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

Neuman, Mark D; Feng, Rui; Ellenberg, Susan S; Sieber, Frederick; Sessler, Daniel I; Magaziner, Jay; Elkassabany, Nabil; Schwenk, Eric S; Dillane, Derek; Marcantonio, Edward R; Menio, Diane; Ayad, Sabry; Hassan, Manal; Stone, Trevor; Papp, Steven; Donegan, Derek; Marshall, Mitchell; Jaffe, J Douglas; Luke, Charles; Sharma, Balram; Azim, Syed; Hymes, Robert; Chin, Ki-Jinn; Sheppard, Richard; Perlman, Barry; Sappenfield, Joshua; Hauck, Ellen; Hoeft, Mark A; Tierney, Ann; Gaskins, Lakisha J; Horan, Annamarie D; Brown, Trina; Dattilo, James; Carson, Jeffrey L; Looke, Thomas; Bent, Sandra; Franco-Mora, Ariana; Hedrick, Pamela; Newbern, Matthew; Tadros, Rafik; Pealer, Karen; Vlassakov, Kamen; Buckley, Carolyn; Gavin, Lauren; Gorbatov, Svetlana; Gosnell, James; Steen, Talora; Vafai, Avery; Zeballos, Jose; Hruslinski, Jennifer; Cardenas, Louis; Berry, Ashley; Getchell, John; Quercetti, Nicholas; Bajracharya, Gauasan; Billow, Damien; Bloomfield, Michael; Cuko, Evis; Elyaderani, Mehrun K; Hampton, Robert; Honar, Hooman; Khoshknabi, Dilara; Kim, Daniel; Krahe, David; Lew, Michael M; Maheshwer, Conjeevram B; Niazi, Azfar; Saha, Partha; Salih, Ahmed; de Swart, Robert J; Volio, Andrew; Bolkus, Kelly; DeAngelis, Matthew; Dodson, Gregory; Gerritsen, Jeffrey; McEniry, Brian; Mitrev, Ludmil; Kwofie, M Kwesi; Belliveau, Anne; Bonazza, Flynn; Lloyd, Vera; Panek, Izabela; Dabiri, Jared; Chavez, Chris; Craig, Jason; Davidson, Todd; Dietrichs, Chad; Fleetwood, Cheryl; Foley, Mike; Getto, Chris; Hailes, Susie; Hermes, Sarah; Hooper, Andy; Koener, Greg; Kohls, Kate; Law, Leslie; Lipp, Adam; Losey, Allison; Nelson, William; Nieto, Mario; Rogers, Pam; Rutman, Steve; Scales, Garrett; Sebastian, Barbara; Stanciu, Tom; Lobel, Gregg; Giampiccolo, Michelle; Herman, Dara; Kaufman, Margit; Murphy, Bryan; Pau, Clara; Puzio, Thomas; Veselsky, Marlene; Apostle, Kelly; Boyer, Dory; Fan, Brenda Chen; Lee, Susan; Lemke, Mike; Merchant, Richard; Moola, Farhad; Payne, Kyrsten; Perey, Bertrand; Viskontas, Darius; Poler, Mark; D'Antonio, Patricia; O'Neill, Greg; Abdullah, Amer; Fish-Fuhrmann, Jamie; Giska, Mark; Fidkowski, Christina; Guthrie, Stuart Trent; Hakeos, William; Hayes, Lillian; Hoegler, Joseph; Nowak, Katherine; Beck, Jeffery; Cuff, Jaslynn; Gaski, Greg; Haaser, Sharon; Holzman, Michael; Malekzadeh, A Stephen; Ramsey, Lolita; Schulman, Jeff; Schwartzbach, Cary; Azefor, Tangwan; Davani, Arman; Jaberi, Mahmood; Masear, Courtney; Haider, Syed Basit; Chungu, Carolyn; Ebrahimi, Ali; Fikry, Karim; Marcantonio, Andrew; Shelvan, Anitha; Sanders, David; Clarke, Collin; Lawendy, Abdel; Schwartz, Gary; Garg, Mohit; Kim, Joseph; Caruci, Juan; Commeh, Ekow; Cuevas, Randy; Cuff, Germaine; Franco, Lola; Furgiuele, David; Giuca, Matthew; Allman, Melissa; Barzideh, Omid; Cossaro, James; D'Arduini, Armando; Farhi, Anita; Gould, Jason; Kafel, John; Patel, Anuj; Peller, Abraham; Reshef, Hadas; Safur, Mohammed; Toscano, Fiore; Tedore, Tiffany; Akerman, Michael; Brumberger, Eric; Clark, Sunday; Friedlander, Rachel; Jegarl, Anita; Lane, Joseph; Lyden, John