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stepped wedge design

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https://www.readbyqxmd.com/read/28616251/physical-micro-environment-interventions-for-healthier-eating-in-the-workplace-protocol-for-a-stepped-wedge-randomised-controlled-pilot-trial
#1
Milica Vasiljevic, Emma Cartwright, Rachel Pechey, Gareth J Hollands, Dominique-Laurent Couturier, Susan A Jebb, Theresa M Marteau
BACKGROUND: An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28595662/behavior-and-evolution-of-young-onset-dementia-part-2-beyond-ii-study-an-intervention-study-aimed-at-improvement-in-the-management-of-neuropsychiatric-symptoms-in-institutionalized-people-with-young-onset-dementia
#2
J C L van Duinen-van den IJssel, B Appelhof, S A Zwijsen, M Smalbrugge, F R J Verhey, M E de Vugt, S U Zuidema, R T C M Koopmans, C Bakker
BACKGROUND: Both neuropsychiatric symptoms (NPS) and psychotropic drug use (PDU) are common in institutionalized People with Young Onset Dementia (PwYOD) and can produce negative outcomes such as reduced quality of life and high workload. In community-dwelling PwYOD, NPS are found to be associated with unmet care needs. This emphasizes the importance of a care program for the management of NPS in institutionalized PwYOD that also addresses unmet care needs and PDU. The objectives of the Behavior and Evolution of Young ONset Dementia part 2 (BEYOND-II) study are to develop a care program for the management of NPS in institutionalized PwYOD and to evaluate its effectiveness...
June 9, 2017: International Psychogeriatrics
https://www.readbyqxmd.com/read/28554911/navigating-high-risk-surgery-protocol-for-a-multisite-stepped-wedge-cluster-randomised-trial-of-a-question-prompt-list-intervention-to-empower-older-adults-to-ask-questions-that-inform-treatment-decisions
#3
Lauren J Taylor, Paul J Rathouz, Ana Berlin, Karen J Brasel, Anne C Mosenthal, Emily Finlayson, Zara Cooper, Nicole M Steffens, Nora Jacobson, Anne Buffington, Jennifer L Tucholka, Qianqian Zhao, Margaret L Schwarze
INTRODUCTION: Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations...
May 29, 2017: BMJ Open
https://www.readbyqxmd.com/read/28549470/rationale-and-protocol-paper-for-the-healthy-active-peaceful-playgrounds-for-youth-happy-study
#4
Wayne Cotton, Dean Dudley, Kirsten Jackson, Matthew Winslade, Janice Atkin
BACKGROUND: A growing body of evidence suggest an association between physical activity levels and students psychological well-being. A number of research studies have evaluated playground interventions that aim to increase physical activity levels, decrease conflict and bullying, and improve students behaviour. The HAPPY Study will evaluate the success of an intervention combining environmental modifications, teacher development, and peer support that can culminate in an easy to implement, low cost and effective model for increasing physical activity, and improving psychological well-being for children...
May 26, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28545498/feasibility-of-a-systematic-comprehensive-one-to-one-training-scoot-program-for-new-scooter-users-study-protocol-for-a-randomized-control-trial
#5
W Ben Mortenson, Sharon Jang, Charlie H Goldsmith, Laura Hurd Clarke, Sandra Hobson, Richelle Emery
BACKGROUND: Mobility scooters can facilitate community participation among individuals with mobility limitations. However, accidents are a serious concern with scooter use. Scooter training has been recommended to improve safety, but there are currently few validated programs available. Therefore, we developed a Systematic, Comprehensive, One-to-One Training (SCOOT) program for scooter users. We will conduct a study to evaluate the outcomes produced by the provision SCOOT. METHODS: This feasibility study will use a mixed-methods, rater-blinded, randomized control trial, with a two-step wedge design...
May 25, 2017: Trials
https://www.readbyqxmd.com/read/28520480/review-of-recent-methodological-developments-in-group-randomized-trials-part-2-analysis
#6
Elizabeth L Turner, Melanie Prague, John A Gallis, Fan Li, David M Murray
In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e...
July 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28514964/help-problems-in-executing-a-pragmatic-randomized-stepped-wedge-trial-on-the-hospital-elder-life-program-to-prevent-delirium-in-older-patients
#7
Noor Heim, Henk F van Stel, Roelof G Ettema, Roos C van der Mast, Sharon K Inouye, Marieke J Schuurmans
BACKGROUND: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. METHODS: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study...
