These are representative sample records from Science.gov related to your search topic.
For comprehensive and current results, perform a real-time search at Science.gov.
1

International Pediatric MS Study Group Clinical Trials Summit  

PubMed Central

Objective: Pediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research. Methods: The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions. Results: The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge. Conclusion: Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders. PMID:23509048

Tardieu, Marc; Amato, Maria Pia; Banwell, Brenda; Bar-Or, Amit; Ghezzi, Angelo; Kornberg, Andrew; Krupp, Lauren B.; Pohl, Daniela; Rostasy, Kevin; Tenembaum, Silvia; Waubant, Emmanuelle; Wassmer, Evangeline

2013-01-01

2

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. PMID:19828593

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

2010-01-01

3

STUDY PROTOCOL Open Access The MATISSE study: a randomised trial of group art therapy for people with schizophrenia  

E-print Network

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 aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia. Method/Design: The MATISSE study is a three-arm, parallel group, pragmatic, randomised, controlled trial of referral to group Art Therapy plus standard care, referral to an attention control ‘activity ’ group plus standard care, or standard care alone. Study participants were recruited from inpatient and community-based mental health and social care services at four centres in England and Northern Ireland. Participants were aged over 18 years with a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria. Participants were then randomised via an independent and remote telephone randomisation service using permuted stacked blocks, stratified by site. Art Therapy and activity groups were made available to participants once a week for up to 12 months. Outcome measures were assessed by researchers masked to allocation status at 12 and 24 months after randomisation. Participants and care givers were aware which arm of the trial participants

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

4

Implementation and Design Issues in Group-Randomized Prevention Trials: Lessons from the Youth Matters Public Schools Study  

ERIC Educational Resources Information Center

Group-randomized trials (GRTs)--studies that evaluate the efficacy or effectiveness of interventions occurring at the group level--are increasingly used to assess the effects of school-based prevention programs on behavioral outcomes of children and adolescents. These designs pose many implementation and design challenges for school…

Jenson, Jeffrey M.; Dieterich, William A.; Rinner, Jenifer R.; Washington, Felicia; Burgoyne, Kathleen E.

2006-01-01

5

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

PubMed Central

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

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

2011-01-01

6

Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial  

PubMed Central

Background When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. Methods We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. Results The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants’ different positions along two continuities from ‘Our participation in trial is not important’ to ‘Our participation in trial is important’, and ‘Vaccine not important to us’ to ‘Vaccine important to us’. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. Conclusions This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents’ disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large. Trial registration The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/) with trial number 2010-021979-85. PMID:24731249

2014-01-01

7

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

Microsoft Academic Search

BackgroundThe possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and\\/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms:

Jim McCambridge; Kaanan Butor-Bhavsar; John Witton; Diana Elbourne; Antje Timmer

2011-01-01

8

Determinants of patient recruitment in a multicenter clinical trials group: trends, seasonality and the effect of large studies. | accrualnet.cancer.gov  

Cancer.gov

The authors developed a model that adequately predicted five-year enrollment trends based on patient enrollment during the first 32 quarters. The study identified key trends and determinants of enrollment in a large multicenter clinical trials group. This information can be used to assess a clinical trials group’s performance over time and plan the strategic development and incorporation of future trials in its program. The predictors and the modeling process may be adapted to other groups and settings.

9

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

E-print Network

months. xi) Any incidents of suicidal behaviour, violence or aggression in the previous year were recorded using a proforma based on the one used by Johnson and collea- gues [34]. xii) Global functioning using the Global Assessment of Functioning Scale... , 10:65 http://www.biomedcentral.com/1471-244X/10/65 Page 7 of 9 Status of the trial Recruitment to the study commenced in January 2007 and ended in September 2008. Four-hundred and seven- teen participants were recruited and the final follow...

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

2010-08-27

10

Analytic methods for individually randomized group treatment trials and group-randomized trials when subjects belong to multiple groups.  

PubMed

Participants in trials may be randomized either individually or in groups and may receive their treatment either entirely individually, entirely in groups, or partially individually and partially in groups. This paper concerns cases in which participants receive their treatment either entirely or partially in groups, regardless of how they were randomized. Participants in group-randomized trials are randomized in groups, and participants in individually randomized group treatment trials are individually randomized, but participants in both types of trials receive part or all of their treatment in groups or through common change agents. Participants who receive part or all of their treatment in a group are expected to have positively correlated outcome measurements. This paper addresses a situation that occurs in group-randomized trials and individually randomized group treatment trials-participants receive treatment through more than one group. As motivation, we consider trials in The Childhood Obesity Prevention and Treatment Research Consortium, in which each child participant receives treatment in at least two groups. In simulation studies, we considered several possible analytic approaches over a variety of possible group structures. A mixed model with random effects for both groups provided the only consistent protection against inflated type I error rates and did so at the cost of only moderate loss of power when intraclass correlations were not large. We recommend constraining variance estimates to be positive and using the Kenward-Roger adjustment for degrees of freedom; this combination provided additional power but maintained type I error rates at the nominal level. PMID:24399701

Andridge, Rebecca R; Shoben, Abigail B; Muller, Keith E; Murray, David M

2014-06-15

11

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

12

African-American attitudes regarding cancer clinical trials and research studies: results from focus group methodology.  

PubMed

Despite federal recommendations highlighting the need to include special population groups (mainly minorities and women) in clinical research, recruitment and retention of these groups present a great challenge to researchers. This paper describes a focus group study that was conducted to examine factors related to minority participation and retention in cancer clinical research studies. In 1996, the National Cancer Institute submitted a request for applicants to receive support for regional conferences. The purpose of the proposed conferences was to share current information and strategies to aid cancer clinical investigators in recruiting and retaining minority participants in clinical cancer research and to stimulate local/regional adaptations of these strategies. The University of Alabama at Birmingham (UAB), The University of Alabama, and Tuskegee University collaborated to respond to the request. Funding was granted by NCI for the regional conference in Alabama. The conference was held in Tuskegee, Alabama, the site of the infamous US Public Health Syphilis Study at Tuskegee. In planning for the conference, focus group sessions were conducted with African-American men and women who represented all regions of Alabama. The focus group information was used to identify important issues to be addressed at the conference. PMID:10764133

Green, B L; Partridge, E E; Fouad, M N; Kohler, C; Crayton, E F; Alexander, L

2000-01-01

13

Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study  

PubMed Central

Background The Veterans Health Administration (VHA) oversees the largest integrated healthcare system in the United States. The feasibility of a large-scale, nationwide, group-randomized implementation trial of VHA outpatient practices has not been reported. We describe the recruitment and enrollment of such a trial testing a clinician-directed, Internet-delivered intervention for improving the care of postmyocardial infarction patients with multiple comorbidities. Methods With a recruitment goal of 200 eligible community-based outpatient clinics, parent VHA facilities (medical centers) were recruited because they oversee their affiliated clinics and the research conducted there. Eligible facilities had at least four VHA-owned and -operated primary care clinics, an affiliated Institutional Review Board (IRB), and no ongoing, potentially overlapping, quality-improvement study. Between December 2003 and December 2005, in two consecutive phases, we used initial and then intensified recruitment strategies. Results Overall, 48 of 66 (73%) eligible facilities were recruited. Of the 219 clinics and 957 clinicians associated with the 48 facilities, 168 (78%) clinics and 401 (42%) clinicians participated. The median time from initial facility contact to clinic enrollment was 222 days, which decreased by over one-third from the first to the second recruitment phase (medians: 323 and 195 days, respectively; p < .001), when more structured recruitment with physician recruiters was implemented and a dedicated IRB manager was added to the coordinating center staff. Conclusions Large group-randomized trials benefit from having dedicated physician investigators and IRB personnel involved in recruitment. A large-scale, nationally representative, group-randomized trial of community-based clinics is feasible within the VHA or a similar national healthcare system. PMID:21906278

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

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

PubMed Central

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

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

1998-01-01

16

Phase II Trial of Amonafide in Central Nervous System Tumors: A Southwest Oncology Group Study  

Microsoft Academic Search

Amonafide 300 mg\\/M2 was administeredintravenously on a daily × 5 schedule to 27eligible patients with recurrent orprogressive central nervous system tumors. There were no objective responses. Themost common toxicities weregastrointestinal, hematologic andneurologic. Further study of amonafide inpatients with central nervous systemmalignancies is not indicated.

Sarah A. Taylor; Cathryn Rankin; Jeannette J. Townsend; Johnny B. Craig; Ralph B. Vance; Dilip L. Solank; Thomas D. Brown; Kurt Jaeckle

2002-01-01

17

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

Microsoft Academic Search

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

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

1995-01-01

18

Phase II trial of edatrexate plus carboplatin in metastatic non-small-cell lung cancer: a Southwest Oncology Group study  

Microsoft Academic Search

Background: Edatrexate and carboplatin are each active single agents in the treatment of non-small-cell lung cancer (NSCLC). Preclinical\\u000a studies in NSCLC lines have demonstrated schedule-dependent synergy of edatrexate followed by carboplatin. In a phase I trial,\\u000a we demonstrated the tolerability of this combination, the ability of ice-chip cryotherapy to ameliorate dose-limiting mucositis,\\u000a and promising activity in NSCLC. This phase II

D. R. Gandara; Martin J. Edelman; John J. Crowley; Derick H. M. Lau; Robert B. Livingston

1997-01-01

19

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

PubMed Central

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 = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women. Conclusion Offering group-based counselling in addition to individual counselling resulted in small, but significantly improved dietary habits at five-year follow-up and a tendency of better maintenance, compared to individual counselling alone. Trial registration The Inter99 study was approved by the local Ethics Committee (KA 98 155) and is registered with ClinicalTrials.gov (registration number: NCT00289237). PMID:19025583

Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen; Ovesen, Lars; Lau, Cathrine; Pisinger, Charlotta; Smith, Lisa von Huth; Borch-Johnsen, Knut; J?rgensen, Torben

2008-01-01

20

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

Microsoft Academic Search

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

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

2007-01-01

21

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. PMID:20447935

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

2010-01-01

22

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

PubMed Central

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

2013-01-01

23

Radiation Therapy Oncology Group clinical trials with misonidazole  

SciTech Connect

This paper presents a review of the progressive clinical trials of the hypoxic cell radiosensitizer, misonidazole, in the Radiation Therapy Oncology Group (RTOG). Presentation is made of all the schemas of the recently completed and currently active RTOG Phase II and Phase III studies. Detailed information is provided on the clinical toxicity of the Phase II trials, specifically regarding neurotoxicity. With limitations in drug total dose, a variety of dose schedules have proven to be tolerable, with a moderate incidence of nausea and vomiting and mild peripheral neuropathy or central neuropathy. No other organ toxicity has been seen, specifically no liver, renal or bone marrow toxicities. An additional Phase III malignant glioma trial in the Brain Tumor Study Group is described.

Wasserman, T.H. (Washington Univ., St. Louis, MO); Stetz, J.; Phillips, T.L.

1981-05-15

24

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group  

PubMed Central

Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Trials registration Current Controlled Trials ISRCTN76061874 PMID:23953975

2013-01-01

25

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

PubMed

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

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

2014-04-01

26

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. PMID:23358564

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

2013-01-01

27

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial  

PubMed Central

Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201 PMID:21917187

2011-01-01

28

Psychosocial group intervention to enhance self-management skills of people with dementia and their caregivers: study protocol for a randomized controlled trial  

PubMed Central

Background After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for self-management skills has been proven to be an effective method to improve prognosis of asthma, heart failure and osteoarthritis. However, self-management interventions have not been studied in dementia. Therefore, our aim was to examine, in an objective-oriented group intervention, the efficacy of self-management support program (SMP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers. Methods During the years 2011 to 12, 160 dementia patients and their spouses will be recruited from memory clinics and randomized into two arms: 80 patients for group-based SMP sessions including topics selected by the participants, 80 patients will serve as controls in usual community care. Sessions may include topics on dementia, community services, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks. Main outcome measures will be patients’ HRQoL (15D) and spousal caregivers’ HRQoL (RAND-36), and sense of competence (SCQ). Secondary measures will be caregivers’ psychological well-being (GHQ-12) and coping resources, patients’ depression, cognition and signs of frailty. Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two-year follow-up. Discussion This is a ‘proof-of-concept’ study to explore the efficacy of group support for self-management skills among dementia families. It will also provide data on cost-effectiveness of the intervention. Trial registration ACTRN12611001173987 PMID:22871107

2012-01-01

29

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

SciTech Connect

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

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

2009-03-01

30

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

PubMed Central

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

2014-01-01

31

Experimental studies: randomized clinical trials.  

PubMed

There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial. PMID:10205986

Gjorgov, A N

1998-01-01

32

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

2011-01-01

33

Measuring Group Dynamics: An Exploratory Trial  

ERIC Educational Resources Information Center

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

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

2004-01-01

34

Effect of early intravenous heparin on coronary patency, infarct size, and bleeding complications after alteplase thrombolysis: results of a randomised double blind European Cooperative Study Group trial.  

PubMed Central

OBJECTIVE--To determine whether concomitant treatment with intravenous heparin affects coronary patency and outcome in patients treated with alteplase thrombolysis for acute myocardial infarction. DESIGN--Double blind randomised trial. TREATMENT REGIMENS--Alteplase 100 mg (not weight adjusted) plus aspirin (250 mg intravenously followed by 75-125 mg on alternate days) plus heparin (5000 units intravenously followed by 1000 units hourly without dose adjustment) was compared with alteplase plus aspirin plus placebo for heparin. SETTING--19 cardiac centres in six European countries. SUBJECTS--652 patients aged 21-70 years with clinical and electrocardiographic features of infarcting myocardium in whom thrombolytic therapy could be started within six hours of the onset of major symptoms. MAIN OUTCOME MEASURE--Angiographic coronary patency 48-120 hours after randomisation. RESULTS--Coronary patency (TIMI grades 2 or 3) was 83.4% in the heparin group and 74.7% in the group given placebo for heparin. The relative risk of an occluded vessel in the heparin treated group was 0.66 (95% confidence interval 0.47 to 0.93). Mortality was the same in both groups. There were non-significant trends towards a smaller enzymatic infarct size and a higher incidence of bleeding complications in the group treated with heparin. CONCLUSIONS--Concomitant intravenous heparin improves coronary patency in patients with alteplase. Whether this can be translated into improved clinical benefit needs to be to be tested in a larger trial. PMID:1540431

de Bono, D P; Simoons, M L; Tijssen, J; Arnold, A E; Betriu, A; Burgersdijk, C; Lopez Bescos, L; Mueller, E; Pfisterer, M; Van de Werf, F

1992-01-01

35

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

E-print Network

CLINICAL TRIALS OFFICE The principal charge of this focus group was to identify the key elements of a Clinical Trials Office at the LSUHSC-NO Campus. We propose that the mission of the Clinical Trials Office. The Clinical Trials Office will function as a single point-of-contact for all aspects of clinical trials

36

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. PMID:10360290

Steinert, R F; Hersh, P S

1998-01-01

37

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. PMID:9251545

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

1997-01-01

38

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  

PubMed Central

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 (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088 PMID:19725979

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

2009-01-01

39

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

PubMed Central

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

2013-01-01

40

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

41

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

42

Discordant Associations between SLCO1B1 521T->C and Plasma Levels of Ritonavir-boosted Protease Inhibitors in AIDS Clinical Trials Group Study A5146  

PubMed Central

Objective Among HIV-positive patients prescribed ritonavir-boosted lopinavir, SLCO1B1 521T?C (rs4149056) is associated with increased plasma lopinavir exposure. Protease inhibitors are also substrates for cytochrome P450 (CYP) 3A and ABCB1, which are induced by NR1I2. We characterized relationships between ABCB1, CYP3A4, CYP3A5, NR1I2 and SLCO1B1 polymorphisms and trough protease inhibitor concentrations among AIDS Clinical Trials Group study A5146 participants. Methods At study entry, subjects with virologic failure on protease inhibitor-containing regimens initiated new ritonavir-boosted protease inhibitor regimens. We studied associations between week 2 protease inhibitor plasma trough concentrations and 143 polymorphisms in these genes, including 4 targeted polymorphisms. Results Among 275 subjects with both drug concentrations and genetic data, allelic frequencies of SLCO1B1 521T?C were 15%, 1%, and 8% in whites, blacks, and Hispanics, respectively. Further analyses were limited to 268 white, black, or Hispanic subjects who initiated ritonavir-boosted lopinavir (n=98), fosamprenavir (n=69), or saquinavir (n=99). Of targeted polymorphisms, SLCO1B1 521T?C tended to be associated with higher lopinavir concentrations, with a 1.38-fold increase in the mean per C allele (95% CI 0.97, 1.96; n=98; p=0.07). With fosamprenavir, SLCO1B1 521T?C was associated with lower amprenavir concentrations, with a 35% decrease in the mean per C allele (geometric mean ratio 0.65, 95% CI 0.44, 0.94; n=69; adjusted p=0.02). There was no significant association with saquinavir concentrations, and none of the remaining 139 exploratory polymorphisms were statistically significant after correcting for multiple comparisons. Conclusions With ritonavir-boosted protease inhibitors, a SLCO1B1 polymorphism that predicts higher lopinavir trough concentrations appears to predict lower amprenavir trough concentrations. The mechanism underlying this discordant association is uncertain. PMID:23503447

Zhang, Xinyan; Tierney, Camlin; Albrecht, Mary; Demeter, Lisa M.; Morse, Gene; DiFrancesco, Robin; Dykes, Carrie; Jiang, Hongyu; Haas, David W.

2013-01-01

43

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

PubMed Central

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

2014-01-01

44

Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study. Family Heart Study Group.  

PubMed Central

OBJECTIVE--To measure the change in cardiovascular risk factors achievable in families over one year by a cardiovascular screening and lifestyle intervention in general practice. DESIGN--Randomised controlled trial in 26 general practices in 13 towns in Britain. SUBJECTS--12,472 men aged 40-59 and their partners (7460 men and 5012 women) identified by household. INTERVENTION--Nurse led programme using a family centred approach with follow up according to degree of risk. MAIN OUTCOME MEASURES--After one year the pairs of practices were compared for differences in (a) total coronary (Dundee) risk score and (b) cigarette smoking, weight, blood pressure, and random blood cholesterol and glucose concentrations. RESULTS--In men the overall reduction in coronary risk score was 16% (95% confidence interval 11% to 21%) in the intervention practices at one year. This was partitioned between systolic pressure (7%), smoking (5%), and cholesterol concentration (4%). The reduction for women was similar. For both sexes reported cigarette smoking at one year was lower by about 4%, systolic pressure by 7 mm Hg, diastolic pressure by 3 mm Hg, weight by 1 kg, and cholesterol concentration by 0.1 mmol/l, but there was no shift in glucose concentration. Weight, blood pressure, and cholesterol concentration showed the greatest difference at the top of the distribution. If maintained long term the differences in risk factors achieved would mean only a 12% reduction in risk of coronary events. CONCLUSIONS--As most general practices are not using such an intensive programme the changes in coronary risk factors achieved by the voluntary health promotion package for primary care are likely to be even smaller. The government's screening policy cannot be justified by these results. PMID:8124121

1994-01-01

45

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. PMID:22348608

2012-01-01

46

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

47

Teachable Trials in the Social Studies Classroom  

ERIC Educational Resources Information Center

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

Weiner, Mark S.

2010-01-01

48

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

PubMed

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

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

1994-05-30

49

Impact of the Self-Determined Learning Model of Instruction on Self-Determination: A Randomized-Trial Control Group Study  

PubMed Central

Promoting self-determination has become best practice in special education. There remains, however, a paucity of causal evidence for interventions to promote self-determination. We conducted a group-randomized, modified equivalent control group design study of the efficacy of the Self-Determined Learning Model of Instruction to promote self-determination. Data on self-determination using multiple measures was collected with 312 high school students with cognitive disabilities in both a control and treatment group. We examined the relationship between the SDLMI and self-determination using structural equation modeling. After determining strong measurement invariance for each latent construct, we found significant differences in latent means across measurement occasions and differential effects attributable to the SDLMI. This was true across disability category, though there was variance across disability populations.

Wehmeyer, Michael L.; Shogren, Karrie A.; Palmer, Susan B.; Williams-Diehm, Kendra L.; Little, Todd; Boulton, Aaron

2014-01-01

50

Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation. Ventriculomegaly Trial Group.  

PubMed Central

Treatment of posthaemorrhagic ventricular dilatation by early repeated cerebrospinal fluid taps was compared with conservative management in a randomised controlled trial of 157 infants in 15 centres. Thirty infants died and six moved abroad before follow up. During the first 14 days after randomisation, the early treatment group had five times more taps, and 12 times more cerebrospinal fluid removed. Infection of the cerebrospinal fluid occurred in seven of the early treated and four of the conservatively managed infants. Of survivors, 62% in both groups ultimately had ventricular shunts. Neurodevelopmental assessment of survivors at 12 months was carried out by a single experienced examiner. Of survivors, 103 (85%) had abnormal neuromotor signs and 88 (73%) had disabilities. There was no detectable benefit of early treatment for children who did not have parenchymal lesions at the time they entered the trial. Nearly all those with parenchymal lesions had neuromotor impairment, but early treatment was associated with a significant reduction in other impairments. PMID:2407200

1990-01-01

51

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

52

Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study)  

PubMed Central

Background The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia. Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition. Self-management interventions share the common objectives of educating about the condition, optimising well-being, enhancing control over the situation and enabling people to take more responsibility for managing the condition. Benefits of such an approach can include improved knowledge, self-efficacy, health status, and better performance of self-management behaviours. However, there is only preliminary evidence that people with early-stage dementia can benefit from such interventions. Methods This feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer’s disease, vascular dementia or mixed Alzheimer’s and vascular dementia. This study is a single-site pilot randomised-controlled trial. Forty-two people with early stage dementia, each with a caregiver (family member/friend), will be randomised to either the self-management group intervention or to treatment as usual. The self-management group intervention will involve eight weekly sessions, each lasting 90 minutes, held at a memory clinic in North Wales. All participants will be re-assessed three and six months post-randomisation. This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence. It will assess the feasibility of the intervention, the study design and the recruitment strategies. It will estimate the parameters and confidence intervals for the research questions of interest. The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation. Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability, mood and well-being at three and six months post-randomisation. Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation. The cost-effectiveness of the intervention will also be examined. Discussion This study will provide preliminary information about the feasibility, efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia. Trial registration Current Controlled Trials, ISRCTN02023181. PMID:24606601

2014-01-01

53

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. PMID:20145276

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

54

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

PubMed Central

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

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

2014-01-01

55

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). PMID:18687253

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

56

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

Microsoft Academic Search

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

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

2004-01-01

57

Epidemiology and reporting of randomized trials employing re-randomization of patient groups: a systematic survey.  

PubMed

Trials employing re-randomization of some or all participants provide opportunities for determining optimal dosing and dosing schedules, potential disease modifying effects, direct comparisons between drugs, and salvage therapy for patients failing their assigned treatments. To date, no data exists about their prevalence, epidemiology, or quality. We undertook a systematic review of all trials re-randomizing patients. Using explicit search criteria, we searched 11 electronic databases independently, in duplicate. We additionally searched pharmaceutical company websites for unpublished studies. We extracted data on the epidemiology of trials, year published, characteristics of the purpose of the re-randomization, what groups of patients were re-randomized, and methodological issues, including allocation, concealment, sequence generation, blinding, intention to treat, and appropriate sample size calculations. We found 65 trials. All trials were reported in English. Of these, 21 employed re-randomization to determine optimal dosing, 8 for optimal dose-scheduling, 3 for salvage therapy, 0 for estimating disease modifying effects, 24 as direct comparison trials, 9 as standard efficacy trials--that did not require re-randomization, and 3 as withdrawal of treatment trials. The median sample size of the period prior to re-randomization is 180 [interquartile range (IQR) 83-480] and after re-randomization is 104 [IQR 36 to 246]. Studies lost a median of 8% of eligible patients from period 1 to period 2 [IQR 0 to 17]. Studies were published between 1975 and 2005, with the vast majority (71%) published since 1995. The findings of our review indicate that trials employing re-randomization are relatively rare, have poor reporting of important methodological features, and, in some circumstances, fail to take advantage of the benefits that re-randomization can permit. PMID:17067857

Mills, Edward J; Kelly, Steven; Wu, Ping; Guyatt, Gordon H

2007-05-01

58

Cluster Randomized Trial on the Effect of Mother Support Groups on Retention-in-Care and PMTCT Outcomes in Zimbabwe: Study Design, Challenges, and National Relevance.  

