Objective To evaluate and synthesise the factors determining patient safety culture in hospitals.
Methods The scoping review protocol was based on the criteria of the Joanna Briggs Institute. Eligibility criteria were as follows: (1) empirical study published in a peer-reviewed journal; (2) used methods or tools to assess, study or measure safety culture or climate; (3) data collected in the hospital setting and (4) studies published in English. Relevant literature was located using PubMed, CINAHL, Web of Science and PsycINFO databases. Quantitative and qualitative analyses were performed using RStudio and the R interface for multidimensional analysis of texts and questionnaires (IRaMuTeQ).
Results A total of 248 primary studies were included. The most used instruments for assessing safety culture were the Hospital Survey on Patient Safety Culture (n=104) and the Safety Attitudes Questionnaire (n=63). The Maslach Burnout Inventory (n=13) and Culture Assessment Scales based on patient perception (n=9) were used in association with cultural instruments. Sixty-six articles were included in the qualitative analysis. In word cloud and similarity analyses, the words ‘communication’ and ‘leadership’ were most prominent. Regarding the descending hierarchical classification analysis, the content was categorised into two main classes, one of which was subdivided into five subclasses: class 1a: job satisfaction and leadership (15.56%), class 1b: error response (22.22%), class 1c: psychological and empowerment nurses (20.00%), class 1d: trust culture (22.22%) and class 2: innovation worker (20.00%).
Conclusion The instruments presented elements that remained indispensable for assessing the safety culture, such as leadership commitment, open communication and learning from mistakes. There was also a tendency for research to assess patient and family engagement, psychological safety, nurses’ engagement in decision-making and innovation.
- Patient safety
- Safety culture
- Organizational Culture
Data availability statement
Data are available on reasonable request.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
The evaluation of safety culture through questionnaires is an important practice in assessing the quality of care provided to patients; however, the literature has shown that these instruments do not broadly consider the construct of patient safety culture. Thus, this review was developed to identify the most evaluated constructs.
WHAT THIS STUDY ADDS
The concepts identified in the assessment of safety culture can be divided into organisational, professional, and patient and family participation. However, these three dimensions were not identified by using the same instrument. Thus, this research can serve for the development and refinement of safety culture instruments addressing constructs aligned to research in the areas and principles outlined in the WHO’s Global Plan of Action for Patient Safety 2021–2030.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Leaders, organisations and health professionals about the importance of patient and family participation in patient safety.
Rethink the most widely used instruments for the assessment of safety culture.
Consider the inclusion of constructs related to professionals and the inclusion of the patient and family in the instruments of evaluation of culture.
Foster the inclusion of the patient and family in their own safety.
Encourage quantitative and qualitative analyses in the literature.
The Global Plan of Action for Patient Safety 2021–2030 (GPAPS), published by the WHO, alerts managers, professionals and patients to the importance of health institutions to strengthen policies and strategies based on science and patient experience, with the objective of eliminating risks and preventable harm to patients and health professionals.1
In this document, GPAPS describes seven principles for guiding the development and implementation of the actions proposed in the global action plan. One of these principles is the recommendation of managers to assess patient safety culture. According to the document, a strong safety culture is not only essential to reduce harm to the patient but is also crucial for providing a safe work environment for health professionals.1
Additional studies have found benefits of a positive safety culture in health institutions. The relevance of a positive culture can be observed in the quality of care provided to the patient, reduction in the number of adverse events, length of hospital stay and mortality, in addition to improving the satisfaction and reduction of stress among professionals.2 3
In the literature, the terms ‘safety culture’ and ‘safety climate’ are used synonymously, although they differ from a conceptual and methodological standpoint. The safety climate is conceptualised as the ‘measurable part’ of culture, the most superficial and visible, based on the attitudes and perceptions of individuals.4 In this study, the term ‘patient safety culture’ is the product of values, attitudes, perceptions, competencies and behavioural patterns of groups and individuals that determine commitment, style and proficiency in managing patient safety in health services,5 as it aligns with the perspective of organisational culture theory and is the most used term in the health context.
