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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., Competing Interests: The authors have declared that no competing interests exist., (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.)

Objective: To develop and test the validity and reliability of a tool measuring patient experiences with patient safety in ambulatory care that is suitable for routine use in general practitioner and specialist practices., Design: Instrument development was based on a literature review, a 3-round Delphi survey with a multidisciplinary expert panel and cognitive interviews with patients. The instrument was piloted in 22 practices using a cross-sectional survey. Exploratory (EFA) and confirmatory factor analysis (CFA) were performed to test construct validity. Internal consistency and the ability of the questionnaire to differentiate between selected subgroups and at the level of individual practices was examined., Setting: General practitioner and specialist practices., Participants: Patients aged >18 years seeking care in ambulatory care practices between February and June 2020., Results: The final ASK-ME-questionnaire consisted of 22 items covering 5 theoretical dimensions. A total of 3042 patients (71.1%) completed the questionnaire. Median item non-response rate was 4.2% (IQR 3.4%-4.7%). EFA yielded 3 factors comprising 14 items explaining 64.8% of the variance representing contributing factors to patient safety incidents. CFA confirmed the factorial structure suggested by EFA. The model fit the data satisfactorily (comparative fit index=0.92, root mean square error of approximation=0.08, standardised root mean square residual=0.08). Internal consistency values ranged from 0.7 to 0.9. Discriminant validity was supported by significant differences between patients of different age and differences in self-reported health status. The factors distinguished well between practices., Conclusion: The ASK-ME-questionnaire showed good psychometric properties. It is suitable for routine use in patient safety measurement and improvement systems in ambulatory care. Further research is required to adequately assess number and type of experienced events in routine measurements., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Routine measurement of patient safety from the patients' perspective receives increasing attention as an important component of safety measurement systems. The aim of this study was to examine patients' experience with patient safety in ambulatory care and the results' implications for routine patient safety measurement in ambulatory care., Design: Cross-sectional mixed-mode survey., Setting: General practitioner and specialist practices., Participants: Patients aged >18 years seeking care in ambulatory care practices between February and June 2020., Methods: A 22-item-questionnaire was completed in the practice or at home either on paper or online. Multivariate logistic regression was used to analyse the influence of survey mode and patient characteristics on patient experience with patient safety., Results: The overall response rate was 71.1%. Most patients completed the questionnaire on site (76.6%) and on paper (96.1%). Between 30.1% to 68.5% of the respondents report the most positive option for patient experience with the main domains of patient safety. A total of 2.9% of patients reported having experienced a patient-safety event (PSE) during the last 12 months. Patients who filled in the questionnaire off site were more likely to report negative experiences for the scales communication & information (OR 1.2, 95% CI 1.0-1.5), rapport & participation (OR 1.4, 95% CI 1.1-1.7) and access (OR 1.3, 95% CI 0.9-1.4) than those who completed it on site. Those who chose a paper questionnaire were more likely to report negative experiences for all five scales compared to web responders., Conclusion: Routine measurement of patient experience with factors contributing to the occurrence of PSEs can achieve high response rates by offering flexible participation options. Results gained from mixed-mode surveys need to take mode-effects into account when interpreting and using the results. Further research is needed in how to adequately assess number and type of experienced events in routine measurements., Competing Interests: KS is employed as Manager Research & Innovation at OptiMedis AG. OG is Vice-Chairman of OptiMedis AG. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objective: To define a checklist that can be used to assess the performance of a department and evaluate the implementation of quality management (QM) activities across departments or pathways in acute care hospitals., Design: We developed and tested a checklist for the assessment of QM activities at department level in a cross-sectional study using on-site visits by trained external auditors., Setting and Participants: A sample of 292 hospital departments of 74 acute care hospitals across seven European countries. In every hospital, four departments for the conditions: acute myocardial infarction (AMI), stroke, hip fracture and deliveries participated., Main Outcome Measures: Four measures of QM activities were evaluated at care pathway level focusing on specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies and clinical review (CR)., Results: Participating departments attained mean values on the various scales between 1.2 and 3.7. The theoretical range was 0-4. Three of the four QM measures are identical for the four conditions, whereas one scale (EBOP) has condition-specific items. Correlations showed that every factor was related, but also distinct, and added to the overall picture of QM at pathway level., Conclusion: The newly developed checklist can be used across various types of departments and pathways in acute care hospitals like AMI, deliveries, stroke and hip fracture. The anticipated users of the checklist are internal (e.g. peers within the hospital and hospital executive board) and external auditors (e.g. healthcare inspectorate, professional or patient organizations).

