Cross-cultural adaptation, reliability and validity of the Spanish version of the long-term quality of life questionnaire.

Purpose: The aim of this study was to translate, culturally adapt, and evaluate the psychometric properties of the Spanish Long-Term Quality of Life (LTQL) questionnaire. Methods: The LTQL was initially translated into Spanish and cross-culturally adapted based on established guidelines. The Spanish LTQL was administered to patients with breast cancer who had completed their initial treatment 5 years earlier, along with other self-report measures: Quality of Life in Adult Cancer Survivors (QLACS), Hospital Anxiety and Depression Scale (HADS) and EORT-QLQ-BR23. Reliability was evaluated using internal consistency and test-retest. Convergent and known-groups validity were examined. Structural validity as determined by confirmatory factor analysis (CFA) and Rasch analyses was used to assess the unidimensionality and item-functioning of the LTQL domains. Results: Cronbach's alpha were above 0.7 in all domains. Test-retest coefficients were between 0.72 to 0.96 for LTQL domains. LTQL total score was correlated with others total scores of other measures: QLACS (r=-0.39), HADS depression (r=-0.57), HADS anxiety (-0.45) and EORTC-QLQ-BR23 (r=-0.50). CFA provided satisfactory fit indices, with RMSEA value of 0.077 and TLI and CFI values of 0.901 and 0.909, respectively. All factor loadings were higher than 0.40 and statistically significant (P<0.001). Rasch analysis showed that Somatic Concerns domain had 4 misfitting items, and Philosophical/Spiritual View of Life and social Support domains only 1 misfit item. However, unidimensionality was supported for the four domains. Conclusion: The findings support the validity and reliability of the Spanish version of LTQL questionnaire to be used in long-term cancer female survivors.

Healthcare Professionals' Perceptions about the Implementation of Shared Decision-Making in Primary Care: A Qualitative Study from a Virtual Community of Practice.

Background: The incorporation of shared decision making (SDM) is a central part of empowerment processes, as it facilitates greater activation on the part of patients, increasing the likelihood of them gaining control over their healthcare and developing skills to solve their health problems. Despite these benefits, there are still difficulties in the implementation of SDM among healthcare professionals due to internal and external factors related to the context and health systems. Aim: To explore primary care professionals (PCPs)' perceptions of the SDM model, based on their preconceptions and experience in clinical practice. Methods: A framework analysis was conducted on qualitative data derived from a virtual community practice forum, within a cluster-randomized clinical trial developed in the e-MPODERA project. Results: The most important points in the opinions of the PCPs were: exploring the patients' values, preferences and expectations, providing them with and checking their understanding of up-to-date and evidence-based health information. The analysis revealed three themes: determinants of the implementation process of SDM, lack of consistency and dilemmas and benefits of PCP active listening, motivation and positive expectations of SDM. Discussion: In our initial analysis, we examined the connections between the categories of the TDC model and its application in the primary care context. The categories related to the model reflect the theoretical understanding of professionals, while those related to perceptions of its application and use show certain discrepancies. These discrepancies could indicate a lack of understanding of the model and its real-world implications or insufficient commitment on the part of professionals or the organization to ensure its effective implementation. Conclusions: Specific targeted training that addresses knowledge, attitudes and practice may resolve the aforementioned findings.

