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1. Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults

Author

Jennifer Hruslinski, Diane A. Menio, Robert A. Hymes, J. Douglas Jaffe, Christine Langlois, Lolita Ramsey, Lakisha J. Gaskins, Mark D. Neuman, Thomas Looke, Sandra Bent, Ariana Franco-Mora, Pamela Hedrick, Matthew Newbern, Rafik Tadros, Karen Pealer, Edward Marcantonio, Kamen Vlassakov, Carolyn Buckley, Svetlana Gorbatov, James Gosnell, Talora Steen, Avery Vafai, Jose Zeballos, Louis Cardenas, Ashley Berry, John Getchell, Nicholas Quercetti, Daniel I. Sessler, Sabry Ayad, Manal Hassan, Assad Ali, Gauasan Bajracharya, Damien Billow, Michael Bloomfield, Kavita Elliott, Robert Hampton, Linda He, Hooman Honar, Dilara Khoshknabi, Daniel Kim, Paul Minko, Adam Morris, Azfar Niazi, Tara Nutcharoen, Jeffrey Roberts, Partha Saha, Ahmed Salih, Alexis Skolaris, Taylor Stang, Victor Strimbu, Jesse Templeton, Andrew Volio, Jiayi Wang, Kelly Bolkus, Matthew DeAngelis, Gregory Dodson, Jeffrey Gerritsen, Brian McEniry, Ludmil Mitrev, Kwesi Kwofie, Flynn Bonazza, Vera Lloyd, Izabela Panek, Jared Dabiri, Chris Chavez, Jason Craig, Todd Davidson, Chad Dietrichs, Cheryl Fleetwood, Mike Foley, Chris Getto, Susie Hailes, Sarah Hermes, Andy Hooper, Greg Koener, Kate Kohls, Leslie Law, Adam Lipp, Allison Losey, William Nelson, Mario Nieto, Pam Rogers, Steve Rutman, Garrett Scales, Barbara Sebastian, Tom Stanciu, Gregg Lobel, Michelle Giampiccolo, Dara Herman, Margit Kaufman, Bryan Murphy, Clara Pau, Thomas Puzio, Marlene Veselsky, Trevor Stone, Kelly Apostle, Dory Boyer, Brenda Chen Fan, Susan Lee, Mike Lemke, Richard Merchant, Farhad Moola, Kyrsten Payne, Bertrand Perey, Darius Viskontas, Mark Poler, Patricia D'Antonio, Richard Sheppard, Amer Abdullah, Jamie Fish-Fuhrmann, Mark Giska, Christina Fidkowski, Trent Guthrie, William Hakeos, Lillian Hayes, Joseph Hoegler, Katherine Nowak, Robert Hymes, Jeffery Beck, Jaslynn Cuff, Greg Gaski, Sharon Haaser, Michael Holzman, A. Stephen Malekzadeh, Jeff Schulman, Cary Schwartzbach, Frederick Sieber, Tangwan Azefor, Charles Brown, Arman Davani, Mahmood Jaberi, Courtney Masear, Balram Sharma, Syed Basit Haider, Carolyn Chungu, Ali Ebrahimi, Karim Fikry, Kerri Gannon, Andrew Marcantonio, Meredith Pace, David Sanders, Collin Clarke, Abdel Lawendy, Gary Schwartz, Mohit Garg, Joseph Kim, Mitchell Marshall, Juan Caurci, Ekow Commeh, Randy Cuevas, Germaine Cuff, Lola Franco, David Furguiele, Matthew Giuca, Melissa Allman, Omid Barzideh, James Cossaro, Armando D'Arduini, Anita Farhi, Jason Gould, John Kafel, Anuj Patel, Abraham Peller, Hadas Reshef, Mohammed Safur, Fiore Toscano, Tiffany Tedore, Michael Akerman, Eric Brumberger, Sunday Clark, Rachel Friedlander, Anita Jegarl, Joseph Lane, John P. Lyden, Nili Mehta, Matthew T. Murrell, Nathan Painter, William Ricci, Kaitlyn Sbrollini, Rahul Sharma, Peter A.D. Steel, Michele Steinkamp, Roniel Weinberg, David Stephenson Wellman, Antoun Nader, Paul Fitzgerald, Michaela Ritz, Steven