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Adaptive trial design

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https://www.readbyqxmd.com/read/28821302/participation-of-adults-with-disorders-differences-of-sex-development-dsd-in-the-clinical-study-dsd-life-design-methodology-recruitment-data-quality-and-study-population
#1
Robert Röhle, Katharina Gehrmann, Maria Szarras-Czapnik, Hedi Claahsen-van der Grinten, Catherine Pienkowski, Claire Bouvattier, Peggy Cohen-Kettenis, Anna Nordenström, Ute Thyen, Birgit Köhler
BACKGROUND: dsd-LIFE is a comprehensive cross-sectional clinical outcome study of individuals with disorders/differences of sex development (DSD). This study focuses on various rare genetic conditions characterized by impaired gonadal or adrenal functionality. METHODS/DESIGN: The study aims to assess quality of life (QoL) as a measure of psychosocial adaptation, psychosexual and mental health aspects as major outcomes. Health status and functioning, medical and surgical therapies, participants' views on health care, psychological and social support, sociodemographic factors and their interrelations will be investigated as factors associated with the outcomes...
August 18, 2017: BMC Endocrine Disorders
https://www.readbyqxmd.com/read/28818487/snap-based-incentive-programs-at-farmers-markets-adaptation-considerations-for-temporary-assistance-for-needy-families-tanf-recipients
#2
Marianna S Wetherill, Mary B Williams, Karen A Gray
OBJECTIVE: To describe the design, implementation, and consumer response to a coupon-style intervention aimed to increase Supplemental Nutrition Assistance Program (SNAP) use at a farmers' market (FM) among Temporary Assistance for Needy Families (TANF) participants. DESIGN: A quasi-experimental trial to evaluate redemption response to 2 coupon interventions; baseline surveys characterized coupon redeemers and non-redeemers. SETTING: Urban...
August 14, 2017: Journal of Nutrition Education and Behavior
https://www.readbyqxmd.com/read/28818225/patient-centered-outcomes-of-a-dual-action-pneumatic-compression-device-in-comparison-to-compression-stockings-for-patients-with-chronic-venous-disease
#3
Fedor Lurie, Marc Schwartz
OBJECTIVE: The ACTitouch (AT) device (Tactile Medical, Minneapolis, Minn) represents a new generation of pneumatic compression devices by combining sustained compression with intermittent pneumatic compression. The sustained compression mode provides automatic pressure adjustment every 30 minutes, ensuring pressure consistency regardless of leg volume changes and environmental influences. Designed for mobile patients, this device has not been studied in comparison to standard compression stockings (CS)...
September 2017: Journal of Vascular Surgery. Venous and Lymphatic Disorders
https://www.readbyqxmd.com/read/28815894/challenges-of-developing-and-conducting-clinical-trials-in-rare-disorders
#4
REVIEW
Lucas Kempf, Jonathan C Goldsmith, Robert Temple
Rare disease drug development is a rapidly expanding field. Clinical researchers in rare diseases face many challenges when conducting trials in small populations. Disease natural history is often poorly understood and the ability to detect clinically meaningful outcomes requires understanding of their rate of occurrence and variability, both of which contribute to difficulties in powering a study. Standard trial designs are not optimized to obtain adequate safety and efficacy data from small numbers of patients, so alternative designs (enrichment, crossover, adaptive, N-of 1) need to be considered...
August 16, 2017: American Journal of Medical Genetics. Part A
https://www.readbyqxmd.com/read/28814435/adaptive-global-innovative-learning-environment-for-glioblastoma-gbm-agile
#5
Brian M Alexander, Sujuan Ba, Mitchel S Berger, Donald A Berry, Webster K Cavenee, Susan M Chang, Timothy F Cloughesy, Tao Jiang, Mustafa Khasraw, Wenbin Li, Robert Mittman, George H Poste, Patrick Y Wen, W K Alfred Yung, Anna D Barker
Glioblastoma (GBM) is a deadly disease with few effective therapies. While much has been learned about the molecular characteristics of the disease, this knowledge has not been translated into clinical improvements for patients. At the same time, many new therapies are being developed. Many of these therapies have potential biomarkers to identify responders. The result is an enormous amount of testable clinical questions that must be answered efficiently. The GBM Adaptive Global Innovative Learning Environment (GBM AGILE) is a novel, multi-arm, platform trial designed to address these challenges...