Before implementing any action that promotes a safety culture in an institution, it must first be evaluated and understood. Each institution is encouraged to find the best way to assess its safety culture, considering its vision, mission and objectives. However, measuring the safety culture in health institutions using scales is an important tool for assessing the quality of care provided to patients and can be performed before and after the implementation of interventions, such as staff training and activities that can minimise the stress of professionals.
To obtain reliable patient safety culture results through questionnaires, researchers must be sure of the validity and reliability of the instruments used in their application. In recent decades, several instruments have been developed to assess patient safety culture. There are those that are exclusive for application in hospital institutions, others in out-of-hospital environments and instruments that can be used in any context. In the study, 139 publications were identified using 12 different questionnaires as measurement instruments. The most used were the Hospital Survey on Patient Safety Culture (HSOPSC), Safety Attitudes Questionnaire (SAQ), Patient Safety Culture in Healthcare Organisations Survey and the Modified Stanford Patient Safety Culture Survey Instrument. It should be noted, however, that among these, there was a predominance of the use of the HSOPSC and SAQ to measure patient safety culture.6
The instruments available for this assessment often do not broadly include the construct of culture of patient safety, although some elements remain indispensable, such as leadership commitment, transparency, open and respectful communication, learning from mistakes and best practices, and a careful balance between a policy of non-blaming and accountability.7
The gap with these systematic reviews is the limited number of articles that discuss the determinants of safety culture in hospital institutions. Classic studies such as those by Zohar,8 Guldenmund9 and Cooper,10 which carried out revisions to the definition of safety culture, cannot keep up with progress and current needs.
There are reviews based on instruments for safety culture evaluation.11 12 In view of the evolution of the global movement for patient safety recently published by the WHO in the GPAPS 2021–2030, there is a need for reassessment of the factors that can determine the patient safety culture in healthcare institutions. Based on this need to identify scientifically proven concepts that determine the safety culture, this scoping review was developed.
A preliminary review was performed in March 2022 in PROSPERO, MEDLINE, the Cochrane Database of Systematic Reviews and Joanna Briggs Institute (JBI) Evidence Synthesis. Fifty-nine systematic reviews were identified in PROSPERO and 12 in JBI Evidence Synthesis, all referring to safety culture interventions. No reviews on factors constituting the safety culture were identified. The objective of this scoping review was to evaluate and synthesise the factors determining patient safety culture in hospitals.
This scoping review was conducted based on the criteria outlined by the JBI Scoping Review Methodology Group and is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.13 14 Scoping reviews aim to identify and map the breadth of evidence available on a particular topic, often irrespective of source, whereas systematic reviews aim to answer a specific research question by identifying, appraising and synthesising primary studies using a rigorous methodology. They clarify key concepts in the literature and identify key characteristics related to a concept, including those related to methodological research.15 The review protocol was registered on Open Science Framework (OSF) (doi: 10.17605/OSF.IO/VTB84). OSF is an open source, free software project that facilitates open collaboration in scientific research.16
The search question was developed using the JBI PCC (Population, Concept and Context) framework. We did not consider a specific population. The concept was the safety culture/safety climate, and the context was the hospital setting. Our scoping review question was: What are the factors determining the culture/patient safety climate in hospitals?
We searched for empirical studies published in peer-reviewed journals that reported on methods or tools used to assess, study or measure safety culture or climate, where data were collected for the hospital setting, and the papers were published in the English language. Articles on cross-cultural adaptation, those that evaluated constructs other than safety climate or culture, and those that did not clarify the assessment method were excluded.
The review followed the three steps recommended by JBI. The first step was a search of the PubMed and CINAHL databases. In this initial search, an analysis was performed of the text words contained in the titles and abstracts of the retrieved articles and the index terms used to describe the articles. The second step was conducted using controlled vocabulary and keywords from four databases: PubMed, CINAHL, Web of Science and PsycINFO. The search strategies for the PubMed, CINAHL, Web of Science and PsycINFO databases are presented in online supplemental appendix A. In the third step, the reference lists of identified reports and articles were searched for additional sources. No additional references were included in this study.
