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stepped wedge design

Adam Martin, Rupert Payne, Edward Cf Wilson
BACKGROUND: The National Health Service (NHS) in England spends over £9 billion on prescription medicines dispensed in primary care, of which over two-thirds is accounted for by repeat prescriptions. Recently, GPs in England have been urged to limit the duration of repeat prescriptions, where clinically appropriate, to 28 days to reduce wastage and hence contain costs. However, shorter prescriptions will increase transaction costs and thus may not be cost saving. Furthermore, there is evidence to suggest that shorter prescriptions are associated with lower adherence, which would be expected to lead to lower clinical benefit...
March 12, 2018: Applied Health Economics and Health Policy
Heather C Kaplan, Eileen King, Beth E White, Susan E Ford, Sandra Fuller, Michael A Krew, Michael P Marcotte, Jay D Iams, Jennifer L Bailit, Jo M Bouchard, Kelly Friar, Carole M Lannon
OBJECTIVE: To evaluate the success of a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data accuracy rapidly and at scale in Ohio. METHODS: Between February 2013 and March 2014, participating hospitals were involved in a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data. This initiative was designed as a learning collaborative model (group webinars and a single face-to-face meeting) and included individual quality improvement coaching...
March 8, 2018: Obstetrics and Gynecology
Stephanie Mazzucca, Rachel G Tabak, Meagan Pilar, Alex T Ramsey, Ana A Baumann, Emily Kryzer, Ericka M Lewis, Margaret Padek, Byron J Powell, Ross C Brownson
Background: The need for optimal study designs in dissemination and implementation (D&I) research is increasingly recognized. Despite the wide range of study designs available for D&I research, we lack understanding of the types of designs and methodologies that are routinely used in the field. This review assesses the designs and methodologies in recently proposed D&I studies and provides resources to guide design decisions. Methods: We reviewed 404 study protocols published in the journal Implementation Science from 2/2006 to 9/2017...
2018: Frontiers in Public Health
Michael J Mello, Sara J Becker, Julie Bromberg, Janette Baird, Mark R Zonfrillo, Anthony Spirito
BACKGROUND: The American College of Surgeons mandates universal screening for alcohol misuse and delivery of an intervention for those screening positive as a requirement for certification as a level 1 trauma center. Though this requirement has been mandated for over a decade, its implementation has been challenging. Our research team completed an implementation study supporting seven pediatric trauma centers' compliance with the requirement by developing and implementing an institutional alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) policy for adolescent trauma patients...
February 22, 2018: Implementation Science: IS
Julia C Dombrowski, James P Hughes, Susan E Buskin, Amy Bennett, David Katz, Mark Fleming, Angela Nunez, Matthew R Golden
BACKGROUND: Many U.S. health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care re-engagment, but the effectiveness of this strategy is uncertain. METHODS: We conducted a stepped wedge cluster randomized evaluation of a Data to Care intervention in King County, Washington 2011-2014. Persons diagnosed with HIV for ≥6 months were eligible based on one of two criteria: 1) VL >500 copies/mL and CD4 <350 cells/μL at last report in the past 12 months or 2) no CD4 or viral load (VL) reported to the health department for ≥12 months...
November 16, 2017: Sexually Transmitted Diseases
Bo Jan Noordman, Bas P L Wijnhoven, Sjoerd M Lagarde, Jurjen J Boonstra, Peter Paul L O Coene, Jan Willem T Dekker, Michael Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A Kouwenhoven, Grard A P Nieuwenhuijzen, Jean-Pierre E N Pierie, Camiel Rosman, Johanna W van Sandick, Maurice J C van der Sangen, Meindert N Sosef, Manon C W Spaander, Roelf Valkema, Edwin S van der Zaag, Ewout W Steyerberg, J Jan B van Lanschot
BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. METHODS: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial...