Antecedentes: La incorporación de la toma de decisiones compartida (TDC) es una parte central del empoderamiento del paciente, ya que facilita una mayor activación, ganar control sobre la atención que recibe y desarrollar habilidades para resolver sus problemas de salud. A pesar de estos beneficios, todavía existen dificultades para implementar la TDC entre los profesionales sanitarios debido a factores internos de los propios profesionales y externos, relacionados con el contexto y los sistemas sanitarios. Objetivo: Explorar en el foro de una comunidad virtual de práctica (CVdP) las percepciones de los profesionales de atención primaria (PAP) sobre el modelo de TDC en función de sus ideas preconcebidas y su experiencia en la práctica clínica. Métodos: Se realizó un análisis de marco desde un abordaje cualitativo de las intervenciones hechas por los PAP en el foro de una CVdP. Esta CVdP se implementó dentro de un ensayo clínico aleatorizado por grupos desarrollado en el proyecto e-MPODERA. Resultados: Los aspectos más importantes relacionados con la TDC desde la perspectiva de los PAP incluyeron: explorar los valores, preferencias y expectativas de los pacientes, proporcionarles información actualizada y basada en la evidencia, y comprobar su comprensión. En el análisis posterior, tres categorías emergieron como los temas más relevantes: determinantes de la implementación del TDC, falta de consistencia y dilemas, y beneficios de la escucha activa de los PAP, motivación y expectativas positivas de la TDC. Discusión: En nuestro análisis inicial, examinamos las conexiones entre las categorías del modelo de TDC y su aplicación en el contexto de atención primaria. Las categorías relacionadas con el modelo reflejan la comprensión teórica de los profesionales, mientras que las relativas a las percepciones de su aplicación y uso muestran ciertas discrepancias. Estas discrepancias podrían indicar una falta de comprensión del modelo y de sus implicaciones en el mundo real o un compromiso insuficiente por parte de los profesionales o de la organización para garantizar su aplicación efectiva. Conclusión: Una formación específica que aborde los conocimientos, las actitudes y la práctica puede resolver los hallazgos mencionados.

Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals.

BACKGROUND: Healthcare professionals traditional education reflects constraints to face the complex needs of people with chronic diseases in primary care settings. Since more innovative and practical solutions are required, Virtual Community of Practices (vCoP) seem to better respond to learning updates, improving professional and organizational knowledge. However, little is known about the value created in vCoPs as social learning environments. The objective of this project was to explore the value creation process of a gamified vCoP ("e-mpodera vCoP") aimed at improving the knowledge and attitudes of primary healthcare professionals (PCPs) (nurses and general practitioners) to the empowerment of people with chronic conditions. METHODS: A framework analysis assessed the value creation process using a mixed methods approach. The framework provided awareness about knowledge and usefulness in a learning community through five cycles: (1) immediate value, (2) potential value, (3) applied value, (4) realized value, and (5) reframing value. Quantitative data included vCoP analytics such as logins, contributions, points, badges, and performance metrics. Qualitative data consisted of PCPs' forum contributions from Madrid, Catalonia, and Canary Islands over 14 months. RESULTS: A total of 185 PCPs had access to the e-mpodera vCoPs. The vCoP showed the dynamic participation of 146 PCPs, along 63 content activities posted, including a total of 3,571 contributions (including text, images, links to webpages, and other files). Regarding the value creation process, the e-mpodera vCoP seems to encompass a broad spectrum of value cycles, with indicators mostly related to cycle 1 (immediate value - activities and interactions) and cycle 2 (potential value - knowledge capital); and to a lesser extent for cycle 3 (applied value - changes in practice) and for cycle 4 (realized value - performance improvement). The presence of indicators related to cycle 5 (reframing value), was minimal, due to few individual redefinitions of success. CONCLUSION: To reach a wider range of value possibilities, a combination of learning objectives, competence framework, challenged-based gamified platform, and pathway model of skill development seems crucial. However, additional research is required to gain clearer insights into organizational values, professionals' lifelong educational needs in healthcare, and the long-term sustainability of performance improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02757781. Registered on 02/05/2016.

Perspectives of women living with type 1 diabetes regarding preconception and antenatal care: A qualitative evidence synthesis.