P; Mehta, Nili; Murrell, Matthew T; Painter, Nathan; Ricci, William; Sbrollini, Kaitlyn; Sharma, Rahul; Steel, Peter A D; Steinkamp, Michele; Weinberg, Roniel; Wellman, David Stephenson; Nader, Antoun; Fitzgerald, Paul; Ritz, Michaela; Bryson, Greg; Craig, Alexandra; Farhat, Cassandra; Gammon, Braden; Gofton, Wade; Harris, Nicole; Lalonde, Karl; Liew, Allan; Meulenkamp, Bradley; Sonnenburg, Kendra; Wai, Eugene; Wilkin, Geoffrey; Troxell, Karen; Alderfer, Mary Ellen; Brannen, Jason; Cupitt, Christopher; Gerhart, Stacy; McLin, Renee; Sheidy, Julie; Yurick, Katherine; Chen, Fei; Dragert, Karen; Kiss, Geza; Malveaux, Halina; McCloskey, Deborah; Mellender, Scott; Mungekar, Sagar S; Noveck, Helaine; Sagebien, Carlos; Biby, Luat; McKelvy, Gail; Richards, Anna; Abola, Ramon; Ayala, Brittney; Halper, Darcy; Mavarez, Ana; Rizwan, Sabeen; Choi, Stephen; Awad, Imad; Flynn, Brendan; Henry, Patrick; Jenkinson, Richard; Kaustov, Lilia; Lappin, Elizabeth; McHardy, Paul; Singh, Amara; Donnelly, Joanne; Gonzalez, Meera; Haydel, Christopher; Livelsberger, Jon; Pazionis, Theresa; Slattery, Bridget; Vazquez-Trejo, Maritza; Baratta, Jaime; Cirullo, Michael; Deiling, Brittany; Deschamps, Laura; Glick, Michael; Katz, Daniel; Krieg, James; Lessin, Jennifer; Mojica, Jeffrey; Torjman, Marc; Jin, Rongyu; Salpeter, Mary Jane; Powell, Mark; Simmons, Jeffrey; Lawson, Prentiss; Kukreja, Promil; Graves, Shanna; Sturdivant, Adam; Bryant, Ayesha; Crump, Sandra Joyce; Verrier, Michelle; Green, James; Menon, Matthew; Applegate, Richard; Arias, Ana; Pineiro, Natasha; Uppington, Jeffrey; Wolinsky, Phillip; Gunnett, Amy; Hagen, Jennifer; Harris, Sara; Hollen, Kevin; Holloway, Brian; Horodyski, Mary Beth; Pogue, Trevor; Ramani, Ramachandran; Smith, Cameron; Woods, Anna; Warrick, Matthew; Flynn, Kelly; Mongan, Paul; Ranganath, Yatish; Fernholz, Sean; Ingersoll-Weng, Esperanza; Marian, Anil; Seering, Melinda; Sibenaller, Zita; Stout, Lori; Wagner, Allison; Walter, Alicia; Wong, Cynthia; Orwig, Denise; Goud, Maithri; Helker, Chris; Mezenghie, Lydia; Montgomery, Brittany; Preston, Peter; Schwartz, J Sanford; Weber, Ramona; Fleisher, Lee A; Mehta, Samir; Stephens-Shields, Alisa J; Dinh, Cassandra; Chelly, Jacques E; Goel, Shiv; Goncz, Wende; Kawabe, Touichi; Khetarpal, Sharad; Monroe, Amy; Shick, Vladislav; Breidenstein, Max; Dominick, Timothy; Friend, Alexander; Mathews, Donald; Lennertz, Richard; Sanders, Robert; Akere, Helen; Balweg, Tyler; Bo, Amber; Doro, Christopher; Goodspeed, David; Lang, Gerald; Parker, Maggie; Rettammel, Amy; Roth, Mary; White, Marissa; Whiting, Paul; Allen, Brian F S; Baker, Tracie; Craven, Debra; McEvoy, Matt; Turnbo, Teresa; Kates, Stephen; Morgan, Melanie; Willoughby, Teresa; Weigel, Wade; Auyong, David; Fox, Ellie; Welsh, Tina; Cusson, Bruce; Dobson, Sean; Edwards, Christopher; Harris, Lynette; Henshaw, Daryl; Johnson, Kathleen; McKinney, Glen; Miller, Scott; Reynolds, Jon; Segal, B