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Objectives: To explore speaking up behaviours, barriers to openly expressing patient safety concerns, and perceived psychological safety climate in the clinical setting in which healthcare trainees from Ibero-America were receiving their practical training. Methods: Cross-sectional survey of healthcare trainees from Colombia, Mexico, and Spain (N = 1,152). Before the field study, the Speaking Up About Patient Safety Questionnaire (SUPS-Q) was translated into Spanish and assessed for face validity. A confirmatory factor analysis was conducted to establish the construct validity of the instrument, and the reliability was assessed. The SUPS-Q was used to evaluate voice behaviours and the perceived psychological safety climate among Ibero-American trainees. Descriptive and frequency analyses, tests for contrasting means and proportions, and logistic regression analyses were performed. Results: Seven hundred and seventy-one trainees had experience in clinical settings. In the previous month, 88.3% had experienced patient safety concerns, and 68.9% had prevented a colleague from making an error. More than a third had remained silent in a risky situation. Perceiving concerns, being male or nursing student, and higher scores on the encouraging environment scale were associated with speaking up. Conclusion: Patient safety concerns were frequent among Ibero-American healthcare trainees and often silenced by personal and cultural barriers. Training in speaking up and fostering safe interprofessional spaces is crucial.

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BACKGROUND: Patient safety is a fundamental aspect of health care practice across global health systems. Safe practices, which include incident reporting systems, have proven valuable in preventing the recurrence of safety incidents. However, the accessibility of this tool for health care discipline students is not consistent, limiting their acquisition of competencies. In addition, there is no tools to familiarize students with analyzing safety incidents. Gamification has emerged as an effective strategy in health care education. OBJECTIVE: This study aims to develop an incident reporting system tailored to the specific needs of health care discipline students, named Safety Incident Report System for Students. Secondary objectives included studying the performance of different groups of students in the use of the platform and training them on the correct procedures for reporting. METHODS: This was an observational study carried out in 3 phases. Phase 1 consisted of the development of the web-based platform and the incident registration form. For this purpose, systems already developed and in use in Spain were taken as a basis. During phase 2, a total of 223 students in medicine and nursing with clinical internships from universities in Argentina, Brazil, Colombia, Ecuador, and Spain received an introductory seminar and were given access to the platform. Phase 3 ran in parallel and involved evaluation and feedback of the reports received as well as the opportunity to submit the students' opinion on the process. Descriptive statistics were obtained to gain information about the incidents, and mean comparisons by groups were performed to analyze the scores obtained. RESULTS: The final form was divided into 9 sections and consisted of 48 questions that allowed for introducing data about the incident, its causes, and proposals for an improvement plan. The platform included a personal dashboard displaying submitted reports, average scores, progression, and score rankings. A total of 105 students participated, submitting 147 reports. Incidents were mainly reported in the hospital setting, with complications of care (87/346, 25.1%) and effects of medication or medical products (82/346, 23.7%) being predominant. The most repeated causes were related confusion, oversight, or distractions (49/147, 33.3%) and absence of process verification (44/147, 29.9%). Statistically significant differences were observed between the mean final scores received by country (P<.001) and sex (P=.006) but not by studies (P=.47). Overall, participants rated the experience of using the Safety Incident Report System for Students positively. CONCLUSIONS: This study presents an initial adaptation of reporting systems to suit the needs of students, introducing a guided and inspiring framework that has garnered positive acceptance among students. Through this endeavor, a pathway toward a safety culture within the faculty is established. A long-term follow-up would be desirable to check the real benefits of using the tool during education. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov NCT05350345; https://clinicaltrials.gov/study/NCT05350345.

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BACKGROUND: The COVID-19 pandemic has generated immense health care pressure, forcing critical decisions to be made in a socially alarmed environment. Adverse conditions have led to acute stress reactions, affective pathologies, and psychosomatic reactions among health personnel, which have been exacerbated by the successive waves of the pandemic. The recovery of the entire health system and its professionals has been hindered, making it essential to increase their resilience. OBJECTIVE: This study aimed to achieve 2 primary objectives. First, it sought to identify coping strategies, both individual and organizational, used by health care workers in Ecuador to navigate the acute stress during the early waves of the pandemic. Second, it aimed to develop training materials to enhance team leaders' capabilities in effectively managing high-stress situations. METHODS: The study used qualitative research techniques to collect information on institutional and personal coping strategies, as well as consensus-building techniques to develop a multimedia psychological tool that reinforces the resilience of professionals and teams in facing future crises. RESULTS: The findings from the actions taken by health care workers in Ecuador were categorized into 4 types of coping strategies based on Lazarus' theories on coping strategies. As a result of this study, a new audiovisual tool was created, comprising a series of podcasts, designed to disseminate these strategies globally within the Spanish-speaking world. The tool features testimonials from health care professionals in Ecuador, narrating their experiences under the pressures of providing care during the pandemic, with a particular emphasis on the coping strategies used. CONCLUSIONS: Ensuring the preparedness of health professionals for potential future outbreaks is imperative to maintain quality and patient safety. Interventions such as this one offer valuable insights and generate new tools for health professionals, serving as a case study approach to train leaders and improve the resilience capacity and skills of their teams.

