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stepped wedge design

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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
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28125927/statistical-methods-for-unidirectional-switch-designs-past-present-and-future
#11
Zhuozhao Zhan, Geertruida H de Bock, Edwin R van den Heuvel
Clinical trials may apply or use a sequential introduction of a new treatment to determine its efficacy or effectiveness with respect to a control treatment. The reasons for choosing a particular switch design have different origins. For instance, they may be implemented for ethical or logistic reasons or for studying disease-modifying effects. Large-scale pragmatic trials with complex interventions often use stepped wedge designs (SWDs), where all participants start at the control group, and during the trial, the control treatment is switched to the new intervention at different moments...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28109321/stepped-wedge-cluster-randomized-controlled-trial-designs-a-review-of-reporting-quality-and-design-features
#12
REVIEW
Michael J Grayling, James M S Wason, Adrian P Mander
BACKGROUND: The stepped wedge (SW) cluster randomized controlled trial (CRCT) design is being used with increasing frequency. However, there is limited published research on the quality of reporting of SW-CRCTs. We address this issue by conducting a literature review. METHODS: Medline, Ovid, Web of Knowledge, the Cochrane Library, PsycINFO, the ISRCTN registry, and ClinicalTrials.gov were searched to identify investigations employing the SW-CRCT design up to February 2015...
January 21, 2017: Trials
https://www.readbyqxmd.com/read/28093263/-cross-sectional-stepped-wedge-designs-always-reduce-the-required-sample-size-when-there-is-no-time-effect
#13
LETTER
Xin Zhou, Xiaomei Liao, Donna Spiegelman
No abstract text is available yet for this article.
January 16, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28065181/effects-of-a-healthier-snack-on-snacking-habits-and-glycated-hb-hba1c-a-6-week-intervention-study
#14
Mary R Yan, Andrew Parsons, Gillian A Whalley, Elaine C Rush
Dietary behaviour modification may change eating habits and reduce the impact of poor nutrition. This study aimed to evaluate the effects of daily consumption of a healthier snack bar on snacking habits and glycated Hb (HbA1c) within a 6-week intervention. In all, twenty-eight participants were randomly allocated to two groups to either consume the bars as the main snack for 6 weeks (n 14) or receipt of the bars was delayed for 6 weeks (n 14) following a stepped-wedge design. All participants had HbA1c concentrations measured at weeks -1, 0, 4, 6, 10 and 12...
December 2016: British Journal of Nutrition
https://www.readbyqxmd.com/read/28061830/age-nutrition-chirugie-anc-study-impact-of-a-geriatric-intervention-on-the-screening-and-management-of-undernutrition-in-elderly-patients-operated-on-for-colon-cancer-a-stepped-wedge-controlled-trial
#15
Marine Dupuis, Elisabetta Kuczewski, Laurent Villeneuve, Sylvie Bin-Dorel, Max Haine, Claire Falandry, Thomas Gilbert, Guillaume Passot, Olivier Glehen, Marc Bonnefoy
BACKGROUND: Undernutrition prior to major abdominal surgery is frequent and increases morbidity and mortality, especially in older patients. The management of undernutrition reduces postoperative complications. Nutritional management should be a priority in patient care during the preoperative period. However undernutrition is rarely detected and the guidelines are infrequently followed. Preoperative undernutrition screening should allow a better implementation of the guidelines. METHODS/DESIGN: The ANC ("Age Nutrition Chirurgie") study is an interventional, comparative, prospective, multicenter, randomized protocol based on the stepped wedge trial design...
