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1. Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial

Author

Jay C. Horrow, Wen Li, Manfred Blobner, John Lombard, Marcel Speek, Matthew DeAngelis, and W. Joseph Herring

Subjects
Recurarization, Bradycardia, Neostigmine, Multicenter trial, Anesthesiology, RD78.3-87.3
Abstract

Abstract Background This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW). Methods Adults with BMI ≥40 kg/m2 were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2 mg/kg ABW; M-neuromuscular block, sugammadex 2 mg/kg IBW; M-neuromuscular block, neostigmine 5 mg, and glycopyrrolate 1 mg; D-neuromuscular block, sugammadex 4 mg/kg ABW; or D-neuromuscular block, sugammadex 4 mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio ≥ 0.9 for ABW and IBW groups pooled across neuromuscular blocking agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis. Results Of 207 patients randomized, 188 received treatment (28% male, BMI 47 ± 5.1 kg/m2, age 48 ± 13 years). Recovery was 1.5 min faster with ABW vs IBW dosing. The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time > 10 min (95% CI of difference: − 4.8 to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences. Conclusions ABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of neuromuscular block or NMBA used. Trial registration Registered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070 .

Published
2021
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2. Making Better Dose Decisions: Using Exposure‐Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment

Author

Chi‐Chung Li, Tiffini Voss, Ken Kowalski, Bei Yang, Huub Jan Kleijn, Christopher J. Jones, Rolien Bosch, David Michelson, Matthew DeAngelis, Yang Xu, Iris Xie, and Prajakti A. Kothare

Subjects
Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270
Abstract

Ubrogepant (MK‐1602) is a novel, oral, calcitonin gene‐related peptide receptor antagonist in clinical development with positive phase III outcomes for acute treatment of migraine. This paper describes the population exposure‐response (E‐R) modeling and simulations, which were used to inform the phase III dose‐selection rationale, based on ~ 800 participants pooled across two phase IIb randomized dose‐finding clinical trials. The E‐R model describes the placebo and ubrogepant treatment effects based on migraine pain end points (2‐hour pain relief and 2‐hour pain freedom) at various dose levels. Sensitivity analyses were conducted to evaluate various assumptions of placebo response in light of the high placebo response observed in one phase II trial. A population pharmacokinetic model describing the effect of formulations was included in the E‐R simulation framework to assess potential dose implications of a formulation switch from phase II to phase III. Model‐based simulations predict that a dose of 25 mg or higher is likely to achieve significantly better efficacy than placebo with desirable efficacy levels. The understanding of E‐R helped support the dose selection for the phase III clinical trials.

Published
2020
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3. Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial

Author

Mark D, Neuman, Rui, Feng, Susan S, Ellenberg, Frederick, Sieber, Daniel I, Sessler, Jay, Magaziner, Nabil, Elkassabany, Eric S, Schwenk, Derek, Dillane, Edward R, Marcantonio, Diane, Menio, Sabry, Ayad, Manal, Hassan, Trevor, Stone, Steven, Papp, Derek, Donegan, Mitchell, Marshall, J Douglas, Jaffe, Charles, Luke, Balram, Sharma, Syed, Azim, Robert, Hymes, Ki-Jinn, Chin, Richard, Sheppard, Barry, Perlman, Joshua, Sappenfield, Ellen, Hauck, Mark A, Hoeft, Ann, Tierney, Lakisha J, Gaskins, Annamarie D, Horan, Trina, Brown, James, Dattilo, Jeffrey L, Carson, Thomas, Looke, Sandra, Bent, Ariana, Franco-Mora, Pamela, Hedrick, Matthew, Newbern, Rafik, Tadros, Karen, Pealer, Kamen, Vlassakov, Carolyn, Buckley, Lauren, Gavin, Svetlana, Gorbatov, James, Gosnell, Talora, Steen, Avery, Vafai, Jose, Zeballos, Jennifer, Hruslinski, Louis, Cardenas, Ashley, Berry, John, Getchell, Nicholas, Quercetti, Gauasan, Bajracharya, Damien, Billow, Michael, Bloomfield, Evis, Cuko, Mehrun K, Elyaderani, Robert, Hampton, Hooman, Honar, Dilara, Khoshknabi, Daniel, Kim, David, Krahe, Michael M, Lew, Conjeevram B, Maheshwer, Azfar, Niazi, Partha, Saha, Ahmed, Salih, Robert J, de Swart, Andrew, Volio, Kelly, Bolkus, Matthew, DeAngelis, Gregory, Dodson, Jeffrey, Gerritsen, Brian, McEniry, Ludmil, Mitrev, M Kwesi, Kwofie, Anne, Belliveau, 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, 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, Greg, O'Neill, Amer, Abdullah, Jamie, Fish-Fuhrmann, Mark, Giska, Christina, Fidkowski, Stuart Trent, Guthrie, William, Hakeos, Lillian, Hayes, Joseph, Hoegler, Katherine, Nowak, Jeffery, Beck, Jaslynn, Cuff, Greg, Gaski, Sharon, Haaser, Michael, Holzman, A Stephen, Malekzadeh, Lolita, Ramsey, Jeff, Schulman, Cary, Schwartzbach, Tangwan, Azefor, Arman, Davani, Mahmood, Jaberi, Courtney, Masear, Syed Basit, Haider, Carolyn, Chungu, Ali, Ebrahimi, Karim, Fikry, Andrew, Marcantonio, Anitha, Shelvan, David, Sanders, Collin, Clarke, Abdel, Lawendy, Gary, Schwartz, Mohit, Garg, Joseph, Kim, Juan, Caruci, Ekow, Commeh, Randy, Cuevas, Germaine, Cuff, Lola, Franco, David, Furgiuele, 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, Greg, Bryson, Alexandra, Craig, Cassandra, Farhat, Braden, Gammon, Wade, Gofton, Nicole, Harris, Karl, Lalonde, Allan, Liew, Bradley, Meulenkamp, Kendra, Sonnenburg, Eugene, Wai, Geoffrey, Wilkin, Karen, Troxell, Mary Ellen, Alderfer, Jason, Brannen, Christopher, Cupitt, Stacy, Gerhart, Renee, McLin, Julie, Sheidy, Katherine, Yurick, Fei, Chen, Karen, Dragert, Geza, Kiss, Halina, Malveaux, Deborah, McCloskey, Scott, Mellender, Sagar S, Mungekar, Helaine, Noveck, Carlos, Sagebien, Luat, Biby, Gail, McKelvy, Anna, Richards, Ramon, Abola, Brittney, Ayala, Darcy, Halper, Ana, Mavarez, Sabeen, Rizwan, Stephen, Choi, Imad, Awad, Brendan, Flynn, Patrick, Henry, Richard, Jenkinson, Lilia, Kaustov, Elizabeth, Lappin, Paul, McHardy, Amara, Singh, Joanne, Donnelly, Meera, Gonzalez, Christopher, Haydel, Jon, Livelsberger, Theresa, Pazionis, Bridget, Slattery, Maritza, Vazquez-Trejo, Jaime, Baratta, Michael, Cirullo, Brittany, Deiling, Laura, Deschamps, Michael, Glick, Daniel, Katz, James, Krieg, Jennifer, Lessin, Jeffrey, Mojica, Marc, Torjman, Rongyu, Jin, Mary Jane, Salpeter, Mark, Powell, Jeffrey, Simmons, Prentiss, Lawson, Promil, Kukreja, Shanna, Graves, Adam, Sturdivant, Ayesha, Bryant, Sandra Joyce, Crump, Michelle, Verrier, James, Green, Matthew, Menon, Richard, Applegate, Ana, Arias, Natasha, Pineiro, Jeffrey, Uppington, Phillip, Wolinsky, 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, Denise, Orwig, Maithri, Goud, Chris, Helker, Lydia, Mezenghie, Brittany, Montgomery, Peter, Preston, J Sanford, Schwartz, Ramona, Weber, Lee A, Fleisher, Samir, Mehta, Alisa J, Stephens-Shields, Cassandra, Dinh, Jacques E, Chelly, Shiv, Goel, Wende, Goncz, Touichi, Kawabe, Sharad, Khetarpal, Amy, Monroe, Vladislav, Shick, Max, Breidenstein, Timothy, Dominick, Alexander, Friend, Donald, Mathews, Richard, Lennertz, Robert, Sanders, Helen, Akere, Tyler, Balweg, Amber, Bo, Christopher, Doro, David, Goodspeed, Gerald, Lang, Maggie, Parker, Amy, Rettammel, Mary, Roth, Marissa, White, Paul, Whiting, Brian F S, 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, B Scott, Segal, Jimmy, Turner, David, VanEenenaam, Robert, Weller, Jineli, Lei, Miriam, Treggiari, Shamsuddin, Akhtar, Marcelle, Blessing, Chanel, Johnson, Michael, Kampp, Kimberly, Kunze, Mary, O'Connor, Jinlei, Li, Duminda N, Wijeysundera, Sachin, Kheterpal, Reneé H, Moore, Alexander K, Smith, Laura L, Tosi, Lee, Fleisher, Christine, Langlois, Samuel, Oduwole, and Thomas, Rose

