Impact of telenurse-led intervention in clinical trials on health literacy, empowerment, and health outcomes in patients with solid tumours: a pilot quasi-experimental study.

BACKGROUND: During the COVID-19 pandemic, decentralised clinical trials incorporated self-monitoring, self-reporting, and telenursing tools to address health literacy and health empowerment of patients enrolled in clinical trials. We aimed to determine the impact of an educational intervention using telenursing consultations on health literacy, health empowerment, and health-related quality of life in cancer patients enrolled in clinical trials by measuring the level of satisfaction with the care received and assessing the views of healthcare professionals concerning the advanced practice nurse (APN) role in oncology clinical trials. METHODS: In this pilot analytical, descriptive, longitudinal, quasi-experimental, and pre-post test study, an educational intervention was conducted by 5 visits with an APN using synchronous teleconsultation in patients starting cancer treatment for the first time in a clinical trial (n = 60), and health professionals working with the APN (n = 31). A descriptive analysis of the samples and questionnaires were utilised along with statistical comparisons. RESULTS: After the intervention, patients' health literacy (31.7%), health empowerment (18.3%), and health-related quality of life (33.3%) increased (p < 0.05), with a decrease and trend towards resolution of care needs (p < 0.05). Satisfaction with the quality and care received in terms of perceived convenience, transition, and continuity of care showed positive results in 64.9 ± 20.7, 77.6 ± 19.5, and 72.1 ± 20.4 of respondents, respectively. On the overall assessment of the APN role, healthcare professionals expressed a high level of agreement with the statements related to their work performance. CONCLUSIONS: The data indicates that a clinical trial APN-led telenursing educational intervention results in an overall increase in health literacy, an improvement in health empowerment and health-related quality of life, and a decrease in care needs of oncology clinical trials patients. Patients stated that they received a high quality of care and health professionals indicated high levels of acceptance with APNs. Based on these results, we suggest that the APN role should gain more recognition in the Spanish healthcare system and their professional competencies should be aligned with those of other countries.

Spanish version of the short European Health Literacy Survey Questionnaire HLS-Q12: Transcultural adaptation and psychometric properties.

BACKGROUND: Health literacy has a direct impact on the health of populations. It is related to education, capacity for self-care, and management of health resources. The Health Literacy Survey Questionnaire HLS-Q12 is one of the reference instruments but has not yet been adapted to Spanish. The aims of the study were to cross-culturally adapt and evaluate the psychometric properties of the Spanish version of the HLS-Q12. METHODS: Data was collected from June 2020 to March 2022. The sample consisted of 60 patients who initiated cancer treatment for the first time within a clinical trial. Double direct translation, back-translation, cognitive debriefing with a 10-patient sample, and an expert committee were used for cross-cultural adaptation. For validation of the HLS-Q12, a psychometric analysis was performed to assess feasibility, reliability, sensitivity to change and construct validity with other measures such as health-related quality of life, empowerment, and health needs. RESULTS: The HLS-Q12 is equivalent at the semantic, conceptual, and content level to the original version and its psychometric properties demonstrated good internal consistency with a Cronbach's alpha of 0.88 and a McDonald´s omega of 0.91, a high degree of fit for the confirmatory factor analysis, and a statistically significant sensitivity to change (p = 0.025). CONCLUSIONS: Based on robust psychometric values, the Spanish version of HLS-Q12 was found to be a good cross-culturally adapted tool for collecting correct information on health literacy in cancer patients regardless of tumour type or stage. Although more studies are needed, this version of HLS-Q12 could be used in research for collecting data on the health literacy needs of Spanish-speaking patients.

Competencias profesionales de las enfermeras oncológicas: reconociendo la Práctica Avanzada en Enfermería / Professional competencies of oncology nurses: Recognizing advanced practice in nursing

