{"paper_id":"05ee3bdf-4147-4ac7-8024-40ca3b1dd0f7","body_text":"Validation of the first Brazilian instrument for patient engagement in patient safety | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Validation of the first Brazilian instrument for patient engagement in patient safety Maiana Regina Gomes de Sousa, Juliana Santana de Freitas, Juliana Carvalho de Lima, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8888829/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 18 You are reading this latest preprint version Abstract Background Patient safety is highlighted as a global health challenge, requiring changes and the implementation of initiatives to minimize risks, prevent care failures, and avoid harm to patients. Patient engagement has been one of the most recommended strategies for improving the quality and safety of care. To understand and monitor this practice, the Patient Engagement in Patient Safety within Canadian Healthcare Organizations tool was developed to self-assess the nature of patient engagement in patient safety at the systemic level in healthcare organizations. To enable research on this topic in Brazilian health organizations, the objective of this study was to produce a cross-culturally adapted Brazilian Portuguese version of this instrument, with content validation, for use in Brazil. Methods This was a methodological study developed in two phases. The first consisted of the cross-cultural adaptation of the instrument to Portuguese and followed six stages: preparation, translation, back-translation, pre-test with nine health organizations, review, and documentation. Equivalences were analyzed using the coefficient of agreement. The second phase involved content validation using the Delphi technique, with a committee of experts (n = 7), including partner patient, in two sequential rounds, measuring the Content Validity Index (CVI) and inter-rater agreement (IRA). Results In the cross-cultural adaptation, 97.9% of the items were considered equivalent by 100% of the evaluators. Items with agreement below 90% were discussed until consensus was reached. In the content validation, most items had acceptable CVI (99.6%) and IRA (99.0%) in terms of comprehensiveness, clarity, and relevance. Items with unsatisfactory values were modified, reassessed, and, after approval by all experts, the instrument was finalized and made available for use in Brazil. Conclusions The instrument is a reliable and valid tool to investigate patient engagement in patient safety in Brazilian health organizations. Patient safety Patient participation Patient-centered care Quality of health care Translating Validation study Figures Figure 1 Background Patient safety, person-centered care and patient partnership have been widely studied in recent years and are recognized worldwide as essential components of healthcare quality [ 1 – 3 ]. The World Health Organization (WHO), through the Global Patient Safety Action Plan 2021–2030, has established guiding principles and values for health activities, the first of which is the engagement of patients and their families as partners in care [ 1 ]. This theme was later reinforced by the motto “Engaging Patients for Patient Safety” of World Patient Safety Day 2023, in order to raise awareness among member countries about the significant gains in safety, satisfaction, and health outcomes related to patient engagement [ 4 ]. Patient engagement is defined as the involvement of patients, family members, companions, or caregivers, in collaboration with health professionals, at different levels of the health system to improve the quality of care [ 5 ]. The results of one study revealed that the rate of adverse events decreased from 20.7 to 12.9, which represents a reduction of 37.9%, after implementing a patient engagement initiative through a patient and family-centered communication program [ 6 ]. Other evidence indicates that patients’ engagement can increase patients’ motivation and self-efficacy in managing their health, resulting in improved physical health and a reduction in depressive symptoms and anxiety over the course of treatment [ 7 ], can improve treatment adherence [ 8 ], can encourage patient involvement in medication self-management and adverse event reporting [ 9 ], and can help control healthcare costs [ 10 ]. Patient engagement efforts therefore reflect and accelerate the shift in patients’ and families’ roles in healthcare as they become more active, informed, and influential [ 8 ]. However, patient engagement initiatives are still at an early stage in Brazil. A study involving 141 health institutions showed that in approximately 70% of their patients were not involved in care or participated only in the evaluation of quality goals [ 11 ]. As patient engagement has been shown to be an important factor in promoting patient safety, it is essential to analyze and understand this process. However, this need contrasts with the lack of valid tools to measure the phenomenon, especially from the patients’ perspective [ 12 ]. The use of reliable and valid instruments is important for the global understanding of a phenomenon, facilitating the universal sharing of information, enabling the comparison of data in different contexts, and generating robust evidence [ 13 ]. It is noteworthy, however, that the specific instruments most used to measure patient engagement in patient safety [ 14 – 17 ] are not able to capture an overall system-level strategy that would help health managers integrate patient engagement at all levels of governance. The Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument was developed with the objective of filling this theoretical gap and enabling the evaluation of initiatives aimed at patient engagement at the clinical, organizational, strategic, and political levels [ 18 ]. In view of the orientation of patient involvement strategies toward quality improvement, the scarcity of Brazilian studies in this area, the relevance of evaluating patient engagement in patient safety, and the lack of tools for this purpose, the need to perform cross-cultural adaptation and validation of this instrument for use in Brazil was identified. Its original version has proven to be a reliable and applicable measure, reinforcing its potential to contribute to the evaluation and improvement of patient engagement practices in the national context. Methods Study aim The objective of this study was to cross-culturally adapt and validate the content of the Brazilian version of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [ 18 ], to self-assess the nature of patient engagement in patient safety at the systemic level in Brazilian health organizations. Study design A recognized methodology for adapting questionnaires in intercultural contexts was used, conducted in two phases: Translation and cross-cultural adaptation of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [ 18 ] to the Portuguese language. Content validation through the Delphi technique. The process of adaptation and validation for use in Brazil was carried out with the authorization of the original authors of the instrument, following their guidelines and based on specialized publications [ 13 , 19 ]. Instrument The Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [ 18 ] was developed to assess the mechanisms of patient engagement in patient safety at the strategic, organizational, and clinical levels in Canadian health institutions. The instrument consists of 75 open and closed questions, organized into five sections: (1) demographic identification of the participants (Q1–Q5); (2) general questions (Q6–Q17); (3) items related to the patient engagement process (Q18–Q33); (4) patient engagement in patient safety processes, including current activities, strategies, structures, resources, and factors (Q34–Q67); and (5) context and impact of patient engagement on patient safety initiatives in health organizations (Q68–Q75), including identification of results, improvement mechanisms and strategies, forms of evaluation, and indicators. The items were grouped into ten analytical dimensions: (1) demographic characteristics; (2) level of experience; (3) incentives; (4) strategies (models); (5) level of intervention; (6) structure and resources; (7) activities (processes); (8) factors; (9) results (impacts); and (10) improvements. Phase 1 - Translation and cross-cultural adaptation The translation and cross-cultural adaptation of the instrument was conducted between January 2020 and June 2021, following six stages: preparation, translation, back-translation, pre-test, review, and documentation. For this process, a translation team was formed, consisting of the principal investigator, two translators for the English-to-Portuguese version, one translator for the Portuguese-to-English back-translation, two reviewers, one subject-matter expert, one methodologist, and a translation judge. Preparation The preparation stage began with sending orientation documents to the team, including: a statement of work containing instructions on the questionnaire; the text designated for translation; a file with the definitions of terms and concepts used in the questions; and the contact information of the research coordinator, to enable direct communication in case of doubts regarding the purpose of the questions or the design of the instrument. Translation The translation of the instrument from English to Brazilian Portuguese was performed by two bilingual translators, linked to a specialized company hired and remunerated for this purpose. The task was executed independently and in parallel, resulting in two initial versions (T1 and T2). Then, the members of the translation team met to discuss and compare the versions produced. The divergences identified were analyzed and, with the support of a literature review, the terms most used in Brazil were chosen. From this first review, the reconciled version of the translated instrument (T1-2) was produced. Back-translation The reconciled version (T1-2) of the instrument was back-translated into English by a native translator fluent in Brazilian Portuguese. This stage resulted in the back-translated version (BT-1). In a subsequent meeting, the members of the translation team compared the back-translated version with the original in English and concluded that there were no relevant discrepancies between the documents, and a new translation was not necessary. Also in this second review, the team considered some changes necessary for the process of cross-cultural adaptation, such as adjustments in the characterization of health organizations, inclusion of concepts and definitions of terms, and insertion of questions pertinent to the Brazilian context. Next, a structured form was sent by email to the judge and the translation reviewers to record their evaluations independently, with three response options: equivalent, partially equivalent, and non-equivalent. The coefficient of agreement for each item was calculated based on the percentage of evaluators who classified it as “equivalent”. According to the adopted criterion, items that reached agreement equal to or greater than 90.0% [ 20 ] in the “equivalent” category were considered satisfactory. Items that did not reach this level were discussed in a new team meeting. At this time, the reasons for the lack of equivalence were analyzed and the possibilities for improvement until consensus was reached were discussed. From this final judgment, the Brazilian Patient Engagement in Patient Safety in Health Organizations instrument, version 1.0 – was consolidated. Pre-test For the pre-test, health institutions accredited in Brazil according to the QMentum International methodology, which confers the Canadian accreditation seal, were conveniently selected. This choice was made because this model adopts the same standard of excellence as in the country of origin of the instrument, which establishes, among its requirements, the active involvement of the patient in the health system. The identification of eligible organizations was carried out by consulting the database of IQG – Instituto Qualisa de Gestão - Health Services Accreditation, an accrediting institution and partner of Accreditation Canada, responsible for the application of the QMentum International methodology in Brazil. Invitations were then sent by email to 21 institutions, containing information about the study and a request for authorization to carry out the research. Of these, ten confirmed their participation, but one of them later withdrew, resulting in a total of nine participating institutions. The organizations provided the contacts of the professionals responsible for the Patient Safety Sector and, based on these, an email was sent containing information about the study, instructions for completing the questionnaire, the deadline for response, and a password-protected link to access the instrument on the SurveyMonkey online platform. Among the guidelines, the recommendation to form a team composed of at least three members to respond to the instrument together was highlighted, in order to reach consensus in the choice of each answer, as provided for in the original instrument. Members were to be those with the most knowledge in the following roles: patient safety leader (or area manager), patient engagement leader (or patient engagement/partnership officer), and patient advisory board leader (or chair of patient groups). In addition to completing the instrument, participants recorded their perceptions about the understanding of each item and the selected answer, indicating any difficulties or doubts in the interpretation of the questions and suggesting modifications. After the conclusion of the pre-test, the third review was carried out, in which the questions that raised interpretation doubts, as well as the suggestions for modification made by the participants, were analyzed and adjusted by the members of the translation team, resulting in version 1.1 of the Brazilian Patient Engagement in Patient Safety in Health Organizations Instrument. Review The review process extended throughout the entire phase of translation and cross-cultural adaptation: the first review occurred after the initial translation of the instrument, the second after the back-translation, and the third after the pre-test results were made available. At all stages of the review, direct contact was maintained with the authors of the original instrument for consultations and clarifications. After the third review, the questionnaire was sent to the authors for approval, with the modifications duly highlighted and accompanied by justifying comments. With their final approval, the version was considered cross-culturally adapted for use in the Brazilian context. Documentation Although documentation is formally considered the final step of the process, it was generated continuously throughout all stages. In stage 1, written specifications and supporting materials were prepared and provided to the translators. In stages 2, 3, 4, and 5, a version numbering system was implemented to track successive translations and to document the rationale for each modification. In stage 4, the documentation was used to support the reproducibility of the translated questionnaire. Finally, in stage 5, all changes were fully documented to ensure traceability, consistency, and control of revisions. Figure 1 illustrates the complete translation and cross-cultural adaptation process of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese. [Insert Fig. 1 about here] Phase 2 - Content validation through the Delphi technique Content validation took place between August and November 2021, with the recruitment of Brazilian experts with experience in the topic of patient engagement in patient safety. To ensure the heterogeneity of the group, professionals from different regions of the country were invited, working in various settings and in different types and profiles of institutions. The invitation was sent by email