Papp, Greg Bryson, Alexandra Craig, Cassandra Farhat, Braden Gammon, Wade Gofton, Nicole Harris, Karl Lalonde, Allan Liew, Bradley Meulenkamp, Kendra Sonnenburg, Eugene Wai, Geoffrey Wilkin, Derek Donegan, Cassandra Dinh, Nabil Elkassabany, Annamarie Horan, Samir Mehta, Karen Troxell, Mary Ellen Alderfer, Jason Brannen, Christopher Cupitt, Stacy Gerhart, Renee McLin, Julie Sheidy, Katherine Yurick, Jeffrey Carson, Fei Chen, Karen Dragert, Geza Kiss, Halina Malveaux, Deborah McCloskey, Scott Mellender, Sagar S. Mungekar, Helaine Noveck, Carlos Sagebien, Barry Perlman, Luat Biby, Gail McKelvy, Anna Richards, Syed Azim, Ramon Abola, Brittney Ayala, Darcy Halper, Ana Mavarez, Stephen Choi, Imad Awad, Brendan Flynn, Patrick Henry, Richard Jenkinson, Lilia Kaustov, Elizabeth Lappin, Paul McHardy, Amara Singh, Ellen Hauck, Joanne Donnelly, Meera Gonzalez, Christopher Haydel, Jon Livelsberger, Theresa Pazionis, Bridget Slattery, Maritza Vazquez-Trejo, Eric Schwenk, Jaime Baratta, Brittany Deiling, Laura Deschamps, Michael Glick, Daniel Katz, James Krieg, Jennifer Lessin, Marc Torjman, Ki Jinn Chin, Rongyu Jin, Mary Jane Salpeter, Mark Powell, Jeffrey Simmons, Prentiss Lawson, Promil Kukreja, Shanna Graves, Adam Sturdivant, Ayesha Bryant, Sandra Joyce Crump, Derek Dillane, Michael Taylor, Michelle Verrier, Richard Applegate, Ana Arias, Natasha Pineiro, Jeffrey Uppington, Phillip Wolinsky, Joshua Sappenfield, Amy Gunnett, Jennifer Hagen, Sara Harris, Kevin Hollen, Brian Holloway, Mary Beth Horodyski, Trevor Pogue, Ramachandran Ramani, Cameron Smith, Anna Woods, Matthew Warrick, Kelly Flynn, Paul Mongan, Yatish Ranganath, Sean Fernholz, Esperanza Ingersoll-Weng, Anil Marian, Melinda Seering, Zita Sibenaller, Lori Stout, Allison Wagner, Alicia Walter, Cynthia Wong, Jay Magaziner, Denise Orwig, Trina Brown, Jim Dattilo, Susan Ellenberg, Rui Feng, Lee Fleisher, Lakisha Gaskins, Maithri Goud, Chris Helker, Lydia Mezenghie, Brittany Montgomery, Peter Preston, Alisa Stephens, J. Sanford Schwartz, Ann Tierney, Ramona Weber, Jacques Chelly, Shiv Goel, Wende Goncz, Touichi Kawabe, Sharad Khetarpal, Kevin King, Frank Kunkel, Charles Luke, Amy Monroe, Vladislav Shick, Anthony Silipo, Caroline Stehle, Katherine Szabo, Sudhakar Yennam, Mark Hoeft, Max Breidenstein, Timothy Dominick, Alexander Friend, Donald Mathews, Richard Lennertz, Helen Akere, Tyler Balweg, Amber Bo, Christopher Doro, David Goodspeed, Gerald Lang, Maggie Parker, Amy Rettammel, Mary Roth, Robert Sanders, Marissa White, Paul Whiting, Brian Allen, Tracie Baker, Debra Craven, Matt McEvoy, Teresa Turnbo, Stephen Kates, Melanie Morgan, Teresa Willoughby, Wade Weigel, David Auyong, Ellie Fox, Tina Welsh, Bruce Cusson, Sean Dobson, Christopher Edwards, Lynette Harris, Daryl Henshaw, Kathleen Johnson, Glen McKinney, Scott Miller, Jon Reynolds, Jimmy Turner, David VanEenenaam, Robert Weller, Shamsuddin Akhtar, Marcelle Blessing, Chanel Johnson, Michael Kampp, Kimberly Kunze, Jinlei Li, Mary O'Connor, and Miriam Treggiari