Objetivo: Identificar el perfil competencial de las enfermeras de práctica avanzada que intervienen en el proceso asistencial del paciente oncológico. Método: Estudio descriptivo transversal. El estudio incluyó a todas las enfermeras que intervienen en el proceso asistencial del paciente oncológico en un hospital terciario de Barcelona. Se recogieron los datos del perfil competencial a través del instrumento de definición del rol de la enfermera de práctica avanzada (IDREPA), así como las variables sociodemográficas y laborales. Se compararon datos sociodemográficos y laborales con el desempeño de actividades de práctica avanzada. Resultados: Participaron un total de 29 (82,9%) enfermeras con una media de edad de 42,6± 12,54 años. Se han identificado 9 (31%) enfermeras que alcanzan el estándar en los 6 dominios en la escala IDREPA para considerarse enfermeras de práctica avanzada (EPA). De estas 9 (31%), cumplían los estándares de formación requeridos por el CIE, 7 (24,1%) con máster oficial y 2 (6,9%) con doctorado. Conclusiones: Existen enfermeras que desarrollan su actividad en el ámbito oncológico del Hospital del Mar con perfil de EPA. La identificación de EPA en nuestro sistema de salud es esencial para poder reconocer las competencias de dichas profesionales y crear puestos específicos que ayuden a abordar la cronicidad, la calidad de vida de los pacientes, su supervivencia y la optimización de los recursos sanitarios. Este estudio pone en relieve la importancia de la cronicidad y el cáncer como ámbitos para el desarrollo de la EPA.(AU)

Objective: To identify the competency profile of advanced practice nurses involved in the care process of cancer patients. Methods: Cross-sectional and descriptive study. The study included all nurses involved in the cancer patient care process in a tertiary hospital in Barcelona. Competence profile data were collected using the instrument for defining the role of the advanced practice nurse (APRD), as well as sociodemographic and occupational variables. Sociodemographic and occupational data were compared against the performance of advanced practice activities. Results: A total of 29 (82.9%) nurses participated with a mean age of 42.6±12.54 years. Nine (31%) nurses were identified as meeting the standard in all 6 domains on the APRD scale to be considered advanced practice nurses. Of these 9 (31%) nurses, 7 (24.1%) met the training standards required by the International Council of Nurses (ICN) with an official master's degree and 2 (6.9%) with a PhD. Conclusions: There are nurses who carry out their activity in the oncology field of the Hospital del Mar with the EPA profile. The identification of advanced practice nurses (APNs) in our health system is essential to be able to recognize the competencies of these professionals and create specific positions that help to address chronicity, patients’ quality of life, their survival, and the optimization of health resources. Our study highlights the importance of chronicity and cancer as areas for the development of the APNs.(AU)

Professional competencies of oncology nurses: Recognizing advanced practice in nursing.

OBJECTIVE: To identify the competency profile of advanced practice nurses involved in the care process of cancer patients. METHODS: Cross-sectional and descriptive study. The study included all nurses involved in the cancer patient care process in a tertiary hospital in Barcelona. Competence profile data were collected using the instrument for defining the role of the advanced practice nurse (APRD), as well as sociodemographic and occupational variables. Sociodemographic and occupational data were compared against the performance of advanced practice activities. RESULTS: A total of 29 (82.9%) nurses participated with a mean age of 42.6±12.54 years. 9 (31%) nurses were identified as meeting the standard in all 6 domains on the APRD scale to be considered advanced practice nurses. Of these 9 (31%) nurses, 7 (24.1%) met the training standards required by the International Council of Nurses (ICN) with an official master's degree and 2 (6.9%) with a PhD. CONCLUSIONS: There are nurses who carry out their activity in the oncology field of the hospital analyzed with the EPA profile. The identification of advanced practice nurses (APNs) in our health system is essential to be able to recognize the competencies of these professionals and create specific positions that help to address chronicity, patients' quality of life, their survival, and the optimization of health resources. Our study highlights the importance of chronicity and cancer as areas for the development of the APNs.

Creating the nursing care map in the evaluation of kidney transplant candidates: A scoping review and narrative synthesis.

AIMS: To analyse the aspects involved in the care of individuals assessed as kidney transplant candidates and to identify the role of nurses in providing specialised care for this population. DESIGN: Scoping review. The results were summarised using a narrative synthesis technique. DATA SOURCES: A review of the literature published between 2001 and 2021 was conducted between October and November 2021 using PubMed, CINAHL and SciELO. REVIEW METHODS: The research team agreed on a search strategy based on clinical practice guidelines for assessing kidney transplantation candidates. Quantitative, qualitative and mixed methods studies published in peer-reviewed journals in English, Spanish, French and Portuguese were included. RESULTS: A total of 377 studies were identified, and 49 articles were included after the inclusion and exclusion criteria were applied. The narrative synthesis was structured into four themes: Physical needs; Psychological and quality of life needs; Education and adherence needs; and Nurses' role. CONCLUSION: Nursing assessment of kidney transplantation candidates should encompass physical, psychosocial and adherence aspects. A variety of methodologies and resources are available for this assessment. Nurses contribute to coordinating access to kidney transplantation, aiming to improve adherence to an appropriate lifestyle to prevent patients from being excluded from kidney transplantation or suffering from kidney transplantation-related complications. IMPACT: Based on our findings, we managed to design a nursing care map for kidney transplantation candidates combining the main elements of nursing care that should be incorporated into this process. Advanced practice nursing professionals play a crucial role in accessing renal transplant care.