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INTRODUCTION: Diabetes is the second leading cause of death in Ecuador, as 79% of the indigenous population live in rural areas that are difficult to access and have below-average health resources. The objective of this study was to define person-centred indicators to monitor the care received by patients with diabetes in the indigenous population. METHOD: Qualitative research combining three focus groups (with the participation of 10 patients and 18 professionals) to capture relevant information and Delphi to reach a consensus on the pertinence, relevance, and feasibility of a set of indicators was conducted. Two rounds of the Delphi technique were performed, with the participation of 64 professionals in the first round (90% response rate) and 34 in the second round (53% response rate). RESULTS: A total of 23 indicators were identified which were distributed in the previously identified six dimensions (cosmovision, accessibility, adaptability to cosmovision, resources, equipment, community care, quality culture and results). CONCLUSIONS: The consensus on the set of indicators among all the participants in this study strengthened the results obtained. These indicators have considered the feasibility and relevance and aimed to achieve comprehensive person-centred care for diabetes among the indigenous population in Ecuador and possibly the Andean community. PATIENT OR PUBLIC CONTRIBUTION: These indicators' development included patients and caregivers since its conception. During the qualitative phase of this research, relevant information on cultural and social beliefs was gathered directly from the study population to achieve patient-centred indicators for adequate diabetes care.

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This study analyzed the frequency and intensity of acute stress among health professionals caring for COVID-19 patients in four Latin American Spanish-speaking countries during the outbreak. A cross-sectional study involved a non-probability sample of healthcare professionals in four Latin American countries. Participants from each country were invited using a platform and mobile application designed for this study. Hospital and primary care workers from different services caring for COVID-19 patients were included. The EASE Scale (SARS-CoV-2 Emotional Overload Scale, in Spanish named Escala Auto-aplicada de Sobrecarga Emocional) was a previously validated measure of acute stress. EASE scores were described overall by age, sex, work area, and experience of being ill with COVID-19. Using the Mann-Whitney U test, the EASE scores were compared according to the most critical moments of the pandemic. Univariate and multivariate analysis was performed to investigate associations between these factors and the outcome 'acute stress'. Finally, the Kruskal-Wallis was used to compare EASE scores and the experience of being ill. A total of 1372 professionals responded to all the items in the EASE scale: 375 (27.3%) Argentines, 365 (26.6%) Colombians, 345 (25.1%) Chileans, 209 (15.2%) Ecuadorians, and 78 (5.7%) from other countries. 27% of providers suffered middle-higher acute stress due to the outbreak. Worse results were observed in moments of peak incidence of cases (14.3 ± 5.3 vs. 6.9 ± 1.7, p < 0.05). Higher scores were found in professionals in COVID-19 critical care (13 ± 1.2) than those in non-COVID-19 areas (10.7 ± 1.9) (p = 0.03). Distress was higher among professionals who were COVID-19 patients (11.7 ± 1) or had doubts about their potential infection (12 ± 1.2) compared to those not infected (9.5 ± 0.7) (p = 0.001). Around one-third of the professionals experienced acute stress, increasing in intensity as the incidence of COVID-19 increased and as they became infected or in doubt whether they were infected. EASE scale could be a valuable asset for monitoring acute stress levels among health professionals in Latin America.ClinicalTrials: NCT04486404.

