Appendix 1. List of Acknowledgements for REVEAL
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1 Appendix 1. List of Acknowledgements for REVEAL CARE UofIowa Bradley, Catherine S Acknowledgement catherine bradley@uiowa.edu CARE Loyola Brubaker, Linda Author Lbrubaker@luc.edu CARE UAB Burgio, Kathryn L Acknowledgement kburgio@uabmc.edu CARE UMich Casher, Yang Wang Acknowledgement yangwang@umich.edu CARE UNC CH Connolly, Anna Marie Acknowledgement annamarie_connolly@med.unc.edu CARE Johns Hopkins Cundiff, Geoffrey W Author GCundiff@providencehealth.bc.ca CARE Baylor Fine, Paul Author pfine@bcm.edu CARE Magee Gruss, Judy Acknowledgement jgruss@mail.magee.edu CARE Johns Hopkins Handa, Victoria L Acknowledgement vhanda1@jhmi.edu CARE UofIowa Kreder, Karl Acknowledgement karl kreder@uiowa.edu CARE UMich Marchant, Bev Acknowledgement bevm@umich.edu CARE Magee Moalli, Pamela Acknowledgement pmoalli@mail.magee.edu CARE UAB Richter, Holly E Author hrichter@uabmc.edu CARE UAB Varner, R Edward Acknowledgement evarner@uabmc.edu CARE Duke Visco, Anthony G Author anthony.visco@duke.edu CARE UMich Wei, John T Acknowledgement jtwei@med.umich.edu CARE UNC CH Whitehead, William Acknowledgement william_whitehead@med.unc.edu CARE UMich Wren, Patricia A Acknowledgement pwren@umich.edu CARE Magee Zyczynski, Halina M Author hzyczynski@mail.magee.edu OPTIMAL UCSD Albo, Michael E Acknowledgement malbo@ucsd.edu OPTIMAL Duke Amundsen, Cindy L Acknowledgement cindy.amundsen@duke.edu OPTIMAL UTSW Atnip, Shanna Acknowledgement SHANNA.ATNIP@phhs.org OPTIMAL Utah Baker, Jan Acknowledgement Jan.baker@hsc.utah.edu OPTIMAL UAB Ballard, Alicia Acknowledgement aballard@uabmc.edu OPTIMAL CC Barber, Matthew D Author Barberm2@ccf.org OPTIMAL Magee Borello France, D Author borellofrance@duq.edu OPTIMAL Loyola Brubaker, Linda Author Lbrubaker@luc.edu 2018 American College of Obstetricians and Gynecologists. Page 1 of 9
2 OPTIMAL UAB Burge, Julie Acknowledgement OPTIMAL UAB Burgio, Kathryn L Author kburgio@uabmc.edu OPTIMAL UAB Carter, Kathy Acknowledgement kcarter@uabmc.edu OPTIMAL UMich Casher, Yang Wang Acknowledgement yangwang@umich.edu OPTIMAL UMich Chen, Yeh Hsin Acknowledgement yehsin@umich.edu OPTIMAL UMich DiFranco, Donna Acknowledgement donnadi@med.umich.edu OPTIMAL Kaiser SD Diwadkar, Gouri Acknowledgement Gouri.B.Diwadkar@kp.org OPTIMAL Kaiser SD Dyer, Keisha Y Acknowledgement Keisha.Y.Dyer@kp.org OPTIMAL CC Frick, Anna Acknowledgement africk76@gmail.com OPTIMAL RTI Gantz, Marie Author mgantz@rti.org OPTIMAL UAB Goode, Patricia S Author pgoode@uabmc.edu OPTIMAL UCSD Grimes, Cara Acknowledgement cara@jhu.edu OPTIMAL Kaiser SD Hall, Lynn M Acknowledgement Lynn.M.Hall@kp.org OPTIMAL Duke Harm Ernandes, Ingrid Acknowledgement harme004@mc.duke.edu OPTIMAL SC Chair Hartmann, Katherine Acknowledgement Katherine.hartmann@vanderbilt.edu OPTIMAL Utah Hsu, Yvonne Acknowledgement yvonne.hsu@hsc.utah.edu OPTIMAL Kaiser Bellflower Jakus Waldman, S Author sharonjakus@hotmail.com OPTIMAL CC Jelovsek, John Eric Acknowledgement JELOVSJ@ccf.org OPTIMAL RTI Klein Warren, Lauren Author lklein@rti.org OPTIMAL UCSD Lukacz, Emily S Author elukacz@ucsd.edu OPTIMAL Kaiser SD Mackinnon, Linda M Acknowledgement linda.m.mackinnon@kp.org OPTIMAL UMich Marchant, Bev Acknowledgement bevm@umich.edu OPTIMAL UAB Markland, Alayne D Acknowledgement amarkland@uabmc.edu OPTIMAL Utah Masters, Maria Acknowledgement Maria.masters@hsc.utah.edu OPTIMAL RTI Matthews, Daryl Acknowledgement dmatthews107@nc.rr.com OPTIMAL RTI Matthews, Daryl Acknowledgement dmatthews107@nc.rr.com OPTIMAL former NICHD Meikle, Susan F Author cocomeikle1@gmail.com OPTIMAL Kaiser SD Menefee, Shawn A Author Shawn.A.Menefee@kp.org OPTIMAL UTSW Moore, Elva Kelly Acknowledgement Kelly.Moore@UTSouthwestern.edu 2018 American College of Obstetricians and Gynecologists. Page 2 of 9
