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Adaptive trial design

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https://www.readbyqxmd.com/read/27919760/proton-therapy-present-and-future
#1
REVIEW
Radhe Mohan, David Grosshans
In principle, proton therapy offers a substantial clinical advantage over the conventional photon therapy. This is because of the unique depth-dose characteristics of protons, which can be exploited to achieve significant reductions in normal tissue doses proximal and distal to the target volume. These may, in turn, allow escalation of tumor doses, greater sparing of normal tissues, thus potentially improving local control and survival while at the same time reducing toxicity and improving quality of life. Protons, accelerated to therapeutic energies ranging from 70 to 250MeV, typically with a cyclotron or a synchrotron, are transported to the treatment room where they enter the treatment head mounted on a rotating gantry...
December 2, 2016: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/27919234/blended-cbt-versus-face-to-face-cbt-a-randomised-non-inferiority-trial
#2
Kim Mathiasen, Tonny E Andersen, Heleen Riper, Annet A M Kleiboer, Kirsten K Roessler
BACKGROUND: Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation...
December 5, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27914780/a-monte-carlo-analysis-of-breast-screening-randomized-trials
#3
Luis I Zamora, Cristina Forastero, Damián Guirado, Antonio M Lallena
PURPOSE: To analyze breast screening randomized trials with a Monte Carlo simulation tool. METHODS: A simulation tool previously developed to simulate breast screening programmes was adapted for that purpose. The history of women participating in the trials was simulated, including a model for survival after local treatment of invasive cancers. Distributions of time gained due to screening detection against symptomatic detection and the overall screening sensitivity were used as inputs...
November 30, 2016: Physica Medica: PM
https://www.readbyqxmd.com/read/27913556/how-does-age-related-macular-degeneration-affect-real-world-visual-ability-and-quality-of-life-a-systematic-review
#4
Deanna J Taylor, Angharad E Hobby, Alison M Binns, David P Crabb
OBJECTIVES: To review systematically the evidence of age-related macular degeneration (AMD) affecting real-world visual ability and quality of life (QoL). To explore trends in specific topics within this body of the literature. DESIGN: Systematic review. METHODS: A systematic literature search was carried out using MEDLINE, EMBASE, CINAHL, PsycINFO, PsychARTICLES and Health and Psychosocial Instruments for articles published up to January 2015 for studies including people diagnosed with AMD, assessing real-world visual ability or QoL as an outcome...
December 2, 2016: BMJ Open
https://www.readbyqxmd.com/read/27912940/panax-ginseng-and-salvia-miltiorrhiza-supplementation-during-eccentric-resistance-training-in-middle-aged-and-older-adults-a-double-blind-randomized-control-trial
#5
Hsin-Fu Lin, Chun-Chung Chou, Hsiao-Han Chao, Hirofumi Tanaka
BACKGROUND: Muscle damage induced by an acute bout of eccentric exercise results in transient arterial stiffening. In this study, we sought to determine the effects of progressive eccentric resistance exercise training on vascular functions, and whether herb supplementation would enhance training adaptation by ameliorating the arterial stiffening effects. METHODS: By using a double-blinded randomized placebo-controlled design, older adults were randomly assigned to either the Panax ginseng and Salvia miltiorrhiza supplementation group (N=12) or the placebo group (N=11)...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27911035/content-validity-of-the-credibility-and-expectancy-questionnaire-in-a-pain-rehabilitation-setting
#6
Vera-Christina Mertens, Albine Moser, Jeanine Verbunt, Rob Smeets, Mariëlle Goossens
: Content validity, the proper reflection of the concept to be measured, is yet unknown for the Credibility and Expectancy Questionnaire (CEQ). It is frequently used in pain rehabilitation because treatment expectancy is influential on the outcome. OBJECTIVE: To test and improve the content validity of the CEQ in a sample of patients with chronic pain in different phases of their treatment. METHODS: A qualitative observational study design using the Three-Step Test-Interview method was used...
December 2, 2016: Pain Practice: the Official Journal of World Institute of Pain
https://www.readbyqxmd.com/read/27905089/novel-paradigm-for-immunotherapy-of-ovarian-cancer-by-engaging-prophylactic-immunity-against-hepatitis-b-virus
#7
Marek Malecki, Emily Putzer, Caroline Quach, Chaitanya Dodivenaka, Xenia Tombokan
BACKGROUND: Only eight women out of one hundred diagnosed with ovarian epithelial cancers, which progressed to the clinical stage IV, survive 10 years. First line therapies: surgery, chemotherapy, and radiation therapy inflict very serious iatrogenic consequences. Passive immunotherapy of ovarian cancers offers only low efficacy. Prophylactic and therapeutic vaccines for ovarian cancers are not available. Interestingly, prophylactic vaccines for Hepatitis B Viruses (HBV) are very effective...