Scott; Turner, Jimmy; VanEenenaam, David; Weller, Robert; Lei, Jineli; Treggiari, Miriam; Akhtar, Shamsuddin; Blessing, Marcelle; Johnson, Chanel; Kampp, Michael; Kunze, Kimberly; O'Connor, Mary; Looke, Thomas; Tadros, Rafik; Vlassakov, Kamen; Cardenas, Louis; Bolkus, Kelly; Mitrev, Ludmil; Kwofie, M Kwesi; Dabiri, Jared; Lobel, Gregg; Poler, Mark; Giska, Mark; Sanders, David; Schwartz, Gary; Giuca, Matthew; Tedore, Tiffany; Nader, Antoun; Bryson, Greg; Troxell, Karen; Kiss, Geza; Choi, Stephen; Powell, Mark; Applegate, Richard; Warrick, Matthew; Ranganath, Yatish; Chelly, Jacques E; Lennertz, Richard; Sanders, Robert; Allen, Brian F S; Kates, Stephen; Weigel, Wade; Li, Jinlei; Wijeysundera, Duminda N; Kheterpal, Sachin; Moore, Reneé H; Smith, Alexander K; Tosi, Laura L; Looke, Thomas; Mehta, Samir; Fleisher, Lee; Hruslinski, Jennifer; Ramsey, Lolita; Langlois, Christine; Mezenghie, Lydia; Montgomery, Brittany; Oduwole, Samuel; Rose, Thomas
BACKGROUND: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. OBJECTIVE:To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia. DESIGN:Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505). SETTING:46 U.S. and Canadian hospitals. PARTICIPANTS:Patients aged 50 years or older undergoing hip fracture surgery. INTERVENTION:Spinal or general anesthesia. MEASUREMENTS:Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care. RESULTS: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. LIMITATION:Missing outcome data and multiple outcomes assessed. CONCLUSION: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. PRIMARY FUNDING SOURCE:
PMID: 35696684
ISSN: 1539-3704
CID: 5277802

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

Hruslinski, Jennifer; Menio, Diane A; Hymes, Robert A; Jaffe, J Douglas; Langlois, Christine; Ramsey, Lolita; Gaskins, Lakisha J; Neuman, Mark D; Looke, Thomas; Bent, Sandra; Franco-Mora, Ariana; Hedrick, Pamela; Newbern, Matthew; Tadros, Rafik; Pealer, Karen; Marcantonio, Edward; Vlassakov, Kamen; Buckley, Carolyn; Gorbatov, Svetlana; Gosnell, James; Steen, Talora; Vafai, Avery; Zeballos, Jose; Cardenas, Louis; Berry, Ashley; Getchell, John; Quercetti, Nicholas; Sessler, Daniel I; Ayad, Sabry; Hassan, Manal; Ali, Assad; Bajracharya, Gauasan; Billow, Damien; Bloomfield, Michael; Elliott, Kavita; Hampton, Robert; He, Linda; Honar, Hooman; Khoshknabi, Dilara; Kim, Daniel; Minko, Paul; Morris, Adam; Niazi, Azfar; Nutcharoen, Tara; Roberts, Jeffrey; Saha, Partha; Salih, Ahmed; Skolaris, Alexis; Stang, Taylor; Strimbu, Victor; Templeton, Jesse; Volio, Andrew; Wang, Jiayi; Bolkus, Kelly; DeAngelis, Matthew; Dodson, Gregory; Gerritsen, Jeffrey; McEniry, Brian; Mitrev, Ludmil; Kwofie, Kwesi; Bonazza, Flynn; Lloyd, Vera; Panek, Izabela; Dabiri, Jared; Chavez, Chris; Craig, Jason; Davidson, Todd; Dietrichs, Chad; Fleetwood, Cheryl; Foley, Mike; Getto, Chris; Hailes, Susie; Hermes, Sarah; Hooper, Andy; Koener, Greg; Kohls, Kate; Law, Leslie; Lipp, Adam; Losey, Allison; Nelson, William; Nieto, Mario; Rogers, Pam; Rutman, Steve; Scales, Garrett; Sebastian, Barbara; Stanciu, Tom; Lobel, Gregg; Giampiccolo, Michelle; Herman, Dara; Kaufman, Margit; Murphy, Bryan; Pau, Clara; Puzio, Thomas; Veselsky, Marlene; Stone, Trevor; Apostle, Kelly; Boyer, Dory; Fan, Brenda