INTRODUCTION: Pregnant women with type 1 diabetes may have an increased risk of complications for both the baby and themselves. Educational programmes, preconception planning, strict glycemic control and comprehensive medical care are some of the antenatal interventions that have been proposed to improve the outcomes of pregnant women with type 1 diabetes. While some evidence-based recommendations about antenatal care are included in clinical practice guidelines (CPGs), the views, and experiences of women with type 1 diabetes about these interventions are not well known. AIM: To understand and synthesize the perceptions of women with type 1 diabetes about the interventions before pregnancy. METHOD: A qualitative evidence synthesis (QES) was carried out with a framework analysis guided by the Cochrane Qualitative and Implementation Methods Group approach. Three online databases (Medline, Embase and Web of Science) were searched. We included qualitative articles that were published from 2011 to 2021 and which were available in English or Spanish. FINDINGS: Ten references met the inclusion criteria of the study and were included. Three main themes were identified: (a) acceptability of antenatal care, (b) feasibility and implementation consideration and (c) equity and accessibility difficulties. CONCLUSION: Continuity of care, coordination between health professionals and services, and a more holistic approach are the key aspects women say need to be considered for more acceptable, feasible and equitable preconception and antenatal care. PATIENT OR PUBLIC CONTRIBUTION: This QES was carried out as part of the CPGs on diabetes mellitus type 1, carried out as part of the Spanish Network of Health Technology Assessment Agencies. In this CPG, the representatives of the patient associations are Francisco Javier Darias Yanes, from the Association for Diabetes of Tenerife, who has participated in all the phases of the CPG; Aureliano Ruiz Salmón and Julián Antonio González Hernández (representatives of the Spanish Diabetes Federation (FEDE) who have participated as collaborator and external reviewer, respectively.

Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer.

The diagnosis of breast cancer (BC) can make the affected person vulnerable to suffering the possible consequences of the use of low-quality health information. Massive open online courses (MOOCs) may be a useful and efficient resource to improve digital health literacy and person-centred care in this population. The aim of this study is to co-create a MOOC for women with BC, using a modified design approach based on patients' experience. Co-creation was divided into three sequential phases: exploratory, development and evaluation. Seventeen women in any stage of BC and two healthcare professionals participated. In the exploratory phase, a patient journey map was carried out and empowerment needs related to emotional management strategies and self-care guidelines were identified, as well as information needs related to understanding medical terminology. In the development phase, participants designed the structure and contents of the MOOC through a Moodle platform. A MOOC with five units was developed. In the evaluation phase, participants strongly agreed that their participation was useful for the MOOC's development and participating in the co-creation process made the content more relevant to them (experience in the co-creation); most of the participants positively evaluated the content or interface of the MOOC (acceptability pilot). Educational interventions designed by women with BC is a viable strategy to generate higher-quality, useful resources for this population.

Ethical, Legal, Organisational and Social Issues of Teleneurology: A Scoping Review.

BACKGROUND: Neurological disorders are the leading cause of disability and the second leading cause of death worldwide. Teleneurology (TN) allows neurology to be applied when the doctor and patient are not present in the same place, and sometimes not at the same time. In February 2021, the Spanish Ministry of Health requested a health technology assessment report on the implementation of TN as a complement to face-to-face neurological care. METHODS: A scoping review was conducted to answer the question on the ethical, legal, social, organisational, patient (ELSI) and environmental impact of TN. The assessment of these aspects was carried out by adapting the EUnetHTA Core Model 3.0 framework, the criteria established by the Spanish Network of Health Technology Assessment Agencies and the analysis criteria of the European Validate (VALues In Doing Assessments of healthcare TEchnologies) project. Key stakeholders were invited to discuss their concerns about TN in an online meeting. Subsequently, the following electronic databases were consulted from 2016 to 10 June 2021: MEDLINE and EMBASE. RESULTS: 79 studies met the inclusion criteria. This scoping review includes 37 studies related to acceptability and equity, 15 studies developed during COVID and 1 study on environmental aspects. Overall, the reported results reaffirm the necessary complementarity of TN with the usual face-to-face care. CONCLUSIONS: This need for complementarity relates to factors such as acceptability, feasibility, risk of dehumanisation and aspects related to privacy and the confidentiality of sensitive data.

Shared decision-making in Spain in 2022: An updated revision of the current situation.

