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Adaptive trial design

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https://www.readbyqxmd.com/read/28644370/adaptation-of-new-colombian-food-based-complementary-feeding-recommendations-using-linear-programming
#1
Marion Tharrey, Gilma A Olaya, Mary Fewtrell, Elaine Ferguson
OBJECTIVE: To use Linear Programming (LP) analyses to adapt New Complementary Feeding Guidelines (NCFg) designed for infants aged 6-12 month (m) living in poor socioeconomic circumstances in Bogota to ensure dietary adequacy for young children aged 12-23 m. DESIGN: A secondary data analysis was performed using dietary and anthropometric data collected from 12 m old infants (n = 72) participating in a randomised controlled trial. LP analyses were performed to identify nutrients whose requirements were difficult to achieve using local foods as consumed; and to test and compare the NCFg and alternative food-based recommendations (FBRs) on the basis of dietary adequacy, for 11 micronutrients, at the population level...
June 21, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28643158/measuring-working-memory-capacity-in-children-using-adaptive-tasks-example-validation-of-an-adaptive-complex-span
#2
Corentin Gonthier, Alexandre Aubry, Béatrice Bourdin
Working memory tasks designed for children usually present trials in order of ascending difficulty, with testing discontinued when the child fails a particular level. Unfortunately, this procedure comes with a number of issues, such as decreased engagement from high-ability children, vulnerability of the scores to temporary mind-wandering, and large between-subjects variations in number of trials, testing time, and proactive interference. To circumvent these problems, the goal of the present study was to demonstrate the feasibility of assessing working memory using an adaptive testing procedure...
June 22, 2017: Behavior Research Methods
https://www.readbyqxmd.com/read/28630525/a-bayesian-adaptive-design-for-clinical-trials-in-rare-diseases
#3
S Faye Williamson, Peter Jacko, Sofía S Villar, Thomas Jaki
Development of treatments for rare diseases is challenging due to the limited number of patients available for participation. Learning about treatment effectiveness with a view to treat patients in the larger outside population, as in the traditional fixed randomised design, may not be a plausible goal. An alternative goal is to treat the patients within the trial as effectively as possible. Using the framework of finite-horizon Markov decision processes and dynamic programming (DP), a novel randomised response-adaptive design is proposed which maximises the total number of patient successes in the trial and penalises if a minimum number of patients are not recruited to each treatment arm...
September 2017: Computational Statistics & Data Analysis
https://www.readbyqxmd.com/read/28628768/internet-delivered-cognitive-behavior-therapy-for-antenatal-depression-a-randomised-controlled-trial
#4
Erik Forsell, Marie Bendix, Fredrik Holländare, Barbara Szymanska von Schultz, Josefine Nasiell, Margareta Blomdahl-Wetterholm, Caroline Eriksson, Sara Kvarned, Johanna Lindau van der Linden, Elin Söderberg, Jussi Jokinen, Katarina Wide, Viktor Kaldo
Major depression occurs in 5-10% of pregnancies and is associated with many negative effects for mother and child, yet treatment options are scarce. To our knowledge, this is the first published randomised controlled trial on Internet delivered Cognitive Behavior Therapy (ICBT) for this group. OBJECTIVE: To test the efficacy of a pregnancy adapted version of an existing 10-week ICBT-program for depression as well as assessing acceptability and adherence DESIGN: Randomised controlled trial...
June 13, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28627310/comparing-cluster-level-dynamic-treatment-regimens-using-sequential-multiple-assignment-randomized-trials-regression-estimation-and-sample-size-considerations
#5
Timothy NeCamp, Amy Kilbourne, Daniel Almirall
Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28623602/protein-requirements-of-collared-peccary-pecari-tajacu
#6
Rogério M Borges, Alcester Mendes, Selene S C Nogueira, Jérôme Bindelle, Sérgio L G Nogueira-Filho
A nitrogen (N) balance digestion trial was conducted to determine the protein requirement of collared peccaries (Pecari tajacu). In a 4 × 4 Latin square design, four captive adult male peccaries were fed four isoenergy diets containing four different levels of N (11.7, 16.3, 22.8, and 26.7 g N/kg of dry matter-DM). After 15 days of adaptation, a total collection of feces and urine was carried out for five consecutive days. Regression analyses between N intake and N in feces and urine allowed to calculate the metabolic fecal nitrogen (MFN = 2...
June 16, 2017: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/28622083/the-importance-of-considering-differences-in-study-design-in-network-meta-analysis-an-application-using-anti-tumor-necrosis-factor-drugs-for-ulcerative-colitis
#7
Chris Cameron, Emmanuel Ewara, Florence R Wilson, Abhishek Varu, Peter Dyrda, Brian Hutton, Michael Ingham
BACKGROUND AND AIMS: Adaptive trial designs present a methodological challenge when performing network meta-analysis (NMA), as data from such adaptive trial designs differ from conventional parallel design randomized controlled trials (RCTs). We aim to illustrate the importance of considering study design when conducting an NMA. METHODS: Three NMAs comparing anti-tumor necrosis factor drugs for ulcerative colitis were compared and the analyses replicated using Bayesian NMA...
