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stepped wedge design

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https://www.readbyqxmd.com/read/29116022/enhancing-mental-and-physical-health-of-women-through-engagement-and-retention-empower-a-protocol-for-a-program-of-research
#1
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
https://www.readbyqxmd.com/read/29101258/impact-on-prehospital-delay-of-a-stroke-preparedness-campaign-a-sw-rct-stepped-wedge-cluster-randomized-controlled-trial
#2
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...
November 3, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/29078810/improving-oxygen-therapy-for-children-and-neonates-in-secondary-hospitals-in-nigeria-study-protocol-for-a-stepped-wedge-cluster-randomised-trial
#3
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
https://www.readbyqxmd.com/read/29071130/scaling-up-quality-improvement-intervention-for-perinatal-care-in-nepal-neperiqip-study-protocol-of-a-cluster-randomised-trial
#4
Ashish Kc, Anna Bergström, Dipak Chaulagain, Olivia Brunell, Uwe Ewald, Abhishek Gurung, Leif Eriksson, Helena Litorp, Johan Wrammert, Erik Grönqvist, Per-Anders Edin, Claire Le Grange, Bikash Lamichhane, Parashuram Shrestha, Amrit Pokharel, Asha Pun, Chahana Singh, Mats Målqvist
INTRODUCTION: Nepal Perinatal Quality Improvement Project (NePeriQIP) intends to scale up a quality improvement (QI) intervention for perinatal care according to WHO/National guidelines in hospitals of Nepal using the existing health system structures. The intervention builds on previous research on the implementation of Helping Babies Breathe-quality improvement cycle in a tertiary healthcare setting in Nepal. The objective of this study is to evaluate the effect of this scaled-up intervention on perinatal health outcomes...
2017: BMJ Global Health
https://www.readbyqxmd.com/read/29045666/quality-improvement-feature-series-article-4-advanced-designs-for-quality-improvement-studies
#5
Lilliam Ambroggio, Amanda Schondelmeyer, Erik Hoefgen, Patrick Brady, Erin Shaughnessy
Each quality improvement (QI) project has an implicit study design, although these designs are not discussed as commonly as they are in clinical research. Most QI projects fall under the quasi-experimental study category, in which observations are made before and after the implementation of an intervention(s). The simplest and most commonly used for QI studies is the pre-post design, in which observations are made before and after each intervention that was implemented over a specified period. More sophisticated designs for QI studies enable a study team to draw stronger inferences about the system that is being changed and the individual effects of the interventions that are implemented...
October 14, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/29027505/impact-of-non-uniform-correlation-structure-on-sample-size-and-power-in-multiple-period-cluster-randomised-trials
#6
J Kasza, K Hemming, R Hooper, Jns Matthews, A B Forbes
Stepped wedge and cluster randomised crossover trials are examples of cluster randomised designs conducted over multiple time periods that are being used with increasing frequency in health research. Recent systematic reviews of both of these designs indicate that the within-cluster correlation is typically taken account of in the analysis of data using a random intercept mixed model, implying a constant correlation between any two individuals in the same cluster no matter how far apart in time they are measured: within-period and between-period intra-cluster correlations are assumed to be identical...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29026932/-protocol-based-mobilization-on-intensive-care-units-design-of-a%C3%A2-cluster-randomized-pilot-study
#7
REVIEW
P Nydahl, A Diers, U Günther, B Haastert, S Hesse, C Kerschensteiner, S Klarmann, S Köpke
BACKGROUND: Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. HYPOTHESIS: Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome)...
October 12, 2017: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28969702/crowdsourcing-to-promote-hiv-testing-among-msm-in-china-study-protocol-for-a-stepped-wedge-randomized-controlled-trial
#8
Joseph D Tucker
BACKGROUND: HIV testing for marginalized populations is critical to controlling the HIV epidemic. However, the HIV testing rate among men who have sex with men (MSM) in China remains low. Crowdsourcing, the process of shifting individual tasks to a group, has been increasingly adopted in public health programs and may be a useful tool for spurring innovation in HIV testing campaigns. We designed a multi-site study to develop a crowdsourced HIV test promotion campaign and evaluate its effectiveness against conventional campaigns among MSM in China...
October 2, 2017: Trials
https://www.readbyqxmd.com/read/28936633/evaluation-of-an-online-family-history-tool-for-identifying-hereditary-and-familial-colorectal-cancer
#9
F G J Kallenberg, C M Aalfs, F O The, C A Wientjes, A C Depla, M W Mundt, P M M Bossuyt, E Dekker
Identifying a hereditary colorectal cancer (CRC) syndrome or familial CRC (FCC) in a CRC patient may enable the patient and relatives to enroll in surveillance protocols. As these individuals are insufficiently recognized, we evaluated an online family history tool, consisting of a patient-administered family history questionnaire and an automated genetic referral recommendation, to facilitate the identification of patients with hereditary CRC or FCC. Between 2015 and 2016, all newly diagnosed CRC patients in five Dutch outpatient clinics, were included in a trial with a stepped-wedge design, when first visiting the clinic...