Chen; Lee, Susan; Lemke, Mike; Merchant, Richard; Moola, Farhad; Payne, Kyrsten; Perey, Bertrand; Viskontas, Darius; Poler, Mark; D'Antonio, Patricia; Sheppard, Richard; Abdullah, Amer; Fish-Fuhrmann, Jamie; Giska, Mark; Fidkowski, Christina; Guthrie, Trent; Hakeos, William; Hayes, Lillian; Hoegler, Joseph; Nowak, Katherine; Hymes, Robert; Beck, Jeffery; Cuff, Jaslynn; Gaski, Greg; Haaser, Sharon; Holzman, Michael; Malekzadeh, A Stephen; Ramsey, Lolita; Schulman, Jeff; Schwartzbach, Cary; Sieber, Frederick; Azefor, Tangwan; Brown, Charles; Davani, Arman; Jaberi, Mahmood; Masear, Courtney; Sharma, Balram; Haider, Syed Basit; Chungu, Carolyn; Ebrahimi, Ali; Fikry, Karim; Gannon, Kerri; Marcantonio, Andrew; Pace, Meredith; Sanders, David; Clarke, Collin; Lawendy, Abdel; Schwartz, Gary; Garg, Mohit; Kim, Joseph; Marshall, Mitchell; Caurci, Juan; Commeh, Ekow; Cuevas, Randy; Cuff, Germaine; Franco, Lola; Furguiele, David; Giuca, Matthew; Allman, Melissa; Barzideh, Omid; Cossaro, James; D'Arduini, Armando; Farhi, Anita; Gould, Jason; Kafel, John; Patel, Anuj; Peller, Abraham; Reshef, Hadas; Safur, Mohammed; Toscano, Fiore; Tedore, Tiffany; Akerman, Michael; Brumberger, Eric; Clark, Sunday; Friedlander, Rachel; Jegarl, Anita; Lane, Joseph; Lyden, John P; Mehta, Nili; Murrell, Matthew T; Painter, Nathan; Ricci, William; Sbrollini, Kaitlyn; Sharma, Rahul; Steel, Peter A D; Steinkamp, Michele; Weinberg, Roniel; Wellman, David Stephenson; Nader, Antoun; Fitzgerald, Paul; Ritz, Michaela; Papp, Steven; Bryson, Greg; Craig, Alexandra; Farhat, Cassandra; Gammon, Braden; Gofton, Wade; Harris, Nicole; Lalonde, Karl; Liew, Allan; Meulenkamp, Bradley; Sonnenburg, Kendra; Wai, Eugene; Wilkin, Geoffrey; Donegan, Derek; Dinh, Cassandra; Elkassabany, Nabil; Horan, Annamarie; Mehta, Samir; Troxell, Karen; Alderfer, Mary Ellen; Brannen, Jason; Cupitt, Christopher; Gerhart, Stacy; McLin, Renee; Sheidy, Julie; Yurick, Katherine; Carson, Jeffrey; Chen, Fei; Dragert, Karen; Kiss, Geza; Malveaux, Halina; McCloskey, Deborah; Mellender, Scott; Mungekar, Sagar S; Noveck, Helaine; Sagebien, Carlos; Perlman, Barry; Biby, Luat; McKelvy, Gail; Richards, Anna; Azim, Syed; Abola, Ramon; Ayala, Brittney; Halper, Darcy; Mavarez, Ana; Choi, Stephen; Awad, Imad; Flynn, Brendan; Henry, Patrick; Jenkinson, Richard; Kaustov, Lilia; Lappin, Elizabeth; McHardy, Paul; Singh, Amara; Hauck, Ellen; Donnelly, Joanne; Gonzalez, Meera; Haydel, Christopher; Livelsberger, Jon; Pazionis, Theresa; Slattery, Bridget; Vazquez-Trejo, Maritza; Schwenk, Eric; Baratta, Jaime; Deiling, Brittany; Deschamps, Laura; Glick, Michael; Katz, Daniel; Krieg, James; Lessin, Jennifer; Torjman, Marc; Chin, Ki