A framework for action to improve patient and public involvement in health technology assessment.

BACKGROUND: Patient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for "social participation." This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA. METHODS: This work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework. RESULTS: According to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies. CONCLUSIONS: Since the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.

Patient Organizations' Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation.

INTRODUCTION: European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. AIM: The aim of this study was to understand patient organizations' perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. METHODS: A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. RESULTS: The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. CONCLUSION: Both study phases show congruent results regarding patients' involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.

Decision Making in Psychiatric Patients: A Qualitative Study with Focus Groups. / Toma de decisiones en pacientes psiquiátricos: un estudio cualitativo con grupos focales.

INTRODUCTION: It has been said that mental illnesses are characterised by poor decision making; there is some neuroscientific evidence of specific alterations in performance in decision making tests, but little is known about how patients make choices about their own treatments. METHODS: Focus groups with patients from two psychiatric clinics, with discourse analysis. RESULTS: Five deductive categories (tools, capacity, therapeutic relationship, method and family and network), plus one additional category from the analysis (stigma), and 35 inductive (posterior) categories were considered. The categories are analysed and the findings presented. CONCLUSIONS: Patients express a need for greater participation in decisions about their treatment, and a more symmetrical psychiatrist-patient relationship, involving families. Decisions may be changed due to stigma, barriers to treatment access, and previous experiences.

An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.

BACKGROUND: Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. HYPOTHESIS: Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. DESIGN: The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy. SUMMARY: The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

Reflective study on participatory diagnosis as a community research strategy.

OBJECTIVES: to conceive a theoretical-reflective discussion about participatory diagnosis as a methodological option in participatory research. METHODS: this is a reflection study, based on an experience that used participatory diagnosis as a research strategy in a socially vulnerable community. It was intended to implicate social groups in the search for identification and solution to the problems. RESULTS: the use of participatory diagnosis has provided significant results regarding the importance given by participants to community empowerment in the fight for health, quality of life and social empowerment. FINAL CONSIDERATIONS: participatory research and its relationship to participatory diagnosis favors the understanding of social issues, including health conditions, education and effective participation in problem solving.

Evaluation of user embracement software with pediatric risk classification.

OBJECTIVE: to evaluate functional performance and technical quality of user embracement software with pediatric risk classification. METHOD: descriptive exploratory study developed based on the quality requirements set forth in ISO/IEC 25010. The evaluated characteristics were: functional adequacy, reliability, usability, performance efficiency, compatibility, safety, maintainability and portability. Eight specialists from the area of informatics and 13 from nursing participated in the evaluation. The characteristics were considered adequate when they reached more than 70% of indication as very and/or completely appropriate in the evaluations of each group of specialists. RESULTS: The results obtained from the evaluation of informatics and nursing specialists were: functional adequacy (100.0%, 96.2%), reliability (82.6%, 88.5%), usability (84.9%; 98.7%), performance efficiency (93.4%; 96.2%), compatibility (85.0%, 98.1%), safety (91.7%, 100.0%), and, yet, maintainability (95.0%) and portability (87.5%) evaluated by the first ones. CONCLUSION: the software was considered adequate regarding technical quality and functional performance.

Evaluation of user embracement software with pediatric risk classification / Evaluación del software para el acogimiento con clasificación de riesgo en pediatria / Avaliação de software para acolhimento com classificação de risco em pediatria

ABSTRACT Objective: to evaluate functional performance and technical quality of user embracement software with pediatric risk classification. Method: descriptive exploratory study developed based on the quality requirements set forth in ISO/IEC 25010. The evaluated characteristics were: functional adequacy, reliability, usability, performance efficiency, compatibility, safety, maintainability and portability. Eight specialists from the area of informatics and 13 from nursing participated in the evaluation. The characteristics were considered adequate when they reached more than 70% of indication as very and/or completely appropriate in the evaluations of each group of specialists. Results: The results obtained from the evaluation of informatics and nursing specialists were: functional adequacy (100.0%, 96.2%), reliability (82.6%, 88.5%), usability (84.9%; 98.7%), performance efficiency (93.4%; 96.2%), compatibility (85.0%, 98.1%), safety (91.7%, 100.0%), and, yet, maintainability (95.0%) and portability (87.5%) evaluated by the first ones. Conclusion: the software was considered adequate regarding technical quality and functional performance.

