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Adaptive trial design

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https://www.readbyqxmd.com/read/29466994/developing-a-framework-to-evaluate-knowledge-into-action-interventions
#1
Sarah Morton, Suzanne Wilson, Sheila Inglis, Karen Ritchie, Ann Wales
BACKGROUND: There are many challenges in delivering and evaluating knowledge for healthcare, but the lack of clear routes from knowledge to practice is a root cause of failures in safety within healthcare. Various types and sources of knowledge are relevant at different levels within the healthcare system. These need to be delivered in a timely way that is useful and actionable for those providing services or developing policies. How knowledge is taken up and used through networks and relationships, and the difficulties in attributing change to knowledge-based interventions, present challenges to understanding how knowledge into action (K2A) work influences healthcare outcomes...
February 21, 2018: BMC Health Services Research
https://www.readbyqxmd.com/read/29466612/bayesian-enhancement-two-stage-design-for-single-arm-phase-ii-clinical-trials-with-binary-and-time-to-event-endpoints
#2
Haolun Shi, Guosheng Yin
Simon's two-stage design is one of the most commonly used methods in phase II clinical trials with binary endpoints. The design tests the null hypothesis that the response rate is less than an uninteresting level, versus the alternative hypothesis that the response rate is greater than a desirable target level. From a Bayesian perspective, we compute the posterior probabilities of the null and alternative hypotheses given that a promising result is declared in Simon's design. Our study reveals that because the frequentist hypothesis testing framework places its focus on the null hypothesis, a potentially efficacious treatment identified by rejecting the null under Simon's design could have only less than 10% posterior probability of attaining the desirable target level...
February 21, 2018: Biometrics
https://www.readbyqxmd.com/read/29466455/a-pneumatic-bionic-voice-prosthesis-pre-clinical-trials-of-controlling-the-voice-onset-and-offset
#3
Farzaneh Ahmadi, Farzad Noorian, Daniel Novakovic, André van Schaik
Despite emergent progress in many fields of bionics, a functional Bionic Voice prosthesis for laryngectomy patients (larynx amputees) has not yet been achieved, leading to a lifetime of vocal disability for these patients. This study introduces a novel framework of Pneumatic Bionic Voice Prostheses as an electronic adaptation of the Pneumatic Artificial Larynx (PAL) device. The PAL is a non-invasive mechanical voice source, driven exclusively by respiration with an exceptionally high voice quality, comparable to the existing gold standard of Tracheoesophageal (TE) voice prosthesis...
2018: PloS One
https://www.readbyqxmd.com/read/29466366/meta-analysis-of-the-clinical-behavior-of-posterior-direct-resin-restorations-low-polymerization-shrinkage-resin-in-comparison-to-methacrylate-composite-resin
#4
Paula de Castro Kruly, Marcelo Giannini, Renata Corrêa Pascotto, Laíse Midori Tokubo, Uhana Seifert Guimarães Suga, Any de Castro Ruiz Marques, Raquel Sano Suga Terada
Polymerization shrinkage of resin composite can compromise the longevity of restorations. To minimize this problem, the monomeric composition of composites have been modified. The objective of this study was to conduct a meta-analysis to assess the clinical behavior of restorations performed with low polymerization shrinkage resin composite in comparison with traditional methacrylates-based resin composite. This systematic review was registered at Prospero data system (CRD42015023940). Studies were searched in the electronic databases PubMed, Web of Science, Scopus, Lilacs and EMBASE according to a predefined search strategy...
2018: PloS One
https://www.readbyqxmd.com/read/29463619/a-comparison-of-direct-aspiration-versus-stent-retriever-as-a-first-approach-compass-protocol
#5
Aquilla S Turk, Adnan H Siddiqui, J Mocco
BACKGROUND AND OBJECTIVE: Acute ischemic stroke is a potentially devastating condition and leading cause of morbidity and mortality, affecting an estimated 800 000 people per year in the USA. The natural history of untreated or unrevascularized large vessel occlusions in acute stroke patients results in mortality rates approaching 30%, with only 25% achieving good neurologic outcomes at 90 days. Recently, data have demonstrated that early endovascular recanalization of large vessel occlusions results in better outcomes than medical therapy alone...