In Spain, there is not a national strategy to promote shared decision making (SDM) in clinical practice, and it is still not a requisite for improving the quality of health services, in either the legal norms or professionals' educational curricula. However, several national strategies in specific health areas increasingly include the principles of person centred care (PCC) and SDM into their objectives, promoting patients' empowerment and activation. Furthermore, several institutions continue to develop Patient Decision Aids (PtDAs) and other resources to facilitate patients' involvement in their own care; training programs for professionals; links between PtDAs and clinical practice guidelines; as well as interventional studies assessing the impact of PCC and SDM interventions in clinical practice. Initiatives to involve patients in health research design and health technology assessment are also being developed. We describe an update of the current state of research, policy and implementation of SDM after five years of substantial advances in Spain. Many challenges remain regarding national and regional policies on PCC and SDM, implementation of SDM in real practice and educational curricula, development of quality indicators and evaluation procedures.

Universal programs to prevent eating disorders in children and adolescents: A scoping review of ethical, legal, organizational and social impacts.

BACKGROUND: Appropriate and timely consideration of ethical, legal, organizational, and social issues in universal preventive programs for eating disorders (UPPED) are relevant for the approval, funding and implementation of health-policy decision making. OBJECTIVE: To identify and analyse the ethical, legal, organizational, and social aspects involved in interventions aimed at the universal prevention of eating disorders (ED) in children, pre-adolescents and adolescents in the school settings. METHOD: A scoping review of the literature was carried out. MEDLINE, EMBASE, CENTRAL, PsycINFO, and Social Science Citation Index were searched for studies published in English or Spanish. The quality of the studies was assessed using specific scales for each study design. RESULTS: Fourteen studies were included: one scoping review; four narrative reviews, six observational studies, two qualitative studies, and one mixed methods study. Results were narratively synthesised according to: (1) equity; (2) gender perspective; (3) potential harm; (4) participants and facilitators profile; (5) feasibility; and (6) acceptability. CONCLUSIONS: Interactive programs with relevant contents for participants have greater acceptability. Programs focussed on developing competencies can reduce the risk of potential harm. Incorporating a gender perspective contributes to improving equity. Teachers with prior training in ED are well suited as facilitators of these programs.

Effectiveness of Mantra-Based Meditation on Mental Health: A Systematic Review and Meta-Analysis.

BACKGROUND: Meditation is defined as a form of cognitive training that aims to improve attentional and emotional self-regulation. This systematic review aims to evaluate the available scientific evidence on the effectiveness and safety of mantra-based meditation techniques (MBM), in comparison to passive or active controls, or other active treatment, for the management of mental health symptoms. METHODS: MEDLINE, EMBASE, Cochrane Library, and PsycINFO databases were consulted up to April 2021. Randomised controlled trials regarding meditation techniques mainly based on the repetition of mantras, such as transcendental meditation or others, were included. RESULTS: MBM, compared to control conditions, was found to produce significant small-to-moderate effect sizes in the reduction of anxiety (g = -0.46, IC95%: -0.60, -0.32; I2 = 33%), depression (g = -0.33, 95% CI: -0.48, -0.19; I2 = 12%), stress (g = -0.45, 95% CI: -0.65, -0.24; I2 = 46%), post-traumatic stress (g = -0.59, 95% CI: -0.79, -0.38; I2 = 0%), and mental health-related quality of life (g = 0.32, 95% CI: 0.15, 0.49; I2 = 0%). CONCLUSIONS: MBM appears to produce small-to-moderate significant reductions in mental health; however, this evidence is weakened by the risk of study bias and the paucity of studies with psychiatric samples and long-term follow-up.

Validación de contenido de la versión en castellano del instrumento Long-term Quality of Life Instrument para mujeres supervivientes de cáncer de mama de larga duración / Content validation of the spanish version of the Long-term Quality of Life Instrument for long-term female breast cancer survivors