RESUMEN Objetivo: evaluar el desempeño funcional y la calidad técnica del software para el acogimiento con clasificación de riesgo en pediatría. Método: estudio exploratorio descriptivo, fundamentado en los requisitos de calidad dispuestos en la norma ISO/IEC 25.010. Las siguientes características fueron evaluadas: adecuación funcional, confiabilidad, facilidad de uso, eficiencia del desempeño, compatibilidad, seguridad, manutención y portabilidad. En la evaluación participaron 8 expertos en el área de informática y 13 en enfermería. Se consideradon adecuadas las características cuando habían alcanzado más del 70,0% de indicación como "muy y/o completamente apropiadas" en las evaluaciones de cada grupo de expertos. Resultados: Los resultados obtenidos a partir de la evaluación de los expertos en informática y en enfermería fueron respectivamente: adecuación funcional (100,0%; 96,2%); confiabilidad (82,6%; 88,5%); facilidad de uso (84,9%; 98,7%); eficiencia del desempeño (93,4%; 96,2%); compatibilidad (85,0%; 98,1%); seguridad (91,7%; 100,0%); y también manutención (95,0%) y portabilidad (87,5%) evaluados por los primeros. Conclusión: se observó que el software es adecuado en relación con la calidad técnica y el rendimiento funcional.

RESUMO Objetivo: avaliar desempenho funcional e qualidade técnica de software para acolhimento com classificação de risco em pediatria. Método: estudo exploratório descritivo desenvolvido com base nos quesitos de qualidade dispostos na norma ISO/IEC 25010. As características avaliadas foram: adequação funcional, confiabilidade, usabilidade, eficiência de desempenho, compatibilidade, segurança, manutenibilidade e portabilidade. Participaram da avaliação oito especialistas da área de informática e 13 de enfermagem. As características foram consideradas adequadas quando atingiram mais de 70,0% de indicação como muito e/ou completamente apropriadas nas avaliações de cada grupo de especialistas. Resultados: Os resultados obtidos a partir da avaliação dos especialistas de informática e de enfermagem foram respectivamente: adequação funcional (100,0%; 96,2%), confiabilidade (82,6%; 88,5%), usabilidade (84,9%; 98,7%), eficiência de desempenho (93,4%; 96,2%), compatibilidade (85,0%; 98,1%), segurança (91,7%; 100,0%), e, ainda, manutenibilidade (95,0%) e portabilidade (87,5%) avaliados pelos primeiros. Conclusão: o software foi considerado adequado em relação à qualidade técnica e ao desempenho funcional.

Use of a smartphone app combined with gamification to increase the level of physical activity of adults and older adults: protocol of a sequential multiple assignment randomized trial.

BACKGROUND: There is scientific evidence suggesting that app-based interventions targeted to increase the level of physical activity might be effective, although multicomponent interventions appear to be more effective than app-based interventions alone. Despite the motivating results, it remains unclear whether or not app-based interventions can increase the level of physical activity and cardiovascular health. Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults. The specific aims are (1) to verify the effects of the intervention on cardiometabolic and cardiovascular health, lung function, and cardiorespiratory fitness; and (2) to verify the relationship between age group and the response rate. METHODS/DESIGN: We will conduct a sequential multiple assignment randomized trial (SMART). The adaptive intervention protocol will last 6 months. After baseline assessments, participants will be randomized into one of three groups (group 1: app + tailored messages; group 2: app + tailored messages + gamification I; control group: physical activity counseling). For 12 weeks, we will record the average number of steps per day of participants from groups 1 and 2. At 6 weeks from initiation of recording, participants will be classified into responders and non-responders according to their increase in the average number of daily steps; all those considered as non-responders will be re-randomized, with the chance to participate in a third group - group 3: app + tailored messages + gamification II. Finally, at 12 weeks, participants will continue using the app but will no longer receive direct intervention from investigators. All participants will be reassessed at 3 and 6 months from baseline. Our pilot SMART will require 42 participants (14 per arm). Following the SMART pilot, we will calculate the sample size for the trial based on the variation of the average number of steps/day, including an up to 40% loss to follow-up and a less optimistic nonresponse rate of 65%. DISCUSSION: To our knowledge, this will be the first trial with adaptive intervention to test the effectiveness of using a smartphone app to increase the level of physical activity of adults and older adults. TRIAL REGISTRATION: Brazilian Clinical Trials Registry: RBR-8xtc9c. Registered on 3 August 2018, http://www.ensaiosclinicos.gov.br; UTN number: U1111-1218-1092.