to twelve experts, seven of whom agreed to participate, a number that meets the recommendations in the literature regarding the ideal size of the committee of judges [ 20 – 21 ]. Among the participants, there were three physicians, two nurses, one biomedical professional, and one patient partner acting as leader of the patient advisory council. To evaluate the instrument, a questionnaire was developed to explore three aspects of each item: comprehensiveness, clarity, and relevance. A 4-point Likert scale was used. In the first round, each item was submitted to the individual judgment of the evaluators, who recorded their degree of agreement using the numerical scale. Regarding comprehensiveness, the experts evaluated whether the structure and content of the items were correct and whether they were representative [ 13 ]. The response options were: 1 = not comprehensive; 2 = needs major revision to be comprehensive; 3 = needs minor revision to be comprehensive; 4 = comprehensive. Regarding clarity, it was verified whether the items were written in such a way as to make the concept understandable and whether they adequately expressed what was intended to be measured [ 13 ]. The response options were: 1 = not clear; 2 = needs major revision to be clear; 3 = needs minor revision to be clear; 4 = clear. Regarding relevance, it was analyzed whether the items reflected the concepts involved and whether they were pertinent and adequate to achieve the proposed objectives [ 13 ]. The response options were: 1 = not relevant; 2 = needs major revision to be relevant; 3 = needs minor revision to be relevant; 4 = relevant. In addition, open text fields were provided for the experts to record comments and suggestions on any items they deemed necessary to change, include, or exclude. At the end of the first round, the results of the experts’ evaluation were tabulated and statistically analyzed using the Content Validity Index (CVI) and inter-rater agreement (IRA), to verify the level of consensus (ref). The CVI was used to measure the proportion of experts who agreed with each item evaluated. The calculation corresponded to the sum of the responses assigned to the agreement points (in this case, 3 and 4), divided by the total number of evaluations [ 20 ]. The IRA, in turn, was applied to verify whether the consensus obtained was significant and reliable, considering the variation among the experts’ responses, the sample size, and the number of response alternatives available [ 22 – 24 ]. The IRA value for each item was calculated using the following formula: IRA = (Expected Var – Observed Var) / Expected Var The observed variance corresponds to the variance obtained from the scores assigned by each evaluator, while the expected variance refers to the estimated variance in a discrete uniform distribution in the interval from 1 to 4, considering that the Likert scale adopted in the study had four points. The formula for calculating the expected variance is as follows [ 23 ]: Expected Var = (number of Likert scale points² – 1) / 12 Thus, for the present study, the expected variance was 1.25, calculated by the formula (4² – 1) / 12. Values higher than 0.8 were considered statistically acceptable, both for the CVI, classified as “excellent” [ 22 ], and for the IRA, classified as “very good” [ 23 ], corresponding to the highest evaluation categories. The interpretation of the CVI values followed the following criteria: < 0.2 = poor; 0.2–0.4 = fair; 0.4–0.6 = moderate; 0.6–0.8 = good; > 0.8 = excellent [ 23 ]. For the IRA, the classification was: < 0.2 = poor; 0.2–0.4 = weak; 0.4–0.6 = moderate; 0.6–0.8 = good; 0.8–1.0 = very good [ 23 ]. After the first round, the responses were analyzed, and according to the statistical results, the items that were not approved were restructured based on the experts’ observations. In some cases, the researchers issued clarification notes to justify the decisions adopted. The questionnaire was resent for a second round of evaluation. At this stage, the experts received: the results of the statistical analysis of all items from the first round; the questionnaire containing only the modified items; and a report with the corresponding comments, so that they could reflect, evaluate, and record their answers, considering the arguments of the other participants. Throughout the process, the anonymity of the evaluators was preserved. The answers from the second round were submitted to a new statistical analysis, which indicated satisfactory results for all items. In view of this consensus, there was no need for another evaluation cycle, and the application of the Delphi technique was concluded. From this process, content validation of the Patient Engagement in Patient Safety in Health Organizations instrument – final version for use in Brazil (see Additional file 1) – was obtained. Data analysis In phase 1, referring to the translation and cross-cultural adaptation of the instrument, the coefficient of agreement was calculated for all items, and those that achieved agreement equal to or greater than 90.0% in the “equivalent” category were considered satisfactory. In phase 2, corresponding to content validation, the CVI and IRA were applied, and values higher than 0.8 for both indicators were considered statistically acceptable. All analyses were conducted using R software, version 4.1.2. Results Translation and cross-cultural adaptation The cross-cultural translation and adaptation phase began with the translations carried out independently by two translators. The differences observed between the T1 and T2 versions referred mainly to the use of distinct expressions, although semantically similar. After discussion, the translation team reached a consensus, selecting the most appropriate terms in Portuguese, always considering their relevance to the study theme. The items that presented divergences, as well as the agreed-upon expressions resulting from the translation team’s consensus during the first revision of the translation and cross-cultural adaptation of items from the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese, are presented in Table 1 . Table 1 Consensus in first revision of translation and cross-cultural adaptation of patient safety engagement instrument items Original Expression T1 T2 Version T1-2 (Consensus) Patient partners (or advisor): An individual who experienced care In the healthcare system (as a patient, family member or caregiver) and who, as part of a patient group (e.g., patient/family council), engages in shaping decisions, policies, and/or practices at all system levels Patient partner (or counselor): An individual who has received care in The health care system (as a patient, relative, or caregiver) and who, as part of a patient's group (e.g., patient council or family council), participates in the process of shaping decisions, policies, and/or practices at all levels of the system Patient partner (or consultant): Individual who has experienced care in The health system (as a patient, family member, or caregiver) and who, as part of a patient group (e.g., patient/family council), participates in decision-making and policy and/or practice at all levels of the system Patient partner (or consultant): An individual who has experienced care In the healthcare system (as a patient, family member, or caregiver) and who, as part of a patient group (e.g., patient/family council), participates in shaping decisions, policies, and/or practices at all levels of the system Patient advisor leader (or the chair of patient groups) Leader of the Patient Advisors (or the Chair of the Patient Groups) Patient Consultant Leader (or Patient Group Chair) Patient Advisory Board Leader (or the chair of patient groups) The full time equivalent (FTE) allocation is sufficient for achieving our patient safety goals in partnership with patients The equivalent allocation to full-time work is sufficient to achieve our patient safety goals in partnership with patients Full-time equivalent staff (FTE) allocation is sufficient to achieve our patient safety goals in partnership with patients Full-time equivalent (FTE) allocation is sufficient to achieve our patient safety goals in partnership with patients The financial resources or budget allocated is Sufficient for achieving our patient safety goals in partnership with patients The financial resources or budget set aside is Sufficient to achieve our patient safety goals in partnership with patients The financial resources or budget allocated is Sufficient to achieve our patient safety goals in partnership with patients The financial resources or budget allocated is Sufficient to achieve our patient safety goals in partnership with patients Training on patient engagement is available to care providers Patient engagement training is available for care providers Patient engagement training available to healthcare providers Patient engagement training is available to healthcare professionals Patient advisors are part of the Board of Directors Patient counselors are part of the board of directors Patient consultants are part of the Board of Directors Patient advisors are part of the Board of Directors The organization has a formal policy on disclosure The organization has a formal transparency policy The organization has a formal disclosure policy The organization has a formal disclosure policy Patients and families report incidents (including near misses) Patients and families report incidents (including near misses) Patients and their family members report incidents (including near misses) Patients and family members report incidents (including near misses) In the last quarter senior management took part in rounding to detect and prevent safety risk In the last quarter, upper management participated in discussions to detect and prevent safety-related risks In the last quarter, senior management participated in analyses to detect and prevent security risks In the last quarter, senior management participated in rounding to detect and prevent safety risks Patients are engaged in preventing healthcare-acquired infections Patients are engaged in avoiding healthcare-acquired infections Patients are involved in the prevention of healthcare-acquired infections Patients are engaged in the prevention of healthcare-associated infections Canadian guides/ frameworks Canadian guides/approaches Canada Guides/Frameworks Brazilian guides/frameworks [Insert Table 1 about here] In the back-translation stage, no difficulties in the translation were identified, nor were any considerable discrepancies found. Some changes were made to the questionnaire to adapt it to the Brazilian context. In the section on the characterization of health organizations, items were added about: the name of the institution; the state in which the institution is located; whether it is public, private, philanthropic, or other; level of complexity; type of specialty; and average length of stay. The definitions of the terms Patient Advisory Council and Disclosure were added, and questions related to patient engagement in the prevention of incidents involving patient identification, pressure injuries, and safe surgery were included, in order to cover all Basic Patient Safety Protocols approved by the Ministry of Health in Brazil [ 25 – 26 ]. This was considered necessary because the original instrument contained questions only about infections related to healthcare, medication, and falls. The instrument was composed of 288 items, and for 97.9% of these, all three evaluators considered them equivalent, that is, there was a coefficient of agreement of 100%. In the remaining 2.1%, one of the evaluators selected the option “Partially equivalent.” It should be noted that no item was considered “Not equivalent.” The items that did not achieve full agreement, along with the evaluators’ comments and the consensual expressions updated in version 1.0 during the second revision of the translation and cross-cultural adaptation of items from the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese, are presented in Table 2 . Table 2 Evaluator consensus in second revision of translation and cross-cultural adaptation of safety engagement instrument items Original expression Version T1‑2 Reviewers' comments Brazilian version 1.0 This questionnaire is completed at the same time by (check all the boxes that apply) This questionnaire is being completed at the same time by (check all options that apply) I don't think it is necessary to keep “at the same time,” as it can be answered by only one person. This questionnaire is being completed by (check all that apply). Public engagement is an approach to encourage the people (citizens) most impacted, to participate actively in defining their issues of concern, and help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement is involving the public/ citizens before or after they access the healthcare system Public engagement is an approach to encourage the most affected people (citizens) to actively participate in defining their problems and to help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement engages the public/citizens before or after they access the health system. Most affected by what? What does it mean to “access” the health system? Use it? Public engagement is an approach to encourage the people (citizens) most involved to actively participate in defining their issues of concern and to help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement involves the public/citizens before or after they use the health system. Funding applications require that patient advisors are engaged in the proposal and/or program plan Funding requests require patient counselors to participate in the program proposal and/or plan. “Plan” refers to planning, so it makes more sense for them to participate in program planning than only in the plan. Funding applications require that patient partners (or consultants) participate in the proposal and/or planning of the program. The public/citizens participated in the development of the organization’s strategic plan The public/citizens participated in the development of the organization's strategic plan. Using “planning” would better convey participation in the process of elaborating the plan. “Plan” alone could be understood as a static document, whereas “planning” suggests a dynamic process. The public participated in the development of the organization’s strategic plan. Patient advisors co-design the incident analysis policy Patient counselors participate in the development of the incident analysis policy. “Co-design” seems to go beyond simple participation; it implies active participation. Patient partners (or consultants) participate in the development (co‑design) of the incident analysis policy. Engaging Patients in Patient Safety – A Canadian Guide Engaging Patients in Patient Safety – A Canadian Guide Does this make sense in Brazil? Does Canadian accreditation advocate this? Item deleted. [Insert Table 2 about here] The participants of the pre-test, in addition to answering the questions of the instrument, recorded whether there were any doubts regarding the understanding of the question and the answer options, to ensure that the translated questionnaire is maintaining its equivalence in an applied situation. Of the 9 organizations that participated, 66.7% were private, 22.2% public, and 11.1% private philanthropic; 66.7% were hospitals; 11.1% medical outpatient clinic, 11.1% blood center and 11.1% home care. In only 3 items/questions, 1.0% of the total items (n = 287, one less than the previous step, as one item was excluded) and 4.3% of the total questions (69), there were doubts recorded by the participants. The comments that the respondents registered were in relation to the lack of understanding of the term \"Full-time allocation\"; doubt whether \"patient safety team\" means care team that is at the forefront of care or a center focused on patient safety; and suggestion to bring an example in the question about monitoring