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stepped wedge design

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https://www.readbyqxmd.com/read/28065181/effects-of-a-healthier-snack-on-snacking-habits-and-glycated-hb-hba1c-a-6-week-intervention-study
#1
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...
January 9, 2017: 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/27890050/interprofessional-medication-management-in-patients-with-multiple-morbidities
#8
Juliane Köberlein-Neu, Hugo Mennemann, Stefanie Hamacher, Isabel Waltering, Ulrich Jaehde, Corinna Schaffert, Olaf Rose
BACKGROUND: Medication reviews and medication management are being used more and more around the world to improve medication safety. Both of these tools were originally conceived as pharmaceutical care activities and have recently been developed into interdisciplinary approaches. We studied the efficacy of interprofessional medication management for multimorbid patients that takes their medical conditions, but also their general living situation into account. METHODS: A comprehensive medication management was performed, which involved the collection of information on the drugs each patient took, the way they were stored, the patient's drug intake and handling, and any problems that arose with pharmacotherapy...
November 4, 2016: Deutsches Ärzteblatt International
https://www.readbyqxmd.com/read/27875528/effectiveness-of-seasonal-malaria-chemoprevention-in-children-under-ten-years-of-age-in-senegal-a-stepped-wedge-cluster-randomised-trial
#9
Badara Cissé, El Hadj Ba, Cheikh Sokhna, Jean Louis NDiaye, Jules F Gomis, Yankhoba Dial, Catherine Pitt, Mouhamed NDiaye, Matthew Cairns, Ernest Faye, Magatte NDiaye, Aminata Lo, Roger Tine, Sylvain Faye, Babacar Faye, Ousmane Sy, Lansana Konate, Ekoue Kouevijdin, Clare Flach, Ousmane Faye, Jean-Francois Trape, Colin Sutherland, Fatou Ba Fall, Pape M Thior, Oumar K Faye, Brian Greenwood, Oumar Gaye, Paul Milligan
BACKGROUND: Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ), given each month during the transmission season, is recommended for children living in areas of the Sahel where malaria transmission is highly seasonal. The recommendation for SMC is currently limited to children under five years of age, but, in many areas of seasonal transmission, the burden in older children may justify extending this age limit. This study was done to determine the effectiveness of SMC in Senegalese children up to ten years of age...
November 2016: PLoS Medicine
https://www.readbyqxmd.com/read/27871269/institutionalizing-postpartum-intrauterine-device-iud-services-in-sri-lanka-tanzania-and-nepal-study-protocol-for-a-cluster-randomized-stepped-wedge-trial
#10
David Canning, Iqbal H Shah, Erin Pearson, Elina Pradhan, Mahesh Karra, Leigh Senderowicz, Till Bärnighausen, Donna Spiegelman, Ana Langer
BACKGROUND: During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals...
November 21, 2016: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/27854354/whole-of-systems-trial-of-prevention-strategies-for-childhood-obesity-who-stops-childhood-obesity
#11
Steven Allender, Lynne Millar, Peter Hovmand, Colin Bell, Marj Moodie, Rob Carter, Boyd Swinburn, Claudia Strugnell, Janette Lowe, Kayla de la Haye, Liliana Orellana, Sue Morgan
Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity...
November 16, 2016: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/27804158/practical-trials-in-medical-education-linking-theory-practice-and-decision-making
#12
Martin G Tolsgaard, Kulamakan M Kulasegaram, Charlotte Ringsted
CONTEXT: Concerns have been raised over the gap between education theory and practice and how research can contribute to inform decision makers on their choices and priorities. Little is known about how educational theories and research outcomes produced under optimal conditions in highly controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges, limitations and future directions for this kind of research...
January 2017: Medical Education
https://www.readbyqxmd.com/read/27798376/leveraging-contact-network-structure-in-the-design-of-cluster-randomized-trials
#13
Guy Harling, Rui Wang, Jukka-Pekka Onnela, Victor De Gruttola
BACKGROUND: In settings like the Ebola epidemic, where proof-of-principle trials have provided evidence of efficacy but questions remain about the effectiveness of different possible modes of implementation, it may be useful to conduct trials that not only generate information about intervention effects but also themselves provide public health benefit. Cluster randomized trials are of particular value for infectious disease prevention research by virtue of their ability to capture both direct and indirect effects of intervention, the latter of which depends heavily on the nature of contact networks within and across clusters...
October 24, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27797997/stepped-wedge-cluster-randomised-controlled-trial-to-assess-the-effectiveness-of-an-electronic-medication-management-system-to-reduce-medication-errors-adverse-drug-events-and-average-length-of-stay-at-two-paediatric-hospitals-a-study-protocol
#14
J I Westbrook, L Li, M Z Raban, M T Baysari, V Mumford, M Prgomet, A Georgiou, T Kim, R Lake, C McCullagh, L Dalla-Pozza, J Karnon, T A O'Brien, G Ambler, R Day, C T Cowell, M Gazarian, R Worthington, C U Lehmann, L White, D Barbaric, A Gardo, M Kelly, P Kennedy
INTRODUCTION: Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS)...
