Literature DB >> 34897710

Registry-based randomized clinical trials in surgery: Working with ACS-NSQIP and the AHPBA to conduct pragmatic trials.

Brett L Ecker1, Brian C Brajcich2,3,4, Ryan J Ellis1,3,4, Clifford Y Ko3,4,5,6, Michael I D'Angelica1.   

Abstract

Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high-quality data to guide clinical care. Registry-based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low-cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS-NSQIP-based registry trial.
© 2021 Wiley Periodicals LLC.

Entities:  

Keywords:  pragmatic clinical trial; randomized controlled trials; registry-based trials; surgical registry; surgical research methods

Mesh:

Year:  2022        PMID: 34897710      PMCID: PMC8787438          DOI: 10.1002/jso.26742

Source DB:  PubMed          Journal:  J Surg Oncol        ISSN: 0022-4790            Impact factor:   3.454


  23 in total

Review 1.  Quality improvement in surgery: the American College of Surgeons National Surgical Quality Improvement Program approach.

Authors:  Angela M Ingraham; Karen E Richards; Bruce L Hall; Clifford Y Ko
Journal:  Adv Surg       Date:  2010

2.  Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial.

Authors:  Kristian Wachtell; Bo Lagerqvist; Göran K Olivecrona; Stefan K James; Ole Fröbert
Journal:  Curr Cardiol Rep       Date:  2016-01       Impact factor: 2.931

3.  The Hawthorne Effect Revisited.

Authors:  Donald E Fry
Journal:  Dis Colon Rectum       Date:  2018-01       Impact factor: 4.585

4.  The REDCap consortium: Building an international community of software platform partners.

Authors:  Paul A Harris; Robert Taylor; Brenda L Minor; Veida Elliott; Michelle Fernandez; Lindsay O'Neal; Laura McLeod; Giovanni Delacqua; Francesco Delacqua; Jacqueline Kirby; Stephany N Duda
Journal:  J Biomed Inform       Date:  2019-05-09       Impact factor: 6.317

5.  Long-term effects of an expanded cardiac rehabilitation programme after myocardial infarction or coronary artery bypass surgery: a five-year follow-up of a randomized controlled study.

Authors:  Catrine Edström Plüss; Ewa Billing; Claes Held; Peter Henriksson; Anna Kiessling; Monica Rydell Karlsson; Håkan N Wallen
Journal:  Clin Rehabil       Date:  2010-08-11       Impact factor: 3.477

6.  Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale.

Authors:  Ole Fröbert; Bo Lagerqvist; Thórarinn Gudnason; Leif Thuesen; Roger Svensson; Göran K Olivecrona; Stefan K James
Journal:  Am Heart J       Date:  2010-12       Impact factor: 4.749

7.  Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research.

Authors:  Samuel J Zolin; Clayton C Petro; Ajita S Prabhu; Aldo Fafaj; Jonah D Thomas; Charlotte M Horne; Luciano Tastaldi; Hemasat Alkhatib; David M Krpata; Steven Rosenblatt; Michael J Rosen
Journal:  J Surg Res       Date:  2020-06-30       Impact factor: 2.192

8.  ACS-NSQIP has the potential to create an HPB-NSQIP option.

Authors:  Henry A Pitt; Molly Kilbane; Steven M Strasberg; Timothy M Pawlik; Elijah Dixon; Nicholas J Zyromski; Thomas A Aloia; J Michael Henderson; Sean J Mulvihill
Journal:  HPB (Oxford)       Date:  2009-08       Impact factor: 3.647

9.  Perioperative antibiotics for surgical site infection in pancreaticoduodenectomy: does the SCIP-approved regimen provide adequate coverage?

Authors:  Graham W Donald; Dharma Sunjaya; Xuyang Lu; Formosa Chen; Barbara Clerkin; Guido Eibl; Gang Li; James S Tomlinson; Timothy R Donahue; Howard A Reber; Oscar J Hines
Journal:  Surgery       Date:  2013-05-10       Impact factor: 3.982

10.  Role of preoperative biliary stents, bile contamination and antibiotic prophylaxis in surgical site infections after pancreaticoduodenectomy.

Authors:  Francesca Gavazzi; Cristina Ridolfi; Giovanni Capretti; Maria Rachele Angiolini; Paola Morelli; Erminia Casari; Marco Montorsi; Alessandro Zerbi
Journal:  BMC Gastroenterol       Date:  2016-03-31       Impact factor: 3.067

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