August 16, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28806908/changing-the-default-for-tobacco-cessation-treatment-in-an-inpatient-setting-study-protocol-of-a-randomized-controlled-trial
#6
Babalola Faseru, Edward F Ellerbeck, Delwyn Catley, Byron J Gajewski, Taneisha S Scheuermann, Theresa I Shireman, Laura M Mussulman, Niaman Nazir, Terry Bush, Kimber P Richter
BACKGROUND: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes...
August 14, 2017: Trials
https://www.readbyqxmd.com/read/28806427/fixed-dental-prostheses-and-single-tooth-crowns-based-on-ceria-stabilized-tetragonal-zirconia-alumina-nanocomposite-frameworks-outcome-after-2-years-in-a-clinical-trial
#7
Fabian Hüttig, Jan P Keitel, Andreas Prutscher, Sebastian Spintzyk, Andrea Klink
PURPOSE: This clinical trial tested bilayered restorations based on ceria-stabilized tetragonal zirconia/alumina frameworks veneered with feldspathic ceramic. MATERIALS AND METHODS: A total of 67 crowns and 40 fixed dental prostheses (FDPs) were luted in 57 patients with self-etching/self-adhesive composite resin cement. Dental status and integrity of restorations were evaluated at 2 weeks, 6 months, and then annually. RESULTS: A total of 66 crowns and 36 FDPs (88% posterior) survived for success rates of 93...
August 14, 2017: International Journal of Prosthodontics
https://www.readbyqxmd.com/read/28806193/speech-perception-in-noise-and-listening-effort-of-older-adults-with-nonlinear-frequency-compression-hearing-aids
#8
James Shehorn, Nicole Marrone, Thomas Muller
OBJECTIVES: The purpose of this laboratory-based study was to compare the efficacy of two hearing aid fittings with and without nonlinear frequency compression, implemented within commercially available hearing aids. Previous research regarding the utility of nonlinear frequency compression has revealed conflicting results for speech recognition, marked by high individual variability. Individual differences in auditory function and cognitive abilities, specifically hearing loss slope and working memory, may contribute to aided performance...
August 10, 2017: Ear and Hearing
https://www.readbyqxmd.com/read/28805518/the-pace-trial-missteps-on-pacing-and-patient-selection
#9
Leonard A Jason
As others have pointed out a variety of complicating factors with the PACE trial (e.g. changing outcome criteria), I will limit my remarks to issues that involve the composition of adaptive pacing therapy and issues involving patient selection. My key points are that the PACE trial investigators were not successful in designing and implementing a valid pacing intervention and patient selection ambiguity further compromised the study's outcomes.
August 2017: Journal of Health Psychology
https://www.readbyqxmd.com/read/28805255/mandibular-complete-denture-versus-single-implant-overdenture-a-systematic-review-of-patient-reported-outcomes
#10
REVIEW
Túlio Eduardo Nogueira, Danilo Rocha Dias, Cláudio Rodrigues Leles
The single-implant mandibular overdenture (SIMO) has been proposed as an alternative for edentulous patients who are poorly adapted to their dentures due to low retention and stability of the conventional mandibular complete denture (CD). However, there is a lack of evidence regarding the effectiveness of SIMO, which can be measured by examining patient perception of treatment effects. The aim of this systematic review was to assess the comparative results of CD and SIMO treatments by using patient-reported outcome measures...