the impact of patient engagement on patient safety. All considerations were accepted, and the questions changed. With the result of the pre-test, it was also perceived the need to include three questions in the characterization of the organization to verify whether there is a position/function of patient safety leader; patient engagement leader; and leader of the patient advisory board, considering that, in Brazil, not all institutions have these well-defined roles. In the question about Factors that influenced patient engagement in patient safety, indicating whether it is a barrier, facilitator, or without effect, it was understood that the term \"barrier\" was not the best option, because in Brazil, this term is widely used in the context of patient safety as something positive, which prevents, or minimizes, the chance of incidents. However, its application in the question has the opposite meaning, as something negative. Therefore, to avoid misinterpretation, it was changed to the term \"hindering\". The changes made were sent to the authors of the original instrument for approval, which was granted without objections, and then the version cross-culturally adapted to Brazilian Portuguese was originated. Instrument validation Content validation was performed using the Delphi technique, involving the evaluation of 7 experts (ref). Among them, 100% had experience with patient engagement; 85.7% had professional experience around patient safety in health organizations and 14.3% were patient partners (family members), leader of the patient advisory board; 71.4% developed teaching activities on the topic of patient safety; 57.1% were involved in research (doctorate/master's degree) and 42.8% had scientific production on the same theme. At this point in the content validation, the number of items in the instrument was equal to 305, since the 18 items created in the characterization part, adapted to the Brazilian reality and that were not part of the translation stage, were included. The experts answered about the comprehensiveness, clarity and relevance of each item of the instrument, using a Likert-type scale, and after the first round of the Delphi technique, the CVI and IRA values were calculated, as shown in Table 3 . Table 3 Absolute and percentage frequencies of CVI and IRA by assessment type of patient engagement items Measure Scope Clarity Relevance number % number % number % CVI 0.714 0 0 1 0.3 0 0 0.857 2 0.7 12 3.9 12 3.9 1.00 303 99.3 292 95.8 293 96.1 IRA 0 a 0.2 0 0 0 0 0 0 0.21 a 0.4 0 0 0 0 0 0 0.41 a 0.6 2 0.7 2 0.7 2 0.7 0.61 a 0.8 1 0.3 1 0.3 1 0.3 0.81 a 1 302 99.0 302 99.0 302 99.0 Note: CVI Content Validity Index, IRA Inter-Rater Agreement. At the end of the evaluation instrument, there was also a question asking the experts to assess the instrument as a whole, and 100% of them considered the questionnaire comprehensive, clear, and relevant. It was observed that only 0.3% of the items did not obtain a satisfactory CVI value, related to clarity, and that 1.0% did not have an acceptable IRA value, across the three aspects. These items were revised and re-evaluated in the second round of the Delphi technique. Table 4 presents the items that did not have satisfactory statistical results in the first round, as well as the experts’ comments and the version re-evaluated and approved after the second round. Table 4 Description of items reassessed by experts during content validation of patient engagement safety instrument Cross-cultural translated and adapted version Expert Comments Re-evaluated version Patient Engagement in Patient Safety in Healthcare Organizations 1 - Replace \"patient engagement in patient safety\" with \"patient engagement in people's safety” since inappropriate patient behavior can compromise the patient's safety and that of others involved in the patient's care. 2 - \"Patient\" must include \"Family members\". 3 - Pay attention to the term engagement: it cannot be said that it is very well known in Brazil, so it will be essential to define it at the beginning of the instrument, as they have already done. 4 - Patient engagement in patient safety processes in healthcare organizations Patient Engagement in Patient Safety in Healthcare Organizations Note: the instrument explains the term \"patient\", which includes: patients, clients, residents, users and their family members (including family members and support persons). The term \"patient\" includes patients, clients, residents, users, and their family members (including family members and support person) 1 - If the idea is to include everyone, why not describe a definition for \"Person\"? The term \"patient\" includes patients, clients, residents, users, and their family members (including family members and support person). Note: the standardization of the term \"patient\" was maintained so as not to confuse it with other people who do not apply, such as \"professionals\". Building a Safer Health System: Strategies Used in Institutionalizing Patient Engagement in Patient Safety 1 - Replace \"in patient safety\" with \"in people's safety\" Building a Safer Health System: Strategies Used in Institutionalizing Patient Engagement in Patient Safety. Note: the standardization of the term \"patient\" was maintained so as not to confuse it with other people who do not apply, such as \"professionals\". Canadian Accreditation - Qmentum Program 1 - All accreditation methodologies have been directing their efforts to patient engagement with greater or lesser intensity for some years. I understand that the instrument should not be restricted to a single methodology. Accreditation Methodologies Tables [Insert Table 4 about here] Discussion This study was conducted to address the lack of validated instruments capable of assessing patient engagement in patient safety at the systemic level within Brazilian healthcare organizations. Although patient engagement is internationally recognized as a key strategy to improve quality and safety of care, Brazil still lacks standardized tools to evaluate how this engagement is structured, implemented, and sustained across different organizational levels. Therefore, the objective of this study was to perform the cross-cultural adaptation and content validation of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument for use in Brazil, following internationally recognized methodological standards. Cross‑cultural adaptation involves multiple steps until the final version of an instrument is obtained. It is a complex process, as it encompasses different languages and cultural contexts [27]. Thus, it is essential to follow the recommended standards and procedures rigorously, since methodological weaknesses can compromise the quality of the process and limit the use of the instrument [27]. Lessons learned from the translation and cross-cultural adaptation phase During the first phase of translation and cross‑cultural adaptation, the different stages of the proposed methodology were carried out, and semantic, conceptual, and normative equivalence between the original instrument and the version adapted for use in Brazil was demonstrated, with an excellent coefficient of agreement (> 90%) for 97.9% of the items in the questionnaire. In the pre‑test, the instrument showed good comprehensibility among participants, given the minimal number of doubts recorded. Adjustments were made to the questionnaire, related to minor divergences in terms and expressions, which were deemed necessary to adapt it to Brazilian culture. It is emphasized that such changes are essential to ensure equivalence between the terms used in different cultures, avoiding errors resulting from literal translation without adaptation to the target population [28]. Modifications are necessary to adjust both the denotative and connotative meanings that words acquire in the new cultural context, so that the new version reflects the original instrument as closely as possible [27]. Another definition that did not exist in the original instrument and was included in the Portuguese questionnaire was the term “Disclosure,” which is also known in the field of patient safety but is not present in most Brazilian health organizations. Disclosure can be defined as the process of revealing or communicating to the patient/family about the occurrence of an adverse event in a clear, honest, and transparent way [29], also informing the causal factors involved and the improvements implemented to prevent the occurrence of similar incidents in the future [30]. Disclosure of adverse events to patients and their families is a fundamental practice of patient‑centered care [31], and some countries require this approach as a standard activity or as an action supported by law [32–33]. However, the implementation of disclosure is a critical and delicate process that requires preparation and organizational maturity for effective execution. It also needs to be aligned with the values and policies of the health institution to ensure patient‑centered care and quality of care. Lessons learned for the content validation It was found that, in the content validation, two rounds of the Delphi technique were necessary for all items to reach consensus, as indicated by satisfactory statistical values. The number of rounds varies according to the profile of the expert committee; however, at least two rounds of evaluation are necessary to characterize the Delphi technique [34]. As described in the results, 1.3% of the items did not obtain acceptable results in the first round. These items were reviewed and submitted for a second evaluation, accompanied by a complete report of the quantitative analysis and the qualitative comments. This process is essential for experts to reflect on the perceptions of others, building a valuable consensus within the group [34]. Among the few observations recorded by the experts in the first round, the discussion around the use of the term “patient” stood out, with suggestions to replace it with “people” or to explicitly include “family members.” However, it was clarified that, in the context of this instrument, the term “patient” encompasses patients, clients, residents, users, and their family members (including family members and support persons), a definition that is already included in the questionnaire, as established in the original instrument. Incorporating patient feedback into the creation and validation of questionnaires The definition of the term “patient advisory council” was added because, although it is a known concept and exists in some institutions, it is not yet part of the reality of the vast majority of Brazilian health organizations. This study showed that none of the organizations participating in the pre-test had this type of council, and there was no participation of a leader or representative of a patient partner. This situation is an important point for the research, as the participation of a representative of these individuals can add substantial value to the results; therefore, the recommendation that the instrument be completed with the participation of a patient partner was maintained. A patient partner or consultant is an individual who has experienced care in the health system (as a patient, family member, or caregiver) and who is active in the organization, participating in decision‑making, policy, and/or practice at different levels of the system [35]. A Patient Advisory Council is a formal group that meets regularly for active collaboration between leaders, health professionals, and patient partners in health policy and program decisions, with the aim of improving care practices [36]. Beyond their definitional role, patient partners and Patient Advisory Councils add substantial value to healthcare organizations by integrating experiential knowledge into strategic, organizational, and clinical decision-making processes. This lived experience perspective allows organizations to identify blind spots that may not be visible through professional or managerial lenses alone, contributing to more responsive, transparent, and safer systems of care. Evidence shows that the meaningful inclusion of patient partners strengthens governance processes, enhances legitimacy of decisions, and supports the co-development of patient safety initiatives that are better aligned with real-world needs and expectations. [18,37] The added value of patient partnership is also well described in conceptual frameworks such as the CADICEE model, which highlights core values including Co-construction, Transparency, Mutual Respect, Experiential Knowledge, Empathy, and Empowerment as foundational elements of effective patient engagement. These dimensions reinforce the idea that patient involvement should not be symbolic or consultative only, but rather embedded in organizational culture and decision-making structures. The CADICEE framework has been increasingly used to guide and evaluate partnership practices, particularly in contexts aiming to institutionalize patient engagement beyond individual projects. [38] In parallel, patient-reported experience measures (PREMs) and patient-reported outcome measures (PROMs) have gained international recognition as essential tools for capturing patients’ perceptions of care processes and outcomes. These measures have been widely adopted to inform quality improvement, monitor safety-related experiences, and support patient-centered evaluation of health services. However, PREMs and PROMs primarily reflect individual-level experiences and outcomes, offering limited insight into how patient engagement is structured, governed, and sustained at the organizational or system level. [37, 39] In this context, the instrument adapted in the present study addresses an important methodological and practical gap by focusing on patient engagement in patient safety at a systemic and organizational level. Rather than measuring isolated experiences or outcomes, it assesses governance arrangements, institutional strategies, available resources, and formal mechanisms that enable or hinder patient participation in patient safety initiatives. As such, the instrument complements existing PREMs and PROMs by providing a broader analytical lens, allowing healthcare organizations to understand not only what patients experience, but how patient engagement is embedded and operationalized within their safety systems. Strengths and limitations The Brazilian Patient Engagement in Patient Safety in Health Organizations is the first instrument published in Brazil aimed at evaluating patient engagement strategies in care safety. Its application makes it possible to compare results with other studies, both nationally and internationally. The instrument can also be used as a management tool in Brazilian health institutions, allowing the analysis of the status of patient engagement in each context and time, identifying gaps and encouraging the implementation of practices related to the theme, as well as the improvement of existing strategies. Patient engagement should be recognized as one of the pillars of care practice and an essential component of patient safety globally. To this end, it is crucial to integrate it into the organizational structures of healthcare, ensuring co‑participation from the formulation of policies and institutional strategies to the implementation of clinical procedures at the bedside. Certain circumstances have limited this study and deserve to be highlighted, particularly in the context of the COVID-19 pandemic. In this context, health organizations needed to focus the efforts of management and professionals on caring for patients affected by the disease and on actions to control the pandemic, which made it impossible to carry out research on a larger scale with health institutions in Brazil. Thus, the application of the instrument was restricted to the health organizations that participated in the pre‑test, which reinforces the need for new studies with larger and more heterogeneous samples to use the Patient Engagement in Patient Safety in Health Organizations instrument. Such studies will allow for a deeper analysis of the instrument’s psychometric properties, as well as a broader diagnosis of the patient engagement strategies adopted in Brazil, enabling more robust comparisons and generalizations. This work is neither simple nor free of difficulties and may even generate some initial discomfort, as it involves a paradigm shift. Even so, it is essential to seek distinct and innovative forms of collaboration, even in the face of challenges, with a view to promoting collective benefits [35]. Conclusion The process of translation, cross-cultural adaptation, and content validation resulted in the development of the Brazilian Patient Engagement in Patient Safety in Health Organizations questionnaire, preserving semantic, conceptual, and normative equivalences. Content validation confirmed that the instrument has measurement properties appropriate to the investigated theme. The instrument proved to be reliable, culturally appropriate, and applicable to the Brazilian context, and can be used both in research and as a management tool in health institutions. This is the first instrument published in Brazil aimed at evaluating patient engagement strategies in patient safety, which reinforces the originality and relevance of this research. In addition to its scientific contribution, the instrument enables the diagnosis of patient engagement strategies, the identification of gaps, and the improvement of institutional practices, also facilitating comparisons at national and international levels. Future studies with larger and more heterogeneous samples are recommended to deepen the analysis of its psychometric properties and broaden the understanding of patient engagement practices in Brazil. Abbreviations IRA Inter-Rater Agreement CVI Content Validity Index WHO World Health Organization Declarations Ethics approval and consent to participate This study was approved by the Research Ethics Committee of the Hospital das Clínicas of the Federal University of Goiás (CAAE: 24973119.9.0000.5078) and followed all the ethical and legal precepts of Resolution No. 466/2012 of the National Health Council [ 40 ]. All procedures performed in this study complied with the ethical standards of the Declaration of Helsinki. All research participants signed the informed consent form. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Note CVI Content Validity Index, IRA Inter-Rater Agreement. Funding This study was developed with financial support from the Goiás Research Foundation (FAPEG) and the National Council for Scientific and Technological Development (CNPq), in relation to the doctoral sandwich internship abroad. Author Contribution MRGS conceived the research question, designed the study, and wrote the original version of this manuscript. AEBCS and MPP oversaw the investigation and research methodology. JSF, JCL, KDCS, and UAG contributed to the review of the different sections and quality aspects of the article, in addition to helping to develop the discussion and conclusion. All authors reviewed and edited the manuscript and approved the final version. Acknowledgement To Laura Schiesari, for her willingness to help, kindly dedicating part of her valuable time to contribute to this work. Data Availability All data generated or analyzed during this study are included in this article, and the result is the Patient Engagement in Patient Safety in Healthcare Organizations instrument, available in Portuguese in the supplementary materials. References World Health Organization. Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care. Geneva: World Health Organization. 2021. Available from: https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan . Accessed 2 Jan 2026. National Health Service. The NHS patient safety strategy: safer culture, safer systems, safer patients. London: NHS England. 2019. Available from: https://www.england.nhs.uk/patient-safety/the-nhs-patient-safety-strategy/ . Accessed 20 Jan 2026. Ministry of Health (BR). 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Strategically advancing patient and family advisory councils in New York State hospitals. New York: NYS Health Foundation. 2018. Available from: https://nyshealthfoundation.org/resource/strategically-advancing-patient-and-family-advisory-councils-in-new-york-state-hospitals/ . Accessed 28 Jan 2026. OECD. Patient-Reported Indicators Survey (PaRIS): Results from the international pilot. OECD Publishing. 2023. Available from: https://www.oecd.org/en/about/programmes/patient-reported-indicator-surveys-paris.html . Accessed 29 Jan 2026. Pomey MP, Clavel N, Normandin L, Del Grande C, Philip Ghadiri D, Fernandez-McAuley I, Boivin A, Flora L, Janvier A, Karazivan P, Pelletier JF, Fernandez N, Paquette J, Dumez V. Assessing and promoting partnership between patients and health-care professionals: Co-construction of the CADICEE tool for patients and their relatives. Health Expect. 2021;24(4):1230–41. https://doi.org/10.1111/hex.13253 . Bull C, Callander EJ, Teede H, Watson D. Selecting and implementing patient-reported outcome and experience measures to assess health system performance. JAMA Health Forum. 2022;3(4):e220326. https://doi.org/10.1001/jamahealthforum.2022.0326 . Ministry of Health (BR). National Health Council. Resolution No. 466, of December 12. 2012. Brasília: Ministry of Health; 2012. Available from: https://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf . Accessed 29 Jan 2026. Additional Declarations No competing interests reported. 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The World Health Organization (WHO), through the Global Patient Safety Action Plan 2021\\u0026ndash;2030, has established guiding principles and values for health activities, the first of which is the engagement of patients and their families as partners in care [\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e]. This theme was later reinforced by the motto \\u0026ldquo;Engaging Patients for Patient Safety\\u0026rdquo; of World Patient Safety Day 2023, in order to raise awareness among member countries about the significant gains in safety, satisfaction, and health outcomes related to patient engagement [\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003ePatient engagement is defined as the involvement of patients, family members, companions, or caregivers, in collaboration with health professionals, at different levels of the health system to improve the quality of care [\\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eThe results of one study revealed that the rate of adverse events decreased from 20.7 to 12.9, which represents a reduction of 37.9%, after implementing a patient engagement initiative through a patient and family-centered communication program [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e]. Other evidence indicates that patients\\u0026rsquo; engagement can increase patients\\u0026rsquo; motivation and self-efficacy in managing their health, resulting in improved physical health and a reduction in depressive symptoms and anxiety over the course of treatment [\\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e], can improve treatment adherence [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e], can encourage patient involvement in medication self-management and adverse event reporting [\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e], and can help control healthcare costs [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003ePatient engagement efforts therefore reflect and accelerate the shift in patients\\u0026rsquo; and families\\u0026rsquo; roles in healthcare as they become more active, informed, and influential [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. However, patient engagement initiatives are still at an early stage in Brazil. A study involving 141 health institutions showed that in approximately 70% of their patients were not involved in care or participated only in the evaluation of quality goals [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eAs patient engagement has been shown to be an important factor in promoting patient safety, it is essential to analyze and understand this process. However, this need contrasts with the lack of valid tools to measure the phenomenon, especially from the patients\\u0026rsquo; perspective [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e]. The use of reliable and valid instruments is important for the global understanding of a phenomenon, facilitating the universal sharing of information, enabling the comparison of data in different contexts, and generating robust evidence [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eIt is noteworthy, however, that the specific instruments most used to measure patient engagement in patient safety [\\u003cspan additionalcitationids=\\\"CR15 CR16\\\" citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR17\\\" class=\\\"CitationRef\\\"\\u003e17\\u003c/span\\u003e] are not able to capture an overall system-level strategy that would help health managers integrate patient engagement at all levels of governance.\\u003c/p\\u003e \\u003cp\\u003eThe Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument was developed with the objective of filling this theoretical gap and enabling the evaluation of initiatives aimed at patient engagement at the clinical, organizational, strategic, and political levels [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eIn view of the orientation of patient involvement strategies toward quality improvement, the scarcity of Brazilian studies in this area, the relevance of evaluating patient engagement in patient safety, and the lack of tools for this purpose, the need to perform cross-cultural adaptation and validation of this instrument for use in Brazil was identified. Its original version has proven to be a reliable and applicable measure, reinforcing its potential to contribute to the evaluation and improvement of patient engagement practices in the national context.\\u003c/p\\u003e\"},{\"header\":\"Methods\",\"content\":\"\\u003cdiv id=\\\"Sec3\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy aim\\u003c/h2\\u003e \\u003cp\\u003eThe objective of this study was to cross-culturally adapt and validate the content of the Brazilian version of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e], to self-assess the nature of patient engagement in patient safety at the systemic level in Brazilian health organizations.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eStudy design\\u003c/h3\\u003e\\n\\u003cp\\u003eA recognized methodology for adapting questionnaires in intercultural contexts was used, conducted in two phases:\\u003c/p\\u003e \\u003cp\\u003e \\u003col\\u003e \\u003cspan\\u003e \\u003cli\\u003e \\u003cp\\u003eTranslation and cross-cultural adaptation of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e] to the Portuguese language.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/span\\u003e \\u003cspan\\u003e \\u003cli\\u003e \\u003cp\\u003eContent validation through the Delphi technique.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/span\\u003e \\u003c/ol\\u003e \\u003c/p\\u003e \\u003cp\\u003eThe process of adaptation and validation for use in Brazil was carried out with the authorization of the original authors of the instrument, following their guidelines and based on specialized publications [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR19\\\" class=\\\"CitationRef\\\"\\u003e19\\u003c/span\\u003e].\\u003c/p\\u003e\\n\\u003ch3\\u003eInstrument\\u003c/h3\\u003e\\n\\u003cp\\u003eThe Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e] was developed to assess the mechanisms of patient engagement in patient safety at the strategic, organizational, and clinical levels in Canadian health institutions.\\u003c/p\\u003e \\u003cp\\u003eThe instrument consists of 75 open and closed questions, organized into five sections: (1) demographic identification of the participants (Q1\\u0026ndash;Q5); (2) general questions (Q6\\u0026ndash;Q17); (3) items related to the patient engagement process (Q18\\u0026ndash;Q33); (4) patient engagement in patient safety processes, including current activities, strategies, structures, resources, and factors (Q34\\u0026ndash;Q67); and (5) context and impact of patient engagement on patient safety initiatives in health organizations (Q68\\u0026ndash;Q75), including identification of results, improvement mechanisms and strategies, forms of evaluation, and indicators.\\u003c/p\\u003e \\u003cp\\u003eThe items were grouped into ten analytical dimensions: (1) demographic characteristics; (2) level of experience; (3) incentives; (4) strategies (models); (5) level of intervention; (6) structure and resources; (7) activities (processes); (8) factors; (9) results (impacts); and (10) improvements.\\u003c/p\\u003e\\n\\u003ch3\\u003ePhase 1 - Translation and cross-cultural adaptation\\u003c/h3\\u003e\\n\\u003cp\\u003eThe translation and cross-cultural adaptation of the instrument was conducted between January 2020 and June 2021, following six stages: preparation, translation, back-translation, pre-test, review, and documentation. For this process, a translation team was formed, consisting of the principal investigator, two translators for the English-to-Portuguese version, one translator for the Portuguese-to-English back-translation, two reviewers, one subject-matter expert, one methodologist, and a translation judge.\\u003c/p\\u003e\\n\\u003ch3\\u003ePreparation\\u003c/h3\\u003e\\n\\u003cp\\u003eThe preparation stage began with sending orientation documents to the team, including: a statement of work containing instructions on the questionnaire; the text designated for translation; a file with the definitions of terms and concepts used in the questions; and the contact information of the research coordinator, to enable direct communication in case of doubts regarding the purpose of the questions or the design of the instrument.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec8\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eTranslation\\u003c/h2\\u003e \\u003cp\\u003eThe translation of the instrument from English to Brazilian Portuguese was performed by two bilingual translators, linked to a specialized company hired and remunerated for this purpose. The task was executed independently and in parallel, resulting in two initial versions (T1 and T2). Then, the members of the translation team met to discuss and compare the versions produced. The divergences identified were analyzed and, with the support of a literature review, the terms most used in Brazil were chosen. From this first review, the reconciled version of the translated instrument (T1-2) was produced.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eBack-translation\\u003c/h3\\u003e\\n\\u003cp\\u003eThe reconciled version (T1-2) of the instrument was back-translated into English by a native translator fluent in Brazilian Portuguese. This stage resulted in the back-translated version (BT-1). In a subsequent meeting, the members of the translation team compared the back-translated version with the original in English and concluded that there were no relevant discrepancies between the documents, and a new translation was not necessary.\\u003c/p\\u003e \\u003cp\\u003eAlso in this second review, the team considered some changes necessary for the process of cross-cultural adaptation, such as adjustments in the characterization of health organizations, inclusion of concepts and definitions of terms, and insertion of questions pertinent to the Brazilian context. Next, a structured form was sent by email to the judge and the translation reviewers to record their evaluations independently, with three response options: equivalent, partially equivalent, and non-equivalent.