Adolescent patients and the clinical decision about their health / O paciente adolescente e a deliberação clínica sobre a sua saúde

ABSTRACT Objective: To carry out a review of the literature on adolescents' participation in decision making for their own health. Data sources: Review in the Scientific Electronic Library Online (SciELO), Latin American and Caribbean Health Sciences Literature (LILACS) and PubMed databases. We consider scientific articles and books between 1966 and 2017. Keywords: adolescence, autonomy, bioethics and adolescence, autonomy, ethics, in variants in the English, Portuguese and Spanish languages. Inclusion criteria: scientific articles, books and theses on clinical decision making by the adolescent patient. Exclusion criteria: case reports and articles that did not address the issue. Among 1,590 abstracts, 78 were read in full and 32 were used in this manuscript. Data synthesis: The age at which the individual is able to make decisions is a matter of debate in the literature. The development of a cognitive and psychosocial system is a time-consuming process and the integration of psychological, neuropsychological and neurobiological research in adolescence is fundamental. The ability to mature reflection is not determined by chronological age; in theory, a mature child is able to consent or refuse treatment. Decision-making requires careful and reflective analysis of the main associated factors, and the approach of this problem must occur through the recognition of the maturity and autonomy that exists in the adolescents. To do so, it is necessary to "deliberate" with them. Conclusions: International guidelines recommend that adolescents participate in discussions about their illness, treatment and decision-making. However, there is no universally accepted consensus on how to assess the decision-making ability of these patients. Despite this, when possible, the adolescent should be included in a serious, honest, respectful and sincere process of deliberation.

RESUMO Objetivo: Realizar uma revisão da literatura sobre a participação do adolescente na tomada de decisão sobre a sua saúde. Fonte de dados: Revisão nos bancos Scientific Electronic Library Online (SciELO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) e PubMed. Consideramos artigos científicos e livros entre 1966 e 2017. Palavras-chave: adolescência, autonomia, bioética e adolescência, autonomia, ética, em línguas inglesa, portuguesa e espanhola. Critérios de inclusão: artigos científicos, livros e dissertações que contemplassem a tomada de decisão clínica pelo paciente adolescente. Critérios de exclusão: relatos de caso e artigos que não abordavam a questão norteada nesta pesquisa. Do total de 1.590 resumos, 78 foram lidos na íntegra, e 36, utilizados neste manuscrito. Síntese dos dados: A idade em que o indivíduo é capaz para tomar decisões é motivo de debate na literatura. O desenvolvimento de um sistema cognitivo e psicossocial é um processo demorado, e faz-se fundamental a integração da investigação psicológica, neuropsicológica e neurobiológica na adolescência. A capacidade de reflexão madura não é determinada pela idade cronológica; em teoria, um menor maduro seria capaz de consentir ou recusar um tratamento. A tomada de decisão exige análise cuidadosa e reflexiva dos principais fatores associados, e a abordagem desse problema deve ocorrer por meio do reconhecimento da maturidade e da autonomia que existe no adolescente. Para tanto, é necessário "deliberar" com ele. Conclusões: Diretrizes internacionais recomendam que os adolescentes participem de discussões sobre sua doença, tratamento e tomada de decisão, entretanto não há nenhum consenso universalmente aceito sobre como avaliar a capacidade de decisão desses pacientes. Apesar disso, quando possível, o adolescente deve ser incluído em um processo sério, honesto, respeitoso e sincero de deliberação.

Predicting intention to participate in self-management behaviors in patients with Familial Hypercholesterolemia: A cross-national study.

RATIONALE: Familial Hypercholesterolemia (FH) is a genetic condition that predisposes patients to substantially increased risk of early-onset atherosclerotic cardiovascular disease. FH risks can be minimized through regular participation in three self-management. BEHAVIORS: physical activity, healthy eating, and taking cholesterol lowering medication. OBJECTIVE: The present study tested the effectiveness of an integrated social cognition model in predicting intention to participate in the self-management behaviors in FH patients from seven countries. METHOD: Consecutive patients in FH clinics from Australia, Hong Kong, Brazil, Malaysia, Taiwan, China, and UK (total N = 726) completed measures of social cognitive beliefs about illness from the common sense model of self-regulation, beliefs about behaviors from the theory of planned behavior, and past behavior for the three self-management behaviors. RESULTS: Structural equation models indicated that beliefs about behaviors from the theory of planned behavior, namely, attitudes, subjective norms, and perceived behavioral control, were consistent predictors of intention across samples and behaviors. By comparison, effects of beliefs about illness from the common sense model were smaller and trivial in size. Beliefs partially mediated past behavior effects on intention, although indirect effects of past behavior on intention were larger for physical activity relative to taking medication and healthy eating. Model constructs did not fully account for past behavior effects on intentions. Variability in the strength of the beliefs about behaviors was observed across samples and behaviors. CONCLUSION: Current findings outline the importance of beliefs about behaviors as predictors of FH self-management behaviors. Variability in the relative contribution of the beliefs across samples and behaviors highlights the imperative of identifying sample- and behavior-specific correlates of FH self-management behaviors.