September 21, 2017: Familial Cancer
https://www.readbyqxmd.com/read/28923034/an-implementation-science-protocol-of-the-women-s-health-coop-in-healthcare-settings-in-cape-town-south-africa-a-stepped-wedge-design
#10
Wendee M Wechsberg, Jacqueline W Ndirangu, Ilene S Speizer, William A Zule, Winnifred Gumula, Courtney Peasant, Felicia A Browne, Laura Dunlap
BACKGROUND: HIV persists as a public health emergency in South Africa, especially among women of childbearing age. In response to the HIV epidemic, the Joint United Nations Programme on HIV/AIDS has put forth the 90-90-90 global goals to achieve an AIDS-free generation by 2020. This goal aspires to have 90% of people living with HIV diagnosed; 90% of those who test positive on sustained antiretroviral therapy (ART); and 90% of those on ART be virally suppressed. Ensuring access to ART is an important first step in reducing HIV incidence, especially among vulnerable populations such as women who use substances and bear the burden of HIV in South Africa...
September 18, 2017: BMC Women's Health
https://www.readbyqxmd.com/read/28885557/evaluation-of-a-pilot-implementation-to-integrate-alcohol-related-care-within-primary-care
#11
Jennifer F Bobb, Amy K Lee, Gwen T Lapham, Malia Oliver, Evette Ludman, Carol Achtmeyer, Rebecca Parrish, Ryan M Caldeiro, Paula Lozano, Julie E Richards, Katharine A Bradley
Alcohol use is a major cause of disability and death worldwide. To improve prevention and treatment addressing unhealthy alcohol use, experts recommend that alcohol-related care be integrated into primary care (PC). However, few healthcare systems do so. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington partnered to design a high-quality Program of Sustained Patient-centered Alcohol-related Care (SPARC). Here, we describe the SPARC pilot implementation, evaluate its effectiveness within three large pilot sites, and describe the qualitative findings on barriers and facilitators...
September 8, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28882116/thistle-trial-of-hands-on-interprofessional-simulation-training-for-local-emergencies-a-research-protocol-for-a-stepped-wedge-clustered-randomised-controlled-trial
#12
Erik Lenguerrand, Catherine Winter, Karen Innes, Graeme MacLennan, Dimitrios Siassakos, Pauline Lynch, Alan Cameron, Joanna Crofts, Alison McDonald, Kirsty McCormack, Mark Forrest, John Norrie, Siladitya Bhattacharya, Tim Draycott
BACKGROUND: Many adverse pregnancy outcomes in the UK could be prevented with better intrapartum care. Training for intrapartum emergencies has been widely recommended but there are conflicting data about their effectiveness. Observational studies have shown sustained local improvements in perinatal outcomes associated with the use of the PRactical Obstetric Multi-Professional Training - (PROMPT) training package. However this effect needs to be investigated in the context of randomised study design in settings other than enthusiastic early adopter single-centres...
September 7, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28877944/effects-of-external-inspection-on-sepsis-detection-and-treatment-a-study-protocol-for-a-quasiexperimental-study-with-a-stepped-wedge-design
#13
Einar Hovlid, Jan C Frich, Kieran Walshe, Roy M Nilsen, Hans Kristian Flaatten, Geir Sverre Braut, Jon Helgeland, Inger Lise Teig, Stig Harthug
INTRODUCTION: Inspections are widely used in health care as a means to improve the health services delivered to patients. Despite their widespread use, there is little evidence of their effect. The mechanisms for how inspections can promote change are poorly understood. In this study, we use a national inspection campaign of sepsis detection and initial treatment in hospitals as case to: (1) Explore how inspections affect the involved organizations. (2) Evaluate what effect external inspections have on the process of delivering care to patients, measured by change in indicators reflecting how sepsis detection and treatment is carried out...
September 5, 2017: BMJ Open
https://www.readbyqxmd.com/read/28864689/stepped-wedge-cluster-randomised-controlled-trial-to-assess-the-cardiovascular-health-effects-of-a-managed-aquifer-recharge-initiative-to-reduce-drinking-water-salinity-in-southwest-coastal-bangladesh-study-design-and-rationale
#14
Abu Mohd Naser, Leanne Unicomb, Solaiman Doza, Kazi Matin Ahmed, Mahbubur Rahman, Mohammad Nasir Uddin, Shamshad B Quraishi, Shahjada Selim, Mohammad Shamsudduha, William Burgess, Howard H Chang, Matthew O Gribble, Thomas F Clasen, Stephen P Luby
INTRODUCTION: Saltwater intrusion and salinisation have contributed to drinking water scarcity in many coastal regions globally, leading to dependence on alternative sources for water supply. In southwest coastal Bangladesh, communities have few options but to drink brackish groundwater which has been associated with high blood pressure among the adult population, and pre-eclampsia and gestational hypertension among pregnant women. Managed aquifer recharge (MAR), the purposeful recharge of surface water or rainwater to aquifers to bring hydrological equilibrium, is a potential solution for salinity problem in southwest coastal Bangladesh by creating a freshwater lens within the brackish aquifer...