June 1, 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/28615010/internet-based-perioperative-exercise-program-in-patients-with-barrett-s-carcinoma-scheduled-for-esophagectomy-ipep-study-a-prospective-randomized-controlled-trial
#8
Daniel Pfirrmann, Suzan Tug, Oana Brosteanu, Matthias Mehdorn, Martin Busse, Peter P Grimminger, Florian Lordick, Torben Glatz, Jens Hoeppner, Hauke Lang, Perikles Simon, Ines Gockel
BACKGROUND: Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonary complications. This is partly due to one-lung ventilation during thoracotomy. This often accounts for prolonged stay on intensive care units, delayed postoperative reconvalescence and reduced quality of life. Socioeconomic disadvantages can result from these problems. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the time period of neoadjuvant therapy...
June 14, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28614960/requirements-on-a-community-based-intervention-for-stimulating-physical-activity-in-physically-disabled-people-a-focus-group-study-amongst-experts
#9
Leonie A Krops, Doortje H J Hols, Nienke Folkertsma, Pieter U Dijkstra, Jan H B Geertzen, Rienk Dekker
PURPOSE: To explore ideas experts, working in the field of physical activity for people with a disability, pose on a stimulating movement intervention for physically disabled people longer than one year post rehabilitation or not familiar with rehabilitation. METHODS: Four semi-structured focus groups were conducted with experts (n = 28). Transcripts were analysed following thematic analysis, using the integrated physical activity for people with a disability and intervention mapping model...
June 14, 2017: Disability and Rehabilitation
https://www.readbyqxmd.com/read/28610569/a-novel-tamponade-agent-for-management-of-post-partum-hemorrhage-adaptation-of-the-xstat-mini-sponge-applicator-for-obstetric-use
#10
Maria I Rodriguez, Jeffrey T Jensen, Kenton Gregory, Mary Bullard, Paul Longo, Jerry Heidel, Alison Edelman
BACKGROUND: Although uterine tamponade is an effective treatment for postpartum hemorrhage (PPH), current methods have key limitations in their use, particularly in low resource settings. The XStat™ Mini Sponge Dressing (MSD) is approved for the management of non-compressible wounds in the battlefield/trauma setting. The MSD applies highly compressed medical sponges capable of stopping high-flow arterial bleeding within seconds. The objective of our study was to adopt the MSD for use in managing PPH...
June 13, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28608165/platelet-related-biomarkers-and-their-response-to-inhibition-with-aspirin-and-p2y12-receptor-antagonists-in-patients-with-acute-coronary-syndrome
#11
Angela Lowenstern, Robert F Storey, Megan Neely, Jie-Lena Sun, Dominick J Angiolillo, Christopher P Cannon, Anders Himmelmann, Kurt Huber, Stefan K James, Hugo A Katus, Joao Morais, Agneta Siegbahn, Phillippe Gabriel Steg, Lars Wallentin, Richard C Becker
The PLATelet inhibition and patient Outcomes (PLATO) trial showed that treatment with ticagrelor reduced the rate of death due to vascular causes, myocardial infarction and stroke when compared to clopidogrel in patients with ST-elevation or non-ST-elevation acute coronary syndrome (ACS). While the comparative benefit of ticagrelor over clopidogrel increased over time, event rates accrued in both groups during the study period. The purpose of our biomarker-based exploratory analysis was to determine whether long-term platelet inhibition may be associated with platelet adaptation...
June 12, 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/28604818/cacna1c-gene-regulates-behavioral-strategies-in-operant-rule-learning
#12
Georgia Koppe, Anne Stephanie Mallien, Stefan Berger, Dusan Bartsch, Peter Gass, Barbara Vollmayr, Daniel Durstewitz
Behavioral experiments are usually designed to tap into a specific cognitive function, but animals may solve a given task through a variety of different and individual behavioral strategies, some of them not foreseen by the experimenter. Animal learning may therefore be seen more as the process of selecting among, and adapting, potential behavioral policies, rather than mere strengthening of associative links. Calcium influx through high-voltage-gated Ca2+ channels is central to synaptic plasticity, and altered expression of Cav1...
June 2017: PLoS Biology
https://www.readbyqxmd.com/read/28602027/assistive-technology-for-memory-support-in-dementia
#13
REVIEW
Henriëtte G Van der Roest, Jennifer Wenborn, Channah Pastink, Rose-Marie Dröes, Martin Orrell
BACKGROUND: The sustained interest in electronic assistive technology in dementia care has been fuelled by the urgent need to develop useful approaches to help support people with dementia at home. Also the low costs and wide availability of electronic devices make it more feasible to use electronic devices for the benefit of disabled persons. Information Communication Technology (ICT) devices designed to support people with dementia are usually referred to as Assistive Technology (AT) or Electronic Assistive Technology (EAT)...
