TY - JOUR
T1 - A core outcome set for damage control laparotomy via modified Delphi method
AU - Byerly, Saskya
AU - Nahmias, Jeffry
AU - Stein, Deborah M.
AU - Haut, Elliott R.
AU - Smith, Jason W.
AU - Gelbard, Rondi
AU - Ziesmann, Markus
AU - Boltz, Melissa
AU - Zarzaur, Ben L.
AU - Bala, Miklosh
AU - Bernard, Andrew
AU - Brakenridge, Scott
AU - Brohi, Karim
AU - Collier, Bryan
AU - Burlew, Clay Cothren
AU - Cripps, Michael
AU - Crookes, Bruce
AU - DIaz, Jose J.
AU - Duchesne, Juan
AU - Harvin, John A.
AU - Inaba, Kenji
AU - Ivatury, Rao
AU - Kasten, Kevin
AU - Kerby, Jeffrey D.
AU - Lauerman, Margaret
AU - Loftus, Tyler
AU - Miller, Preston R.
AU - Scalea, Thomas
AU - Yeh, D. Dante
N1 - Funding Information:
the study and to acquisition, analysis, and interpretation of the data. She drafted the article and revised it critically for important intellectual content and gave final approval of the version to be published as the guarantor of the article. JN, DMS, ERH, JWS, RG, MZ, MB, BLZ, and DDY made substantial contributions to the conception and design of the study, and to analysis and interpretation of the data. They revised the article critically for important intellectual content and gave final approval of the version to be published. MB, AB, SB, KB, BC, CCB, MC, BC, JJD, JD, JAH, KI, RI, KK, JDK, ML, TL, PM, and TS made substantial contributions to the acquisition and interpretation of the data. They revised the article critically for important intellectual content and gave final approval of the version to be published. Funding EH reports research funding from The Patient-Centered Outcomes Research Institute (PCORI), the Agency for Healthcare Research and Quality (AHRQ), the NIH/NHLBI, the DOD/Army Medical Research Acquisition Activity, and the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). EH receives royalties from Lippincott, Williams, Wilkins for a book—’Avoiding Common ICU Errors’. EH was a paid speaker for the Vizient Hospital Improvement Innovation Network (HIIN) VTE Prevention Acceleration Network. TL was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number K23 GM140268.
Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/1/4
Y1 - 2022/1/4
N2 - Objectives Damage control laparotomy (DCL) remains an important tool in the trauma surgeon's armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias. Methods A modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) 'landmark' DCL papers and EAST ad hoc COS task force consensus. Results Of 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus. Conclusions Through an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes.
AB - Objectives Damage control laparotomy (DCL) remains an important tool in the trauma surgeon's armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias. Methods A modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) 'landmark' DCL papers and EAST ad hoc COS task force consensus. Results Of 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus. Conclusions Through an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes.
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U2 - 10.1136/tsaco-2021-000821
DO - 10.1136/tsaco-2021-000821
M3 - Article
C2 - 35047673
AN - SCOPUS:85122770317
SN - 2397-5776
VL - 7
JO - Trauma Surgery and Acute Care Open
JF - Trauma Surgery and Acute Care Open
IS - 1
M1 - e000821
ER -