REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system
Introduction Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medi...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e078711.full |
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| author | Brian Williams Jennifer Holder-Murray Kathirvel Subramaniam Kert Viele Oscar C Marroquin Scott Berry Aman Mahajan Luca La Colla Charles Luke Alison R Althans Stephen A Esper Joshua Knight Joseph Derenzo Ryan Ball Shawn Beaman Nicholas Schott Elizabeth Lorenzi Lindsay R Berry Miranda Masters Katie A Meister Todd Wilkinson William Garrard |
| author_facet | Brian Williams Jennifer Holder-Murray Kathirvel Subramaniam Kert Viele Oscar C Marroquin Scott Berry Aman Mahajan Luca La Colla Charles Luke Alison R Althans Stephen A Esper Joshua Knight Joseph Derenzo Ryan Ball Shawn Beaman Nicholas Schott Elizabeth Lorenzi Lindsay R Berry Miranda Masters Katie A Meister Todd Wilkinson William Garrard |
| author_sort | Brian Williams |
| collection | DOAJ |
| description | Introduction Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.Methods and analysis In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.Ethics and dissemination The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.Trial registration number NCT04606264. |
| format | Article |
| id | doaj-art-a50d33e7c3104d919c0bbd8d8932ed41 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a50d33e7c3104d919c0bbd8d8932ed412025-08-20T03:52:16ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-078711REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare systemBrian Williams0Jennifer Holder-Murray1Kathirvel Subramaniam2Kert Viele3Oscar C Marroquin4Scott Berry5Aman Mahajan6Luca La Colla7Charles Luke8Alison R Althans9Stephen A Esper10Joshua Knight11Joseph Derenzo12Ryan Ball13Shawn Beaman14Nicholas Schott15Elizabeth Lorenzi16Lindsay R Berry17Miranda Masters18Katie A Meister19Todd Wilkinson20William Garrard21Anesthesiology, University of Pittsburgh, Pittsburgh, PA 15260, USA3 Department of Surgery, Division of Colon and Rectal Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USAAnesthesiology, UPMC, Pittsburgh, Pennsylvania, USABerry Consultants Statistical Innovation, Austin, Texas, USAPhysician Services Division, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USATrillium Health Partners, Mississauga, Ontario, CanadaDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USABerry Consultants, Austin, Texas, USABerry Consultants, Austin, Texas, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USAClinical Analytics, UPMC, Pittsburgh, Pennsylvania, USAIntroduction Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.Methods and analysis In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.Ethics and dissemination The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.Trial registration number NCT04606264.https://bmjopen.bmj.com/content/13/12/e078711.full |
| spellingShingle | Brian Williams Jennifer Holder-Murray Kathirvel Subramaniam Kert Viele Oscar C Marroquin Scott Berry Aman Mahajan Luca La Colla Charles Luke Alison R Althans Stephen A Esper Joshua Knight Joseph Derenzo Ryan Ball Shawn Beaman Nicholas Schott Elizabeth Lorenzi Lindsay R Berry Miranda Masters Katie A Meister Todd Wilkinson William Garrard REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system BMJ Open |
| title | REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system |
| title_full | REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system |
| title_fullStr | REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system |
| title_full_unstemmed | REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system |
| title_short | REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system |
| title_sort | remap periop a randomised embedded multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a us healthcare system |
| url | https://bmjopen.bmj.com/content/13/12/e078711.full |
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