January 7, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28049480/effectiveness-of-sensor-monitoring-in-an-occupational-therapy-rehabilitation-program-for-older-individuals-after-hip-fracture-the-so-hip-trial-study-protocol-of-a-three-arm-stepped-wedge-cluster-randomized-trial
#16
Margriet C Pol, Gerben Ter Riet, Margo van Hartingsveldt, Ben Kröse, Sophia E de Rooij, Bianca M Buurman
BACKGROUND: The performance of activities of daily living (ADL) at home is important for the recovery of older individuals after hip fracture. However, 20-90% of these individuals lose ADL function and never fully recover. It is currently unknown to what extent occupational therapy (OT) with coaching based on cognitive behavioral treatment (CBT) improves recovery. The same holds for sensor monitoring-based coaching in addition to OT. Here, we describe the design of a study investigating the effect of sensor monitoring embedded in an OT rehabilitation program on the recovery of ADL among older individuals after hip fracture...
January 3, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28048260/su-f-p-37-implementation-of-an-end-to-end-qa-test-of-the-radiation-therapy-imaging-planning-and-delivery-process-to-identify-and-correct-possible-sources-of-deviation
#17
F Salinas Aranda, V Suarez, S Arbiser, R Sansogne
PURPOSE: To implement an end-to-end QA test of the radiation therapy imaging, planning and delivery process, aimed to assess the dosimetric agreement accuracy between planned and delivered treatment, in order to identify and correct possible sources of deviation. To establish an internal standard for machine commissioning acceptance. METHODS: A test involving all steps of the radiation therapy: imaging, planning and delivery process was designed. The test includes analysis of point dose and planar dose distributions agreement between TPS calculated and measured dose...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28013104/the-impact-of-nursing-delirium-preventive-innterventions-in-the-intensive-care-unit-underpin-icu-a-study-protocol-for-a-multi-centre-stepped-wedge-randomized-controlled-trial
#18
Annelies Wassenaar, Paul Rood, Lisette Schoonhoven, Steven Teerenstra, Marieke Zegers, Peter Pickkers, Mark van den Boogaard
BACKGROUND: Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU)...
December 8, 2016: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/27998277/the-pulsar-primary-care-protocol-a-stepped-wedge-cluster-randomized-controlled-trial-to-test-a-training-intervention-for-general-practitioners-in-recovery-oriented-practice-to-optimize-personal-recovery-in-adult-patients
#19
Joanne C Enticott, Frances Shawyer, Lisa Brophy, Grant Russell, Ellie Fossey, Brett Inder, Danielle Mazza, Shiva Vasi, Penelope June Weller, Elisabeth Wilson-Evered, Vrinda Edan, Graham Meadows
BACKGROUND: General practitioners (GPs) in Australia play a central role in the delivery of mental health care. This article describes the PULSAR (Principles Unite Local Services Assisting Recovery) Primary Care protocol, a novel mixed methods evaluation of a training intervention for GPs in recovery-oriented practice. The aim of the intervention is to optimize personal recovery in patients consulting study GPs for mental health issues. METHODS: The intervention mixed methods design involves a stepped-wedge cluster randomized controlled trial testing the outcomes of training in recovery-oriented practice, together with an embedded qualitative study to identify the contextual enablers and challenges to implementing recovery-oriented practice...
December 20, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27965823/feasibility-of-a-stepped-wedge-cluster-rct-and-concurrent-observational-sub-study-to-evaluate-the-effects-of-modified-ward-night-lighting-on-inpatient-fall-rates-and-sleep-quality-a-protocol-for-a-pilot-trial
#20
Satyan R Chari, Simon Smith, Alison Mudge, Alex A Black, Mariana Figueiro, Muhtashimuddin Ahmed, Mark Devitt, Terry P Haines
BACKGROUND: Falls among hospitalised patients impose a considerable burden on health systems globally and prevention is a priority. Some patient-level interventions have been effective in reducing falls, but others have not. An alternative and promising approach to reducing inpatient falls is through the modification of the hospital physical environment and the night lighting of hospital wards is a leading candidate for investigation. In this pilot trial, we will determine the feasibility of conducting a main trial to evaluate the effects of modified night lighting on inpatient ward level fall rates...
2016: Pilot and Feasibility Studies
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