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Adaptive trial design

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https://www.readbyqxmd.com/read/29689045/two-year-impact-of-community-based-health-screening-and-parenting-groups-on-child-development-in-zambia-follow-up-to-a-cluster-randomized-controlled-trial
#1
Peter C Rockers, Arianna Zanolini, Bowen Banda, Mwaba Moono Chipili, Robert C Hughes, Davidson H Hamer, Günther Fink
BACKGROUND: Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. METHODS AND FINDINGS: We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads)...
April 2018: PLoS Medicine
https://www.readbyqxmd.com/read/29688139/a-multi-site-community-randomized-trial-of-community-health-workers-to-provide-counseling-and-support-for-patients-newly-entering-hiv-care-in-rural-ethiopia-study-design-and-baseline-implementation
#2
Alan R Lifson, Sale Workneh, Abera Hailemichael, Richard F MacLehose, Keith J Horvath, Rose Hilk, Lindsey Fabian, Anne Sites, Tibebe Shenie
BACKGROUND: Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. OBJECTIVES: We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. METHODS: Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites...
April 24, 2018: HIV Clinical Trials
https://www.readbyqxmd.com/read/29686289/cold-adaptation-recorded-in-tree-rings-highlights-risks-associated-with-climate-change-and-assisted-migration
#3
David Montwé, Miriam Isaac-Renton, Andreas Hamann, Heinrich Spiecker
With lengthening growing seasons but increased temperature variability under climate change, frost damage to plants may remain a risk and could be exacerbated by poleward planting of warm-adapted seed sources. Here, we study cold adaptation of tree populations in a wide-ranging coniferous species in western North America to inform limits to seed transfer. Using tree-ring signatures of cold damage from common garden trials designed to study genetic population differentiation, we find opposing geographic clines for spring frost and fall frost damage...
April 23, 2018: Nature Communications
https://www.readbyqxmd.com/read/29685830/-implementationof-a-low-fodmap-dietforfunctional-abdominal-pain
#4
María Luisa Baranguán Castro, Ignacio Ros Arnal, Ruth García Romero, Gerardo Rodríguez Martínez, Eduardo Ubalde Sainz
INTRODUCTION: The low FODMAP diet (fermentable oligosaccharides, monosaccharides, disaccharides, and polyols) has shown to be effective in adult patients with irritable bowel syndrome, but there are few studies on paediatric patients. The aim of this study is to assess the implementation and the outcomes of a low FODMAP diet in the treatment of functional abdominal pain in children from a Mediterranean area. MATERIAL AND METHODS: A table was designed in which foods were classified according to their FODMAP content, as well as a 'Symptoms and Stools Diary'...
April 20, 2018: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría (A.E.P.)
https://www.readbyqxmd.com/read/29682309/australasian-society-for-hiv-viral-hepatitis-and-sexual-health-medicine-hiv-pre-exposure-prophylaxis-clinical-guidelines-update-april-2018
#5
EDITORIAL
Edwina Wright, Andrew Grulich, Katy Roy, Mark Boyd, Vincent Cornelisse, Darren Russell, Darryl O'Donnell, Bill Whittaker, Levinia Crooks, Iryna Zablotska
Daily use of coformulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine's (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control's PrEP guidelines and are designed to: •Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials•Assist clinicians in the evaluation of patients who are seeking PrEP•Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition...
April 1, 2018: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29681185/cognitively-based-compassion-training-cbct-in-breast-cancer-survivors-a-randomized-clinical-trial-study
#6
Edgar Gonzalez-Hernandez, Rocio Romero, Daniel Campos, Diana Burichka, Rebeca Diego-Pedro, Rosa Baños, Lobsang Tenzin Negi, Ausiàs Cebolla
CONTEXT: Breast cancer (BC) requires a significant psychological adaptation once treatment is finished. There is growing evidence of how compassion training enhances psychological and physical well-being, however, there are very few studies analyzing the efficacy of compassion-based Interventions on BC survivors. OBJECTIVE: To study the efficacy of the Cognitively-Based Compassion Training (CBCT) protocol in a BC survivor sample on quality of life, psychological well-being, fear of cancer recurrence, self-compassion, and compassion domains and mindfulness facets...
April 1, 2018: Integrative Cancer Therapies
https://www.readbyqxmd.com/read/29672881/response-adaptive-treatment-allocation-for-survival-trials-with-clustered-right-censored-data
#7
Pei-Fang Su, Siu Hung Cheung
A comparison of 2 treatments with survival outcomes in a clinical study may require treatment randomization on clusters of multiple units with correlated responses. For example, for patients with otitis media in both ears, a specific treatment is normally given to a single patient, and hence, the 2 ears constitute a cluster. Statistical procedures are available for comparison of treatment efficacies. The conventional approach for treatment allocation is the adoption of a balanced design, in which half of the patients are assigned to each treatment arm...
