subsequent clinical trial for the disease. The BSTTSG has currently been conducting a Phase III trial, JCOG 0905, to investigate the superiority of the addition of ifosfamide to the standard chemotherapy with methotrexate, cisplatin and doxorubicin for operable, high-grade osteosarcoma. The BSTTSG is also conducting a JCOG ancillary study, JCOG 0905-A1, to evaluate the gene expression profiles of osteosarcoma treated in the JCOG 0905 study. The BSTTSG will further try to develop new standard therapy for bone and soft tissue tumors. PMID:22628611

Iwamoto, Yukihide; Tanaka, Kazuhiro

2012-05-23

293

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  

SciTech Connect

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 and Materials: This study was designed such that if fewer than 5 cases out of the first 42 patients evaluable were scored as unacceptable, the treatment would be considered reproducible. Patients received 38.5 Gy in 3.85 Gy/fraction delivered twice daily. The clinical target volume included the lumpectomy cavity plus a 10-15-mm margin bounded by 5 mm within the skin surface and the lung-chest wall interface. The planning target volume (PTV) included the clinical target volume plus a 10-mm margin. Treatment plans were judged as follows: (1) No variations (total coverage), 95% isodose surface covers 100% of the PTV and all specified critical normal tissue dose-volume histogram (DVH) limits met. (2) Minor variation (marginal coverage), 95% isodose surface covers between {>=}95% and <100% of the PTV. No portion of PTV receives <93% of prescription (isocenter) dose. All specified critical normal tissue DVH limits fall within 5% of the guidelines. (3) Major variation (miss), 95% isodose surface covers <95% of the PTV. Portion of PTV receives <93% of prescription isocenter dose. Any critical normal tissue DVH limit exceeds 5% of the specified value. Results: A total of 58 patients were enrolled on this study between 8/15/03 and 4/30/04, 5 of whom were ineligible or did not receive protocol treatment. Two additional patients were excluded, one because the on-study form was not submitted, and the other because no treatment planning material was submitted. This primary end point analysis is based on the first 42 (out of 51) evaluable patients, which were accrued from 17 different institutions (31 centers were credentialed for case enrollment, but because of rapid accrual, not all centers were able to submit cases before trial closure). These 42 patients had the following characteristics: median age was 61 years; 48% had a maximum tumor dimension of <1 cm; 86% had invasive ductal carcinoma; 64% were postmenopausal; the location of tumor was upper outer for 40% and upper central for 21%; 79% had no chemotherapy, and 64% had no hormonal therapy. There were 4 cases with major variations (all 4 related to normal tissue DVHs exceeding 5% of the specified limit). A total of 32 cases with minor variations in treatment plans were detected (16 related to normal tissue DVHs exceeding the specified limits [by {<=}5%], 6 related to suboptimal coverage of the PTV, and 10 related to both). There were 6 cases with no variations. Of the 51 total evaluable patients, 1 additional major variation was noted (PTV receiving <93% of the prescription dose). An additional 5 cases with minor variations in treatment plans were detected (3 related to normal tissue DVHs exceeding the specified limits [by {<=}5%], 1 related to suboptimal coverage of the PTV, and 1 related to both). There were 3 more cases with no variations. Conclusion: Accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy was shown in this preliminary analysis of the first 42 evaluable patients to be technically feasible and reproducible in a multi-institutional trial using exceptionally strict dosimetric criteria.

Vicini, Frank [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States)]. E-mail: fvicini@beaumont.edu; Winter, Kathryn M.S. [Department of Statistics, Radiation Therapy Oncology Group (RTOG), Philadelphia, PA (United States); Straube, William [Department of Radiation Oncology, Washington University, St. Louis, MO (United States); Wong, John [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Pass, Helen [Department of Surgery, William Beaumont Hospital, Royal Oak, MI (United States); Rabinovitch, Rachel [University of Colorado Health Sciences Center, Denver, CO (United States); Chafe, Susan [Cross Cancer Institute, University of Alberta, Edmonton, Alberta (Canada); Arthur, Douglas [Virginia Commonwealth University Medical Center, Richmond, VA (United States); Petersen, Ivy [Mayo Clinic, Rochester, MN (United States); McCormick, Beryl [Memorial Sloan-Kettering Cancer Center, New York, NY (United States)

2005-12-01

294

Parent training with high-risk immigrant chinese families: a pilot group randomized trial yielding practice-based evidence.  

PubMed

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

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

2011-03-16

295

The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial  

PubMed Central

Background Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program. Discussion This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609000507280

2013-01-01

296

Successful Coordination and Execution of Non-Therapeutic Studies in a Cooperative Group Setting: Lessons Learned from Children's Oncology Group Studies  

PubMed Central

The immense progress made in childhood cancer survival has been due to the systematic and efficient conduct of large multicenter therapeutic trials, utilizing the infrastructure developed by national cooperative groups. These therapeutic trials have been successful, in part due to the high participation rates by the participating member institutions. However, participation in non-therapeutic trials in the cooperative group setting has lagged behind that of therapeutic trials for a variety of reasons, such as lack of institutional resources, leading to low priority given to such activities. The purpose of this report is to share some of the methods developed and successfully implemented by a Coordinating Center (City of Hope National Medical Center) to maximize institutional participation and patient enrollment and to standardize data collection and quality control, in order to ensure successful execution of two large, extramurally funded, cooperative group non-therapeutic studies. To date, over 175 institutions have obtained regulatory approval for the protocols showcased here, accrual has been on target, and completeness and quality of the collected data has been excellent. The successful execution of these non-therapeutic studies demonstrates the advantages of diverse study publicity techniques, detailed standardized operating procedures, and effective utilization of technological resources.

Carter, Andrea; Landier, Wendy; Schad, Amy; Moser, Allison; Schaible, Alexandra; Hanby, Cara; Kurian, Seira; Lennie Wong, F.; Villaluna, Doojduen; Bhatia, Smita

2008-01-01

297

Promoting Professional Student Learning through Study Groups: A Case Study  

ERIC Educational Resources Information Center

|The purpose of this research was to analyze how 24 graduate students perceived the study group experience and how study groups fostered a change in their knowledge and teaching of comprehension. Data sources included pre-post questionnaires, text concepts, International Reading Association process form, facilitator logs, and post-survey. Data…

Shaw, Donita Massengill

2011-01-01

298

The Counseling Older Adults to Control Hypertension (COACH) Trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults  

PubMed Central

The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body weight; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.