Screening and data abstraction
The titles and abstracts were imported into the Rayyan QCRI online systematic review management programme17 and duplicates were removed. Rayyan is a free, online application developed by QCRI to assist researchers with systematic review methodology and meta-analysis projects.18
The eligibility of the articles was determined based on the inclusion and exclusion criteria described above. Titles and abstracts were independently screened for relevance by two reviewers (REFLdC, IA, NO, LS, APA and JG). All studies that met the inclusion criteria were considered. No instrument was used to assess the quality of the studies. Disagreements between the reviewers were resolved at a consensus meeting.
Full texts were evaluated for inclusion by two independent reviewers (REFLdC, IA, NO and LS), and disagreements were resolved by reaching consensus. Data from the primary studies included in the review were extracted by one reviewer (REFLdC, IA, NO and LS) using an abstraction tool developed by the study team. The following data were collected: authors, title, study design, year of publication, country of study, instrument(s) used to assess the culture/safety climate and safety culture domains evaluated.
A data analysis was performed to assess the constructs that were most frequently mentioned in safety culture assessments (online supplemental appendix B).
The data were organised by frequency and analysed using RStudio Software. R is a free programming language that offers various packages related to data quality assessment for observational health studies.19 The analysis of the domains identified in the surveys was performed using the R interface for multidimensional analysis of texts and questionnaires (IRaMuTeQ) V.0.7 alpha 2.20 This software can be a useful tool for processing data from qualitative health research.21
Initially, in the analysis of the constructs, a figure used as a basis on graph theory (similitude analysis) and a word cloud were formed, through which it is possible to identify the textual occurrences between the words, helping to identify the structure of the content of a textual corpus. Three textual analyses were performed: (1) similitude analysis, which makes it possible to identify the occurrences between the words and its result indicates the connection between the words; (2) word cloud, in order to group the words and organise them graphically according to their relevance, the largest being those with the highest frequency, considering words with a frequency equal to or greater than 10 and (3) descending hierarchical classification to develop a dendrogram showing the classes that emerged, and the higher the χ², the more the word is associated with the class, and words with a frequency equal to or greater than the value of the word were not included.
The qualitative synthesis of the study results was presented in tabular form describing factors identified through this review related to safety culture and climate, based on the identified culture and domain assessment instruments.
At the end of the search for the primary studies, 1864 records were identified in the selected databases (figure 1). After eliminating duplicates (n=446), 1418 references remained (online supplemental appendix C).
The titles and abstracts of these publications were read, and 605 studies were selected for full-text review. Of these, 357 were excluded because they did not meet the eligibility criteria, and the sample comprised 248 primary studies (figure 1) (online supplemental appendix D).
In the 248 primary studies included in the review, it was found that research about the culture of safety was conducted on all continents and in 64 different countries, with the USA leading the evaluations (n=78), followed by Brazil (n=22), Saudi Arabia (n=12), China (n=11) and Taiwan (n=10). Regarding the year of publication of the articles, we found that there was a record of studies published between 1997 and 2022.
The most instruments for assessing safety culture were the HSOPSC (n=104), SAQ (n=63), Safety Climate Survey and Safety Organising Scale (n=8) in their original versions, which evaluate the entire health institution, and the versions adapted to the operating room, outpatient clinic and intensive care unit. The most used instruments in association with culture assessment scales were the Maslach Burnout Inventory/Bargen Burnout Indicator22 23 (n=13) and Culture Assessment Scales based on patient perception (n=9).24 25
Regarding the study type, most studies evaluated safety culture using a cross-sectional design (n=233; 94%), nine used intervention studies and five used cohort studies. There were also eight mixed-methods studies and four qualitative studies that used interview techniques, open-ended questions, focus groups and brainstorming to assess safety culture.
The number of domains evaluated by the instruments varied from 5 to 12, and the number of items ranged from 9 to 46.
An additional 18 safety culture assessment tools have been developed since 2008. These instruments address factors that influence safety culture aimed at workers, organisations, patients and families. Domains such as teamwork, communication and management support continue to be important factors for assessing safety culture; however, there is a trend of instruments aimed at assessing patient and family engagement, psychological safety of the health team and engagement of nurses in decision-making. Table 1 lists the surveys as well as the respective domains, number of items and levels of application of the instrument.