PubMed

: Prevention of mother-to-child transmission (PMTCT) elimination goals are hampered by low rates of retention and antiretroviral treatment adherence. The Eliminating Pediatric AIDS in Zimbabwe (EPAZ) project is assessing whether mother support groups (MSGs) increase rates of retention-in-care of HIV-positive mothers and their exposed infants, increase male participation, and improve other maternal and infant health outcomes. EPAZ is a cluster randomized study involving 30 rural facilities in 2 health districts in Mutare province in eastern Zimbabwe. Facilities were randomly assigned to either the standard-of-care or intervention arms. We established MSGs for HIV-positive mothers at the 15 health facilities in the intervention arm. MSGs met every 2 weeks and were led by an HIV-positive mother who was appointed as MSG coordinator (MSG-C). MSG-Cs contacted nonattending patient-members of support groups by cell phone. If members still do not attend, MSG-Cs inform a health worker who initiates further outreach actions that are standard within the health system. At least 10 HIV-positive mothers are enrolled per facility. Enrollment started in July 2014. The primary outcome measure is retention-in-care of HIV-exposed infants at 12 months of age. Secondary outcome measures are: retention-in-care of HIV-positive mothers at 12 months postpartum, male participation, and other maternal and child health indicators. The study relies on routine health system data supplemented by additional data using tools created for the study. If shown to improve PMTCT retention outcomes, facility-based MSGs have the potential to be scaled up throughout the Zimbabwe National PMTCT program and could be considered in other country programs. PMID:25310121

Foster, Geoff; Kangwende, Abigail; Magezi, Vhumani; Maphosa, Talent; Mashapa, Richard; Mukora-Mutseyekwa, Fadzai; Mushavi, Angela; Rusakaniko, Simba; Shumba, Bridget; Zambezi, Pemberai

2014-11-01

59

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  

PubMed Central

Background The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. Methods/Design The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N = 454: web-based brief alcohol intervention) or control condition (N = 454: no intervention). The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. Discussion This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief alcohol intervention. We expect a reduction of mean weekly alcohol consumption and frequency of binge drinking in the experimental condition compared to the control condition as a direct result of the intervention. If the website is effective, it will be implemented in alcohol prevention initiatives, which will facilitate the implementation of the protocol. Trial registration Netherlands Trial Register NTR2665. PMID:21492412

2011-01-01

60

Why ethnic minority groups are under-represented in clinical trials: a review of the literature.  

PubMed

Randomised controlled trials (RCTs) are considered to be the gold standard in evaluating medical interventions; however, people from ethnic minorities are frequently under-represented in such studies. The present paper addresses a previously neglected debate about the tensions which inform clinical trial participation amongst people from ethnic minorities, in particular, South Asians, the largest ethnic minority group in the UK. In a narrative review of the available literature, based mainly on US studies, the present authors aim to make sense of the issues around under-representation by providing a theoretical reconciliation. In addition, they identify a number of potential barriers to ethnic minority participation in clinical trials. In so doing, the authors recognise that the recent history of eugenic racism, and more general views on clinical trials as a form of experimentation, means that clinical trial participation among people from ethnic minorities becomes more problematic. Lack of participation and the importance of representational sampling are also considered, and the authors argue that health professionals need to be better informed about the issues. The paper concludes by offering a number of strategies for improving ethnic minority accrual rates in clinical trials, together with priorities for future research. PMID:15373816

Hussain-Gambles, Mahvash; Atkin, Karl; Leese, Brenda

2004-09-01

61

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

PubMed Central

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

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

2014-01-01

62

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. PMID:22759880

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

63

Comparative evaluation of clindamycin/gentamicin and cefoxitin/doxycycline for treatment of pelvic inflammatory disease: a multi-center trial. The European Study Group.  

PubMed

The clinical efficacy and safety of clindamycin-gentamicin versus doxycycline-cefoxitin in the treatment of acute pelvic inflammatory disease was evaluated in a comparative, randomized, prospective, multicenter study. Ten investigators enrolled 170 patients. Those judged to be eligible for efficacy were 60/88 (68%) who received the clindamycin-gentamicin regimen and 55/82 (67%) of those treated with cefoxitin-doxycycline. A successful clinical outcome was attained for 52/60 (87%) and 46/55 (84%) for patients treated with clindamycin-gentamicin and cefoxitin-doxycycline, respectively, a difference that was not statistically significant. In the clindamycin-gentamicin series, 8/8 (100%) of patients with positive C. trachomatis culture at baseline were culture negative at the late follow-up 21-35 days after treatment. For those given cefoxitin-doxycycline, 9/11 (82%) who had C. trachomatis at pretreatment showed eradication at follow-up. Neisseria gonorrhoeae was present at baseline in 8/60 (13%) of the clindamycin-gentamicin patients and in 9/55 (16%) of those treated with cefoxitin-doxycycline. Of those who had appropriate follow-up cultures performed, 6 in the clindamycin-gentamicin group and 8 in the cefoxitin-doxycycline series, all showed eradication of the organism. It is concluded that clindamycin-gentamicin and cefoxitin-doxycycline have similar clinical cure rates for acute pelvic inflammatory disease, and based on this limited experience, it is suggested that the clindamycin-gentamicin combination will satisfactorily eradicate Chlamydia trachomatis and Neisseria gonorrhoeae when either or both of these pathogens are present. PMID:1316041

1992-02-01

64

A Randomized Controlled Trial Comparing Laparoscopic Surgery with Open Surgery in Palliative Resection of Primary Tumor in Incurable Stage IV Colorectal Cancer: Japan Clinical Oncology Group Study JCOG 1107 (ENCORE Trial).  

PubMed

A randomized controlled trial was started in Japan to evaluate the non-inferiority of overall survival of laparoscopic surgery to open surgery for palliative resection of primary tumor in incurable Stage IV colorectal cancer. Symptomatic, Stage IV colorectal cancer patients with non-curable metastasis are pre-operatively randomized to either open or laparoscopic colorectal resection. Surgeons in 56 specialized institutions will recruit 450 patients. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, the proportion of conversion from laparoscopic surgery to open surgery, the proportion of patients who fulfill the criteria of starting chemotherapy by 6 weeks after operation, intraoperative and post-operative complications, adverse events during chemotherapy and serious adverse events. PMID:25156683

Inomata, Masafumi; Akagi, Tomonori; Katayama, Hiroshi; Kimura, Aya; Mizusawa, Junki; Etoh, Tsuyoshi; Yamaguchi, Shigeki; Ito, Masaaki; Kinugasa, Yusuke; Saida, Yoshihisa; Hasegawa, Hirotoshi; Ota, Mitsuyoshi; Kanemitsu, Yukihide; Shimada, Yasuhiro; Kitano, Seigo

2014-11-01

65

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

PubMed Central

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

2013-01-01

66

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

SciTech Connect

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

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

2013-10-01

67

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

SciTech Connect

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

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

2012-10-01

68

Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group.  

PubMed

From May 1991 to January 1996, 54 patients with advanced malignant melanoma were enrolled into a phase II trial testing the new nitrosourea cystemustine, administrated intravenously as a 15 min infusion every 2 weeks at 90 mg/m2 for three cycles followed by 60 mg/m2. Out of the 54 enrolled patients, 10 were Ineligible, leaving 44 fully evaluable patients (World Health Organization criteria). Twenty one patients had already received first-line palliative chemotherapy and/or immunotherapy. The median age was 62 years (range 30-74 years) and the median performance status was 0 (grade 0, 19 patients; grade 1, 21 patients; grade 2, 4 patients). Five patients with partial responses (lasting 16-29 weeks, mean duration 24 weeks), nine with stable disease and 28 showing progression were observed, giving an overall response rate of 11% (confidence interval 3.8-24.6%). Toxicity was mild and consisted mainly of neutropenia (39% grade III-IV), thrombocytopenia (42% grade III-IV); febrile aplasia was rare. Cystemustine administered to this schedule appears to have limited clinical activity and acceptable toxicity in untreated or second-line advanced malignant melanoma. PMID:10661773

Cure, H; Souteyrand, P; Ouabdesselam, R; Roche, H; Ravaud, A; D'incan, M; Viens, P; Fargeot, P; Lentz, M A; Fumoleau, P; Hanauske, A; Chollet, P

1999-12-01

69

Radiotherapy quality assurance review in a multi-center randomized trial of limited-disease small cell lung cancer: the Japan Clinical Oncology Group (JCOG) trial 0202  

Microsoft Academic Search

BACKGROUND: The purpose of this study was to analyze the radiotherapy (RT) quality assurance (QA) assessment in Japan Clinical Oncology Group (JCOG) 0202, which was the first trial that required on-going RT QA review in the JCOG. METHODS: JCOG 0202 was a multi-center phase III trial comparing two types of consolidation chemotherapy after concurrent chemoradiotherapy for limited-disease small cell lung

Naoko Sanuki-Fujimoto; Satoshi Ishikura; Kazushige Hayakawa; Kaoru Kubota; Yutaka Nishiwaki; Tomohide Tamura

2009-01-01

70

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. PMID:19917861

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

71

Children's Cancer Group trials in childhood acute lymphoblastic leukemia: 1983–1995  

Microsoft Academic Search

Since 1968, the Children's Cancer Group (CCG) has treated more than 16 000 children with acute lymphoblastic leukemia (ALL). Herein, we report improvements obtained in CCG trials during two successive series of studies (1983–1988 and 1989–1995). Overall, 10-year EFS was 62% ± 10% for the 1983–1988 series and 72% ± 1% for the 1988–1995 series (P < 0.0001). Five-year cumulative

PS Gaynon; ME Trigg; NA Heerema; MG Sensel; HN Sather; GD Hammond; WA Bleyer

2000-01-01

72

Children's Cancer Group trials in childhood acute lymphoblastic leukemia: 1983- 1995  

Microsoft Academic Search

Since 1968, the Children's Cancer Group (CCG) has treated more than 16 000 children with acute lymphoblastic leukemia (ALL). Herein, we report improvements obtained in CCG trials during two successive series of studies (1983-1988 and 1989- 1995). Overall, 10-year EFS was 62% ? 10% for the 1983-1988 series and 72% ? 1% for the 1988-1995 series (P , 0.0001). Five-year

PS Gaynon; ME Trigg; NA Heerema; MG Sensel; HN Sather; GD Hammond; WA Bleyer

2000-01-01

73

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  

Microsoft Academic Search

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

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

2003-01-01

74

A randomised comparison of treosulfan and carboplatin in patients with ovarian cancer: A study by the Scottish Gynaecological Cancer Trials Group (SGCTG)  

Microsoft Academic Search

The management of older and unfit women with advanced ovarian cancer requires post-operative chemotherapy but many of these patients are not suitable for high-dose cisplatin-based regimes. Carboplatin has been an easier alternative and can be given in the ambulatory setting. Historical data suggests that oral alkylating agents to be just effective with similar efficacy. In this study we have compared

N. S. Reed; C. J. Poole; R. Coleman; D. Parkin; J. D. Graham; S. B. Kaye; J. Ostrowski; I. Duncan; J. Paul; A. Hay

2006-01-01

75

Chemotherapy versus hormonal treatment in platinum- and paclitaxel-refractory ovarian cancer: a randomised trial of the German Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group Ovarian Cancer  

Microsoft Academic Search

Background: The majority of patients with ovarian cancer are not cured by first-line treatment. Until now, no study could demonstrate any substantial benefit when exposing ovarian cancer patients to second-line chemotherapy. However, most treatment regimens induce toxicity, thus negatively influ- encing the quality of rather limited life spans. Here we evaluate whether a second-line chemotherapy can offer any benefit compared

W. Meier; H. J. Lück; G. Emons; V. Moebus; W. Schroeder; S. Costa; T. Bauknecht; S. Olbricht; C. Jackisch; B. Richter; U. Wagner; Universitaetsfrauenklinik Marburg; Universitaetsfrauenklinik Ulm; Zentralkrankenhaus Bremen; Universitaetsfrauenklinik Aachen; Universitaetsfrauenklinik Bonn; Universitaetsfrauenklinik Freiburg; Universitaetsfrauenklinik Münster; Universitaetsfrauenklinik Dresden

76

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) PMID:22677437

Kramer, Jeannet; Gerrits, Rob; Cuijpers, Pim

2012-01-01

77

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. PMID:22995043

2012-01-01

78

Why study group therapy?  

PubMed

Group therapy training is highly valuable for the overall professional practice of psychotherapy. Learning to be a group therapist means learning about shame, resistance, fears of engulfment and abandonment, maintaining a self in relation to others, promoting empathic connection, strong affects in the moment, multiple experiences of the same interaction or event, and group dynamics. These concepts are highly relevant to all clinical work and other aspects of professional life. Training in group therapy should place greater emphasis on its broader applicability. PMID:18399741

Counselman, Eleanor F

2008-04-01

79

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. PMID:22970105

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

80

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. PMID:21536837

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

2011-01-01

81

Changes in human immunodeficiency virus type 1 virus load during mobilization and harvesting of hemopoietic progenitor cells. Adult AIDS Clinical Trials Group 285 Study Team.  

PubMed

Genetic modification of hemopoietic progenitor cells ex vivo, followed by the infusion of the genetically modified cells into the human immunodeficiency virus-1 (HIV-1) infected donor, has been proposed as a treatment for HIV-1 infection. The current study was undertaken to evaluate the effect of hemopoietic stem cell mobilization and harvesting on HIV-1 replication in persons with HIV-1 infection. Eighteen HIV-1-infected persons received recombinant granulocyte colony-stimulating factor (G-CSF; Filgrastim) 10 microg/kg per day, for 7 days. On days 4 and 5, peripheral blood mononuclear cells were harvested by leukapheresis. The CD4+ lymphocyte count at entry was >500/microL for 6 subjects, 200 to 500/microL for 6 subjects, and <200/microL for 6 subjects. For 9 of 18 subjects, plasma HIV-1 RNA levels increased 4- to 100-fold (>0.6 log(10)) above baseline between days 4 and 7 and returned to baseline by day 27. Significant increases of plasma HIV-1 RNA levels occurred in 5 subjects despite 3-drug antiretroviral therapy. Changes in CD4+ and CD34+ cells during mobilization and harvesting were similar in all subjects whether they had or did not have increased plasma HIV-1 RNA levels. Thus, mobilization and harvesting of bone marrow progenitor cells from persons infected with HIV-1 induced a transient increase in viral replication in some patients but was not associated with adverse effects. (Blood. 2000;95: 48-55) PMID:10607683

Campbell, T B; Sevin, A; Coombs, R W; Peterson, G C; Rosandich, M; Kuritzkes, D R; Mladenovic, J; Landay, A; Wong, R; Ambruso, D; Miles, S; Pomerantz, R J; Schooley, R T

2000-01-01

82

Glossary -ClinicalTrials.gov Home Search Study Topics Glossary  

E-print Network

of drugs. Onset may be sudden or develop over time (See Side Effects). ADVOCACY AND SUPPORT GROUPS in clinical trials. ADVERSE REACTION: (Adverse Event.) An unwanted effect caused by the administration is a research study to answer specific questions about vaccines or new therapies or new ways of using known

Quirk, Gregory J.

83

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)  

NASA Astrophysics Data System (ADS)

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 16 participating institutions and examined the absolute dose at the centre of a simulated spherical tumour of 3.0 cm diameter in the lung using the radiation treatment planning systems in each institution. A lung phantom for stereotactic body radiotherapy (SBRT) was developed and used for the treatment planning and film dosimetry. In the JCOG radiotherapy study group, the no model-based calculation algorithm or the model-based calculation algorithm with a dose kernel unscaled for heterogeneities were selected for use in the initial SBRT trials started in 2004, and the model-based calculation algorithm with a dose kernel scaled for heterogeneities was selected for the coming trial. The findings of this study suggest that the clinical results of lung SBRT trials should be carefully evaluated in comparison with the actual dose given to patients.

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

2006-11-01

84

Results From the Scandinavian Prostate Cancer Group Trial Number 4: A Randomized Controlled Trial of Radical Prostatectomy Versus Watchful Waiting  

PubMed Central

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

2012-01-01

85

Rationale, design and organization of the Second Chinese Cardiac Study (CCS-2): a randomized trial of clopidogrel plus aspirin, and of metoprolol, among patients with suspected acute myocardial infarction. Second Chinese Cardiac Study (CCS-2) Collaborative Group.  

PubMed

Assessing combined anti-platelet therapy in suspected acute myocardial infarction Aspirin has been shown to be effective in the emergency treatment of acute myocardial infarction. It irreversibly inhibits platelet cyclo-oxygenase and thereby prevents the formation of the platelet aggregating agent thromboxane A2. Clopidogrel is an anti-platelet agent that acts by a different mechanism, inhibiting adenosine diphosphate-induced platelet aggregation. Simultaneous inhibition of both of these pathways might produce significantly greater anti-platelet effects than inhibition of either alone. The Second Chinese Cardiac Study (CCS-2) will reliably determine whether adding oral clopidogrel to aspirin for up to 4 weeks in hospital after suspected acute myocardial infarction can produce a greater reduction in the risk of major vascular events than can be achieved by giving aspirin alone. In order to be able to detect a further reduction of 10-15%, some 20,000-40,000 patients in over 1000 Chinese hospitals will be randomized. Assessing early beta-blocker therapy in suspected acute myocardial infarction Although over 27,000 patients have been studied previously in randomized trials of short-term beta-blocker therapy in acute myocardial infarction, the reduction in early mortality (513 (3.7%) for beta-blocker therapy deaths versus 586 (4.3%) for control deaths) was only just conventionally significant (P = 0.02) and, overall, the absolute benefits were small in the relatively low-risk patients studied. Although there might be worthwhile benefit in higher risk patients, there is currently little routine use of beta-blocker therapy in acute myocardial infarction. Hence, patients in CCS-2 will also be randomly allocated to receive metoprolol (intravenous then oral) or matching placebo for up to 4 weeks in hospital in a 2 x 2 factorial design. Such a design allows all patients to contribute fully to assessment of the separate effects of the anti-platelet regimen and the beta-blocker (without any material effect on study cost or sample size requirements) whilst also providing information about their combined effects. A streamlined trial in a wide range of patients In order to randomize 20,000-40,000 patients, the design of CCS-2 has been streamlined: data collection and other extra work for collaborators is minimal, allowing busy hospitals to take part easily. All patients presenting within 24 h of the onset of suspected acute myocardial infarction are eligible for the study provided they have a definite ECG abnormality and are not persistently hypotensive, and provided the doctor responsible considers there to be no clear indication for or contraindication to either of the trial treatments. Apart from administration of the trial treatments, all other aspects of individual patient management are entirely at the discretion of the doctor responsible. By including many different types of patient from many different types of hospital, with wide variation in ancillary management, the CCS-2 results will be of direct clinical relevance to the heterogeneous realities of future clinical practice. The trial began in July 1999 and is expected to be completed by the year 2003. PMID:11189013

2000-12-01

86

After AIDS clinical trial 076: the changing pattern of zidovudine use during pregnancy, and the subsequent reduction in the vertical transmission of human immunodeficiency virus in a cohort of infected women and their infants. Women and Infants Transmission Study Group.  

PubMed

To determine the impact of the AIDS Clinical Trials Group (ACTG) Protocol 076 results on the subsequent use of zidovudine during pregnancy and the transmission rate of human immunodeficiency virus (HIV) in a cohort of mother-infant pairs (Women and Infants Transmission Study), a retrospective analysis was done. Transmission rates were calculated by simple proportion for infants with at least 6 months of follow-up, stratified by date of birth (n = 453 born on or before 1 March 1994; n = 103 born after 1 March 1994). Transmission rates decreased from 19% to 8% (P = .005, Fisher's exact test). Zidovudine use increased during pregnancy (22% vs. 89%) and in newborns (1% vs. 79%). Both cohorts were similar with respect to maternal immunosuppression, mode of delivery, and demographics. In summary, in a perinatal HIV observational study, the release of results of ACTG Protocol 076 was associated with an increase in zidovudine use during pregnancy and a concomitant decline in HIV transmission from mothers to infants. PMID:8940210

Cooper, E R; Nugent, R P; Diaz, C; Pitt, J; Hanson, C; Kalish, L A; Mendez, H; Zorrilla, C; Hershow, R; Moye, J; Smeriglio, V; Fowler, M G

1996-12-01

87

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial  

PubMed Central

Background Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. Methods The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting. The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care. Trial registration ClinicalTrials.gov NCT01318486 PMID:23725299

2013-01-01

88

Multicentre controlled trial of parenting groups for childhood antisocial behaviour in clinical practice  

PubMed Central

Objective To see whether a behaviourally based group parenting programme, delivered in regular clinical practice, is an effective treatment for antisocial behaviour in children. Design Controlled trial with permuted block design with allocation by date of referral. Setting Four local child and adolescent mental health services. Participants 141 children aged 3-8 years referred with antisocial behaviour and allocated to parenting groups (90) or waiting list control (51). Intervention Webster-Stratton basic videotape programme administered to parents of six to eight children over 13-16 weeks. This programme emphasises engagement with parental emotions, rehearsal of behavioural strategies, and parental understanding of its scientific rationale. Main outcome measures Semistructured parent interview and questionnaires about antisocial behaviour in children administered 5-7 months after entering trial; direct observation of parent-child interaction. Results Referred children were highly antisocial (above the 97th centile on interview measure). Children in the intervention group showed a large reduction in antisocial behaviour; those in the waiting list group did not change (effect size between groups 1.06 SD (95% confidence interval 0.71 to 1.41), P<0.001). Parents in the intervention group increased the proportion of praise to ineffective commands they gave their children threefold, while control parents reduced it by a third (effect size between groups 0.76 (0.16 to 1.36), P=0.018). If the 31 children lost to follow up were included in an intention to treat analysis the effect size on antisocial behaviour was reduced by 16%. Conclusions Parenting groups effectively reduce serious antisocial behaviour in children in real life conditions. Follow up is needed to see if the children's poor prognosis is improved and criminality prevented. What is already known on this topicChildren who persistently display a high level of antisocial behaviour are at high risk of social rejection, juvenile delinquency, and long term unemployment; the cost to society is highWhile some behaviourally based parenting programmes have been shown to be effective in university centre trials with volunteers or specially selected cases, most trials of psychological treatments for children in real life settings have shown no effectWhat this study addsAn evidence based intervention is available for use in regular clinical practice that effectively reduces antisocial behaviour in referred childrenThe intervention works well with children at risk of criminality from a combination of highly antisocial behaviour, multiple psychopathology, and social deprivation PMID:11473908

Scott, Stephen; Spender, Quentin; Doolan, Moira; Jacobs, Brian; Aspland, Helen

2001-01-01

89

ALTS Trial Design and Study Centers  

Cancer.gov

Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the ALTS trial was to use the information we have gained about the role of HPV to design better treatment and prevention strategies to reduce the burden of cervical cancer and its precursors.

90

The treatment of mild hypertension study. A randomized, placebo-controlled trial of a nutritional-hygienic regimen along with various drug monotherapies. The Treatment of Mild Hypertension Research Group.  