Fundamentos: La calidad de vida de mujeres afectadas de cáncer de mama diagnosticadas hace 5 o másaños ha sido relativamente poco explorada en España, no existen instrumentos para su medida validados. El objetivo del estudio fue traducir al castellano, adaptar culturalmente y examinar la validez de contenido del cuestionario Long-Term Quality of Life Instrument (LTQL Métodos: La traducción inicial fue realizada por dos traductores con castellano como lengua materna que tradujeron independientemente el cuestionario (versiones T1 y T2). Se realizó un análisis de los resultados y se elaboró una única versión preliminar en castellano (T-1-2). La retrotraducción se realizó por dos traductores con inglés como lengua materna que tradujeron independientemente la versión conjunta (T-1-2) al idioma original (RT1 y RT2) para identificar inconsistencias. Finalmente, se obtuvo una versión final del cuestionario. Para la validación de contenido se constituyó un comité de expertas (siete mujeres afectadas de cáncer de mama) que valoró el grado de claridad, precisión, comprensión y relevancia de cada uno de los ítems del cuestionario traducido al castellano y se calculó el índice de validez de contenido (CVI) del cuestionario según Lawshe y Tristán. Resultados: Se tradujo el cuestionario LTQL al castellano con una baja discrepancia entre los traductores. Se obtuvo un CVI adecuado mayor de 0,58 en claridad (0,95), precisión (0,93), comprensión (0,91) y relevancia (0,72). Conclusiones: El LTQL en un cuestionario de utilidad en el campo de la salud para la evaluación de la calidad de vida de mujeres supervivientes de cáncer de mama de larga duración.(AU)

Background: The quality of life of women affected by breast cancer diagnosed 5 or more years ago has been relatively unexplored in Spain; there are no instruments for its measurement validated. The objective of the study is to translate into Spanish, culturally adapt and examine the content validity of the Spanish version of the LongTerm Quality of Life Instrument (LTQL). Methods: The initial translation was performed by two translators with Spanish as their mother tongue carried out the translation of the questionnaire, obtaining two initial versions in Spanish (T1 and T2). An analysis of the results and elaboration of a single preliminary version in Spanish (T-1-2) were performed. The retro-translation wasperformed by two translators with English as their mother tongue not familiar with the original version translated the joint version (T-1-2) back into the original language (RT1and RT2) to identify inconsistencies. Finally, a final version of the questionnaire was obtained. For content validation a committee of experts (seven women affected by breast cancer) assessed the degree of clarity, accuracy and understanding of each of the items in the questionnaire translated into Spanish, and calculated the content validity index (CVI) of the questionnaire according to Lawshe and Tristán.Results: The LTQL questionnaire was translated into Spanish with a low discrepancy between translators. An adequate CVI higher than 0.58 was obtained in clarity (0.95), precision (0.93), comprehension (0.91) and relevance (0.72). Conclusions: The LTQL is a useful questionnaire in the health field for the assessment of quality of life of women survivors of long-term breast cancer.(AU)

Co-Creation of Massive Open Online Courses to Improve Digital Health Literacy in Pregnant and Lactating Women.

BACKGROUND: Digital health literacy (DHL) increases the self-efficacy and empowerment of pregnant and lactating women (PLW) in using the Internet for health issues. The European project IC-Health aimed to improve DHL among PLW, through the co-creation of Massive Open Online Courses (MOOCs). METHODS: The co-creation of the MOOCs included focus groups and the creation of communities of practice (CoPs) with PLW and healthcare professionals aimed to co-design the MOOCs. The quantitative measures of MOOCs' acceptability, experience in the co-creation process and increase in DHL (dimensions of finding, understanding and appraisal) were assessed. RESULTS: 17 PLW participated in focus groups, 113 participants were included in CoPs and 68 participants evaluated the acceptability of MOOCs. A total of 6 MOOCs aimed at improving PLW's DHL were co-designed. There was a significant improvement in self-perceived DHL after using MOOCs (p-value < 0.001). The acceptability of MOOCs and co-creation experience were positively valued. CONCLUSIONS: The preliminary results of the quantitative assessment showed a higher self-perceived DHL after the IC-Health MOOCs. These results suggest that IC-Health MOOCs and the co-creation methodology appear to be a viable process to carry out an intervention aimed to improve DHL levels in European PLW.

Transcranial Magnetic Stimulation for the Treatment of Cocaine Addiction: A Systematic Review.