For the analysis of the constructs, cultural assessment surveys were conducted using only the most frequently mentioned instruments described in online supplemental table 1. Of the 248 articles, 66 included in their texts the assessment of safety culture based on other constructs, in addition to the domains of the most cited instruments.
A similarity analysis (figure 2A) was conducted and it was observed that there are two prominent words, ‘communication’ and ‘leadership,’ with which all other words are connected, and it should be noted that the words ‘satisfaction,’ ‘engagement,’ ‘nurse,’ ‘psychological,’ ‘stress’ and ‘autonomy’ are connected to the word ‘leadership’. The word ‘communication’ connects ‘teamwork,’ ‘empowerment,’ ‘learn’ and ‘management,’ ‘feedback,’ ‘punitive’ and ‘trust’.
The word cloud allowed confirmation of the most frequently cited words: ‘communication’ (f=23), ‘leadership’ (f=24), ‘nurse’ (f=19), ‘management’ (f=16), ‘teamwork’ (f=13) and ‘job satisfaction’ (f=12). It should be noted that the words ‘learn’ (f=8), ‘report’ (f=9), ‘empowerment’ (f=6) and ‘conflict’ (f=6) appeared with little expressiveness; however, there was an increase in the number of studies that associated safety culture with these constructs (figure 2B).
Descending hierarchical classification
The general corpus consisted of 66 texts separated by 67 text segments (TS), using 45 text segments (67.16%). There were 1159 occurrences, 430 distinct words and 261 words with a single occurrence. The analysed content was categorised into two main classes, one of which was subdivided into four classes. Class 1a: job satisfaction and leadership (15.56%), class 1b: error response (22.22%), class 1c: psychological and empowerment nurses (20.00%), class 1d: trust culture (22.22%) and class 2: innovation worker (20.00%) (figure 3).
Class 1a: Job satisfaction and leadership comprised 15.56% (f=9 TS) of the total corpus analysed. Consisting of words and radicals in the interval between χ²=3.41 (communication) and χ²=22.5 (satisfaction). This class also includes words such as ‘leadership’ (χ²=10.23), ‘quality’ (χ²=8.46) and ‘engagement’ (χ²=6.39). Class 1b: Error response comprised 22.22% (f=10 TS) of the total corpus analysed and included words and radicals in the interval between χ²=3.09 (learn) and χ²=34.17 (error). This class is also composed of words such as ‘response’ (χ²=19.69); ‘punitive’ (χ²=15.37); ‘feedback’ (χ²=14.96), ‘communication’ (χ²=13.39) and ‘openness’ (χ²=10.86), ‘teamwork’ (χ²=5.85). Class 1c: Psychological and empowerment nurses and physician comprised 20.00% (f=9 TS) of the total corpus analysed and consisted of words and radicals in the interval between χ²=2.47 (conflict) and χ²=17.56 (psychological). This class was composed of words such as ‘empowerment’ (χ²=12.66); ‘nurse’ (χ²=9.42); ‘physician’ (χ²=9.42), ‘support’ (χ²=4.75) and ‘interpersonal’ (χ²=4.37). Class 1d: Trust culture comprises 22.22% (f=10 TS) of the total corpus analysed and included words and radicals in the interval χ²=5.85 (report) and χ²=15.37 (trust). In addition to these two words, this class is composed of the word ‘culture’ (χ²=7.95). Class 2: Innovation worker comprises 20.00% (f=9 TS) of the total corpus analysed and consisted of words and radicals in the interval between χ²=17.56 (4 words) and χ²=22.50 (innovation). This class was composed of words such as ‘worker’ (χ²=17.56), ‘equipment’ (χ²=17.56), ‘availability’ (χ²=17.56) and ‘control’ (χ²=17.56).
Based on the results of this review, we constructed a summary of the domains that make up safety culture, based on the factors related to organisations in general, health professionals, and patient and family participation (table 1).
We investigated, evaluated and synthesised the safety culture factors addressed in assessment instruments in the literature. We found an increasing number of articles published starting in 1999 were observed, a year that was considered a milestone for patient safety due to the To Err and Human report by the American Institute of Medicine.26 This report, in addition to drawing attention to the number of errors that occurred due to avoidable events, showed the multicausality of these events, presenting the environmental and individual factors that could be involved in the error. Several studies began to appear to assess the organisational and individual factors that could lead to such events.