Objective: To explore how European hospitals have implemented patient safety strategies (PSS) and evidence-based organization of care pathway (EBOP) recommendations and examine the extent to which implementation varies between countries and hospitals., Design: Mixed-method multilevel cross-sectional design in seven countries as part of the European Union-funded project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE)., Setting and Participants: Seventy-four acute care hospitals with 292 departments managing acute myocardial infarction (AMI), hip fracture, stroke, and obstetric deliveries. Main outcome measure Five multi-item composite measures-one generic measure for PSS and four pathway-specific measures for EBOP., Results: Potassium chloride had only been removed from general medication stocks in 9.4-30.5% of different pathways wards and patients were adequately identified with wristband in 43.0-59.7%. Although 86.3% of areas treating AMI patients had immediate access to a specialist physician, only 56.0% had arrangements for patients to receive thrombolysis within 30 min of arrival at the hospital. A substantial amount of the total variance observed was due to between-hospital differences in the same country for PSS (65.9%). In EBOP, between-country differences play also an important role (10.1% in AMI to 57.1% in hip fracture)., Conclusions: There were substantial gaps between evidence and practice of PSS and EBOP in a sample of European hospitals and variations due to country differences are more important in EBOP than in PSS, but less important than within-country variations. Agencies supporting the implementation of PSS and EBOP should closely re-examine the effectiveness of their current strategies.

ObjectiveThis study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians.MethodWe used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods.Setting and participantsData on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians.Main outcome measuresPerceived teamwork and safety climate.ResultsTeamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate.ConclusionsOur findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate.

BackgroundGiven the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness.ObjectiveTo assess variations in clinical practice and explore associations with hospital- and department-level quality management systems.DesignMulticenter, multilevel cross-sectional study.Setting and participantsSeventy-three acute care hospitals with 276 departments managing acute myocardial infarction, deliveries, hip fracture, and stroke in seven countries.InterventionNone.MeasuresPredictor variables included 3 hospital- and 4 department-level quality measures. Six measures were collected through direct observation by an external surveyor and one was assessed through a questionnaire completed by hospital quality managers. Dependent variables included 24 clinical practice indicators based on case note reviews covering the 4 conditions (acute myocardial infarction, deliveries, hip fracture and stroke). A directed acyclic graph was used to encode relationships between predictors, outcomes, and covariates and to guide the choice of covariates to control for confounding.Results and limitationsData were provided on 9021 clinical records by 276 departments in 73 hospitals. There were substantial variations in compliance with the 24 clinical practice indicators. Weak associations were observed between hospital quality systems and 4 of the 24 indicators, but on analyzing department-level quality systems, strong associations were observed for 8 of the 11 indicators for acute myocardial infarction and stroke. Clinical indicators supported by higher levels of evidence were more frequently associated with quality systems and activities.ConclusionsThere are significant gaps between recommended standards of care and clinical practice in a large sample of hospitals. Implementation of department-level quality strategies was significantly associated with good clinical practice. Further research should aim to develop clinically relevant quality standards for hospital departments, which appear to be more effective than generic hospital-wide quality systems.