ADOLESCENT PATIENTS AND THE CLINICAL DECISION ABOUT THEIR HEALTH.

OBJECTIVE: To carry out a review of the literature on adolescents' participation in decision making for their own health. DATA SOURCES: Review in the Scientific Electronic Library Online (SciELO), Latin American and Caribbean Health Sciences Literature (LILACS) and PubMed databases. We consider scientific articles and books between 1966 and 2017. Keywords: adolescence, autonomy, bioethics and adolescence, autonomy, ethics, in variants in the English, Portuguese and Spanish languages. Inclusion criteria: scientific articles, books and theses on clinical decision making by the adolescent patient. Exclusion criteria: case reports and articles that did not address the issue. Among 1,590 abstracts, 78 were read in full and 32 were used in this manuscript. DATA SYNTHESIS: The age at which the individual is able to make decisions is a matter of debate in the literature. The development of a cognitive and psychosocial system is a time-consuming process and the integration of psychological, neuropsychological and neurobiological research in adolescence is fundamental. The ability to mature reflection is not determined by chronological age; in theory, a mature child is able to consent or refuse treatment. Decision-making requires careful and reflective analysis of the main associated factors, and the approach of this problem must occur through the recognition of the maturity and autonomy that exists in the adolescents. To do so, it is necessary to "deliberate" with them. CONCLUSIONS: International guidelines recommend that adolescents participate in discussions about their illness, treatment and decision-making. However, there is no universally accepted consensus on how to assess the decision-making ability of these patients. Despite this, when possible, the adolescent should be included in a serious, honest, respectful and sincere process of deliberation.

"No Estas Solo": Navigation Programs Support Engagement in HIV Care for Mexicans and Puerto Ricans Living in the Continental U.S.

A range of social and structural barriers continue to impede timely diagnosis and consistent access to care for Latinos living with HIV in the U.S. Navigation programs have helped other populations overcome comparable barriers to care. This qualitative paper examined nine navigation programs that were culturally tailored for Mexicans or Puerto Ricans, using a transnational framework that situated clients in the context of lives that bridge the U.S. and their countries of origin. We completed in-depth semi-structured interviews with 48 clients and 27 intervention providers. A framework approach guided analysis. We identified two overarching themes: developing trusting and supportive relationships between navigators and clients and empowering clients to connect and stay in primary care, which summarized the impact of the interventions on participants' lives and the approaches used to increase their care engagement. Our findings highlight the importance of tailoring intervention strategies to the unique experiences of specific Latino populations.

Community assembly as a promotion of participatory management in healthcare.

OBJECTIVE: To report the participatory management experience of a Family Health Strategy by means of community assemblies. METHODS: Community assemblies were performed with the population of a Family Health Strategy center in the city of Criciúma/SC. The meetings occurred between 2016 and 2017, including health care professionals, managers, members of the organized civil society and the healthcare system clients. RESULTS: The activity enable us to rethink the teamwork process regarding the system of health appointment scheduling and the replication of this process for all the family health teams of the municipality. FINAL REMARKS: Participatory management provided opportunities for new collective spaces that facilitate the democratization of healthcare in order to mobilize the role of the health system client in the development of more welcoming, resolute and integral health practices.

Patients participation in pharmaceutical care consultations in Brazil.

Background The effectiveness of pharmaceutical care has already been evidenced in several studies and scenarios; the lack of patient's consultation has been little explored in the literature. Unprovided care is a missed opportunity to offer care to another individual who needs attention to their health. The need for investigation of missed consultations in a Brazilian pharmaceutical care service arises. Objective To evaluate the participation and characteristics of patients in pharmaceutical care consultations in a university outpatient unit in the Brazilian city of Divinópolis. Methods A descriptive study was carried out from a secondary source of information. The socio-demographic profile of the patients who were absent from the pharmacy consultations from January to December 2017 was outlined. Results Of the 832 scheduled appointments from January to December 2017, 501 were not attended by patients, revealing 60.2% missed consultations. The female gender was predominant, corresponding to 67.8% of the patients. A total of 63.8% of the absentees were over 60 years of age. Most of the patients had two comorbidities (32.5%) and came from an active identification by the Outpatient unit pharmacists (86.60%). Furthermore, the patients who were more absent from the consultations had their primary health care units farther away from the outpatient unit, and this could be one of the causes of the high number of absent patients from the pharmaceutical consultations. Conclusion The lack of participation in patient's consultations is high. It is necessary to articulate new strategies aimed at reducing absences from consultations, since this is a source of waste of financial resources and opportunities to improve the patients' health and quality of life.