Since March 1999, it has been observed that the USA remains at the forefront of research on the development and evaluation of the culture of safety (n=129). However, many other countries have reported and published results on the assessment of the safety culture of their institutions, including Brazil,27–29 Saudi Arabia,30–32 China33–35 and Taiwan.36 37 Although the assessment of the culture of a particular location, region or country is an area of interest to local managers and professionals, it has been observed that these publications have helped refine the instruments for this purpose.38 39 It allows for the comparison of perceptions among health professionals,40 in addition to allowing systematic literature reviews on the subject.11
The HSOPSC was the most used instrument worldwide to assess safety culture, followed by the SAQ and the SCS, similar results were reported in the literature.11 41 These instruments have 5–12 domains focused on the organisational assessment of patient safety and evaluate domains related to teamwork environment, management, communication, working conditions, error reporting and job satisfaction, except for the SCORE,42 43 which evaluates burnout climate and personal burnout. This is the only instrument that considers, in addition to organisational factors, factors related to professionals.
Evaluating safety culture is a complex process, and researchers have drawn attention to the fact that the available instruments have evaluated tangible concepts of safety culture and suggested an approach that combines different methodologies to assess intangible factors, that is, factors that are not easily evaluated by questionnaires, but which are just as important as measurable constructs. For the authors, intangible factors are trust, commitment, psychological safety, guilt and shame.12
Regarding the methodological approach, although most studies used a cross-sectional design, 12 studies used a mixed- methods or qualitative approach, showing that researchers have been evaluating the constructs that permeate safety culture in greater depth. The techniques used for qualitative analysis included interviews, focus groups and brainstorming. To correlate safety culture with other concepts, research has been associated with burnout,44–46 patient perception of their safety47 and teamwork.48
Such research shows that more than a decade ago, factors related to the well-being of health workers and the participation of patients and families may have directly resulted in the institutional safety climate. In 2022, the WHO included as one of the strategic objectives to strengthen patient safety in health institutions, the engagement of patients and families at all levels of healthcare, ranging from policy development and planning to the supervision of performance, to fully informed consent and shared decision-making in healthcare.1
These results can be confirmed by the number of instruments developed since 2008 that assess factors related to the safety culture aimed at health workers, organisations and the patient and family. In addition to the most evaluated domains, these instruments assess factors related to patient and family engagement, the psychological safety of the health team, and nurses’ engagement in decision-making. Lower levels of psychological safety and organisational support were significant predictors for remaining silent about safety concerns.49 There are positive relationships between quality and a climate of safety, empowerment and satisfaction with the provision of care with the culture of safety and empowerment of the family.50 In addition to the fact that there is already a body of evidence that the involvement of nurses in decision-making is beneficial for patient safety51 52 it can also be said that the involvement of this profession can reduce the costs of health institutions.53
Regarding the analysis of the data of the identified constructs, it was observed that two words (‘communication’ and ‘leadership’) were more prominent about connectivity with other words. The dendrogram confirms the findings in the word cloud and similarity analysis of the constructs extracted from the articles. According to the research articles, the constructs that form safety culture can be divided into two main classes, one of which is subdivided into five: class 1a ‘job satisfaction and leadership,’ class 1b ‘error response,’ class 1c ‘psychological and empowerment nurse,’ class 1d ‘trust culture’ and class 2 ‘innovation worker’.
