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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-08

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pulmonary Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Delphi Panellists

An international panel of 35-40 panellists from Anesthesiology, Surgery or Intensive Care Medicine and including patient representatives, will be invited to this Delphi study. A concerted effort will be made to include panellists from low- and middle-income countries and both sexes.

Delphi study

Intervention Type OTHER

This Delphi study involves multiple iterative rounds until a stable consensus or dissensus is reached on all the statements.

Patient 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.

Structured Interview

Intervention Type OTHER

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. Patient care representatives will be engaged in anonymous voting on the questionnaire. PPCs' rankings and key themes synthesised from the interviews will be shared with the panel in the second Delphi round, facilitating the integration of patient perspectives into the consensus process.

Interventions

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Delphi study

This Delphi study involves multiple iterative rounds until a stable consensus or dissensus is reached on all the statements.

Intervention Type 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. Patient care representatives will be engaged in anonymous voting on the questionnaire. PPCs' rankings and key themes synthesised from the interviews will be shared with the panel in the second Delphi round, facilitating the integration of patient perspectives into the consensus process.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.