February 20, 2018: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/29463288/reactive-community-based-self-administered-treatment-against-residual-malaria-transmission-study-protocol-for-a-randomized-controlled-trial
#6
Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D'Alessandro
BACKGROUND: Systematic treatment of all individuals living in the same compound of a clinical malaria case may clear asymptomatic infections and possibly reduce malaria transmission, where this is focal. High and sustained coverage is extremely important and requires active community engagement. This study explores a community-based approach to treating malaria case contacts. METHODS/DESIGN: This is a cluster-randomized trial to determine whether, in low-transmission areas, treating individuals living in the same compound of a clinical malaria case with dihydroartemisinin-piperaquine can reduce parasite carriage and thus residual malaria transmission...
February 20, 2018: Trials
https://www.readbyqxmd.com/read/29463246/next-generation-personalised-model-based-critical-care-medicine-a-state-of-the-art-review-of-in-silico-virtual-patient-models-methods-and-cohorts-and-how-to-validation-them
#7
REVIEW
J Geoffrey Chase, Jean-Charles Preiser, Jennifer L Dickson, Antoine Pironet, Yeong Shiong Chiew, Christopher G Pretty, Geoffrey M Shaw, Balazs Benyo, Knut Moeller, Soroush Safaei, Merryn Tawhai, Peter Hunter, Thomas Desaive
Critical care, like many healthcare areas, is under a dual assault from significantly increasing demographic and economic pressures. Intensive care unit (ICU) patients are highly variable in response to treatment, and increasingly aging populations mean ICUs are under increasing demand and their cohorts are increasingly ill. Equally, patient expectations are growing, while the economic ability to deliver care to all is declining. Better, more productive care is thus the big challenge. One means to that end is personalised care designed to manage the significant inter- and intra-patient variability that makes the ICU patient difficult...
February 20, 2018: Biomedical Engineering Online
https://www.readbyqxmd.com/read/29462835/controlling-the-type-i-error-rate-in-two-stage-sequential-adaptive-designs-when-testing-for-average-bioequivalence
#8
Willi Maurer, Byron Jones, Ying Chen
In a 2×2 crossover trial for establishing average bioequivalence (ABE) of a generic agent and a currently marketed drug, the recommended approach to hypothesis testing is the two one-sided test (TOST) procedure, which depends, among other things, on the estimated within-subject variability. The power of this procedure, and therefore the sample size required to achieve a minimum power, depends on having a good estimate of this variability. When there is uncertainty, it is advisable to plan the design in two stages, with an interim sample size reestimation after the first stage, using an interim estimate of the within-subject variability...
February 20, 2018: Statistics in Medicine
https://www.readbyqxmd.com/read/29461414/validity-and-reliability-of-an-on-court-fitness-test-for-assessing-and-monitoring-aerobic-fitness-in-squash
#9
Carl Alexander James, Florencio Tenllado Vallejo, Melvin Kantebeen, Saro Farra
Current on-court assessments of aerobic fitness in squash are not designed to yield a wealth of physiological data. Moreover, tests may require complex computer equipment or involve simulated racket strokes, which are difficult to standardize at high intensities. This study investigated the validity and reliability of a squash-specific fitness test which can yield both a standalone performance score, as well as pertinent physiological markers such as V[Combining Dot Above]O2max, the lactate turnpoint and oxygen cost, in a sport-specific environment...
February 14, 2018: Journal of Strength and Conditioning Research
https://www.readbyqxmd.com/read/29457638/a-dialectical-behavior-therapy-skills-intervention-for-women-with-suicidal-behaviors-in-rural-nepal-a-single-case-experimental-design-series
#10
Megan K Ramaiya, Caitlin McLean, Upasana Regmi, Devika Fiorillo, Clive J Robins, Brandon A Kohrt
BACKGROUND: Suicide in low- and middle-income countries (LMICs) accounts for 75% of the world's burden of suicide mortality and is the leading single cause of death among Nepali reproductive age women. To advance treatment for suicidal behaviors in LMICs, a single-case experimental design (SCED) was conducted of a culturally adapted Dialectical Behavior Therapy skills intervention for Nepali populations (DBT-N). METHOD: Ten Nepali women with histories of suicidality participated in the 10-session intervention...