Community assembly as a promotion of participatory management in healthcare / Asamblea comunitaria como promoción de la gestión participativa en salud / Assembleia comunitária como promoção da gestão participativa em saúde

ABSTRACT Objective: To report the participatory management experience of a Family Health Strategy by means of community assemblies. Methods: Community assemblies were performed with the population of a Family Health Strategy center in the city of Criciúma/SC. The meetings occurred between 2016 and 2017, including health care professionals, managers, members of the organized civil society and the healthcare system clients. Results: The activity enable us to rethink the teamwork process regarding the system of health appointment scheduling and the replication of this process for all the family health teams of the municipality. Final remarks: Participatory management provided opportunities for new collective spaces that facilitate the democratization of healthcare in order to mobilize the role of the health system client in the development of more welcoming, resolute and integral health practices.

RESUMEN Objetivo: Relatar la experiencia de gestión participativa de una Estrategia de Salud de la Familia (ESF) a través de las asambleas comunitarias. Método: Se realizaron asambleas comunitarias con la población adscrita de una Estrategia Salud de la Familia en el municipio de Criciúma / SC. Los encuentros ocurrieron entre los años 2016 y 2017 con la participación de profesionales de salud, gestores, representantes de la sociedad civil organizada y clientes. Resultados: La actividad permitió repensar el proceso de trabajo del equipo en cuanto a la forma de programación de consultas y la replicación de esta iniciativa en todos los equipos de Salud de la Familia del municipio. Consideraciones finales: La gestión participativa oportunizó nuevos espacios colectivos que posibilitaron la democratización de la salud para movilizar el protagonismo del cliente en la construcción de prácticas más acogedoras, resolutivas e integrales para la salud.

RESUMO Objetivo: Relatar a experiência de gestão participativa de uma Estratégia de Saúde da Família (ESF) por meio das assembleias comunitárias. Método: Foram realizadas assembleias comunitárias com a população adstrita de uma Estratégia Saúde da Família no município de Criciúma/SC. Os encontros aconteceram entre os anos de 2016 e 2017 envolvendo a participação de profissionais de saúde, gestores, representantes da sociedade civil organizada e usuários. Resultados: A atividade permitiu repensar o processo de trabalho da equipe no tocante a forma de agendamento de consultas e a replicação desta iniciativa em todas as equipes de Saúde da Família do município. Considerações finais: A gestão participativa oportunizou novos espaços coletivos que possibilitaram a democratização da saúde de forma a mobilizar o protagonismo do usuário na construção de práticas mais acolhedoras, resolutivas e integrais para a saúde.

Psychometric validation of an empowerment scale for Spanish-speaking patients with rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) knowledge has been constructed with studies performed in Caucasians patients; Latin American patients present unique characteristics. Empowerment is a social multidimensional construct that has been associated to better health-related quality of life in RA. There is no validated instrument for use with Spanish-speaking patients. The objective of the study was to adapt the Spanish version of the Health Empowerment Scale (S-HES), which was selected for its psychometric properties and suitability for low-literacy populations, for RA Hispanic patients (RAEH), and to perform its psychometric validation. METHODS: RAEH adaptation, pilot testing, and psychometric validation were performed. Three convenience samples of RA outpatients from a national tertiary care level center were used. For RAEH adaptation, the word "health" was substituted with "RA" in the original S-HES, integrated by 8 items. Pilot testing (in 50 patients) assessed feasibility. Psychometric validation included content validity (nine experts rated item convenience, clarity, and cultural semantic accuracy), internal consistency (in 200 patients, Cronbach's alpha) and test-retest (in a subsample of 50 patients, ICC and 95% CI), construct validity (factor analysis), and face validity (in 20 patients, % of agreement). Patients gave written informed consent. RESULTS: Patients were primarily middle-aged females and had typical long-standing disease, although early disease was represented. In the psychometric validation sample, the majority of the outpatients had autoantibodies; meanwhile, half of them had no evidence of disease activity, with acute reactants phase determinations within normal range. Patients with comorbidities and joint replacement were also included. Experts agreed upon the attributes of content validity: 83-100% considered the item was essential, 100% agreed on the item's clarity and 80-100% on the cultural semantic accuracy. In the pilot sample, ≥ 80% of the patients agreed with the item's clarity and format. In the psychometric validation sample, mean RAEH was 34 (maximum possible score: 40 = highest score). RAEH had a good internal consistency, Cronbach's α = 0.86, and moderately good reliability (ICC [95% CI] test-retest: 0.79 [0.62-0.88]). Factor analysis for construct validity showed a single factor explaining 52% of the variance. Patients agreed with each item content validity (85-100%) and clarity (75-100%). CONCLUSIONS: RAEH was valid and reliable to evaluate empowerment in Spanish-speaking RA patients.

