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https://www.readbyqxmd.com/read/28426295/review-of-recent-methodological-developments-in-group-randomized-trials-part-1-design
#1
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...
April 20, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28412466/proposed-variations-of-the-stepped-wedge-design-can-be-employed-to-accommodate-multiple-interventions
#2
Vivian H Lyons, Lingyu Li, James P Hughes, Ali Rowhani-Rahbar
OBJECTIVE: 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 a 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 12, 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
#3
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
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/28388937/advancing-engagement-methods-for-trials-the-core-study-relational-model-of-engagement-for-a-stepped-wedge-cluster-randomised-controlled-trial-of-experience-based-co-design-for-people-living-with-severe-mental-illnesses
#7
Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn, Victoria J Palmer
BACKGROUND: Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study...
April 8, 2017: Trials
https://www.readbyqxmd.com/read/28376839/a-hybrid-iii-stepped-wedge-cluster-randomized-trial-testing-an-implementation-strategy-to-facilitate-the-use-of-an-evidence-based-practice-in-va-homeless-primary-care-treatment-programs
#8
Molly M Simmons, Sonya Gabrielian, Thomas Byrne, Megan B McCullough, Jeffery L Smith, Thom J Taylor, Tom P O'Toole, Vincent Kane, Vera Yakovchenko, D Keith McInnes, David A Smelson
BACKGROUND: Homeless veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address housing and health care needs of homeless veterans. However, while 70% of HPACT's veteran enrollees have co-occurring mental health and substance use disorders, HPACT does not have a uniform, embedded treatment protocol for this subpopulation...
April 4, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28367785/cognitive-stimulation-therapy-as-a-sustainable-intervention-for-dementia-in-sub-saharan-africa-feasibility-and-clinical-efficacy-using-a-stepped-wedge-design-erratum
#9
Stella-Maria Paddick, Sarah Mkenda, Godfrey Mbowe, Aloyce Kisoli, William K Gray, Catherine L Dotchin, Laura Ternent, Adesola Ogunniyi, John Kissima, Olaide Olakehinde, Declare Mushi, Richard W Walker
In the above article (Paddick, 2017) The corresponding author's details were previously listed incorrectly. The correct details are; contact number +44 191 293 2709 and email address William.gray@nhct.nhs.uk. The original article has been updated with the correct contact details. The publishers apologise for any inconvenience and confusion this error has caused.
April 3, 2017: International Psychogeriatrics
https://www.readbyqxmd.com/read/28341910/effectiveness-and-cost-benefit-evaluation-of-a-comprehensive-workers-health-surveillance-program-for-sustainable-employability-of-meat-processing-workers
#10
Berry J van Holland, Michiel F Reneman, Remko Soer, Sandra Brouwer, Michiel R de Boer
Objective To evaluate the effectiveness of a comprehensive workers' health surveillance (WHS) program on aspects of sustainable employability and cost-benefit. Methods A cluster randomized stepped wedge trial was performed in a Dutch meat processing company from february 2012 until march 2015. In total 305 workers participated in the trial. Outcomes were retrieved during a WHS program, by multiple questionnaires, and from company registries. Primary outcomes were sickness absence, work ability, and productivity...
March 24, 2017: Journal of Occupational Rehabilitation
https://www.readbyqxmd.com/read/28314746/protocol-for-a-cluster-randomised-stepped-wedge-trial-assessing-the-impact-of-a-community-level-hygiene-intervention-and-a-water-intervention-using-riverbank-filtration-technology-on-diarrhoeal-prevalence-in-india
#11
Sarah L McGuinness, Joanne E O'Toole, Thomas B Boving, Andrew B Forbes, Martha Sinclair, Sumit K Gautam, Karin Leder
INTRODUCTION: Diarrhoea is a leading cause of death globally, mostly occurring as a result of insufficient or unsafe water supplies, inadequate sanitation and poor hygiene. Our study aims to investigate the impact of a community-level hygiene education program and a water quality intervention using riverbank filtration (RBF) technology on diarrhoeal prevalence. METHODS AND ANALYSIS: We have designed a stepped wedge cluster randomised trial to estimate the health impacts of our intervention in 4 rural villages in Karnataka, India...
