Core Outcome Set for patient safety in perioperative care: SAFEST Project

Between 8 to 12% of patients admitted to hospitals in the European Union experience adverse events. Among in-hospital adverse events, surgical-related adverse effects are one of the most common, with several studies showing that most surgical errors occur outside the operating room, before and after surgery. There is a need to standardise a minimum set of outcomes to improve the quality of monitoring and evaluation of patient safety practices in perioperative care, including patient-relevant data.

In the context of SAFEST, we aim to develop a Core Outcome Set (COS) for patient safety in perioperative care, following a multimethod approach based on COS-STAD recommendations: 1) An initial list of outcomes (ILO) will be developed by conducting an umbrella review of outcomes and outcome measurement instruments on patient safety in perioperative care in surgical adult patients, complemented by outcomes identified in a systematic review of Clinical Practice Guidelines and a systematic review of successful interventions directed at reducing adverse events in surgical care; 2) the ILO will be prioritised, by relevant stakeholders, in a two-round eDelphi process, incorporating additional outcomes identified by participants in round one of the eDelphi into round two; 3) a final list of outcomes will be defined in a consensus conference, where the relevant stakeholders, including patients, will be invited to discuss the results from the eDelphi using a modified nominal group technique; 4) the COS for patient safety in perioperative care will be finalised by the researchers and reported according to COS-STAR guidance.

This COS will contribute to improving the monitoring and evaluation of patient safety practices in perioperative care, highlighting the importance of patient safety data in improving the quality of care and healthcare decision-making.

Contributors

Ana Beatriz Nunes, NOVA National School of Public Health, NOVA University Lisbon, Lisbon, Portugal.

Paulo Sousa, NOVA National School of Public Health, Public Health Research Centre, CISP, NOVA University Lisbon, Lisbon, Portugal. NOVA National School of Public Health, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisbon, Portugal.

Andreia Leite, Departamento de Epidemiologia, Instituto Nacional de Saúde Doutor Ricardo Jorge, Lisbon, Portugal. NOVA National School of Public Health, Public Health Research Centre, CISP, NOVA University Lisbon, Lisbon, Portugal. NOVA National School of Public Health, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisbon, Portugal.

José Pedro Teixeira, NOVA National School of Public Health, NOVA University Lisbon, Lisbon, Portugal.

Margarida Paixão, NOVA National School of Public Health, NOVA University Lisbon, Lisbon, Portugal.

Carola Orrego, Avedis Donabedian Research Institute, Barcelona, Spain.

Claudia Valli, Avedis Donabedian Research Institute, Barcelona, Spain.

Willemijn L.A. Schäfer, Netherlands Institute for Health Services Research (Nivel), Utrecht, The Netherlands.

Lilian Huibertina Davida van Tuyl, Netherlands Institute for Health Services Research (Nivel), Utrecht, The Netherlands.

Cordula Wagner, Netherlands Institute for Health Services Research (Nivel), Utrecht, The Netherlands.

Daniel Arnal-Velasco, Anaesthesia and Reanimation Unit, Hospital Universitario Fundacion Alcorcon. Sistema Español de Notificacion en Seguridad en Anestesia y Reanimacion (SENSAR), Spain

Ismael Martinez-Nicolas, Sistema Español de Notificacion en Seguridad en Anestesia y Reanimacion (SENSAR), Spain

Further Study Information

Current Stage: Ongoing
Date: August 2022 - April 2023
Funding source(s): The development of this Core Outcome Set is part of SAFEST (Improving quality and patient SAFEty in surgical care through STandardisation and harmonisation of perioperative care in Europe), a project financed under the European Union’s Horizon Europe Research and Innovation Programme (Grant agreement 101057825).


Health Area

Disease Category: Public health

Disease Name: Perioperative medicine

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Governmental agencies
- Guideline developers
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Private sector representatives
- Service providers
- Service users
- Regulatory agency representatives

Study Type

- COS for practice

Method(s)

- Consensus conference
- Delphi process
- Literature review
- Nominal group technique (NGT)

We aim to develop a Core Outcome Set (COS) for patient safety in perioperative care, following a multimethod approach based on COS-STAD recommendations: 1) An initial list of outcomes (ILO) will be developed by conducting an umbrella review of outcomes and outcome measurement instruments on patient safety in perioperative care in surgical adult patients, complemented by outcomes identified in a systematic review of Clinical Practice Guidelines and a systematic review of successful interventions directed at reducing adverse events in surgical care; 2) the ILO will be prioritised, by relevant stakeholders, in a two-round eDelphi process, incorporating additional outcomes identified by participants in round one of the eDelphi into round two; 3) a final list of outcomes will be defined in a consensus conference, where the relevant stakeholders, including patients, will be invited to discuss the results from the eDelphi using a modified nominal group technique; 4) the COS for patient safety in perioperative care will be finalised by the researchers and reported according to COS-STAR guidance.