Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

Abstract

Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n¼19), 71% (n¼55), and 89% (n¼17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined.

Days alive and at home after hip fracture: a cross-sectional validation of a patient-centred outcome measure using routinely collected data

“…These were selected as each is validly captured in administrative data 32 34 49 and each represents a meaningful departure from an uneventful clinical course. [50][51][52] As MIDs could differ between relevant subgroups, we also estimated MIDs within prespecified groups (male vs female, frailty vs none (≤0.21 vs >0.21), long-term care prefracture versus home, and surgical versus non-surgical patients).…”

Dose–response effect of postprocedural elevated cardiac troponin level on adverse clinical outcomes following adult noncardiac surgery: a systematic review protocol of prospective studies

“…The following three types of cut-off value will exist: (1) detection limit below the URL, (2) detection at the URL and (3) detection above the URL. This definition based only on biomarkers of myocardial injury is not based on the UDMI 6 or Standardised Endpoints in Perioperative Medicine initiative 19 due to the lack of availability of additional information such as ECG, echocardiography, coronary CT or angiography data.…”

“…The definition of MINS with a precise cut-off value in each study will be accepted. The following three types of cut-off value will exist: (1) detection limit below the URL, (2) detection at the URL and (3) detection above 19 due to the lack of availability of additional information such as ECG, echocardiography, coronary CT or angiography data.…”

The emergence of a postoperative myocardial injury epidemic: true or false?

“…Instead, StEP endorsed the approach to postoperative myocardial injury outlined in the UDMI. 44 The StEP initiative collaborated with global trialists to provide expert, consensus-based guidelines and to standardize clinical outcomes used in perioperative medicine. The StEP methodology comprised a systematic review of the current (last 15 years) cardiovascular literature to seek all endpoints in current use, and then conducted three rounds of blinded modified DELPHI consensus-seeking to endorse cardiovascular outcomes.…”

“…Plutôt, elle a endossé l'approche des lésions myocardiques postopératoires telle que décrite dans la Définition universelle de l'infarctus du myocarde. 44 L'initiative StEP a collaboré avec des auteurs d'études à l'échelle mondiale afin de proposer des lignes directrices expertes et consensuelles et de standardiser les résultats cliniques utilisés en médecine périopératoire. La méthodologie StEP comprenait une revue systématique de la littérature cardiovasculaire actuelle (des 15 dernières années) afin de rechercher tous les critères d'évaluation actuellement utilisés, puis a mené trois séries d'analyses de Delphi modifiées en aveugle pour trouver consensus afin d'approuver les critères d'évaluation cardiovasculaires.…”