August 14, 2017: Journal of Oral Rehabilitation
https://www.readbyqxmd.com/read/28803942/an-adaptive-individualized-fmri-delay-discounting-procedure-to-increase-flexibility-and-optimize-scanner-time
#11
Mikhail N Koffarnus, Harshawardhan U Deshpande, Jonathan M Lisinski, Anders Eklund, Warren K Bickel, Stephen M LaConte
Research on the rate at which people discount the value of future rewards has become increasingly prevalent as discount rate has been shown to be associated with many unhealthy patterns of behavior such as drug abuse, gambling, and overeating. fMRI research points to a fronto-parietal-limbic pathway that is active during decisions between smaller amounts of money now and larger amounts available after a delay. Researchers in this area have used different variants of delay discounting tasks and reported various contrasts between choice trials of different types from these tasks...
August 10, 2017: NeuroImage
https://www.readbyqxmd.com/read/28803923/stress-induced-neural-reorganization-a-conceptual-framework-linking-depression-and-alzheimer-s-disease
#12
REVIEW
Jennifer A Ross, Gediminas Gliebus, Elisabeth J Van Bockstaele
Chronic stress is a risk factor for a number of physiological disorders including cardiovascular disease, obesity and gastrointestinal disorders, as well as psychiatric and neurodegenerative disorders. There are a number of underlying molecular and cellular mechanisms altered in the course of chronic stress, which may increase the vulnerability of individuals to develop psychiatric disorders such as depression, and neurodegenerative disorders such as Alzheimer's Disease (AD). This is evident in the influence of stress on large-scale brain networks, including the resting state Default Mode Network (DMN), the effects of stress on neuronal circuitry and architecture, and the cellular and molecular adaptations to stress, which may render individuals with stress related psychiatric disorders more vulnerable to neurodegenerative disease later in life...
August 10, 2017: Progress in Neuro-psychopharmacology & Biological Psychiatry
https://www.readbyqxmd.com/read/28801856/the-effects-of-supplementing-acacia-mearnsii-tannin-extract-on-dairy-cow-dry-matter-intake-milk-production-and-methane-emission-in-a-tropical-pasture
#13
Tiago Pansard Alves, Aline Cristina Dall-Orsoletta, Henrique Mendonça Nunes Ribeiro-Filho
The study assessed the effect of Acacia mearnsii tannin extract supplementation grazing dairy cows on dry matter (DM) intake, enteric methane (CH4) emission, and performance. Twelve Holstein cows were divided into two groups and subjected to two treatments that consisted of millet pasture (Pennisetum glaucum L.) plus supplementation with 6 kg of concentrate (750-g/kg ground corn and 250-g/kg soybean meal) including or excluding 120-g tannin extract. The trial design was a double reversal using three periods of 28 days each, with 21 days for the adaption period, and 7 days for sample collection...
August 11, 2017: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/28800444/do-parental-adhd-symptoms-reduce-the-efficacy-of-parent-training-for-preschool-adhd-a-secondary-analysis-of-a-randomized-controlled-trial
#14
Rex Forehand, Justin Parent, Virginia D Peisch, Edmund Sonuga-Barke, Nicholas Long, Nicole Lafko Breslend, Howard B Abikoff
Previous studies have suggested that children with Attention-Deficit/Hyperactivity Disorder (ADHD) may benefit less from behavioral parent training (BPT) if their parents have high levels of ADHD symptoms. We conducted a secondary analysis of data from a randomized controlled trial to test the hypothesis that parental ADHD symptoms reduce the efficacy of two BPT programs in a sample of preschoolers with ADHD. One intervention was specifically designed for children with ADHD (NFPP: New Forest Parenting Programme) and one was designed for children with Oppositional Defiant Disorder (ODD) (HNC: Helping the Noncompliant Child)...
August 4, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/28800417/buccal-delivery-of-small-molecules-and-biologics-of-mucoadhesive-polymers-films-and-nanoparticles
#15
REVIEW
Javier O Morales, David J Brayden
Buccal delivery of macromolecules (biologics) sets a great challenge for researchers. Although several niche small molecule products have been approved as simple sprays, tablets and oral films, it is not simply a case of adapting existing technologies to biologics. Buccal delivery of insulin has reached clinical trials with two approaches: oromucosal sprays of the peptide with permeation enhancers, and embedded gold nanoparticles in a dissolvable film. However, neither of these approaches have led to FDA approvals likely due to poor efficacy, submaximal peptide loading in the dosage form, and to wide intra-subject variability in pharmacokinetics and pharmacodynamics...