March 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28297425/investigation-on-using-high-energy-proton-beam-for-total-body-irradiation-tbi
#12
Miao Zhang, Nan Qin, Xun Jia, Wei J Zou, Atif Khan, Ning J Yue
This work investigated the possibility of using proton beam for total body irradiation (TBI). We hypothesized the broad-slow-rising entrance dose from a monoenergetic proton beam can deliver a uniform dose to patient with varied thickness. Comparing to photon-based TBI, it would not require any patient-specific compensator or beam spoiler. The hypothesis was first tested by simulating 250 MeV, 275 MeV, and 300 MeV protons irradiating a wedge-shaped water phantom in a paired opposing arrangement using Monte Carlo (MC) method...
September 2016: Journal of Applied Clinical Medical Physics
https://www.readbyqxmd.com/read/28279222/minimum-number-of-clusters-and-comparison-of-analysis-methods-for-cross-sectional-stepped-wedge-cluster-randomised-trials-with-binary-outcomes-a-simulation-study
#13
Daniel Barker, Catherine D'Este, Michael J Campbell, Patrick McElduff
BACKGROUND: Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations and generalised linear mixed models. A topic of much research into these methods has been their application to cluster randomised trial data and, in particular, the number of clusters required to make reasonable inferences about the intervention effect. However, for stepped wedge trials, which have been claimed by many researchers to have a statistical power advantage over the parallel cluster randomised trial, the minimum number of clusters required has not been investigated...
March 9, 2017: Trials
https://www.readbyqxmd.com/read/28270224/an-imbalance-in-cluster-sizes-does-not-lead-to-notable-loss-of-power-in-cross-sectional-stepped-wedge-cluster-randomised-trials-with-a-continuous-outcome
#14
Caroline A Kristunas, Karen L Smith, Laura J Gray
BACKGROUND: The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in SW-CRTs are likely to vary in size, which in other designs of CRT leads to a reduction in power. The effect of an imbalance in cluster size on the power of SW-CRTs has not previously been reported, nor what an appropriate adjustment to the sample size calculation should be to allow for any imbalance...
March 7, 2017: Trials
https://www.readbyqxmd.com/read/28267469/acute-coronary-syndrome-quality-improvement-in-kerala-acs-quik-rationale-and-design-for-a-cluster-randomized-stepped-wedge-trial
#15
Mark D Huffman, Padinhare Purayil Mohanan, Raji Devarajan, Abigail S Baldridge, Dimple Kondal, Lihui Zhao, Mumtaj Ali, Donald M Lloyd-Jones, Dorairaj Prabhakaran
Ischemic heart disease is the leading cause of death in India, and there are likely more myocardial infarctions in India than in any other country in the world. We have previously reported heterogeneous care for patients with myocardial infarction in Kerala, a state in southern India, including both gaps in optimal care and inappropriate care. Based on that prior work, limitations from previous nonrandomized quality improvement studies and promising gains in process of care measures demonstrated from previous randomized trials, we and the Cardiological Society of India-Kerala chapter sought to develop, implement, and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients...
March 2017: American Heart Journal
https://www.readbyqxmd.com/read/28264941/strategies-for-assessing-delivery-system-innovations
#16
Elizabeth A McGlynn, Mark McClellan
Driven by evidence of continuing gaps in health care quality and efficiency and inspired by the emergence of new value-based payment models, both large and small health care organizations are developing and deploying a wide range of care delivery innovations. But how can decision makers in these organizations determine if the innovations really improve service delivery, patient experience, clinical outcomes, or costs? Organization leaders need appropriate, timely evidence to inform their decision making. In this article we describe a range of approaches to evaluating innovations and pose key questions about the validity of the results...