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INTRODUCTION: The global prevalence of diabetes in 2019 in adults was estimated to be 9.3%. This study developed in Ecuador, for the first time, instruments to assess patient-reported outcomes and experiences. METHODS: The Experiences of the Person with Diabetes (EPD) Questionnaire is a diabetes-specific instrument. A mixed-methods study was conducted. First, a qualitative item development phase that included four focus groups and six semi-structured interviews with patients was conducted in different rural and urban areas of Ecuador to obtain information on culture, beliefs, demographics, diet and social perspectives. A second quantitative phase for psychometric validation was carried out in primary care settings of rural and urban areas of Ecuador. RESULTS: Forty-two and four hundred and eighty-nine participants were included in each phase, respectively. The item development phase resulted in a questionnaire of 44 items (23 for perceived outcomes and 21 for experiences). In the validation study, most participants were women (58%) and from urban areas (57%). Exploratory factor analysis revealed three dimensions for each instrument. Outcomes instrument dimensions were symptoms and burnout, worries and fears and social limitations. Experiences instrument dimensions were information, patient-centred care and care delivery. Cronbach's α values of the total score and dimensions were high, ranging between .81 and .93 in both instruments. Confirmatory factor analysis showed an acceptable fit of the data. CONCLUSION: The EPD Questionnaire is probably the first instrument developed to assess patient-reported experiences and perceived outcomes in a middle-income country that included patients to capture all dimensions relevant for the intended population. Its psychometric properties are robust and could provide valuable information for clinicians and policymakers in the region. PATIENT OR PUBLIC CONTRIBUTION: The development of these instruments has taken into consideration patients and the public since their conception. A qualitative approach gathered relevant information related to the cultural, social and economic burden of different populations in Ecuador. Before validation, a pilot test was carried out with users of the National Health Services to obtain their perspectives and insights of the developed instrument. Finally, during the data analysis, we have given special consideration to social variables such as rural and urban populations.

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[EXCERPT]. Analyzing the causes of unsafe care can reduce the number of ‘near misses’ (incidents that may cause harm to patients) and adverse events (that actually produce harm). This is an important mandate for health care organizations committed to providing a safe environment for patients. Although guaranteeing absolute safety in all interventions is not always possible, hospitals and other health care institutions implement safety practices and surveillance methods to understand how these unsafe incidents occur. In many cases, these incidents were not generated by a single cause; and remote causes are as significant as more proximate ones...

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OBJECTIVE: To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. METHODS: In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. RESULTS: The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. CONCLUSIONS: The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

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OBJECTIVE: To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. METHODS: In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimatedfor each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. RESULTS: The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. CONCLUSIONS: The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

OBJETIVO: Diseñar y validar un cuestionario de evaluación de las actitudes y los conocimientos en materia de seguridad del paciente con una muestra de estudiantes de medicina y enfermería que reciben formación médica en Espana y en cuatro países de América Latina. MÉTODOS: En este estudio transversal se llevó a cabo una revisión bibliográfica y se encuestó a un total de 786 estudiantes de medicina y enfermería de ocho universidades de cinco países (Chile, Colombia, El Salvador, Espana y Guatemala) con objeto de elaborar y corregir un cuestionario en espanol sobre conocimientos y actitudes en materia de seguridad del paciente. El ámbito del cuestionario se basó en cinco dimensiones (factores) presentadas en estudios relacionados con la cultura de la seguridad del paciente encontrados en PubMed y Scopus. Con base en los cinco factores, se elaboraron 25 ítems reactivos. Se calcularon los índices de fiabilidad compuesta y alfa de Cronbach para cada factor, y se realizó un análisis factorial confirmatorio para evaluar la validez. Tras una prueba piloto se corrigió el cuestionario mediante modelos confirmatorios, el cálculo de la máxima probabilidad y la matriz de variancia-covariancia (como insumo). Se utilizaron modelos de regresión lineal múltiple para confirmar la validez externa, considerando las variables relacionadas con la cultura de seguridad del paciente como variables dependientes y los cinco factores como variables independientes. RESULTADOS: El instrumento final fue una encuesta autoadministrada mediante escala de Likert estructurada en cinco puntos ("Cuestionario de Seguridad del Paciente para Estudiantes Latinos"), que consta de 21 ítems agrupados en cinco factores. Los índices de fiabilidad compuesta (prueba estadística de alfa de Cronbach) calculados para los cinco factores fueron aproximadamente de 0,7 o superiores. Los resultados de los análisis de regresión lineal múltiple indicaron un buen ajuste del modelo (índice de bondad de ajuste: 0,9). Las correlaciones ítem-total fueron superiores a 0,3 en todos los casos. La validez convergente y discriminatoria fue adecuada. CONCLUSIONES: El cuestionario disenado y validado en este estudio evalúa las actitudes y los conocimientos de los estudiantes de enfermería y medicina en materia de seguridad del paciente. Este instrumento podría utilizarse para evaluar indirectamente si los estudiantes de disciplinas de la salud están adquiriendo, y por lo tanto, es probable que pongan en práctica, las habilidades profesionales consideradas actualmente como más apropiadas para la seguridad del paciente.

