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Adaptive trial design

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https://www.readbyqxmd.com/read/28346823/design-and-monitoring-of-multi-arm-multi-stage-clinical-trials
#1
Pranab Ghosh, Lingyun Liu, P Senchaudhuri, Ping Gao, Cyrus Mehta
Two-arm group sequential designs have been widely used for over 40 years, especially for studies with mortality endpoints. The natural generalization of such designs to trials with multiple treatment arms and a common control (MAMS designs) has, however, been implemented rarely. While the statistical methodology for this extension is clear, the main limitation has been an efficient way to perform the computations. Past efforts were hampered by algorithms that were computationally explosive. With the increasing interest in adaptive designs, platform designs, and other innovative designs that involve multiple comparisons over multiple stages, the importance of MAMS designs is growing rapidly...
March 27, 2017: Biometrics
https://www.readbyqxmd.com/read/28344449/the-effects-of-3-weeks-of-uphill-and-downhill-walking-on-blood-lipids-and-glucose-metabolism-in-pre-diabetic-men-a-pilot-study
#2
Marc Philippe, Hannes Gatterer, Erika Maria Eder, Alexander Dzien, Matthias Somavilla, Andreas Melmer, Christoph Ebenbichler, Tom Müller, Martin Burtscher
The prevention of type 2 diabetes in persons at risk for diabetes is of utmost importance. Physical activity in general and even exercises at moderate intensities such as walking significantly reduce the risk of the development of type 2 diabetes. However, it is still a matter of debate whether lipids and glucose metabolism are differently affected by regular concentric (e.g., uphill walking) and eccentric (e.g., downhill walking) endurance exercise. The aim of this study was to investigate the effects of short-term (3 weeks) uphill and downhill walking on glucose metabolism and blood lipids in pre-diabetic middle-aged men in a real world setting...
March 2017: Journal of Sports Science & Medicine
https://www.readbyqxmd.com/read/28344448/is-empirical-research-on-periodization-trustworthy-a-comprehensive-review-of-conceptual-and-methodological-issues
#3
REVIEW
José Afonso, Pantelis T Nikolaidis, Patrícia Sousa, Isabel Mesquita
Periodization is a core concept in training. Recently, systematic reviews and meta-analyses have attempted to provide a comprehensive overview of the topic, but theoretical criticisms have arisen with regard to how such research has been conducted. The purpose of the study was to review comprehensively the conceptual and methodological issues surrounding empirical research on periodization in training with human subjects. A search was conducted late in February 2016 on Academic Search Complete, CINAHL Plus, MedicLatina, MEDLINE, PsycINFO, PubMed, Scielo, Scopus, SPORTDiscus and Web of Science...
March 2017: Journal of Sports Science & Medicine
https://www.readbyqxmd.com/read/28342829/effects-of-peer-mentoring-on-self-efficacy-and-hospital-readmission-following-inpatient-rehabilitation-of-individuals-with-spinal-cord-injury-a-randomized-controlled-trial
#4
Julie Gassaway, Michael L Jones, W Mark Sweatman, Minna Hong, Peter Anziano, Karen DeVault
OBJECTIVE: Investigate the effect of intensive peer mentoring on patient reported outcomes of self-efficacy and unplanned hospital readmissions for persons with spinal cord injury/disease (SCI/D) within the first 6 months after discharge from inpatient rehabilitation DESIGN: Randomized controlled trial; SETTING: Non-profit inpatient rehabilitation hospital specializing in care of persons with SCI/D and brain injury PARTICIPANTS: 158 patients admitted to the SCI rehabilitation program whose discharge location was a community setting...
March 22, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28339723/leveraging-molecular-datasets-for-biomarker-based-clinical-trial-design-in-glioblastoma
#5
Shyam K Tanguturi, Lorenzo Trippa, Shakti H Ramkissoon, Kristine Pelton, David Knoff, David Sandak, Neal I Lindeman, Azra H Ligon, Rameen Beroukhim, Giovanni Parmigiani, Patrick Y Wen, Keith L Ligon, Brian M Alexander
Background.: Biomarkers can improve clinical trial efficiency, but designing and interpreting biomarker-driven trials require knowledge of relationships among biomarkers, clinical covariates, and endpoints. We investigated these relationships across genomic subgroups of glioblastoma (GBM) within our institution (DF/BWCC), validated results in The Cancer Genome Atlas (TCGA), and demonstrated potential impacts on clinical trial design and interpretation. Methods.: We identified genotyped patients at DF/BWCC, and clinical associations across 4 common GBM genomic biomarker groups were compared along with overall survival (OS), progression-free survival (PFS), and survival post-progression (SPP)...