Ogedegbe, Gbenga; Fernandez, Senaida; Luerassi, Leanne; Silver, Stephanie A.; Kong, Jian; Midberry, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A.

2013-01-01

299

Clinicians' perceptions of reporting methods for back pain trials: a qualitative study  

PubMed Central

Background How outcomes of clinical trials are reported alters the way treatment effectiveness is perceived: clinicians interpret the outcomes of trials more favourably when results are presented in relative (such as risk ratio) rather than absolute terms (such as risk reduction). However, it is unclear which methods clinicians find easiest to interpret and use in decision making. Aim To explore which methods for reporting back pain trials clinicians find clearest and most interpretable and useful to decision making. Design and setting Indepth interviews with clinicians at clinical practices/research centre. Method Clinicians were purposively sampled by professional discipline, sex, age, and practice setting. They were presented with several different summaries of the results of the same hypothetical trial. Each summary used a different reporting method, and the study explored participants' preferences for each method and how they would like to see future trials reported. Results The 14 clinicians interviewed (comprising GPs, manual therapists, psychologists, a rheumatologist, and surgeons) stated that clinical trial reports were not written with them in mind. They were familiar with mean differences, proportion improved, and numbers needed to treat (NNT), but unfamiliar with standardised mean differences, odds ratios, and relative risks (RRs). They found the proportion improved, RR, and NNT most intuitively understandable, and thought reporting between-group mean differences, RRs, and odds ratios could mislead. Conclusion Clinicians stated that additional reporting methods facilitate the interpretation of trial results, and using a variety of methods would make results easier to interpret in context and incorporate into practice. Authors of future back pain trials should report data in a format that is accessible to clinicians.

Froud, Robert; Underwood, Martin; Carnes, Dawn; Eldridge, Sandra

2012-01-01

300

Prognostic factors and treatment outcome in primary progressive Hodgkin lymphoma: a report from the German Hodgkin Lymphoma Study Group  

Microsoft Academic Search

To determine prognostic factors and treat- ment outcome, patients with primary pro- gressive Hodgkin lymphoma (HD) regis- tered in the database of the German Hodgkin Lymphoma Study Group (GHSG) were analyzed retrospectively. Detailed records from randomized prospective multicenter trials performed between 1988 and 1998 of 3807 patients recruited in these trials were reviewed. The median age of the 206 patients

Andreas Josting; Ulrich Rueffer; Jeremy Franklin; Markus Sieber; Volker Diehl; Andreas Engert

2000-01-01

301

Randomized controlled trial versus comparative cohort study in verifying the therapeutic role of lymphadenectomy in endometrial cancer.  

PubMed

A consensus regarding the therapeutic role of lymphadenectomy in endometrial cancer has not been reached because of conflicting negative results of randomized controlled trials and positive results of a cohort study. Since the effects of new treatments tend to be overestimated in observational studies, positive results of an observational study should be validated by a future trial. However, special difficulties are presented in randomized controlled trials in surgery. External validity is important for guaranteeing the reliability of a result of the trial. Physicians' recruitment of eligible patients into a trial depends on the confidence of those physicians for a surgical procedure, workplace environment and feelings of personal responsibility relevant to patients' risk of recurrence. When two surgical procedures are compared in a randomized controlled trial, technical quality control may be reduced in the complicated surgery group due to experienced surgeons' non-participation. It is highly possible that the recruitment issue is a threat to external validity. Therefore, a randomized controlled trial may not be the best format for demonstrating the full benefits of complicated surgery. Multiple studies have demonstrated that the results of well-designed observational studies can be reliable and are comparable with those of randomized controlled trials. Journal editors and funding sources are requested to become more generous with observational studies, especially prospective cohort studies. PMID:23203151

Todo, Yukiharu; Sakuragi, Noriaki

2012-12-01

302

Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials.  

PubMed

The Mini Mental Status Exam (MMSE) instrument has been commonly used in the Radiation Therapy Oncology Group (RTOG) to assess mental status in brain cancer patients. Evaluating patient factors in relation to patterns of incomplete MMSE assessments can provide insight into predictors of missingness and optimal MMSE collection schedules in brain cancer clinical trials. This study examined eight RTOG brain cancer trials with ten treatment arms and 1,957 eligible patients. Patient data compliance patterns were categorized as: (1) evaluated at all time points (Complete), (2) not evaluated from a given time point or any subsequent time points but evaluated at all the previous time points (Monotone drop-out), (3) not evaluated at any time point (All missing), and (4) all other patterns (Mixed). Patient characteristics and reasons for missingness were summarized and compared among the missing pattern groups. Baseline MMSE scores and change scores after radiation therapy (RT) were compared between these groups, adjusting for differences in other characteristics. There were significant differences in frequency of missing patterns by age, treatment type, education, and Zubrod performance status (ZPS; P < 0.001). Ninety-two percent of patients were evaluated at least once: seven percent of patients were complete pattern, 49% were Monotone pattern, and 36% were mixed pattern. Patients who received RT only regimens were evaluated at a higher rate than patients who received RT + other treatments (49-64% vs. 27-45%). Institutional error and request to not be contacted were the most frequent known reasons for missing data, but most often, reasons for missing MMSE was unspecified. Differences in baseline mean MMSE scores by missing pattern (Complete, Monotone dropout, Mixed) were statistically significant (P < 0.001) but differences were small (<1.5 points) and significance did not persist after adjustment for age, ZPS, and other factors related to missingness. Post-RT change scores did not differ significantly by missing pattern. While baseline and change scores did not differ widely by missing pattern for available measurements, incomplete data was common and of unknown reason, and has potential to substantially bias conclusions. Higher compliance rates may be achievable by addressing institutional compliance with assessment schedules and patient refusal issues, and further exploration of how educational and health status barriers influence compliance with MMSE and other tools used in modern neurocognitive batteries. PMID:21603964

Bae, K; Bruner, D W; Baek, S; Movsas, B; Corn, B W; Dignam, J J

2011-05-21

303

A randomized trial of contingency management delivered in the context of group counseling  