Nurse-led clinical activity in kidney transplantation care in Spain: A cross-sectional observational study.

OBJECTIVES: To explore the presence of specialist outpatient nursing activity in care for kidney transplant recipients in Spain and to determine the level of competence development of this activity according to the Advanced Practice Nurse model. DESIGN: Descriptive, cross-sectional study. PARTICIPANTS AND MEASUREMENTS: All outpatient nurses specialising in renal transplantation in the 39 transplant hospitals in Spain were included. To fulfil the study objectives, an ad hoc questionnaire and the 'Advanced Practice Nurse Role Definition Instrument (IDREPA)' were administered to assess the nurses' level of competence development. RESULTS: Of the facilities included in the study, 25 (64.1%) had posttransplant nursing activity, 13 (33.3%) had pretransplant nursing activity and 11 (28.2%) had nursing activity involving kidney donor candidates. Twenty-seven specialist nurse's offices were identified. The results of the IDREPA reflect the presence of advanced practice in the domains of 'expert care planning' and 'comprehensive care'. Three (11.1%) nurses met all criteria for advanced nursing practice. CONCLUSION: The results on specialised outpatient nursing activity at the 39 transplantation facilities in Spain indicate a low presence of this type of activity, with an even lower presence of advanced practice nurses. IMPLICATIONS FOR CLINICAL PRACTICE: Management teams should consider investing in the quality of care provided by advanced nurse practice to ensure that suitable treatment is provided and better clinical outcomes are obtained.

The role of Advanced Practice Nurses in creating the Kidney Transplant candidate care map (APN-preKT): a convergent-parallel mixed methods research protocol.

BACKGROUND: Waiting time for kidney transplants (KT) is an important health determinant for patients with chronic kidney disease (CKD). During this time, ongoing evaluation and participation is necessary in order to guarantee the quality and suitability of the proposed treatment. There is no existing literature on the potential impact of inclusion of an Advanced Practice Nurse (APN) role in the hospital setting on care for CKD patients who are candidates for KT. The main objectives of this protocol are: to analyse outpatient nursing activity in the care of individuals with KT in Spain; to identify the needs of individuals who are KT candidates; and to measure the impact of the APN role through patient outcomes and experiences. These objectives are fulfilled through 5 specific related substudies. METHODS: A convergent parallel mixed methods approach will be conducted between July 2021 and April 2024. Quantitative and qualitative data will be collected and analysed separately to ascertain whether the findings confirm or contradict one another. Each of the 5 substudies of the project require a specific design, sampling method, and data collection procedure in order to meet the overall objectives for the project. DISCUSSION: The results of the project are expected to inform the design of future nursing roles and contribute to future improvements in the quality of care provided. The data that may be obtained from this protocol are limited to the specific context of the study facility and may be extrapolated but not compared to other settings due to the variability of care pathways for KT candidates internationally. TRIAL REGISTRATION: This project was approved by the Clinical Research Ethics Committee (no.2020/9418/I). The study was supported by the "Strategic Plan for Health Research and Innovation" from the Generalitat de Catalunya, registration number SLT017/20/000001, with a contribution of 57,239 euros.

Psychosocial factors partially explain gender differences in health-related quality of life in heart failure patients.

AIMS: There is little information about the influence of gender on quality of life (QoL) in heart failure. The purpose of this study was to evaluate whether the health-related QoL gap between men and women can be explained by the interaction between psychosocial factors and clinical determinants in a real-word cohort of patients with chronic heart failure. METHODS AND RESULTS: We conducted a single-centre, observational, prospective cohort study of 1236 consecutive patients diagnosed with chronic heart failure recruited between 2004 and 2014. To assess QoL, we used the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Female gender was associated with worse global QoL compared to male gender (MLHFQ overall summary score: 49 ± 23 vs. 43 ± 24; P value <0.001, respectively) and similarly had poorer scores in physical and emotional dimensions but scored better on social dimension. In univariate models and in models adjusted for clinical determinants, female gender behaved as a predictor of worse global, physical and emotional QoL, and better social QoL compared with men. In models only including psychosocial determinants and in comprehensive models including all psychosocial and clinical factors, these differences according to gender were no longer significant. CONCLUSIONS: In this study, we have shown that the gap in health-related QoL between men and women with chronic heart failure can be partially explained by the interaction between biological and psychosocial factors. Biological factors are the main drivers of QoL in HF patients. However, the contribution of psychosocial factors is essential to definitively understand the role of gender in this field.