PubMed

There is no consensus for the optimal treatment program for individuals with mild hypertension, including whether treatment should emphasize life-style changes alone, such as weight loss, reduction of sodium and alcohol intake, and increased physical activity, or whether it should also include a pharmacologic component. The dilemma is accentuated by the availability of many drugs from different classes to lower blood pressure. To study the relative efficacy and safety of a combination of pharmacologic and nutritional-hygienic intervention compared with nutritional-hygienic intervention alone, a double-blind, controlled clinical trial was initiated. Nine hundred two men and women with mild hypertension (average blood pressure, 140/91 mm Hg) were randomized to receive nutritional-hygienic intervention plus one of six treatments: (1) placebo; (2) diuretic (chlorthalidone); (3) beta-blocker (acebutolol); (4) alpha 1-antagonist (doxazosin mesylate); (5) calcium antagonist (amlodipine maleate); or (6) angiotensin-converting enzyme inhibitor (enalapril maleate). After 12 months, weight loss averaged 4.5 kg, urinary sodium excretion was reduced by 23%, and reported leisure-time physical activity was nearly doubled. Systolic and diastolic blood pressure in the group given nutritional-hygienic intervention alone (placebo) were reduced by 10.6 and 8.1 mm Hg, respectively. For participants in the five groups receiving antihypertensive medication in addition to nutritional-hygienic treatment, blood pressure reductions were significantly greater than those achieved with nutritional-hygienic treatment alone (range, 16 to 22 mm Hg for systolic and 12 to 14 mm Hg for diastolic blood pressure). Although differences among treatment groups in certain dimensions of quality of life, self-reported side effects, plasma lipid levels, and biochemical measures were observed, no consistent pattern in the differences was noted. Nutritional-hygienic therapy is an effective first-step treatment for persons with mild hypertension, and significant additional blood pressure lowering with minimal short-term side effects can be achieved by adding one of five different classes of antihypertensive agents. PMID:2064494

1991-07-01

91

Randomization Inference in a GroupRandomized Trial of Treatments for Depression: Covariate  

E-print Network

Randomization Inference in a Group­Randomized Trial of Treatments for Depression: Covariate a "depression care manager" to treat its depressed patients. Randomization inference, properly performed individual patients: depression outcomes, baseline covariates, compliance with treatment. The methods

Rosenbaum, Paul R.

92

Placebo group improvement in trials of pharmacotherapies for alcohol use disorders: A multivariate meta-analysis examining change over time  

PubMed Central

Objective Placebo group improvement in pharmacotherapy trials has been increasing over time across several pharmacological treatment areas. However, it is unknown to what degree increasing improvement has occurred in pharmacotherapy trials for alcohol use disorders or what factors may account for placebo group improvement. This meta-analysis of 47 alcohol pharmacotherapy trials evaluated (1) the magnitude of placebo group improvement, (2) the extent to which placebo group improvement has been increasing over time, and (3) several potential moderators that might account for variation in placebo group improvement. Method Random-effects univariate and multivariate analyses were conducted that examined the magnitude of placebo group improvement in the 47 studies and several potential moderators of improvement: (a) publication year, (b) country in which the study was conducted, (c) outcome data source/type, (d) number of placebo administrations, (e) overall severity of study participants, and (f) additional psychosocial treatment. Results Substantial placebo group improvement was found overall and improvement was larger in more recent studies. Greater improvement was found on moderately subjective outcomes, with more frequent administrations of the placebo, and in studies with greater participant severity of illness. However, even after controlling for these moderators, placebo group improvement remained significant, as did placebo group improvement over time. Conclusion Similar to previous pharmacotherapy placebo research, substantial pre- to post-test placebo group improvement has occurred in alcohol pharmacotherapy trials, an effect that has been increasing over time. However, several plausible moderator variables were not able to explain why placebo group improvement has been increasing over time. PMID:23857312

Del Re, AC; Maisel, Natalya; Blodgett, Janet; Wilbourne, Paula; Finney, John

2014-01-01

93

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

PubMed

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

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

2012-10-01

94

Radiotherapy Protocol Deviations and Clinical Outcomes: A Meta-analysis of Cooperative Group Clinical Trials  

PubMed Central

Background Noncompliance with radiotherapy (RT) protocol guidelines has been linked to inferior clinical outcomes. We performed a meta-analysis of cooperative group trials to examine the association between RT quality assurance (QA) deviations and disease control and overall survival (OS). Methods We searched MEDLINE and the Cochrane Central Register of Controlled Trials for multi-institutional trials that reported clinical outcomes in relation to RT QA results. Hazard ratios (HRs) describing the association between RT protocol noncompliance and patient outcomes were extracted directly from the original studies or calculated from survival curves. Inverse variance meta-analyses were performed to assess the association between RT QA deviations and OS. A second meta-analysis tested the association between RT QA deviations and secondary outcomes, including local or locoregional control, event-free survival, and relapse. Random-effects models were used in cases of statistically significant (P < .10) effect heterogeneity. The Egger test was used to detect publication bias. All statistical tests were two-sided. Results Eight studies (four pediatric, four adult) met all inclusion criteria and were incorporated into this analysis. The frequency of RT QA deviations ranged from 8% to 71% (median = 32%). In a random-effects model, RT deviations were associated with a statistically significant decrease in OS (HR of death = 1.74, 95% confidence interval [CI] = 1.28 to 2.35; P < .001). A similar effect was seen for secondary outcomes (HR of treatment failure = 1.79, 95% CI = 1.15 to 2.78; P = .009). No evidence of publication bias was detected. Conclusion In clinical trials, RT protocol deviations are associated with increased risks of treatment failure and overall mortality. PMID:23468460

2013-01-01

95

Compliance with Therapeutic Guidelines in Radiation Therapy Oncology Group Prospective Gastrointestinal Clinical Trials  

PubMed Central

Background This report analyzes the adherence to radiation therapy protocol guidelines in contemporary Radiation Therapy Oncology Group (RTOG) gastrointestinal trials. We aim to provide insight into current standards and compliance of radiation therapy field design and administration. Methods From 1994 to 2006, the Gastrointestinal Cancer Committee of the RTOG initiated and completed 15 phase I-III clinical trials utilizing radiation therapy in the multimodality treatment of gastrointestinal cancers. In each protocol, details for planning and executing radiation therapy were outlined and each protocol contained scoring criteria for these components of radiation therapy, characterized according to per-protocol, variation acceptable and deviation unacceptable. Review of treatment planning and implementation was performed in all studies following therapy completion. Results Radiation therapy planning and implementation was reviewed in 2,309 of 2,312 (99.9%) patients. The mean rate of compliance over all for the 15 protocols was 65% (total of the 2,309 analyzed patients). The mean variation acceptable rate was 21% whereas the mean deviation unacceptable rate was 5%. The mean “other” rate (no RT given or incomplete RT due to death, progression or refusal) was 8%. Two of the 15 trials (13%) had deviation unacceptable rates > 10%. In four studies incorporating pre-treatment review of radiation therapy planning and treatment, compliance with protocol therapy was enhanced. Conclusion The fidelity of radiation planning and execution detailed in protocol to actual therapy is heterogeneous, with a mean per-protocol rate of 65%. As clinical trials evolve, available technology should permit efficient pre-treatment review processes, thus facilitating compliance to protocol therapy. These analyses should also permit prospective analysis of outcome measures by compliance to therapy. PMID:23084596

Willett, Christopher G.; Moughan, Jennifer; O'Meara, Elizabeth; Galvin, James M.; Crane, Christopher H.; Winter, Kathryn; Manfredi, Denise; Rich, Tyvin A.; Rabinovitch, Rachel; Lustig, Robert; Machtay, Mitchell; Curran, Walter J

2014-01-01

96

Randomized phase II/III trial of post-operative chemoradiotherapy comparing 3-weekly cisplatin with weekly cisplatin in high-risk patients with squamous cell carcinoma of head and neck: Japan Clinical Oncology Group Study (JCOG1008).  

PubMed

A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m(2)) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m(2)) for post-operative high-risk patients with locally advanced squamous cell carcinoma of head and neck. This study began in October 2012, and a total of 260 patients will be accrued from 18 institutions within 5 years. The primary endpoint of the Phase II part is proportion of treatment completion and that of the Phase III part is overall survival. The secondary endpoints are relapse-free survival, local relapse-free survival, nutrition-support-free survival, non-hospitalized treatment period during permissible treatment period and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009125 [http://www.umin.ac.jp/ctr/]. PMID:24842866

Kunieda, Futoshi; Kiyota, Naomi; Tahara, Makoto; Kodaira, Takeshi; Hayashi, Ryuichi; Ishikura, Satoshi; Mizusawa, Junki; Nakamura, Kenichi; Fukuda, Haruhiko; Fujii, Masato

2014-08-01

97

A powerful and robust test statistic for randomization inference in group-randomized trials with matched pairs of groups.  

PubMed

For group-randomized trials, randomization inference based on rank statistics provides robust, exact inference against nonnormal distributions. However, in a matched-pair design, the currently available rank-based statistics lose significant power compared to normal linear mixed model (LMM) test statistics when the LMM is true. In this article, we investigate and develop an optimal test statistic over all statistics in the form of the weighted sum of signed Mann-Whitney-Wilcoxon statistics under certain assumptions. This test is almost as powerful as the LMM even when the LMM is true, but it is much more powerful for heavy tailed distributions. A simulation study is conducted to examine the power. PMID:21732926

Zhang, Kai; Traskin, Mikhail; Small, Dylan S

2012-03-01

98

Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.  

PubMed

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. PMID:23648336

Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

2014-12-01

99

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus  

PubMed Central

Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. Discussion The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505). Trial registration Current controlled trials ISRCTN89333241. PMID:23915015

2013-01-01

100

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

101

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial  

PubMed Central

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

Plenty, Stephanie; Bejerot, Susanne

2014-01-01

102

The role of internal pilot studies in increasing the efficiency of clinical trials  

Microsoft Academic Search

SUMMARY Investigators often design clinical trials without knowing precisely the values of such necessary parameters as the variances or the event rates in the control group. In order to determine reasonable values for such parameters, they may design a small pilot study external to the main trial. In this paper we propose designs, which we term internal pilot studies, that

JANET WITTES; ERICA BRITTAIN

1990-01-01

103

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

ERIC Educational Resources Information Center

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

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-01-01

104

Randomized Controlled Trial Comparing Gastrectomy Plus Chemotherapy with Chemotherapy Alone in Advanced Gastric Cancer with A Single Non-curable Factor: Japan Clinical Oncology Group Study JCOG 0705 and Korea Gastric Cancer Association Study KGCA01  

Microsoft Academic Search

A randomized controlled trial has started in both Japan and Korea to evaluate the role of gas- trectomy in the management of incurable advanced gastric cancer (AGC). Patients with AGC diagnosed as having a single non-curable factor are randomized to gastrectomy plus che- motherapy or chemotherapy alone. Surgeons at 33 specialized centers in Japan and at 15 high-volume hospitals in

Kazumasa Fujitani; Han-Kwang Yang; Yukinori Kurokawa; Do Joong Park; Toshimasa Tsujinaka

105

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

PubMed Central

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

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

2011-01-01

106

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

107

Analysis Plan: Study to Measure the Cost of CHAMPUS-Eligible Participants in Southwest Oncology Group NCI Cooperative Program Cancer Clinical Trials 1988-1996: Technical Report No. 1.  

National Technical Information Service (NTIS)

The National Cancer Institute's Division of Cancer Treatment, Diagnosis, and Centers (DCTDC) has initiated effort to expand clinical trial participation by proposing coverage agreement of NCI clinical trial participants with various third party payers. An...

S. A. Optenbeerg, S. L. Schneider, A. Potosky, M. McCabe

1997-01-01

108

Development of Grid Frameworks for Clinical Trials and Epidemiological Studies  

E-print Network

Development of Grid Frameworks for Clinical Trials and Epidemiological Studies Richard SINNOTT. E-Health initiatives such as electronic clinical trials and epidemiological studies require access to be overcome, however the clinical trials domain places special demands on security and data which hitherto

Glasgow, University of

109

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

E-print Network

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

Davis, Kristina

2004-09-30

110

What is a Clinical Trial? Clinical trials are research studies conducted with patients who participate on a  

E-print Network

What is a Clinical Trial? Clinical trials are research studies conducted with patients who cancer treatments. If you enroll in a clinical trial, you can expect to receive at least the standardYaleCancerCenterisconductedaccordingtostrictscientificandethical principles. Every clinical trial has a protocol, or action plan for conducting the trial. The plan describes

111

Violations of the independent increment assumption when using generalized estimating equation in longitudinal group sequential trials.  

PubMed

In phase 3 clinical trials, ethical and financial concerns motivate sequential analyses in which the data are analyzed prior to completion of the entire planned study. Existing group sequential software accounts for the effects of these interim analyses on the sampling density by assuming that the contribution of subsequent increments is independent of the contribution from previous data. This independent increment assumption is satisfied in many common circumstances, including when using the efficient estimator. However, certain circumstances may dictate using an inefficient estimator, and the independent increment assumption may then be violated. Consequences of assuming independent increments in a setting where the assumption does not hold have not been previously explored. One important setting in which independent increments may not hold is the setting of longitudinal clinical trials. This paper considers dependent increments that arise because of heteroscedastic and correlated data in the context of longitudinal clinical trials that use a generalized estimating equation (GEE) approach. Both heteroscedasticity over time and correlation of observations within subjects may lead to departures from the independent increment assumption when using GEE. We characterize situations leading to greater departures in this paper. Despite violations of the independent increment assumption, simulation results suggest that operating characteristics of sequential designs are largely maintained for typically observed patterns of accrual, correlation, and heteroscedasticity even when using analyses that use standard software that depends on an independent increment structure. More extreme scenarios may require greater care to avoid departures from the nominal type I error rate and power. Copyright © 2014 John Wiley & Sons, Ltd. PMID:25224560

Shoben, Abigail B; Emerson, Scott S

2014-12-20

112

Changes in Fat Mitochondrial DNA and Function in Subjects Randomized to Abacavir-Lamivudine or Tenofovir DF-Emtricitabine With Atazanavir-Ritonavir or Efavirenz: AIDS Clinical Trials Group Study A5224s, Substudy of A5202  

PubMed Central

Background.?The effect of nonthymidine nucleoside reverse-transcriptase inhibitors (NRTIs) on fat mitochondrial DNA (mtDNA) content and function is unclear. Methods.?A5202 randomized antiretroviral therapy–naive human immunodeficiency virus–infected subjects to abacavir-lamivudine (ABC/3TC) versus tenofovir DF–emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-ritonavir (ATV/r). A5224s, substudy of A5202, enrolled 269 subjects with fat measurements by dual-energy x-ray absorptiometry and computed tomography. A subset of subjects underwent fat biopsies at baseline and week 96 for mtDNA content (real-time polymerase chain reaction) and oxidative phosphorylation nicotinamide adenine dinucleotide (reduced) dehydrogenase (complex I) and cytochrome c oxidase (complex IV) activity levels (immunoassays). Intent-to-treat analyses were performed using analysis of variance and paired t tests. Results.?Fifty-six subjects (87% male; median age, 39 years) were included; their median body mass index, CD4 cell count, and fat mtDNA level were 26 kg/m2, 227 cells/?L, and 1197 copies/cell, respectively. Fat mtDNA content decreased within the ABC/3TC and TDF/FTC groups (combining EFV and ATV/r arms; median change, ?341 [interquartile range, ?848 to 190; P = .03] and ?400 [?661 to ?221; P < .001] copies/cell, respectively), but these changes did not differ significantly between the 2 groups (P = .57). Complex I and IV activity decreased significantly in the TDF/FTC group (median change, ?12.45 [interquartile range, ?24.70 to 2.90; P = .003] and ?8.25 [?13.90 to ?1.30; P < .001], optical density × 103/µg, respectively) but not the ABC/3TC group. Differences between the ABC/3TC and TDF/FTC groups were significant for complex I (P = .03). Conclusions.?ABC/3TC and TDF/FTC significantly and similarly decreased fat mtDNA content, but only TDF/FTC decreased complex I and complex IV activity levels. Clinical Trials Registration.?NCT00118898. PMID:23204164

McComsey, Grace A.; Daar, Eric S.; O'Riordan, MaryAnn; Collier, Ann C.; Kosmiski, Lisa; Santana, Jorge L.; Fichtenbaum, Carl J.; Fink, Heidi; Sax, Paul E.; Libutti, Daniel E.; Gerschenson, Mariana

2013-01-01

113

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. PMID:21730080

2011-01-01

114

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

115

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

Cancer.gov

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

116

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

117

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

SciTech Connect

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

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

2011-11-01

118

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

Microsoft Academic Search

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

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

2008-01-01

119

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

PubMed Central

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

2014-01-01

120

Serum folate levels after UVA exposure: a two-group parallel randomised controlled trial  

PubMed Central

Background Photodegradation of certain vitamins such as riboflavins, carotinoids, tocopherol, and folate has been well-documented. Previous observations suggest that ultraviolet (UV) radiation may cause folate deficiency. This is of great importance since folate deficiency is also known to be linked with the development of neural tube defects. To investigate the influence of UVA radiation on serum folate levels in vivo, we conducted a two-group randomised controlled trial on healthy subjects. Material and methods Twenty-four healthy volunteers with skin type II were enrolled into the study. Eight volunteers of the study population were randomly assigned to the control group. UVA irradiation was administered with an air-conditioned sunbed. Blood samples were taken from all volunteers at baseline (T1), 30 min after the first UVA exposure (T2), and at the end of the study 24 h after the sixth UV exposure (T3). The volunteers had two UVA exposures weekly within three weeks (cumulative UVA dose: 96 J/cm2). Volunteers of the control group had no UVA exposures. Serum folate was analysed with an automated immunoassay system. Results At all times of blood collection the differences between serum folate levels were insignificant (P > 0.05), except of the non-exposed controls at T2 (P < 0.05). We did not observed significant differences of folate levels between UVA exposed and non-exposed volunteers (P > 0.05). Conclusions Our data suggest that both single and serial UVA exposures do not significantly influence serum folate levels of healthy subjects. Therefore, neural tube defects claimed to occur after periconceptual UVA exposure are probably not due to UVA induced folate deficiency. PMID:11737876

Gambichler, Thilo; Bader, Armin; Sauermann, Kirsten; Altmeyer, Peter; Hoffmann, Klaus

2001-01-01

121

Neonatal ECMO Study of Temperature (NEST) - a randomised controlled trial  

PubMed Central

Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO) their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK) ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C) will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III) at age of 2 years (24 - 27 months). Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For the primary outcome the analysis will compare the mean scores for each group of surviving babies. The rationale for this choice of primary analysis is to give a fair representation of the average ability of assessable children, accepting the limitation that excluding deaths might impose. The consistency of the effect of cooling on the group of babies recruited to the trial will be explored to see whether cooling is of particular help, or not, to specific subgroups of infants, using the statistical test of interaction. Therefore pre-specified subgroup analyses include: (i) whether the ECMO is veno-arterial or veno-venous; (ii) whether the child's oxygenation index at the time of recruitment is <60 or ? 60; (iii) initial aEEG pattern shown on the cerebral function monitor, and (iv) primary diagnostic group. Trial Registration Current Controlled Trials ISRCTN72635512. PMID:20403176

2010-01-01

122

Comparative study of group A and group C meningococcal infection.  

PubMed Central

114 patients with meningococcal infection were studied; 72 had group C infection and 42 group A infection. 14 patients had acute meningococcaemia, all of whom had group C infection and 9 of whom died. Clinical and laboratory findings were similar in patients with meningitis due to a group A and C organisms, but arthritis and cutaneous vasculitis were more common in patients with group C infection. The overall mortality was 22% in patients with group C infection, and 12% in patients with group A infection, but was the same in both groups when cases of acute meningococcaemia are excluded. PMID:860875

Evans-Jones, L G; Whittle, H C; Onyewotu, I I; Egler, L J; Greenwood, B M

1977-01-01

123

Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial  

PubMed Central

Background This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme for type 1 diabetes. Methods Economic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland. Group follow-up involved two group education ‘booster’ sessions post-DAFNE. Individual follow-up involved two standard one-to-one hospital clinic visits. Incremental costs, quality-adjusted life years (QALYs) gained and cost effectiveness were estimated at 18 months. Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves. Results Group follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient (P value, 0.052; 95% CI, ?0.08 to 0.01, intra-class correlation (ICC), 0.033) and a mean reduction in total healthcare costs of €772 (P value, 0.020; 95% CI, ?1,415 to ?128: ICC, 0.016) per patient. At alternative threshold values of €5,000, €15,000, €25,000, €35,000, and €45,000, the probability of group follow-up being cost effective was estimated to be 1.000, 0.762, 0.204, 0.078, and 0.033 respectively. Conclusions The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE. Given the reported cost savings, future studies should explore the cost effectiveness of alternative models of group care for diabetes. Trial registration Current Controlled Trials ISRCTN79759174 (assigned: 9 February 2007). PMID:24927851

2014-01-01

124

Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial  

PubMed Central

Background Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. Methods and design This will be an open-label randomized, controlled trial conducted at Women’s College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the ‘multiple comparisons with the best’ approach for data analyses, as this strategy allows practical considerations of ease of use and tolerability to guide selection of the preparation for future studies. Discussion Data from this protocol will be used to develop a randomized, controlled trial of nitrates to prevent osteoporotic fractures. Trial registration ClinicalTrials.gov Identifier: NCT01387672. Controlled-Trials.com: ISRCTN08860742. PMID:24010992

2013-01-01

125

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

PubMed Central

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

2013-01-01

126

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.  

PubMed

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. PMID:24440100

Logvinov, Ilana

2014-03-01

127

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

128

Continuous Sunitinib Treatment in Patients with Advanced Hepatocellular Carcinoma: A Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) Multicenter Phase II Trial (SAKK 77/06)  

PubMed Central

Background. Sunitinib (SU) is a multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activity. The objective of this trial was to demonstrate antitumor activity of continuous SU treatment in patients with hepatocellular carcinoma (HCC). Patients and Methods. Key eligibility criteria included unresectable or metastatic HCC, no prior systemic anticancer treatment, measurable disease, and Child-Pugh class A or mild Child-Pugh class B liver dysfunction. Patients received 37.5 mg SU daily until progression or unacceptable toxicity. The primary endpoint was progression-free survival at 12 weeks (PFS12). Results. Forty-five patients were enrolled. The median age was 63 years; 89% had Child-Pugh class A disease and 47% had distant metastases. PFS12 was rated successful in 15 patients (33%; 95% confidence interval, 20%–47%). Over the whole trial period, one complete response and a 40% rate of stable disease as the best response were achieved. The median PFS duration, disease stabilization duration, time to progression, and overall survival time were 1.5, 2.9, 1.5, and 9.3 months, respectively. Grade 3 and 4 adverse events were infrequent. None of the 33 deaths were considered drug related. Conclusion. Continuous SU treatment with 37.5 mg daily is feasible and has moderate activity in patients with advanced HCC and mild to moderately impaired liver dysfunction. Under this trial design (>13 PFS12 successes), the therapy is considered promising. This is the first trial describing the clinical effects of continuous dosing of SU in HCC patients on a schedule that is used in an ongoing, randomized, phase III trial in comparison with the current treatment standard, sorafenib (ClinicalTrials.gov identifier, NCT00699374). PMID:20203173

Montemurro, Michael; Samaras, Panagiotis; Majno, Pietro; Simcock, Mathew; Limacher, Andreas; Lerch, Stefanie; Kovacs, Katalin; Inauen, Roman; Hess, Vivianne; Saletti, Piercarlo; Borner, Markus; Roth, Arnaud; Bodoky, Gyorgy

2010-01-01

129

Effectiveness of Peer-Led Dissonance-Based Eating Disorder Prevention Groups: Results from Two Randomized Pilot Trials  

PubMed Central

Objective The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. Method In Study 1, female undergraduates (N = 171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N = 148) were randomized to either immediate peer-led groups or a waitlist control condition. Results In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d = .64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence rating, and produced stronger effects at posttest (M d = .32) and at 1-year follow-up (M d = .26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d = .75). Conclusions Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. PMID:23419888

Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

2014-01-01

130

Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles  

Microsoft Academic Search

Objective To determine whether and how eligibility criteria of participants prespecified in protocols of randomised trials are reported in subsequent articles.Design Cohort study.Setting Protocols submitted to the ethics committee of a German medical faculty.Data sources 52 trial protocols and 78 subsequent publications published between 2000 and 2006.Main outcome measure Proportion of matching, missing, modified, or newly added eligibility criteria between

Anette Blümle; Joerg J Meerpohl; Gerta Rücker; Gerd Antes; Martin Schumacher; Erik von Elm

2011-01-01

131

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 PMID:22984466

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

2012-01-01

132

The EHR solution to clinical trial recruitment in physician groups. | accrualnet.cancer.gov  

Cancer.gov

This article was written by the president and founder of the Holston Medical Group and explains his company’s success with an electronic health record (EHR). The EHR is used among 102 providers in 26 locations and has been used to enroll thousands of patients in more than 250 clinical trials. The Holston Medical Group has determined that the use of the EHR Web-based technology can significantly streamline patient recruitment, speed monitoring, and help to prevent protocol failure—all while increasing revenue stream.