\\u003c/p\\u003e \\u003cp\\u003eThe coefficient of agreement for each item was calculated based on the percentage of evaluators who classified it as \\u0026ldquo;equivalent\\u0026rdquo;. According to the adopted criterion, items that reached agreement equal to or greater than 90.0% [\\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e] in the \\u0026ldquo;equivalent\\u0026rdquo; category were considered satisfactory.\\u003c/p\\u003e \\u003cp\\u003eItems that did not reach this level were discussed in a new team meeting. At this time, the reasons for the lack of equivalence were analyzed and the possibilities for improvement until consensus was reached were discussed. From this final judgment, the Brazilian Patient Engagement in Patient Safety in Health Organizations instrument, version 1.0 \\u0026ndash; was consolidated.\\u003c/p\\u003e\\n\\u003ch3\\u003ePre-test\\u003c/h3\\u003e\\n\\u003cp\\u003eFor the pre-test, health institutions accredited in Brazil according to the QMentum International methodology, which confers the Canadian accreditation seal, were conveniently selected. This choice was made because this model adopts the same standard of excellence as in the country of origin of the instrument, which establishes, among its requirements, the active involvement of the patient in the health system.\\u003c/p\\u003e \\u003cp\\u003eThe identification of eligible organizations was carried out by consulting the database of IQG \\u0026ndash; Instituto Qualisa de Gest\\u0026atilde;o - Health Services Accreditation, an accrediting institution and partner of Accreditation Canada, responsible for the application of the QMentum International methodology in Brazil.\\u003c/p\\u003e \\u003cp\\u003eInvitations were then sent by email to 21 institutions, containing information about the study and a request for authorization to carry out the research. Of these, ten confirmed their participation, but one of them later withdrew, resulting in a total of nine participating institutions.\\u003c/p\\u003e \\u003cp\\u003eThe organizations provided the contacts of the professionals responsible for the Patient Safety Sector and, based on these, an email was sent containing information about the study, instructions for completing the questionnaire, the deadline for response, and a password-protected link to access the instrument on the SurveyMonkey online platform.\\u003c/p\\u003e \\u003cp\\u003e Among the guidelines, the recommendation to form a team composed of at least three members to respond to the instrument together was highlighted, in order to reach consensus in the choice of each answer, as provided for in the original instrument. Members were to be those with the most knowledge in the following roles: patient safety leader (or area manager), patient engagement leader (or patient engagement/partnership officer), and patient advisory board leader (or chair of patient groups).\\u003c/p\\u003e \\u003cp\\u003eIn addition to completing the instrument, participants recorded their perceptions about the understanding of each item and the selected answer, indicating any difficulties or doubts in the interpretation of the questions and suggesting modifications.\\u003c/p\\u003e \\u003cp\\u003eAfter the conclusion of the pre-test, the third review was carried out, in which the questions that raised interpretation doubts, as well as the suggestions for modification made by the participants, were analyzed and adjusted by the members of the translation team, resulting in version 1.1 of the Brazilian Patient Engagement in Patient Safety in Health Organizations Instrument.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec11\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eReview\\u003c/h2\\u003e \\u003cp\\u003eThe review process extended throughout the entire phase of translation and cross-cultural adaptation: the first review occurred after the initial translation of the instrument, the second after the back-translation, and the third after the pre-test results were made available.\\u003c/p\\u003e \\u003cp\\u003eAt all stages of the review, direct contact was maintained with the authors of the original instrument for consultations and clarifications. After the third review, the questionnaire was sent to the authors for approval, with the modifications duly highlighted and accompanied by justifying comments. With their final approval, the version was considered cross-culturally adapted for use in the Brazilian context.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec12\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eDocumentation\\u003c/h2\\u003e \\u003cp\\u003eAlthough documentation is formally considered the final step of the process, it was generated continuously throughout all stages. In stage 1, written specifications and supporting materials were prepared and provided to the translators. In stages 2, 3, 4, and 5, a version numbering system was implemented to track successive translations and to document the rationale for each modification. In stage 4, the documentation was used to support the reproducibility of the translated questionnaire. Finally, in stage 5, all changes were fully documented to ensure traceability, consistency, and control of revisions.\\u003c/p\\u003e \\u003cp\\u003eFigure \\u003cspan refid=\\\"Fig1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e illustrates the complete translation and cross-cultural adaptation process of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese.\\u003c/p\\u003e \\u003cp\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec13\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003e[Insert Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e about here]\\u003c/h2\\u003e \\u003cdiv id=\\\"Sec14\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003ePhase 2 - Content validation through the Delphi technique\\u003c/h2\\u003e \\u003cp\\u003eContent validation took place between August and November 2021, with the recruitment of Brazilian experts with experience in the topic of patient engagement in patient safety. To ensure the heterogeneity of the group, professionals from different regions of the country were invited, working in various settings and in different types and profiles of institutions. The invitation was sent by email to twelve experts, seven of whom agreed to participate, a number that meets the recommendations in the literature regarding the ideal size of the committee of judges [\\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR21\\\" class=\\\"CitationRef\\\"\\u003e21\\u003c/span\\u003e]. Among the participants, there were three physicians, two nurses, one biomedical professional, and one patient partner acting as leader of the patient advisory council.\\u003c/p\\u003e \\u003cp\\u003eTo evaluate the instrument, a questionnaire was developed to explore three aspects of each item: comprehensiveness, clarity, and relevance. A 4-point Likert scale was used. In the first round, each item was submitted to the individual judgment of the evaluators, who recorded their degree of agreement using the numerical scale.\\u003c/p\\u003e \\u003cp\\u003eRegarding comprehensiveness, the experts evaluated whether the structure and content of the items were correct and whether they were representative [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. The response options were: 1\\u0026thinsp;=\\u0026thinsp;not comprehensive; 2\\u0026thinsp;=\\u0026thinsp;needs major revision to be comprehensive; 3\\u0026thinsp;=\\u0026thinsp;needs minor revision to be comprehensive; 4\\u0026thinsp;=\\u0026thinsp;comprehensive.\\u003c/p\\u003e \\u003cp\\u003eRegarding clarity, it was verified whether the items were written in such a way as to make the concept understandable and whether they adequately expressed what was intended to be measured [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. The response options were: 1\\u0026thinsp;=\\u0026thinsp;not clear; 2\\u0026thinsp;=\\u0026thinsp;needs major revision to be clear; 3\\u0026thinsp;=\\u0026thinsp;needs minor revision to be clear; 4\\u0026thinsp;=\\u0026thinsp;clear.\\u003c/p\\u003e \\u003cp\\u003eRegarding relevance, it was analyzed whether the items reflected the concepts involved and whether they were pertinent and adequate to achieve the proposed objectives [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. The response options were: 1\\u0026thinsp;=\\u0026thinsp;not relevant; 2\\u0026thinsp;=\\u0026thinsp;needs major revision to be relevant; 3\\u0026thinsp;=\\u0026thinsp;needs minor revision to be relevant; 4\\u0026thinsp;=\\u0026thinsp;relevant.\\u003c/p\\u003e \\u003cp\\u003eIn addition, open text fields were provided for the experts to record comments and suggestions on any items they deemed necessary to change, include, or exclude.\\u003c/p\\u003e \\u003cp\\u003eAt the end of the first round, the results of the experts\\u0026rsquo; evaluation were tabulated and statistically analyzed using the Content Validity Index (CVI) and inter-rater agreement (IRA), to verify the level of consensus (ref).\\u003c/p\\u003e \\u003cp\\u003eThe CVI was used to measure the proportion of experts who agreed with each item evaluated. The calculation corresponded to the sum of the responses assigned to the agreement points (in this case, 3 and 4), divided by the total number of evaluations [\\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eThe IRA, in turn, was applied to verify whether the consensus obtained was significant and reliable, considering the variation among the experts\\u0026rsquo; responses, the sample size, and the number of response alternatives available [\\u003cspan additionalcitationids=\\\"CR23\\\" citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR24\\\" class=\\\"CitationRef\\\"\\u003e24\\u003c/span\\u003e]. The IRA value for each item was calculated using the following formula:\\u003c/p\\u003e \\u003cp\\u003eIRA = (Expected Var \\u0026ndash; Observed Var) / Expected Var\\u003c/p\\u003e \\u003cp\\u003eThe observed variance corresponds to the variance obtained from the scores assigned by each evaluator, while the expected variance refers to the estimated variance in a discrete uniform distribution in the interval from 1 to 4, considering that the Likert scale adopted in the study had four points.\\u003c/p\\u003e \\u003cp\\u003eThe formula for calculating the expected variance is as follows [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e]:\\u003c/p\\u003e \\u003cp\\u003eExpected Var = (number of Likert scale points\\u0026sup2; \\u0026ndash; 1) / 12\\u003c/p\\u003e \\u003cp\\u003eThus, for the present study, the expected variance was 1.25, calculated by the formula (4\\u0026sup2; \\u0026ndash; 1) / 12.\\u003c/p\\u003e \\u003cp\\u003eValues higher than 0.8 were considered statistically acceptable, both for the CVI, classified as \\u0026ldquo;excellent\\u0026rdquo; [\\u003cspan citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e], and for the IRA, classified as \\u0026ldquo;very good\\u0026rdquo; [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e], corresponding to the highest evaluation categories.\\u003c/p\\u003e \\u003cp\\u003eThe interpretation of the CVI values followed the following criteria: \\u0026lt; 0.2\\u0026thinsp;=\\u0026thinsp;poor; 0.2\\u0026ndash;0.4\\u0026thinsp;=\\u0026thinsp;fair; 0.4\\u0026ndash;0.6\\u0026thinsp;=\\u0026thinsp;moderate; 0.6\\u0026ndash;0.8\\u0026thinsp;=\\u0026thinsp;good; \\u0026gt; 0.8\\u0026thinsp;=\\u0026thinsp;excellent [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eFor the IRA, the classification was: \\u0026lt; 0.2\\u0026thinsp;=\\u0026thinsp;poor; 0.2\\u0026ndash;0.4\\u0026thinsp;=\\u0026thinsp;weak; 0.4\\u0026ndash;0.6\\u0026thinsp;=\\u0026thinsp;moderate; 0.6\\u0026ndash;0.8\\u0026thinsp;=\\u0026thinsp;good; 0.8\\u0026ndash;1.0\\u0026thinsp;=\\u0026thinsp;very good [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eAfter the first round, the responses were analyzed, and according to the statistical results, the items that were not approved were restructured based on the experts\\u0026rsquo; observations. In some cases, the researchers issued clarification notes to justify the decisions adopted.\\u003c/p\\u003e \\u003cp\\u003eThe questionnaire was resent for a second round of evaluation. At this stage, the experts received: the results of the statistical analysis of all items from the first round; the questionnaire containing only the modified items; and a report with the corresponding comments, so that they could reflect, evaluate, and record their answers, considering the arguments of the other participants. Throughout the process, the anonymity of the evaluators was preserved.\\u003c/p\\u003e \\u003cp\\u003eThe answers from the second round were submitted to a new statistical analysis, which indicated satisfactory results for all items. In view of this consensus, there was no need for another evaluation cycle, and the application of the Delphi technique was concluded. From this process, content validation of the Patient Engagement in Patient Safety in Health Organizations instrument \\u0026ndash; final version for use in Brazil (see Additional file 1) \\u0026ndash; was obtained.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec15\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eData analysis\\u003c/h2\\u003e \\u003cp\\u003eIn phase 1, referring to the translation and cross-cultural adaptation of the instrument, the coefficient of agreement was calculated for all items, and those that achieved agreement equal to or greater than 90.0% in the \\u0026ldquo;equivalent\\u0026rdquo; category were considered satisfactory.\\u003c/p\\u003e \\u003cp\\u003eIn phase 2, corresponding to content validation, the CVI and IRA were applied, and values higher than 0.8 for both indicators were considered statistically acceptable.\\u003c/p\\u003e \\u003cp\\u003eAll analyses were conducted using R software, version 4.1.2.\\u003c/p\\u003e \\u003c/div\\u003e\"},{\"header\":\"Results\",\"content\":\"\\u003cdiv id=\\\"Sec17\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eTranslation and cross-cultural adaptation\\u003c/h2\\u003e \\u003cp\\u003eThe cross-cultural translation and adaptation phase began with the translations carried out independently by two translators. The differences observed between the T1 and T2 versions referred mainly to the use of distinct expressions, although semantically similar. After discussion, the translation team reached a consensus, selecting the most appropriate terms in Portuguese, always considering their relevance to the study theme. The items that presented divergences, as well as the agreed-upon expressions resulting from the translation team\\u0026rsquo;s consensus during the first revision of the translation and cross-cultural adaptation of items from the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese, are presented in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e.