keyword
MENU ▼
Read by QxMD icon Read
search

Adaptive trial design

keyword
https://www.readbyqxmd.com/read/28228115/weight-loss-and-exercise-for-communities-with-arthritis-in-north-carolina-we-can-design-and-rationale-of-a-pragmatic-assessor-blinded-randomized-controlled-trial
#1
Stephen P Messier, Leigh F Callahan, Daniel P Beavers, Kate Queen, Shannon L Mihalko, Gary D Miller, Elena Losina, Jeffrey N Katz, Richard F Loeser, Sara A Quandt, Paul DeVita, David J Hunter, Mary F Lyles, Jovita Newman, Betsy Hackney, Joanne M Jordan
BACKGROUND: Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown...
February 22, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28224926/a-30-month-worksite-based-lifestyle-program-to-promote-cardiovascular-health-in-middle-aged-bank-employees-design-of-the-tansnip-pesa-randomized-controlled-trial
#2
Jennifer K Coffeng, Hidde P van der Ploeg, José M Castellano, Juan M Fernández-Alvira, Borja Ibáñez, Inés García-Lunar, Allard J van der Beek, Antonio Fernández-Ortiz, Agustín Mocoroa, Laura García-Leal, Evelyn Cárdenas, Carolina Rojas, María I Martínez-Castro, Silvia Santiago-Sacristán, Miriam Fernández-Gallardo, José M Mendiguren, Sameer Bansilal, Willem van Mechelen, Valentín Fuster
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. OBJECTIVE: The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care...
February 2017: American Heart Journal
https://www.readbyqxmd.com/read/28222798/fracture-risk-in-dialysis-and-kidney-transplanted-patients-a-protocol-for-systematic-review-and-meta-analysis
#3
Aboubacar Sidibé, Lynne Moore, Sonia Jean, Fabrice Mac-Way
BACKGROUND: Chronic kidney disease (CKD) is associated with an increased risk of fracture and cardiovascular mortality. The risk of fracture in hemodialysis (HD), peritoneal dialysis (PD), and kidney transplantation (KT) is higher when compared to the general population. However, uncertainties remain about which group has the highest risk of fracture. We aim to identify the risk of fracture and cardiovascular mortality post-fracture in HD compared to PD or KT and in PD compared to KT population...
February 22, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28219430/digital-health-system-for-personalised-copd-long-term-management
#4
Carmelo Velardo, Syed Ahmar Shah, Oliver Gibson, Gari Clifford, Carl Heneghan, Heather Rutter, Andrew Farmer, Lionel Tarassenko
BACKGROUND: Recent telehealth studies have demonstrated minor impact on patients affected by long-term conditions. The use of technology does not guarantee the compliance required for sustained collection of high-quality symptom and physiological data. Remote monitoring alone is not sufficient for successful disease management. A patient-centred design approach is needed in order to allow the personalisation of interventions and encourage the completion of daily self-management tasks...
February 20, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28217694/probiotics-for-prevention-of-urinary-stones
#5
John C Lieske
BACKGROUND: Urinary supersaturation is one key determinant of calcium oxalate (CaOx) urinary stone formation, and urinary excretions of oxalate and citrate are two key determinants. Each is influenced by gastrointestinal processes. METHODS: Open label and randomized placebo studies have examined the effect of oral probiotic preparations on urinary supersaturation and oxalate excretion. Cross sectional studies in humans have studied the association of Oxalobacter formigenes colonization status and urinary oxalate excretion and prevalence of urinary stones...
January 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28215878/neuroactive-steroids-and-ptsd-treatment
#6
REVIEW
Ann M Rasmusson, Christine E Marx, Suzanne L Pineles, Andrea Locci, Erica R Scioli-Salter, Yael I Nillni, Jennifer J Liang, Graziano Pinna
This review highlights early efforts to translate pre-clinical and clinical findings regarding the role of neuroactive steroids in stress adaptation and PTSD into new therapeutics for PTSD. Numerous studies have demonstrated PTSD-related alterations in resting levels or the reactivity of neuroactive steroids and their targets. These studies also have demonstrated substantial variability in the dysfunction of specific neuroactive steroid systems among PTSD subpopulations. These variabilities have been related to the developmental timing of trauma, severity and type of trauma, genetic background, sex, reproductive state, lifestyle influences such as substance use and exercise, and the presence of comorbid conditions such as depression and chronic pain...
February 12, 2017: Neuroscience Letters
https://www.readbyqxmd.com/read/28211944/bayesian-response-adaptive-designs-for-basket-trials
#7
Steffen Ventz, William T Barry, Giovanni Parmigiani, Lorenzo Trippa
We develop a general class of response-adaptive Bayesian designs using hierarchical models, and provide open source software to implement them. Our work is motivated by recent master protocols in oncology, where several treatments are investigated simultaneously in one or multiple disease types, and treatment efficacy is expected to vary across biomarker-defined subpopulations. Adaptive trials such as I-SPY-2 (Barker et al., 2009) and BATTLE (Zhou et al., 2008) are special cases within our framework. We discuss the application of our adaptive scheme to two distinct research goals...