133

Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study  

PubMed Central

Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n?=?5) (200 mg twice daily for four weeks) or placebo group (n?=?5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

2014-01-01

134

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.

135

"I will miss the study, God bless you all": participation in a nutritional chemoprevention trial.  

PubMed

Randomized controlled clinical trials are often considered to be the "gold standard" for health research. Consequently, understanding the reasons people participate in these trials, especially minority groups who are often under-represented in clinical trials, or populations who have chronic illnesses or abuse drugs, is salient for successful recruitment, retention, and project design. This paper describes the results of a study that was designed to examine some of the ways in which participants in a randomized double blind clinical trial perceived their participation in the clinical trial, and the reasons they gave for continuing in the study. All of the participants were individuals who were using drugs and were infected with the HIV-1 virus, and had participated in a chemoprevention trial. The data from an exit interview were analyzed thematically in order to reveal units of meaning concerning participation and continuation in the clinical trial. The analysis revealed 3 higher-level concepts, or themes, that guided participation: increased health awareness, personal enhancement, and sociability. The data clearly indicated that involvement and retention in the trial were directly related to the ways in which the participants interpreted the study, perceived the benefits they derived from participating, and imbued their participation with value so that it was important and relevant to their own perceptions of health, as well as personal and social well being. PMID:15724764

Moreno-Black, Geraldine; Shor-Posner, Gail; Miguez, Maria-Jose; Burbano, Ximena; O'Mellan, Sandra; Yovanoff, P

2004-01-01

136

THE ROLE OF PLANT PIGMENTS IN DIGESTION TRIAL STUDIES  

Microsoft Academic Search

R EID et al. (1950) first used natural occurring plant pigments as a marker in digestion trial work. In their studies the acetone extract of hays and feces produced absorption curves which invariably crossed one another at 406 mt~. They assumed that no changes occurred at this isobestic point and satisfactorily demonstrated its applicability as a marker in digestion trials

H. M. IRVIN; H. G. WISEMAN; J. C. SHAW

2010-01-01

137

Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial  

PubMed Central

Background Cognitive Stimulation Therapy (CST) is a psychosocial evidence-based group intervention for people with dementia recommended by the UK NICE guidelines. In clinical trials, CST has been shown to improve cognition and quality of life, but little is known about the best way of ensuring implementation of CST in practice settings. A recent pilot study found that a third of people who attend CST training go on to run CST in practice, but staff identified a lack of support as a key reason for the lack of implementation. Methods/design There are three projects in this study: The first is a pragmatic multi-centre, randomised controlled trial (RCT) of staff training, comparing CST training and outreach support with CST training only; the second, the monitoring and outreach trial, is a phase IV trial that evaluates implementation of CST in practice by staff members who have previously had the CST manual or attended training. Centres will be randomised to receive outreach support. The primary outcome measure for both of these trials is the number of CST sessions run for people with dementia. Secondary outcomes include the number of attenders at sessions, job satisfaction, dementia knowledge and attitudes, competency, barriers to change, approach to learning and a controllability of beliefs and the level of adherence. Focus groups will assess staff members’ perceptions of running CST groups and receiving outreach support. The third study involves monitoring centres running groups in their usual practice and looking at basic outcomes of cognition and quality of life for the person with dementia. Discussion These studies assess the effects of outreach support on putting CST into practice and running groups effectively in a variety of care settings with people with dementia; evaluate the effectiveness of CST in standard clinical practice; and identify key factors promoting or impeding the successful running of groups. Trial registration Clinical trial ISRCTN28793457. PMID:22735077

2012-01-01

138

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

139

Individual vs. Group-Based Incentives for Weight Loss: A Randomized, Controlled Trial  

PubMed Central

Background There are limited data on the effectiveness of employer-sponsored financial incentives for employee weight loss. Objective To test the effectiveness of two financial incentive designs for promoting weight loss among obese employees. Design Randomized controlled trial. Allocation sequence was generated dynamically at the time of request of treatment assignment. Participants were unblinded to assignment; investigators were blinded to assignment until collection of primary outcome data. Setting Children’s Hospital of Philadelphia Participants 105 employees with a body mass index between 30 and 40 kg/m2 Interventions 24 weeks of monthly weigh-ins (control)(n=35); individual incentive, designed as $100 per person per month for meeting or exceeding target weight loss (individual arm)(n=35); group incentive, designed as $500 per month split between any participant within groups of 5 who met or exceeded their target weight loss (group arm)(n=35). Measurements Weight loss after 24 weeks (primary outcome); weight loss after 36 weeks, changes in behavioral mediators of weight loss (secondary outcomes). Results Group incentive participants lost more weight than individual arm participants (between-group difference in weight loss favoring group = mean 9.7 pounds, 95% CI 4.4 to 14.9; P < 0.001). Twelve weeks after incentives ended and adjusting for 3-group comparisons, group arm participants maintained greater weight loss than control arm participants (between-group difference in weight loss = mean 6.5 pounds, 95% CI 1.2 to 11.7; P = 0.016) but not more than individual arm participants (difference = 5.9 pounds, 95% CI, 0.8 to 11.0; P = 0.024). Limitations Single employer, short follow-up Conclusions A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. Primary Funding Source National Institute on Aging Trial Registration ClinicalTrials.gov Identifier: NCT01208350 PMID:23546562

Kullgren, Jeffrey T.; Troxel, Andrea B.; Loewenstein, George; Asch, David A.; Norton, Laurie A.; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G.

2014-01-01

140

Zoledronic acid prevents bone loss in premenopausal women with early breast cancer undergoing adjuvant chemotherapy: a phase III trial of the Korean Cancer Study Group (KCSG-BR06-01)  

Microsoft Academic Search

To determine whether zoledronic acid (ZA) can prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for\\u000a breast cancer. In this randomized, open-label, phase III multicenter trial, premenopausal women >40 years were randomly assigned\\u000a to ZA treatment (4 mg IV, every 6 months) or observation after surgery. All patients were treated with four cycles of AC followed\\u000a by four cycles of taxane. Between March

Jeong Eun Kim; Jin-Hee Ahn; Kyung Hae Jung; Sung-Bae Kim; Hwa Jung Kim; Keun-Suk Lee; Jung-Sil Ro; Yun-Hee Park; Jin-Suk Ahn; Young-Hyk Im; Seock-Ah Im; Moon-Hee Lee; Si-Young Kim

2011-01-01

141

Study design considerations for irritable bowel syndrome clinical trials  

PubMed Central

Clinical trials of therapies intended to alleviate symptoms of irritable bowel syndrome (IBS) are prevalent. However, the ideal study design remains elusive since there is no obvious pathophysiological target and no universally accepted endpoint to assess symptom improvement in IBS. The purpose of this paper is to identify and discuss the most problematic issues in the design of clinical trials intended to evaluate the effectiveness of treatments for IBS symptoms. Lack of standardized diagnostic criteria, symptom variability, heterogeneous subject characteristics, large placebo effects, lack of statistical power, inappropriate endpoint selection, and poorly selected study design are the most critical issues that may confound study outcomes in IBS clinical trials. PMID:25330749

Miller, Larry E.

2014-01-01

142

Placebo versus Best-Available-Therapy Control Group in Clinical Trials for Pharmacologic Therapies: Which Is Better?  

Microsoft Academic Search

There are valid scientific and ethical considerations for using a control group in a clinical trial. Placebo-controlled trials are justifi- able when they are supported by sound methodologic consider- ation and when their use does not expose research participants to excessive risk of harm. Consideration should be given to \\

Mario Castro

2007-01-01

143

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

PubMed Central

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

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

2014-01-01

144

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 PMID:19247497

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

2009-01-01

145

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

2013-07-01

146

From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences  

ERIC Educational Resources Information Center

This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies

Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

2013-01-01

147

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial  

PubMed Central

Background Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. Methods/design In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Discussion Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. Trial registration ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013). PMID:24950841

2014-01-01

148

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation2 (STOPIT-2)  

Microsoft Academic Search

BACKGROUND: Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of

Matthias Briel; Victor M Montori; Dirk Bassler; Paul Glasziou; German Malaga; Elie A Akl; Ignacio Ferreira-Gonzalez; Pablo Alonso-Coello; Gerard Urrutia; Regina Kunz; Carolina Ruiz Culebro; Suzana da Alves Silva; David N Flynn; Mohamed B Elamin; Brigitte Strahm; M Hassan Murad; Benjamin Djulbegovic; Neill KJ Adhikari; Edward J Mills; Femida Gwadry-Sridhar; Haresh Kirpalani; Heloisa P Soares; Nisrin O Abu Elnour; John J You; Paul J Karanicolas; Heiner C Bucher; Julianna F Lampropulos; Alain J Nordmann; Karen EA Burns; Sohail M Mulla; Heike Raatz; Amit Sood; Jagdeep Kaur; Clare R Bankhead; Rebecca J Mullan; Kara A Nerenberg; Per Olav Vandvik; Fernando Coto-Yglesias; Holger Schünemann; Fabio Tuche; Pedro Paulo M Chrispim; Deborah J Cook; Kristina Lutz; Christine M Ribic; Noah Vale; Patricia J Erwin; Rafael Perera; Qi Zhou; Diane Heels-Ansdell; Tim Ramsay; Stephen D Walter; Gordon H Guyatt

2009-01-01

149

Randomized Controlled Trial of a Cognitive–Behavioral Motivational Intervention in a Group Versus Individual Format for Substance Use Disorders  

Microsoft Academic Search

Although group therapy is widely used for individuals with substance use disorders (SUDs), randomized clinical trials (RCTs) comparing the same treatment in a group versus individual format are rare. This paper presents the results of a RCT comparing guided self-change (GSC) treatment, a cognitive–behavioral motivational intervention, conducted in a group versus individual format with 212 alcohol abusers and 52 drug

Linda Carter Sobell; Mark B. Sobell; Sangeeta Agrawal

2009-01-01

150

Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial  

PubMed Central

Background Knee osteoarthritis is the most common type of arthritis, with pain being its most common symptom. Little is known about the psychological aspects of knee osteoarthritis pain. There is an emerging consensus among osteoarthritis specialists about the importance of addressing not only biological but also psychosocial factors in the assessment and treatment of osteoarthritis. As few studies have evaluated the effect of psychological interventions on knee osteoarthritis pain, good quality randomized controlled trials are needed to determine their effectiveness. Methods/Design We intend to conduct a 6-week single-blinded randomized controlled trial with a 12-month follow-up. Altogether, 108 patients aged from 35 to 75 years with clinical symptoms and radiographic grading (KL 2–4) of knee osteoarthritis will be included. The clinical inclusion criteria are pain within the last year in or around the knee occurring on most days for at least one month, and knee pain of ?40 mm on a 100-mm visual analogue scale in the WOMAC pain subscale for one week prior to study entry. Patients with any severe psychiatric disorder, other back or lower limb pain symptoms more aggravating than knee pain, or previous or planned lower extremity joint surgery will be excluded. The patients will be randomly assigned to a combined GP care and cognitive-behavioral intervention group (n = 54) or to a GP care control group (n = 54). The cognitive-behavioral intervention will consist of 6 weekly group sessions supervised by a psychologist and a physiotherapist experienced in the treatment of pain. The main goals of the intervention are to reduce maladaptive pain coping and to increase the self-management of pain and disability. The follow-up-points will be arranged at 3 and 12 months. The primary outcome measure will be the WOMAC pain subscale. Secondary outcome measures will include self-reports of pain and physical function, a health related quality of life questionnaire, and various psychological questionnaires. Personnel responsible of the data analysis will be blinded. Discussion This study addresses the current topic of non-pharmacological conservative treatment of knee OA-related pain. We anticipate that these results will provide important new insights to the current care recommendations. Trial registration Current Controlled Trials ISRCTN64794760 PMID:23356455

2013-01-01

151

International subarachnoid aneurysm trial - ISAT Part II: Study protocol for a randomized controlled trial  

PubMed Central

Background The International Subarachnoid Aneurysm Trial (ISAT) demonstrated improved one-year clinical outcomes for patients with ruptured intracranial aneurysms treated with endovascular coiling compared to surgical clipping. Patients included in ISAT were mostly good grade subarachnoid hemorrhage (SAH) patients with small anterior circulation aneurysms. The purported superiority of coiling is commonly extrapolated to patients not studied in the original trial or to those treated using new devices not available at the time. Conversely, many patients are treated by clipping despite ISAT, because they are thought either to be better candidates for surgery, or to offer more durable protection from aneurysm recurrences. These practices have never been formally validated. Thus, for many ruptured aneurysm patients the question of which treatment modality leads to a superior clinical outcome remains unclear. Methods/trial design ISAT II is a pragmatic, multicenter, randomized trial comparing clinical outcomes for non-ISAT patients with subarachnoid hemorrhage allocated to coiling or clipping. Inclusion criteria are broad. The primary end-point is the incidence of poor clinical outcome (defined as mRS >2) at one year, just as in ISAT. Secondary end-points include measures of treatment safety for a number of pre-specified subgroups, with efficacy end-points including the presence of a major recurrence at one year; 1,896 patients (862 each arm plus 10% losses) are required to demonstrate a significant difference between coiling and clipping, hypothesizing 23% and 30% poor clinical outcome rates, for coiling and clipping, respectively. The trial should involve at least 50 international centers, and will take approximately 12 years to complete. Analysis will be by intention-to-treat. Trial registration ISAT II is registered at clinicaltrials.gov: NCT01668563. PMID:23714335

2013-01-01

152

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 PMID:22340088

2012-01-01

153

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

2013-01-01

154

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

PubMed Central

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 IJzendoorn, M H

2013-01-01

155

Dental Budget Process: Determination Schema Industry Sponsored, Industry Supported, University to University, Co-operative Group or Foundation Supported Clinical Trials  

E-print Network

, University to University, Co-operative Group or Foundation Supported Clinical Trials DENTAL BUDGET PROCESS OR FOUNDATION SUPPORTED CLINICAL TRIALS Following Procedure I flow chart A. PRE-TRIAL: o In order to open an industry sponsored, industry supported, university to university or foundation clinical trial

Oliver, Douglas L.

156

Numerical study of group effects for pile groups in sands  

Microsoft Academic Search

The OpenSees finite element framework was used to simulate the response of 3×3 and 4×3 pile groups founded in loose and medium dense sands. Several numerical static pushover tests were conducted to investigate the interaction effects for pile groups. The results were then compared with those from centrifuge study. It is shown that our simulations can predict the behaviour of

Zhaohui Yang; Boris Jeremi

2003-01-01

157

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 PMID:23181667

2012-01-01

158

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. PMID:23666475

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

2013-01-01

159

Roswell Park-led study finds most cancer research trials do not assess participants’ tobacco use  

Cancer.gov

While tobacco use can significantly hamper cancer treatment, few cancer researchers are incorporating tobacco assessment into their clinical studies. That’s the conclusion a group of investigators led by researchers at Roswell Park Cancer Institute drew from a recent survey of cancer clinical trials.

160

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

PubMed Central

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

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

2013-01-01

161

Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial  

PubMed Central

Background Pressure ulcers are one of the most common health complaints, which often take months or years to heal, and affect patients’ morbidity and quality of life. Medical options for pressure ulcers are limited. Electroacupuncture (EA) has been employed to relieve the symptoms for patients with pressure ulcers, but there is limited clinical evidence for its effectiveness. Methods/Design This study consists of a randomized controlled trial (RCT) with two parallel arms: a control group and an EA group. Both groups will receive standard wound care (including changing position, using mattresses and cushions, and a good diet) of five sessions per week for a total of 40 sessions during the 8-week treatment period. In addition, the EA group will receive the EA intervention. The following outcome measurements will be used in examination of participants: wound surface area (WSA), visual analogue scale (VAS), and the proportion of ulcers healed within trial period (PUHTP). All the outcomes will be evaluated at the start of the study, at the end of the fourth week, at 8 weeks after randomization, and 1 month after treatment cessation. Discussion The aim of this study is to evaluate the effectiveness of EA for the treatment of patients with pressure ulcers. Trial registration Chinese Clinical Trial Register: ChiCTR-TRC-11001693 PMID:24393344

2014-01-01

162

Sample size determination in group-sequential clinical trials with two co-primary endpoints.  

PubMed

We discuss sample size determination in group-sequential designs with two endpoints as co-primary. We derive the power and sample size within two decision-making frameworks. One is to claim the test intervention's benefit relative to control when superiority is achieved for the two endpoints at the same interim timepoint of the trial. The other is when superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size and power with varying design elements and provide a real example to illustrate the proposed sample size methods. In addition, we discuss sample size recalculation based on observed data and evaluate the impact on the power and Type I error rate. PMID:24676799

Asakura, Koko; Hamasaki, Toshimitsu; Sugimoto, Tomoyuki; Hayashi, Kenichi; Evans, Scott R; Sozu, Takashi

2014-07-30

163

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 PMID:23118850

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

2012-01-01

164

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

2013-03-01

165

A Longitudinal Study of Exercise Barriers in Colorectal Cancer Survivors Participating in a Randomized Controlled Trial  

Microsoft Academic Search

Background: The Colorectal Cancer and Home-Based Physical Exercise (CAN-HOPE) trial compared the effects of a 16-week home-based exercise\\u000a program to usual care on quality of life in colorectal cancer survivors.Purpose: In this study, we report the weekly exercise barriers from the exercise group.Methods: Participants randomized to the exercise group (N = 69) were asked to report their exercise on a

Kerry S. Courneya; Christine M. Friedenreich; H. Arthur Quinney; Anthony L. A. Fields; Lee W. Jones; Jeffrey K. H. Vallance; Adrian S. Fairey

2005-01-01

166

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

PubMed Central

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

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

2013-01-01

167

Radiotherapy quality assurance review in a multi-center randomized trial of limited-disease small cell lung cancer: the Japan Clinical Oncology Group (JCOG) trial 0202  

PubMed Central

Background The purpose of this study was to analyze the radiotherapy (RT) quality assurance (QA) assessment in Japan Clinical Oncology Group (JCOG) 0202, which was the first trial that required on-going RT QA review in the JCOG. Methods JCOG 0202 was a multi-center phase III trial comparing two types of consolidation chemotherapy after concurrent chemoradiotherapy for limited-disease small cell lung cancer. RT requirements included a total dose of 45 Gy/30 fx (bis in die, BID/twice a day) without heterogeneity correction; elective nodal irradiation (ENI) of 30 Gy; at least 1 cm margin around the clinical target volume (CTV); and interfraction interval of 6 hours or longer. Dose constraints were defined in regards to the spinal cord and the lung. The QA assessment was classed as per protocol (PP), deviation acceptable (DA), violation unacceptable (VU), and incomplete/not evaluable (I/NE). Results A total of 283 cases were accrued, of which 204 were fully evaluable, excluding 79 I/NE cases. There were 18 VU in gross tumor volume (GTV) coverage (8% of 238 evaluated); 4 VU and 23 DA in elective nodal irradiation (ENI) (2% and 9% of 243 evaluated, respectively). Some VU were observed in organs at risk (1 VU in the lung and 5 VU in the spinal cord). Overall RT compliance (PP + DA) was 92% (187 of 204 fully evaluable). Comparison between the former and latter halves of the accrued cases revealed that the number of VU and DA had decreased. Conclusion The results of the RT QA assessment in JCOG 0202 seemed to be acceptable, providing reliable results. PMID:19490617

Sanuki-Fujimoto, Naoko; Ishikura, Satoshi; Hayakawa, Kazushige; Kubota, Kaoru; Nishiwaki, Yutaka; Tamura, Tomohide

2009-01-01

168

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 PMID:21592347

2011-01-01

169

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

170

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

PubMed Central

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

2013-01-01

171

Topotecan versus treosulfan, an alkylating agent, in patients with epithelial ovarian cancer and relapse within 12 months following 1st-line platinum\\/paclitaxel chemotherapy. A prospectively randomized phase III trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR)  

Microsoft Academic Search

ObjectiveEffective therapies with a low rate of side effects are warranted in the 2nd-line setting in ovarian cancer. Both topotecan and the alkylating agent treosulfan have demonstrated efficacy in this patient group and are broadly used in Germany. Therefore, we started a prospectively randomized phase III trial comparing these two drugs in early recurrent ovarian cancer.

Werner Meier; Andreas du Bois; Alexander Reuss; Walther Kuhn; Sigrid Olbricht; Martina Gropp; Barbara Richter; Hans-Joachim Lück; Rainer Kimmig; Jacobus Pfisterer

2009-01-01

172

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 PMID:23072576

2012-01-01

173

Hassle Free Mealtimes Triple P: a randomised controlled trial of a brief parenting group for childhood mealtime difficulties.  

PubMed

Mealtime difficulties are common in typically developing young children. Easily accessible, wide-reaching, early intervention is needed to meet demand for assistance, and prevent the development of more serious feeding and psychosocial problems. Behavioural parent training is an efficacious intervention for childhood mealtime problems, however, existing programmes are long, intensive, and costly. The current study aimed to evaluate the efficacy of a brief parenting discussion group for young children's mealtime difficulties. Eighty-six parents of 2- to 5-year-old children with mealtime difficulties participated in a randomised controlled trial of Hassle Free Mealtimes Triple P (HFMTP; Morawska & Sanders, 2012), a 2-h discussion group on positive parenting strategies specific to the mealtime context. Results of parent-report measures showed that after intervention, there were significant improvements with large effect sizes in children's mealtime behaviour, parents' mealtime practices and cognitions, and both mealtime and general parenting confidence, compared to a waitlist control group. Parents also reported high satisfaction with the programme and effects were maintained at 6-month follow-up. These results support the efficacy of a brief parenting discussion group for childhood mealtime difficulties. This low intensity format of intervention has the potential to meet the high demand for assistance with young children's mealtime difficulties. PMID:24362359

Morawska, Alina; Adamson, Michelle; Hinchliffe, Kaitlin; Adams, Tracey

2014-02-01

174

Consolidation with alemtuzumab in patients with chronic lymphocytic leukemia (CLL) in first remission – experience on safety and efficacy within a randomized multicenter phase III trial of the German CLL Study Group (GCLLSG)  

Microsoft Academic Search

Patients with CLL responding to initial chemotherapy with fludarabine alone (F) or in combination with cyclophosphamide (FC) were randomized for treatment with alemtuzumab (30 mg i.v. TIW, 12 weeks) or observation. Of 21 evaluable patients, 11 were randomized to alemtuzumab before the study was stopped due to severe infections in seven of 11 patients. These infections (one life-threatening pulmonary aspergillosis

C-M Wendtner; M Ritgen; C D Schweighofer; G Fingerle-Rowson; H Campe; G Jäger; B Eichhorst; R Busch; H Diem; A Engert; S Stilgenbauer; H Döhner; M Kneba; B Emmerich; M Hallek

2004-01-01

175

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

176

A Randomized Trial of Contingency Management Delivered in the Context of Group Counseling  

Microsoft Academic Search

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.

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

2011-01-01

177

Preparing for microbicide trials in Rwanda: Focus group discussions with Rwandan women and men  

Microsoft Academic Search

The acceptability and feasibility of microbicide studies and future microbicide use are influenced by existing norms and values regarding sexual and contraceptive behaviour. In preparation for microbicide research in Rwanda, focus group discussions were conducted to assess sexual and contraceptive behaviour, preferences for vaginal lubrication, and hypothetical acceptability of microbicides among Rwandan women and men. Seven focus group discussions were

N. Veldhuijzen; J. Nyinawabega; M. Umulisa; B. Kankindi; E. Geubbels; P. Basinga; J. Vyankandondera; J. Van De Wijgert

2006-01-01

178

A Randomized Trial of Contingency Management Delivered in the Context of Group Counseling  

ERIC Educational Resources Information Center

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…

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

2011-01-01

179

Exemestane as primary systemic treatment for hormone receptor positive post-menopausal breast cancer patients: a phase II trial of the Austrian Breast and Colorectal Cancer Study Group (ABCSG-17)  

Microsoft Academic Search

Background A multicenter phase II study was conducted to analyze the clinical activity of the steroidal aromatase inhibitor exemestane\\u000a in the neoadjuvant treatment of post-menopausal women with strongly ER- and\\/or PgR- positive operable breast cancer. Patients and methods From September 2000 to December 2003, 80 women were recruited for treatment with exemestane 25 mg once daily for 4 months.\\u000a The primary end-point

Brigitte Mlineritsch; Christoph Tausch; Christian Singer; Gero Luschin-Ebengreuth; Raimund Jakesz; Ferdinand Ploner; Michael Stierer; Elisabeth Melbinger; Christian Menzel; Andrea Urbania; Michael Fridrik; Günther Steger; Peter Wohlmuth; Michael Gnant; Richard Greil

2008-01-01

180

A multi-center trial of the effects of oral nutritional supplementation in critically ill older inpatients. GAGE Group. Groupe Aquitain Geriatrique d'Evaluation.  

