Assessing Patient Safety culture in Primary Health Care: a scoping review protocol

Larissa Carvalho de Castro¹, Bianca Silveira Ferreira¹, Luciana Regina Ferreira da Mata², Helen Cristiny Teodoro Couto Ribeiro¹

¹Universidade Federal de São João del-Rei (MG), Brazil. ²Universidade Federal de Minas Gerais (MG), Brazil.

Introduction

Patient safety (PS) has gained international attention as a key factor in improving quality of care in healthcare services. This discussion seeks to strengthen practices that reduce risks, prevent adverse events (AEs), and ensure safer care across different healthcare settings. PS encompasses actions aimed at managing and preventing risks, thus decreasing avoidable harm, reducing failures in care processes, and mitigating their effects when they occur^1-2.

Historically, most PS research has focused on hospital settings, where severe cases and frequent procedures and interventions make AEs more visible. However, national and international studies show that AEs may also occur in Primary Health Care (PHC)^3-4. Evidence shows that incidents are relatively common at this care level, with a median of two to three events per 100 consultations, and about 4% lead to serious harm^5-6. Although PHC settings deal with lower-complexity cases, a Brazilian study reported that 82% of observed incidents resulted in patient harm, with administrative and communication errors being the most frequent⁷.

PHC serves as the patient’s first contact with the healthcare system, assuming responsibility for managing most health issues while promoting continuity in care, patient-provider relationships, and coordinated care. These factors emphasize the need to understand and monitor PS at this healthcare level⁷.

Building a strong safety culture is essential for effectively integrating PS actions into professional practice in PHC. Patient safety culture encompasses values, attitudes, skills, and behaviors that guide institutional and professional commitment to safe practices and risk management⁸. A well-structured culture promotes organizational learning, shifting the focus from punitive approaches toward continuous analysis and improvement, and enabling errors to be recognized and managed without assigning blame⁹.

Several studies indicate that PS culture continues to be poorly understood and inadequately assessed in PHC^2,7,9-11. Validated instruments such as the Primary Care Safety Questionnaire (PC-Safe) and the Medical Office Survey on Patient Safety Culture (MOSPSC) offer a way to systematically and consistently assess the elements making up this construct^12-13. However, national and international studies that thoroughly describe available instruments for assessing PS culture in PHC are still scarce, along with analyses that help researchers select the most appropriate tool to achieve this goal^14-15.

In response to this gap, the present review aims to map validated instruments reported in the literature for assessing Patient Safety culture in Primary Health Care. 

Method

Following the JBI methodology, this scoping review protocol seeks to map scientific evidence in a specific field of knowledge¹⁶. This review will also be guided by the PRISMA checklist extension (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), known as the PRISMA-ScR, which has been specifically adapted for scoping reviews.¹⁷ Consequently, this approach is expected to facilitate a rigorous review process while upholding high-quality standards. This protocol is registered on the Open Science Framework (OSF) platform and can be accessed at the following link: https://osf.io/xypnb/.

Review question

The research question for this scoping review protocol was formulated using the PCC strategy: “P” represents the population, “C” the concept, and the second “C”, the context¹⁶. Accordingly, the following questions are posed: What validated instruments have been identified in the literature for assessing Patient Safety culture in Primary Health Care? How have validated instruments for assessing Patient Safety culture been structured and applied in Primary Health Care settings?

Inclusion criteria

Participants

The scoping review will consider instruments developed and validated for PHC professionals to assess organizational culture with a focus on Patient Safety.

Concept

This scoping review will focus on studies that report how instruments for assessing patient safety culture were developed and validated. In this study, patient safety culture is defined as the combination of values, attitudes, skills, and behaviors that reflect commitment to managing health and safety, focusing on learning from errors rather than assigning blame, while enhancing healthcare delivery⁸.

Instruments will be organized according to their dimensions or factors, domains, items, scoring systems, and approaches to classifying patient safety culture in PHC. Analytical results supporting the instrument’s validity and reliability will be examined in the studies. For this purpose, psychometric evidence and instrument validation will be classified according to the COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) taxonomy of measurement properties¹⁸.