August 8, 2017: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/28798898/dark-adapted-chromatic-perimetry-for-measuring-rod-visual-fields-in-patients-with-retinitis-pigmentosa
#16
Lea D Bennett, Martin Klein, Kirsten G Locke, Kelly Kiser, David G Birch
PURPOSE: Although rod photoreceptors are initially affected in retinitis pigmentosa (RP), the full-field of rod vision is not routinely characterized due to the unavailability of commercial devices detecting rod sensitivity. The purpose of this study was to quantify rod-mediated vision in the peripheral field from patients with RP using a new commercially available perimeter. METHODS: Participants had one eye dilated and dark-adapted for 45 minutes. A dark-adapted chromatic (DAC) perimeter tested 80 loci 144° horizontally and 72° vertically with cyan stimuli...
July 2017: Translational Vision Science & Technology
https://www.readbyqxmd.com/read/28798225/ethical-issues-in-alzheimer-s-disease-research-involving-human-subjects
#17
Dena S Davis
As we aggressively pursue research to cure and prevent Alzheimer's disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are (1) the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects' death; (2) the creation of cohorts of 'study ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; (3) reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; (4) the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants' welfare if the information is obtained by insurance companies or long-term care providers; (5) the use of study partners that creates unique risks of harm to the relationship of subject and study partner...
August 10, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28796864/individualized-adaptive-stereotactic-body-radiotherapy-for-liver-tumors-in-patients-at-high-risk-for-liver-damage-a-phase-2-clinical-trial
#18
Mary Feng, Krithika Suresh, Matthew J Schipper, Latifa Bazzi, Edgar Ben-Josef, Martha M Matuszak, Neehar D Parikh, Theodore H Welling, Daniel Normolle, Randall K Ten Haken, Theodore S Lawrence
Importance: Patients with preexisting liver dysfunction could benefit the most from personalized therapy for liver tumors to balance maximal tumor control and minimal risk of liver failure. We designed an individualized adaptive trial testing the hypothesis that adapting treatment based on change in liver function could optimize the therapeutic index for each patient. Objective: To characterize the safety and efficacy of individualized adaptive stereotactic body radiotherapy (SRBT) for liver tumors in patients who have preexisting liver dysfunction...
August 10, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28796303/measurement-tools-of-resource-use-and-quality-of-life-in-clinical-trials-for-dementia-or-cognitive-impairment-interventions-a-systematically-conducted-narrative-review
#19
REVIEW
Fan Yang, Piers Dawes, Iracema Leroi, Brenda Gannon
OBJECTIVE: Knowledge is limited about the standardised instruments used to collect resource use and quality of life data alongside trials of dementia interventions. This review aimed to identify the trials using such instruments in order to guide the design of future trial-based cost-effectiveness studies. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement, this review examined all original, peer-reviewed research in major databases and general searches published until June 2017, including randomised clinical trials, pilot studies, or feasibility studies about interventions for older adults with dementia or cognitive impairment...
August 10, 2017: International Journal of Geriatric Psychiatry
https://www.readbyqxmd.com/read/28795420/inference-for-multimarker-adaptive-enrichment-trials
#20
Richard Simon, Noah Simon
Identification of treatment selection biomarkers has become very important in cancer drug development. Adaptive enrichment designs have been developed for situations where a unique treatment selection biomarker is not apparent based on the mechanism of action of the drug. With such designs, the eligibility rules may be adaptively modified at interim analysis times to exclude patients who are unlikely to benefit from the test treatment.We consider a recently proposed, particularly flexible approach that permits development of model-based multifeature predictive classifiers as well as optimized cut-points for continuous biomarkers...
August 10, 2017: Statistics in Medicine
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