\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab1\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 1\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003eConsensus in first revision of translation and cross-cultural adaptation of patient safety engagement instrument items\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"4\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eOriginal Expression\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eT1\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eT2\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eVersion T1-2 (Consensus)\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatient partners (or advisor): An individual who experienced care In the healthcare system (as a patient, family member or caregiver) and who, as part of a patient group (e.g., patient/family council), engages in shaping decisions, policies, and/or practices at all system levels\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatient partner (or counselor): An individual who has received care in The health care system (as a patient, relative, or caregiver) and who, as part of a patient's group (e.g., patient council or family council), participates in the process of shaping decisions, policies, and/or practices at all levels of the system\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatient partner (or consultant): Individual who has experienced care in The health system (as a patient, family member, or caregiver) and who, as part of a patient group (e.g., patient/family council), participates in decision-making and policy and/or practice at all levels of the system\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatient partner (or consultant): An individual who has experienced care In the healthcare system (as a patient, family member, or caregiver) and who, as part of a patient group (e.g., patient/family council), participates in shaping decisions, policies, and/or practices at all levels of the system\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatient advisor leader (or the chair of patient groups)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eLeader of the Patient Advisors (or the Chair of the Patient Groups)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatient Consultant Leader (or Patient Group Chair)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatient Advisory Board Leader (or the chair of patient groups)\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThe full time equivalent (FTE) allocation is sufficient for achieving our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe equivalent allocation to full-time work is sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eFull-time equivalent staff (FTE) allocation is sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eFull-time equivalent (FTE) allocation is sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThe financial resources or budget allocated is Sufficient for achieving our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe financial resources or budget set aside is Sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eThe financial resources or budget allocated is Sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eThe financial resources or budget allocated is Sufficient to achieve our patient safety goals in partnership with patients\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eTraining on patient engagement is available to care providers\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatient engagement training is available for care providers\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatient engagement training available to healthcare providers\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatient engagement training is available to healthcare professionals\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatient advisors are part of the Board of Directors\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatient counselors are part of the board of directors\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatient consultants are part of the Board of Directors\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatient advisors are part of the Board of Directors\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThe organization has a formal policy on disclosure\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe organization has a formal transparency policy\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eThe organization has a formal disclosure policy\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eThe organization has a formal disclosure policy\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatients and families report incidents (including near misses)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatients and families report incidents (including near misses)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatients and their family members report incidents (including near misses)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatients and family members report incidents (including near misses)\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eIn the last quarter senior management took part in rounding to detect and prevent safety risk\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eIn the last quarter, upper management participated in discussions to detect and prevent safety-related risks\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eIn the last quarter, senior management participated in analyses to detect and prevent security risks\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eIn the last quarter, senior management participated in rounding to detect and prevent safety risks\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatients are engaged in preventing healthcare-acquired infections\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatients are engaged in avoiding healthcare-acquired infections\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatients are involved in the prevention of healthcare-acquired infections\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatients are engaged in the prevention of healthcare-associated infections\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eCanadian guides/ frameworks\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eCanadian guides/approaches\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eCanada Guides/Frameworks\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eBrazilian guides/frameworks\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec18\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003e[Insert Table\\u0026nbsp;\\u003cspan refid=\\\"Tab1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e about here]\\u003c/h2\\u003e \\u003cp\\u003eIn the back-translation stage, no difficulties in the translation were identified, nor were any considerable discrepancies found. Some changes were made to the questionnaire to adapt it to the Brazilian context. In the section on the characterization of health organizations, items were added about: the name of the institution; the state in which the institution is located; whether it is public, private, philanthropic, or other; level of complexity; type of specialty; and average length of stay.\\u003c/p\\u003e \\u003cp\\u003eThe definitions of the terms Patient Advisory Council and Disclosure were added, and questions related to patient engagement in the prevention of incidents involving patient identification, pressure injuries, and safe surgery were included, in order to cover all Basic Patient Safety Protocols approved by the Ministry of Health in Brazil [\\u003cspan citationid=\\\"CR25\\\" class=\\\"CitationRef\\\"\\u003e25\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR26\\\" class=\\\"CitationRef\\\"\\u003e26\\u003c/span\\u003e]. This was considered necessary because the original instrument contained questions only about infections related to healthcare, medication, and falls.\\u003c/p\\u003e \\u003cp\\u003eThe instrument was composed of 288 items, and for 97.9% of these, all three evaluators considered them equivalent, that is, there was a coefficient of agreement of 100%. In the remaining 2.1%, one of the evaluators selected the option \\u0026ldquo;Partially equivalent.\\u0026rdquo; It should be noted that no item was considered \\u0026ldquo;Not equivalent.\\u0026rdquo;\\u003c/p\\u003e \\u003cp\\u003eThe items that did not achieve full agreement, along with the evaluators\\u0026rsquo; comments and the consensual expressions updated in version 1.0 during the second revision of the translation and cross-cultural adaptation of items from the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument into Brazilian Portuguese, are presented in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e.\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab2\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 2\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003eEvaluator consensus in second revision of translation and cross-cultural adaptation of safety engagement instrument items\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"4\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eOriginal expression\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eVersion T1‑2\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eReviewers' comments\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eBrazilian version 1.0\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThis questionnaire is completed at the same time by (check all the boxes that apply)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThis questionnaire is being completed at the same time by (check all options that apply)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eI don't think it is necessary to keep \\u0026ldquo;at the same time,\\u0026rdquo; as it can be answered by only one person.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eThis questionnaire is being completed by (check all that apply).\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePublic engagement is an approach to encourage the people (citizens) most impacted, to participate actively in defining their issues of concern, and help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement is involving the public/ citizens before or after they access the healthcare system\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePublic engagement is an approach to encourage the most affected people (citizens) to actively participate in defining their problems and to help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement engages the public/citizens before or after they access the health system.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eMost affected by what? What does it mean to \\u0026ldquo;access\\u0026rdquo; the health system? Use it?\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePublic engagement is an approach to encourage the people (citizens) most involved to actively participate in defining their issues of concern and to help decide, plan, deliver, implement, evaluate, and improve initiatives, processes, and/or policies. Public engagement involves the public/citizens before or after they use the health system.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eFunding applications require that patient advisors are engaged in the proposal and/or program plan\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eFunding requests require patient counselors to participate in the program proposal and/or plan.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026ldquo;Plan\\u0026rdquo; refers to planning, so it makes more sense for them to participate in program planning than only in the plan.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eFunding applications require that patient partners (or consultants) participate in the proposal and/or planning of the program.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThe public/citizens participated in the development of the organization\\u0026rsquo;s strategic plan\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe public/citizens participated in the development of the organization's strategic plan.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eUsing \\u0026ldquo;planning\\u0026rdquo; would better convey participation in the process of elaborating the plan. \\u0026ldquo;Plan\\u0026rdquo; alone could be understood as a static document, whereas \\u0026ldquo;planning\\u0026rdquo; suggests a dynamic process.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eThe public participated in the development of the organization\\u0026rsquo;s strategic plan.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatient advisors co-design the incident analysis policy\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePatient counselors participate in the development of the incident analysis policy.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026ldquo;Co-design\\u0026rdquo; seems to go beyond simple participation; it implies active participation.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePatient partners (or consultants) participate in the development (co‑design) of the incident analysis policy.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eEngaging Patients in Patient Safety \\u0026ndash; A Canadian Guide\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eEngaging Patients in Patient Safety \\u0026ndash; A Canadian Guide\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eDoes this make sense in Brazil? Does Canadian accreditation advocate this?\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eItem deleted.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec19\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003e[Insert Table\\u0026nbsp;\\u003cspan refid=\\\"Tab2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e about here]\\u003c/h2\\u003e \\u003cp\\u003eThe participants of the pre-test, in addition to answering the questions of the instrument, recorded whether there were any doubts regarding the understanding of the question and the answer options, to ensure that the translated questionnaire is maintaining its equivalence in an applied situation.\\u003c/p\\u003e \\u003cp\\u003eOf the 9 organizations that participated, 66.7% were private, 22.2% public, and 11.1% private philanthropic; 66.7% were hospitals; 11.1% medical outpatient clinic, 11.1% blood center and 11.1% home care. In only 3 items/questions, 1.0% of the total items (n\\u0026thinsp;=\\u0026thinsp;287, one less than the previous step, as one item was excluded) and 4.3% of the total questions (69), there were doubts recorded by the participants.\\u003c/p\\u003e \\u003cp\\u003eThe comments that the respondents registered were in relation to the lack of understanding of the term \\\"Full-time allocation\\\"; doubt whether \\\"patient safety team\\\" means care team that is at the forefront of care or a center focused on patient safety; and suggestion to bring an example in the question about monitoring the impact of patient engagement on patient safety. All considerations were accepted, and the questions changed.\\u003c/p\\u003e \\u003cp\\u003eWith the result of the pre-test, it was also perceived the need to include three questions in the characterization of the organization to verify whether there is a position/function of patient safety leader; patient engagement leader; and leader of the patient advisory board, considering that, in Brazil, not all institutions have these well-defined roles.\\u003cdiv class=\\\"BlockQuote\\\"\\u003e\\u003cp\\u003eIn the question about Factors that influenced patient engagement in patient safety, indicating whether it is a barrier, facilitator, or without effect, it was understood that the term \\\"barrier\\\" was not the best option, because in Brazil, this term is widely used in the context of patient safety as something positive, which prevents, or minimizes, the chance of incidents. However, its application in the question has the opposite meaning, as something negative. Therefore, to avoid misinterpretation, it was changed to the term \\\"hindering\\\".\\u003c/p\\u003e\\u003cp\\u003eThe changes made were sent to the authors of the original instrument for approval, which was granted without objections, and then the version cross-culturally adapted to Brazilian Portuguese was originated.\\u003c/p\\u003e\\u003c/div\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec20\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eInstrument validation\\u003c/h2\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"BlockQuote\\\"\\u003e \\u003cp\\u003eContent validation was performed using the Delphi technique, involving the evaluation of 7 experts (ref). Among them, 100% had experience with patient engagement; 85.7% had professional experience around patient safety in health organizations and 14.3% were patient partners (family members), leader of the patient advisory board; 71.4% developed teaching activities on the topic of patient safety; 57.1% were involved in research (doctorate/master's degree) and 42.8% had scientific production on the same theme.