PubMed

The purpose of this study was to assess the effect of nutritional supplementation on dietary intake and on pressure ulcer development in critically ill older patients. The multi-center trial involved 19 wards stratified according to specialty and recruitment for critically ill older patients; 9 wards were randomly selected for nutritional intervention (nutritional intervention group), consisting of the daily distribution of two oral supplements, with each supplement containg 200 kcal, for 15 d. Pressure ulcer incidence was prospectively recorded for grades I (erythema), II (superficial broken skin), and III (subcutaneous lesion) for 15 d. Nutritional intake was monitored by using estimates in units of quarters validated by comparison with weight measurement. There were 672 subjects older than 65 y, and 295 were in the nutritional intervention group versus 377 in the control group. The patients were similar for age, sex ratio, and C-reactive protein. In comparison with the control group, the nutritional intervention group included more patients with stroke, heart failure, and dyspnea and fewer with antecedent falls, delirium, lower limb fractures, and digestive disease. The nutritional intervention group had a lower risk of pressure ulcers according to the Norton score but was less dependent (Kuntzman score) and had a lower serum albumin level. During the trial, energy and protein intakes were higher in the nutritional intervention group (day 2: 1081 +/- 595 kcal versus 957 +/- 530 kcal, P = 0.006; 45.9 +/- 27.8 g protein versus 38.3 +/- 23.8 g protein in the control group, P < 0.001). At 15 d, the cumulative incidence of pressure ulcers was 40.6% in the nutritional intervention group versus 47.2% in the control group. The proportion of grade I cases relative to the total number of cases was 90%. Multivariate analysis, taking into account all diagnoses, potential risk factors, and the intra-ward correlation, indicated that the independent risk factors of developing a pressure ulcer during this period were: serum albumin level at baseline, for 1 g/L decrease: 1.05 (95% confidence interval: 1.02 to 1.07, P < 0.001); Kuntzmann score at baseline, for 1-point increase: 1.22 (0.32 to 4.58, P = 0.003); lower limb fracture: 2.68 (1.75 to 4.11, P < 0.001); Norton score < 10 versus > 14: 1.28 (1.01 to 1.62, P = 0.04); and belonging to the control group: 1.57 (1.03 to 2.38, P = 0.04). In conclusion, it was possible to increase the dietary intake of critically ill elderly subjects by systematic use of oral supplements. This intervention was associated with a decreased risk of pressure ulcer incidence. PMID:10674226

Bourdel-Marchasson, I; Barateau, M; Rondeau, V; Dequae-Merchadou, L; Salles-Montaudon, N; Emeriau, J P; Manciet, G; Dartigues, J F

2000-01-01

181

Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial  

PubMed Central

Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice. Trial registration Current Controlled Trials ISRCTN33031001. Registered 27 April 2012. PMID:25052334

2014-01-01

182

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

PubMed Central

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

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

2011-01-01

183

Randomized controlled trial of transdiagnostic group treatments for primary care patients with common mental disorders  

PubMed Central

Background. The purpose was to test the effectiveness of two transdiagnostic group interventions compared to care as usual (CAU) for patients with anxiety, depressive or stress-related disorders within a primary health care context. Objectives. To compare the effects of cognitive-based-behavioural therapy (CBT) and multimodal intervention (MMI) on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre. Methods. Patients (n = 278), aged 18–65 years, were referred to the study by the GPs and 245 were randomized to CAU or one of two group interventions in addition to CAU: (i) group CBT administered by psychologists and (ii) group MMI administered by assistant nurses. The primary outcome measure was the Mental Component Summary score of short form 36. Secondary outcome measures were Perceived Stress Scale and Self-Rating Scale for Affective Syndromes. The data were analysed using intention-to-treat with a linear mixed model. Results. On the primary outcome measure, the mean improvement based on mixed model analyses across post- and follow-up assessment was significantly larger for the MMI group than for the CBT (4.0; P = 0.020) and CAU (7.5; P = .001) groups. Participants receiving CBT were significantly more improved than those in the CAU group. On four of the secondary outcome measures, the MMI group was significantly more improved than the CBT and CAU groups. The course of improvement did not differ between the CBT group and the CAU group on these measures. Conclusions. Transdiagnostic group treatment can be effective for patients with common mental disorders when delivered in a primary care setting. The group format and transdiagnostic approach fit well with the requirements of primary care. PMID:24642702

Ejeby, Kersti

2014-01-01

184

Clinical trial participants' experiences of completing questionnaires: a qualitative study  

PubMed Central

Objectives To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8?years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. Setting The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. Participants The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8)?years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. Outcomes We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Results Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Conclusions Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies. Trial registration number ISRCTN77108101807. PMID:24662446

Holmberg, Christine; Karner, Julia J; Rappenecker, Julia; Witt, Claudia M

2014-01-01

185

Positive psychology group intervention for breast cancer patients: a randomised trial.  

PubMed

This study assessed the effects of a psychological group intervention based on positive psychology in women with breast cancer. 175 women were randomly assigned either to an experimental group, receiving the 14-session intervention (n = 87), or to a wait list group (n = 88) that did not receive any type of intervention. For treatment, a group intervention was applied, based on improving psychological strengths and enhancing positive psychology-based styles of coping. Strength-related outcomes, self-esteem, well-being, and happiness were assessed before and after the intervention. The experimental group showed higher scores on all of the study variables after the intervention. Participants reported improved self-esteem, emotional intelligence-related abilities, resilience, and optimism, as well as positive affectivity, well-being, and happiness. The results show a beneficial effect of this psychological intervention based on positive psychology on female breast cancer patients' psychological health. PMID:25153949

Victoria Cerezo, M; Ortiz-Tallo, Margarita; Cardenal, Violeta; De La Torre-Luque, Alejandro

2014-08-01

186

Predictors of accrual success for cooperative group trials: The Cancer and Leukemia Group B (Alliance) experience. | accrualnet.cancer.gov  

Cancer.gov

Gordon DH,Liu Q,Kleinman B,Karrison T,Kelly M,Fleming GF. Alliance for Clinical Trials in Oncology, Chicago, IL; University of Chicago, Chicago, IL. ASCO 2013 Annual Meeting. 2013 May 31. 2013 Jun 04. Chicago, IL.

187

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

188

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

PubMed Central

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

2013-01-01

189

Effect of tamoxifen and transdermal hormone replacement therapy on cardiovascular risk factors in a prevention trial. Italian Chemoprevention Group.  

PubMed Central

The combination of tamoxifen and transdermal hormone replacement therapy (HRT) may potentially reduce risks and side-effects of either agent, but an adverse interaction could attenuate their beneficial effects. We assessed the effects of their combination on cardiovascular risk factors within a prevention trial of tamoxifen. Baseline and 12-month measurements of total, low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, platelets and white blood cells were obtained in the following four groups: tamoxifen (n = 1117), placebo (n = 1112), tamoxifen and HRT (n = 68), placebo and HRT (n = 87). The analysis was further extended to women who were on HRT at randomization but discontinued it during the 12-month intervention period (n = 33 on tamoxifen and n = 35 on placebo) and to women who were not on HRT but started it during intervention (n = 36 in both arms of the study). Compared with small changes in the placebo group, tamoxifen was associated with changes in total, LDL- and HDL-cholesterol of approximately -9%, -19% and +0.2% in continuous HRT users compared with -9%, -14% and -0.8% in never HRT users. Similarly, there was no interaction on platelet count. In contrast, the decrease in total and LDL-cholesterol levels induced by tamoxifen was blunted by two-thirds in women who started HRT while on tamoxifen (P = 0.051 for the interaction term). We conclude that the beneficial effects of tamoxifen on cardiovascular risk factors are unchanged in current HRT users, whereas they may be attenuated in women who start transdermal HRT while on tamoxifen. Whereas a trial of tamoxifen in women already on transdermal HRT is warranted, prescription of HRT during tamoxifen may attenuate its activity. PMID:9744493

Decensi, A.; Robertson, C.; Rotmensz, N.; Severi, G.; Maisonneuve, P.; Sacchini, V.; Boyle, P.; Costa, A.; Veronesi, U.

1998-01-01

190

A Study of Bion's Basic Assumption Groups  

Microsoft Academic Search

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

Sigmund Karterud

1989-01-01

191

Reverse Auction Bidding - Multiple Group Study  

E-print Network

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

Zhou, Xun

2012-10-19

192

Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial  

PubMed Central

Introduction Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial. Methods and analysis The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery. Ethics and dissemination The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media. Trial registration number ClinicalTrials.gov NCT01758211. PMID:25341453

Zhao, Bing; Cao, Yong; Zhao, Yuanli; Wu, Jun; Wang, Shuo

2014-01-01

193

Vaginal birth after cesarean delivery: a group practice’s approach to minimizing failed trial of labor  

Microsoft Academic Search

Objective: Among women attempting a trial of labor (TOL) after a prior abdominal delivery, 60–80% accomplish a vaginal birth after cesarean (VBAC). McMahon and coworkers (N Engl J Med, 1996) have indicated that at a 60% success level for TOL, the remaining 40% incurred enough major complications that the scheduled repeat cesarean section group was less morbid overall. The same

Charles M. Stedman; Susan R. Scudder; Gerald F. Joseph

1998-01-01

194

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

Cancer.gov

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

195

Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial  

PubMed Central

We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT) on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a quasi-experimental, group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16–18, to a CBT/MT intervention (youth n = 147) or an active control intervention (youth n = 117). Both arms received approximately 750 min of intervention in a small-group setting over a 3–5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. PMID:24265621

Leonard, Noelle R.; Jha, Amishi P.; Casarjian, Bethany; Goolsarran, Merissa; Garcia, Cristina; Cleland, Charles M.; Gwadz, Marya V.; Massey, Zohar

2013-01-01

196

Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial.  

PubMed

We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT) on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a quasi-experimental, group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16-18, to a CBT/MT intervention (youth n = 147) or an active control intervention (youth n = 117). Both arms received approximately 750 min of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. PMID:24265621

Leonard, Noelle R; Jha, Amishi P; Casarjian, Bethany; Goolsarran, Merissa; Garcia, Cristina; Cleland, Charles M; Gwadz, Marya V; Massey, Zohar

2013-01-01

197

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. PMID:22848802

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

2012-01-01

198

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. PMID:18056618

Chan, Kevin

2007-01-01

199

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

200

How Does Tele-Mental Health Affect Group Therapy Process? Secondary Analysis of a Noninferiority Trial  

ERIC Educational Resources Information Center

Objective: Video teleconferencing (VTC) is used for mental health treatment delivery to geographically remote, underserved populations. However, few studies have examined how VTC affects individual or group psychotherapy processes. This study compares process variables such as therapeutic alliance and attrition among participants receiving anger…

Greene, Carolyn J.; Morland, Leslie A.; Macdonald, Alexandra; Frueh, B. Christopher; Grubbs, Kathleen M.; Rosen, Craig S.

2010-01-01

201

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

Cancer.gov

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

202

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

PubMed

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

Currie, Michael; Startup, Mike

2012-08-01

203

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

PubMed Central

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 middle school—aged girls. TAAG provided a unique opportunity to recruit large cohorts of randomly sampled girls within 36 diverse middle schools across the United States. METHODS Key elements of the formative planning, coordination, and design of TAAG’s recruitment efforts included flexibility, tailoring, and the use of incentives. Various barriers, including a natural disaster, political tension, and district regulations, were encountered throughout the recruitment process, but coordinated strategies and frequent communication between the 6 TAAG sites were helpful in tailoring the recruitment process at the 36 intervention and control schools. RESULTS Progressively refined recruitment strategies and specific attention to the target audience of middle school girls resulted in overall study recruitment rates of 80%, 85%, and 89%, for the baseline, posttest, and follow-up period, respectively. DISCUSSION The steady increase in recruitment rates over time is attributed to an emphasis on successful strategies and a willingness to modify less successful methods. Open and consistent communication, an increasingly coordinated recruitment strategy, interactive recruitment presentations, and participant incentives resulted in an effective recruitment campaign. PMID:18808471

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

2009-01-01

204

Grouping Multivariate Time Series: A Case Study  

Microsoft Academic Search

We present a case study to demonstrate a process for grouping massive multivariate time series based on nonpara- metric statistical summaries aided by information visualization. We want a method that allows us to quickly find approximate groups in time series, both to identify typical aggregate behaviors and to find aberrant outliers. We use simple statistical summaries to capture the temporal

Tamraparni Dasu; Deborah F. Swayne; David Poole

205

Facebook Groups as LMS: A Case Study  

ERIC Educational Resources Information Center

This paper describes a pilot study in using Facebook as an alternative to a learning management system (LMS). The paper reviews the current research on the use of Facebook in academia and analyzes the differences between a Facebook group and a regular LMS. The paper reports on a precedent-setting attempt to use a Facebook group as a course…

Meishar-Tal, Hagit; Kurtz, Gila; Pieterse, Efrat

2012-01-01

206

Advice from Successful Students Study Groups  

E-print Network

something, you automatically have people to ask about it. Cooperative learning with others, when done" on Gustavus Adolphus College's web site and "Group and Cooperative Learning" on Muskingum College's Center of information and learning strategies, completing homework assignments and more. I find study groups to be very

207

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 PMID:23806013

2013-01-01

208

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

SciTech Connect

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

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

2011-06-01

209

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

2011-09-01

210

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

211

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

212

What are the effects of group cognitive behaviour therapy for voices? A randomised control trial  

Microsoft Academic Search

BackgroundLittle evidence exists for the effects of psychological treatment on voices even though it is clear that CBT does affect delusions and symptoms overall. This study tested whether a group based on cognitive behavioural principles could produce beneficial effects on hallucinations.

Til Wykes; Peter Hayward; Neil Thomas; Nicola Green; Simon Surguladze; Dominic Fannon; Sabine Landau

2005-01-01

213

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

214

The effect of acupuncture on stroke recovery: study protocol for a randomized controlled trial  

PubMed Central

Background Stroke is one of the leading causes of death and disability in China. Current treatments for stroke are limited and achieve no optimal effect. Acupuncture is widely used in the treatment of stroke and in improving the quality of life for patients in China. In most previous clinical studies, the effects of acupuncture have been diverse, and few well-designed randomized controlled trials have been conducted to investigate the long-term effect of acupuncture on acute stroke recovery. Method Three hundred and twenty eight subjects with acute cerebral apoplexy will be recruited. The patients will be randomized into two different groups: the intervention group will receive acupuncture treatment together with Western standard treatment for 2 weeks plus the secondary prevention treatment for 22 weeks; the control group will receive only the Western standard treatment for 2 weeks and the secondary prevention treatment for 22 weeks. The primary outcome measures are Barthel Index and the Stroke-Specific Quality Of Life. The secondary outcome measures are the National Institutes of Health Stroke Scale and Modified Rankin Scale. All assessments will be conducted at the baseline and at weeks 4, 12 and 24 of follow-up. Discussion This study will evaluate the effects of acupuncture on the long-term recovery of acute stroke and on improving the quality of life of the patients. The results of this study will help establish optimal integrated therapeutic strategies for patients with stroke. Trial registration Current Controlled Trials ISRCTN29932220 PMID:23145765

2012-01-01

215

Multiple Hypotheses Testing Procedures in Clinical Trials and Genomic Studies  

PubMed Central

We review and compare multiple hypothesis testing procedures used in clinical trials and those in genomic studies. Clinical trials often employ global tests, which draw an overall conclusion for all the hypotheses, such as SUM test, Two-Step test, Approximate Likelihood Ratio test (ALRT), Intersection-Union Test (IUT), and MAX test. The SUM and Two-Step tests are most powerful under homogeneous treatment effects, while the ALRT and MAX test are robust in cases with non-homogeneous treatment effects. Furthermore, the ALRT is robust to unequal sample sizes in testing different hypotheses. In genomic studies, stepwise procedures are used to draw marker-specific conclusions and control family wise error rate (FWER) or false discovery rate (FDR). FDR refers to the percent of false positives among all significant results and is preferred over FWER in screening high-dimensional genomic markers due to its interpretability. In cases where correlations between test statistics cannot be ignored, Westfall-Young resampling method generates the joint distribution of P-values under the null and maintains their correlation structure. Finally, the GWAS data from a clinical trial searching for SNPs associated with nephropathy among Type 1 diabetic patients are used to illustrate various procedures. PMID:24350232

Pan, Qing

2013-01-01

216

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

PubMed Central

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

2011-01-01

217

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 PMID:23587364

2013-01-01

218

Impact of recent findings on study design of future autism clinical trials.  

PubMed

There are specific challenges to studying the design of pharmacologic trials in child/adolescent and adult autism, such as subject stratification and parallel versus crossover designs. This article describes how optimal study design is influenced by subject selection and outcome measures chosen. Lessons learned in study design from the Research Units on Pediatric Psychopharmacology Autism Network trial with risperidone, Seaver Center trials with fluoxetine and valproate, Dartmouth trials with amantadine, and National Institutes of Health secretin trials are highlighted. The Internet System for Assessing Autistic Children system for managing multicenter clinical trials in autism and statistical issues in autism research are also described. PMID:14999175

Hollander, Eric; Phillips, Ann; King, Bryan H; Guthrie, Donald; Aman, Michael G; Law, Paul; Owley, Thomas; Robinson, Ricki

2004-01-01

219

Manual and Electroacupuncture for Labour Pain: Study Design of a Longitudinal Randomized Controlled Trial  

PubMed Central

Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women's experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950. PMID:22577468

Vixner, Linda; Martensson, Lena B.; Stener-Victorin, Elisabet; Schytt, Erica

2012-01-01

220

Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial  

PubMed Central

Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure ?30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method. Trial registration ClinicalTrials.gov Identifier: NCT01374022 PMID:22929542

2012-01-01

221

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

Microsoft Academic Search

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

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

2011-01-01

222

Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)  

Microsoft Academic Search

Backgroundandpurpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270).Materialsandmethods: Independent audits to assess compliance with eligibility\\/exclusion criteria and appropriateness of

Daniel E. Roos; Sidney R. Davis; Sandra L. Turner; Peter C. O'Brien; Nigel A. Spry; Bryan H. Burmeister; Peter J. Hoskin; David L. Ball

2003-01-01

223

Space Station concept development group studies  

NASA Technical Reports Server (NTRS)

The NASA study activities in preparation for a Space Station began in the early 1970's. The early studies included many in-house NASA and contracted studies. A group of representatives from all the NASA Centers, titled the Space Station Concept Development Group (CDG) was involved in the studies which led to the initiation of the Space Station Program. The CDG studies were performed over a period of approximately one year and consisted of four phases. The initial phase had the objective to determine the functions required of the station as opposed to a configuration. The activities of the second phase were primarily concerned with a sizing of the facilities required for payloads and the resources necessary to support these mission payloads. The third phase of studies was designed to develop a philosophical approach to a number of areas related to autonomy, maintainability, operations and logistics, and verification. The fourth phase of the study was to be concerned with configuration assessment activities.

Powell, L. E.

1984-01-01

224

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

225

A generalised model for individualising a treatment recommendation based on group-level evidence from randomised clinical trials  

PubMed Central

Objectives Randomised controlled trials report group-level treatment effects. However, an individual patient confronting a treatment decision needs to know whether that person's expected treatment benefit will exceed the expected treatment harm. We describe a flexible model for individualising a treatment decision. It individualises group-level results from randomised trials using clinical prediction guides. Methods We constructed models that estimate the size of individualised absolute risk reduction (ARR) for the target outcome that is required to offset individualised absolute risk increase (ARI) for the treatment harm. Inputs to the model include estimates for the individualised predicted absolute treatment benefit and harm, and the relative value assigned by the patient to harm/benefit. A decision rule recommends treatment when the predicted benefit exceeds the predicted harm, value-adjusted. We also derived expressions for the maximum treatment harm, or the maximum relative value for harm/benefit, above which treatment would not be recommended. Results For the simpler model, including one kind of benefit and one kind of harm, the individualised ARR required to justify treatment was expressed as required ARRtarget(i)=ARIharm(i)?×?RVharm/target(i). A complex model was also developed, applicable to treatments causing multiple kinds of benefits and/or harms. We demonstrated the applicability of the models to treatments tested in superiority trials (either placebo or active control, either fixed harm or variable harm) and non-inferiority trials. Conclusions Individualised treatment recommendations can be derived using a model that applies clinical prediction guides to the results of randomised trials in order to identify which individual patients are likely to derive a clinically important benefit from the treatment. The resulting individualised prediction-based recommendations require validation by comparison with strategies of treat all or treat none. PMID:23943775

Marcucci, Maura; Sinclair, John C

2013-01-01

226

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 PMID:22880056

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

2012-01-01

227

Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial  

PubMed Central

Background Several studies using acupuncture to treat essential hypertension have been carried out. However, whether acupuncture is efficacious for hypertension is still controversial. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for patients with mild hypertension. Methods/Design This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. We will recruit 428 hypertensive patients with systolic blood pressure (SBP) between 140 and 159 mmHg, diastolic blood pressure (DBP) between 90 and 99 mmHg. The participants will be randomly assigned to four different groups (three acupuncture groups and one waiting list group) (1).The affected meridian acupuncture group (n?=?107) is treated with acupoints on the affected meridians (2).The non-affected meridian acupuncture group (n?=?107) is treated with acupoints on the non-affected meridians (3).The invasive sham acupuncture group (n?=?107) is provided with sham acupoints treatment (4).The waiting-list group (n?=?107) is not offered any intervention until they complete the trial. Each patient allocated to acupuncture groups will receive 18 sessions of acupuncture treatment over 6 weeks. This trial will be conducted in 11 hospitals in China. The primary endpoint is the change in average 24-hSBP before and 6 weeks after randomization. The secondary endpoints are average SBP and average DBP during the daytime and night-time, and 36-Item Short Form Survey (SF-36), and so on. Discussion This is the first large scale, multicenter, randomized, sham controlled trial of acupuncture for essential hypertension in China. It may clarify the efficacy of acupuncture as a treatment for mild hypertension. Trial registration Clinicaltrials.gov Identifier: NCT01701726 PMID:24216113

2013-01-01

228

Attraction to Group, Group Cohesiveness, and Individual Outcome: A Study of Training Groups.  

ERIC Educational Resources Information Center

Examined relationships between attraction to group and individual outcome in groups and between group cohesiveness and individual outcome in groups in four groups of 27 graduate students participating in a group psychotherapy experiential training program. Results revealed that attraction to group and group cohesiveness were both related to…

Wright, Thomas L.; Duncan, Douglas

1986-01-01

229

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

E-print Network

Generalizing from Clinical Trial Data: A Case Study. The Risk of Suicidality Among Pediatric University, Columbus, OH 3 Center for Innovation in Pediatric Practice, Columbus Children's Research of suicidality among pediatric antidepressant users. 1. Introduction Randomized clinical trials (RCTs

230

Gemcitabine for malignant mesothelioma: A phase II trial by the Cancer and Leukemia Group B  

Microsoft Academic Search

Purpose: The CALGB conducted a phase II multicenter trial to evaluate the activity of gemcitabine in malignant mesothelioma (CALGB protocol 9530). Patients and methods: Seventeen patients were accrued between February 1996 and May 1996 and received gemcitabine 1500 mg\\/m2 by intravenous infusion over 30 min weekly for 3 weeks, followed by a 1 week break. Eligibility included a performance status

Hedy L. Kindler; Frederick Millard; James E. Herndon II; Nicholas J. Vogelzang; Yasunosuke Suzuki; Mark R. Green

2001-01-01

231

Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial  

PubMed Central

Background The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care. Methods/designs This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n?=?106) and the usual care group (n?=?106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach. Discussion This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis. Trial registration Trial registration number: KCT0000130 PMID:23497032

2013-01-01

232

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 PMID:23289548

2013-01-01

233

Medicare Clinical Trial Policy Phase I and Phase II Studies  

Cancer.gov

National Cancer Institute National Cancer Institute Clinical Trials Advisory Committee (CTAC) Meeting Clinical Trials Advisory Committee (CTAC) Meeting December 8, 2008 December 8, 2008 Leslye K. Fitterman, PhD Leslye K.

