a research protocol for a mixed methods study

Funding Information: This work was supported by the European Union under the Horizon Europe Research and Innovation Programme under the grant agreement no 101057825. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2024 Valli et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Introduction Adverse events in health care affect 8% to 12% of patients admitted to hospitals in the European Union (EU), with surgical adverse events being the most common types reported. Aim SAFEST project aims to enhance perioperative care quality and patient safety by establishing and implementing widely supported evidence-based perioperative patient safety practices to reduce surgical adverse events. Methods We will conduct a mixed-methods hybrid type III implementation study supporting the development and adoption of evidence-based practices through a Quality Improvement Learning Collaborative (QILC) in co-creation with stakeholders. The project will be conducted in 10 hospitals and related healthcare facilities of 5 European countries. We will assess the level of adherence to the standardised practices, as well as surgical complications incidence, patient-reported outcomes, contextual factors influencing the implementation of the patient safety practices, and sustainability. The project will consist of six components: 1) Development of patient safety standardised practices in perioperative care; 2) Guided self-evaluation of the standardised practices; 3) Identification of priorities and actions plans; 4) Implementation of a QILC strategy; 5) Evaluation of the strategy effectiveness; 6) Patient empowerment for patient safety. Sustainability of the project will be ensured by systematic assessment of sustainability factors and business plans. Towards the end of the project, a call for participation will be launched to allow other hospitals to conduct the self-evaluation of the standardized practices. Discussion The SAFEST project will promote patient safety standardized practices in the continuum of care for adult patients undergoing surgery. This project will result in a broad implementation of evidence-based practices for perioperative care, spanning from the care provided before hospital admission to post-operative recovery at home or outpatient facilities. Different implementation challenges will be faced in the application of the evidence-based practices, which will be mitigated by developing context-specific implementation strategies. Results will be disseminated in peer-reviewed publications and will be available in an online platform.publishersversionpublishe

Prospective methods for identifying perioperative risk-assessment methods for patient safety over 20 years: a systematic review

Contains fulltext : 218905.pdf (publisher's version ) (Open Access)BACKGROUND: Serious preventable surgical events still occur despite considerable efforts to improve patient safety. In addition to learning from retrospective analyses, prospective risk-assessment methods may help to decrease preventable events further by targeting perioperative hazards. The aim of this systematic review was to assess the methods used to identify perioperative patient safety risks prospectively, and to describe the risk areas targeted, the quality characteristics and feasibility of methods. METHODS: MEDLINE, Embase, CINAHL and Cochrane databases were searched, adhering to PRISMA guidelines. All studies describing the development and results of prospective methods to identify perioperative patient safety risks were included and assessed on methodological quality. Exclusion criteria were interventional studies, studies targeting one specific issue, studies reporting on structural factors relating to fundamental hospital items, and non-original or case studies. RESULTS: The electronic search resulted in 16 708 publications, but only 20 were included for final analysis, describing five prospective risk-assessment methods. Direct observation was used in most studies, often in combination. Direct (16 studies) and indirect (4 studies) observations identified (potential) adverse events (P)AEs, process flow disruptions, poor protocol compliance and poor practice performance. (Modified) Healthcare Failure Mode and Effect Analysis (HFMEA) (5 studies) targeted potential process flow disruption failures, and direct (P)AE surveillance (3 studies) identified (P)AEs prospectively. Questionnaires (3 studies) identified poor protocol compliance, surgical flow disturbances and patients' willingness to ask questions about their care. Overall, quality characteristics and feasibility of the methods were poorly reported. CONCLUSION: The direct (in-person) observation appears to be the primary prospective risk-assessment method that currently may best help to target perioperative hazards. This is a reliable method and covers a broad spectrum of perioperative risk areas