April 19, 2018: Statistics in Medicine
https://www.readbyqxmd.com/read/29671799/from-the-paper-to-the-tablet-on-the-design-of-an-ar-based-tool-for-the-inspection-of-pre-fab-buildings-preliminary-results-of-the-sirae-project
#8
Cristina Portalés, Sergio Casas, Jesús Gimeno, Marcos Fernández, Montse Poza
Energy-efficient Buildings (EeB) are demanded in today’s constructions, fulfilling the requirements for green cities. Pre-fab buildings, which are modularly fully-built in factories, are a good example of this. Although this kind of building is quite new, the in situ inspection is documented using traditional tools, mainly based on paper annotations. Thus, the inspection process is not taking advantage of new technologies. In this paper, we present the preliminary results of the SIRAE project that aims to provide an Augmented Reality (AR) tool that can seamlessly aid in the regular processes of pre-fab building inspections to detect and eliminate the possible existing quality and energy efficiency deviations...
April 19, 2018: Sensors
https://www.readbyqxmd.com/read/29670611/advances-in-biomarker-guided-therapy-for-pediatric-and-adult-onset-neuroinflammatory-disorders-targeting-chemokines-cytokines
#9
REVIEW
Michael R Pranzatelli
The concept and recognized components of "neuroinflammation" are expanding at the intersection of neurobiology and immunobiology. Chemokines (CKs), no longer merely necessary for immune cell trafficking and positioning, have multiple physiologic, developmental, and modulatory functionalities in the central nervous system (CNS) through neuron-glia interactions and other mechanisms affecting neurotransmission. They issue the "help me" cry of neurons and astrocytes in response to CNS injury, engaging invading lymphoid cells (T cells and B cells) and myeloid cells (dendritic cells, monocytes, and neutrophils) (adaptive immunity), as well as microglia and macrophages (innate immunity), in a cascade of events, some beneficial (reparative), others destructive (excitotoxic)...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29664708/adaptive-and-resilient-soft-tensegrity-robots
#10
John Rieffel, Jean-Baptiste Mouret
Living organisms intertwine soft (e.g., muscle) and hard (e.g., bones) materials, giving them an intrinsic flexibility and resiliency often lacking in conventional rigid robots. The emerging field of soft robotics seeks to harness these same properties to create resilient machines. The nature of soft materials, however, presents considerable challenges to aspects of design, construction, and control-and up until now, the vast majority of gaits for soft robots have been hand-designed through empirical trial-and-error...
April 17, 2018: Soft Robotics
https://www.readbyqxmd.com/read/29659003/state-of-science-bridging-the-science-practice-gap-in-aging-dementia-and-mental-health
#11
Christopher M Callahan, Daniel R Bateman, Sophia Wang, Malaz A Boustani
The workforce available to care for older adults has not kept pace with the need. In response to workforce limitations and the growing complexity of healthcare, scientists have tested new models of care that redesign clinical practice. This article describes why new models of care in aging, dementia, and mental health diffuse inadequately into the healthcare systems and communities where they might benefit older adults. We review a general framework for the diffusion of innovations and highlight the importance of other features of innovations that deter or facilitate diffusion...
April 2018: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/29644545/adaptive-recruitment-and-parenting-interventions-for-immigrant-latino-families-with-adolescents
#12
Diego Garcia-Huidobro, Maria O Diaspro-Higuera, Dora Palma, Roberto Palma, Luis Ortega, Rebecca Shlafer, Elizabeth Wieling, Timothy Piehler, Gerald August, Maria V Svetaz, Iris W Borowsky, Michele L Allen
Parenting programs are an effective strategy to prevent multiple risky outcomes during adolescence. However, these programs usually enroll one caregiver and have low attendance. This study evaluated the preliminary results, cost, and satisfaction of adaptive recruitment and parenting interventions for immigrant Latino families. A mixed methods study was conducted integrating a pre-post design with embedded qualitative and process evaluations. Fifteen immigrant Latino families with an adolescent child aged 10-14 were recruited...
April 11, 2018: Prevention Science: the Official Journal of the Society for Prevention Research
https://www.readbyqxmd.com/read/29644408/modul-a-multicenter-randomized-clinical-trial-of-biomarker-driven-maintenance-therapy-following-first-line-standard-induction-treatment-of-metastatic-colorectal-cancer-an-adaptable-signal-seeking-approach
#13
Hans-Joachim Schmoll, Dirk Arnold, Aimery de Gramont, Michel Ducreux, Axel Grothey, Peter J O'Dwyer, Eric Van Cutsem, Frank Hermann, Ivan Bosanac, Belguendouz Bendahmane, Christoph Mancao, Josep Tabernero
PURPOSE: The old approach of one therapeutic for all patients with mCRC is evolving with a need to target specific molecular aberrations or cell-signalling pathways. Molecular screening approaches and new biomarkers are required to fully characterize tumours, identify patients most likely to benefit, and predict treatment response. METHODS: MODUL is a signal-seeking trial with a design that is highly adaptable, permitting modification of different treatment cohorts and inclusion of further additional cohorts based on novel evidence on new compounds/combinations that emerge during the study...