September 1, 2017: BMJ Open
https://www.readbyqxmd.com/read/28832927/innovation-in-a-learning-health-care-system-veteran-directed-home-and-community-based-services
#15
Melissa M Garrido, Richard M Allman, Steven D Pizer, James L Rudolph, Kali S Thomas, Nina R Sperber, Courtney H Van Houtven, Austin B Frakt
A path-breaking example of the interplay between geriatrics and learning healthcare systems is the Veterans Health Administration's (VHA's) planned roll-out of a program for providing participant-directed home- and community-based services to veterans with cognitive and functional limitations. We describe the design of a large-scale, stepped-wedge, cluster-randomized trial of the Veteran-Directed Home- and Community-Based Services (VD-HCBS) program. From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers will be randomized to times to begin offering VD-HCBS to veterans at risk of nursing home placement...
August 21, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28821264/impact-of-early-initiation-versus-national-standard-of-care-of-antiretroviral-therapy-in-swaziland-s-public-sector-health-system-study-protocol-for-a-stepped-wedge-randomized-trial
#16
Fiona J Walsh, Till Bärnighausen, Wim Delva, Yvette Fleming, Gavin Khumalo, Charlotte L Lejeune, Sikhathele Mazibuko, Charmaine Khudzie Mlambo, Ria Reis, Donna Spiegelman, Mandisa Zwane, Velephi Okello
BACKGROUND: There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics...
August 18, 2017: Trials
https://www.readbyqxmd.com/read/28817643/peripheral-clinic-versus-centralized-laboratory-based-xpert-mtb-rif-performance-experience-gained-from-a-pragmatic-stepped-wedge-trial-in-botswana
#17
Tefera Agizew, Rosanna Boyd, Ndwapi Ndwapi, Andrew Auld, Joyce Basotli, Sambayawo Nyirenda, Zegabriel Tedla, Anikie Mathoma, Unami Mathebula, Chawangwa Lesedi, Sherri Pals, Anand Date, Heather Alexander, Thomas Kuebrich, Alyssa Finlay
BACKGROUND: In 2011, the Botswana National Tuberculosis Program adopted World Health Organization guidelines and introduced Xpert MTB/RIF (Xpert) assay to support intensified case finding among people living with HIV enrolling in care. An evaluation was designed to assess performance under operational conditions to inform the national Xpert scale-up. METHODS: Xpert was implemented from August 2012 through November 2014 with 13 GeneXpert instruments (GeneXpert) deployed in a phased approach over nine months: nine centralized laboratory and four point-of-care (POC) peripheral clinics...
2017: PloS One
https://www.readbyqxmd.com/read/28804809/therapeutic-patient-education-in-cancer-pain-management-from-practice-to-research-proposals-and-strategy-of-the-french-effadol-program
#18
Virginie Prevost, Bénédicte Clarisse, Natacha Heutte, Alexandra Leconte, Cécile Bisson, Rachel Bignon, Sonia Cauchin, Maryline Feuillet, Sylvie Gehanne, Maud Gicquère, Marie-Christine Grach, Cyril Guillaumé, Christine Le Gal, Joelle Le Garrec, Franck Lecaer, Isabelle Lepleux, Anne-Laure Millet, Marie-Claude Ropartz, Nathalie Roux, Virith Sep Hieng, Carole Van Delook, Aline Le Chevalier, Claire Delorme
In the field of cancer pain, therapeutic patient education (TPE) allows patients to develop skills to better manage their pain. In the Lower Normandy region of France, the management of pain is based on networking, thus allowing proximity and accessibility for all concerned. We have thus designed and initiated a broad five-stage research program that includes the following: (1) training for caregivers in TPE; (2) identifying the educational expectations of patients and their relatives with regard to cancer pain; (3) the design of a TPE program; (4) the evaluation of its quality; and (5) the evaluation of its effectiveness by comparative randomization...
August 13, 2017: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
https://www.readbyqxmd.com/read/28801392/can-promoting-awareness-of-fetal-movements-and-focusing-interventions-reduce-fetal-mortality-a-stepped-wedge-cluster-randomised-trial-affirm
#19
Alexander E P Heazell, Christopher J Weir, Sarah J E Stock, Catherine J Calderwood, Sarah Cunningham Burley, J Frederik Froen, Michael Geary, Alyson Hunter, Fionnuala M McAuliffe, Edile Murdoch, Aryelly Rodriguez, Mary Ross-Davie, Janet Scott, Sonia Whyte, Jane E Norman
BACKGROUND: In 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth...
August 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28797179/the-optimal-design-of-stepped-wedge-trials-with-equal-allocation-to-sequences-and-a-comparison-to-other-trial-designs
#20
Jennifer A Thompson, Katherine Fielding, James Hargreaves, Andrew Copas
Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
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