Long-term cocaine use is associated with cognitive deficits and neuro-psychiatric pathologies. Repetitive transcranial magnetic stimulation (rTMS) is an emerging therapeutic strategy relating to changes in brain activity. It stimulates the prefrontal cortex and is involved in inhibitory cognitive control, decision making and care. This systematic review aims to evaluate and synthesize the evidence on the safety, effectiveness, and cost-effectiveness of rTMS for the treatment of cocaine addiction. A systematic review of the literature was carried out. The following electronic databases were consulted from inception to October 2020: MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials and Web of Science. Randomised controlled trials, non-randomised controlled trials and case-series and full economic evaluations were included. Twelve studies were included. No identified study reported data on cost-effectiveness. Significant results of the efficacy of TMS have been observed in terms of the reduction of craving to consume and the number of doses consumed. No serious adverse effects have been observed. Despite the low quality of the studies, the first results were observed in terms of reduction of cocaine use and craving. In any case, this effect is considered moderate. Studies with larger sample sizes and longer follow-ups are required.

Cocreation of Massive Open Online Courses to Improve Digital Health Literacy in Diabetes: Pilot Mixed Methods Study.

BACKGROUND: Self-management education is a fundamental aspect in the health care of people with diabetes to develop the necessary skills for the improvement of health outcomes. Patients are required to have the competencies to manage electronic information resources-that is, an appropriate level of digital health literacy. The European project IC-Health aimed to improve digital health literacy among people with diabetes through the cocreation of massive open online courses (MOOCs). OBJECTIVE: We report the preliminary results obtained in 3 participating countries in the IC-Health project (Italy, Spain, and Sweden) regarding (1) experience of the participants during the cocreation process of MOOCs, (2) perceived changes in their digital health literacy level after using MOOCs, and (3) a preliminary assessment of the acceptability of MOOCs. METHODS: The cocreation of the MOOCs included focus groups with adults and adolescents with diabetes and the creation of independent communities of practice for type 1 diabetes and type 2 diabetes participants aimed to co-design the MOOCs. Quantitative measures of the acceptability of MOOCs, experience in the cocreation process, and increase in digital health literacy (dimensions of finding, understanding, and appraisal) were assessed. RESULTS: A total of 28 participants with diabetes participated in focus groups. Adults and adolescents agreed that the internet is a secondary source of health-related information. A total of 149 participants comprised the diabetes communities of practice. A total of 9 MOOCs were developed. Acceptability of the MOOCs and the cocreation experience were positively valued. There was a significant improvement in digital health literacy in both adults and adolescents after using MOOCs (P<.001). CONCLUSIONS: Although the results presented on self-perceived digital health literacy are preliminary and exploratory, this pilot study suggests that IC-Health MOOCs represent a promising tool for the medical care of diabetes, being able to help reduce the limitations associated with low digital health literacy and other communication barriers in the diabetes population.

Information needs and research priorities for fertility preservation in women with breast cancer: patients and experts' perspectives.

OBJECTIVE: To identify the information needs and research priorities that women with breast cancer (BC), their families and BC experts perceive on the fertility preservation. METHODS: We conducted two Delphi-based studies through three online rounds. The first was aimed to identify information and research needs; the second one to assess the importance of those needs and the third one to obtain consensus, defined as an interquartile range ≤2. RESULTS: The participation rate was 76.2% in study 1 and 53.7% in study 2. The most important information needs were the referral protocol, pregnancy options for women with BC, side effects of tamoxifen and menopause as a consequence of treatment. The most important research priorities were the participation of different health professionals to provide oncofertility information, referral protocols and efficacy and safety of FP options. CONCLUSION: Information about fertility preservation in the context of BC and different ways to get pregnant, considering risks and benefits, has emerged as an unmet need for patients and careers. The need for a participatory and coordinated approach to the provision of information on oncofertility has been agreed. Other research needs are described in an attempt to focus future research in the most necessary areas.

Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment.

INTRODUCTION: This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence. METHODS: A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study. RESULTS: The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients' experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study. CONCLUSIONS: The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

Co-Design Process of a Virtual Community of Practice for the Empowerment of People with Ischemic Heart Disease.

