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

Research output: Contribution to journalArticlepeer-review

1 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 languageEnglish
Article numbere000821
JournalTrauma Surgery and Acute Care Open
Volume7
Issue number1
DOIs
StatePublished - Jan 4 2022

Bibliographical note

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.

Keywords

  • abdominal injuries
  • laparotomy
  • patient outcome assessment

ASJC Scopus subject areas

  • Surgery
  • Critical Care and Intensive Care Medicine

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