A Core Outcome Set for Research Evaluating Interventions to Prevent and/or Treat Delirium in Critically Ill Adults: An International Consensus Study (Del-COrS)

Rose, Louise; Burry, Lisa; Agar, Meera; Campbell, Noll L.; Clarke, Mike; Lee, Jacques; Marshall, John C.; Devlin, John W.; Blackwood, Bronagh; Siddiqi, Najma; Page, Valérie

doi:10.1097/ccm.0000000000005028

Cited by 24 publications

(21 citation statements)

References 45 publications

(57 reference statements)

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“…One way to approach this challenge is by developing a core outcome set (COS) [12][13][14] for all future studies. A COS is a minimum set of outcomes reported that does not preclude investigators from reporting data on additional outcomes.…”

Section: Introductionmentioning

confidence: 99%

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

Byerly

Nahmias

Stein

et al. 2022

Trauma Surg Acute Care Open

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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

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Section: Introductionmentioning

confidence: 99%

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

Byerly

Nahmias

Stein

et al. 2022

Trauma Surg Acute Care Open

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“…The selection of outcomes was informed by the core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium [17,18]. The primary outcome was delirium occurrence; secondary outcomes were numbers of delirium-free and coma-free days, delirium duration, delirium severity, incidence of sub-syndromal delirium, duration of mechanical ventilation, length of stay, mortality, long-term outcomes (cognitive, discharge disposition, health-related quality of life), and adverse events.…”

Section: Discussionmentioning

confidence: 99%

“…While we found no effect of these strategies, similar to another review [9], further investigation is warranted given their common use. Finally, outcomes recently recommended as part of a core set, such delirium severity, time to delirium resolution, health-related quality of life, and emotional distress were generally not reported [18].…”

Section: Strengths and Limitationsmentioning

confidence: 98%

Pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: a systematic review and network meta-analysis

et al. 2021

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Purpose To compare the effects of prevention interventions on delirium occurrence in critically ill adults. Methods MEDLINE, Embase, PsychINFO, CINAHL, Web of Science, Cochrane Library, Prospero, and WHO international clinical trial registry were searched from inception to April 8, 2021. Randomized controlled trials of pharmacological, sedation, non-pharmacological, and multi-component interventions enrolling adult critically ill patients were included. We performed conventional pairwise meta-analyses, NMA within Bayesian random effects modeling, and determined surface under the cumulative ranking curve values and mean rank. Reviewer pairs independently extracted data, assessed bias using Cochrane Risk of Bias tool and evidence certainty with GRADE. The primary outcome was delirium occurrence; secondary outcomes were durations of delirium and mechanical ventilation, length of stay, mortality, and adverse effects. Results Eighty trials met eligibility criteria: 67.5% pharmacological, 31.3% non-pharmacological and 1.2% mixed pharmacological and non-pharmacological interventions. For delirium occurrence, 11 pharmacological interventions (38 trials, N = 11,993) connected to the evidence network. Compared to placebo, only dexmedetomidine (21/22 alpha 2 agonist trials were dexmedetomidine) probably reduces delirium occurrence (odds ratio (OR) 0.43, 95% Credible Interval (CrI) 0.21–0.85; moderate certainty). Compared to benzodiazepines, dexmedetomidine (OR 0.21, 95% CrI 0.08–0.51; low certainty), sedation interruption (OR 0.21, 95% CrI 0.06–0.69; very low certainty), opioid plus benzodiazepine (OR 0.27, 95% CrI 0.10–0.76; very low certainty), and protocolized sedation (OR 0.27, 95% CrI 0.09–0.80; very low certainty) may reduce delirium occurrence but the evidence is very uncertain. Dexmedetomidine probably reduces ICU length of stay compared to placebo (Ratio of Means (RoM) 0.78, CrI 0.64–0.95; moderate certainty) and compared to antipsychotics (RoM 0.76, CrI 0.61–0.98; low certainty). Sedative interruption, protocolized sedation and opioids may reduce hospital length of stay compared to placebo, but the evidence is very uncertain. No intervention influenced mechanical ventilation duration, mortality, or arrhythmia. Single and multi-component non-pharmacological interventions did not connect to any evidence networks to allow for ranking and comparisons as planned; pairwise comparisons did not detect differences compared to standard care. Conclusion Compared to placebo and benzodiazepines, we found dexmedetomidine likely reduced the occurrence of delirium in critically ill adults. Compared to benzodiazepines, sedation-minimization strategies may also reduce delirium occurrence, but the evidence is uncertain. Supplementary Information The online version contains supplementary material available at 10.1007/s00134-021-06490-3.

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“…16,17 Several other protocols of COS have been published that are relevant to adult and paediatric critical care 18,19 including our own protocol for a delirium COS. 20 This COS is now complete and published in Critical Care Medicine. 21 In this special issue of the journal, there are three research studies, one integrative review, and a quality improvement project focused on delirium, emphasizing the importance of this topic among the journal's readership. In reading these papers, and indeed all deliriumrelated studies in the critically ill, we urge readers to pay particular attention to reported outcomes, measures, and the time horizon of each measurement (i.e.…”

Section: Core Outcome Set Development Commences With Determinationmentioning

confidence: 99%

Core outcome sets in intensive care–what are they and why do we need them? An example for delirium

Rose

Burry

Blackwood

et al. 2021

Nursing in Critical Care

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A Core Outcome Set for Research Evaluating Interventions to Prevent and/or Treat Delirium in Critically Ill Adults: An International Consensus Study (Del-COrS)

Cited by 24 publications

References 45 publications

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

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

Pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: a systematic review and network meta-analysis

Core outcome sets in intensive care–what are they and why do we need them? An example for delirium

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