Usefulness of telemedicine-based heart failure monitoring according to 'eHealth literacy' domains: Insights from the iCOR randomized controlled trial.

BACKGROUND: The potential positive effect of electronic health (eHealth)-based heart failure (HF) monitoring remains uncertain mainly in the 'low literacy' or 'computer or digital illiterate' patients. The aim of this study was to determine the effectiveness of a telemedicine (TM)-based managed care solution across literacy levels and information and communications technology (ICT) skills. METHODS: We performed a sub-analysis on the basis of two literacy domains encompassed in the definition of 'eHealth literacy' to the HF-patients included in the 'insuficiència Cardíaca Optimització Remota' (iCOR) randomized study comparing TM vs. usual care (UC) in HF-patients. The primary study endpoint was the incidence of a non-fatal HF event after 6 months of inclusion. The event rates of primary and secondary study endpoints were calculated for each literacy domains and its combination. Cox proportional-hazards regression models were used to evaluate the effect of 'eHealth literacy' dimensions, treatment group and the interaction term 'eHealth literacy' domains by treatment group on study endpoints. RESULTS: The beneficial effect of TM compared to UC strategy was consistent across all literacy domains (p-value for interaction 0.207 and 0.117 respectively). The risk of experiencing a primary event was significantly lower in patients that underwent allocation to the TM arm compared to UC in both clustered in the 'lower literacy' (p-value=0.001) and those allocated to the 'lower ICT skills' (p-value=0.001) subgroup. CONCLUSIONS: Non-invasive eHealth-based HF monitoring tools are effective compared to UC in preventing HF events in the early post-discharge period, regardless of two 'eHealth literacy' domains ('traditional and computer literacy').

Necesidades asistenciales durante el estudio de personas candidatas a donantes de riñón “PREMIO SEDEN SOBRE DONACIÓN Y TRASPLANTE 2021” / Care needs during the study of kidney donor candidates

Objetivos: Describir las necesidades asistenciales del candidato a donante de riñón; sus características sociodemográficas y clínicas; y analizar los resultados desde una perspectiva de género.Material y Método: Estudio observacional descriptivo transversal. Se recogieron datos clínicos; sociodemográficos; y el número y tipo de visitas y pruebas realizadas durante el año 2020.Resultados: Se incluyeron 60 candidatos a donantes de riñón (n=37 mujeres; 61,67%) con una media de 51,98±14,50 años y una mediana de 2,5 [RIQ (0,69-5,29)] meses de estudio. 16 (26,67%) fueron aptos para la donación, correspondiendo al 14,16% de la actividad en Trasplante Renal (TR) del centro de referencia. Se requirieron 757 visitas (20,60% de la actividad) de las que 341 (45,05%) fueron visitas con la enfermera. Se requirieron 423 pruebas (19,60% de la actividad) durante el estudio. Se identificó una media de 1,87±1,35 factores de riesgo cardiovascular en la muestra analizada, siendo de 1,56±0,81 en los que finalmente fueron donantes. Más mujeres (n=12; 75%) que hombres (n=4; 25%) fueron finalmente donantes renales.Conclusiones: El estudio del candidato a donante de riñón es complejo e implica el doble de actividad que en el de los candidatos a receptores de trasplante renal. El proceso finaliza en donación en el 27% de los candidatos estudiados. La enfermera concentra el 45% de las visitas que se requieren. Es necesario explorar estrategias para optimizar el proceso de estudio. Hay diferencias de género en cuanto a la predisposición para estudiarse voluntariamente como candidata a donante renal. (AU)