PubMed Central

Objective Contingency management (CM) is efficacious in reducing drug use. Typically, reinforcers are provided on an individual basis to patients for submitting drug-negative samples. However, most treatment is provided in a group context, and poor attendance is a substantial concern. This study evaluated whether adding CM to group-based outpatient treatment would increase attendance and drug abstinence relative to standard care. Methods Substance abusing patients (N = 239) initiating outpatient treatment at two community-based clinics were randomized to standard care with frequent urine sample monitoring for 12 weeks (SC) or that same treatment with CM delivered in the context of group counseling sessions. In the CM condition, patients earned opportunities to put their names in a hat based on attendance and submission of drug-negative samples. At group counseling sessions, therapists selected names randomly from the hat, and individuals whose names were drawn won prizes ranging from $1 to $100. Results Patients assigned to CM earned a median of $160 in prizes, and they attended significantly more days of treatment (d = 0.25), remained in treatment for more continuous weeks (d = 0.40), and achieved longer durations of drug abstinence (d = 0.26) than patients randomized to SC. Group adherence and therapeutic alliance also improved with CM. In addition, HIV risk behaviors were significantly lower in CM relative to SC patients during early phases of treatment and at the 12-month follow-up. Conclusions These data demonstrate that CM delivered in the context of outpatient group counseling can increase attendance and improve drug abstinence.

Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.

2013-01-01

304

Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1): study protocol for a randomized controlled trial  

PubMed Central

Background Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. Methods/design The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT) design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3?months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice) or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. Discussion This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention. Trial registration ISRCTN28328154

2012-01-01

305

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials  

PubMed Central

Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55–2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

Hutchison, C; Cowan, C; McMahon, T; Paul, J

2007-01-01

306

Should football players wear custom fitted mouthguards? Results from a group randomised controlled trial  

PubMed Central

Objective: Head/orofacial (H/O) injuries are common in Australian rules football. Mouthguards are widely promoted to prevent these injuries, in spite of the lack of formal evidence for their effectiveness. Design: The Australian football injury prevention project was a cluster randomized controlled trial to evaluate the effectiveness of mouthguards for preventing H/O injuries in these players. Setting and subjects: Twenty three teams (301 players) were recruited from the largest community football league in Australia. Intervention: Teams were randomly allocated to either the MG: custom made mouthguard or C: control (usual mouthguard behaviours) study arm. Main outcome measures: All injuries, participation in training and games, and mouthguard use were monitored over the 2001 playing season. Injury rates were calculated as the number of injuries per 1000 person hours of playing time. Adjusted incidence rate ratios were obtained from Poisson regression models. Results: Players in both study arms wore mouthguards, though it is unlikely that many controls wore custom made ones. Wearing rates were higher during games than training. The overall rate of H/O injury was 2.7 injuries per 1000 exposure hours. The rate of H/O injury was higher during games than training. The adjusted H/O injury incidence rate ratio was 0.56 (95% CI 0.32 to 0.97) for MG versus C during games and training, combined. Conclusions: There was a significant protective effect of custom made mouthguards, relative to usual mouthguard use, during games. However, the control players still wore mouthguards throughout the majority of games and this could have diluted the effect.

Finch, C; Braham, R; McIntosh, A; McCrory, P; Wolfe, R

2005-01-01

307

PILOT STUDY DEMONSTRATING EFFECTIVENESS OF TARGETED EDUCATION TO IMPROVE INFORMED CONSENT UNDERSTANDING IN AIDS CLINICAL TRIALS  

PubMed Central

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants’ informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention) or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to 3-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P.; Eron, Joseph; Gifford, Allen L.

2011-01-01

308

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study  

PubMed Central

The randomized controlled trial is the “gold standard” for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.

Chan, Kevin

2007-01-01

309

Validation of the serum bactericidal assay for measurement of functional antibodies against group B meningococci associated with vaccine trials  

Microsoft Academic Search

Provisional licensure of the trial vaccine, MeNZB™, required demonstration of immune responses in vaccines, as measured by a validated Serum Bactericidal Assay (SBA). Reported are the investigations undertaken to define test parameters, lower limits of quantitation and measurement of SBA reproducibility. Results helped to formulate the operating procedure for the measurement of serum bactericidal antibodies during six age-group MeNZB™ vaccine

D. Martin; L. McCallum; A. Glennie; N. Ruijne; P. Blatchford; J. O’Hallahan; P. Oster

2005-01-01

310

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

ERIC Educational Resources Information Center

|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…

Soronson, Bryan M.; Shaw, Diana V.

1994-01-01

311

A trial for the use of qigong in the treatment of pre and mild essential hypertension: a study protocol for a randomized controlled trial  

PubMed Central

Background Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have side effects and poor adherence. Qigong has been studied as an alternative therapy for hypertension; however, the types of qigong used in those studies were diverse, and there have not been many well-designed randomized controlled trials. Our objectives are the following: 1) To evaluate the effects of qigong on blood pressure, health status and hormone levels for pre- or mild hypertension. 2) To test the methodological appropriateness of this clinical trial and calculate a sample size for future randomized trials. Methods Forty subjects with pre- or mild hypertension will be randomized to either the qigong exercise group or the non-treated group. Participants in the qigong group will conduct qigong exercises 5 times per week for 8 weeks, and participants in the non-treated group will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint is a change in patient blood pressure. Secondary endpoints are patient health status (as measured by the SF-36 and the MYMOP2 questionnaires) and changes in hormone levels, including norepinephrine, epinephrine, and cortisol. Discussion This study will be the first randomized trial to investigate the effectiveness of qigong exercises for the treatment of pre- and mild hypertension. The results of this study will help to establish the optimal approach for the care of adults with pre- or mild hypertension. Trial registration Clinical Research Information Service KCT0000140

2011-01-01

312

16 Sequential and Group Sequential Designs in Clinical Trials: Guidelines for Practitioners  

Microsoft Academic Search

In a classical fixed sample design, the sample size is set in advance of collecting any data. The main design focus is choosing the sample size that allows the clinical trial to discriminate between the null hypothesis of no difference and the alternative hypothesis of a specified difference of scientific interest. A disadvantage of fixed sample design is that the