March 1, 2017: Health Affairs
https://www.readbyqxmd.com/read/28241643/fourier-transform-spectroscopy-in-the-vibrational-fingerprint-region-with-a-birefringent-interferometer
#17
J Réhault, R Borrego-Varillas, A Oriana, C Manzoni, C P Hauri, J Helbing, G Cerullo
We introduce a birefringent interferometer for Fourier transform (FT) spectroscopy in the mid-infrared, covering the vibrational fingerprint region (5-10 µm, 1000-2000 cm<sup>-1</sup>), which is crucial for molecular identification. Our interferometer employs the crystal calomel (Hg<sub>2</sub>Cl<sub>2</sub>), which combines high birefringence (n<sub>e</sub>-n<sub>o</sub>≈0.55) with a broad transparency range (0.38-20 µm). We adopt a design based on birefringent wedges, which is simple and compact and guarantees excellent delay accuracy and long-term stability...
February 20, 2017: Optics Express
https://www.readbyqxmd.com/read/28222815/cognitive-stimulation-therapy-as-a-sustainable-intervention-for-dementia-in-sub-saharan-africa-feasibility-and-clinical-efficacy-using-a-stepped-wedge-design
#18
Stella-Maria Paddick, Sarah Mkenda, Godfrey Mbowe, Aloyce Kisoli, William K Gray, Catherine L Dotchin, Laura Ternent, Adesola Ogunniyi, John Kissima, Olaide Olakehinde, Declare Mushi, Richard W Walker
BACKGROUND: Cognitive stimulation therapy (CST) is a psychosocial group-based intervention for dementia shown to improve cognition and quality of life with a similar efficacy to cholinesterase inhibitors. Since CST can be delivered by non-specialist healthcare workers, it has potential for use in low-resource environments, such as sub-Saharan Africa (SSA). We aimed to assess the feasibility and clinical effectiveness of CST in rural Tanzania using a stepped-wedge design. METHODS: Participants and their carers were recruited through a community dementia screening program...
February 22, 2017: International Psychogeriatrics
https://www.readbyqxmd.com/read/28166849/assessing-patient-progress-in-psychological-therapy-through-feedback-in-supervision-the-memos-randomized-controlled-trial-measuring-and-monitoring-clinical-outcomes-in-supervision-memos
#19
Kate M Davidson, Michelle L Rankin, Amelie Begley, Suzanne Lloyd, Sarah J E Barry, Paula McSkimming, Lisa Bell, Carole Allan, Morag Osborne, George Ralston, Geraldine Bienkowski, John Mellor-Clark, Andrew Walker
BACKGROUND: Psychological therapy services are often required to demonstrate their effectiveness and are implementing systematic monitoring of patient progress. A system for measuring patient progress might usefully 'inform supervision' and help patients who are not progressing in therapy. AIMS: To examine if continuous monitoring of patient progress through the supervision process was more effective in improving patient outcomes compared with giving feedback to therapists alone in routine NHS psychological therapy...
February 7, 2017: Behavioural and Cognitive Psychotherapy
https://www.readbyqxmd.com/read/28166804/addressing-the-gaps-in-diabetes-care-in-first-nations-communities-with-the-reorganizing-the-approach-to-diabetes-through-the-application-of-registries-radar-the-project-protocol
#20
Dean T Eurich, Sumit R Majumdar, Lisa A Wozniak, Allison Soprovich, Kari Meneen, Jeffrey A Johnson, Salim Samanani
BACKGROUND: Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited community nursing capacity, isolated environments and a lack of electronic health records (EHR)/registries lead to a reactive, disorganized approach to diabetes care for many First Nations people. The Reorganizing the Approach to Diabetes through the Application of Registries (RADAR) project was developed in alignments with federal calls for innovative, culturally relevant, community-specific programs for people with type-2 diabetes developed and delivered in partnership with target communities...
February 6, 2017: BMC Health Services Research
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