Empowerment of the mothers of children in a pediatric intensive care unit.

OBJECTIVE: to analyze the process of empowerment of the mothers of children hospitalized in a pediatric intensive care unit (PICU) according to Cheryl H. Gibson's framework. METHOD: a qualitative study with a non-directive interview in groups was carried out with 14 mothers in the PICU of a pediatric teaching hospital in the state of Rio de Janeiro, whose data were submitted to thematic analysis. RESULTS: all mothers underwent at least one phase of the process of empowerment. Some of them achieved the phase of participatory competence in the care for their children, being heard by the team and expressing their needs, opinions, and questions. Final considerations: attentive listening and information sharing with mothers is necessary, in order to provide essential support so that they undergo the process of empowerment, thus involving themselves in care and decision-making regarding their children.

Empowerment of the mothers of children in a pediatric intensive care unit / Empoderamiento de madres de niños internados en unidad de terapia intensiva pediátrica / O empoderamento de mães de crianças numa unidade de terapia intensiva pediátrica

ABSTRACT Objective: to analyze the process of empowerment of the mothers of children hospitalized in a pediatric intensive care unit (PICU) according to Cheryl H. Gibson's framework. Method: a qualitative study with a non-directive interview in groups was carried out with 14 mothers in the PICU of a pediatric teaching hospital in the state of Rio de Janeiro, whose data were submitted to thematic analysis. Results: all mothers underwent at least one phase of the process of empowerment. Some of them achieved the phase of participatory competence in the care for their children, being heard by the team and expressing their needs, opinions, and questions. Final considerations: attentive listening and information sharing with mothers is necessary, in order to provide essential support so that they undergo the process of empowerment, thus involving themselves in care and decision-making regarding their children.

RESUMEN Objetivo: analizar el proceso de empoderamiento de madres de niños internados en una Unidad de Terapia Intensiva Pediátrica (UTIP) a la luz del referencial de Cheryl H. Gibson. Método: investigación cualitativa, con entrevista no directiva, en grupo, de 14 madres de una UTIP de hospital universitario pediátrico de Rio de Janeiro, cuyos datos fueron sometidos a análisis temático. Resultados: todas las madres pasaron, por, al menos, una fase del proceso de empoderamiento. Parte de ellas alcanzó la fase de la competencia participativa en el cuidado del niño, siendo oídas por el equipo y manifestando necesidades, opiniones y cuestionamientos. Consideraciones finales: es necesario escuchar atentamente y compartir la información con las madres, de manera de brindar las ayudas esenciales para que pasen por el proceso de empoderamiento y, así, involucrarse en la atención y en las tomas de decisiones relacionadas con sus hijos.

RESUMO Objetivo: analisar o processo de empoderamento de mães de crianças internadas numa Unidade de Terapia Intensiva Pediátrica (UTIP) à luz do referencial de Cheryl H. Gibson. Método: pesquisa qualitativa, com entrevista não diretiva, em grupo, de 14 mães de uma UTIP de um hospital universitário pediátrico do Rio de Janeiro, cujos dados foram submetidos à análise temática. Resultados: todas as mães passaram por, pelo menos, uma fase do processo de empoderamento. Parte delas atingiu a fase da competência participativa no cuidado ao filho, sendo ouvida pela equipe e manifestando suas necessidades, opiniões e questionamentos. Considerações finais: é necessário escuta atenta e compartilhamento de informações com as mães, de modo a proporcionar os subsídios essenciais para que passem pelo processo de empoderamento e, assim, envolvam-se nos cuidados e nas tomadas de decisão relacionadas a seus filhos.