Madhu Mazumdar; Heejung Bang

2007-01-01

313

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

ERIC Educational Resources Information Center

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…

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

2004-01-01

314

A group sequential, response-adaptive design for randomized clinical trials  

Microsoft Academic Search

There has been considerable methodological research on response-adaptive designs for clinical trials but they have seldom been used in practice. The many reasons for this are summarized in an article by Rosenberger and Lachin, but the two main reasons generally cited are logistical difficulties and the potential for bias due to selection effects, “drift” in patient characteristics or risk factors

Theodore G. Karrison; Dezheng Huo; Rick Chappell

2003-01-01

315

Weight change in control group participants in behavioural weight loss interventions: a systematic review and meta-regression study  

PubMed Central

Background Unanticipated control group improvements have been observed in intervention trials targeting various health behaviours. This phenomenon has not been studied in the context of behavioural weight loss intervention trials. The purpose of this study is to conduct a systematic review and meta-regression of behavioural weight loss interventions to quantify control group weight change, and relate the size of this effect to specific trial and sample characteristics. Methods Database searches identified reports of intervention trials meeting the inclusion criteria. Data on control group weight change and possible explanatory factors were abstracted and analysed descriptively and quantitatively. Results 85 trials were reviewed and 72 were included in the meta-regression. While there was no change in control group weight, control groups receiving usual care lost 1 kg more than control groups that received no intervention, beyond measurement. Conclusions There are several possible explanations why control group changes occur in intervention trials targeting other behaviours, but not for weight loss. Control group participation may prevent weight gain, although more research is needed to confirm this hypothesis.

2012-01-01

316

Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial  

PubMed Central

Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child. Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers, as well as reduced risk of adverse pregnancy outcomes. There is however a lack of high quality, randomized controlled trials on the effects of regular exercise training in pregnancy, especially those with a pre-pregnancy body mass index (BMI) at or above 30 kg/m2. Methods We are conducting a randomised, controlled trial in Norway with two parallel arms; one intervention group and one control group. We will enroll 150 previously sedentary, pregnant women with a pre-pregnancy BMI at or above 30 kg/m2. The intervention group will meet for organized exercise training three times per week, starting in gestation week 14 (range 12-16). The control group will get standard antenatal care. The main outcome measure will be weight gain from baseline to delivery. Among the secondary outcome measures are changes in exercise capacity, endothelial function, physical activity level, body composition, serum markers of cardiovascular risk, incontinence, lumbopelvic pain and cardiac function from baseline to gestation week 37 (range 36-38). Offspring outcome measures include anthropometric variables at birth, Apgar score, as well as serum markers of inflammation and metabolism in cord blood. Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary, obese pregnant women. If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes, such programs should be considered as part of routine pregnancy care for obese women. Trial Registration ClinicalTrials.gov: NCT01243554

2011-01-01

317

Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial  

PubMed Central

Background Nutritional support is an essential part of the management of critically ill patients. However, optimal caloric intake has not been systematically evaluated. We aim to compare two strategies of enteral feeding: permissive underfeeding versus target feeding. Method/Design This is an international multi-center randomized controlled trial in critically ill medical- surgical adult patients. Using a centralized allocation, 862 patients will be randomized to permissive underfeeding or target feeding. Patients in the permissive group receive 50% (acceptable range is 40% to 60%) of the calculated caloric requirement, while those in the targeted group receive 100% (acceptable range 70% to 100%) of the calculated caloric requirement. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, 28-day, and 180-day mortality as well as health care-associated infections, organ failure, and length of stay in the ICU and hospital. The trial has 80% power to detect an 8% absolute reduction in 90-day mortality assuming a baseline risk of death of 25% at an alpha level of 0.05. Discussion Patient recruitment started in November 2009 and is currently active in five centers. The Data Monitoring Committee advised continuation of the trial after the first interim analysis. The study is expected to finish by November 2013. Trial registration Current Controlled Trials ISRCTN68144998

2012-01-01

318

Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial  

PubMed Central

Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1) placebo prednisolone group, 2) prednisolone group, 3) placebo prednisolone plus acute stage acupuncture group, 4) prednisolone plus acute stage acupuncture group, 5) placebo prednisolone plus resting stage acupuncture group, 6) prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain), the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the efficacy of using prednisolone and staging acupuncture to treat Bell's palsy, and to determine a best combination therapy with prednisolone and acupuncture for treating Bell's palsy. Trial Registration ClinicalTrials.gov: NCT01201642

2011-01-01

319

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Extract Sceletium tortuosum (Zembrin) in Healthy Adults.  

PubMed

Abstract Objectives: The objective of the study was to evaluate the safety and tolerability of two doses (8?mg and 25?mg once daily) of a 2:1 standardized extract of the South African medicinal plant Sceletium tortuosum (L.) N.E. Br., trademarked Zembrin(®)(,) in healthy adult volunteers over a three-month period. Design: This was a randomized, double-blind, parallel-group, placebo-controlled single center study. Setting: Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, Cape Town, South Africa. Participants: The study took place between February 2 and July 27, 2009. Thirty-seven healthy adults were recruited from the general population. Intervention: Participants were randomized to receive either one of two doses of study medication, or an identical placebo, taken once daily for 3 months. Of the 37 subjects, 12, 12, and 13 subjects received 8?mg extract Sceletium tortuosum (Zembrin(®)), 25?mg extract Sceletium tortuosum (Zembrin(®)), and placebo treatment, respectively. Outcome measures: No efficacy variables were assessed. The safety and tolerability variables comprised of vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory assessments (hematology, biochemistry, and urinalysis), and the recording of adverse events (AEs). Results: There were no apparent differences between the three treatments with regard to vital signs, 12-lead ECG, body weight, and physical examination from screening to the end of the 3-month treatment period. No significant changes were observed in hematology or biochemistry parameters between initial screening and the end of the study. Both doses of extract Sceletium tortuosum (Zembrin(®)) were well-tolerated. The most commonly reported AE was headache, followed by abdominal pain and upper respiratory tract infections, all with greater incidence in the placebo group than in the treatment groups. Unsolicited positive effects on well-being were noted in patient diaries by some participants taking extract Sceletium tortuosum (Zembrin(®)), including improved coping with stress and sleep. Conclusion: Both doses of extract Sceletium tortuosum (Zembrin(®)) (8?mg and 25?mg) were well tolerated when used by healthy human subjects once daily for 3 months. PMID:23441963