May 17, 2017: Trials
https://www.readbyqxmd.com/read/28507990/development-of-an-online-evidence-based-patient-information-portal-for-congenital-heart-disease-a-pilot-study
#8
Jonathan R G Etnel, Arie P J van Dijk, Jolanda Kluin, Robin A Bertels, Elisabeth M W J Utens, Eugene van Galen, Ad J J C Bogers, Johanna J M Takkenberg
OBJECTIVES: In response to an increased need for patient information on congenital heart disease in the Netherlands, we initiated a nationwide initiative to develop an online, evidence-based patient information portal, starting with a pilot project aimed at the subgroup of patients with congenital aortic and pulmonary valve disease. METHODS AND RESULTS: We developed an information portal that aims to (1) improve patient knowledge and involvement and to subsequently reduce anxiety and decisional conflict and improve mental quality of life and (2) to support physicians in informing and communicating with their patients...
2017: Frontiers in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28490560/nursing-home-team-care-deprescribing-study-a-stepped-wedge-randomised-controlled-trial-protocol
#9
Chong-Han Kua, Cindy Ying Ying Yeo, Cheryl Wai Teng Char, Cheryl Wei Yan Tan, Poh Ching Tan, Vivienne Sl Mak, Shaun Wen Huey Lee, Ian Yi-Onn Leong
INTRODUCTION: An ageing population has become an urgent concern for Asia in recent times. In nursing homes, polypharmacy has also become a compounding issue. Deprescribing practice is an evidence-based strategy to provide a better outcome in this group of patients; however, its implementation in nursing homes is often challenging, and prospective outcome data on deprescribing practice in the elderly is lacking. Our study assesses the implementation of team-care deprescribing to understand the benefits of this practice in geriatric setting and to explore the factors affecting deprescribing practice...
May 9, 2017: BMJ Open
https://www.readbyqxmd.com/read/28489410/strategically-designing-a-pumpless-microfluidic-device-on-an-inert-polypropylene-substrate-with-potential-application-in-biosensing-and-diagnostics
#10
Elham Shirani, Amir Razmjou, Hossein Tavassoli, Amir Landarani-Isfahani, Saghar Rezaei, Abolghasem Abbasi Kajani, Mohsen Asadnia, Jingwei Hou, Majid Ebrahimi Warkiani
This study is an attempt to make a step forward to implement the very immature concept of pumpless transportation of liquid into a real miniaturized device or lab-on-chip (LOC) on a plastic substrate. "Inert" plastic materials such as polypropylene (PP) are used in a variety of biomedical applications but their surface engineering is very challenging. Here, it was demonstrated that with a facile innovative wettability patterning route using fluorosilanized UV-independent TiO2 nanoparticle coating it is possible to create wedge-shaped open microfluidic tracks on inert solid surfaces for low-cost biomedical devices (lab-on-plastic)...
June 6, 2017: Langmuir: the ACS Journal of Surfaces and Colloids
https://www.readbyqxmd.com/read/28482829/the-pulsar-specialist-care-protocol-a-stepped-wedge-cluster-randomized-control-trial-of-a-training-intervention-for-community-mental-health-teams-in-recovery-oriented-practice
#11
Frances Shawyer, Joanne C Enticott, Lisa Brophy, Annie Bruxner, Ellie Fossey, Brett Inder, John Julian, Ritsuko Kakuma, Penelope Weller, Elisabeth Wilson-Evered, Vrinda Edan, Mike Slade, Graham N Meadows
BACKGROUND: Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention...
May 8, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28482059/predictors-of-the-effectiveness-of-accreditation-on-hospital-performance-a-nationwide-stepped-wedge-study
#12
Søren Bie Bogh, Anne Mette Falstie-Jensen, Erik Hollnagel, René Holst, Jeffrey Braithwaite, Ditte Caroline Raben, Søren Paaske Johnsen
HASH(0x4be1728) Objective: To identify predictors of the effectiveness of hospital accreditation on process performance measures. Design: A multi-level, longitudinal, stepped-wedge, nationwide study. Participants: All patients admitted for acute stroke, heart failure, ulcers, diabetes, breast cancer and lung cancer at Danish hospitals. Intervention: The Danish Healthcare Quality Programme that was designed to create a framework for continuous quality improvement...
May 8, 2017: International Journal for Quality in Health Care
https://www.readbyqxmd.com/read/28464567/the-use-of-permutation-tests-for-the-analysis-of-parallel-and-stepped-wedge-cluster-randomized-trials
#13
Rui Wang, Victor De Gruttola
We investigate the use of permutation tests for the analysis of parallel and stepped-wedge cluster-randomized trials. Permutation tests for parallel designs with exponential family endpoints have been extensively studied. The optimal permutation tests developed for exponential family alternatives require information on intraclass correlation, a quantity not yet defined for time-to-event endpoints. Therefore, it is unclear how efficient permutation tests can be constructed for cluster-randomized trials with such endpoints...