April 11, 2018: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29642858/vaginal-birth-after-caesarean-versus-elective-repeat-caesarean-delivery-after-one-previous-caesarean-section-a-cost-effectiveness-analysis-in-four-european-countries
#14
Maaike Fobelets, Katrien Beeckman, Gilles Faron, Déirdre Daly, Cecily Begley, Koen Putman
BACKGROUND: The OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries...
April 11, 2018: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/29618331/design-implementation-and-evaluation-of-a-web-based-computer-tailored-intervention-to-prevent-binge-drinking-in-adolescents-study-protocol
#15
Marta Lima-Serrano, José Manuel Martínez-Montilla, Joaquín S Lima-Rodríguez, Liesbeth Mercken, Hein de Vries
BACKGROUND: Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications with community implications. This paper describes the design, implementation and evaluation of the first web-based computer tailored intervention aimed at the prevention of binge drinking in Spanish adolescents. METHODS: The Alerta Alcohol program is based on the I-Change Model. First, feedback from focus and Delphi groups are used for cultural adaptation and to obtain further information on the items to be included on the program...
April 4, 2018: BMC Public Health
https://www.readbyqxmd.com/read/29617911/ontrack-development-and-feasibility-of-a-smartphone-app-designed-to-predict-and-prevent-dietary-lapses
#16
Evan M Forman, Stephanie P Goldstein, Fenqing Zhang, Brittney C Evans, Stephanie M Manasse, Meghan L Butryn, Adrienne S Juarascio, Pramod Abichandani, Gerald J Martin, Gary D Foster
Given that the overarching goal of weight loss programs is to remain adherent to a dietary prescription, specific moments of nonadherence known as "dietary lapses" can threaten weight control via the excess energy intake they represent and by provoking future lapses. Just-in-time adaptive interventions could be particularly useful in preventing dietary lapses because they use real-time data to generate interventions that are tailored and delivered at a moment computed to be of high risk for a lapse...
March 29, 2018: Translational Behavioral Medicine
https://www.readbyqxmd.com/read/29616042/gene-therapy-with-regulatory-t-cells-a-beneficial-alliance
#17
REVIEW
Moanaro Biswas, Sandeep R P Kumar, Cox Terhorst, Roland W Herzog
Gene therapy aims to replace a defective or a deficient protein at therapeutic or curative levels. Improved vector designs have enhanced safety, efficacy, and delivery, with potential for lasting treatment. However, innate and adaptive immune responses to the viral vector and transgene product remain obstacles to the establishment of therapeutic efficacy. It is widely accepted that endogenous regulatory T cells (Tregs) are critical for tolerance induction to the transgene product and in some cases the viral vector...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29609942/convenient-and-live-movement-calm-for-women-undergoing-breast-cancer-treatment-challenges-and-recommendations-for-internet-based-yoga-research
#18
Elizabeth L Addington, Stephanie J Sohl, Janet A Tooze, Suzanne C Danhauer
OBJECTIVE: To conduct a pilot trial of internet-based, cancer-adapted yoga for women receiving breast cancer treatment. DESIGN: Women undergoing radiation or chemotherapy for breast cancer were recruited for 12, 75-min, biweekly, cancer-adapted yoga classes delivered via internet-based, multipoint videoconferencing. Data were collected on feasibility and acceptability, including qualitative feedback from participants and the yoga instructor. RESULTS: Among 42 women approached, 13 declined eligibility screening, and 23 were ineligible...
April 2018: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/29609630/rationale-and-design-for-cognitive-behavioral-therapy-for-anxiety-disorders-in-children-with-autism-spectrum-disorder-a-study-protocol-of-a-randomized-controlled-trial
#19
Tina R Kilburn, Merete Juul Sørensen, Mikael Thastum, Ronald M Rapee, Charlotte Ulrikka Rask, Kristian Bech Arendt, Per Hove Thomsen
BACKGROUND: Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD...
April 2, 2018: Trials
https://www.readbyqxmd.com/read/29606891/critical-concepts-in-adaptive-clinical-trials
#20
REVIEW
Jay Jh Park, Kristian Thorlund, Edward J Mills
Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules...
2018: Clinical Epidemiology
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