Subjects
medicine.medical_specialty, Canada, Research Subjects, Patient engagement, Hip fracture surgery, Patient Advocacy, Anesthesia, General, Patient advocacy, Anesthesia, Spinal, 03 medical and health sciences, 0302 clinical medicine, Nursing, 030202 anesthesiology, Fracture Fixation, Medicine, Humans, General anaesthesia, Cooperative Behavior, Geriatrics, Hip fracture, business.industry, Hip Fractures, Lived experience, Age Factors, Research process, medicine.disease, United States, Anesthesiology and Pain Medicine, Research Design, Patient Participation, business, Decision Making, Shared
Abstract

Summary Engaging patients—defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them—as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Published
2020

2. Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies

Author

Noel Dybdal, Jason Cordes, Nick Edmunds, Gemma Ward, Helen Prior, Aileen Milne, Brian M. Roche, Michael Gerhard Hoffmann, Pascal Champéroux, Stéphane Milano, Mike Engwall, Ken Meecham, Rick Nelson, Jean-Pierre Valentin, Eric Delpy, Anna Bottomley, Mike Foley, Robert Kaiser, and Kathryn Chapman

Subjects
Veterinary medicine, Swine, Applied psychology, Drug Evaluation, Preclinical, 030204 cardiovascular system & hematology, R&D, research and development, Social Environment, Toxicology, 030226 pharmacology & pharmacy, Toxicology studies, 0302 clinical medicine, ARRIVE, Animal Research: Reporting of In Vivo Experiments, Surveys and Questionnaires, Dog, Methods, Telemetry, Medicine, NC3Rs, National Centre for the Replacement, Refinement and Reduction of Animals in Research, NHP, non-human primate, Safety pharmacology, MTD, maximum tolerated dose, Housing, Animal, GLP, good laboratory practice, Minipig, 3Rs, Replacement, Refinement And Reduction, CCTV, closed circuit television, Swine, Miniature, NCEs, new chemical entities, Safety, Primates, Public housing, Best practice, Food consumption, CRO, contract research organisation, IACUC, Institutional Animal Care and Use Committee, Article, 3Rs, Outsourcing, ICH, International Conference on Harmonisation, 03 medical and health sciences, Dogs, AAALAC, Association for Assessment and Accreditation of Laboratory Animal Care International, Animals, Temperament, Pharmacology, Non human primate, business.industry, Hemodynamics, Social housing, Social environment, Non-human primate, SPS, Safety Pharmacology Society, AWERB, Animal Welfare and Ethical Review Body, ECG, electrocardiogram, Non-rodents, business
Abstract

Introduction The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing. Methods Thirty-nine sites, either running studies (Sponsors or Contract Research Organisations, CROs) and/or outsourcing work responded to the survey (51% from Europe; 41% from USA). Results During safety pharmacology studies, 84, 67 and 100% of respondents socially house dogs, minipigs and non-human primates (NHPs) respectively on non-recording days. However, on recording days 20, 20 and 33% of respondents socially house the animals, respectively. The main barriers for social housing were limitations in the recording equipment used, study design and animal temperament/activity. During toxicology studies, 94, 100 and 100% of respondents socially house dogs, minipigs and NHPs respectively on non-recording days. However, on recording days 31, 25 and 50% of respondents socially house the animals, respectively. The main barriers for social housing were risk of damage to and limitations in the recording equipment used, food consumption recording and temperament/activity of the animals. Conclusions Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best practice and data from companies already socially housing, combined with technology improvements and investments in infrastructure are required to maintain the forward momentum of this refinement across the industry.