Nell, Haylene; Siebert, Mirna; Chellan, Pashini; Gericke, Nigel

2013-02-26

320

Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial  

PubMed Central

Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies (virtual reality, advanced sensors and smartphones) is a feasible way to address actual limitations of existing protocols for psychological stress. Trial registration http://clinicaltrials.gov/ct2/show/NCT01683617

2013-01-01

321

Effective Group Training for Patients with Unexplained Physical Symptoms: A Randomized Controlled Trial with a Non-Randomized One-Year Follow-Up  

PubMed Central

Background Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. Methodology/Principal Findings The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d?=?0.38;p?=?.002), but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d?=?0.43;p?=?0.01), emotional (Cohen's d?=?0.44;p?=?.0.01), and social (Cohen's d?=?0.36;p?=?0.01) functioning, less pain and better functioning despite pain (Cohen's d?=?0.51;p?=?<0.001), less physical symptoms (Cohen's d?=??.23;p?=?0.05) and less sleep difficulties (Cohen's d?=??0.25;p?=?0.04) than time in the waiting group. During the non-randomized follow-ups, there were no relapses. Conclusions/Significance The cognitive-behavioral group training tailored for UPS in primary care and provided by an outreaching secondary mental-health service appears to be effective and to broaden the accessibility of treatment for UPS. Trial Registration TrialRegister.nl NTR1609

Zonneveld, Lyonne N. L.; van Rood, Yanda R.; Timman, Reinier; Kooiman, Cornelis G.; van't Spijker, Adriaan; Busschbach, Jan J. V.

2012-01-01

322

Cardiac Home Education and Support Trial (CHEST): A pilot study  

PubMed Central

BACKGROUND: Coronary artery bypass graft (CABG) surgery is performed more frequently in individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery. OBJECTIVES: To test the feasibility of a peer support program and determine indicators of the effects of peer support on recovery outcomes of individuals following CABG surgery. METHODS AND RESULTS: A pre-post test pilot randomized clinical trial design enrolled men and women undergoing first-time nonemergency CABG surgery at a single site in Ontario. Patients were randomly assigned to either usual care or peer support. Patients allocated to usual care (n=50) received standard preoperative and postoperative education. Patients in the peer support group (n=45) received individualized education and support via telephone from trained cardiac surgery peer volunteers for eight weeks following hospital discharge. Most (93%) peer volunteers believed they were prepared for their role, with 98% of peer volunteers initiating calls within 72 h of the patient’s discharge. Peer volunteers made an average of 12 calls, less than 30 min in duration over the eight-week recovery period. Patients were satisfied with their peer support (n=45, 98%). The intervention group reported statistical trends toward improved physical function (physical component score) (t [89]=?1.6; P=0.12) role function (t [93]=?1.9; P=0.06), less pain (t [93]=1.30; P=0.20) and improved cardiac rehabilitation enrollment (?2=2.50, P=0.11). CONCLUSIONS: These preliminary results suggest that peer support may improve recovery outcomes following CABG. Data from the present pilot trial also indicate that a home-based peer support intervention is feasible and an adequately powered trial should be conducted.

Parry, Monica; Watt-Watson, Judy; Hodnett, Ellen; Tranmer, Joan; Dennis, Cindy-Lee; Brooks, Dina

2009-01-01

323

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial  

PubMed Central

Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK.?This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n?=?31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

2012-01-01

324

Facilitating support groups: a pilot study.  

PubMed

A group of senior nurses and the hospital chaplain planned to provide support for nursing staff in a large general hospital in Edinburgh. Three pilot support groups took place during 1990-1991. The evaluations from all group sessions and retrospective evaluations make a strong case for this method of support for nurses. The need to accept support is now acknowledged by nursing staff at all grades; there is a growing awareness of the importance of feeling valued by the organisation, and of nurses valuing themselves and each other. However, regular commitment to group support on a weekly basis is difficult for many nurses. PMID:1547133

Kellet, J

325

An Exploratory Study of Expert Group Leadership  

ERIC Educational Resources Information Center

This article presents the results of a grounded theory exploration that described expert group leaders' experiences and perceptions during the process of leading groups in terms of influence of experience, preexisting knowledge and attitudes, and in-the-moment leadership process. The discussion presents implications for practice, counselor…

Rubel, Deborah J.; Kline, William B.

2008-01-01

326

An Exploratory Study of Expert Group Leadership  

Microsoft Academic Search

This article presents the results of a grounded theory exploration that described expert group leaders' experiences and perceptions during the process of leading groups in terms of influence of experience, preexisting knowledge and attitudes, and in-the-moment leadership process. The discussion presents implications for practice, counselor education, supervision, and research.

Deborah J. Rubel; William B. Kline

2008-01-01

327

Group Communication Specifications: A Comprehensive Study  

Microsoft Academic Search

View-oriented group communication is an important and widely used building block for manydistributed applications. Much current research has been dedicated to specifying the semanticsand services of view-oriented Group Communication Systems (GCSs). However, the guaranteesof different GCSs are formulated using varying terminologies and modeling techniques, and thespecifications vary in their rigor. This makes it difficult to analyze and compare the differentsystems.

Roman Vitenberg

1999-01-01

328

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

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

2011-01-01

329

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

Microsoft Academic Search

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

Kim S Thomas

2010-01-01

330

Household obesity prevention: Take Action--a group-randomized trial.  