234

Plasma exchange in Canada. The Canadian Apheresis Study Group.  

PubMed Central

Since 1982 the Canadian Apheresis Study Group (CASG) has collected data on plasma exchange activities in Canada. In 1987, 5907 such procedures were carried out on 700 patients for more than 22 different diseases; this represented an increase of 28% over the figure for 1982. A shift in activity has occurred over the years; originally hematologic disorders accounted for most of the procedures; however, in 1987, 60% of the exchanges were done to treat neurologic disorders, mainly myasthenia gravis and acute and chronic Guillain-Barré syndrome. Several prospective randomized clinical trials have recently been completed by the CASG in the hope of determining the optimal application of plasma exchange. These studies, currently under review, include 168 patients with multiple sclerosis, 100 with thrombotic thrombocytopenic purpura and 43 with rapidly progressive glomerulonephritis. Reactions occur in 12% of cases; they are usually minor and are limited to circumoral paresthesia, mild hypertension or hypotension and hives. PMID:2178759

Rock, G A; Tricklebank, G W; Kasaboski, C A

1990-01-01

235

Stanford University Glossary of Clinical Trials Terms  

E-print Network

Stanford University HRPP Glossary of Clinical Trials Terms {From http://clinicaltrials.gov/ct2/info A clinical trial is "Blind" if participants are unaware of whether they are in the experimental or control arm of the study; also called masked. CONTROLLED TRIALS In clinical trials, one group is given

Puglisi, Joseph

236

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial  

PubMed Central

Background Migraine is one of the most frequent headache diseases and impairs patients’ quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG). Methods This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4?weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist’s supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson’s progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12?weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires. Discussion The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis. Trial registration The trial is registered at ClinicalTrials.gov: NCT01407861. PMID:22540391

2012-01-01

237

Balancing collective responsibility, individual opportunities and risks: a qualitative study on how police officers reason around volunteering in an HIV vaccine trial in Dar es Salaam, Tanzania  

Microsoft Academic Search

BACKGROUND: Results from HIV vaccine trials on potential volunteers will contribute to global efforts to develop an HIV vaccine. The purpose of this study among police officers in Dar es Salaam, Tanzania, was to explore the underlying reasons that induce people to enrol in an HIV vaccine trial. METHODS: We conducted discussions with eight focus groups, containing a total of

Edith A. M. Tarimo; Anna Thorson; Thecla W. Kohi; Joachim Mwami; Muhammad Bakari; Eric Sandström; Asli Kulane

2010-01-01

238

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

PubMed Central

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

2013-01-01

239

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

PubMed Central

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

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

2014-01-01

240

Metacognition and Group Differences: A Comparative Study  

ERIC Educational Resources Information Center

In this study, metacognition refers to performing visual analysis and discrimination of real life events and situations in naïve psychology, naïve physics, and naïve biology domains. It is used, along with measuring reaction time, to examine differences in the ability of four groups of students to select appropriate pictures that correspond with…

Al-Hilawani, Yasser A.

2014-01-01

241

Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial  

PubMed Central

Background There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study. Methods Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue. Results Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval ?15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable. Conclusions Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans. Trial registration ISRCTN29666484 PMID:23768153

2013-01-01

242

Increasing Adherence to Obstructive Sleep Apnea Treatment with a Group Social Cognitive Therapy Treatment Intervention: A Randomized Trial  

PubMed Central

Objective: To examine whether a social cognitive therapy (SCT) intervention increases continuous positive airway pressure (CPAP) use compared to equivalent social interaction (SI) time. Participants: Individuals with obstructive sleep apnea (OSA) referred for CPAP therapy. Intervention: Participants received a 30-min group education session regarding OSA and CPAP. Groups of three to four participants were then randomly assigned to an SCT session or social interaction. Measurements: CPAP usage was assessed at 7 nights, then 1, 3, and 6 months. The two primary outcomes were adherence, usage ? 4 h per night at 6 months, and uptake of CPAP. Questionnaires were given pretreatment and posttreatment. Results: Two hundred six individuals were randomized to SI (n = 97) or SCT (n = 109). CPAP uptake was not different between groups (82% in SI, 88% in SCT groups, P = 0.35). There were no differences between groups in adherence: 63-66% at 1 week, and at 6 months 55-47% (P = 0.36). Higher pretreatment apnea-hypopnea index, higher baseline self-efficacy, and use of CPAP (? 4 h) at 1 week were independent predictors of CPAP adherence at 6 months. CPAP adherence increased by a factor of 1.8 (odds ratio = 1.8, 95% confidence interval 1.1-3.0) for every one-unit increase in self-efficacy. There was no difference between groups postintervention in self-efficacy scores, sleepiness, mood, or sleep quality. Conclusions: In this randomized trial, a single SCT application did not increase adherence when compared with SI time. Although self-efficacy scores prior to CPAP predicted adherence, self-efficacy was not increased by the interventions. Increasing intensity and understanding of SCT interventions may be needed to improve CPAP adherence. Clinical Trials Registration: Australian New Zealand Clinical Trials Registry, ACTRN12607000424404. Citation: Bartlett D; Wong K; Richards D; Moy E; Espie CA; Cistulli PA; Grunstein R. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial. SLEEP 2013;36(11):1647-1654. PMID:24179297

Bartlett, Delwyn; Wong, Keith; Richards, Dianne; Moy, Emma; Espie, Colin A.; Cistulli, Peter A.; Grunstein, Ronald

2013-01-01

243

Evaluation of a group based cognitive behavioural therapy programme for menstrual pain management in young women with intellectual disabilities: protocol for a mixed methods controlled clinical trial  

PubMed Central

Background Menstrual pain which is severe enough to impact on daily activities is very common amongst menstruating females. Research suggests that menstrual pain which impacts on daily functioning may be even more prevalent amongst those with intellectual disabilities. Despite this, little research attention has focused on pain management programmes for those with intellectual disabilities. The aims of this pilot study were to develop and evaluate a theory-based cognitive behavioural therapy (CBT) programme for menstrual pain management in young women with intellectual disabilities. Methods/Design The study utilised a mixed methods controlled clinical trial to evaluate elements from a CBT programme called Feeling Better (McGuire & McManus, 2010). The Feeling Better programme is a modular, manualised intervention designed for people with an intellectual disability and their carers. The programme was delivered to 36 young women aged 12 – 30 years who have a Mild - Moderate Intellectual Disability, split between two conditions. The treatment group received the Feeling Better intervention and the control group received treatment as usual. To evaluate the effectiveness of the programme, measures were taken of key pain variables including impact, knowledge, self-efficacy and coping. Process evaluation was conducted to examine which elements of the programme were most successful in promoting change. Discussion Participants in the intervention group were expected to report the use of a greater number of coping strategies and have greater knowledge of pain management strategies following participation in the intervention and at three month follow-up, when compared to control group participants. A significant advantage of the study was the use of mixed methods and inclusion of process evaluation to determine which elements of a cognitive behavioural therapy programme work best for individuals with intellectual disabilities. Trial registration Current Controlled Trials ISRCTN75567759 PMID:25201648

2014-01-01

244

The Effect of Group Reminiscence on the Cognitive Status of Elderly People Supported by Ilam Welfare Organization in 2013; A Randomized Controlled Clinical Trial  

PubMed Central

Background: Cognitive impairments, which are common problems among the elderly people, account for a wide range of aging disorders. Group reminiscence can be used as a profitable therapeutic method for preventing cognitive-behavioral disorders in older adults. Therefore, we aimed to investigate the effect of group reminiscence on the cognitive status of elderly people. Methods: This study was a non-blinded randomized controlled trial. We enrolled 100 elderly people who were under the support of Ilam Welfare Organization, western Iran in 2013. Balanced block randomization method was used to randomize the participants into intervention and control groups.Elderly people in the intervention group participated in a group reminiscence program consisted of two one-hour sessions per week for 8 consecutive weeks. Data were collected using Mini Mental State Examination (MMSE). The questionnaire was completed four times by the participants; before, immediately after, two and three months after the intervention. Results: The mean±SD of cognitive status scores in the intervention group was 24.66±3.8 which increased to 25.02±3.67, 25.04±3.72 and 24.72±3.66 immediately after, two and three months after the intervention respectively. The results showed that the changes in the mean scores were statistically significant in the intervention group immediately after the intervention (P=0.001) and at second month (P=0.003) follow-ups. However, we found no statistically significant difference in the intervention group at the mentioned time intervals in this regards (P=1.000).  Conclusion: We concluded that continuous programs of group reminiscence could improve cognitive status of elderly population. Trial Registration Number: IRCT201405147531N7 PMID:25349866

Jahanbin, Iran; Mohammadnejad, Sara; Sharif, Farkhondeh

2014-01-01

245

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

PubMed Central

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). The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries. Methods A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees. Results Six broad, interrelated factors influenced the intervention's impact: (1) acceptability; (2) a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3) community involvement beyond the groups; (4) a focus on marginalized communities; (5) the active recruitment of newly pregnant women into groups; (6) high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial. Conclusions Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to local contexts. Scaling-up such interventions requires (1) a detailed understanding of the way in which context affects the acceptability and delivery of the intervention; (2) planned but flexible replication of key content and implementation features; (3) strong support for participatory methods from implementing agencies. PMID:20969787

2010-01-01

246

Quality control in multicentric clinical trials. An experience of the EORTC Gynecological Cancer Cooperative Group. | accrualnet.cancer.gov  

Cancer.gov

The authors conducted a data quality study for a European Organization for Research and Treatment of Cancer (EORTC) multicenter randomized phase III treatment trial focusing on cervical cancer. Analysis of the causes of inaccuracies revealed problems in data management, but the investigators also associated some errors with lack of clarity in the protocol and case report forms (CRFs).

247

Workplace health concerns: a focus group study.  

PubMed

Addresses the workplace health concerns of employees at an Acute Hospital Trust. The research conducted utilised a focus group methodology to investigate the health concerns of multidisciplinary groups of health care workers (n = 27). The findings indicate that the concern for the majority was workplace stress. Stressors that were identified as important to the groups were for example, the nature of the work they were undertaking, staffing levels, volume of the work, management styles and their work environments. Health promotion and prevention topics such as motivation and health status, smoking, alcohol and drug misuse, nutrition and weight control and physical exercise were seen of subsidiary concern. Limitations of the study are given. Future research in the subject area is identified. PMID:10747454

Jinks, A M; Daniels, R

1999-01-01

248

Usefulness of C-reactive protein testing in acute cough/respiratory tract infection: an open cluster-randomized clinical trial with C-reactive protein testing in the intervention group  

PubMed Central

Background Point of care testing for C-reactive protein (CRP) has shown promise as a measure to reduce unnecessary antibiotic prescribing in respiratory tract infections (RTI), but its use in primary care is still controversial. We aimed to evaluate the effect of CRP testing on the prescription of antibiotics, referral for radiography, and the outcome of patients in general practice with acute cough/RTI. Methods An open-cluster randomized clinical trial was conducted, with CRP testing performed in the intervention group. Antibiotic prescribing and referral for radiography were the main outcome measures. Results A total of 179 patients were included: 101 in the intervention group and 78 in the control group. The two groups were similar in clinical characteristics. In the intervention group, the antibiotic prescribing rate was 37.6%, which was significantly lower than that in the control group (58.9%) (P?=?0.006). Referral for chest X-ray was also significantly lower in the intervention group (55.4%) than in the control group (75.6%) (P?=?0.004). The recovery rate, as recorded by the GPs, was 92.9% and 93.6% in the intervention and control groups, respectively. Conclusion The study showed that CRP testing in patients with acute cough/RTI may reduce antibiotic prescribing and referral for radiography, probably without compromising recovery. Trial registration The trial was registered in the ClinicalTrials.gov Protocol Registration System (identification number: NCT01794819). PMID:24886066

2014-01-01

249

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

PubMed Central

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

2014-01-01

250

Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study  

PubMed Central

Objectives To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Design Cross sectional study. Data sources Cochrane Database of Systematic Reviews. Selection criteria Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Results Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Conclusions Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews. PMID:22906823

2012-01-01

251

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial  

PubMed Central

Background Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. Methods/Design This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%. The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. Discussion The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. Trial registration U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153 PMID:24341348

2013-01-01

252

Assessment of osteopontin in early breast cancer: correlative study in a randomised clinical trial  

PubMed Central

Introduction Osteopontin (OPN) is a malignancy-associated glycoprotein that contributes functionally to tumor aggressiveness. In metastatic breast cancer, we previously demonstrated that elevated OPN in primary tumor and blood was associated with poor prognosis. Methods We measured OPN in plasma by ELISA, and in tumors by immunohistochemistry, in 624 (94%) and 462 (69%), respectively, of 667 postmenopausal women with hormone responsive early breast cancer treated by surgery followed by adjuvant treatment with tamoxifen +/? octreotide in a randomized trial (NCIC CTG MA.14; National Cancer Institute of Canada Clinical Trials Group Mammary.14). Results Plasma OPN was measured in 2,540 samples; 688 at baseline and 1,852 collected during follow-up. Mean baseline plasma OPN was 46 ng/ml (range 22.6 to 290) which did not differ from normal levels. Mean percentage OPN tumor cell positivity was 33.9 (95% CI: 30.2 to 37.9). There was no correlation between plasma and tumor OPN values. In multivariate analysis, neither was associated with event-free survival (EFS), relapse-free survival (RFS), overall survival (OS), bone RFS or non-bone RFS. An exploratory analysis in patients with recurrence showed higher mean OPN plasma levels 60.7 ng/ml (23.9 to 543) in the recurrence period compared with baseline levels. Conclusions The hypothesis that OPN tumor expression would have independent prognostic value in early breast cancer was not supported by multivariate analysis of this study population. Plasma OPN levels in women with hormone responsive early breast cancer in the MA.14 trial were not elevated and there was no evidence for prognostic value of plasma OPN in this defined group of patients. However, our finding of elevated mean OPN plasma level around the time of recurrence warrants further study. Trial registration NCT00002864, http://clinicaltrials.gov/show/NCT00002864 PMID:24451146

2014-01-01

253

Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design.  

PubMed

The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non-advancement appliance (MNA); and (c) no intervention. The appliances were custom made, in one piece. The MAAs had a mean protrusion of the mandible of 74% (range 64-85%). Outcome measures, assessed after continuous use for 4 weeks, were AHI (polysomnography), daytime sleepiness (Epworth) and quality of life (SF-36). Eighty-one patients (87%) completed the trial. The MAA group achieved mean AHI and Epworth scores significantly lower (P < 0.001 and P < 0.05) than the MNA group and the no-intervention group. No significant differences were found between the MNA group and the no-intervention group. The MAA group had a mean AHI reduction of 14.1 (95% CI 7.4-20.8), and a mean Epworth score reduction of 3.3 (95% CI 1.8-4.8). Eight MAA patients (30%) achieved a reduction in AHI > or = 75% ending with an AHI < 5, half of them having baseline AHI > 30. Sensitivity analyses confirmed these results. MAA had a significant beneficial effect on the vitality domain of SF-36. Four MAA patients (14.8%) and two MNA patients (8%) discontinued interventions because of adverse effects. Our conclusion is that MAA has significant beneficial effects on OSA, including cure in some cases of severe OSA. Protrusion of the mandible is essential for the effect. MNA has no placebo effect. MAA may be a good alternative to CPAP in subsets of OSA patients. PMID:18482111

Petri, Niels; Svanholt, Palle; Solow, Beni; Wildschiødtz, Gordon; Winkel, Per

2008-06-01

254

An experimental and trial study on the second- generation MSTP  

NASA Astrophysics Data System (ADS)

With the explosive growth of data services, SDH/SONET network, which is designed for voice traffic, is required to be optimized for data services. SDH-based Multi-Service Transport Platform (MSTP), which greatly improves the data capabilities of SDH networks, has been attracting much interest of vendors as well as network operators. As a leading operator in China, we have conducted a field trial study and extensive experiments on MSTP. In this paper, we present the results of our experiments. It is verified via extensive experiments that the products from some leading vendors conform to the standards. In addition, it is shown that the performance of the new value-added metro Ethernet services is highly satisfied, i.e., with tight QOS guarantees and flexible bandwidth that fits the user"s requirement exactly. We have also performed experiments for multi-vendors interoperability, and the results are highly satisfied, paving the way for large scale deployment of 2G MSTP. Our trial work showed MSTP can be used to optimize the existing metro networks, i.e., to improve the utilization of the fiber and the bandwidth that are used to carry the ADSL traffic and the IP traffic. In addition, MSTP presents a new array of opportunities for operators to increase their revenues.

Xiao, Xiaojun; Yang, Liu; Zuo, Jian

2004-04-01

255

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

Microsoft Academic Search

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

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

2001-01-01

256

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

PubMed

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

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

2010-06-01

257

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.

258

BOLD correlates of trial-by-trial reaction time variability in gray and white matter: a multi-study fMRI analysis  

Microsoft Academic Search

Background: Reaction time (RT) is one of the most widely used measures of performance in experimental psychology, yet relatively few fMRI studies have included trial-by-trial differences in RT as a predictor variable in their analyses. Using a multi- study approach, we investigated whether there are brain regions that show a general relationship between trial-by-trial RT variability and activation across a

Tal Yarkoni; Deanna M. Barch; Jeremy R. Gray; Thomas E. Conturo; Todd S. Braver

2009-01-01

259

Allocation of patients to treatment groups in a controlled clinical study.  

PubMed Central

In a controlled clinical study ("clinical trial") to compare 2 or more treatments for a disease, an objective method of allocating patients to treatment groups is needed. Various existing methods of allocation are described, including those which take account of patients' pre-treatment characteristics. PMID:350254

White, S. J.; Freedman, L. S.

1978-01-01

260

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) PMID:23482332

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

2013-01-01

261

Recruitment and retention of under-represented groups with health disparities into clinical trials: a formative approach.  

PubMed

We evaluated the perceived success of recruitment and retention protocols for Native Hawaiian/Pacific Islander/Filipino populations. These three groups were found to have a significantly higher incidence of health disparities than the general population. Training applications of selected vignettes were also generated. Focus groups and questionnaires were used to achieve the objective: identification of themes related to facilitators and deterrents to participation in clinical trials in these populations. This mixed methods approach evaluated promotional materials preferred. Responses to animated videos and vignettes with actors regarding clinical research participation were analyzed. Participants included adults of Hawaiian/Pacific Islander or Filipino ethnicity. Analysis included grounded theory methods, such as constant comparative techniques. The results revealed that attention to the following categories is essential: culturally sensitive knowledge, attitudes, and beliefs related to individuals, families and communities. These themes are recommended as the structure for future interventions to improve participation and retention within these groups. PMID:23377577

Harrigan, Rosanne; Perez, Michael H; Beaudry, Steven; Johnson, Crystal; Sil, Payel; Mead, Kau'ion?lani; Apau-Ludlum, Noelani

2014-10-01

262

The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial  

PubMed Central

Background Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes in thyroid cells. Previous randomized controlled trials have found that selenium supplementation decreases thyroid-disease-specific antibody levels. We hypothesize that selenium might be beneficial in the treatment of chronic autoimmune thyroiditis. Methods/Design The CATALYST trial is an investigator-initiated randomized, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis. Inclusion criteria: age ?18 years; serum thyroid peroxidase antibody level ?100 IU/ml within the previous 12 months; treatment with levothyroxine and written informed consent. Exclusion criteria: previous diagnosis of toxic nodular goitre, Graves’ hyperthyroidism, postpartum thyroiditis, Graves’ orbitopathy; previous antithyroid drug treatment, radioiodine therapy or thyroid surgery; immune-modulatory or other medication affecting thyroid function; pregnancy, planned pregnancy or breastfeeding; allergy towards any intervention or placebo component; intake of selenium supplementation >55 ?g/day; inability to read or understand Danish or lack of informed consent. The trial will include 2?×?236 participants. The experimental intervention and control groups will receive 200 ?g selenium-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise®. The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire. Secondary outcomes include serum thyroid peroxidase antibody concentration; serum triiodothyronine/thyroxine ratio; levothyroxine dosage; adverse reactions and serious adverse reactions and events. Discussion In this pragmatic trial, participating patients follow their usual treatment at their usual hospitals. In order to collect high-quality data on the clinical course and quality of life, and to minimize missing data, an elaborate trial management system has been designed. 12 months intervention duration was selected in consideration of the primary outcome, thyroid-related quality of life. Trial registration ClinicalTrials.gov ID: NCT02013479. PMID:24716668

2014-01-01

263

Group hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol  

PubMed Central

Background A significant number of smokers would like to stop smoking. Despite the demonstrated efficacy of pharmacological smoking cessation treatments, many smokers are unwilling to use them; however, they are inclined to try alternative methods. Hypnosis has a long-standing reputation in smoking cessation therapy, but its efficacy has not been scientifically proven. We designed this randomised controlled trial to evaluate the effects of group hypnosis as a method for smoking cessation, and we will compare the results of group hypnosis with group relaxation. Methods/Design This is a randomised controlled trial (RCT) to compare the efficacy of a single session of hypnosis with that of relaxation performed in groups of 8-15 smokers. We intend to include at least 220 participants in our trial. The inclusion criteria include smoking at least 5 cigarettes per day, not using other cessation methods and being willing to quit smoking. The intervention is performed by a trained hypnotist/relaxation therapist. Both groups first receive 40 min of mental preparation that is based on motivational interviewing. Then, a state of deep relaxation is induced in the hypnosis condition, and superficial relaxation is induced in the control condition. Suggestions are made in the hypnosis condition that aim to switch the mental self-image of the participants from that of smokers to that of non-smokers. Each intervention lasts for 40 min. The participants also complete questionnaires that assess their smoking status and symptoms of depression and anxiety at baseline, 2 weeks and 6 months post-intervention. In addition, saliva samples are collected to assess cotinine levels at baseline and at 6 months post-intervention. We also assess nicotine withdrawal symptoms at 2 weeks post-intervention. Discussion To the best of our knowledge, this RCT is the first to test the efficacy of group hypnosis versus group relaxation. Issues requiring discussion in the outcome paper include the lack of standardisation of hypnotic interventions in smoking cessation, the debriefing of the participants, the effects of group dynamics and the reasons for dropouts. Trial registration Current Controlled Trials, ISRCTN72839675. PMID:22475087

2012-01-01

264

Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial  

PubMed Central

Background Aortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the ‘gold standard’ treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses. Methods and design First, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery. Discussion This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient’s morphological characteristics. Trial registration ClinicalTrials.gov Identifier: NCT01522352 PMID:24299218

2013-01-01

265

2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference.  

PubMed

2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer. This report provides the outcomes from the Fourth Ovarian Cancer Consensus Conference. PMID:21543936

Stuart, Gavin C E; Kitchener, Henry; Bacon, Monica; duBois, Andreas; Friedlander, Michael; Ledermann, Jonathan; Marth, Christian; Thigpen, Tate; Trimble, Edward

2011-05-01

266

The SHED-IT community trial study protocol: a randomised controlled trial of weight loss programs for overweight and obese men  

PubMed Central

Background Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men. Methods and Design The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology) study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II) and randomised to one of three groups: (1) SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure) with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group (Resources, Online, and Control), time (treated as categorical with levels baseline, 3-months and 6-months) and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants. Discussion Our study will compare evidence-based and theoretically driven, low cost and easily disseminated strategies specifically targeting weight loss in men. The SHED-IT community trial will provide evidence to inform development and dissemination of sustainable strategies to reduce obesity in men. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN12610000699066) PMID:21078200

2010-01-01

267

Randomised controlled trials in education research: a case study of an individually randomised pragmatic trial  

Microsoft Academic Search

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

Carole J. Torgerson

2009-01-01

268

Clinical Trials  

MedlinePLUS

Clinical Trials What is a clinical trial? A clinical trial is a study carried out in human volunteers to help doctors learn more about the human body and ... work. What can I gain from joining a clinical trial? You will: • Take a more active role in ...

