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Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication--protocol for an international mixed-method consensus study (PrECiSIOn)

Por: Nasa · P. · Yurttas · T. · Battaglini · D. · Blot · S. · Fernandez-Bustamante · A. · Gama de Abreu · M. · van Meenen · D. M. · Myatra · S. N. · Serpa Neto · A. · Oppong · R. · Paulus · F. · Renukappa · S. · Schultz · M. J. · Slutsky · A. S. · Hemmes · S. N. T. · for the PrECiSIOn-gro
Introduction

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

Methods

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Analysis

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.

Ethics and dissemination

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

Trial registration number

NCT06916598 (clinicaltrials.gov).

International consensus-based core outcome set for airway management clinical trials and observational studies: the Airway Terminology and Outcome Measures (ATOM) protocol

Por: Hansel · J. · Fuchs · A. · Radcliffe · G. · Sotiriou · A. · Rivett · K. · Bohnenblust · V. · Grimes · R. · Fally · M. · Greif · R. · Cook · T. M. · El-Boghdadly · K. · on behalf of the Airway Terminology and Outcome Measures (ATOM) Group · Perin · Brewster · Myatra · Hofmeyr · Li
Introduction

Airway management describes a range of commonly performed procedures undertaken to enable invasive respiratory support for patients. Studies of airway management interventions report heterogeneous outcomes, impeding evidence synthesis and translation of findings into clinical practice. A core outcome set is a consensus-based standardised minimum collection of outcomes to be reported in a given area of healthcare. The Airway Terminology and Outcome Measures project aims to define a core outcome set and select outcome measurement instruments for future airway management research.

Methods and analysis

Following a systematic literature search, we generated a list of candidate outcomes by extracting outcomes and their measurement instruments from a random sample of included studies until saturation was reached and no new outcomes emerged. The search resulted in a long list of 64 outcomes for inclusion in the consensus building stage. Key stakeholders, including patients, clinicians and researchers, will be invited to participate in a multiround modified Delphi process and a panel meeting to finalise the core outcome set and agree to their measurement instruments.

Ethics and dissemination

The study was approved by the Health Research Authority and the London – Fulham Research Ethics Committee (24/LO/0544). All participants will provide informed consent. Study findings will be presented as conference proceedings and published in peer-reviewed medical journals.

Estimated start of this study

20 November 2024

Registration number

COMET 3146

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