February 17, 2017: Biometrics
https://www.readbyqxmd.com/read/28211056/targeted-mass-media-interventions-promoting-healthy-behaviours-to-reduce-risk-of-non-communicable-diseases-in-adult-ethnic-minorities
#8
REVIEW
Annhild Mosdøl, Ingeborg B Lidal, Gyri H Straumann, Gunn E Vist
BACKGROUND: Physical activity, a balanced diet, avoidance of tobacco exposure, and limited alcohol consumption may reduce morbidity and mortality from non-communicable diseases (NCDs). Mass media interventions are commonly used to encourage healthier behaviours in population groups. It is unclear whether targeted mass media interventions for ethnic minority groups are more or less effective in changing behaviours than those developed for the general population. OBJECTIVES: To determine the effects of mass media interventions targeting adult ethnic minorities with messages about physical activity, dietary patterns, tobacco use or alcohol consumption to reduce the risk of NCDs...
February 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28206996/the-quest-for-sustained-multiple-morbidity-reduction-in-very-low-birth-weight-infants-the-antifragility-project
#9
J W Kaempf, N M Schmidt, S Rogers, C Novack, M Friant, L Wang, N Tipping
OBJECTIVE: Can a comprehensive, explicitly directive evidence-based guideline for all therapies that might affect the major morbidities of very low-birth-weight (VLBW) infants help a neonatal intensive care unit (NICU) further improve generally favorable morbidity rates? Can Antifragility principles of provider adaptive growth from stressors, enhanced infant risk assessment and adherence to effective therapies minimize unproven treatments and reduce all morbidities? STUDY DESIGN: Prospectively planned observational trial in VLBW infants: control group born October 2011 to September 2013 and study group October 2013 to September 2015...
February 16, 2017: Journal of Perinatology: Official Journal of the California Perinatal Association
https://www.readbyqxmd.com/read/28202500/canwalk-a-feasibility-study-with-embedded-randomised-controlled-trial-pilot-of-a-walking-intervention-for-people-with-recurrent-or-metastatic-cancer
#10
Vicki Tsianakas, Jenny Harris, Emma Ream, Mieke Van Hemelrijck, Arnie Purushotham, Lorelei Mucci, James S A Green, Jacquetta Fewster, Jo Armes
OBJECTIVES: Walking is an adaptable, inexpensive and accessible form of physical activity. However, its impact on quality of life (QoL) and symptom severity in people with advanced cancer is unknown. This study aimed to assess the feasibility and acceptability of a randomised controlled trial (RCT) of a community-based walking intervention to enhance QoL in people with recurrent/metastatic cancer. DESIGN: We used a mixed-methods design comprising a 2-centre RCT and nested qualitative interviews...
February 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/28193189/assessment-of-dha-on-reducing-early-preterm-birth-the-adore-randomized-controlled-trial-protocol
#11
Susan E Carlson, Byron J Gajewski, Christina J Valentine, Lynette K Rogers, Carl P Weiner, Emily A DeFranco, Catalin S Buhimschi
BACKGROUND: Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (<34 weeks) (ePTB), which has decreased little since 1990 and has the greatest impact on the overall infant mortality, resulting in the greatest cost to society. Docosahexaenoic acid (DHA) supplementation provides a potential high yield, low risk strategy to reduce early preterm delivery in the US by up to 75%...
February 13, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28193170/generating-evidence-on-a-risk-based-monitoring-approach-in-the-academic-setting-lessons-learned
#12
Belinda von Niederhäusern, Annette Orleth, Sabine Schädelin, Nawal Rawi, Martin Velkopolszky, Claudia Becherer, Pascal Benkert, Priya Satalkar, Matthias Briel, Christiane Pauli-Magnus
BACKGROUND: In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution. METHODS: We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01...
February 14, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28187284/clonal-heterogeneity-and-tumor-evolution-past-present-and-the-future
#13
REVIEW
Nicholas McGranahan, Charles Swanton
Intratumor heterogeneity, which fosters tumor evolution, is a key challenge in cancer medicine. Here, we review data and technologies that have revealed intra-tumor heterogeneity across cancer types and the dynamics, constraints, and contingencies inherent to tumor evolution. We emphasize the importance of macro-evolutionary leaps, often involving large-scale chromosomal alterations, in driving tumor evolution and metastasis and consider the role of the tumor microenvironment in engendering heterogeneity and drug resistance...
