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

Author:

Byerly SaskyaORCID,Nahmias JeffryORCID,Stein Deborah MORCID,Haut Elliott RORCID,Smith Jason W,Gelbard Rondi,Ziesmann Markus,Boltz Melissa,Zarzaur Ben L,Bala Miklosh,Bernard AndrewORCID,Brakenridge Scott,Brohi Karim,Collier Bryan,Burlew Clay Cothren,Cripps Michael,Crookes Bruce,Diaz Jose J,Duchesne Juan,Harvin John AORCID,Inaba Kenji,Ivatury Rao,Kasten Kevin,Kerby Jeffrey D.ORCID,Lauerman Margaret,Loftus Tyler,Miller Preston R.,Scalea Thomas,Yeh D Dante

Abstract

ObjectivesDamage 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.MethodsA 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.ResultsOf 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.ConclusionsThrough 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.Level of evidenceV, criteria

Publisher

BMJ

Subject

Critical Care and Intensive Care Medicine,Surgery

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