ObjectiveTo investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals.DesignA mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways.Setting and participantsSeventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.Main outcome measureFour composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways.ResultsAccreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke).ConclusionsAccreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

ObjectiveThe assessment of integral quality management (QM) in a hospital requires measurement and monitoring from different perspectives and at various levels of care delivery. Within the DUQuE project (Deepening our Understanding of Quality improvement in Europe), seven measures for QM were developed. This study investigates the relationships between the various quality measures.DesignIt is a multi-level, cross-sectional, mixed-method study.Setting and participantsAs part of the DUQuE project, we invited a random sample of 74 hospitals in 7 countries. The quality managers of these hospitals were the main respondents. Furthermore, data of site visits of external surveyors assessing the participating hospitals were used.Main outcome measuresThree measures of QM at hospitals level focusing on integral systems (QMSI), compliance with the Plan-Do-Study-Act quality improvement cycle (QMCI) and implementation of clinical quality (CQII). Four measures of QM activities at care pathway level focusing on Specialized expertise and responsibility (SER), Evidence-based organization of pathways (EBOP), Patient safety strategies (PSS) and Clinical review (CR).ResultsPositive significant associations were found between the three hospitals level QM measures. Results of the relationships between levels were mixed and showed most associations between QMCI and department-level QM measures for all four types of departments. QMSI was associated with PSS in all types of departments.ConclusionBy using the seven measures of QM, it is possible to get a more comprehensive picture of the maturity of QM in hospitals, with regard to the different levels and across various types of hospital departments.

ObjectiveTo define a checklist that can be used to assess the performance of a department and evaluate the implementation of quality management (QM) activities across departments or pathways in acute care hospitals.DesignWe developed and tested a checklist for the assessment of QM activities at department level in a cross-sectional study using on-site visits by trained external auditors.Setting and participantsA sample of 292 hospital departments of 74 acute care hospitals across seven European countries. In every hospital, four departments for the conditions: acute myocardial infarction (AMI), stroke, hip fracture and deliveries participated.Main outcome measuresFour measures of QM activities were evaluated at care pathway level focusing on specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies and clinical review (CR).ResultsParticipating departments attained mean values on the various scales between 1.2 and 3.7. The theoretical range was 0-4. Three of the four QM measures are identical for the four conditions, whereas one scale (EBOP) has condition-specific items. Correlations showed that every factor was related, but also distinct, and added to the overall picture of QM at pathway level.ConclusionThe newly developed checklist can be used across various types of departments and pathways in acute care hospitals like AMI, deliveries, stroke and hip fracture. The anticipated users of the checklist are internal (e.g. peers within the hospital and hospital executive board) and external auditors (e.g. healthcare inspectorate, professional or patient organizations).

ObjectiveTo explore how European hospitals have implemented patient safety strategies (PSS) and evidence-based organization of care pathway (EBOP) recommendations and examine the extent to which implementation varies between countries and hospitals.DesignMixed-method multilevel cross-sectional design in seven countries as part of the European Union-funded project 'Deepening our Understanding of Quality improvement in Europe' (DUQuE).Setting and participantsSeventy-four acute care hospitals with 292 departments managing acute myocardial infarction (AMI), hip fracture, stroke, and obstetric deliveries. Main outcome measure Five multi-item composite measures-one generic measure for PSS and four pathway-specific measures for EBOP.ResultsPotassium chloride had only been removed from general medication stocks in 9.4-30.5% of different pathways wards and patients were adequately identified with wristband in 43.0-59.7%. Although 86.3% of areas treating AMI patients had immediate access to a specialist physician, only 56.0% had arrangements for patients to receive thrombolysis within 30 min of arrival at the hospital. A substantial amount of the total variance observed was due to between-hospital differences in the same country for PSS (65.9%). In EBOP, between-country differences play also an important role (10.1% in AMI to 57.1% in hip fracture).ConclusionsThere were substantial gaps between evidence and practice of PSS and EBOP in a sample of European hospitals and variations due to country differences are more important in EBOP than in PSS, but less important than within-country variations. Agencies supporting the implementation of PSS and EBOP should closely re-examine the effectiveness of their current strategies.