Jinn; Jin, Rongyu; Salpeter, Mary Jane; Powell, Mark; Simmons, Jeffrey; Lawson, Prentiss; Kukreja, Promil; Graves, Shanna; Sturdivant, Adam; Bryant, Ayesha; Crump, Sandra Joyce; Dillane, Derek; Taylor, Michael; Verrier, Michelle; Applegate, Richard; Arias, Ana; Pineiro, Natasha; Uppington, Jeffrey; Wolinsky, Phillip; Sappenfield, Joshua; Gunnett, Amy; Hagen, Jennifer; Harris, Sara; Hollen, Kevin; Holloway, Brian; Horodyski, Mary Beth; Pogue, Trevor; Ramani, Ramachandran; Smith, Cameron; Woods, Anna; Warrick, Matthew; Flynn, Kelly; Mongan, Paul; Ranganath, Yatish; Fernholz, Sean; Ingersoll-Weng, Esperanza; Marian, Anil; Seering, Melinda; Sibenaller, Zita; Stout, Lori; Wagner, Allison; Walter, Alicia; Wong, Cynthia; Magaziner, Jay; Orwig, Denise; Brown, Trina; Dattilo, Jim; Ellenberg, Susan; Feng, Rui; Fleisher, Lee; Gaskins, Lakisha; Goud, Maithri; Helker, Chris; Mezenghie, Lydia; Montgomery, Brittany; Preston, Peter; Stephens, Alisa; Schwartz, J Sanford; Tierney, Ann; Weber, Ramona; Chelly, Jacques; Goel, Shiv; Goncz, Wende; Kawabe, Touichi; Khetarpal, Sharad; King, Kevin; Kunkel, Frank; Luke, Charles; Monroe, Amy; Shick, Vladislav; Silipo, Anthony; Stehle, Caroline; Szabo, Katherine; Yennam, Sudhakar; Hoeft, Mark; Breidenstein, Max; Dominick, Timothy; Friend, Alexander; Mathews, Donald; Lennertz, Richard; Akere, Helen; Balweg, Tyler; Bo, Amber; Doro, Christopher; Goodspeed, David; Lang, Gerald; Parker, Maggie; Rettammel, Amy; Roth, Mary; Sanders, Robert; White, Marissa; Whiting, Paul; Allen, Brian; Baker, Tracie; Craven, Debra; McEvoy, Matt; Turnbo, Teresa; Kates, Stephen; Morgan, Melanie; Willoughby, Teresa; Weigel, Wade; Auyong, David; Fox, Ellie; Welsh, Tina; Jaffe, J Douglas; Cusson, Bruce; Dobson, Sean; Edwards, Christopher; Harris, Lynette; Henshaw, Daryl; Johnson, Kathleen; McKinney, Glen; Miller, Scott; Reynolds, Jon; Turner, Jimmy; VanEenenaam, David; Weller, Robert; Akhtar, Shamsuddin; Blessing, Marcelle; Johnson, Chanel; Kampp, Michael; Kunze, Kimberly; Li, Jinlei; O'Connor, Mary; Treggiari, Miriam
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.
PMID: 33279102
ISSN: 1471-6771
CID: 5022622

A multicenter randomized phase 2 trial of atezolizumab as monotherapy or in combination with cobimetinib in biliary tract cancers (BTCs): A NCI Experimental Therapeutics Clinical Trials Network (ETCTN) study [Meeting Abstract]

Yarchoan, Mark; Cope, Leslie; Anders, Robert A.; Noonan, Anne; Goff, Laura W.; Goyal, Lipika; Lacy, Jill; Li, Daneng; Patel, Anuj; He, Aiwu R.; Abou-Alfa, Ghassan; Spencer, Kristen; Kim, Edward; Xavier, Stephanie; Ruggieri, Amanda; Davis, S. Lindsey; McRee, Autumn; Kunk, Paul; Zhu, Qingfeng; Wang-Gillam, Andrea; Poklepovic, Andrew; Chen, Helen; Sharon, Elad; Lesinski, Gregory B.; Azad, Nilo
ISI:000590059302169
ISSN: 0008-5472
CID: 5180742

Triple play [Letter]

Wax, David B; Patel, Anuj
PMID: 25695589
ISSN: 1526-7598
CID: 5043782