A core outcome set for damage control laparotomy via modified Delphi method

Saskya Byerly; Jeffry Nahmias; Deborah M. Stein; Elliott R. Haut; Jason W. Smith; Rondi Gelbard; Markus Ziesmann; Melissa Boltz; Ben L. Zarzaur; Miklosh Bala; Andrew Bernard; Scott Brakenridge; Karim Brohi; Bryan Collier; Clay Cothren Burlew; Michael Cripps; Bruce Crookes; Jose J. DIaz; Juan Duchesne; John A. Harvin; Kenji Inaba; Rao Ivatury; Kevin Kasten; Jeffrey D. Kerby; Margaret Lauerman; Tyler Loftus; Preston R. Miller; Thomas Scalea; D. Dante Yeh

doi:10.1136/tsaco-2021-000821

A core outcome set for damage control laparotomy via modified Delphi method

Saskya Byerly
, Jeffry Nahmias
, Deborah M. Stein
, Elliott R. Haut
, Jason W. Smith
, Rondi Gelbard
, Markus Ziesmann
, Melissa Boltz
, Ben L. Zarzaur
, Miklosh Bala
, Andrew Bernard
, Scott Brakenridge
, Karim Brohi
, Bryan Collier
, Clay Cothren Burlew
, Michael Cripps
, Bruce Crookes
, Jose J. DIaz
, Juan Duchesne
, John A. Harvin

Kenji Inaba, Rao Ivatury, Kevin Kasten, Jeffrey D. Kerby, Margaret Lauerman, Tyler Loftus, Preston R. Miller, Thomas Scalea, D. Dante Yeh

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

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.

Original language	English
Article number	e000821
Journal	Trauma Surgery and Acute Care Open
Volume	7
Issue number	1
DOIs	https://doi.org/10.1136/tsaco-2021-000821
State	Published - Jan 4 2022

Bibliographical note

Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.

Funding

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.

Funders	Funder number
Army
National Institutes of Health (NIH)	K23 GM140268
U.S. Department of Defense
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of General Medical Sciences DP2GM119177 Sophie Dumont National Institute of General Medical Sciences
Agency for Healthcare Research and Quality
Henry M. Jackson Foundation
Patient-Centered Outcomes Research Institute

Keywords

abdominal injuries
laparotomy
patient outcome assessment

ASJC Scopus subject areas

Surgery
Critical Care and Intensive Care Medicine

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10.1136/tsaco-2021-000821

Cite this

Byerly, S., Nahmias, J., Stein, D. M., Haut, E. R., Smith, J. W., Gelbard, R., Ziesmann, M., Boltz, M., Zarzaur, B. L., Bala, M., Bernard, A., Brakenridge, S., Brohi, K., Collier, B., Burlew, C. C., Cripps, M., Crookes, B., DIaz, J. J., Duchesne, J., ... Yeh, D. D. (2022). A core outcome set for damage control laparotomy via modified Delphi method. Trauma Surgery and Acute Care Open, 7(1), Article e000821. https://doi.org/10.1136/tsaco-2021-000821

@article{e2835d5d89284c8098fc91b70342e57d,

title = "A core outcome set for damage control laparotomy via modified Delphi method",

abstract = "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.",

keywords = "abdominal injuries, laparotomy, patient outcome assessment",

author = "Saskya Byerly and Jeffry Nahmias and Stein, \{Deborah M.\} and Haut, \{Elliott R.\} and Smith, \{Jason W.\} and Rondi Gelbard and Markus Ziesmann and Melissa Boltz and Zarzaur, \{Ben L.\} and Miklosh Bala and Andrew Bernard and Scott Brakenridge and Karim Brohi and Bryan Collier and Burlew, \{Clay Cothren\} and Michael Cripps and Bruce Crookes and DIaz, \{Jose J.\} and Juan Duchesne and Harvin, \{John A.\} and Kenji Inaba and Rao Ivatury and Kevin Kasten and Kerby, \{Jeffrey D.\} and Margaret Lauerman and Tyler Loftus and Miller, \{Preston R.\} and Thomas Scalea and Yeh, \{D. Dante\}",

year = "2022",

month = jan,

day = "4",

doi = "10.1136/tsaco-2021-000821",

language = "English",

volume = "7",

number = "1",

}

Byerly, S, Nahmias, J, Stein, DM, Haut, ER, Smith, JW, Gelbard, R, Ziesmann, M, Boltz, M, Zarzaur, BL, Bala, M, Bernard, A, Brakenridge, S, Brohi, K, Collier, B, Burlew, CC, Cripps, M, Crookes, B, DIaz, JJ, Duchesne, J, Harvin, JA, Inaba, K, Ivatury, R, Kasten, K, Kerby, JD, Lauerman, M, Loftus, T, Miller, PR, Scalea, T & Yeh, DD 2022, 'A core outcome set for damage control laparotomy via modified Delphi method', Trauma Surgery and Acute Care Open, vol. 7, no. 1, e000821. https://doi.org/10.1136/tsaco-2021-000821

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

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.

KW - abdominal injuries

KW - laparotomy

KW - patient outcome assessment

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UR - https://www.scopus.com/pages/publications/85122770317#tab=citedBy

U2 - 10.1136/tsaco-2021-000821

DO - 10.1136/tsaco-2021-000821

M3 - Article

AN - SCOPUS:85122770317

VL - 7

JO - Trauma Surgery and Acute Care Open

JF - Trauma Surgery and Acute Care Open

IS - 1

M1 - e000821

ER -

A core outcome set for damage control laparotomy via modified Delphi method

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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