Objetives: To describe the care needs of the kidney donor candidate; the socio-demographic and clinical characteristics; and to analyse the results from a gender perspective.Material and Method: Cross-sectional descriptive observational study. Clinical and socio-demographic data, number and type of visits and clinical tests performed during 2020 were collected.Results: Sixty kidney donor candidates (n=37 women; 61.67%) with a mean age of 51.98±14.50 years and a median of 2.5 [RIQ (0.69-5.29)] months of study were included. 16 (26.67%) were eligible for donation, corresponding to 14.16% of the Renal Transplant (RT) activity of the reference centre. 757 visits were required (20.60% of the activity) of which 341 (45.05%) were visits with a nurse. 423 tests (19.60% of the activity) were required during the study. A mean of 1.87±1.35 cardiovascular risk factors was identified in the sample analysed, being 1.56±0.81 in those who were donors. More women (n=12; 75%) than men (n=4; 25%) were ultimately renal donors.Conclusions: The study of kidney donor candidates is complex and involves twice as much activity as that of kidney transplant recipient candidates. The process ends in donation in 27% of the candidates studied. The nurse concentrates 45% of the visits required. Strategies need to be explored to optimise the study process. There are gender differences in the predisposition to be studied voluntarily as a kidney donor candidate. (AU)

The relationship between self-care, long-term mortality, and heart failure hospitalization: insights from a real-world cohort study.

AIMS: The assumption that improved self-care in the setting of heart failure (HF) care necessarily translates into improvements in long-term mortality and/or hospitalization is not well established. We aimed to study the association between self-care and long-term mortality and other major adverse HF events (MAHFE). METHODS AND RESULTS: We conducted an observational, prospective, cohort study of 1123 consecutive patients with chronic HF. The primary endpoint was all-cause mortality. We used the European Heart Failure Self-care Behaviour Scale 9-item version (EHFSCBS-9) to measure global self-care (overall score) and three specific dimensions of self-care including autonomy-based adherence, consulting behaviour and provider-based adherence. After a mean follow-up of 3.3 years, all-cause death occurred in 487 patients (43%). In adjusted analysis, higher EHFScBS-9 scores (better self-care) at baseline were associated with lower risk of all-cause death [hazard ratio (HR) 0.993, 95% confidence interval (CI) (0.988-0.997), P-value = 0.002], cardiovascular (CV) death [HR 0.989, 95% CI (0.981-0.996), P-value = 0.003], HF hospitalization [HR 0.993, 95% CI (0.988-0.998), P-value = 0.005], and the combination of MAHFE [HR 0.995, 95% CI (0.991-0.999), P-value = 0.018]. Similarly, impaired global self-care [HR 1.589, 95% CI (1.201-2.127), P-value = 0.001], impaired autonomy-based adherence [HR 1.464, 95% CI (1.114-1.923), P-value = 0.006], and impaired consulting behaviour dimensions [HR 1.510, 95% CI (1.140-1.923), P-value = 0.006] were all associated with higher risk of all-cause mortality. CONCLUSION: In this study, we have shown that worse self-care is an independent predictor of long-term mortality (both, all-cause and CV), HF hospitalization, and the combinations of these endpoints in patients with chronic HF. Important dimensions of self-care such as autonomy-based adherence and consulting behaviour also determine the risk of all these outcomes in the long term.

The Impact of Motivational Interviewing on Self-care and Health-Related Quality of Life in Patients With Chronic Heart Failure.

BACKGROUND: Self-care is an integral component of successful chronic heart failure (HF) management. Structured educational programs have already been shown to be effective in improving self-care, but some patients show resistance and little motivation for change. OBJECTIVE: The objective of this study was to compare efficacy in improving self-care and health-related quality of life (HRQoL) for an educational intervention based on motivational interviewing (MI) compared with a conventional educational intervention. METHODS: This experimental pretest-posttest study with an equivalent historical control group included 93 patients in the intervention group and 93 matched patients in the control group. Participants attended a first visit after HF hospitalization discharge and 6 to 7 follow-up visits during 6 months. The European Heart Failure Self-care Behavior scale and the Minnesota Living with Heart Failure Questionnaire were used to assess self-care and HRQoL, respectively. Data on mortality and hospital readmissions were collected as adverse events. RESULTS: Self-care improved significantly more in the MI-based intervention group than in the control group ( P = .005). Although both self-care and HRQoL improved in both groups over time ( P < .05), there was no significant between-group difference in terms of HRQoL improvement over time ( P = .13). CONCLUSIONS: Our findings suggest that MI delivered by MI-trained nurses is effective in significantly improving self-care by patients with HF. Nonetheless, further studies are required to evaluate the impact of MI on other outcomes, such as HRQoL and adverse clinical events.