December 2016: Clinical and Translational Medicine
https://www.readbyqxmd.com/read/27903282/start-now-a-comprehensive-skills-training-programme-for-female-adolescents-with-oppositional-defiant-and-conduct-disorders-study-protocol-for-a-cluster-randomised-controlled-trial
#8
Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M Freitag, Robert L Trestman, Christina Stadler
BACKGROUND: In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27900953/feedback-control-policies-employed-by-people-using-intracortical-brain-computer-interfaces
#9
Francis R Willett, Chethan Pandarinath, Beata Jarosiewicz, Brian A Murphy, William D Memberg, Christine H Blabe, Jad Saab, Benjamin L Walter, Jennifer A Sweet, Jonathan P Miller, Jaimie M Henderson, Krishna V Shenoy, John D Simeral, Leigh R Hochberg, Robert F Kirsch, A Bolu Ajiboye
OBJECTIVE: When using an intracortical BCI (iBCI), users modulate their neural population activity to move an effector towards a target, stop accurately, and correct for movement errors. We call the rules that govern this modulation a 'feedback control policy'. A better understanding of these policies may inform the design of higher-performing neural decoders. APPROACH: We studied how three participants in the BrainGate2 pilot clinical trial used an iBCI to control a cursor in a 2D target acquisition task...
November 30, 2016: Journal of Neural Engineering
https://www.readbyqxmd.com/read/27900778/predicting-post-traumatic-stress-disorder-treatment-response-in-refugees-multilevel-analysis
#10
Joris F G Haagen, F Jackie June Ter Heide, Trudy M Mooren, Jeroen W Knipscheer, Rolf J Kleber
OBJECTIVES: Given the recent peak in refugee numbers and refugees' high odds of developing post-traumatic stress disorder (PTSD), finding ways to alleviate PTSD in refugees is of vital importance. However, there are major differences in PTSD treatment response between refugees, the determinants of which are largely unknown. This study aimed at improving PTSD treatment for adult refugees by identifying PTSD treatment response predictors. DESIGN: A prospective longitudinal multilevel modelling design was used to predict PTSD severity scores over time...
November 30, 2016: British Journal of Clinical Psychology
https://www.readbyqxmd.com/read/27898865/monensin-virginiamycin-and-flavomycin-in-a-no-roughage-finishing-diet-fed-to-zebu-cattle
#11
B J M Lemos, F G F Castro, L S Santos, B P C Mendonça, V R M Couto, J J R Fernandes
Two experiments were designed to evaluate the effects of monensin, virginiamycin, and flavomycin on growth performance, carcass characteristics, apparent total tract nutrient digestibility, and rumen fermentation of zebu cattle fed a no-roughage finishing diet (whole shelled corn [WSC] based). In Exp. 1, 100 crossbred bulls (; 392 kg [SD 46.8] average initial BW) were blocked by initial BW in a 101-d feedlot trial. Five treatments were evaluated using 4 pens per treatment (5 bulls/pen): monensin at 30 mg/kg DM, virginiamycin at 25 mg/kg DM, monensin at 20 mg/kg DM plus virginiamycin at 25 mg/kg DM, flavomycin at 4...
October 2016: Journal of Animal Science
https://www.readbyqxmd.com/read/27895297/power-of-an-adaptive-trial-design-for-endovascular-stroke-studies-simulations-using-ims-interventional-management-of-stroke-iii-data
#12
Maarten G Lansberg, Ninad S Bhat, Sharon D Yeatts, Yuko Y Palesch, Joseph P Broderick, Gregory W Albers, Tze L Lai, Philip W Lavori
BACKGROUND AND PURPOSE: Adaptive trial designs that allow enrichment of the study population through subgroup selection can increase the chance of a positive trial when there is a differential treatment effect among patient subgroups. The goal of this study is to illustrate the potential benefit of adaptive subgroup selection in endovascular stroke studies. METHODS: We simulated the performance of a trial design with adaptive subgroup selection and compared it with that of a traditional design...
December 2016: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/27894822/a-parallel-group-randomised-open-blinded-evaluation-of-acceptance-and-commitment-therapy-for-depression-after-psychosis-pilot-trial-outcomes-adapt
#13
Andrew Gumley, Ross White, Andy Briggs, Ian Ford, Sarah Barry, Corinna Stewart, Sara Beedie, Jacqueline McTaggart, Caoimhe Clarke, Rachel MacLeod, Emma Lidstone, Bruno Salgado Riveros, Robin Young, Hamish McLeod
BACKGROUND: Depression is one of the major contributors to poorer quality of life amongst individuals with psychosis and schizophrenia. The study was designed as a Pilot Trial to determine the parameters of a larger, definitive pragmatic multi-centre randomised controlled trial of Acceptance and Commitment Therapy for depression after psychosis (ACTdp) for individuals with a diagnosis of schizophrenia who also meet diagnostic criteria for major depression. METHODS: Participants were required to meet criteria for schizophrenia and major depression...