February 20, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28337139/a-mixed-methods-trial-of-broad-band-noise-and-nature-sounds-for-tinnitus-therapy-group-and-individual-responses-modeled-under-the-adaptation-level-theory-of-tinnitus
#6
Mithila Durai, Grant D Searchfield
Objectives: A randomized cross-over trial in 18 participants tested the hypothesis that nature sounds, with unpredictable temporal characteristics and high valence would yield greater improvement in tinnitus than constant, emotionally neutral broadband noise. Study Design: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary measures were: loudness and annoyance ratings, loudness level matches, minimum masking levels, positive and negative emotionality, attention reaction and discrimination time, anxiety, depression and stress...
2017: Frontiers in Aging Neuroscience
https://www.readbyqxmd.com/read/28326196/iact-cel-a-feasibility-trial-of-a-face-to-face-and-internet-based-acceptance-and-commitment-therapy-intervention-for-chronic-pain-in-singapore
#7
Su-Yin Yang, Rona Moss-Morris, Lance M McCracken
Psychological interventions are increasingly utilising online or mobile phone based platforms to deliver treatment, including that for people with chronic pain. The aims of this study were to develop an adapted form of Acceptance and Commitment Therapy (ACT) for chronic pain in Singapore and to test the feasibility of elements of this treatment delivered via the internet and email. Methods. Thirty-three participants recruited from a tertiary pain management clinic and via the clinic website participated in this program over a period of five weeks with a 3-month follow-up...
2017: Pain Research and Treatment
https://www.readbyqxmd.com/read/28326095/potential-of-legume-brassica-intercrops-for-forage-production-and-green-manure-encouragements-from-a-temperate-southeast-european-environment
#8
REVIEW
Ana M Jeromela, Aleksandar M Mikić, Svetlana Vujić, Branko Ćupina, Đorđe Krstić, Aleksandra Dimitrijević, Sanja Vasiljević, Vojislav Mihailović, Sandra Cvejić, Dragana Miladinović
Legumes and brassicas have much in common: importance in agricultural history, rich biodiversity, numerous forms of use, high adaptability to diverse farming designs, and various non-food applications. Rare available resources demonstrate intercropping legumes and brassicas as beneficial to both, especially for the latter, profiting from better nitrogen nutrition. Our team aimed at designing a scheme of the intercrops of autumn- and spring-sown annual legumes with brassicas for ruminant feeding and green manure, and has carried out a set of field trials in a temperate Southeast European environment and during the past decade, aimed at assessing their potential for yields of forage dry matter and aboveground biomass nitrogen and their economic reliability via land equivalent ratio...
2017: Frontiers in Plant Science
https://www.readbyqxmd.com/read/28323322/adaptations-following-an-intermittent-hypoxia-hyperoxia-training-in-coronary-artery-disease-patients-a-controlled-study
#9
Oleg Glazachev, Phylipp Kopylov, Davide Susta, Elena Dudnik, Elena Zagaynaya
BACKGROUND: Repeated exposure to intermittent normobaric hypoxia improves exercise tolerance in cardiac patients. Little is known on the effects of intermittent normobaric hypoxia-hyperoxia exposure in coronary artery disease (CAD) patients (New York Heart Association II-III). HYPOTHESIS: IHHT improves exercise tolerance, cardiometabolic profile, and quality of life in CAD patients. METHODS: The study design was a nonrandomized, controlled, before-and-after trial...