Subjects
Male, Analgesics, Canada, Pain, Postoperative, Hip Fractures, Pain, General Medicine, Anesthesia, General, Anesthesia, Spinal, Patient Satisfaction, Internal Medicine, Humans, Female, Aged
Abstract

The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).46 U.S. and Canadian hospitals.Patients aged 50 years or older undergoing hip fracture surgery.Spinal or general anesthesia.Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.Missing outcome data and multiple outcomes assessed.Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.Patient-Centered Outcomes Research Institute

Published
2022

4. Making Better Dose Decisions: Using Exposure‐Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment

Author

Bei Yang, Prajakti A. Kothare, Tiffini Voss, Iris Xie, Chi-Chung Li, Yang Xu, Matthew DeAngelis, David Michelson, Ken Kowalski, Christopher Jones, Rolien Bosch, and Huub Jan Kleijn

Subjects
Male, Oncology, 030213 general clinical medicine, Time Factors, Pyridines, Phases of clinical research, 030226 pharmacology & pharmacy, 0302 clinical medicine, Medicine, General Pharmacology, Toxicology and Pharmaceutics, Pain Measurement, education.field_of_study, General Neuroscience, lcsh:Public aspects of medicine, Articles, General Medicine, Middle Aged, Treatment Outcome, Female, Adult, medicine.medical_specialty, Adolescent, Migraine Disorders, Clinical Decision-Making, Population, Placebo, Models, Biological, Article, General Biochemistry, Genetics and Molecular Biology, Young Adult, 03 medical and health sciences, Double-Blind Method, Pharmacokinetics, Internal medicine, Humans, Pyrroles, Migraine treatment, education, Aged, Dose-Response Relationship, Drug, business.industry, Research, lcsh:RM1-950, Antagonist, lcsh:RA1-1270, medicine.disease, Clinical trial, lcsh:Therapeutics. Pharmacology, Clinical Trials, Phase III as Topic, Migraine, business
Abstract

Ubrogepant (MK‐1602) is a novel, oral, calcitonin gene‐related peptide receptor antagonist in clinical development with positive phase III outcomes for acute treatment of migraine. This paper describes the population exposure‐response (E‐R) modeling and simulations, which were used to inform the phase III dose‐selection rationale, based on ~ 800 participants pooled across two phase IIb randomized dose‐finding clinical trials. The E‐R model describes the placebo and ubrogepant treatment effects based on migraine pain end points (2‐hour pain relief and 2‐hour pain freedom) at various dose levels. Sensitivity analyses were conducted to evaluate various assumptions of placebo response in light of the high placebo response observed in one phase II trial. A population pharmacokinetic model describing the effect of formulations was included in the E‐R simulation framework to assess potential dose implications of a formulation switch from phase II to phase III. Model‐based simulations predict that a dose of 25 mg or higher is likely to achieve significantly better efficacy than placebo with desirable efficacy levels. The understanding of E‐R helped support the dose selection for the phase III clinical trials.

Published
2020

5. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study

Author

Tiffini Voss, Aobo Wang, Matthew DeAngelis, Marcel Speek, Vera Saldien, Gregory B. Hammer, Rebecca Wrishko, and W. Joseph Herring

Subjects
Vecuronium Bromide, Neostigmine, Sugammadex, Anesthesiology and Pain Medicine, Pediatrics, Perinatology and Child Health, Bradycardia, Neuromuscular Blockade, Humans, Human medicine, Rocuronium, Child, Anaphylaxis, Anesthetics, Neuromuscular Nondepolarizing Agents
Abstract