February 6, 2018: BMC Cancer
Elizabeth H Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa
BACKGROUND: Community-acquired pneumonia is a leading worldwide cause of hospital admissions and healthcare resource consumption. The largest proportion of hospitalisations now occurs in older patients, with high rates of multimorbidity and complex care needs. In Australia, this population is usually managed by hospital inpatient general internal medicine units. Adherence to consensus best-practice guidelines is poor. Ensuring evidence-based care and reducing length of stay may improve patient outcomes and reduce organisational costs...
February 5, 2018: Trials
Ugo Grossi, Natasha Stevens, Eleanor McAlees, Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H Knowles
BACKGROUND: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence. METHODS: An individual level, stepped-wedge randomised trial has been designed to allow observer-blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate...
February 5, 2018: Trials
Kate Widdows, Holly E Reid, Stephen A Roberts, Elizabeth M Camacho, Alexander E P Heazell
BACKGROUND: Reducing stillbirth and early neonatal death is a national priority in the UK. Current evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as the National Health Service (NHS) England's Saving Babies' Lives care bundle. However, there is significant variation in the degree of implementation of the care bundle between and within maternity units and the effectiveness in reducing stillbirth and improving service delivery has not yet been evaluated...
January 30, 2018: BMC Pregnancy and Childbirth
Margaret A Handley, Courtney R Lyles, Charles McCulloch, Adithya Cattamanchi
Interventional researchers face many design challenges when assessing intervention implementation in real-world settings. Intervention implementation requires holding fast on internal validity needs while incorporating external validity considerations (such as uptake by diverse subpopulations, acceptability, cost, and sustainability). Quasi-experimental designs (QEDs) are increasingly employed to achieve a balance between internal and external validity. Although these designs are often referred to and summarized in terms of logistical benefits, there is still uncertainty about (a) selecting from among various QEDs and (b) developing strategies to strengthen the internal and external validity of QEDs...
January 12, 2018: Annual Review of Public Health
Julie Haesebaert, Norbert Nighoghossian, Catherine Mercier, Anne Termoz, Sylvie Porthault, Laurent Derex, Pierre-Yves Gueugniaud, Estelle Bravant, Muriel Rabilloud, Anne-Marie Schott
BACKGROUND AND PURPOSE: A suboptimal number of ischemic stroke patients eligible for thrombolysis actually receive it, partly because of extended inhospital delays. We developed a comprehensive program designed for emergency unit staff and evaluated its effectiveness for reducing intrahospital times and improving access to thrombolysis. METHODS: We conducted a randomized stepped-wedge controlled trial in 18 emergency unit. The sequentially implemented training intervention, targeting emergency physicians and nurses, was based on specifically designed videos and interactive simulation workshops on intrahospital management optimization...
January 10, 2018: Stroke; a Journal of Cerebral Circulation
Jenny Downs, Jenny Rodger, Chen Li, Xuesong Tan, Nan Hu, Kingsley Wong, Nicholas de Klerk, Helen Leonard
BACKGROUND: Rett syndrome is caused by a pathogenic mutation in the MECP2 gene with major consequences for motor and cognitive development. One of the effects of impaired MECP2 function is reduced production of Brain Derived Neurotrophic Factor (BDNF), a protein required for normal neuronal development. When housed in an enriched environment, MECP2 null mice improved motor abilities and increased levels of BDNF in the brain. We investigated the effects of environmental enrichment on gross motor skills and blood BDNF levels in girls with Rett syndrome...
January 10, 2018: Orphanet Journal of Rare Diseases
Karla Hemming, Monica Taljaard, Andrew Forbes
Cluster randomized trials are frequently used in health service evaluation. It is common practice to use an analysis model with a random effect to allow for clustering at the analysis stage. In designs where clusters are exposed to both control and treatment conditions, it may be of interest to examine treatment effect heterogeneity across clusters. In designs where clusters are not exposed to both control and treatment conditions, it can also be of interest to allow heterogeneity in the degree of clustering between arms...
January 8, 2018: Statistics in Medicine
Kate S Wilson, Cyrus Mugo, David Bukusi, Irene Inwani, Anjuli D Wagner, Helen Moraa, Tamara Owens, Joseph B Babigumira, Barbra A Richardson, Grace C John-Stewart, Jennifer A Slyker, Dalton C Wamalwa, Pamela K Kohler
BACKGROUND: Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10-24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills...