Classes 1a–d consist of constructs that have already been researched and have scientific evidence showing their association with a positive safety culture. Institutions with strengthened and inclusive leadership favour the autonomy of professionals, improve nurses’ engagement and consequently increase their satisfaction and the well-being of professionals. A study conducted with 451 nurses from 5 hospitals in Wuhan, China, showed that nurses who were on the front line of COVID-19 care presented severe psychological distress; however, nurses who had more inclusive managers showed less psychological distress. Inclusive leaders involved the team in decision-making and created work environments that were considered psychologically safe.54 Leadership is identified as a strong influencing factor for a culture of trust in which professionals can speak openly about mistakes without guilt or fear, because in trustworthy environments, in addition to talking about mistakes, there is certainty of collective learning.55
However, research highlights that it is critical to pay attention to the need to train first-line nursing leaders to establish advice in a shared governance structure that can significantly contribute to the realisation of an improved safety culture. Nursing leadership style is perhaps the most critical factor in determining the culture and climate that will be created in a unit and within an organisation.56 57
The nursing leadership style can promote professional autonomy by enhancing decision-making, allowing nurses to make timely and accurate judgments based on their knowledge, which leads to greater patient safety. It also encourages critical thinking, allowing the independent analysis of patient conditions, identification of risks and immediate action. It promotes a culture of accountability and commitment to patient safety as professionals take responsibility for their practices and outcomes. Finally, it fosters improved communication and collaboration among healthcare teams by facilitating the expression of concerns, ideas and suggestions, leading to better coordination, sharing of vital information, and, ultimately, safety patient care.
Although leadership is the basis for strengthening all other constructs of safety culture, it was observed that open communication is a cross-cutting factor in this process and favours the empowerment of professionals, teamwork and the construction of a reliable environment to talk about errors and learn from them. There are strong associations between satisfactory communication and aspects of the patient’s safety climate, such as teamwork and job satisfaction.58
Finally, the class 2 ‘innovation worker,’ which in the literature can also be found to be associated with innovative behaviours and innovation climate, is a novel result among the findings of the present review, since it is a construct that has been addressed in studies on safety culture, but emerged in this study as a preeminent class, highlighting its importance as a component factor. An innovative climate can be defined as shared employee perceptions that encourage employees to develop innovative behaviours. Institutions with a good safety climate support employees and create a positive attitude towards innovation.59 60 Organisational climate has a significant impact on innovative behaviour and suggests that nursing managers should foster innovation through improvements in the organisational climate.37 Initially, the innovation construct was included as one of the climate assessment constructs in the team climate inventory (TCI).61 According to the authors, four theoretical factors support TCI: vision, participatory safety, task orientation and support for innovation. Although the instrument is considered valid and reliable, further studies are required to strengthen its psychometric properties.61
A limitation of this review is the analysis of articles in English only, which may have excluded important research in other languages.
The identified instruments presented elements that remain indispensable for assessing safety culture, such as leadership commitment, open communication and learning from mistakes. However, there is a trend in research aimed at evaluating patient and family engagement, psychological safety, nurses’ engagement in decision-making and innovation. The concepts identified in the safety culture assessment can be divided into organisational, professional, and patient and family participation. However, these three dimensions were not identified by using the same instrument. Thus, this review may serve to construct and update safety culture instruments addressing constructs aligned with research in the area and with the principles of the WHO GPAPS 2021–2030.
Although tools such as questionnaires are generally easy to administer, the true improvement in safety culture lies in the effective implementation and action of the results obtained. By examining change management processes and the ease of implementing interventions based on questionnaire findings, researchers can gain insights into how organisations translate survey results into meaningful actions that enhance the safety culture. This broader perspective would provide a more comprehensive understanding of the impact of questionnaires on safety culture improvements.
Exploring topics such as leadership support, employee engagement, organisational readiness and the effectiveness of interventions derived from the questionnaire results can contribute to the development of best practices and strategies for leveraging survey data to drive positive change and improve safety culture in healthcare settings.
Expanding research in this direction would enable a deeper exploration of the practical applications and outcomes of questionnaire-based assessments, ultimately providing valuable insights for organisations seeking to foster a safety culture.
Data availability statement
Data are available on reasonable request.
Patient consent for publication
Contributors Conceptualisation, REFLdC; data curation: REFLdC, IA, NO and LS; formal analysis, REFLdC, DWB, AS and IA; methodology: APA, REFLdC, LS, JG and MG; project administration: REFLdC; visualisation: REFLdC; writing—original draft preparation: REFLdC, DWB and AS; writing—review and editing: REFLdC, IA, APA, LS, JG, MG, NO and DWB. All authors have read and agreed to the published version of the manuscript. The guarantor was REFLdC.
Funding This research was funded by the CNPQ in the form of a post-doctoral scholarship, process number 203394/2020-8.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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