pragmatic randomized controlled trial

White Paper: Pragmatic Randomized Trials: Considerations ... This paper describes the study protocol. This pragmatic randomised controlled trial provides evidence suggesting that at-home app-based exercise in various forms (high intensity interval training or yoga or their combination) can significantly improve depressive symptoms over a 6-week period in adults during the pandemic. Relton C, Torgerson D, O'Cathain A, Nicholl J. Multiple direct-acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The call for more pragmatic clinical trials arose out of concerns that many traditional randomized trials did not adequately inform practice because they were optimized to determine efficacy under idealized circumstances with relatively . Objective To determine whether a tailored multifaceted implementation strategy improves the initial management of patients with suspected encephalitis. The Essential Oils for Agitation in Dementia [rELOAD] study was a pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial. This pragmatic randomized controlled trial demonstrates that a short-term multifaceted intervention including a limited pharmacist intervention, pharmacist-physician collaboration, a CKD registry, and patient education improved adherence to KDOQI guidelines for process measures but not clinical outcomes. Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial. A pragmatic, open, block-randomised controlled trial. Approach and Results. All participants will be informed about the general aims and procedures of the study. Design Pragmatic two arm cluster randomised controlled trial. Design Pragmatic cluster randomised controlled trial. Study design and setting. A multicentric randomized clinical trial was conducted in 2017 in 12 PC centres belonging to the health areas of V alladolid-East and Valladolid-West of SACYL (Public Service of Health of Castilla We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m 2 , not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. We deliberately chose an open label design because we wanted to study how these two management strategies work in clinical practice . NCCIH Pragmatic trials measure effectiveness-the benefit the treatment produces in routine clinical practice. Design: This was a multi-center, pragmatic, randomized, comparative effectiveness trial. The TBC-HTA study is an ongoing 3-year multicenter pragmatic randomized controlled trial comparing a 6-month team-based care interprofessional intervention, involving nurses, community pharmacists and physicians, to a usual care group among 110 outpatients followed in ambulatory clinics and their nearby community pharmacies in Lausanne and Geneva areas, Switzerland . ICEAGE is a pragmatic, multicentre, parallel-group, randomised controlled trial. Trial Recruitment of Investigators and Participants Intervention and Its Delivery Follow-up Determination and Analysis randomized, controlled . We conducted a scoping review of articles addressing . ↓ Follow on Facebook: ww. Objective To determine whether a tailored multifaceted implementation strategy improves the initial management of patients with suspected encephalitis. In the largest published randomized trial on migraine prevention, the drop-out rate due to adverse effects was 6.7% for 160 mg of propranolol, 6.9% for 10 mg of flunarizine, and 8.0% for 5 mg of flunarizine. Setting Hospitals within the United Kingdom. Trials of healthcare interventions are often described as either explanatory or pragmatic. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. METHODS: Endoscopists practicing in Ontario, Canada, in 2014 were randomly assigned in October 2015 (index date) to receive (intervention group, n = 417) or not receive (control group, n = 416) an A/F report . The nutrigenomics, overweight/obesity and weight management trial (NOW Trial) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle Balance™ (GLB™) Program. BMJ 2010 ;340: c1066 . A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Heal Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required) RFA-AT-19-005. . This study was a prospective, multi-center, highly pragmatic, randomized, comparative-effectiveness trial. Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. 2020;14:1-10. Results. This was a blind assessed, multicenter, pragmatic randomized controlled trial of patient-led upper-limb mirror therapy and patient-led lower leg exercises. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and . Explanatory and pragmatic are the extremes of a continuum. Research electronic data capture (REDCap): a metadata-driven methodology . 