\\u003c/p\\u003e \\u003cp\\u003eAt this point in the content validation, the number of items in the instrument was equal to 305, since the 18 items created in the characterization part, adapted to the Brazilian reality and that were not part of the translation stage, were included.\\u003c/p\\u003e \\u003cp\\u003eThe experts answered about the comprehensiveness, clarity and relevance of each item of the instrument, using a Likert-type scale, and after the first round of the Delphi technique, the CVI and IRA values were calculated, as shown in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab3\\\" class=\\\"InternalRef\\\"\\u003e3\\u003c/span\\u003e.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab3\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 3\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003eAbsolute and percentage frequencies of CVI and IRA by assessment type of patient engagement items\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"7\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c6\\\" colnum=\\\"6\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c7\\\" colnum=\\\"7\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"1\\\" rowspan=\\\"2\\\"\\u003e \\u003cp\\u003eMeasure\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"2\\\" nameend=\\\"c3\\\" namest=\\\"c2\\\"\\u003e \\u003cp\\u003eScope\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"2\\\" nameend=\\\"c5\\\" namest=\\\"c4\\\"\\u003e \\u003cp\\u003eClarity\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"2\\\" nameend=\\\"c7\\\" namest=\\\"c6\\\"\\u003e \\u003cp\\u003eRelevance\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003enumber\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e%\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003enumber\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e%\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003enumber\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e%\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eCVI\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.714\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e1\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e0.3\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.857\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e2\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0.7\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e12\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e3.9\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e12\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e3.9\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e1.00\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e303\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e99.3\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e292\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e95.8\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e293\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e96.1\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eIRA\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0 a 0.2\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.21 a 0.4\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e0\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.41 a 0.6\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e2\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0.7\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e2\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e0.7\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e2\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e0.7\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.61 a 0.8\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e1\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0.3\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e1\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e0.3\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e1\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e0.3\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e0.81 a 1\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e302\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e99.0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e302\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e99.0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e302\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e99.0\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003ctfoot\\u003e \\u003ctr\\u003e\\u003ctd colspan=\\\"7\\\"\\u003eNote: CVI Content Validity Index, IRA Inter-Rater Agreement.\\u003c/td\\u003e\\u003c/tr\\u003e \\u003c/tfoot\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003cp\\u003eAt the end of the evaluation instrument, there was also a question asking the experts to assess the instrument as a whole, and 100% of them considered the questionnaire comprehensive, clear, and relevant. It was observed that only 0.3% of the items did not obtain a satisfactory CVI value, related to clarity, and that 1.0% did not have an acceptable IRA value, across the three aspects. These items were revised and re-evaluated in the second round of the Delphi technique. Table\\u0026nbsp;\\u003cspan refid=\\\"Tab4\\\" class=\\\"InternalRef\\\"\\u003e4\\u003c/span\\u003e presents the items that did not have satisfactory statistical results in the first round, as well as the experts\\u0026rsquo; comments and the version re-evaluated and approved after the second round.\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab4\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 4\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003eDescription of items reassessed by experts during content validation of patient engagement safety instrument\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"3\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eCross-cultural translated and adapted version\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eExpert Comments\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eRe-evaluated version\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePatient Engagement in Patient Safety in Healthcare Organizations\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e1 - Replace \\\"patient engagement in patient safety\\\" with \\\"patient engagement in people's safety\\u0026rdquo; since inappropriate patient behavior can compromise the patient's safety and that of others involved in the patient's care.\\u003c/p\\u003e \\u003cp\\u003e2 - \\\"Patient\\\" must include \\\"Family members\\\".\\u003c/p\\u003e \\u003cp\\u003e3 - Pay attention to the term engagement: it cannot be said that it is very well known in Brazil, so it will be essential to define it at the beginning of the instrument, as they have already done.\\u003c/p\\u003e \\u003cp\\u003e4 - Patient engagement in patient safety processes in healthcare organizations\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003ePatient Engagement in Patient Safety in Healthcare Organizations\\u003c/p\\u003e \\u003cp\\u003eNote: the instrument explains the term \\\"patient\\\", which includes: patients, clients, residents, users and their family members (including family members and support persons).\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eThe term \\\"patient\\\" includes patients, clients, residents, users, and their family members (including family members and support person)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e1 - If the idea is to include everyone, why not describe a definition for \\\"Person\\\"?\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eThe term \\\"patient\\\" includes patients, clients, residents, users, and their family members (including family members and support person).\\u003c/p\\u003e \\u003cp\\u003eNote: the standardization of the term \\\"patient\\\" was maintained so as not to confuse it with other people who do not apply, such as \\\"professionals\\\".\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eBuilding a Safer Health System: Strategies Used in Institutionalizing Patient Engagement in Patient Safety\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e1 - Replace \\\"in patient safety\\\" with \\\"in people's safety\\\"\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eBuilding a Safer Health System: Strategies Used in Institutionalizing Patient Engagement in Patient Safety.\\u003c/p\\u003e \\u003cp\\u003eNote: the standardization of the term \\\"patient\\\" was maintained so as not to confuse it with other people who do not apply, such as \\\"professionals\\\".\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eCanadian Accreditation - Qmentum Program\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e1 - All accreditation methodologies have been directing their efforts to patient engagement with greater or lesser intensity for some years. I understand that the instrument should not be restricted to a single methodology.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eAccreditation Methodologies\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003ctfoot\\u003e \\u003ctr\\u003e\\u003ctd colspan=\\\"3\\\"\\u003e\\u003cb\\u003eTables\\u003c/b\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e \\u003c/tfoot\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec21\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003e[Insert Table\\u0026nbsp;\\u003cspan refid=\\\"Tab4\\\" class=\\\"InternalRef\\\"\\u003e4\\u003c/span\\u003e about here]\\u003c/h2\\u003e \\u003c/div\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eThis study was conducted to address the lack of validated instruments capable of assessing patient engagement in patient safety at the systemic level within Brazilian healthcare organizations. Although patient engagement is internationally recognized as a key strategy to improve quality and safety of care, Brazil still lacks standardized tools to evaluate how this engagement is structured, implemented, and sustained across different organizational levels.\\u003c/p\\u003e\\n\\u003cp\\u003eTherefore, the objective of this study was to perform the cross-cultural adaptation and content validation of the Patient Engagement in Patient Safety within Canadian Healthcare Organizations instrument for use in Brazil, following internationally recognized methodological standards.\\u003c/p\\u003e\\n\\u003cp\\u003eCross‑cultural adaptation involves multiple steps until the final version of an instrument is obtained. It is a complex process, as it encompasses different languages and cultural contexts [27]. Thus, it is essential to follow the recommended standards and procedures rigorously, since methodological weaknesses can compromise the quality of the process and limit the use of the instrument [27].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eLessons learned from the translation and cross-cultural adaptation phase\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eDuring the first phase of translation and cross‑cultural adaptation, the different stages of the proposed methodology were carried out, and semantic, conceptual, and normative equivalence between the original instrument and the version adapted for use in Brazil was demonstrated, with an excellent coefficient of agreement (\\u0026gt; 90%) for 97.9% of the items in the questionnaire.\\u003c/p\\u003e\\n\\u003cp\\u003eIn the pre‑test, the instrument showed good comprehensibility among participants, given the minimal number of doubts recorded. Adjustments were made to the questionnaire, related to minor divergences in terms and expressions, which were deemed necessary to adapt it to Brazilian culture.\\u003c/p\\u003e\\n\\u003cp\\u003eIt is emphasized that such changes are essential to ensure equivalence between the terms used in different cultures, avoiding errors resulting from literal translation without adaptation to the target population [28]. Modifications are necessary to adjust both the denotative and connotative meanings that words acquire in the new cultural context, so that the new version reflects the original instrument as closely as possible [27].\\u003c/p\\u003e\\n\\u003cp\\u003eAnother definition that did not exist in the original instrument and was included in the Portuguese questionnaire was the term \\u0026ldquo;Disclosure,\\u0026rdquo; which is also known in the field of patient safety but is not present in most Brazilian health organizations.\\u003c/p\\u003e\\n\\u003cp\\u003eDisclosure can be defined as the process of revealing or communicating to the patient/family about the occurrence of an adverse event in a clear, honest, and transparent way [29], also informing the causal factors involved and the improvements implemented to prevent the occurrence of similar incidents in the future [30].\\u003c/p\\u003e\\n\\u003cp\\u003eDisclosure of adverse events to patients and their families is a fundamental practice of patient‑centered care [31], and some countries require this approach as a standard activity or as an action supported by law [32\\u0026ndash;33].\\u003c/p\\u003e\\n\\u003cp\\u003eHowever, the implementation of disclosure is a critical and delicate process that requires preparation and organizational maturity for effective execution. It also needs to be aligned with the values and policies of the health institution to ensure patient‑centered care and quality of care.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eLessons learned for the content validation\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eIt was found that, in the content validation, two rounds of the Delphi technique were necessary for all items to reach consensus, as indicated by satisfactory statistical values. The number of rounds varies according to the profile of the expert committee; however, at least two rounds of evaluation are necessary to characterize the Delphi technique [34].\\u003c/p\\u003e\\n\\u003cp\\u003eAs described in the results, 1.3% of the items did not obtain acceptable results in the first round. These items were reviewed and submitted for a second evaluation, accompanied by a complete report of the quantitative analysis and the qualitative comments. This process is essential for experts to reflect on the perceptions of others, building a valuable consensus within the group [34].\\u003c/p\\u003e\\n\\u003cp\\u003eAmong the few observations recorded by the experts in the first round, the discussion around the use of the term \\u0026ldquo;patient\\u0026rdquo; stood out, with suggestions to replace it with \\u0026ldquo;people\\u0026rdquo; or to explicitly include \\u0026ldquo;family members.\\u0026rdquo; However, it was clarified that, in the context of this instrument, the term \\u0026ldquo;patient\\u0026rdquo; encompasses patients, clients, residents, users, and their family members (including family members and support persons), a definition that is already included in the questionnaire, as established in the original instrument.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eIncorporating patient feedback into the creation and validation of questionnaires\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe definition of the term \\u0026ldquo;patient advisory council\\u0026rdquo; was added because, although it is a known concept and exists in some institutions, it is not yet part of the reality of the vast majority of Brazilian health organizations. This study showed that none of the organizations participating in the pre-test had this type of council, and there was no participation of a leader or representative of a patient partner. This situation is an important point for the research, as the participation of a representative of these individuals can add substantial value to the results; therefore, the recommendation that the instrument be completed with the participation of a patient partner was maintained.