INTRODUCTION: Virtual Communities of Practices (vCoP) offer patients the possibility to interact and share tools and knowledge necessary for their empowerment. This paper describes the co-design process of a vCoP for the empowerment of people with ischemic heart disease (IHD). METHODS: We used a modified experience-based design approach to co-design the vCoP in collaboration with people with IHD and health professionals consisting of two phases: exploratory and development phase. Data collection techniques included listening labs, workshops, and online participation. RESULTS: Twenty-five people with IHD and ten health professionals participated. Experiences and needs for empowerment in IHD were identified in the exploratory phase allowing for the development of a Patient Journey Map. In the development phase, people with IHD prioritized needs to be addressed by the vCoP content framework in addition to content proposals. DISCUSSION: The Patient Journey Map helped to easily visualize the empowerment needs of people with IHD and it might be transferable for the development of other people-centred interventions. The co-design process also allowed the development of training materials adapted to the priorities of people with IHD. CONCLUSION: A people-centred co-design process of a vCoP may facilitate the empowerment of people with IHD.

Framing the process in the implementation of care for people with generalized anxiety disorder in primary care: a qualitative evidence synthesis.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most common mental disorders in primary care (PC). GAD has low remission and high relapse rates over long follow-up periods. Qualitative evidence was synthesized to understand the implementation of care and treatment options for people with GAD in PC. METHODS: Research published from 2008 to September 2020 was searched in five databases (MEDLINE, EMBASE, CINAHL, WOS and PsycArticles). Studies that used qualitative methods for data collection and analysis to investigate the implementation of care and treatment options for people with GAD in PC and outpatient settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to assess the overall confidence in the findings. RESULTS: The results with a moderate level of confidence showed that the trajectory of care for people with GAD in PC and outpatient settings is long and fluctuates over time, involving multiple difficulties in accessing and maintaining initial treatment or successive treatment options. In addition, there are wide variations in the preferences for and acceptability of different treatment options. The results with a high level of confidence indicated that more information on GAD and its treatment options is needed for PC practitioners, GAD patients and their carers. The results with a low level of confidence suggested that patients use antidepressants for longer than recommended and that the interruption of treatment is not usually planned. CONCLUSIONS: Initial resistance to new treatments among people with GAD can make access and adherence to treatment difficult. Improving care may require patients to be informed of possible trajectories in stepped care pathways before the initiation of treatment so they are aware that they may need to try a number of options until the most effective treatment for them is found. Increased awareness of and information materials on GAD may facilitate both appropriate diagnosis and long-term care.

Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial.

INTRODUCTION: Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases. In view of the scarce evidence on the clinical and economic impact of these interventions on chronic conditions, we aim to evaluate the effectiveness and cost-effectiveness of a VCoP in the improvement of the activation and other patient empowerment measures in patients with ischaemic heart disease (IHD). METHODS AND ANALYSIS: A pragmatic randomised controlled trial will be performed in Catalonia, Madrid and Canary Islands, Spain. Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres will be selected and randomised to the intervention or control group. The intervention group will be offered participation for 12 months in a VCoP based on a gamified web 2.0 platform where there is interaction with other patients and a multidisciplinary professional team. Intervention and control groups will receive usual care. The primary outcome will be measured with the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary outcomes will include: clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use. Data will be collected from self-reported questionnaires and electronic medical records. ETHICS AND DISSEMINATION: The trial was approved by Clinical Research Ethics Committee of Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local/international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03959631). Pre-results.

Evaluation of patient involvement strategies in health technology assessment in Spain: the viewpoint of HTA researchers.

OBJECTIVE: The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework. METHODS: A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors. RESULTS: Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future. CONCLUSIONS: PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.

The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial.

BACKGROUND: Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care. Previous research has focused almost exclusively on knee OA, and therefore, the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA. METHODS: The general design consists of two phases: (1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients, and (2) to evaluate the impact of the PtDA on hip OA patients' decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care. DISCUSSION: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04241978 . Registered on 24 January 2020.