February 19, 2018: Journal of Clinical Psychology
https://www.readbyqxmd.com/read/29455722/computer-assisted-motivational-interviewing-intervention-to-facilitate-teen-pregnancy-prevention-and-fitness-behavior-changes-a-randomized-trial-for-young-men
#11
David L Bell, Samantha Garbers, Marina Catallozzi, R Stanley Hum, Meredith Nechitilo, Ian W McKeague, Emilia H Koumans, L Duane House, Susan L Rosenthal, Melanie A Gold
PURPOSE: Despite recent declines, teen unintended pregnancy and sexually transmitted infections in the United States remain at levels higher than comparable nations. Initiatives to prevent teen pregnancy have focused primarily on female adolescents; how to effectively engage young men to reduce their risk of fathering a teen pregnancy has not been well studied. We proposed to adapt an innovative computer-assisted motivational interviewing (CAMI) intervention, originally designed and tested with young women, for use with young men, aged 15-24 years, to reduce their risk of fathering a teen pregnancy...
March 2018: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
https://www.readbyqxmd.com/read/29455428/potential-of-feeding-beef-cattle-with-whole-corn-crop-silage-and-rice-straw-in-malaysia
#12
Muhamad Hazim Nazli, Ridzwan Abdul Halim, Amin Mahir Abdullah, Ghazali Hussin, Anjas Asmara Samsudin
The potential of using whole corn crop silage and rice straw as an alternative feed for the beef cattle based on the intake and growth performance were evaluated. Using randomised completely block design, nine adult Mafriwal cattle were blocked intro three groups and treated with three different forage diets supplemented with 20% pelleted palm kernel cake on dry matter basis. The treatments were 100% rice straw (RS), 100% corn silage (CS) and an equal mixture of rice straw and corn silage (MIX) fed ad libitum...
February 17, 2018: Tropical Animal Health and Production
https://www.readbyqxmd.com/read/29454141/a-cluster-randomized-pilot-trial-of-a-tailored-worksite-smoking-cessation-intervention-targeting-hispanic-latino-construction-workers-intervention-development-and-research-design
#13
Taghrid Asfar, Alberto J Caban-Martinez, Laura A McClure, Estefania C Ruano-Herreria, Danielle Sierra, G Gilford Clark, Daniel Samano, Noella A Dietz, Kenneth D Ward, Kristopher L Arheart, David J Lee
Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers...
February 14, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29451922/identifying-classifier-input-signals-to-predict-a-cross-slope-during-transtibial-amputee-walking
#14
Courtney E Shell, Glenn K Klute, Richard R Neptune
Advanced prosthetic foot designs often incorporate mechanisms that adapt to terrain changes in real-time to improve mobility. Early identification of terrain (e.g., cross-slopes) is critical to appropriate adaptation. This study suggests that a simple classifier based on linear discriminant analysis can accurately predict a cross-slope encountered (0°, -15°, 15°) using measurements from the residual limb, primarily from the prosthesis itself. The classifier was trained and tested offline using motion capture and in-pylon sensor data collected during walking trials in mid-swing and early stance...
2018: PloS One
https://www.readbyqxmd.com/read/29446711/neurophysiological-adaptations-in-the-untrained-side-in-conjunction-with-cross-education-of-muscle-strength-a-systematic-review-and-meta-analysis
#15
Andrea Manca, Tibor Hortobagyi, John C Rothwell, Franca Deriu
We reviewed the evidence from randomized controlled trials (RCTs) focusing on the neurophysiological adaptations in the untrained side associated with cross-education of strength (CE) and pooled data into definite effect estimates for neurophysiological variables assessed in chronic CE studies. Furthermore, scoping directions for future research were provided to enhance the homogeneity and comparability of studies investigating the neural responses to CE. The magnitude of CE was 21.1{plus minus}18.2% (p<0...