PubMed

The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year. Weight, height, eating behaviors, physical activity (PA), and TV viewing were measured among HH members ages ? 12 years. Follow-up rate at 1 year was 96%. No significant intervention effects were observed for change in HH BMI-z score. Intervention HHs significantly reduced TV viewing, snacks/sweets intake, and dollars per person spent eating out, and increased (adults only) PA and self-weighing frequency compared with control HHs. A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing, snack/sweets intake and eating out purchases. Innovative methods are needed to strengthen the home food environment intervention component. Longer intervention durations also need to be evaluated. PMID:21212771

French, Simone A; Gerlach, Anne F; Mitchell, Nathan R; Hannan, Peter J; Welsh, Ericka M

2011-01-06

331

How to Improve the Implementation of Academic Clinical Pediatric Trials Involving Drug Therapy? A Qualitative Study of Multiple Stakeholders  

PubMed Central

Objective The need for encouraging pediatric drug research is widely recognized. However, hospital-based clinical trials of drug treatments are extremely time-consuming, and delays in trial implementation are common. The objective of this qualitative study was to collect information on the perceptions and experience of health professionals involved in hospital-based pediatric drug trials. Methods Two independent researchers conducted in-depth semi-structured interviews with principal investigators (n?=?17), pharmacists (n?=?7), sponsor representatives (n?=?4), and drug regulatory agency representatives (n?=?3) who participated in institutionally sponsored clinical trials of experimental drugs in pediatric patients between 2002 and 2008. Results Dissatisfaction was reported by 67% (16/24) of principal investigators and pharmacists: all 7 pharmacists felt they were involved too late in the trial implementation process, whereas 11 (65%) principal investigators complained of an excessive regulatory burden and felt they were insufficiently involved in the basic research questions. Both groups perceived clinical trial implementation as burdensome and time-consuming. The sponsor and regulatory agency representatives reported a number of difficulties but were not dissatisfied. Conclusions The heavy burden related to regulatory requirements, and suboptimal communication across disciplines involved, seem to be the main reasons for the major delays in pediatric drug trial implementation. The pharmaceutical aspects are intrinsically tied to trial methodology and implementation and must therefore be examined, in particular by involving Clinical Research Pharmacists at early stages of study conception.

Girard, Delphine; Bourdon, Olivier; Abdoul, Hendy; Prot-Labarthe, Sonia; Brion, Francoise; Tibi, Annick; Alberti, Corinne

2013-01-01

332

Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial  

PubMed Central

Background Recently, catheter-based renal sympathetic denervation (RSD) has been verified to be safely used to substantially reduce the levels of blood pressure, left ventricular hypertrophy, sleep apnea severity and norepinephrine spillover, and improve glucose tolerance. All these pathological changes are recognized as independent risk factors for the development and recurrence of atrial fibrillation (AF). A randomized, single-blind, parallel-control, multicenter clinical trial is being conducted to compare RSD with antiarrhythmic drugs (AAD) in patients with drug-resistant hypertension and symptomatic AF (RSDforAF trial). Methods/design Patients with drug-resistant hypertension and symptomatic AF will be randomized to RSD and the drug treatment groups. Patients will be followed for 12 months until study closure. Up to 200 patients may be enrolled in six medical centers in China. The primary objective is to study the effects of RSD on AF burden and blood pressure in patients with hypertension and symptomatic AF. Discussion RSDforAF trial will test the hypothesis that RSD is superior to AAD in reducing AF burden and blood pressure in patients with drug-resistant hypertension and symptomatic AF. Trial registration ClinicalTrials.gov, NCT01713270

2013-01-01

333

Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study)  

PubMed Central

Objective To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer’s disease compared with usual care in memory clinics. Design Cluster randomised trial. Setting 50 memory clinics in France. Participants Patients with Alzheimer’s disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation. Intervention The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment. Main outcome measures The primary outcome measure was change on the Alzheimer’s Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality. Results At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer’s Disease Cooperative Study-activities of daily living was estimated at ?5.73 (95% confidence interval ?6.89 to ?4.57) in the intervention group and ?5.96 (?7.05 to ?4.86) in the control group (P=0.78). Conclusion A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer’s disease. Future research should aim to determine the effects of more direct involvement of general practitioners. Trial registration ClinicalTrials.gov NCT00480220.

2010-01-01

334

Intraclass Correlation Values for Planning Group-Randomized Trials in Education  

ERIC Educational Resources Information Center

|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…

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

2007-01-01

335

A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol  

PubMed Central

Background Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE). Methods/Design One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention. Discussion If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes. Trial registration NCT01523561

2013-01-01

336

The NAILED stroke risk factor trial (Nurse based Age independent Intervention to Limit Evolution of Disease after stroke): study protocol for a randomized controlled trial  

PubMed Central

Background Secondary prevention after stroke and transient ischemic attack (TIA) is essential in order to reduce morbidity and mortality. Secondary stroke prevention studies have, however, been fairly small, or performed as clinical trials with non-representative patient selection. Long-term follow-up data is also limited. A nurse-led follow-up for risk factor improvement may be effective but the evidence is limited. The aims of this study are to perform an adequately sized, nurse-led, long-term secondary preventive follow-up with a population-based inclusion of stroke and TIA patients. The focus will be on blood pressure and lipid control as well as tobacco use and physical activity. Methods A randomized, controlled, long-term, population-based trial with two parallel groups. The patients will be included during the initial hospital stay. Important outcome variables are sitting systolic and diastolic blood pressure, LDL cholesterol and total cholesterol. Outcomes will be measured after 12, 24 and 36 months of follow-up. Trained nurses will manage the intervention group with a focus on reaching set treatment goals as soon as possible. The control group will receive usual care. At least 200 patients will be included in each group, in order to reliably detect a difference in mean systolic blood pressure of 5 mmHg. This sample size is also adequate for detection of clinically meaningful group differences in the other outcomes. Discussion This study will test the hypothesis that a nurse-led, long-term follow-up after stroke with a focus on reaching set treatment goals as soon as possible, is an effective secondary preventive method. If proven effective, this method could be implemented in general practice at a low cost. Trial registration Current Controlled Trials ISRCTN23868518

2013-01-01

337

Psychiatric Symptom Improvement in Women Following Group Substance Abuse Treatment: Results from the Women's Recovery Group Study  

PubMed Central

The Women’s Recovery Group study was a Stage I randomized clinical trial comparing a new manual-based group treatment for women with substance use disorders with Group Drug Counseling. Data from this study were examined to determine whether co-occurring symptoms of depression and anxiety would improve with treatment and whether these improvements would demonstrate durability over the follow-up period. The sample consisted of 36 women (29 WRG, 7 GDC) who were administered self-report and clinician-rated measures of anxiety, depression, and general psychiatric symptoms. Although there were no group differences in psychiatric symptom improvement, analyses demonstrated significant within-subject improvement in depression, anxiety, and general psychiatric symptoms. Symptom reduction was not mediated by changes in substance use. This study demonstrated significant psychiatric symptom reduction that remained durable through 6 month follow-up for women receiving group therapy focused on substance abuse relapse prevention. Reduction in psychiatric symptoms may be an additional benefit of substance abuse group therapy for women.

