Core outcome set for research in necrotising soft tissue infection patients: an international, multidisciplinary, modified Delphi consensus study

INTRODUCTION: Necrotising soft tissue infections (NSTI) are serious infections associated with considerable morbidity and mortality. Heterogeneity of outcome reporting in the NSTI literature precludes the synthesis of high-quality evidence. There is substantial interest in studying the efficacy of hyperbaric oxygen treatment as an adjunctive treatment in NSTI. The aim of this study was to develop a set of core outcome measures for future trials evaluating interventions for NSTI.

METHODS: A modified Delphi consensus method was used to conduct a three-round survey of a diverse panel of clinicians and researchers with expertise in NSTI, and patients with lived experience of NSTI. Participants rated the preliminary list of outcomes using a 9-point scale from 1 (least important) to 9 (most critical). The a priori definition of consensus required outcomes to be rated critical (score ≥ 7) by ≥ 70% of participants, and not important (score ≤ 3) by ≤ 15% of participants. After meeting consensus, outcomes were removed from subsequent rounds. Outcomes that did not meet consensus were included in subsequent rounds.

RESULTS: Ninety-eight participants from 14 countries registered and 86%, 69% and 57% responded for each round, respectively. Outcome measures quantifying five core areas achieved consensus: Death, surgical procedures of debridements and amputations, functional outcome among survivors, measures of sepsis, including septic shock and organ dysfunction and resource use measured through length of hospital and intensive care unit stay.

CONCLUSIONS: This initial core set of outcome measures will be evaluated and optimised and can harmonise outcome measurements for investigations among patients with NSTI.