Published
2016
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3. Proposed diagnostic criteria for the case definition of amniotic fluid embolism in research studies

Author

Arthur W. Bracey, Roberto Romero, Gary D.V. Hankins, Mike Foley, Richard L. Berkowitz, Richard M. Smiley, Mary E. D'Alton, J. Patrick Herlihy, Steven L. Clark, Rakesh B. Vadhera, Luis D. Pacheco, William M. Callaghan, Michael A. Belfort, and Gary A. Dildy

Subjects
Embolism, Amniotic Fluid, medicine.medical_specialty, Biomedical Research, Child health, Article, Diagnosis, Differential, 03 medical and health sciences, Amniotic fluid embolism, 0302 clinical medicine, Pregnancy, Coagulopathy, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, 030219 obstetrics & reproductive medicine, business.industry, Peripartum Women, Obstetrics and Gynecology, Congresses as Topic, medicine.disease, Case definition, Surgery, Practice Guidelines as Topic, Research studies, Female, Differential diagnosis, business
Abstract

Amniotic fluid embolism is a leading cause of maternal mortality in developed countries. Our understanding of risk factors, diagnosis, treatment, and prognosis is hampered by a lack of uniform clinical case definition; neither histologic nor laboratory findings have been identified unique to this condition. Amniotic fluid embolism is often overdiagnosed in critically ill peripartum women, particularly when an element of coagulopathy is involved. Previously proposed case definitions for amniotic fluid embolism are nonspecific, and when viewed through the eyes of individuals with experience in critical care obstetrics, would include women with a number of medical conditions much more common than amniotic fluid embolism. We convened a working group under the auspices of a committee of the Society for Maternal-Fetal Medicine and the Amniotic Fluid Embolism Foundation whose task was to develop uniform diagnostic criteria for the research reporting of amniotic fluid embolism. These criteria rely on the presence of the classic triad of hemodynamic and respiratory compromise accompanied by strictly defined disseminated intravascular coagulopathy. It is anticipated that limiting research reports involving amniotic fluid embolism to women who meet these criteria will enhance the validity of published data and assist in the identification of risk factors, effective treatments, and possibly useful biomarkers for this condition. A registry has been established in conjunction with the Perinatal Research Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to collect both clinical information and laboratory specimens of women with suspected amniotic fluid embolism in the hopes of identifying unique biomarkers of this condition.

Published
2016

4. Right ventricular outflow tract tumour: an unsuspected intracardiac ectopic thyroid mass

Author

Mike Foley, Helen Oxenham, Ed Peng, and Andrew T. Goodwin

Subjects
Pulmonary and Respiratory Medicine, congenital, hereditary, and neonatal diseases and abnormalities, Pathology, medicine.medical_specialty, Choristoma, Heart Ventricles, Thyroid Gland, Case Reports, Intracardiac injection, Heart Neoplasms, medicine, Humans, Ventricular outflow tract, Thyroid Neoplasms, cardiovascular diseases, Cardiac Surgical Procedures, Foramen caecum, Ultrasonography, Ectopic thyroid, business.industry, Thyroid, Foramen cecum, Middle Aged, Radiography, Treatment Outcome, medicine.anatomical_structure, Ectopic tissue, cardiovascular system, Female, Surgery, Radiology, Cardiology and Cardiovascular Medicine, business
Abstract

Ectopic thyroid is a rare embryogenic anomaly that occurs during its migration from foramen caecum to its pretracheal position. An intracardiac ectopic location is even rarer and found most commonly in the right ventricular outflow tract in sporadic reports. While surgery in symptomatic patients seems appropriate, resection of non-neoplastic ectopic tissue remains a clinical equipoise. Its occurrence is often unsuspected by clinicians, but its possibility should be considered due to its typical location in the right ventricular outflow tract. Unlike true neoplastic intracardiac tumour which mandates surgical resection, both surgical and non-surgical approach may be considered for an intracardiac ectopic thyroid mass.

Published
2013

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