McHugh, R. Kathryn; Greenfield, Shelly F.

2010-01-01

338

New Groups Study Science's Effect on Society  

ERIC Educational Resources Information Center

Describes the chief aims of the Council for Science and Society in London and the International Institute for Applied Systems Analysis in Vienna. Indicates that both groups are planning to function as a multinational interdisciplinary organization. (CC)

O'Sullivan, Dermot A.

1973-01-01

339

Bayesian model selection maps for group studies  

PubMed Central

This technical note describes the construction of posterior probability maps (PPMs) for Bayesian model selection (BMS) at the group level. This technique allows neuroimagers to make inferences about regionally specific effects using imaging data from a group of subjects. These effects are characterised using Bayesian model comparisons that are analogous to the F-tests used in statistical parametric mapping, with the advantage that the models to be compared do not need to be nested. Additionally, an arbitrary number of models can be compared together. This note describes the integration of the Bayesian mapping approach with a random effects analysis model for BMS using group data. We illustrate the method using fMRI data from a group of subjects performing a target detection task.

Rosa, M.J.; Bestmann, S.; Harrison, L.; Penny, W.

2010-01-01

340

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

PubMed Central

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.

Lee, Myeong Soo; Lee, Jung-Sook

2010-01-01

341

Group communication specifications: a comprehensive study  

Microsoft Academic Search

View-oriented group communication is an important and widely usedbuilding block for many distributed applications. Much currentresearch has been dedicated to specifying the semantics andservices of view-oriented group communication systems (GCSs).However, the guarantees of different GCSs are formulated usingvarying terminologies and modeling techniques, and thespecifications vary in their rigor. This makes it difficult toanalyze and compare the different systems. This survey

Gregory V. Chockler; Idit Keidar; Roman Vitenberg

2001-01-01

342

Industry Front Groups: A Tobacco Case Study  

Microsoft Academic Search

:  We consider how industries use front groups to combat public health measures by relating the history of “Get Government Off\\u000a Our Back”, a coalition created by the tobacco industry to fight government regulation. Using tobacco industry documents, contemporaneous\\u000a media reports, journal articles, and press releases, we review the establishment by RJ Reynolds of an industry front group,\\u000a Get Government Off

D. E. Apollonio; L. A. Bero

2007-01-01

343

Behavioral studies relevant to vaccine trial preparation: an introduction.  

PubMed

Preparations for large-scale trials to test the efficacy of candidate HIV vaccines can benefit in several crucial ways from a targeted program of behavioral and social research. Randomized field experiments testing alternative procedures for the recruitment and retention of subjects can help identify research procedures that will ensure adequate sample sizes while minimizing sample attrition over time. Similarly, assuring that subjects accurately comprehend the potential risks of participation will require more than simply presenting scientifically accurate information. Ensuring both the adequacy and appropriateness of risk communications as well as the accuracy of subject perception of risks (across the social and cultural milieux in which vaccine trials will be undertaken) is a critical task. Ethnographic and behavioral studies can help to ensure that our obligation to obtain truly informed consent from our research subjects is fully met and documented. Monitoring risk behaviors over the course of the vaccine trials could also benefit from strategic investments in new technologies developed by social researchers to permit the collection of sensitive personal data while affording complete privacy to subjects. These new measurement technologies include procedures that permit private data collection (without a human interviewer) in any spoken language and without requiring that subjects be literate. PMID:7865317

Turner, C F; Sheon, A R

1994-01-01

344

What is a factorial trial?  

PubMed

Randomized controlled trials (RCTs), typically, randomize participants to one of two intervention groups. It has been shown, however, that about 25% of RCTs published in the scientific literature randomize participants to three or more treatment groups. These studies are called 'multi-arm' trials: there may be, for instance, two or more experimental intervention groups with a common control group, or two control intervention groups such as a placebo group and a standard treatment group. A special case of multi-arm studies are factorial trials, which address two or more intervention comparisons carried out simultaneously, using four or more intervention groups. PMID:23676770

Cipriani, A; Barbui, C

2013-05-16

345

Randomized Trial of Tapas Acupressure Technique® for Weight Loss Maintenance: Rationale and Study Design  

PubMed Central

Abstract Objectives The aim of this article is to present the rationale, study design, and methods of an ongoing randomized controlled trial assessing the efficacy of an energy psychology intervention, Tapas Acupressure Technique® (TAT®), to prevent weight regain following successful weight loss. Design This is a randomized controlled trial. Settings/location The study is being conducted at a large group-model health maintenance organization (HMO). Subjects The study subjects are adult members of an HMO. Interventions TAT is being compared to a self-directed social support comparison intervention. Outcome measures The primary outcome measure is weight-loss maintenance at 6 and 12 months postrandomization. Conclusions This randomized controlled trial will test the efficacy of an energy psychology intervention, TAT, by comparing it with a self-directed social support group intervention. This is, to our knowledge, the largest randomized controlled study to date of an energy psychology intervention. Positive findings would support the use of TAT as a tool to prevent weight regain following successful weight loss.

Gallison, Cherri; Lindberg, Nangel M.; DeBar, Lynn; Funk, Kristine; Ritenbaugh, Cheryl; Stevens, Victor J.