2010) naprapathy improved bodily pain, physical function and health related quality of life (HRQoL) more than orthopaedic standard care, when treating working age orthopaedic outpatients. Setting 40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Objective To assess the impact of 'Parenting for Lifelong Health: Sinovuyo Teen', a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. This pragmatic randomized controlled trial enrolled 120 patients with first-episode psychosis within five years of illness onset and 12 weeks of antipsychotic exposure. Participants who enroll in RCTs differ from one another in known and . These disorders frequently go undetected, and when they are recognised treatment is often haphazard, with inappropriate use of antidepressants and poorly coordinated psychological services. PURPOSE Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. Setting Hospitals within the United Kingdom. The trial was registered with the Australian New Zealand Clinical Trial Registry [ACTRN12617001159347]. A cluster randomised trial (CRT) is a randomised controlled trial in which pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. 2016;387(10029):1743-52. Methods We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. Participants Twenty-four hospitals nested within 12 postgraduate deaneries. PrCTs, referring to studies where several pragmatic elements are used (eligibility, endpoints, follow-up, etc. Referrals were mostly from inpatient psychiatric units, and enrollees were randomly allocated to STEP or usual treatment. Effects were strongest for those who were provided . Take this course for free on edX: https://www.edx.org/course/pragmatic-randomized-controlled-trials-kix-kipractihx↓ More info below. The experimental group (EG) conducted a program of pain neuroscience education (6 sessions, 10 h) and group physical exercise with playful, dual-tasking, and socialization-promoting components (18 sessions in 6 weeks, 18 h), and the control group performed the usual . Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Pragmatic Randomized Trials. The trial design and baseline characteristics are available elsewhere. Eligible patients will be randomly assigned via concealed allocation into one of two physiotherapy treatment arms (Table 1 ). By combining real-world evidence and randomization, pragmatic randomized clinical trials (PrCTs) can be used to inform treatment effectiveness and healthcare decisions. The movement toward supporting pragmatic randomized controlled trials (pRCTs) hopes to make sure that money spent on RCTs is well spent by providing information that actually matters to real-world outcomes, regardless of conclusively tying causation to particular variables. The pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial was a pragmatic, cluster-randomised open-label trial including adults with non-traumatic, out-of-hospital cardiac arrest from four UK Ambulance Services (West Midlands, North East England, Wales, South Central). Effects were strongest for those who were provided . The pragmatic randomised controlled trial Matthew Hotopf Matthew Hotopf is Reader in Psychological Medicine at Guy's, King's and St Thomas' School of Medicine (103 Denmark Hill, London SE5 8AZ, UK) and the South London and Maudsley Trust. Keywords: trial, randomized controlled trial, pragmatic, comparative, evidencebased medicine. NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Notice of Intent to Publish a Funding Opportunity Announcement for Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3, Clinical Trial Required) NOT-AT-19-005. Most depression and anxiety is treated in primary care. In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Exemplar Trials and Their Main Pragmatic Features. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. His research interests include medically unexplained The data are extracted from a pragmatic, multicentered, randomized controlled trial that has been conducted to evaluate the effectiveness and cost-effectiveness of a 12-week progressive program of yoga . Trial registration: Trial NL7190 (NTR7381), registered prospectively 03-08-2018. Article Google Scholar 24. Patients were identified retrospectively by searching . Cluster Randomised Trials. It includes video presentations, slide sets, suggested reading materials, guided activities, and a list of course references (PDF). Patients and Methods We conducted a pragmatic, randomized controlled trial comparing acupuncture with enhanced usual care. in. It is patient and assessor blinded, and powered for superiority. Christine M. Eisenhauer 1, Fabiana Brito 2, Kevin Kupzyk 3, Aaron Yoder 4, Fabio Almeida 5, Rebecca Johnson Beller 1, Jessica Miller 1 & Patricia A. Hageman 6 A randomized multicentre clinical trial has been carried out in 12 PC centres. Exemplar Trials and Their Main Pragmatic Features. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The problem. Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD Sankar D. Navaneethan , Stacey E. Jolly , Jesse D. Schold , Susana Arrigain , Georges Nakhoul , Victoria Konig , Jennifer Hyland , Yvette K. Burrucker , Priscilla Davis Dann , Barbara H. Tucky , John Sharp and Joseph V. Nally 10 It was a pragmatic, assessor- and participant-blind, randomized controlled superiority trial with a 2-group parallel design conducted in Denmark from May 1, 2016, to October 29, 2018. Three hundred two outpatients with breast cancer participated. 