February 9, 2017: Cell
https://www.readbyqxmd.com/read/28179221/frontostriatal-and-behavioral-adaptations-to-daily-sugar-sweetened-beverage-intake-a-randomized-controlled-trial
#14
Kyle S Burger
Background: Current obesity theories suggest that the repeated intake of highly palatable high-sugar foods causes adaptions in the striatum, parietal lobe, and prefrontal and visual cortices in the brain that may serve to perpetuate consumption in a feed-forward manner. However, the data for humans are cross-sectional and observational, leaving little ability to determine the temporal precedence of repeated consumption on brain response.Objective: We tested the impact of regular sugar-sweetened beverage intake on brain and behavioral responses to beverage stimuli...
February 8, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28178876/designing-fecal-microbiota-transplant-trials-that-account-for-differences-in-donor-stool-efficacy
#15
Scott W Olesen, Thomas Gurry, Eric J Alm
Fecal microbiota transplantation is a highly effective intervention for patients suffering from recurrent Clostridium difficile, a common hospital-acquired infection. Fecal microbiota transplantation's success as a therapy for C. difficile has inspired interest in performing clinical trials that experiment with fecal microbiota transplantation as a therapy for other conditions like inflammatory bowel disease, obesity, diabetes, and Parkinson's disease. Results from clinical trials that use fecal microbiota transplantation to treat inflammatory bowel disease suggest that, for at least one condition beyond C...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28178849/adaptive-designs-from-a-data-safety-monitoring-board-perspective-some-controversies-and-some-case-studies
#16
Bruce W Turnbull
This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.
February 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28173775/evaluation-and-implementation-of-highly-challenging-balance-training-in-clinical-practice-for-people-with-parkinson-s-disease-protocol-for-the-hibalance-effectiveness-implementation-trial
#17
Breiffni Leavy, Lydia Kwak, Maria Hagströmer, Erika Franzén
BACKGROUND: If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented...
February 7, 2017: BMC Neurology
https://www.readbyqxmd.com/read/28169450/quantitating-the-effect-of-prosthesis-design-on-femoral-remodeling-using-high-resolution-region-free-densitometric-analysis-dxa-rfa
#18
Mohsen Farzi, Richard M Morris, Jeannette Penny, Lang Yang, Jose M Pozo, Søren Overgaard, Alejandro F Frangi, J Mark Wilkinson
Dual energy X-ray absorptiometry (DXA) is the reference standard method used to study bone mineral density (BMD) after total hip arthroplasty (THA). However, the subtle, spatially-complex changes in bone mass due to strain-adaptive bone remodeling relevant to different prosthesis designs are not readily resolved using conventional DXA analysis. DXA region free analysis (DXA RFA) is a novel computational image analysis technique that provides a high-resolution quantitation of periprosthetic BMD. Here we applied the technique to quantitate the magnitude and areal size of periprosthetic BMD changes using scans acquired during two previous randomized clinical trials (2004 to 2009); one comparing three cemented prosthesis design geometries, and the other comparing a hip resurfacing versus a conventional cementless prosthesis...
February 7, 2017: Journal of Orthopaedic Research: Official Publication of the Orthopaedic Research Society
https://www.readbyqxmd.com/read/28168753/using-data-mining-to-predict-success-in-a-weight-loss-trial
#19
M Batterham, L Tapsell, K Charlton, J O'Shea, R Thorne
BACKGROUND: Traditional methods for predicting weight loss success use regression approaches, which make the assumption that the relationships between the independent and dependent (or logit of the dependent) variable are linear. The aim of the present study was to investigate the relationship between common demographic and early weight loss variables to predict weight loss success at 12 months without making this assumption. METHODS: Data mining methods (decision trees, generalised additive models and multivariate adaptive regression splines), in addition to logistic regression, were employed to predict: (i) weight loss success (defined as ≥5%) at the end of a 12-month dietary intervention using demographic variables [body mass index (BMI), sex and age]; percentage weight loss at 1 month; and (iii) the difference between actual and predicted weight loss using an energy balance model...
February 7, 2017: Journal of Human Nutrition and Dietetics: the Official Journal of the British Dietetic Association
https://www.readbyqxmd.com/read/28166741/efficient-confidence-limits-for-adaptive-one-arm-two-stage-clinical-trials-with-binary-endpoints
#20
Guogen Shan, Hua Zhang, Tao Jiang
BACKGROUND: Recently, several adaptive one-arm two-stage designs have been developed by fully using the information from previous stages to reduce the expected sample size in clinical trials with binary endpoints as primary outcome. It is important to compute exact confidence limits for these studies. METHODS: In this article, we propose three new one-sided limits by ordering the sample space based on p-value, average response rate at each stage, and asymptotic lower limit, as compared to another three existing sample size ordering approaches based on average response rate...
February 6, 2017: BMC Medical Research Methodology
keyword
keyword
78017
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"