Background Few randomized studies have assessed recovery from rocuronium- or vecuronium-induced moderate or deep neuromuscular blockade with sugammadex in pediatric participants. Aim To assess sugammadex for reversal of neuromuscular blockade in pediatric participants. Methods This was a randomized, phase IV, active comparator-controlled, double-blind study. Participants aged 2 to = 0.9 in participants receiving sugammadex 2 mg/kg versus neostigmine for reversal of moderate neuromuscular blockade, analyzed by analysis of variance adjusted for neuromuscular blocking agent and age. Results Of 288 randomized participants, 272 completed the study and 276 were included in the analyses. Clinically relevant bradycardia was experienced by 2.0%, 1.6%, and 5.9% of participants in the sugammadex 2 mg/kg, sugammadex 4 mg/kg, and neostigmine groups, respectively. No hypersensitivity or anaphylaxis events were observed. Recovery to a train-of-four ratio of >= 0.9 with sugammadex 2 mg/kg was faster than neostigmine (1.6 min, 95% CI 1.3 to 2.0 vs. 7.5 min, 95% CI 5.6 to 10.0; p < .0001) and was comparable to sugammadex 4 mg/kg (2.0 min, 95% CI 1.8 to 2.3). Conclusions Pediatric participants recovered from rocuronium- or vecuronium-induced moderate neuromuscular blockade significantly faster with sugammadex 2 mg/kg than with neostigmine. Time to reversal of deep neuromuscular blockade with sugammadex 4 mg/kg was consistent with that of moderate neuromuscular blockade reversal. No meaningful differences in clinically relevant bradycardia, hypersensitivity, or anaphylaxis were seen with sugammadex vs neostigmine. These results support the use of sugammadex for reversal of moderate and deep rocuronium- and vecuronium-induced neuromuscular blockade in patients aged 2 to

Published
2021

6. 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

7. A Randomized Trial Evaluating Actual Versus Ideal Body Weight Dosing of Sugammadex in Morbidly Obese Patients 

Author

W. Joseph Herring, Wen Li, Jay Horrow, Matthew DeAngelis, Marcel Speek, John Lombard, and Manfred Blobner

Subjects
Randomized controlled trial, law, business.industry, Anesthesia, medicine, Dosing, Morbidly obese, Body weight, business, Sugammadex, medicine.drug, law.invention
Abstract

Background: This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep neuromuscular block (D-NMB) in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW). Methods: Adults with BMI ≥40 kg/m2 were randomized to 1 of 5 groups: M-NMB, sugammadex 2 mg/kg ABW; M-NMB, sugammadex 2 mg/kg IBW; M-NMB, neostigmine 5 mg, and glycopyrrolate 1 mg; D-NMB, sugammadex 4 mg/kg ABW; or D-NMB, sugammadex 4 mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio ≥0.9 for ABW and IBW groups pooled across NMB agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis. Results: Of 207 patients randomized, 188 received treatment (28% male, BMI 47±5.1 kg/m2, age 48±13 years). Recovery was 1.5 min faster with ABW vs IBW dosing. The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time >10 min (95% CI of difference: -4.8% to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences. Conclusions: ABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of NMB or NMBA used. Trial registration: Registered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070. https://clinicaltrials.gov/ct2/show/results/NCT03346070?term=NCT03346070&draw=2&rank=1

Published
2020

8. Quantitative Trait Loci Affecting the Difference in Pigmentation Between Drosophila yakuba and D. santomea

Author

Mary Anna Carbone, Jerry A. Coyne, Trudy F. C. Mackay, Ana Llopart, and Matthew deAngelis

Subjects
Male, Genotype, Quantitative Trait Loci, Genes, Insect, Skin Pigmentation, Investigations, Biology, Quantitative trait locus, Species Specificity, Genetic variation, Genetics, Animals, Crosses, Genetic, X chromosome, Directional selection, Haplotype, Chromosome Mapping, Genetic Variation, food and beverages, Epistasis, Genetic, biology.organism_classification, Haplotypes, Evolutionary biology, Backcrossing, Hybridization, Genetic, Epistasis, Female, Drosophila yakuba
Abstract

Using quantitative trait locus (QTL) mapping, we studied the genetic basis of the difference in pigmentation between two sister species of Drosophila: Drosophila yakuba, which, like other members of the D. melanogaster subgroup, shows heavy black pigmentation on the abdomen of males and females, and D. santomea, an endemic to the African island of São Tomé, which has virtually no pigmentation. Here we mapped four QTL with large effects on this interspecific difference in pigmentation: two on the X chromosome and one each on the second and third chromosomes. The same four QTL were detected in male hybrids in the backcrosses to both D. santomea and D. yakuba and in the female D. yakuba backcross hybrids. All four QTL exhibited strong epistatic interactions in male backcross hybrids, but only one pair of QTL interacted in females from the backcross to D. yabuka. All QTL from each species affected pigmentation in the same direction, consistent with adaptive evolution driven by directional natural selection. The regions delimited by the QTL included many positional candidate loci in the pigmentation pathway, including genes affecting catecholamine biosynthesis, melanization of the cuticle, and many additional pleiotropic effects.