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Objetivo. Diseñar y validar un cuestionario de evaluación de las actitudes y los conocimientos en materia de seguridad del paciente con una muestra de estudiantes de medicina y enfermería que reciben formación médica en España y en cuatro países de América Latina. Métodos. En este estudio transversal se llevó a cabo una revisión bibliográfica y se encuestó a un total de 786 estudiantes de medicina y enfermería de ocho universidades de cinco países (Chile, Colombia, El Salvador, España y Guatemala) con objeto de elaborar y corregir un cuestionario en español sobre conocimientos y actitudes en materia de seguridad del paciente. El ámbito del cuestionario se basó en cinco dimensiones (factores) presentadas en estudios relacionados con la cultura de la seguridad del paciente encontrados en PubMed y Scopus. Con base en los cinco factores, se elaboraron 25 ítems reactivos. Se calcularon los índices de fiabilidad compuesta y alfa de Cronbach para cada factor, y se realizó un análisis factorial confirmatorio para evaluar la validez. Tras una prueba piloto se corrigió el cuestionario mediante modelos confirmatorios, el cálculo de la máxima probabilidad y la matriz de variancia-covariancia (como insumo). Se utilizaron modelos de regresión lineal múltiple para confirmar la validez externa, considerando las variables relacionadas con la cultura de seguridad del paciente como variables dependientes y los cinco factores como variables independientes. Resultados. El instrumento final fue una encuesta autoadministrada mediante escala de Likert estructurada en cinco puntos (“Cuestionario de Seguridad del Paciente para Estudiantes Latinos”), que consta de 21 ítems agrupados en cinco factores. Los índices de fiabilidad compuesta (prueba estadística de alfa de Cronbach) calculados para los cinco factores fueron aproximadamente de 0,7 o superiores. Los resultados de los análisis de regresión lineal múltiple indicaron un buen ajuste del modelo (índice de bondad de ajuste: 0,9). Las correlaciones ítem-total fueron superiores a 0,3 en todos los casos. La validez convergente y discriminatoria fue adecuada. Conclusiones. El cuestionario diseñado y validado en este estudio evalúa las actitudes y los conocimientos de los estudiantes de enfermería y medicina en materia de seguridad del paciente. Este instrumento podría utilizarse para evaluar indirectamente si los estudiantes de disciplinas de la salud están adquiriendo, y por lo tanto, es probable que pongan en práctica, las habilidades profesionales consideradas actualmente como más apropiadas para la seguridad del paciente.

Objective. To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. Methods. In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach’s alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance–covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. Results. The final instrument was a structured five-point Likert self-administered survey (the “Latino Student Patient Safety Questionnaire”) consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach’s alpha statistic) calculated for the ive factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item–total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. Conclusions. The questionnaire designed and validated in this study assesses nursing and medical students’ attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

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OBJETIVO: Analizar la frecuencia de errores de medicación que son cometidos e informados por los pacientes. MÉTODOS: Estudio descriptivo basado en encuestas telefónicas a una muestra aleatoria de pacientes adultos del nivel primario de salud del sistema público español. Respondieron un total de 1 247 pacientes (tasa de respuesta, 75 por ciento). El 63 por ciento eran mujeres y 29 por ciento eran mayores de 70 años. RESULTADOS: Mientras 37 pacientes (3 por ciento, IC 95 por ciento: 2-4) sufrieron complicaciones asociadas a la medicación en el curso del tratamiento, 241 (19,4 por ciento, IC 95 por ciento: 17-21) informaron haber cometido algún error con la medicación. Un menor tiempo de consulta (P < 0,01) y una peor valoración de la información proporcionada por el médico (P < 0,01) se asociaron al hecho de que en la dispensación en la farmacia le indicaran al paciente que el tratamiento prescrito no era apropiado. CONCLUSIONES: A los riesgos conocidos de sufrir un evento adverso, fruto de la intervención sanitaria por error del sistema o del profesional, hay que sumar los asociados a los errores de los pacientes en la autoadministración de la medicación. Los pacientes insatisfechos con la información proporcionada por el médico informaron un mayor número de errores.

OBJECTIVE: Analyze the frequency of medication errors committed and reported by patients. METHODS: Descriptive study based on a telephone survey of a random sample of adult patients from the primary care level of the Spanish public health care system. A total of 1 247 patients responded (75 percent response rate); 63 percent were women and 29 percent were older than 70 years. RESULTS: While 37 patients (3 percent, 95 percent CI: 2-4) experienced complications associated with medication in the course of treatment, 241 (19.4 percent, 95 percent CI: 17-21) reported having made some mistake with their medication. A shorter consultation time (P < 0.01) and a worse assessment of the information provided by the physician (P < 0.01) were associated with the fact that during pharmacy dispensing the patient was told that the prescribed treatment was not appropriate. CONCLUSIONS: In addition to the known risks of an adverse event due to a health intervention resulting from a system or practitioner error, there are risks associated with patient errors in the self-administration of medication. Patients who were unsatisfied with the information provided by the physician reported a greater number of errors.

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