October 21, 2016: BMJ Open
https://www.readbyqxmd.com/read/27782821/implementation-of-a-pragmatic-stepped-wedge-cluster-randomized-trial-to-evaluate-impact-of-botswana-s-xpert-mtb-rif-diagnostic-algorithm-on-tb-diagnostic-sensitivity-and-early-antiretroviral-therapy-mortality
#15
Andrew F Auld, Tefera Agizew, Sherri Pals, Alyssa Finlay, Ndwapi Ndwapi, Rosanna Boyd, Heather Alexander, Anikie Mathoma, Joyce Basotli, Sambayawo Gwebe-Nyirenda, James Shepherd, Tedd V Ellerbrock, Anand Date
BACKGROUND: In 2012, as a pilot for Botswana's national Xpert MTB/RIF (Xpert) rollout plans, intensified tuberculosis (TB) case finding (ICF) activities were strengthened at 22 HIV treatment clinics prior to phased activation of 13 Xpert instruments. Together, the strengthened ICF intervention and Xpert activation are referred to as the "Xpert package". METHODS: The evaluation, called the Xpert Package Rollout Evaluation using a Stepped-wedge design (XPRES), has two key objectives: (1) to compare sensitivity of microscopy-based and Xpert-based pulmonary TB diagnostic algorithms in diagnosing sputum culture-positive TB; and (2) to evaluate impact of the "Xpert package" on all-cause, 6-month, adult antiretroviral therapy (ART) mortality...
October 26, 2016: BMC Infectious Diseases
https://www.readbyqxmd.com/read/27769177/application-of-a-nonrandomized-stepped-wedge-design-to-evaluate-an-evidence-based-quality-improvement-intervention-a-proof-of-concept-using-simulated-data-on-patient-centered-medical-homes
#16
Alexis K Huynh, Martin L Lee, Melissa M Farmer, Lisa V Rubenstein
BACKGROUND: Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method's analytic advantages and applying to a broader set of evaluations...
October 21, 2016: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/27764102/safety-of-seasonal-malaria-chemoprevention-smc-with-sulfadoxine-pyrimethamine-plus-amodiaquine-when-delivered-to-children-under-10-years-of-age-by-district-health-services-in-senegal-results-from-a-stepped-wedge-cluster-randomized-trial
#17
J L NDiaye, B Cissé, E H Ba, J F Gomis, C T Ndour, J F Molez, F B Fall, C Sokhna, B Faye, E Kouevijdin, F K Niane, M Cairns, J F Trape, C Rogier, O Gaye, B M Greenwood, P J M Milligan
BACKGROUND: It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age...
2016: PloS One
https://www.readbyqxmd.com/read/27756376/telemedicine-with-clinical-decision-support-for-critical-care-a-systematic-review
#18
Nicola Mackintosh, Marius Terblanche, Ritesh Maharaj, Andreas Xyrichis, Karen Franklin, Jamie Keddie, Emily Larkins, Anna Maslen, James Skinner, Samuel Newman, Joana Hiew De Sousa Magalhaes, Jane Sandall
BACKGROUND: Telemedicine applications aim to address variance in clinical outcomes and increase access to specialist expertise. Despite widespread implementation, there is little robust evidence about cost-effectiveness, clinical benefits, and impact on quality and safety of critical care telemedicine. The primary objective was to determine the impact of critical care telemedicine (with clinical decision support available 24/7) on intensive care unit (ICU) and hospital mortality and length of stay in adults and children...
October 18, 2016: Systematic Reviews
https://www.readbyqxmd.com/read/27754861/deciphering-assumptions-about-stepped-wedge-designs-the-case-of-ebola-vaccine-research
#19
Adélaïde Doussau, Christine Grady
Ethical concerns about randomising persons to a no-treatment arm in the context of Ebola epidemic led to consideration of alternative designs. The stepped wedge (SW) design, in which participants or clusters are randomised to receive an intervention at different time points, gained popularity. Common arguments in favour of using this design are (1) when an intervention is likely to do more good than harm, (2) all participants should receive the experimental intervention at some time point during the study and (3) the design might be preferable for practical reasons...
October 17, 2016: Journal of Medical Ethics
https://www.readbyqxmd.com/read/27728839/examining-evidence-based-resistance-plus-balance-training-in-community-dwelling-older-adults-with-complex-health-care-needs-trial-protocol-for-the-muscling-up-against-disability-project
#20
Justin W L Keogh, Tim Henwood, Paul Gardiner, Anthony Tuckett, Brent Hodgkinson, Kevin Rouse
Progressive resistance plus balance training (PRBT) has been demonstrated as effective in reducing later life physical disability, falls risk and poor health, even among those with complex health care needs. However, few studies have examined the influence of PRBT on health service utilisation, cognitive wellbeing and training modality acceptance or undertaken a cost benefit analysis. This project will investigate the broad scope benefits of PRBT participation among community-dwelling older Australians receiving Government supported aged care packages for their complex health care needs...
January 2017: Archives of Gerontology and Geriatrics
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