February 15, 2018: Journal of Applied Physiology
https://www.readbyqxmd.com/read/29446469/clinical-trials-in-allergen-immunotherapy-current-concepts-and-future-needs
#16
REVIEW
O Pfaar, M Alvaro, V Cardona, E Hamelmann, R Mösges, J Kleine-Tebbe
Allergen immunotherapy (AIT) is a safe, effective treatment for allergic rhinoconjunctivitis and allergic asthma. However, AIT's clinical effect is still contested - primarily due to heterogeneity in clinical trial designs, study populations, therapeutic formulations and efficacy criteria. After discussing current concepts and unmet needs, an international panel of experts made several recommendations: (i) explore and validate definitions for [clinical] responders in AIT-trials; (ii) use of well-documented, standardized provocation tests prior to inclusion of subjects with relevant diseases in AIT trials; (iii) monitoring neo-sensitizations and occurrence of new allergy in extended AIT trials, and exclusion of polyallergic participants; (iv) validation of allergen exposure chambers with regard to natural exposure; (v) in studies of seasonal allergies, focus on peak exposure but also consider organising two parallel, geographically distinct but otherwise identical trials; (vi) discuss adaptive trial designs with the regulatory authorities; (vii) use e-health and m-health technologies to capture more information on individual exposure to allergens; (viii) initiate research on potential psychological, biochemical, immune, neural and even genomic markers of the placebo response; (ix) identify trial designs and primary endpoints that will give children with allergies easier, faster access to AIT formulations; and (x) promote and apply standardized methods for reporting systemic and local adverse events...
February 15, 2018: Allergy
https://www.readbyqxmd.com/read/29445521/a-method-for-co-creation-of-an-evidence-based-patient-workbook-to-address-alcohol-use-when-quitting-smoking-in-primary-care-a-case-study
#17
Nadia Minian, Aliya Noormohamed, Laurie Zawertailo, Dolly Baliunas, Norman Giesbrecht, Bernard Le Foll, Jürgen Rehm, Andriy Samokhvalov, Peter L Selby
Plain English summary: The purpose of this paper is to describe a patient engagement event designed to create an educational workbook with smokers who drink alcohol at harmful levels. The goal was to create a workbook that combined scientific evidence with patients' values, preferences, and needs. Fourteen adult smokers who drink alcohol were invited to the Centre for Addiction and Mental Health (CAMH) to take part in a four-hour event to help design the workbook with the CAMH research team...
2018: Research involvement and engagement
https://www.readbyqxmd.com/read/29442610/balancing-statistical-and-ethical-considerations-in-planning-clinical-trials-recommendations-for-response-adaptive-randomization-urn-designs
#18
Annalisa V Piccorelli, Sarah A Fraker
During a clinical trial, balancing statistical and ethical considerations are important. Response-adaptive randomization methods use the information from past patients to increase the probability of the next patient receiving the better treatment while avoiding the statistical concern of selection bias. We compared three response-adaptive randomization urn designs, Randomized Play-the-Winner, Modified Play-the-Winner, and Birth-and-Death Urn with Immigration, to the traditional equal allocation design with respect to power and allocation of patients to the better treatment...
February 14, 2018: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29440160/interventions-to-increase-access-to-or-uptake-of-physical-health-screening-in-people-with-severe-mental-illness-a-realist-review
#19
Frédérique Lamontagne-Godwin, Caroline Burgess, Sarah Clement, Melanie Gasston-Hales, Carolynn Greene, Anne Manyande, Deborah Taylor, Paul Walters, Elizabeth Barley
OBJECTIVES: To identify and evaluate interventions aimed at increasing uptake of, or access to, physical health screening by adults with severe mental illness; to examine why interventions might work. DESIGN: Realist review. SETTING: Primary, secondary and tertiary care. RESULTS: A systematic search identified 1448 studies, of which 22 met the inclusion criteria. Studies were from Australia (n=3), Canada (n=1), Hong Kong (n=1), UK (n=11) and USA (n=6)...
February 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29440155/adaptive-design-clinical-trials-a-review-of-the-literature-and-clinicaltrials-gov
#20
Laura E Bothwell, Jerry Avorn, Nazleen F Khan, Aaron S Kesselheim
OBJECTIVES: This review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials. DESIGN: Review of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of Controlled Clinical Trials, Web of Science and ClinicalTrials.gov. Phase I and seamless Phase I/II trials were excluded. Variables extracted from trials included basic study characteristics, adaptive design features, size and use of independent data monitoring committees (DMCs) and blinded interim analyses...
February 10, 2018: BMJ Open
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