Effectiveness of telemedicine in patients with heart failure according to frailty phenotypes: Insights from the iCOR randomised controlled trial.

BACKGROUND: The potential impact of telemedicine (TM) in the monitoring of patients with heart failure (HF) is still uncertain particularly in the frailest patients. The aim of this study was to define the efficacy of a TM-based managed care solution across different HF patient frailty phenotypes. METHODS: We performed a clustering analysis on the basis of 8 frailty-related dimensions to the HF-patients included in the 'insuficiència Cardíaca Optimització Remota' (iCOR) randomised study comparing TM vs. usual care (UC) in HF patients. The primary study endpoint was the incidence of a non-fatal HF event after 6 months of inclusion. The healthcare-related costs in each study group and cluster were also evaluated. The event rates of primary and secondary study endpoints were calculated for each cluster. Cox proportional-hazards regression models were used to evaluate the effect of cluster, treatment group and the interaction term cluster by treatment group on study endpoints. RESULTS: 5 different frailty phenotypes were identified. The positive effect of TM compared to UC strategy was consistent across all frailty phenotypes (p-value for interaction 0.711). The risk of experiencing a primary event was significantly lower in patients that underwent allocation to the TM arm compared to UC (p-value = 0.016). Ultimately, the healthcare costs were significantly reduced in patients allocated to the TM compared to UC in all 5 frailty phenotypes (all p-value < 0.05). CONCLUSIONS: Non-invasive TM-based follow-up tools are effective compared to UC follow-up in preventing HF events in the early post-discharge period, regardless of the 5 frailty phenotypes.

Quality of life and disease experience in patients with heart failure with reduced ejection fraction in Spain: a mixed-methods study.

OBJECTIVES: To gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients' experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers. DESIGN: Observational, descriptive, multicentre, cross-sectional, mixed-methods study. SETTING: Secondary care, patient's homes. PARTICIPANTS: Twenty patients with HFrEF (New York Heart Association (NYHA) classification I-III) aged 38-85 years. MEASURES: PROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation. RESULTS: A total of 20 patients with HFrEF participated in the study. The patients' mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients' quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed. CONCLUSIONS: PROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient's status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.

Validation of the Spanish version of the questionnaire on Patient Empowerment in Long-Term Conditions.

BACKGROUND: Patient empowerment is a key factor in improving health outcomes. OBJECTIVE: To evaluate the psychometric properties of the Spanish version of the questionnaire on Patient Empowerment in Long-Term Conditions (PELC) that evaluates the degree of empowerment of patients with chronic diseases. METHODS: Three measurements were made (at baseline, 2 weeks and 12 weeks) of quality of life (QoL), self-care, self-efficacy and empowerment. Reliability was evaluated as internal consistency for the entire sample. Test-retest reproducibility was evaluated for patients who were stable from baseline to week 2 (n = 70). Validity was analysed (n = 124) as baseline correlations with QoL, self-care, self-efficacy, clinical data and psychosocial variables. Sensitivity to change was analysed in terms of effect size for patients who had improved between baseline and week 12 (n = 48). RESULTS: The study was carried out with 124 patients with a diagnosis of heart failure. Cronbach's alpha was high, at >0.9, and the interclass correlation coefficient was low, at 0.47. PELC questionnaire scores showed differences depending on New York Heart Association functional class (p<0.05) and, as posited in the a priori hypotheses, were moderately correlated with emotional dimensions of QoL (0.53) and self-efficacy (0.43). Effect size for the clinically improved subsample was moderate (0.67). CONCLUSIONS: The results suggest that the Spanish version of the PELC questionnaire has appropriate psychometric properties in terms of internal consistency and validity and is low in terms of reproducibility and sensitivity to change.

Adaptación transcultural al español del cuestionario Patient empowerment in long-term conditions / Transcultural adaptation into Spanish of the Patient empowerment in long-term conditions questionnaire