269

The effectiveness of a training for patients with unexplained physical symptoms: protocol of a cognitive behavioral group training and randomized controlled trial  

PubMed Central

Background In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training. Methods and design A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial. Discussion If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group in the daily practice of a mental healthcare institution, its transfer to practice should be relatively easy. Trial registration Nederlands Trial Register, NTR1609 PMID:19619297

Zonneveld, Lyonne NL; van 't Spijker, Adriaan; Passchier, Jan; van Busschbach, Jan J; Duivenvoorden, Hugo J

2009-01-01

270

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

PubMed Central

Objectives To 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). Methods Two-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 (weekly) 2 h sessions, and consolidation session (week 14). Control participants received fatigue self-management information in a 1 h didactic group session. Primary outcome at 18 weeks was the impact of fatigue measured using two methods (Multi-dimensional Assessment of Fatigue (MAF) 0–50; VAS 0–10), analysed using intention-to-treat analysis of covariance with multivariable regression models. Results Of 168 participants randomised, 41 withdrew before entry and 127 participated. There were no major baseline differences between the 65 CBT and 62 control participants. At 18 weeks CBT participants reported better scores than control participants for fatigue impact: MAF 28.99 versus 23.99 (adjusted difference ?5.48, 95% CI ?9.50 to ?1.46, p=0.008); VAS 5.99 versus 4.26 (adjusted difference ?1.95, 95% CI ?2.99 to ?0.90, p<0.001). Standardised effect sizes for fatigue impact were MAF 0.59 (95% CI 0.15 to 1.03) and VAS 0.77 (95% CI 0.33 to 1.21), both in favour of CBT. Secondary outcomes of perceived fatigue severity, coping, disability, depression, helplessness, self-efficacy and sleep were also better in CBT participants. Conclusions Group CBT for fatigue self-management in RA improves fatigue impact, coping and perceived severity, and well-being. Trial registration: ISRCTN 32195100 PMID:21540202

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

2011-01-01

271

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

PubMed Central

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

2014-01-01

272

Renormalization group study of random quantum magnets  

E-print Network

We have developed a very efficient numerical algorithm of the strong disorder renormalization group method to study the critical behaviour of the random transverse-field Ising model, which is a prototype of random quantum magnets. With this algorithm we can renormalize an N-site cluster within a time N*log(N), independently of the topology of the graph and we went up to N~4*10^6. We have studied regular lattices with dimension D<=4 as well as Erdos-Renyi random graphs, which are infinite dimensional objects. In all cases the quantum critical behaviour is found to be controlled by an infinite disorder fixed point, in which disorder plays a dominant role over quantum fluctuations. As a consequence the renormalization procedure as well as the obtained critical properties are asymptotically exact for large systems. We have also studied Griffiths singularities in the paramagnetic and the ferromagnetic phases and generalized the numerical algorithm for another random quantum systems.

István A. Kovács; Ferenc Iglói

2011-09-20

273

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

PubMed Central

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

2014-01-01

274

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial  

PubMed Central

Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. Trial registration ISRCTN48600346 PMID:23035669

2012-01-01

275

A sham controlled trial of transurethral microwave therapy with subsequent treatment of the control group.  

PubMed

To investigate whether there is a significant placebo component to the improvements seen after 1-session transurethral microwave treatment, 40 patients with significant symptoms of prostatism and unequivocally benign glands were recruited to take part in a sham controlled study. After an active treatment the mean American Urological Association symptom scores improved by 63% (19.2 to 7.1) while after a sham treatment symptom scores improved only marginally (18.8 to 16.2, p < 0.001). Residual volumes decreased by 50% (104 to 52 ml.) and flow rates increased by 2.3 ml. per second after an active treatment with no improvement after a sham treatment. There was a consistently greater improvement after an active treatment compared to a sham treatment. Patients who had received a sham treatment were then offered an active treatment and showed improvements similar to those in the original actively treated group and much greater than after the original sham treatment. Mean symptom scores decreased from 16.2 to 9.9 (p < 0.004). Residual volumes decreased from 94 to 40 ml. (p < 0.005) and flow rates increased by 1.6 ml. per second, while these same criteria had deteriorated after a sham treatment. Side effects were mild and short lived, with no patients reporting sexual dysfunction as a consequence of treatment. Transurethral microwave therapy is an effective well tolerated treatment for select patients with benign prostatic hypertrophy and the placebo effect of treatment is minimal. PMID:7516979

Bdesha, A S; Bunce, C J; Snell, M E; Witherow, R O

1994-08-01

276

Augmented Therapy Improves Outcome For Pediatric High Risk Acute Lymphocytic Leukemia: Results Of Children's Oncology Group Trial P9906  

PubMed Central

Background The augmented BFM regimen improves outcome for children with NCI high acute lymphoblastic leukemia (ALL). Patient age, sex, and presenting white blood cell count (WBC) can be used to identify a subset of approximately 12% of children with B-precursor ALL that had a 5-year continuous complete remission (CCR) rate of only about 50% on earlier Pediatric Oncology Group (POG) trials. Procedures Children’s Oncology Group trial P9906 evaluated a modified augmented BFM regimen in 267 patients with particularly high risk B-precursor ALL. Minimal residual disease (MRD) was assessed in blood at day 8 and in marrow at day 29 of Induction and correlated with outcome. Results The 5-year CCR probability for patients in P9906 was significantly better than that observed for similar patients on POG trials 8602/9006 (62.2 ±3.7% versus 50.6 ±2.4%; p=0.0007) but similar to POG 9406 (63.5±2.4%; p=0.81). Interim analysis showed poor central nervous system (CNS) control, especially in patients with initial WBC ?100,000/microliter. Day 29 marrow MRD positive (>=0.01%) vs. negative patients had 5 year CCR rates of 37.1±7.4% vs. 72.6±4.3%; day 8 blood MRD positive vs. negative patients had 5 year CCR rates of 57.1 ±4.6 % vs.83.6±6.3%. End induction marrow MRD predicted marrow but not CNS relapse. In multivariate analysis, day 29 MRD>0.01%, initial WBC?100,000/µl, male gender, and day 8 blood MRD>0.01% were significant prognostic factors. Conclusions Augmented BFM therapy improved outcome for children with higher risk ALL. Day 8 blood and day 29 marrow MRD were strong prognostic factors in these patients. PMID:21360654

Bowman, W. Paul; Larsen, Eric L; Devidas, Meenakshi; Linda, Stephen B.; Blach, Laurie; Carroll, Andrew J; Carroll, William L; Pullen, D. Jeanette; Shuster, Jonathan; Willman, Cheryl L; Winick, Naomi; Camitta, Bruce M; Hunger, Stephen P; Borowitz, Michael J

2011-01-01

277

Combined modality trials in unresectable stage III non-small cell lung cancer: the Cancer and Leukemia Group B experience.  

PubMed

Lung cancer remains the leading cause of cancer-related mortality in the United States and 30% to 40% of newly diagnosed patients with non-small cell lung cancer present with regionally advanced and unresectable stage III disease. Combined-modality therapy is the current standard of care in patients with good performance status at the time of diagnosis and recent trials have suggested a survival advantage for the concurrent use of chemotherapy and thoracic radiation therapy at the risk of increased toxicity (mainly esophagitis and myelosuppression). The Cancer and Leukemia Group B has been instrumental in shaping the standard of care in the combined-modality approach to unresectable stage III non-small cell lung cancer. Currently, Cancer and Leukemia Group B is conducting trials evaluating novel thoracic radiation therapy strategies as well as the incorporation of molecularly targeted agents, yielding encouraging preliminary data. In addition, a change in the therapeutic platform is planned that explores a full-dose systemic approach with the antifolate pemetrexed that possesses radiosensitizing properties. PMID:16015547

Socinski, Mark A

2005-04-01

278

Environmental studies group. Annual report for 1978  

SciTech Connect

Group projects included radioecological studies of aquatic and terrestrial systems, land management activities, foodstuff monitoring, dust transport studies including fugitive dust measurements and modeling, and several support programs involving evaluation of the plant's ambient air samplers and airborne tritium monitoring techniques. Some salient results from the several project reports include determination of an appropriate model for mechanically generated fugitive dust dispersion, a radionuclide inventory of Smart Ditch Pond (Pond D-1), a coefficient of community determination for two terrestrial sample plots on the plant site buffer zone, a natality and mortality rate determination for fawns in the plant deer herd (including one positive coyote-kill determination), inlet loss and filter paper collection efficiencies for the plant ambient air samplers, and differential tritium sampling measurements of the vapor in Building 771 stack effluent.

Hunt, D. C.; Hurley, J. D. [eds.] [eds.

1980-08-21

279

Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial  

PubMed Central

Introduction Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3?months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in ‘at-risk’ individuals. Methods/analysis Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18–75?years, with acute LBP (<4?weeks’ duration) preceded by at least a 1?month pain-free period and at-risk of developing chronic LBP. Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded. Eligible participants who agree to take part will be randomly allocated to receive 2×1?h sessions of pain biology education or 2×1?h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3?months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1?week post-intervention, and at 3, 6 and 12?months post LBP onset. Ethics/dissemination Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings. Trial registration number https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808 PMID:24889854

Traeger, Adrian C; Moseley, G Lorimer; Hubscher, Markus; Lee, Hopin; Skinner, Ian W; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; McAuley, James H

2014-01-01

280

Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues  

PubMed Central

Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784). PMID:22439919

2012-01-01

281

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

PubMed Central

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

2013-01-01

282

Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial  

PubMed Central

Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. PMID:24143917

2013-01-01

283

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

284

Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials  

PubMed Central

Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

2014-01-01

285

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial  

PubMed Central

Background In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of ‘Smoke Free Homes’, an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. Methods/Design This is a pilot cluster randomised controlled trial of ‘Smoke Free Homes’, with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. Discussion The results of this pilot study will inform the protocol for a definitive trial. Trial registration Current Controlled Trials ISRCTN03035510 PMID:24034853

2013-01-01

286

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

PubMed

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

Whyte, Susan Reynolds

2014-11-01

287

[Clinical single case study (n-of-1 trial)].  

PubMed

We conducted a single case (N-of-1) randomized trial in two patients. In the first case with bronchiolitis obliterans after lung transplantation a beneficial effect of inhaled steroids could be documented. The second patient suffered from symptoms compatible with HIV-associated M. Addison improving after cortisone, but the adrenocortical function was normal. Because the patient required the cortison treatment to be continued, we performed a n-of-1 trial which demonstrated the inefficacy of cortisone. This experience underscores the feasibility and usefulness of N-of-1 randomized clinical trials in medical practice. PMID:9789474

Speich, R

1998-09-01

288

Single dental implant retained mandibular complete dentures - influence of the loading protocol: study protocol for a randomized controlled trial  

PubMed Central

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

2014-01-01

289

Effects of tai chi program on neuromuscular function for patients with knee osteoarthritis: study protocol for a randomized controlled trial  

PubMed Central

Background Knee osteoarthritis (OA) is a major cause of disability as well as a burden on healthcare resources. Tai chi has been proposed as an alternative and complementary treatment for the management of knee osteoarthritis, but there appears to be no consensus on its usefulness. This study aims to develop an innovative tai chi rehabilitation program (ITCRP) for patients with knee OA, and to investigate the effect of ITCRP intervention on a range of outcomes including pain, function, balance, neuromuscular response, and biomechanics in knee OA. Methods/Design We will conduct a prospective, single-blind, randomized controlled trial of 140 individuals with symptomatic knee OA. Patients will be randomly assigned into either an ITCRP group or a control group. The ITCRP group will participate in tai chi two or three times a week for 6 months. The control group will receive health education. After the 6-month intervention period, there will be a 6-month follow-up period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 6 months, and 12 months. Primary outcome measures will be a visual analog scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index,and the Lequesne Knee Score. The secondary outcome measures will include the Berg balance scale, knee and ankle proprioception, neuromuscular response, and 3D functional biomechanics. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysiswill be performed. Discussion Important features of this trial include the randomization procedures, large sample size, and a standardized protocol for ITCRP for knee OA. This study aims to determine the feasibility of ITCRP for knee OA and provide data on the effects of ITCRP. Hence, our results will be useful for patients with knee OA as well as for medical staff and healthcare decision makers. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-13003264. PMID:24195862

2013-01-01

290

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

PubMed Central

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

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

2011-01-01

291

Clinical Trials  

MedlinePLUS

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

292

Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial.  

PubMed

In a long-standing fear-of-flying program, persons with fear of flying (N=150) were after a diagnostic assessment and individual preparation phase randomly assigned to either a 1-day behavioral group treatment (BGT) program, a 2-day cognitive-behavioral group treatment (CBGT) program or a waiting list (WL) control group. A post-treatment flight on a commercial airline measured participants' ability to fly. Different self-report flight anxiety questionnaires were completed before, during and after treatment at 3-, 6- and 12-month follow-up. Results indicated that both treatments were superior to the WL, and equally effective on the flying test and later independent flying, but also that the 2-day CBGT program was significantly more effective than the 1-day BGT program on subjective measures of fear and self-efficacy. PMID:16828460

Van Gerwen, Lucas J; Spinhoven, Philip; Van Dyck, Richard

2006-12-01

293

Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study  

PubMed Central

Summary Background Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer. Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy. The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer. Methods From 85 centres in four countries, 1408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were randomly allocated by a minimisation method to standard surgery (hysterectomy and BSO, peritoneal washings, and palpation of para-aortic nodes; n=704) or standard surgery plus lymphadenectomy (n=704). The primary outcome measure was overall survival. To control for postsurgical treatment, women with early-stage disease at intermediate or high risk of recurrence were randomised (independent of lymph-node status) into the ASTEC radiotherapy trial. Analysis was by intention to treat. This study is registered, number ISRCTN 16571884. Findings After a median follow-up of 37 months (IQR 24–58), 191 women (88 standard surgery group, 103 lymphadenectomy group) had died, with a hazard ratio (HR) of 1·16 (95% CI 0·87–1·54; p=0·31) in favour of standard surgery and an absolute difference in 5-year overall survival of 1% (95% CI ?4 to 6). 251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), with an HR of 1·35 (1·06–1·73; p=0·017) in favour of standard surgery and an absolute difference in 5-year recurrence-free survival of 6% (1–12). With adjustment for baseline characteristics and pathology details, the HR for overall survival was 1·04 (0·74–1·45; p=0·83) and for recurrence-free survival was 1·25 (0·93–1·66; p=0·14). Interpretation Our results show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early endometrial cancer. Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials. Funding Medical Research Council and National Cancer Research Network. PMID:19070889

2009-01-01

294

A geometric study of Fibonacci groups  

Microsoft Academic Search

. Fibonacci groups are recovered as fundamental groups of certain closed hyperbolic 3-manifolds. This is achieved by constructing compact hyperbolic polyhedra in dimension3 which are fundamental domains of torsion free lattices in SL 2 (C) . Their presentation can beread off by classical methods. This presentation can easily be given standard Fibonacci form.IntroductionIf a group G is only given by

H. Helling; A. C. Kim; J. L. Mennicke

1998-01-01

295

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

PubMed Central

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

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

2013-01-01

296

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

PubMed

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

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

2013-06-01

297

Study of therapeutic hypothermia (32 to 35?C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial  

PubMed Central

Background Clinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates. In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol. Methods All aspects of the pilot phase of the trial were conducted as for the main trial. The pilot phase had oversight by independent Steering and Data Monitoring committees. Results Forty sites across 12 countries gained ethical approval. Thirty seven of 40 sites were initiated for recruitment. Of these, 29 had screened patients and 21 randomized at least one patient. Lead times to ethics approval (6.8 weeks), hospital approval (18 weeks), interest to set up (61 weeks), set up to screening (11 weeks), and set up to randomization (31.6 weeks) are comparable with other international trials. Sixteen per cent of screened patients were eligible. We found 88% compliance rate with trial protocol. Conclusion The pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered. Trial registration Current Controlled Trials: ISRCTN34555414. PMID:24004918

2013-01-01

298

Randomised clinical trial of a group parent education programme for Australian Indigenous families  

Microsoft Academic Search

Aim: Parenting programmes have been shown to improve children's adjustment and reduce problem behaviour; however, little research has addressed outcomes for Indigenous families. The aim of this project was to assess the impact and cultural appropriateness of a parenting programme tailored for Indigenous families, an adaptation of the evidence-based Group Triple P - Positive Parenting Program. Methods: A repeated measures

Karen MT; Mary Richards Turner; Matthew R Sanders

2007-01-01

299

A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis  

Microsoft Academic Search

BACKGROUND: To study the relation between reported drug performance in published trials and support of the trials by the manufacturer of the drug under evaluation, we studied a sample of trials of nonsteroidal anti-inflammatory drugs (NSAIDs) used in the treatment of arthritis. METHODS: All randomized control trials of NSAIDs published between September 1987 and May 1990 identified by MEDLINE were

Paula A. Rochon; Jerry H. Gurwitz; Robert W. Simms; Paul R. Fortin; David T. Felson; Kenneth L. Minaker; Thomas C. Chalmers

1994-01-01

300

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

PubMed Central

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

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

2014-01-01

301

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

Microsoft Academic Search

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

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

2011-01-01

302

Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study  

PubMed Central

Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. Conclusions Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial. PMID:24913438

2014-01-01

303

Clinical Study on the Prevention of Oxaliplatin-Induced Neurotoxicity with Guilongtongluofang: Results of a Randomized, Double-Blind, Placebo-Controlled Trial  

PubMed Central

Objective. Oxaliplatin-induced peripheral neurotoxicity continues to be a kind of frequent dose-limiting toxicity for many cancer patients. This study evaluated the preventive effects of Guilongtongluofang on peripheral neurotoxicity induced by oxaliplatin in patients with colorectal tumor. Patients and Methods. From May 2007 to May 2011, we conducted a randomized, double-blind, placebo-controlled trial. 120 patients of colorectal cancer treated with adjuvant oxaliplatin-based chemotherapy were randomly enrolled into the trial group and the control group. The trial group received Guilongtongluofang (at a dose of 200?mL once a day) from 3 days prior to chemotherapy. The control group received a placebo from 3 days prior to chemotherapy. Every 2-week cycle, neurotoxicity was evaluated using numeric rating scale for pain intensity and experienced relief. The primary endpoint was efficacy measurement which included oxaliplatin-induced neurotoxicity and tumor response. The differences of side effects between the two groups were also analyzed. Results. The percentage of grades 1-2 neurotoxicity was significantly lower in the trial group than that in the control group (13.3% versus 20.0%; P < 0.05) after two cycles of treatment. The difference of the percentage of neurotoxicity between the two groups was significant after six cycles (51.7% versus 70.0%; P < 0.05). Significant difference for the mean time to the development of grade 1+ neurotoxicity was found between the two groups (9.4?w in the trial group versus 6.5?w in the control group, P < 0.05). The cumulative incidence of grade 1 or more sensory neurotoxicity was significantly lower in the trial group than that in the control group (P < 0.05). No significant differences of tumor response rate were found between the two groups the trial group and the control group. No significant difference was found between the trial group and the control group (all P > 0.05). Conclusion. This study provides evidence that Guilongtongluofang is a promising drug for the prevention of oxaliplatin-induced neurotoxicity in patients with colorectal cancer, and it does not reduce the efficacy of oxaliplatin. PMID:24324514

Liu, Yunfang; Zhu, Guangying; Han, Li; Liu, Jie; Ma, Ting; Yu, Huiming

2013-01-01

304

Administration of B-group vitamins reduces circulating homocysteine in polycystic ovarian syndrome patients treated with metformin: a randomized trial  

Microsoft Academic Search

BACKGROUND: The aim of the current study was to assess the effects of B-group vitamins and folic acid admin- istration on serum levels of homocysteine (Hcy) in patients with polycystic ovarian syndrome (PCOS) on short- term metformin treatment. METHODS: Patients were randomly assigned to one of three treatment groups. Group 1 patients (n 5 20) received metformin (850mg twice daily);

Esra Bulgan Kilicdag; Tayfun Bagis; Ebru Tarim; Erdogan Aslan; Serkan Erkanli; Erhan Simsek; Bulent Haydardedeoglu; Esra Kuscu

2005-01-01

305

A randomized controlled trial of group cognitive-behavioral therapy vs. enhanced supportive therapy for auditory hallucinations  

Microsoft Academic Search

There has been little research examining group cognitive-behavioral therapy (CBT) for schizophrenia, especially compared to an active control treatment. The purpose of this study was to investigate the effectiveness of group CBT for auditory hallucinations compared to an enhanced supportive therapy (ST). Sixty five participants with schizophrenia spectrum disorders and persistent hallucinations were randomly assigned to group CBT or enhanced

David L. Penn; Piper S. Meyer; Elizabeth Evans; R. J. Wirth; Karen Cai; Margaret Burchinal

2009-01-01

306

Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial.  

PubMed

The objective of this study was to compare the effectiveness of electroacupuncture and TENS for low back pain when the electroacupuncture is applied in a clinically realistic manner. The study was designed as an evaluator-blinded randomised controlled trial (RCT). The study was performed at the Tsukuba College of Technology Clinic in Japan. Twenty subjects, who suffered from low back pain (LBP) without sciatica, were recruited, using leaflets in Tsukuba city. Subjects were allocated to either an electroacupuncture (EA) group (10 patients) or a transcutaneous electrical nerve stimulation (TENS) group (10 patients). The procedure for EA was in accordance with standard practice at our clinic. The main outcome measures were a pain relief scale (100 mm visual analogue scale: VAS) and a LBP score recommended by the Japanese Orthopaedic Association (JOA Score). Mean VAS value during the 2-weeks experimental period of the EA group was significantly smaller than that of the TENS group (65 mm vs 86 mm; 95% CI, 4.126 - 37.953). JOA Score in the EA group improved significantly while that in the TENS group showed no change. Although some placebo effect may be included, EA appeared more useful than TENS in the short-term effect on low back pain. We suggest that more realistic acupuncture interventions based on standard practice should be employed in pragmatic RCTs. PMID:12512791

Tsukayama, Hiroshi; Yamashita, Hitoshi; Amagai, Hitoshi; Tanno, Yasuo

2002-12-01

307

Gamified physical activation of young men - a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study)  

PubMed Central

Background Inactive and unhealthy lifestyles are common among adolescent men. The planned intervention examines the effectiveness of an interactive, gamified activation method, based on tailored health information, peer networks and participation, on physical activity, health and wellbeing in young men. We hypothesize that following the intervention the physical activation group will have an improved physical activity, as well as self-determined and measured health compared with the controls. Methods/design Conscription-aged men (18 years) attending compulsory annual call-ups for military service in the city of Oulu in Finland (n?=?1500) will be randomized to a 6-months intervention (n?=?640) or a control group (n?=?640) during the fall 2013. A questionnaire on health, health behaviour, diet and wellbeing is administered in the beginning and end of the intervention. In addition, anthropometric measures (height, weight and waist circumference), body composition, grip strength, heart rate variability and aerobic fitness will be measured. The activation group utilizes an online gamified activation method in combination with communal youth services, objective physical activity measurement, social networking, tailored health information and exercise programs according to baseline activity level and the readiness of changes of each individual. Daily physical activity of the participants is monitored in both the activation and control groups. The activation service rewards improvements in physical activity or reductions in sedentary behaviour. The performance and completion of the military service of the participants will also be followed. Discussion The study will provide new information of physical activity, health and health behaviour of young men. Furthermore, a novel model including methods for increasing physical activity among young people is developed and its effects tested through an intervention. This unique gamified service for activating young men can provide a translational model for community use. It can also be utilized as such or tailored to other selected populations or age groups. Trial registration ClinicalTrials.gov Identifier: NCT01376986 PMID:23311678

2013-01-01

308

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study)  

PubMed Central

Background Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements. PMID:22928744

2012-01-01

309

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

PubMed Central

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

2013-01-01

310

Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial  

PubMed Central

Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session. Clinical Trials Registry ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1 PMID:21929768

2011-01-01

311

Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial  

PubMed Central

Background Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam. Methods and Findings In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73–1.25]). There was a significant downward time trend of NMR in intervention communes (p?=?0.003) but not in control communes (p?=?0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30–0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07–4.8]). Conclusions A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period. Trial registration Current Controlled Trials ISRCTN44599712 Please see later in the article for the Editors' Summary PMID:23690755

Persson, Lars Ake; Nga, Nguyen T.; Malqvist, Mats; Thi Phuong Hoa, Dinh; Eriksson, Leif; Wallin, Lars; Selling, Katarina; Huy, Tran Q.; Duc, Duong M.; Tiep, Tran V.; Thi Thu Thuy, Vu; Ewald, Uwe

2013-01-01

312

PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial  

PubMed Central

Introduction Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach. Methods and analysis 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36?h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV. Ethics and dissemination Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results. Trial registration number Australian New Zealand Clinical Trials Registry—ACTRN12614000589684. PMID:25394818

Cooke, Marie; Rickard, Claire; Rapchuk, Ivan; Shekar, Kiran; Marshall, Andrea P; Comans, Tracy; Doi, Suhail; McDonald, John; Spooner, Amy

2014-01-01

313

Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non–small cell lung cancer  

Microsoft Academic Search

ObjectivesThe American College of Surgeons Oncology Group undertook a trial to ascertain whether positron emission tomography with 18F-fluorodeoxyglucose could detect lesions that would preclude pulmonary resection in a group of patients with documented or suspected non–small cell lung cancer found to be surgical candidates by routine staging procedures.

