Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications

Official title

Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications- an International Delphi Study

Overview

An international team of experts is working on a project called PrECiSIOn to develop a clear, consistent definition of PPCs. The goals of this study are to: * Define postoperative pulmonary complications in a way that makes sense for patients, families, and healthcare providers. * Rank complications by severity so doctors can focus on the most serious ones first. * Decide how and when to monitor patients after surgery to catch problems early.

Detailed description

Postoperative pulmonary complications (PPCs) are associated with prolonged hospital stays, increased mortality, and significant clinical and economic burdens. Despite their importance, the definition of PPCs varies across studies, leading to inconsistencies in reported incidence rates and research outcomes. Existing definitions, such as the EPCO criteria, have been developed based on expert opinion but lack systematic consensus-building methods.

To address these limitations, the StEP collaboration conducted a systematic review and Delphi process to refine PPC classifications. However, challenges remain, including the lack of universal definitions, hierarchical ranking of complications, and representation from diverse healthcare settings. Composite outcome measures improve statistical power but may obscure differences in severity and clinical significance among PPC subtypes.

The PrECiSIOn Delphi initiative aims to develop an expert consensus on defining PPCs, grading their severity, and determining standardized monitoring methods. The goal is to create a valid, reliable, and universally accepted patient-centered definition of PPCs that enhances comparability across studies and informs clinical decision-making.

Interventions

• Other Delphi study
  This Delphi study involves multiple iterative rounds until a stable consensus or dissensus is reached on all the statements.
• Other Structured Interview
  Structured interviews will be conducted by members of the steering committee and an independent qualitative research expert. A pilot-tested case vignette along with a Likert scale-based questionnaire, will be employed to gather insights regarding the impact and severity of PPCs. The impact of the individual components of PPCs will be evaluated on a 7-point Global Rate of Change (GRC) scale (from "very much worse" to very much better") to calculate the minimal clinical important difference. Patie

Primary outcome measures

• Generate consensus on the postoperative pulmonary complications construct [Time frame: 3-6 months]

Secondary outcome measures (4)

• Generate consensus on the postoperative pulmonary complications definition and components [Time frame: 3-6 months]
• Generate consensus on the on the timeframe of monitoring for postoperative pulmonary complications [Time frame: 3-6 months]
• Generate consensus on the methods of monitoring of postoperative pulmonary complications [Time frame: 3-6 months]
• Generate consensus on weightage grade of individual postoperative pulmonary complications [Time frame: 3-6 months]

Eligibility criteria

Inclusion Criteria: Panellists will be identified based on either of the following criteria

• At least 10 years of clinical experience as a staff member in Anesthesiology, Surgery or Intensive Care Medicine with involvement in care of patients with postoperative complications
• Author of at least three publications (observational studies or randomised controlled trials) using postoperative pulmonary complications as a primary or secondary outcome For patients and public involvement Individuals who have either personally experienced PPCs following surgery within the last 5 years or, primary caregivers of such patients will be recruited as patient care representatives. Proficiency in English is required. To mitigate potential bias, patient care representatives mustn't maintain a professional or advisory relationship with the steering committee or panellists.

Exclusion criteria

\- None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• New Cross Hospital — Wolverhampton

Publications

• Myles PS, Grocott MP, Boney O, Moonesinghe SR; COMPAC-StEP Group. Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth. 2016 May;116(5):586-9. doi: 10.1093/bja/aew066. No abstract available. PMID 27106961
• Gottlieb M, Caretta-Weyer H, Chan TM, Humphrey-Murto S. Educator's blueprint: A primer on consensus methods in medical education research. AEM Educ Train. 2023 Jul 11;7(4):e10891. doi: 10.1002/aet2.10891. eCollection 2023 Aug. PMID 37448627
• Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27. PMID 29661384
• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in p PMID 25058504
• Lusquinhos J, Tavares M, Abelha F. Postoperative Pulmonary Complications and Perioperative Strategies: A Systematic Review. Cureus. 2023 May 9;15(5):e38786. doi: 10.7759/cureus.38786. eCollection 2023 May. PMID 37303413
• Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522. PMID 21572323
• Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223. PMID 26020123
• Piccioni F, Langiano N, Bignami E, Guarnieri M, Proto P, D'Andrea R, Mazzoli CA, Riccardi I, Bacuzzi A, Guzzetti L, Rossi I, Scolletta S, Comi D, Benigni A, Pierconti F, Coccia C, Biscari M, Murzilli A, Umari M, Peratoner C, Serra E, Baldinelli F, Accardo R, Diana F, Fasciolo A, Amodio R, Ball L, Greco M, Pelosi P, Della Rocca G; One-Lung Ventilation Investigators Group (Supplementary Appendix S1) PMID 37730455

Identifiers

NCT: NCT06916598 · PrECiSIOn

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