Objetivo: Describir el proceso de traducción y adaptación transcultural del instrumento Patient empowerment in long-term condition al español. Diseño: Traducción, adaptación transcultural y análisis de la comprensibilidad mediante entrevistas cognitivas. Emplazamiento: Asistencia primaria y hospitalaria. Participantes: Diez pacientes ingresados en un servicio de cardiología de un hospital universitario. Mediciones principales 1) Traducción directa; 2) síntesis y conciliación de las versiones por un comité de expertos; 3) traducción inversa; 4) conciliación de la traducción inversa con la autora del cuestionario original, y 5) análisis de la comprensibilidad mediante entrevistas cognitivas a una muestra de pacientes. Resultados: Las versiones de traducción directa no presentaron grandes diferencias entre ellas. De los 47 ítems que componen el cuestionario, el comité de expertos introdujo cambios en 23 ítems. La versión de la traducción inversa fue aceptada por la autora del cuestionario original. En las entrevistas cognitivas, los pacientes señalaron una dificultad alta en un ítem y baja en 4. Conclusiones: La versión española del cuestionario Patient Empowerment in long-term conditions es equivalente semántica y conceptualmente al instrumento original. En una fase posterior se procederá a un proceso de validación en el que se establecerán las propiedades psicométricas

Purpose: To describe the process of translation and cultural adaptation of the Patient empowerment in long-term condition to the Spanish language. Design: Translation, cross-cultural adaptation, and pilot testing (cognitive debriefing). Location: Primary and Hospital care. Participants: Ten patients admitted to a cardiology department of a University Hospital Main measurements: 1) Direct translation, 2) conciliation and synthesis of the versions by expert panel, 3) back- translation, 4) agreement on the back-translated version with the author of the original version, 5) analysis of comprehensibility through cognitive interviews. Results: There were no differences between the direct-translated versions. The expert panel introduced changes in 23 out of the 47 items of the questionnaire. The author of the original version agreed with the version of the back-translation. In the cognitive interviews, patients reported high difficulty in one item and low difficulty in 4. Conclusions: The Spanish version of the Patient Empowerment in long-term conditions questionnaire is semantically and conceptually equivalent to the original tool. The assessment of the psychometric properties of the Spanish version of the questionnaire will be carried out at a later stage

[Transcultural adaptation into Spanish of the Patient empowerment in long-term conditions questionnaire]. / Adaptación transcultural al español del cuestionario Patient empowerment in long-term conditions.

PURPOSE: To describe the process of translation and cultural adaptation of the Patient empowerment in long-term condition to the Spanish language. DESIGN: Translation, cross-cultural adaptation, and pilot testing (cognitive debriefing) LOCATION: Primary and Hospital care. PARTICIPANTS: Ten patients admitted to a cardiology department of a University Hospital MAIN MEASUREMENTS: 1) Direct translation, 2) conciliation and synthesis of the versions by expert panel, 3) back- translation, 4) agreement on the back-translated version with the author of the original version, 5) analysis of comprehensibility through cognitive interviews. RESULTS: There were no differences between the direct-translated versions. The expert panel introduced changes in 23 out of the 47 items of the questionnaire. The author of the original version agreed with the version of the back-translation. In the cognitive interviews, patients reported high difficulty in one item and low difficulty in 4. CONCLUSIONS: The Spanish version of the Patient Empowerment in long-term conditions questionnaire is semantically and conceptually equivalent to the original tool. The assessment of the psychometric properties of the Spanish version of the questionnaire will be carried out at a later stage.

Transcultural adaptation and validation of the patient empowerment in long-term conditions questionnaire.

BACKGROUND: Patient empowerment is a key element to improve the results in health, increase satisfaction amongst users and obtain higher treatment compliance. The main objective of this study is to validate the Spanish version of the questionnaire "Patient empowerment in long-term conditions" which evaluates the patients' level of empowerment of chronic diseases. The secondary objective is to identify factors which predict basal empowerment and changes (improvement or deterioration) in patients with Heart Failure (HF). METHODS: An observational and prospective design of psychometric type to validate a questionnaire (aim 1) and a prospective study of cohorts (aim 2). The study will include 121 patients with confirmed diagnosis of HF. Three measurements (basal, at 15 days and at 3 months) will be carried out: quality of life, self-care and empowerment. Descriptive and inferential analyses will be used. For the first aim of the study (validation), the test-retest reproducibility will be assessed through intraclass correlation coefficient; internal consistency will be assessed through Cronbach's alpha coefficient; construct validity through Pearson's correlation coefficient; and sensibility to change through effect size coefficient. DISCUSSION: Set a valid questionnaire to measure the level of empowerment of patients with chronic diseases could be an effective tool to assess the results from the provision of the health care services. It will also allow us to identify at an early stage, those groups of patients with a low level of empowerment. Hence, they could become a risk group due to poor management of the disease, with a high rate of decompensation and a higher use rate of the health system resources.