Context

This scoping review will focus on services that provide primary health care, encompassing diverse organizational models and care practices. No restrictions will be applied to study location, allowing evidence from a variety of countries, healthcare systems, and socioeconomic contexts to be included.

This review will focus on studies exploring validated instruments used to assess patient safety culture in PHC, encompassing all types of first-level care units and services, including basic health units, primary care clinics, health care centers, medical offices, and community-based services. Cultural, organizational, and regional factors that could impact these instruments’ use, interpretation, or performance will also be considered, including variations in the following aspects: care models, multidisciplinary teams, available resources, and health management practices. 

Types of evidence-based sources

Studies employing any methodological design or format, including articles, dissertations, theses, editorials, and conference abstracts that address the research question will be included. Eligible studies may be published in Spanish, English, French, or Portuguese, with no time restrictions. Evidence-based sources will be accessed through the following databases: MEDLINE (PubMed), Biblioteca Virtual em Saúde (BVS) [Virtual Health Library], EMBASE, COCHRANE, CINAHL, SCOPUS, and Web of Science. In addition, grey literature will be searched through Open Access Theses and Dissertations, Biblioteca Digital Brasileira de Teses e Dissertações [Brazilian Digital Library of Theses and Dissertations], and the CAPES Theses and Dissertations Catalog. The review will also examine references cited in both included and excluded studies that report instruments relevant to the concept under investigation.

Research Strategy

Following the JBI methodology, the scoping review will be conducted according to predefined inclusion and exclusion criteria. An electronic search will be carried out in the databases previously mentioned. The search strategy was developed by the reviewers in collaboration with a librarian, to guarantee proper use of vocabulary across all databases. Chart 1 presents the full search strategy for each research database, employing advanced searches with DECs (Health Sciences Descriptors) and MeSH (Medical Subject Headings). In turn, EMTREE terms were used for EMBASE, and CINAHL Subject Headings for CINAHL, applying the Boolean operators OR and AND.

Chart 1 - Scoping review approach applied to instruments for assessing Patient Safety Culture in Primary Health Care. Divinópolis, MG, Brazil, 2025.

DATABASE	STRATEGY	RETRIEVED RECORDS
BVS*	("Segurança do Paciente" OR "Patient Safety" OR "Seguridad del Paciente" OR " Securité des malades" OR "Gestão da Segurança" OR "Safety Management" OR "Administración de la Seguridad" OR "Gestion de la sécurité" OR "Cultura Organizacional" OR "Organizational Culture" OR "Cultura Organizacional" OR "Culture organisationnelle") AND ("Mecanismos de Avaliação da Assistência à Saúde" OR "Health Care Evaluation Mechanisms" OR "Mecanismos de Evaluación de la Atención de Salud" OR "Mécanismes d'évaluation des soins de santé" OR avaliação OR "Instrumento de Avaliação" OR "Instrumentos de Avaliação" OR evaluation OR assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Atenção Primária à Saúde" OR "Primary Health Care" OR "Atención Primaria de Salud" OR "Soins de santé primaires") AND ( db:("IBECS" OR "LILACS" OR "BDENF" OR "PAHOIRIS" OR "RHS" OR "SMS-SP" OR "campusvirtualsp_ops" OR "colecionaSUS"))	59
MEDLINE (PubMed)	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	950
COCHRANE	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	99
CINAHL	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	401
SCOPUS	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	841
WEB OF SCIENCE	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	514
EMBASE	('patient safety' or 'organizational culture') and (assessment or 'assessment test' or 'assessment tool') and ('primary health care')	388
Open Access Theses and Dissertations	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	27
Biblioteca Digital Brasileira de Teses e Dissertações [Brazilian Digital Library of Theses and Dissertations]	("Patient Safety" OR "Safety Management" OR "Organizational Culture") AND ("Health Care Evaluation Mechanisms" OR Evaluation OR Assessment OR "Assessment Tool" OR "Assessment Tools") AND ("Primary Health Care")	28

   *Note: Biblioteca Virtual em Saúde [Virtual Health Library]. Source: Prepared by the authors, 2025.