March 21, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28320473/which-neural-mechanisms-mediate-the-effects-of-a-parenting-intervention-program-on-parenting-behavior-design-of-a-randomized-controlled-trial
#10
Laura Kolijn, Saskia Euser, Bianca G van den Bulk, Renske Huffmeijer, Marinus H van IJzendoorn, Marian J Bakermans-Kranenburg
BACKGROUND: The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) has proven effective in increasing parental sensitivity. However, the mechanisms involved are largely unknown. In a randomized controlled trial we examine parental neurocognitive factors that may mediate the intervention effects on parenting behavior. Our aims are to (1) examine whether the intervention influences parents' neural processing of children's emotional expressions and the neural precursors of response inhibition and to (2) test whether neural changes mediate intervention effects on parenting behavior...
March 21, 2017: BMC Psychology
https://www.readbyqxmd.com/read/28315481/a-patient-advocate-to-facilitate-access-and-improve-communication-care-and-outcomes-in-adults-with-moderate-or-severe-asthma-rationale-design-and-methods-of-a-randomized-controlled-trial
#11
Andrea J Apter, Knashawn H Morales, Xiaoyan Han, Luzmercy Perez, Jingru Huang, Grace Ndicu, Anna Localio, Alyssa Nardi, Heather Klusaritz, Marisa Rogers, Alexis Phillips, Zuleyha Cidav, J Sanford Schwartz
Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28304312/cognitive-rehabilitation-in-alzheimer-s-disease-a-controlled-intervention-trial
#12
Katharina Brueggen, Elisabeth Kasper, Sina Ochmann, Henrike Pfaff, Steffi Webel, Wolfgang Schneider, Stefan Teipel
BACKGROUND: Cognitive Rehabilitation for Alzheimer's disease (AD) is an integrative multimodal intervention. It aims to maintain autonomy and quality of life by enhancing the patients' abilities to compensate for decreased cognitive functioning. OBJECTIVE: We evaluated the feasibility of a group-based Cognitive Rehabilitation approach in mild AD dementia and assessed its effect on activities of daily living (ADL). METHODS: We included 16 patients with AD dementia in a controlled partial-randomized design...
March 18, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28303586/estimation-of-treatment-effect-in-two-stage-confirmatory-oncology-trials-of-personalized-medicines
#13
Wen Li, Cong Chen, Xiaoyun Li, Robert A Beckman
A personalized medicine may benefit a subpopulation with certain predictive biomarker signatures or certain disease types. However, there is great uncertainty about drug activity in a subpopulation when designing a confirmatory trial in practice, and it is logical to take a two-stage approach with the study unless credible external information is available for decision-making purpose. The first stage deselects (or prunes) non-performing subpopulations at an interim analysis, and the second stage pools the remaining subpopulations in the final analysis...
March 17, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28300506/adding-celecoxib-with-or-without-zoledronic-acid-for-hormone-na%C3%A3-ve-prostate-cancer-long-term-survival-results-from-an-adaptive-multiarm-multistage-platform-randomized-controlled-trial
#14
Malcolm D Mason, Noel W Clarke, Nicholas D James, David P Dearnaley, Melissa R Spears, Alastair W S Ritchie, Gerhardt Attard, William Cross, Rob J Jones, Christopher C Parker, J Martin Russell, George N Thalmann, Francesca Schiavone, Estelle Cassoly, David Matheson, Robin Millman, Cyrill A Rentsch, Jim Barber, Clare Gilson, Azman Ibrahim, John Logue, Anna Lydon, Ashok D Nikapota, Joe M O'Sullivan, Emilio Porfiri, Andrew Protheroe, Narayanan Nair Srihari, David Tsang, John Wagstaff, Jan Wallace, Catherine Walmsley, Mahesh K B Parmar, Matthew R Sydes
Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases...
March 13, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28292304/design-and-implementation-of-electronic-health-record-integrated-clinical-prediction-rules-icpr-a-randomized-trial-in-diverse-primary-care-settings
#15
David A Feldstein, Rachel Hess, Thomas McGinn, Rebecca G Mishuris, Lauren McCullagh, Paul D Smith, Michael Flynn, Joseph Palmisano, Gheorghe Doros, Devin Mann
BACKGROUND: Clinical prediction rules (CPRs) represent a method of determining individual patient risk to help providers make more accurate decisions at the point of care. Well-validated CPRs are underutilized but may decrease antibiotic overuse for acute respiratory infections. The integrated clinical prediction rules (iCPR) study builds on a previous single clinic study to integrate two CPRs into the electronic health record and assess their impact on practice. This article discusses study design and implementation of a multicenter cluster randomized control trial of the iCPR clinical decision support system, including the tool adaptation, usability testing, staff training, and implementation study to disseminate iCPR at multiple clinical sites across two health care systems...