December 28, 2017: Trials
Priscilla M Lopez, Jennifer Zanowiak, Keith Goldfeld, Katarzyna Wyka, Ahmad Masoud, Susan Beane, Rashi Kumar, Phoebe Laughlin, Chau Trinh-Shevrin, Lorna Thorpe, Nadia Islam
BACKGROUND: The Million Hearts® initiative aims to prevent heart disease and stroke in the United States by mobilizing public and private sectors around a core set of objectives, with particular attention on improving blood pressure control. South Asians in particular have disproportionately high rates of hypertension and face numerous cultural, linguistic, and social barriers to accessing healthcare. Interventions utilizing Health information technology (HIT) and community health worker (CHW)-led patient coaching have each been demonstrated to be effective at advancing Million Hearts® goals, yet few studies have investigated the potential impact of integrating these strategies into a clinical-community linkage initiative...
December 6, 2017: BMC Health Services Research
James Fotheringham, Tania Barnes, Louese Dunn, Sonia Lee, Steven Ariss, Tracey Young, Stephen J Walters, Paul Laboi, Andy Henwood, Rachel Gair, Martin Wilkie
BACKGROUND: The study objective is to assess the effectiveness and economic impact of a structured programme to support patient involvement in centre-based haemodialysis and to understand what works for whom in what circumstances and why. It implements a program of Shared Haemodialysis Care (SHC) that aims to improve experience and outcomes for those who are treated with centre-based haemodialysis, and give more patients the confidence to dialyse independently both at centres and at home...
November 24, 2017: BMC Nephrology
Ceri Battle, Hayley Hutchings, Zoe Abbott, Claire O'neill, Sam Groves, Alan Watkins, Fiona Lecky, Sally Jones, James Gagg, Rick Body, Phillip Evans
INTRODUCTION: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design...
December 2017: Emergency Medicine Journal: EMJ
Alison B Hamilton, Melissa M Farmer, Tannaz Moin, Erin P Finley, Ariel J Lang, Sabine M Oishi, Alexis K Huynh, Jessica Zuchowski, Sally G Haskell, Bevanne Bean-Mayberry
BACKGROUND: The Enhancing Mental and Physical health of Women through Engagement and Retention or EMPOWER program represents a partnership with the US Department of Veterans Health Administration (VA) Health Service Research and Development investigators and the VA Office of Women's Health, National Center for Disease Prevention and Health Promotion, Primary Care-Mental Health Integration Program Office, Women's Mental Health Services, and the Office of Patient Centered Care and Cultural Transformation...
November 7, 2017: Implementation Science: IS
Licia Denti, Caterina Caminiti, Umberto Scoditti, Andrea Zini, Giovanni Malferrari, Maria Luisa Zedde, Donata Guidetti, Mario Baratti, Luca Vaghi, Enrico Montanari, Barbara Marcomini, Silvia Riva, Elisa Iezzi, Paola Castellini, Silvia Olivato, Filippo Barbi, Eva Perticaroli, Daniela Monaco, Ilaria Iafelice, Guido Bigliardi, Laura Vandelli, Angelica Guareschi, Andrea Artoni, Carla Zanferrari, Peter J Schulz
BACKGROUND AND PURPOSE: Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. METHODS: According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence...
December 2017: Stroke; a Journal of Cerebral Circulation
Hamish R Graham, Adejumoke I Ayede, Ayobami A Bakare, Oladapo B Oyewole, David Peel, Amy Gray, Barbara McPake, Eleanor Neal, Shamim Qazi, Rasa Izadnegahdar, Adegoke G Falade, Trevor Duke
BACKGROUND: Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and low human resource capacity. METHODS/DESIGN: This trial will evaluate the implementation of improved oxygen systems at secondary-level hospitals in southwest Nigeria...
October 27, 2017: Trials
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