May 2, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28456068/summary-of-comparison-between-fft-cw-%C3%A2-and-usual-care-sample-from-administration-for-children-s-services
#14
Charles W Turner, Michael S Robbins, Sylvia Rowlands, Lisa R Weaver
This evaluation compared the efficiency and effectiveness of Functional Family Therapy-Child Welfare (FFT-CW(®), n=1625) to Usual Care (UC: n=2250) in reducing child maltreatment. FFT-CW(®) is a continuum of care model based on the family's risk status. In a child welfare setting, families received either UC or FFT-CW(®) in a quasi-experimental, stepped wedge design across all five boroughs of New York City. The families were matched using stratified propensity scoring on their pre-service risk status and followed for 16 months...
April 26, 2017: Child Abuse & Neglect
https://www.readbyqxmd.com/read/28426295/review-of-recent-methodological-developments-in-group-randomized-trials-part-1-design
#15
REVIEW
Elizabeth L Turner, Fan Li, John A Gallis, Melanie Prague, David M Murray
In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have highlighted the developments of the past 13 years in design with a companion article to focus on developments in analysis. As a pair, these articles update the 2004 review. We have discussed developments in the topics of the earlier review (e.g., clustering, matching, and individually randomized group-treatment trials) and in new topics, including constrained randomization and a range of randomized designs that are alternatives to the standard parallel-arm GRT...
June 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28412466/proposed-variations-of-the-stepped-wedge-design-can-be-used-to-accommodate-multiple-interventions
#16
Vivian H Lyons, Lingyu Li, James P Hughes, Ali Rowhani-Rahbar
OBJECTIVES: Stepped-wedge design (SWD) cluster-randomized trials have traditionally been used for evaluating a single intervention. We aimed to explore design variants suitable for evaluating multiple interventions in an SWD trial. STUDY DESIGN AND SETTING: We identified four specific variants of the traditional SWD that would allow two interventions to be conducted within a single cluster-randomized trial: concurrent, replacement, supplementation, and factorial SWDs...
April 13, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28399810/a-programme-to-spread-egfr-graph-surveillance-for-the-early-identification-support-and-treatment-of-people-with-progressive-chronic-kidney-disease-assist-ckd-protocol-for-the-stepped-wedge-implementation-and-evaluation-of-an-intervention-to-reduce-late-presentation
#17
Hugh Gallagher, Shona Methven, Anna Casula, Nicola Thomas, Charles R V Tomson, Fergus J Caskey, Tracey Rose, Stephen J Walters, David Kennedy, Anne Dawnay, Martin Cassidy, Richard Fluck, Hugh C Rayner, Michael Nation
BACKGROUND: Patients who start renal replacement therapy (RRT) for End-Stage Kidney Disease (ESKD) without having had timely access to specialist renal services have poor outcomes. At one NHS Trust in England, a community-wide CKD management system has led to a decline in the incident rate of RRT and the lowest percentage of patients presenting within 90 days of starting RRT in the UK. We describe the protocol for a quality improvement project to scale up and evaluate this innovation...
April 11, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28399510/assessing-dose-response-effects-of-national-essential-medicine-policy-in-china-comparison-of-two-methods-for-handling-data-with-a-stepped-wedge-like-design-and-hierarchical-structure
#18
Yan Ren, Min Yang, Qian Li, Jay Pan, Fei Chen, Xiaosong Li, Qun Meng
OBJECTIVES: To introduce multilevel repeated measures (RM) models and compare them with multilevel difference-in-differences (DID) models in assessing the linear relationship between the length of the policy intervention period and healthcare outcomes (dose-response effect) for data from a stepped-wedge design with a hierarchical structure. DESIGN: The implementation of national essential medicine policy (NEMP) in China was a stepped-wedge-like design of five time points with a hierarchical structure...
February 22, 2017: BMJ Open
https://www.readbyqxmd.com/read/28393537/inadequacy-of-ethical-conduct-and-reporting-of-stepped-wedge-cluster-randomized-trials-results-from-a-systematic-review
#19
Monica Taljaard, Karla Hemming, Lena Shah, Bruno Giraudeau, Jeremy M Grimshaw, Charles Weijer
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28391964/associations-between-fathers-and-sons-sexual-risk-in-rural-kenya-the-potential-for-intergenerational-transmission
#20
Ali M Giusto, Eric P Green, Eve S Puffer
PURPOSE: Despite high rates of HIV in areas of Sub-Saharan Africa and men's role in driving the epidemic, little is known about whether or how sexual risk-both behaviors and beliefs-may be passed down through generations of males. This study examined associations between sexual risk behaviors and sex-related beliefs of adolescent males and those of their male caregivers in Kenya, as well as the potential moderating effects of parenting characteristics and father-son relationship quality...
April 5, 2017: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
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