Published
2005

9. Quantitative Trait Loci for Sexual Isolation Between Drosophila simulans and D. mauritiana

Author

Amanda J. Moehring, Shelly G. Smith, Matthew deAngelis, Jerry A. Coyne, Trudy F. C. Mackay, Jian Li, and Malcolm D. Schug

Subjects
Male, Positional cloning, Sterility, Quantitative Trait Loci, Quantitative trait locus, Sexual Behavior, Animal, Species Specificity, Genetics, Animals, Drosophila, Mauritiana, Crosses, Genetic, X chromosome, DNA Primers, Polymorphism, Genetic, biology, Reproduction, food and beverages, Chromosome Mapping, Reproductive isolation, biology.organism_classification, Chromosome 3, Evolutionary biology, Female, Research Article, Microsatellite Repeats
Abstract

Sexual isolating mechanisms that act before fertilization are often considered the most important genetic barriers leading to speciation in animals. While recent progress has been made toward understanding the genetic basis of the postzygotic isolating mechanisms of hybrid sterility and inviability, little is known about the genetic basis of prezygotic sexual isolation. Here, we map quantitative trait loci (QTL) contributing to prezygotic reproductive isolation between the sibling species Drosophila simulans and D. mauritiana. We mapped at least seven QTL affecting discrimination of D. mauritiana females against D. simulans males, three QTL affecting D. simulans male traits against which D. mauritiana females discriminate, and six QTL affecting D. mauritiana male traits against which D. simulans females discriminate. QTL affecting sexual isolation act additively, are largely different in males and females, and are not disproportionately concentrated on the X chromosome: The QTL of greatest effect are located on chromosome 3. Unlike the genetic components of postzygotic isolation, the loci for prezygotic isolation do not interact epistatically. The observation of a few QTL with moderate to large effects will facilitate positional cloning of genes underlying sexual isolation.

Published
2004

10. Mate grasping in drosophila pegasa by

Author

Stephen Pruett-Jones, Philip S. Ward, Matthew deAngelis, Carina J. Gronlund, and Jerry A. Coyne

Subjects
Communication, biology, Courtship display, business.industry, musculoskeletal, neural, and ocular physiology, media_common.quotation_subject, Zoology, Captivity, biology.organism_classification, Sperm, Intraspecific competition, body regions, Courtship, Behavioral Neuroscience, Female sperm storage, Animal Science and Zoology, Mating, business, human activities, Drosophila, psychological phenomena and processes, media_common
Abstract

Abstract Among all species in the genus Drosophila whose sexual behavior has been studied, D. pegasa is unique in that males exhibit no courtship behaviour before they mount females. Instead, the male simply climbs on top of the female and rides on her abdomen ('grasping') for long intervals, often an entire 8-h observation period. In this study we conducted a series of observations and experiments to quantitatively describe grasping behaviour in D. pegasa and examine its relationship to social environment and the reproductive biology of the species. All observed courtship bouts involved grasping behavior, and males always initiated copulation during a grasping bout. The frequency of grasping and the average duration of a single grasping bout increased with the number of flies present. Males often copulated several times during a single grasping bout, and such multiple copulations during a single mounting also appear unique in the genus. Unexpectedly, the number of sperm that a male transferred to a female during a single grasping bout was negatively correlated with the number of copulations. This relationship was apparently due to repeated copulations by males who were unsuccessful at transferring sperm. Multiple copulations without sperm transfer may result from cryptic female choice. Male grasping behaviour in this species appears to have evolved as a substitute for display and courtship behaviours, but possibly also as a mate-guarding behaviour since males continue to grasp after they have successfully transferred sperm. The tarsal claws and pulvillar pads of D. pegasa are disproportionately larger than those of related Drosophila species, evolutionary changes that may facilitate grasping by males.

Published
2002

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