2010-01-01

346

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

PubMed Central

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)

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

2013-01-01

347

GROUP  

Microsoft Academic Search

In this paper we continue the study ofalg 1 (S) for minimal surfaces of general type S satisfying K2 S < 3?(S). We show that, if K 2 S = 3?(S) 1 and |?alg 1 (S)| = 8, then S is a Campedelli surface. In view of the results of (MP1) and (MP2), this implies that the fundamental group of

CIRO CILIBERTO; MARGARIDA MENDES LOPES; RITA PARDINI

348

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

Microsoft Academic Search

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

Markus Jansson; Steven J. Linton

2005-01-01

349

Elementary Teacher Talk in Mathematics Study Groups  

ERIC Educational Resources Information Center

In this article, the author examines the character of the conversations generated in an elementary teacher group as they worked on mathematical problems together and analyzed their students' work. Two distinct forms of talk--"exploratory" and "expository"--were found. The first type of talk occurred most prominently when discussions centered on…

Crespo, Sandra

2006-01-01

350

Elementary Teacher Talk in Mathematics Study Groups  

Microsoft Academic Search

In this article, the author examines the character of the conversations generated in an elementary teacher group as they worked on mathematical problems together and analyzed their students' work. Two distinct forms of talk — exploratory and expository — were found. The first type of talk occurred most prominently when discussions centered on the teachers' own mathematical work and the

Sandra Crespo

2006-01-01

351

Religious and national group identification in adolescence: A study among three religious groups in Mauritius  

Microsoft Academic Search

Religious group identification is an important but understudied social identity. The present study investigates religious group identification among adolescents of different faiths (Hindu, Muslim, Christian) living in multicultural Mauritius. It further explores how religious and national group identities come together among religious majority and minority adolescents. For three age groups (11 to 19 years, N?=?2152) we examined the strength of

Caroline Ng Tseung-Wong; Maykel Verkuyten

2012-01-01

352

The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.  

PubMed

The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination. PMID:23462343

Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

2013-02-24

353

Bright Start: Description and main outcomes from a group-randomized obesity prevention trial in American Indian children  

PubMed Central

The aim of the Bright Start study was to develop and test the effectiveness of a school environment intervention, supplemented with family involvement, to reduce excessive weight gain by increasing physical activity and healthy eating practices among kindergarten and first grade American Indian children. Bright Start was a group-randomized, school-based trial involving 454 children attending 14 schools on the Pine Ridge Reservation in South Dakota. Children were followed from the beginning of their kindergarten year through the end of first grade. Main outcome variables were mean BMI, mean percent body fat, and prevalence of overweight/obese children. The goals of the intervention were to: increase physical activity at school to at least 60 min/day; modify school meals and snacks; and involve families in making behavioral and environmental changes at home. At baseline, 32% of boys and 25% of girls were overweight/obese. While the intervention was not associated with statistically significant change in mean levels of BMI, BMI-Z, skinfolds or percentage body fat, the intervention was associated with a statistically significant net decrease of 10% in the prevalence of overweight. Intervention children experienced a 13.4% incidence of overweight, while the control children experienced a corresponding incidence of 24.8%; a difference of ?11.4% (p=0.033). The intervention significantly reduced parent reported mean child intakes of sugar-sweetened beverages, whole milk and chocolate milk. Changes in duration of school physical activity were not significant. Because obesity is the most daunting health challenge facing American Indian children today, more intervention research is needed to identify effective approaches.

Story, Mary; Hannan, Peter J; Fulkerson, Jayne A.; Rock, Bonnie Holy; Smyth, Mary; Arcan, Chrisa; Himes, John H.

2012-01-01

354

Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial  

PubMed Central

Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible limitations to the success of the trial intervention include general practitioner approval of the intervention, general practitioner acceptance of pharmacists' recommendations, and pharmacists' ability to make appropriate recommendations. A detailed monitoring process will detect any barriers to the success of the trial. Given that poor medication persistence following acute coronary syndrome is a worldwide problem, the findings of our study may have international implications for the care of this patient group. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000452998

2012-01-01

355

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial  

PubMed Central

Background Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. Methods/design The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. Discussion This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people. Trial registration ClinicalTrials.gov Identifier NCT00671099

2013-01-01

356

The relationship between study design, results, and reporting of randomized clinical trials of HIV infection  

Microsoft Academic Search

We examined whether the study design of randomized clinical trials for medications against human immunodeficiency virus (HIV) may affect the results and whether the outcomes of these trials affect reporting and publication. We used a database of 71 published randomized HIV-related drug efficacy trials and considered the following study design factors: endpoint definition and method of analysis, masked design, sample

John P. A. Ioannidis; Joseph C. Cappelleri; Henry S. Sacks; Joseph Lau

1997-01-01

357

A Phase II Trial of Complete Resection for Stage IV Melanoma: Results of Southwest Oncology Group (SWOG) Clinical Trial S9430  

PubMed Central

PURPOSE Patients with stage IV melanoma who undergo complete resection have a favorable outcome compared to patients with disseminated stage IV disease, based on retrospective experience at individual centers. SWOG performed a prospective trial in patients with metastatic melanoma enrolled prior to complete resection of metastatic disease providing prospective outcomes in the cooperative group setting. PATIENTS AND METHODS Patients with stage IV melanoma judged amenable to complete resection by their surgeon, based on physical examination and radiologic imaging, underwent surgery within 28 days of enrollment. All eligible patients were followed with scans (CT or PET) every 6 months until relapse and death. RESULTS 77 patients were enrolled from 18 different centers. Of those, 5 patients were ineligible; 2 had stage III disease alone and 3 had no melanoma in their surgical specimen. In addition, 8 eligible patients had incompletely resected tumor. Therefore, the primary analysis included 64 completely resected patients. Twenty (31%) patients had visceral disease. With median follow-up of 5 years, the median relapse-free survival (RFS) was 5 months (95% CI 3–7 months) while median overall survival (OS) was 21 months (95% CI 16–34 months). OS at 3 and 4 years were 36% and 31%, respectively. CONCLUSIONS In a prospective, multi-center setting, appropriately selected patients with stage IV melanoma can achieve prolonged OS after complete surgical resection. While median RFS was only five months, patients can still frequently undergo subsequent surgery for isolated recurrences. This patient population is appropriate for aggressive surgical therapy and for trials evaluating adjuvant therapy.

Sosman, Jeffrey A.; Moon, James; Tuthill, Ralph J.; Warneke, James A.; Vetto, John T.; Redman, Bruce G.; Liu, P.Y.; Unger, Joseph M.; Flaherty, Lawrence E.; Sondak, Vernon K.

2010-01-01

358

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

Microsoft Academic Search

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

Ellen C. Flannery-Schroeder; Philip C. Kendall

2000-01-01