Carolyn E Reed; David H Harpole; Katherine E Posther; Sandra L Woolson; Robert J Downey; Bryan F Meyers; Robert T Heelan; Homer A MacApinlac; Sin-Ho Jung; Gerard A Silvestri; Barry A Siegel; Valerie W Rusch

2003-01-01

314

Group Communication Speci cations: A Comprehensive Study  

E-print Network

, and Roman Vitenberg The Technion Department of Computer Science. View-oriented group communication light on the usefulness of the presented speci#12;cations. This paper is aimed at both system builders and theoretical researchers. The speci#12;cation framework presented in this paper will help builders of group

Keidar, Idit

315

Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial  

PubMed Central

Background Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients’ mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. Methods/design The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. Discussion The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD. This novel treatment format, if shown effective, could represent a cost-effective option and could further be modified to treat other conditions, as well. Trial registration ISRCTN75894275 PMID:24735420

2014-01-01

316

Clinical guidelines for the management of neutropenic patients with unexplained fever in Japan: validation by the Japan Febrile Neutropenia Study Group  

Microsoft Academic Search

The Japan Febrile Neutropenia Study Group (JFNSG) Trial was a multicenter, open, randomized study designed to validate the first Japanese guidelines for the management of neutropenic cancer patients with unexplained fever issued in 1998. The trial compared cefepime monotherapy with cefepime plus amikacin combination therapy in febrile neutropenic patients with hematological disorders. The JFNSG found that monotherapy with cefepime was,

Kazuo Tamura

2005-01-01

317

STUDIES ON THE PSITTACOSIS-LYMPHOGRANULOMA GROUP  

PubMed Central

Because of the peculiar properties of the psittacosis-lymphogranuloma group of viruses, the pattern of multiplication in the allantois of the chick embryo of one of their number, meningopneumonitis virus, was studied. This was done by determination of the changes in its infectivity for mice and chick embryos. Titration of infectivity in embryos proved to be a more sensitive procedure than titration in mice; the latter procedure however, had the advantage of greater simplicity and gave more clear-cut results. The mouse titration method was used in most of the experiments. Following inoculation of virus into the allantois, there was a slow decrease in infectivity in the allantoic fluids followed by an increase due to appearance of new virus between 24 and 48 hours. The slope of declining infectivity in the allantoic fluids in ovo was similar if not identical with the slope of decreasing infectivity in allantoic fluids in vitro caused by thermal degradation of virus. Multiplication of the virus in allantoic membranes was characterized by the following pattern: (a) Increase in infectivity in the first few hours (exact duration of increase depended on concentration of virus in inoculum) due to adsorption of virus. (b) Decrease in infectivity up to about 20 to 24 hours. (c) Increase in infectivity due to appearance of the new generation of virus. The growth curve of meningopneumonitis is analyzed and the pattern of growth is discussed in the light of the present concepts of viral multiplication. PMID:14888822

Sigel, M. Michael; Girardi, Anthony J.; Allen, Emma G.

1951-01-01

318

Acupuncture in treatment of carpal tunnel syndrome: A randomized controlled trial study  

PubMed Central

BACKGROUND: Carpal tunnel syndrome (CTS) is the most preva lent form of peripheral neuropathy. The efficacy of acupuncture in management of mild to moderate CTS has been investigated in limited studies with controversial results. The aim of this study was to assess the short-term effects of acupuncture in treatment of mild to moderate carpal tunnel syndrome. METHODS: In a randomized controlled trial study, participants were randomly assigned to either control group which night splinting, vitamin B1, B6 and sham acupuncture for four weeks were administered, or intervention group that underwent acupuncture in 8 sessions over 4 weeks and night splinting. The clinical symptoms using global symptom score (GSS) and electrophysiological parameters were assessed at baseline and four weeks after the intervention. RESULTS: Of 72 patients met the inclusion criteria, 64 patients actually completed the 4 week intervention and were evaluated for the outcome. There was a statistically significant difference in GSS between two arms of treatment after the intervention (p < 0.001) Using repeated measure ANOVA, the GSS in acupuncture group was significantly different after 4 weeks (p <0.001). Among electrophysiological parameters, nerve conduction velocity (NCV) was significantly different between two groups after 4 weeks (p = 0.02). Other parameters showed no statistically significant difference after intervention (p > 0.05). CONCLUSIONS: Our findings indicated that the acupuncture can improve the overall subjective symptoms of carpal tunnel syndrome and could be adopted in comprehensive care programs of these patients. PMID:23248650

Khosrawi, Saeid; Moghtaderi, Alireza; Haghighat, Shila

2012-01-01

319

Selenium supplementation for patients with Graves’ hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial  

PubMed Central

Background Graves’ hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmune hypothyroidism and on Graves' orbitopathy, but the effects of selenium on Graves' hyperthyroidism is unknown. We hypothesize that adjuvant selenium may be beneficial in the treatment of Graves' hyperthyroidism. The objective is to investigate if selenium supplementation plus standard treatment with anti-thyroid drugs versus standard treatment with anti-thyroid drugs will lead to a decrease in anti-thyroid drug treatment failure (that is, failure to remain euthyroid, without further treatment, one year after cessation of anti-thyroid drug treatment), faster and longer lasting remission (that is, anti-thyroid drug treatment success), and improved quality of life in patients with Graves’ hyperthyroidism. Methods and design The trial is an investigator-initiated, randomised, blinded, multicentre clinical trial. Inclusion criteria are: age 18 years or older; diagnosis of active Graves' hyperthyroidism within the last two months; and informed consent. Exclusion criteria are major co-morbidity; previous radioactive iodine treatment; ongoing anti-thyroid drug treatment for more than two months; treatment with immunomodulatory drugs; known allergy towards the components in the selenium and placebo pills; pregnancy or breast-feeding; and intake of selenium supplementation above 70 ?g per day. We plan to include 492 participants, randomised (1:1) to two tablets of 100 ?g selenium once daily for the 24 to 30 months intervention period versus two identical placebo tablets once daily. The primary outcome is the proportion of participants with anti-thyroid drug treatment failure (see above) at the end of the intervention period (24 to 30 months). Secondary outcomes are: thyroid-specific quality of life during the first year after randomisation; level of thyroid stimulating hormone-receptor antibodies at 18 months after randomisation and at the end of the intervention period (24 to 30 months); hyperthyroid symptoms during the first year after randomisation; eye symptoms during the first year after randomisation, and at the end of the intervention period (24 to 30 months); adverse reactions during the intervention period; and serious adverse events during the intervention period. Discussion It was of great importance to the initiators of this trial, that the results would be directly applicable to daily clinical practice. Therefore, it was designed as a pragmatic trial: the patients follow their usual treatment at their usual hospitals. In order to still collect high quality data on the clinical course and quality of life, an elaborate trial management system was designed to keep track of patient input, need for trial personnel input and action, and to collect data from medical chart systems. Meticulous follow-up on missing responses to the QoL measurements has been incorporated into the system, to minimise missing quality of life data. Monitoring of adverse reactions and events is achieved by thorough instruction of the participants, surveillance of patient-reported outcomes, and integration with national databases regarding hospitalizations. A very long intervention period was necessary, since patients are not considered in remission until one year after stopping anti-thyroid drugs. Usually, patients are treated for 12 to 18 months with anti-thyroid drugs, yielding a total intervention period of 24 to 30 months. Trial registration ClinicalTrials.gov: NCT01611896. PMID:23782950

2013-01-01

320

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial  

PubMed Central

Background Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines. In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. Methods/Design This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Discussion Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage. Trial registration www.clinicaltrials.gov Identifier: NCT01258257 PMID:21917146

2011-01-01

321

Group Therapy for Patients with Mild Cognitive Impairment and Their Significant Others: Results of a Waiting-List Controlled Trial  

Microsoft Academic Search

Background: Patients with mild cognitive impairment (MCI) have to deal with an uncertain prognosis and also face a multitude of memory-related problems and psychosocial consequences. A newly developed group programme proved to be feasible, however, it needed confirmation by a controlled study. Aim: This controlled study evaluates this group therapy for MCI patients aimed to help them accept and manage

Liesbeth W. A. Joosten-Weyn Banningh; Judith B. Prins; Myrra J. F. J. Vernooij-Dassen; Hugo H. Wijnen; Marcel G. M. Olde Rikkert; Roy P. C. Kessels

2011-01-01

322

Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations  

Microsoft Academic Search

Abstract\\u000a\\u000aCurrently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary outcome and consequently COPD treatment guidelines do not indicate a preference for either bronchodilator. Therefore, an international, randomized, double-blind, double-dummy, parallel-group clinical trial has been designed to

K. M. Beeh; B. Hederer; T. Glaab; A. Müller; M. P. M. H. Rutten-van Mölken; S. Kesten; C. Vogelmeier

2009-01-01

323

Acupuncture for dry eye syndrome after refractive surgery: study protocol for a randomized controlled trial  

PubMed Central

Background Dry eye syndrome is a frequent complication of refractive surgery. Acupuncture has been widely used to alleviate the associated symptoms. However, the use of acupuncture for patients who suffer from dry eye syndrome following refractive surgery has certain drawbacks. This pilot study aims to evaluate the efficacy of acupuncture treatment in treating the signs and symptoms of dry eye syndrome after refractive surgery. Methods/design Forty participants will be randomly assigned to the acupuncture plus usual care group or the usual care control group. The acupuncture plus usual care group will undergo treatments on seventeen acupuncture points, three times per week for four weeks. The control group will receive only usual care during the same period. The primary outcomes will be scores on the Ocular Surface Disease Index (OSDI) and the results of examinations at 1, 3, 5, and 13 weeks. The secondary outcomes will be Tear Film Break-up Time (TBUT), as well as scores on the Schirmer-I test, visual analog scale (VAS), and quality of life (QOL) questionnaire for the self-assessment of ocular discomfort. Digital photographs will be taken to document the pattern of fluorescein staining observed on the corneal surface. The results of the Schirmer-I test, TBUT, and fluorescein-stained corneal surface digital photographs will be assessed at the screening and at week 13. VAS scores will be assessed at the screening, as well as at 1, 3, 5, and 13 weeks. QOL will be evaluated at 1, 3, 5, and 13 weeks. Discussion This trial will provide primary data with which to investigate the clinical effectiveness and safety of acupuncture treatment for dry eye syndrome after refractive surgery. Trial registration Current Controlled (Identifier: KCT0000727) PMID:24156469

2013-01-01

324

A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial  

PubMed Central

Background There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention. Methods/design The primary outcome measure is change in body mass index standardised deviation score at 12 months. The secondary aim is to compare the effect of treatment on secondary outcomes, including waist circumference, insulin sensitivity, quality of life, physical activity and psychosocial health. Adolescents with a body mass index at or above the 98th percentile (12 to 17 years) will be recruited from the Obesity clinic at Temple Street Children’s University Hospital in Dublin, Ireland. W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months. In the current study, participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application. One hundred and thirty-four participants will be randomised between the two study arms. An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months. Discussion The results of this study will be disseminated via open access publication and will provide important information for clinicians, patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity. Trial registration Clinicaltrials.gov NCT01804855. PMID:24485327

2014-01-01

325

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

PubMed Central

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

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

2013-01-01

326

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. PMID:19732837

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

2010-01-01

327

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

PubMed Central

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

2012-01-01

328

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

329

Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters  

PubMed Central

Background Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs). Methods Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on exercise adherence and performance, providing outside monitoring of exercise adherence, varying the exercise routine, encouraging group exercise and competition, and scheduling exercise during each work shift. PMID:23515182

Mayer, John M; Nuzzo, James L; Dagenais, Simon

2013-01-01

330

Parameters for Sample Size Estimation from a Group-Randomized HIV Prevention Trial in HIV Clinics in Sub-Saharan Africa.  

PubMed

Sample size calculations for a group-randomized trial (GRT) require an estimate of the expected intraclass correlation coefficient (ICC). However, few ICC estimates from GRTs in HIV/AIDS research have been published, leaving investigators with little data on which to base expectations. We used data from a multi-country study to estimate ICCs for variables related to physical and mental health and HIV risk behaviors. ICCs for perceptions of physical and mental health tended to be higher than those for HIV risk behavior variables, which were higher than ICCs for CD4 count. Covariate adjustment for country and socio-demographic variables reduced most ICC estimates. For risk behavior variables, adjustment for country and socio-demographic variables reduced ICC estimates by as much as 84 %. Variability in ICC estimates has important implications for study design, as a larger ICC reduces power. ICC estimates presented in this analysis will allow more precise sample size estimates for future GRTs. PMID:24146070

Zhang, Jun; Pals, Sherri L; Medley, Amy; Nichols, Catherine; Bachanas, Pam; van Zyl, Deon; Katuta, Frieda; Juma, James

2014-12-01

331

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial  

PubMed Central

Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH?=?day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

2013-01-01

332

Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial  

PubMed Central

Introduction Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. Methods and analysis The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65?years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16?weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients. Ethics and dissemination All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement. Trial registration number UMIN Clinical Trials Registry: UMIN000001218. PMID:25335963

Nakagawa, Atsuo; Sado, Mitsuhiro; Mitsuda, Dai; Fujisawa, Daisuke; Kikuchi, Toshiaki; Abe, Takayuki; Sato, Yuji; Iwashita, Satoru; Mimura, Masaru; Ono, Yutaka

2014-01-01

333

Cognitive Distance, Absorptive Capacity and Group Rationality: A Simulation Study  

PubMed Central

We report the results of a simulation study in which we explore the joint effect of group absorptive capacity (as the average individual rationality of the group members) and cognitive distance (as the distance between the most rational group member and the rest of the group) on the emergence of collective rationality in groups. We start from empirical results reported in the literature on group rationality as collective group level competence and use data on real-life groups of four and five to validate a mathematical model. We then use this mathematical model to predict group level scores from a variety of possible group configurations (varying both in cognitive distance and average individual rationality). Our results show that both group competence and cognitive distance are necessary conditions for emergent group rationality. Group configurations, in which the groups become more rational than the most rational group member, are groups scoring low on cognitive distance and scoring high on absorptive capacity. PMID:25314132

Curseu, Petru Lucian; Krehel, Oleh; Evers, Joep H. M.; Muntean, Adrian

2014-01-01

334

Angiogenic gene therapy for heart disease: a review of animal studies and clinical trials  

Microsoft Academic Search

The current published clinical literature on angiogenic gene therapy for the treatment of myocardial ischemia does not include a single randomized, placebo-controlled trial. Based on current clinical literature, it is an unproven therapy. Successful animal studies combined with published reports of good outcomes in patients enrolled in uncontrolled trials has led to the expectation that angiogenic gene therapy will ultimately

H. Kirk Hammond; M. Dan McKirnan

2001-01-01

335

Social Studies Now!: Put Storybook Characters on Trial to Spark Students' Interest in the Justice System.  

ERIC Educational Resources Information Center

This social studies activity helps primary students understand the trial process by putting literary characters on trial (e.g., Goldilocks for breaking and entering or Cruella DeVille for stealing dalmatians). Alternatively, students can try real-life problems such as bullying on the playground. Through role playing, students learn how the justice…

Lindquist, Tarry

1998-01-01

336

No short-cut in assessing trial quality: a case study  

PubMed Central

Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review. PMID:19128475

Hirji, Karim F

2009-01-01

337

Group Processes and EFL Learners' Motivation: A Study of Group Dynamics in EFL Classrooms  

ERIC Educational Resources Information Center

This study explores how group processes, such as group cohesiveness and group norms, influence an individual EFL learner's motivation. The uniqueness of this research lies in shifting the focus from an analysis of the individual's experience being seen as apart from the group to considering the individual's experience in relation to the social…

Chang, Lilian Ya-Hui

2010-01-01

338

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

339

Comparison of forgiveness and anger-reduction group treatments: A randomized controlled trial  

Microsoft Academic Search

Interventions to promote forgiveness are effective. However, in what ways and in comparison to what other treatments is still unresolved. College students (n=112) who had been hurt in the past and struggled to overcome their negative experiences of it participated in this study. They were randomly assigned to one of two treatments, one focused on promoting forgiveness and one focused

Daniel B. Goldman; Nathaniel G. Wade

2012-01-01

340

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

PubMed Central

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

2013-01-01

341

Results of an intervention study to improve communication about randomised clinical trials of cancer therapy. | accrualnet.cancer.gov  

Cancer.gov

The authors conducted an intervention study to improve communication during consultation about randomized trials. Questionnaires were used to collect information about patients’ information needs and their attitudes toward clinical trials. The Preferences for Information Questionnaire was helpful to doctors in understanding their patients’ interest in receiving specific details about clinical trials. The Patient Attitudes to Trials Questionnaire accurately predicted which patients would consent to enroll in the trials they were offered.

342

The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial  

PubMed Central

Background Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Design BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3. Discussion The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755). PMID:23835026

2013-01-01

343

Which cancer clinical trials should be considered for economic evaluation? Selection criteria from the National Cancer Institute of Canada's Working Group on Economic Analysis.  

PubMed

Rising health care costs, expensive new health care technologies and increasing patient expectations are placing huge pressures on the publicly funded health care system in Canada. As a result, policy makers need information on the cost and cost-effectiveness of new therapies in addition to their clinical benefits. In response to this need, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) established a Working Group on Economic Analysis (WGEA) to provide advice on the economic evaluation of new cancer therapies. This article describes the WGEA's recommendations on which trials should be considered for concurrent analysis of economic, as well as related issues, such as the number of patients required for an economic analysis within a prospective clinical trial and the selection of participating centres. The recommendations in this document are meant to be pragmatic, as the WGEA recognizes that both the research funds and human resource capacity for this type of research in Canada are limited. These recommendations are currently guiding priority setting with regard to trials for economic evaluation in NCIC trials. Examples of how these recommendations have been applied to actual trials are presented. PMID:14733759

Evans, William K; Coyle, Douglas; Gafni, Amiram; Walker, Hugh

2003-01-01

344

Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol  

PubMed Central

Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for M?ori (indigenous), Pacific and non-M?ori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs. Trial Registration ACTRN12611000164998 PMID:21718543

2011-01-01

345

Group Communication Specifications: A Comprehensive Study  

E-print Network

of Jerusalem Computer Science Institute, Idit Keidar MIT Laboratory for Computer Science, and Roman Vitenberg. This paper is aimed at both system builders and theoretical researchers. The specification framework presented in this paper will help builders of group communication systems understand and specify

Keidar, Idit

346

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

PubMed Central

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

2012-01-01

347

Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials  

PubMed Central

Background: Tumour biopsy for pharmacodynamic (PD) study is increasingly common in early-phase cancer trials. As they are non-diagnostic, the ethical justification for such procedures rests on their knowledge value. On the premise that knowledge value is related to reporting practices and outcome diversity, we assessed in a sample of recent invasive PD studies within cancer trials. Methods: We assessed reporting practices and outcomes for PD studies in a convenience sample of cancer trials published from 2000 to 2010 that employed invasive, non-diagnostic tissue procurement. Extracted data were used to measure outcome reporting in individual trials. Using a reporting scale we developed for exploratory purposes, we tested whether reporting varied with study characteristics, such as funding source or drug novelty. Results: Reporting varied widely within and across studies. Some practices were sporadically reported, including results of all planned tests (78% trials reporting), use of blinded histopathological assessment (43% trials reporting), biopsy dimensions (38% trials reporting), and description of patient flow through PD analysis (62%). Pharmacodynamic analysis as a primary end point and mandatory biopsy had statistically significant positive relationships with overall quality of reporting. A preponderance of positive results (61% of the studies described positive PD results) suggests possible publication bias. Conclusion: Our results highlight the need for PD-reporting guidelines, and suggest several avenues for improving the risk/benefit for studies involving invasive, non-diagnostic tissue procurement. PMID:23887602

Freeman, G A; Kimmelman, J; Dancey, J; Monzon, J G

2013-01-01

348

Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial  

PubMed Central

Background Tobacco consumption is the most preventable cause of morbidity-mortality in the world. One aspect of smoking cessation that merits in-depth study is the use of an application designed for smartphones (app), as a supportive element that could assist younger smokers in their efforts to quit. To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop smoking. Methods/design Cluster randomised clinical trial. Setting: Primary Health Care centres (PHCCs) in Catalonia. Analyses based on intention to treat. Participants: motivated smokers of 10 or more cigarettes per day, aged 18 to 30 years, consulting PHCCs for any reason and who provide written informed consent to participate in the trial. Intervention group will receive a 6-month smoking cessation programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme. Control group will receive the usual care. The outcome measure will be abstinence at 12 months confirmed by exhaled-air carbon monoxide concentration of at least 10 parts per million at each control test. Discussion To our knowledge this is the first randomised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app. If effective, the modality could offer a universal public health management approach to this common health concern. Trial registration NCT01734421 PMID:23915067

2013-01-01

349

Reducing Aggressive Behavior in Boys with a Social Cognitive Group Treatment: Results of a Randomized, Controlled Trial.  

ERIC Educational Resources Information Center

Objective: To evaluate the effectiveness of a social cognitive intervention program for Dutch aggressive boys and to compare it with a social skills training and a waitlist control group. Method: A randomized, controlled treatment outcome study with 97 aggressive boys (aged 9-13 years) was presented. An 11 session group treatment, a social…

Van Manen, Teun G.; Prins, Pier J.M.; Emmelkamp, Paul M.G.

2004-01-01

350

Prophylactic Effect of Low Dose Vitamin D in Osteopenia of Prematurity:a Clinical Trial Study.  

PubMed

Osteopenia of prematurity (OOP) is a preventable disease. Improved survival of premature newborns is associated with an increased incidence of OOP. The purpose of this study was to compare the prophylactic effects of two low doses of vitamin D (200 and 400 IU/Day) on the clinical, biochemical and radiological indices of the rickets of prematurity. In a randomized clinical trial, 60 preterm newborns with birth weight < 2000 g & gestational age < 37 weeks were randomly divided in two groups. Thirtynewborns received 200 IU/d of vitamin D in group one and 30 ones received 400 IU/day of vitamin D in group two. On the 6th to8th weeks of life, serum calcium, phosphate, alkaline phosphates, and 25 - hydroxy vitamin D concentrationswere measured and x- ray of left wrist and physical examination were performed. Both groups had no difference in biochemical, radiological or clinical presentationof rickets. Currentstudy indicated that low dose vitamin D (200 IU/Day) is enough for prevention of OOP. PMID:25325204

Alizadeh Taheri, Paymaneh; Sajjadian, Negar; Beyrami, Bahram; Shariat, Mamak

2014-09-01

351

Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial  

PubMed Central

Background Persistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction. This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence. Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure. Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90% of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation. In this trial, we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation, followed by a second percutaneous procedure in case of recurrence, has a higher success rate than repeated percutaneous procedures. Methods/Design This is a controlled (2:1) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation. The inclusion and exclusion criteria, definitions, and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation. Patients will be randomized to either percutaneous catheter (n?=?100) or surgical (n?=?50) ablation as the first procedure. After 3 months, they are re-evaluated, according to the same guidelines, and receive a second procedure if necessary. Crossover will be allowed and data analyzed on an “intention-to-treat” basis. Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure. Discussion The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation. Trial registration ISRCTN08035058 Reg 06.20.2013 PMID:24885377

2014-01-01

352

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8  

PubMed Central

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology. PMID:21948873

2011-01-01

353

Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study  

PubMed Central

Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the