\\u003c/p\\u003e\\n\\u003cp\\u003eA patient partner or consultant is an individual who has experienced care in the health system (as a patient, family member, or caregiver) and who is active in the organization, participating in decision‑making, policy, and/or practice at different levels of the system [35]. A Patient Advisory Council is a formal group that meets regularly for active collaboration between leaders, health professionals, and patient partners in health policy and program decisions, with the aim of improving care practices [36].\\u003c/p\\u003e\\n\\u003cp\\u003eBeyond their definitional role, patient partners and Patient Advisory Councils add substantial value to healthcare organizations by integrating experiential knowledge into strategic, organizational, and clinical decision-making processes. This lived experience perspective allows organizations to identify blind spots that may not be visible through professional or managerial lenses alone, contributing to more responsive, transparent, and safer systems of care. Evidence shows that the meaningful inclusion of patient partners strengthens governance processes, enhances legitimacy of decisions, and supports the co-development of patient safety initiatives that are better aligned with real-world needs and expectations. [18,37]\\u003c/p\\u003e\\n\\u003cp\\u003eThe added value of patient partnership is also well described in conceptual frameworks such as the CADICEE model, which highlights core values including Co-construction, Transparency, Mutual Respect, Experiential Knowledge, Empathy, and Empowerment as foundational elements of effective patient engagement. These dimensions reinforce the idea that patient involvement should not be symbolic or consultative only, but rather embedded in organizational culture and decision-making structures. The CADICEE framework has been increasingly used to guide and evaluate partnership practices, particularly in contexts aiming to institutionalize patient engagement beyond individual projects. [38]\\u003c/p\\u003e\\n\\u003cp\\u003eIn parallel, patient-reported experience measures (PREMs) and patient-reported outcome measures (PROMs) have gained international recognition as essential tools for capturing patients\\u0026rsquo; perceptions of care processes and outcomes. These measures have been widely adopted to inform quality improvement, monitor safety-related experiences, and support patient-centered evaluation of health services. However, PREMs and PROMs primarily reflect individual-level experiences and outcomes, offering limited insight into how patient engagement is structured, governed, and sustained at the organizational or system level. [37, 39]\\u003c/p\\u003e\\n\\u003cp\\u003eIn this context, the instrument adapted in the present study addresses an important methodological and practical gap by focusing on patient engagement in patient safety at a systemic and organizational level. Rather than measuring isolated experiences or outcomes, it assesses governance arrangements, institutional strategies, available resources, and formal mechanisms that enable or hinder patient participation in patient safety initiatives. As such, the instrument complements existing PREMs and PROMs by providing a broader analytical lens, allowing healthcare organizations to understand not only what patients experience, but how patient engagement is embedded and operationalized within their safety systems.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eStrengths and limitations\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe Brazilian Patient Engagement in Patient Safety in Health Organizations is the first instrument published in Brazil aimed at evaluating patient engagement strategies in care safety. Its application makes it possible to compare results with other studies, both nationally and internationally.\\u003c/p\\u003e\\n\\u003cp\\u003eThe instrument can also be used as a management tool in Brazilian health institutions, allowing the analysis of the status of patient engagement in each context and time, identifying gaps and encouraging the implementation of practices related to the theme, as well as the improvement of existing strategies.\\u003c/p\\u003e\\n\\u003cp\\u003ePatient engagement should be recognized as one of the pillars of care practice and an essential component of patient safety globally. To this end, it is crucial to integrate it into the organizational structures of healthcare, ensuring co‑participation from the formulation of policies and institutional strategies to the implementation of clinical procedures at the bedside.\\u003c/p\\u003e\\n\\u003cp\\u003eCertain circumstances have limited this study and deserve to be highlighted, particularly in the context of the COVID-19 pandemic. In this context, health organizations needed to focus the efforts of management and professionals on caring for patients affected by the disease and on actions to control the pandemic, which made it impossible to carry out research on a larger scale with health institutions in Brazil.\\u003c/p\\u003e\\n\\u003cp\\u003eThus, the application of the instrument was restricted to the health organizations that participated in the pre‑test, which reinforces the need for new studies with larger and more heterogeneous samples to use the\\u0026nbsp;Patient Engagement in Patient Safety in Health Organizations\\u0026nbsp;instrument. Such studies will allow for a deeper analysis of the instrument\\u0026rsquo;s psychometric properties, as well as a broader diagnosis of the patient engagement strategies adopted in Brazil, enabling more robust comparisons and generalizations.\\u003c/p\\u003e\\n\\u003cp\\u003eThis work is neither simple nor free of difficulties and may even generate some initial discomfort, as it involves a paradigm shift. Even so, it is essential to seek distinct and innovative forms of collaboration, even in the face of challenges, with a view to promoting collective benefits [35].\\u003c/p\\u003e\"},{\"header\":\"Conclusion\",\"content\":\"\\u003cp\\u003eThe process of translation, cross-cultural adaptation, and content validation resulted in the development of the Brazilian Patient Engagement in Patient Safety in Health Organizations questionnaire, preserving semantic, conceptual, and normative equivalences. Content validation confirmed that the instrument has measurement properties appropriate to the investigated theme.\\u003c/p\\u003e \\u003cp\\u003e The instrument proved to be reliable, culturally appropriate, and applicable to the Brazilian context, and can be used both in research and as a management tool in health institutions. This is the first instrument published in Brazil aimed at evaluating patient engagement strategies in patient safety, which reinforces the originality and relevance of this research.\\u003c/p\\u003e \\u003cp\\u003eIn addition to its scientific contribution, the instrument enables the diagnosis of patient engagement strategies, the identification of gaps, and the improvement of institutional practices, also facilitating comparisons at national and international levels. Future studies with larger and more heterogeneous samples are recommended to deepen the analysis of its psychometric properties and broaden the understanding of patient engagement practices in Brazil.\\u003c/p\\u003e\"},{\"header\":\"Abbreviations\",\"content\":\"\\u003cdiv class=\\\"DefinitionList\\\"\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eIRA\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eInter-Rater Agreement\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eCVI\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eContent Validity Index\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eWHO\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eWorld Health Organization\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003c/div\\u003e\"},{\"header\":\"Declarations\",\"content\":\" \\u003cp\\u003e \\u003cstrong\\u003eEthics approval and consent to participate\\u003c/strong\\u003e \\u003cp\\u003e This study was approved by the Research Ethics Committee of the Hospital das Cl\\u0026iacute;nicas of the Federal University of Goi\\u0026aacute;s (CAAE: 24973119.9.0000.5078) and followed all the ethical and legal precepts of Resolution No. 466/2012 of the National Health Council [\\u003cspan citationid=\\\"CR40\\\" class=\\\"CitationRef\\\"\\u003e40\\u003c/span\\u003e]. All procedures performed in this study complied with the ethical standards of the Declaration of Helsinki. All research participants signed the informed consent form.\\u003c/p\\u003e \\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eConsent for publication\\u003c/strong\\u003e \\u003cp\\u003eNot applicable.\\u003c/p\\u003e \\u003ch2\\u003eCompeting interests\\u003c/h2\\u003e \\u003cp\\u003eThe authors declare that they have no competing interests.\\u003c/p\\u003e \\u003ch2\\u003eNote\\u003c/h2\\u003e \\u003cp\\u003eCVI Content Validity Index, IRA Inter-Rater Agreement.\\u003c/p\\u003e \\u003c/p\\u003e\\u003ch2\\u003eFunding\\u003c/h2\\u003e \\u003cp\\u003eThis study was developed with financial support from the Goi\\u0026aacute;s Research Foundation (FAPEG) and the National Council for Scientific and Technological Development (CNPq), in relation to the doctoral sandwich internship abroad.\\u003c/p\\u003e\\u003ch2\\u003eAuthor Contribution\\u003c/h2\\u003e\\u003cp\\u003eMRGS conceived the research question, designed the study, and wrote the original version of this manuscript. AEBCS and MPP oversaw the investigation and research methodology. JSF, JCL, KDCS, and UAG contributed to the review of the different sections and quality aspects of the article, in addition to helping to develop the discussion and conclusion. All authors reviewed and edited the manuscript and approved the final version.\\u003c/p\\u003e\\u003ch2\\u003eAcknowledgement\\u003c/h2\\u003e\\u003cp\\u003eTo Laura Schiesari, for her willingness to help, kindly dedicating part of her valuable time to contribute to this work.\\u003c/p\\u003e\\u003ch2\\u003eData Availability\\u003c/h2\\u003e\\u003cp\\u003eAll data generated or analyzed during this study are included in this article, and the result is the Patient Engagement in Patient Safety in Healthcare Organizations instrument, available in Portuguese in the supplementary materials.\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\u003cli\\u003e\\u003cspan\\u003eWorld Health Organization. Global patient safety action plan 2021\\u0026ndash;2030: towards eliminating avoidable harm in health care. Geneva: World Health Organization. 2021. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan\\u003c/span\\u003e\\u003cspan address=\\\"https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e. Accessed 2 Jan 2026.\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eNational Health Service. The NHS patient safety strategy: safer culture, safer systems, safer patients. London: NHS England. 2019. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://www.england.nhs.uk/patient-safety/the-nhs-patient-safety-strategy/\\u003c/span\\u003e\\u003cspan address=\\\"https://www.england.nhs.uk/patient-safety/the-nhs-patient-safety-strategy/\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e. Accessed 20 Jan 2026.\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eMinistry of Health (BR). Ordinance No. 529, of April 1, 2013. Establishes the National Patient Safety Program (PNSP). Bras\\u0026iacute;lia: Ministry of Health. 2013. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt0529_01_04_2013.htm\\u003c/span\\u003e\\u003cspan address=\\\"https://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt0529_01_04_2013.htm\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e. Accessed 14 Jan 2026.\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eWorld Health Organization. World Patient Safety Day 2023: engaging patients for patient safety. Geneva: World Health Organization. 2023. 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Health Aff. 2013;32(2):223\\u0026ndash;31. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1377/hlthaff.2012.1133\\u003c/span\\u003e\\u003cspan address=\\\"10.1377/hlthaff.2012.1133\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e.\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eKhan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, et al. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. 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National Health Council. Resolution No. 466, of December 12. 2012. Bras\\u0026iacute;lia: Ministry of Health; 2012. Available from: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf\\u003c/span\\u003e\\u003cspan address=\\\"https://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e. Accessed 29 Jan 2026.\\u003c/span\\u003e\\u003c/li\\u003e\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":false,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":false,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"bmc-health-services-research\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"bhsr\",\"sideBox\":\"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)\",\"snPcode\":\"\",\"submissionUrl\":\"https://www.editorialmanager.com/BHSR/default.aspx\",\"title\":\"BMC Health Services Research\",\"twitterHandle\":\"BMC_series\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"em\",\"reportingPortfolio\":\"BMC Series\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":true},\"keywords\":\"Patient safety, Patient participation, Patient-centered care, Quality of health care, Translating, Validation study\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-8888829/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-8888829/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003ch2\\u003eBackground\\u003c/h2\\u003e \\u003cp\\u003ePatient safety is highlighted as a global health challenge, requiring changes and the implementation of initiatives to minimize risks, prevent care failures, and avoid harm to patients. Patient engagement has been one of the most recommended strategies for improving the quality and safety of care. To understand and monitor this practice, the Patient Engagement in Patient Safety within Canadian Healthcare Organizations tool was developed to self-assess the nature of patient engagement in patient safety at the systemic level in healthcare organizations. To enable research on this topic in Brazilian health organizations, the objective of this study was to produce a cross-culturally adapted Brazilian Portuguese version of this instrument, with content validation, for use in Brazil.\\u003c/p\\u003e\\u003ch2\\u003eMethods\\u003c/h2\\u003e \\u003cp\\u003eThis was a methodological study developed in two phases. The first consisted of the cross-cultural adaptation of the instrument to Portuguese and followed six stages: preparation, translation, back-translation, pre-test with nine health organizations, review, and documentation. Equivalences were analyzed using the coefficient of agreement. The second phase involved content validation using the Delphi technique, with a committee of experts (n\\u0026thinsp;=\\u0026thinsp;7), including partner patient, in two sequential rounds, measuring the Content Validity Index (CVI) and inter-rater agreement (IRA).\\u003c/p\\u003e\\u003ch2\\u003eResults\\u003c/h2\\u003e \\u003cp\\u003eIn the cross-cultural adaptation, 97.9% of the items were considered equivalent by 100% of the evaluators. Items with agreement below 90% were discussed until consensus was reached. In the content validation, most items had acceptable CVI (99.6%) and IRA (99.0%) in terms of comprehensiveness, clarity, and relevance. Items with unsatisfactory values were modified, reassessed, and, after approval by all experts, the instrument was finalized and made available for use in Brazil.\\u003c/p\\u003e\\u003ch2\\u003eConclusions\\u003c/h2\\u003e \\u003cp\\u003eThe instrument is a reliable and valid tool to investigate patient engagement in patient safety in Brazilian health organizations.\\u003c/p\\u003e\",\"manuscriptTitle\":\"Validation of the first Brazilian instrument for patient engagement in patient safety\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2026-03-28 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