March 14, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28291393/early-positron-emission-tomography-response-adapted-treatment-in-stage-i-and-ii-hodgkin-lymphoma-final-results-of-the-randomized-eortc-lysa-fil-h10-trial
#16
Marc P E André, Théodore Girinsky, Massimo Federico, Oumédaly Reman, Catherine Fortpied, Manuel Gotti, Olivier Casasnovas, Pauline Brice, Richard van der Maazen, Alessandro Re, Véronique Edeline, Christophe Fermé, Gustaaf van Imhoff, Francesco Merli, Réda Bouabdallah, Catherine Sebban, Lena Specht, Aspasia Stamatoullas, Richard Delarue, Valeria Fiaccadori, Monica Bellei, Tiana Raveloarivahy, Annibale Versari, Martin Hutchings, Michel Meignan, John Raemaekers
Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated-according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)-stage I and II HL...
March 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28290760/translation-of-fit-strong-for-use-by-hispanics-with-arthritis-a-feasibility-trial-of-%C3%A2-en-forma-y-fuerte
#17
Cheryl Der Ananian, Renae Smith-Ray, Brad Meacham, Amy Shah, Susan Hughes
This study evaluated the feasibility and effectiveness of translating the evidence-based program, Fit & Strong! into a Spanish program, ¡En Forma y Fuerte!. A single-group, quasi-experimental design (n=34, mean age = 58.8 [8.1], 87.2% Female, 87.2% reported speaking mostly Spanish) was used to assess implementation feasibility and the impact of ¡En Forma y Fuerte! on arthritis-related outcomes in Hispanics with arthritis. Significant improvements in lower-extremity strength, perceived physical function and pain were observed from baseline to 8 weeks (p<0...
March 14, 2017: Journal of Aging and Physical Activity
https://www.readbyqxmd.com/read/28289112/cannabis-and-young-users-a-brief-intervention-to-reduce-their-consumption-canabic-a-cluster-randomized-controlled-trial-in-primary-care
#18
Catherine Laporte, Hélène Vaillant-Roussel, Bruno Pereira, Olivier Blanc, Bénédicte Eschalier, Shérazade Kinouani, Georges Brousse, Pierre-Michel Llorca, Philippe Vorilhon
PURPOSE: Brief intervention to reduce cannabis is a promising technique that could be adapted for use in primary care, but it has not been well studied in this setting. We tested the efficacy of a brief intervention conducted by general practitioners among cannabis users aged 15 to 25 years. METHODS: We performed a cluster randomized controlled trial with 77 general practitioners in France. The intervention consisted of an interview designed according to the FRAMES (feedback, responsibility, advice, menu, empathy, self-efficacy) model, while the control condition consisted of routine care...
March 2017: Annals of Family Medicine
https://www.readbyqxmd.com/read/28287876/crispr-cas9-from-a-bacterial-immune-system-to-genome-edited-human-cells-in-clinical-trials
#19
Leonhard Kick, Marion Kirchner, Sabine Schneider
The adaptive bacterial immune system CRISPR-Cas is revolutionising all fields of life science and has opened up new frontiers towards personalised medicine. Since the elucidation of the molecular mechanism of Cas9 from Streptococcus pyogenes in 2012 and its development as a genomic engineering tool, genetic modifications in more than 40 species have been carried out, over 290 patents have been filed worldwide and the first clinical trials using CRISPR-Cas-modified T-cells have recently been started in China and in the US...
March 13, 2017: Bioengineered
https://www.readbyqxmd.com/read/28283026/preventing-recurrence-of-endometriosis-by-means-of-long-acting-progestogen-therapy-pre-empt-report-of-an-internal-pilot-multi-arm-randomised-controlled-trial-incorporating-flexible-entry-design-and-adaption-of-design-based-on-feasibility-of-recruitment
#20
Lee J Middleton, Jane P Daniels, Annalise Weckesser, Siladitya Bhattacharya
BACKGROUND: Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis...
March 11, 2017: Trials
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