3 OPTIMAL Loyola Mueller, Elizabeth Acknowledgement OPTIMAL UCSD Nager, Charles W Acknowledgement cnager@ucsd.edu OPTIMAL Kaiser Nguyen, John N Author John.N.Nguyen@kp.org OPTIMAL CC O'Dougherty, Betsy Acknowledgement ODOUGHB@ccf.org OPTIMAL Utah Orr, Amy Acknowledgement Amy.orr@hsc.utah.edu OPTIMAL UAB Pair, Lisa S Acknowledgement lpair@uab.edu OPTIMAL CC Paraiso, Marie FR Acknowledgement paraism@ccf.org OPTIMAL UAB Parker Autry, Candace Acknowledgement cparkera@wakehealth.edu OPTIMAL CC Pung, Ly Acknowledgement pungl@ccf.org OPTIMAL UTSW Rahn, David Acknowledgement David.Rahn@UTSouthwestern.edu OPTIMAL Duke Raynor, Mary Acknowledgement maryjraynor@gmail.com OPTIMAL UAB Richter, Holly E Author hrichter@uabmc.edu OPTIMAL CC Ridgeway, Beri M Acknowledgement Beri.Ridgeway@medsch.ucr.edu OPTIMAL UTSW Schaffer, Joseph Author Joseph.Schaffer@UTSouthwestern.edu OPTIMAL RTI Shaffer, Amanda Acknowledgement ashaffer@rti.org OPTIMAL Duke Siddiqui, Nazema Y Acknowledgement nazema.siddiqui@dm.duke.edu OPTIMAL UMich Spino, Cathie Author spino@umich.edu OPTIMAL Kaiser SD Tan Kim, Jasmine Acknowledgement Jasmine.X.Tan Kim@kp.org OPTIMAL RTI Terry, Tamara T Acknowledgement tterry@rti.org OPTIMAL RTI Thornberry, Jutta Acknowledgement juttathornberry@gmail.com OPTIMAL Loyola Tulke, Mary Acknowledgement mtulke@luc.edu OPTIMAL UAB Varner, R Edward Acknowledgement evarner@uabmc.edu OPTIMAL Duke Visco, Anthony G Acknowledgement anthony.visco@duke.edu OPTIMAL UTSW Wai, Clifford Acknowledgement clifford.wai@utsouthwestern.edu OPTIMAL RTI Wallace, Dennis Acknowledgement dwallace@rti.org OPTIMAL UMich Wei, John T Acknowledgement jtwei@med.umich.edu OPTIMAL Duke Weidner, Alison C Author alison.weidner@dm.duke.edu OPTIMAL RTI Whitworth, Ryan E Acknowledgement whitworthryan@hotmail.com OPTIMAL CC Williams, Cheryl Acknowledgement williac@ccf.org 2018 American College of Obstetricians and Gynecologists. Page 3 of 9
4 OPTIMAL RTI Wilson, Kevin A Acknowledgement kwilson@rti.org OPTIMAL UAB Wilson, Tracey S Acknowledgement traceywilson@uabmc.edu OPTIMAL Duke Wu, Jennifer M Acknowledgement jmwu@med.unc.edu OPTIMAL Kaiser SD Zazueta Damian, Gisselle Acknowledgement Gisselle.Zazueta Damian@kp.org OPUS Duke Amundsen, Cindy L Author cindy.amundsen@duke.edu OPUS CC Barber, Matthew D Author matthew.barber@duke.edu OPUS NICHD Meikle, Susan F Author cocomeikle1@gmail.com OPUS UCSD Nager, Charles W Author cnager@ucsd.edu OPUS UAB Richter, Holly E Author hrichter@uabmc.edu OPUS UTSW Schaffer, Joseph Author Joseph.Schaffer@UTSouthwestern.edu OPUS UMich Spino, Cathie Author spino@umich.edu OPUS UMich Wei, John T Author jtwei@med.umich.edu 2018 American College of Obstetricians and Gynecologists. Page 4 of 9
5 Appendix 2. Primary Outcome Results of Women Undergoing Surgery With a Vaginal Approach Outcome Statistic/ Vault Uterovaginal Adjusted difference Raw P Adjusted P value Category Prolapse Prolapse or odds ratio(95% value (N=193) (N=508) CI*) POPq Ba Overall ( 0.01,0.50) Month ( 0.11,0.56) Month ( 0.08,0.60) Month ( 0.02,0.54) Month ( 0.10,0.60) POPq C Overall ( 0.04,0.82) Month (0.02,1.37) Month ( 0.43,0.94) Month ( 0.12,0.93) Month ( 0.51,0.93) POPq Bp Overall ( 0.13,0.22) Month ( 0.24,0.29) Month ( 0.26,0.28) Month ( 0.12,0.30) Month ( 0.24,0.33) Absence of bother some Overall 0.48 (0.24,0.97) bulge: n (%) 2018 American College of Obstetricians and Gynecologists. Page 5 of 9