June 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28598227/integration-of-a-palliative-care-intervention-into-community-practice-for-lung-cancer-a-study-protocol-and-lessons-learned-with-implementation
#14
Huong Q Nguyen, Thomas Cuyegkeng, Tieu O Phung, Karisa Jahn, Tami Borneman, Mayra Macias, Nora Ruel, Betty Ferrell
BACKGROUND: A notable gap in the evidence base for outpatient palliative care (PC) for cancer is that most trials were conducted in specialized oncology or academic centers with limited translation and further evaluation in "real-world" settings. Health systems are desperate for guidance regarding the most effective and sustainable PC service models. OBJECTIVE: Describe the study protocol to evaluate the dissemination of a previously tested nurse-led PC intervention (PCI) for patients with lung cancer and their family caregiver in community-based settings, lessons learned in adapting and implementing the PCI, and implications for future dissemination-translational efforts Design: Two-group, prospective sequential, quasi-experimental design with Phase 1 (Usual care) followed by Phase 2 (Intervention) setting/subjects...
June 9, 2017: Journal of Palliative Medicine
https://www.readbyqxmd.com/read/28596245/computerised-cognitive-behavioural-therapy-for-adults-with-intellectual-disability-randomised-controlled-trial
#15
Patricia Cooney, Catherine Jackman, David Coyle, Gary O'Reilly
BackgroundDespite the evidence base for computer-assisted cognitive-behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2×3 (group×time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up...
June 8, 2017: British Journal of Psychiatry: the Journal of Mental Science
https://www.readbyqxmd.com/read/28593103/natural-history-of-rod-mediated-dark-adaptation-over-2-years-in-intermediate-age-related-macular-degeneration
#16
Cynthia Owsley, Mark E Clark, Gerald McGwin
PURPOSE: To characterize the natural history of rod-mediated dark adaptation (RMDA) over 2 years in eyes with intermediate age-related macular degeneration (AMD). This information will be useful in understanding the potential of RMDA to serve as a functional endpoint in proof-of-concept studies and clinical trials on intermediate AMD. METHODS: RMDA was measured in eyes with intermediate AMD at baseline and follow-up visits over 2 years at 6, 12, 18, and 24 months...
June 2017: Translational Vision Science & Technology
https://www.readbyqxmd.com/read/28592459/the-effects-of-10-days-of-separate-heat-and-hypoxic-exposure-on-heat-acclimation-and-temperate-exercise-performance
#17
Rebecca A Neal, Jamie Prout, Joseph Costello, Heather C Massey, Michael J Tipton, John S Young, Jo Corbett
Adaptations to heat and hypoxia are typically studied in isolation, but are often encountered in combination. Whether the adaptive response to multiple stressors affords the same response as when examined in isolation is unclear. We examined: i) the influence of overnight moderate normobaric hypoxia on the time course and magnitude of adaption to daily heat exposure; ii) whether heat acclimation (HA) was ergogenic and if this was influenced by an additional hypoxic-stimulus. Eight males (V̇O2max=58.5[8.3] mL·kg(-1)·min(-1)) undertook two 11-day HA programmes (balanced-crossover design), once with overnight normobaric hypoxia (8[1] h per night; 10 nights; FIO2=0...
June 7, 2017: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://www.readbyqxmd.com/read/28589752/a-framework-for-prospectively-defining-progression-rules-for-internal-pilot-studies-monitoring-recruitment
#18
Lisa V Hampson, Paula R Williamson, Martin J Wilby, Thomas Jaki
Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28589085/immune-system-friend-or-foe-of-oncolytic-virotherapy
#19
REVIEW
Anna C Filley, Mahua Dey
Oncolytic viruses (OVs) are an emerging class of targeted anticancer therapies designed to selectively infect, replicate in, and lyse malignant cells without causing harm to normal, healthy tissues. In addition to direct oncolytic activity, OVs have shown dual promise as immunotherapeutic agents. The presence of viral infection and subsequently generated immunogenic tumor cell death trigger innate and adaptive immune responses that mediate further tumor destruction. However, antiviral immune responses can intrinsically limit OV infection, spread, and overall therapeutic efficacy...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28589027/developing-a-globally-applicable-evidence-informed-competency-framework-to-support-capacity-strengthening-in-clinical-research
#20
Amélie Julé, Tamzin Furtado, Liam Boggs, Francois van Loggerenberg, Victoria Ewing, Manhaz Vahedi, Pascal Launois, Trudie Lang
Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials...
March 2017: BMJ Global Health
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