The strategies used in this study were conducted in three phases, following JBI guidelines¹⁶. Initially, a simple search was performed in the MEDLINE (PubMed) and BVS databases to identify the main indexing terms and keywords. The descriptors used were the following: Patient Safety, Primary Health Care, Organizational Culture, Healthcare Personnel, Safety Management, and Culture. In the second phase, a subsequent search using these terms was conducted in the following databases: BVS, MEDLINE (PubMed), COCHRANE, CINAHL, SCOPUS, EMBASE, and Web of Science.

In the third phase, references from both included and excluded studies that report instruments used to assess patient safety culture in primary health care (as defined for this review) will be manually examined. This step may include additional relevant studies identified through this search. Google Scholar will be used to identify studies in grey literature.

Study selection

All studies retrieved will be managed using Rayyan software (Qatar Computing Research Institute, Doha, Qatar)¹⁹. This software will be used to remove duplicate records and include studies reporting instruments designed to assess patient safety culture in PHC. The selection process will be conducted independently by two reviewers, who will assess all articles, with any disagreements resolved by a third reviewer.

Studies deemed eligible for the scoping review will initially undergo a pre-selection through title and abstract screening. Pre-selected studies will then be read in full to assess inclusion criteria. After all studies are selected, the process will be documented in a flowchart showing included and excluded studies, as well as the reasons for their exclusion, following the PRISMA-ScR flowchart¹⁷.

Data extraction

Data extracted from the studies and selected for the scoping review will be entered into a spreadsheet created in Microsoft Office Excel Online by the researchers. This spreadsheet will include information identifying each study, such as author, title, year of publication, country, language, study design, objective, instrument used to assess Patient Safety culture (domains, factors, items, scoring), type of validation/reliability applied to the instrument, study participants, as well as sample size and study setting, main findings related to the level of Patient Safety Culture assessed, and each study’s conclusions.

An instrument developed by the reviewers (Chart 2), based on the model provided in the JBI manual, will be used to extract data from the selected articles¹⁶. The process will be performed independently by the researchers, and each will be responsible for mapping and entering the data into the spreadsheet.

Chart 2 - Data extraction related to the selected studies. Divinópolis, MG, Brazil, 2025.

Title of the Scoping Review: Assessing Patient Safety culture in Primary Health Care: a scoping review protocol. Scoping Review Question: What validated instruments have been identified in the literature for assessing Patient Safety culture in Primary Health Care? What criteria define an appropriate instrument for assessing patient safety culture in primary health care? Data extracted from the study Title  Author(s)       Year of publication Country and language Study design Objective       Instrument used to assess Patient Safety (domains, factors, items, scoring) Type of validation/reliability applied to the instrument Population/sample size           Study setting Main findings related to the level of Patient Safety culture assessed Conclusions of the study

Analysis and presentation of results

A chart will display the data extracted from instruments assessing patient safety culture in PHC, and a thematic analysis will guide a narrative discussion, with instruments categorized by type.

Authors’ contributions

Study conception: Helen Cristiny Teodoro Couto Ribeiro; Bianca Silveira Ferreira. Data collection: Bianca Silveira Ferreira; Larissa Carvalho de Castro. Data analysis and interpretation: Bianca Silveira Ferreira; Larissa Carvalho de Castro. Manuscript drafting: Bianca Silveira Ferreira; Larissa Carvalho de Castro; Luciana Regina Ferreira da Mata. Critical review of the manuscript: Helen Cristiny Teodoro Couto Ribeiro; Luciana Regina Ferreira da Mata. Final version approval: Helen Cristiny Teodoro Couto Ribeiro; Luciana Regina Ferreira da Mata.

Conflict of interest

The authors reported that there is no conflict of interest.

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Corresponding Author

Name: Bianca Silveira Ferreira

E-mail: biancasferreira11@gmail.com 

The Author(s) 2026.  This work is licensed under Creative Commons Attribution 4.0 International. License text for use: https://creativecommons.org/licenses/by/4.0/deed.pt_BR