91 urban and semi-urban ambulance stations were selected for participation. The NO COVID-19 Study is a single center, two-arm, open label, group-sequential, pragmatic randomized controlled trial of hydroxychloroquine sulfate in adults hospitalized with COVID-19. T1 - A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C. T2 - The PRIORITIZE Study. However, these studies raise ethical issues for researchers and regulators. Primary hypotheses- Methods: We conducted a pragmatic randomized controlled trial involving adults (age 18-65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a "moderate to severe" impact of sinus symptoms on their quality of life. The GLB™ Program (formerly referred to as the Diabetes Prevention Program) is an evidence-based, intensive weight management program, which was offered to overweight/obese patients . Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 . treatment with vaginal misoprostol or expectant management (ClinicalTrials.gov ID: NCT01033903). In this large pragmatic randomized controlled trial, we compared A/F to improve endoscopists' colonoscopy performance to usual practice. Explanatory trials generally measure efficacy-the benefit a treatment produces under ideal conditions, often using carefully defined subjects in a research clinic. A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis (GETUP-PIANO) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Article Google Scholar 20. The MatheoAlz trial (Maintenance of Occupational Therapy in Alzheimer's disease) is a multi-center, pragmatic randomized controlled trial testing maintenance of OT over 4 supplementary months compared to routine OT delivered as recommended. An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i). PRTs represent a hybrid between traditional randomized controlled clinical trials that have been the gold standard for regulatory decision making, and pragmatic, observational research studies that are often used to generate real‑world evidence to support health technology assessment (HTA) and payer decision making. A cluster randomised trial (CRT) is a randomised controlled trial in which pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. This pragmatic trial demonstrated high SVR12 for participants treated with EBR/GZR and LDV/SOF with few adverse . This pragmatic randomised controlled trial provides evidence suggesting that at-home app-based exercise in various forms (high intensity interval training or yoga or their combination) can significantly improve depressive symptoms over a 6-week period in adults during the pandemic. Hypotheses2.2.1. Pharmacist based interventions have effectively improved management of hypertension. 20 AU - Darling, Jama M. AU - Muir, Andrew J. AU - Khalili, Mandana. activities and interests for young patients with the disease in its early stages. Pragmatic randomized control trial. 21 22 The trial protocol is available in supplementary appendix 1. 2.2. Stroke survivors with upper and lower limb limitations, undergoing inpatient rehabilitation and able to consent were recruited at least 1 week poststroke. Participants 552 families reporting conflict with . Andreas Eklund 1, Jan Hagberg 1, Irene Jensen 1, Sholzberg, M., Tang, G.H., Negri, E. et al. Consequently, according to the extension of the CONSORT statement concerning the criteria of a pragmatic randomized, controlled trial (Zwarenstein et al. To address this gap, we are conducting a pragmatic randomized controlled trial (RCT) in thoracic (lung, esophageal, and gastric) cancer patients—the Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) trial—designed to evaluate the impact of integrative care delivered by NDs alongside usual care. Los ensayos clínicos han sido la principal herramienta empleada por la comunidad de las ciencias de la salud para probar y evaluar las intervenciones. The results were analysed according to the intention-to-treat principle. For example, clusters may be clinical practices or schools where the individuals are patients and school children, respectively. Trial Recruitment of Investigators and Participants Intervention and Its Delivery Follow-up Determination and Analysis randomized, controlled . The Treatment of Advanced Glaucoma Study (TAGS) was a pragmatic, multicentre, randomised unblinded controlled trial conducted in 27 centres in the UK. In pragmatic trials, participants are often randomized at the group level. Methods. Yoga has been shown as an effective intervention for treating chronic or recurrent low back pain. Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. Email: GRT@mail.nih.gov. The pragmatic randomised controlled trial - Volume 8 Issue 5. In a previously published, 12 months follow-up of a pragmatic randomized controlled trial (original research of Lilje et al. AU - Sulkowski, Mark S. AU - Moon, Juhi S. AU - Sherman, Kenneth E. AU - Morelli, Giuseppe. This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Conclusions. Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a Pragmatic Randomized Controlled Trial Andrew McWilliams, MD,MPH1, Jason Roberge . 2008), no blinding concerning treatment conditions will be implemented in the current study. Cluster Randomised Trials. The study consisted of a multicenter pragmatic randomized controlled trial. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Keywords: Depression, Ecological momentary assessment (EMA), Mental health care, Personalized experience sampling method (ESM) monitoring and feedback, Pragmatic randomized controlled trial Background Major depressive disorder (MDD) is a highly prevalent AU - Fishbein, Dawn A. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG - RAPID Trial): A structured summary of a study protocol for a randomised controlled trial. Patients were identified retrospectively by searching . Participants Twenty-four hospitals nested within 12 postgraduate deaneries. Patients: This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training. METHODS We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Randomized clinical trials often serve the purpose of assessing the efficacy and safety of a compound. Design Pragmatic two arm cluster randomised controlled trial. ), pose unique . This is the pragmatic element of such designs. Methods. Purpose We aimed to assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in patients with breast cancer. For example, clusters may be clinical practices or schools where the individuals are patients and school children, respectively. Abstract. High satisfaction in control group, low family attendance and the relatively short treatment period may explain the less than expected benefits of the programme. Los ensayos se pueden clasificar en dos grandes categorías: pragmáticos y explicatívos. A two-arm pragmatic randomized controlled trial (RCT) with a wait-list control group (who attended the intervention program after completing 20 week data collection) was conducted. Summary of Background Data. However, there is little evidence on its cost-effectiveness. Psychol Med. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments.. Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie , Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert , Vitaly D. Herasevich, Jalal . A 7-part online course to help researchers design and analyze group-randomized trials (GRTs). However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG - RAPID Trial): A structured summary of a study protocol for a randomised controlled trial. This is the primary trial report for the Strengthening Exercises in Shoulder Impingement Trial (SExSI Trial). One group of participants treated in a setting such as a hospital, nursing home, clinic, or physician's practice, might receive the intervention, while people matched to be treated in a similar setting might serve as the control group. Lancet. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. The study protocol is described in detail elsewhere . AU - the PRIORITIZE Study Team. Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. 19 A recent large randomized trial of topiramate reported a drop-out rate of more than 20%. The study was conducted without extra resources in a normal setting . for pragmatic trials. pragmatic randomized controlled trial assessed whether this condition is more likely to improve when long-term psycho-analytic psychotherapy (LTPP) is provided in addition to treatment-as-usual according to UK national guidelines (TAU), but excluding the short-term forms of psychological Setting: Treatment took place within 8 outpatient physical therapy clinics. Randomized: Intervention Model: Parallel Assignment: Intervention Model Description: This study is a 2-arm, parallel, pragmatic, multi-centre, open-label randomized controlled trial to determine the effect of therapeutic anticoagulation on the composite outcome of ICU admission, mechanical ventilation and/or death in hospitalized patients with . This was a randomized controlled, open-label trial with individual randomization into two parallel groups 1:1, i.e. NCCIH We randomly assigned 75 patients to usual care and 227 patients to acupuncture plus . Sholzberg, M., Tang, G.H., Negri, E. et al. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥ 3.4 years since last Pap) aged 30-64 years: 1) usual care (annual patient reminders and ad hoc outreach by . Hallsworth M, Chadborn T, Sallis A, Sanders M, Berry D, Greaves F, et al. We performed a pragmatic, randomized, controlled trial to evaluate the effect of a pharmacist based quality improvement program on 1) outcomes for patients with CKD and 2) adherence to CKD guidelines in the primary care setting. Participants were eligible if they were aged 18 years or older, and smoked at .

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