6 Month 3 91 ( 95) 227 ( 99) 0.17 (0.04,0.78) Month 6 80 ( 93) 229 ( 94) 0.55 (0.20,1.51) Month ( 91) 412 ( 90) 0.81 (0.41,1.59) Month ( 88) 191 ( 87) 0.73 (0.30,1.79) Support above hymen: n (%) Overall 0.71 (0.45,1.12) Month 3 80 ( 87) 198 ( 88) 0.81 (0.36,1.84) Month 6 77 ( 88) 220 ( 92) 0.58 (0.27,1.26) Month ( 80) 367 ( 82) 0.82 (0.49,1.39) Month ( 82) 195 ( 86) 0.65 (0.31,1.35) No report of retreatment: n Month 3 96 (100) 235 (100) Not Est. (%) Month 6 92 (100) 250 ( 99) Not Est. Month (97) 475 ( 98) Not Est. Month ( 97) 241 ( 95) Not Est. Success: n (%) Overall 0.67 (0.43,1.04) Month 3 79 ( 85) 192 ( 88) 0.73 (0.34,1.56) Month 6 69 ( 83) 196 ( 86) 0.59 (0.30,1.15) Month (71) 326 ( 75) 0.71 (0.44,1.14) Month ( 71) 160 ( 74) 0.66 (0.34,1.28) * CI Confidence Interval 2018 American College of Obstetricians and Gynecologists. Page 6 of 9
7 For continuous outcomes, adjusted means and differences are presented based on repeated measure mixed models adjusting for center where possible as well as occurrence of anterior or posterior surgeries, prior POP surgery, age, BMI and POP q stage. For binary outcomes, proportions and adjusted odds ratios of vault vs. uterovaginal prolapse are presented based on subjects with available data at the visit. Raw p values based on analyses with no adjustments. Adjusted p values based on repeated measure mixed models adjusting for center where possible as well as occurrence of anterior or posterior surgeries, prior POP surgery, age, BMI and POP q stage Note that the p values included in this table are considered to be descriptive, not inferential and should be interpreted cautiously given the number of comparisons, as 3 to 4 p values of 0.05 or less would be expected simply by chance American College of Obstetricians and Gynecologists. Page 7 of 9
8 Appendix 3. Adverse Events Vault Prolapse (N=421) Uterovaginal Prolapse (N=601) Raw P value * Adjusted P value Any Serious Adverse Event 86 ( 20) 90 ( 15) (%) Number of Serious 0.2 +/ 0.5 (0, 3) 0.2 +/ 0.5(0, 3) Adverse Events per subject Mean +/ SD (Range) Maximum reported DINDO score, n(%) 1 12 ( 3) 5 ( 1) ( 5) 26 ( 4) 3 51 ( 12) 57 ( 10) 4 3 ( 1) 1 ( 0) *CI Confidence Interval P values based on comparing outcomes between groups while excluding missing outcomes. Adjusted p value controls for center, apical procedure type and occurrence of posterior or anterior procedure. SD Standard Devia on 2018 American College of Obstetricians and Gynecologists. Page 8 of 9
9 Appendix 4. Perioperative Complications Uterovaginal Characteristic Vault Prolapse (N=421) Prolapse (N=599) P value * Ureteral injury during surgery(%) 5 ( 1) 12 ( 2) Blood transfusion during 8 ( 2) 17 ( 3) hospitalization(%) Cystotomy/urethral injury(%) 20 ( 5) 38 ( 6) Bowel injury(%) 1 ( 0) Vascular injury(%) 1 ( 0) Nerve injury(%) 0 2 ( 0) Deep vein thrombosis injury(%) 1 ( 0) 1 ( 0) Pulmonary embolism(%) 1 ( 0) 2 ( 0) Mesh erosion (%) 1 ( 0) 3 ( 1) * P values based on comparing outcomes between groups while excluding missing outcomes. Due to small cell counts, p values are based on unadjusted, Fisher exact tests American College of Obstetricians and Gynecologists. Page 9 of 9
Supplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to
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