November 25, 2016: Schizophrenia Research
https://www.readbyqxmd.com/read/27894289/the-patient-reporting-and-action-for-a-safe-environment-prase-intervention-a-feasibility-study
#14
Jane K O'Hara, Rebecca J Lawton, Gerry Armitage, Laura Sheard, Claire Marsh, Kim Cocks, Rosie R C McEachan, Caroline Reynolds, Ian Watt, John Wright
BACKGROUND: There is growing interest in the role of patients in improving patient safety. One such role is providing feedback on the safety of their care. Here we describe the development and feasibility testing of an intervention that collects patient feedback on patient safety, brings together staff to consider this feedback and to plan improvement strategies. We address two research questions: i) to explore the feasibility of the process of systematically collecting feedback from patients about the safety of care as part of the PRASE intervention; and, ii) to explore the feasibility and acceptability of the PRASE intervention for staff, and to understand more about how staff use the patient feedback for service improvement...
November 28, 2016: BMC Health Services Research
https://www.readbyqxmd.com/read/27891651/developing-a-bayesian-adaptive-design-for-a-phase-i-clinical-trial-a-case-study-for-a-novel-hiv-treatment
#15
Alexina J Mason, Juan Gonzalez-Maffe, Killian Quinn, Nicki Doyle, Ken Legg, Peter Norsworthy, Roy Trevelion, Alan Winston, Deborah Ashby
The design of phase I studies is often challenging, because of limited evidence to inform study protocols. Adaptive designs are now well established in cancer but much less so in other clinical areas. A phase I study to assess the safety, pharmacokinetic profile and antiretroviral efficacy of C34-PEG4 -Chol, a novel peptide fusion inhibitor for the treatment of HIV infection, has been set up with Medical Research Council funding. During the study workup, Bayesian adaptive designs based on the continual reassessment method were compared with a more standard rule-based design, with the aim of choosing a design that would maximise the scientific information gained from the study...
November 27, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27890145/gait-adaptation-on-surfaces-with-different-degrees-of-slipperiness
#16
Wen-Ruey Chang, Chien-Chi Chang, Mary F Lesch, Simon Matz
Gait adaptation to employ different ways to avoid a potential slip is needed to continue walking safely on a new surface, especially when transitioning to a slippery surface. In this experiment, participants walked back and forth five times (trials) on surfaces with different degrees of slipperiness. The results show that trial 1 was significantly different from other trials for most of the dependent variables, especially for the low and high friction conditions. Kinematics on high and medium friction surfaces were very similar, but more adjustments were needed for low friction surfaces...
March 2017: Applied Ergonomics
https://www.readbyqxmd.com/read/27888180/northern-manhattan-hispanic-caregiver-intervention-effectiveness-study-protocol-of-a-pragmatic-randomised-trial-comparing-the-effectiveness-of-two-established-interventions-for-informal-caregivers-of-persons-with-dementia
#17
José A Luchsinger, Louis Burgio, Mary Mittelman, Ilana Dunner, Jed A Levine, Jian Kong, Stephanie Silver, Mildred Ramirez, Jeanne A Teresi
INTRODUCTION: The prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH)...
November 25, 2016: BMJ Open
https://www.readbyqxmd.com/read/27886393/blinded-versus-unblinded-estimation-of-a-correlation-coefficient-to-inform-interim-design-adaptations
#18
Cornelia U Kunz, Nigel Stallard, Nicholas Parsons, Susan Todd, Tim Friede
Regulatory authorities require that the sample size of a confirmatory trial is calculated prior to the start of the trial. However, the sample size quite often depends on parameters that might not be known in advance of the study. Misspecification of these parameters can lead to under- or overestimation of the sample size. Both situations are unfavourable as the first one decreases the power and the latter one leads to a waste of resources. Hence, designs have been suggested that allow a re-assessment of the sample size in an ongoing trial...
November 25, 2016: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/27882498/parent-training-programs-for-ethnic-minorities-a-meta-analysis-of-adaptations-and-effect
#19
K van Mourik, M R Crone, M S de Wolff, R Reis
This meta-analysis focuses on parent training programs for ethnic minority families and reports on (i) the adaptation of program content and (ii) the process that informs these adaptations. Relevant studies are reviewed to determine the adaptations made and the impact of the adaptations on parenting and child outcomes. Studies were eligible for inclusion if they enrolled predominantly ethnic minority parents with children aged 0-12 years, used a randomized controlled trial design with post-intervention assessments, focused on group-based parent training programs and on prevention of parenting problems, and reported parenting behavior outcomes...
November 23, 2016: Prevention Science: the Official Journal of the Society for Prevention Research
https://www.readbyqxmd.com/read/27879980/theory-based-interventions-for-contraception
#20
REVIEW
Laureen M Lopez, Thomas W Grey, Mario Chen, Elizabeth E Tolley, Laurie L Stockton
BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base. OBJECTIVES: To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use...
November 23, 2016: Cochrane Database of Systematic Reviews
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