María Padilla-Ruiz

Background: Survivors of breast cancer frequently experience anxiety, stress, and depression during the follow-up and survivorship phases, when access to psychosocial support is often limited. Although psychological interventions have demonstrated effectiveness, their implementation in routine clinical practice remains challenging. Digital mental health interventions offer a promising alternative. However, many existing solutions show limited personalization, engagement, and long-term adherence, partly due to insufficient involvement of end users in their design. Objective: This study aims to develop and pilot-test a cocreated digital psychological intervention (SerenApp) aimed at improving psychological well-being among women during breast cancer follow-up and to evaluate its feasibility, usability, and preliminary effectiveness. Methods: This mixed methods study adopts a participatory cocreation approach structured into 3 phases. Phase 1 focuses on identifying unmet psychosocial needs and co-designing the app’s content and functionalities through workshops involving patients and health care professionals, applying design thinking principles and the Cocre-Ar-E (cocreate, assemble, and evaluate) framework. Phase 2 involves the technical development of the intervention using an agile scrum framework methodology, followed by usability and technical validation (alpha testing). Phase 3 consists of a pilot randomized controlled trial (n=90; 45 participants in each of the intervention and control groups) conducted in Andalusia and the Canary Islands, Spain. Outcomes include acceptability, usability, adherence, psychological well-being, and cost-effectiveness. Validated instruments include the Cancer Patients’ Stress Coping Questionnaire (CAEPO), Patient Health Questionnaire-9 (PHQ-9), Hospital Anxiety and Depression Scale (HADS), EQ-5D-5L, System Usability Scale (SUS), Client Satisfaction Questionnaire-8 (CSQ-8), Client Service Receipt Inventory (CSRI), and Mobile App Rating Scale (MARS). Quantitative analyses will include ANOVA, multilevel regression models, and cost-effectiveness analyses (incremental cost-effectiveness ratio and incremental cost-utility ratio), whereas qualitative data will be analyzed using reflexive thematic analysis supported by NVivo software. Results: Funding was awarded by the Instituto de Salud Carlos III (PI24/01193) in 2024. The SerenApp project began in January 2025 with an exploratory phase and a comprehensive literature review. The cocreation phase was conducted between September 2025 and May 2026, involving 24 breast cancer survivors and 15 multidisciplinary health care professionals. Development and alpha testing are ongoing, with recruitment expected to begin in 2027. Data analysis has not yet started, and the main study findings are expected to be published in 2028. Conclusions: This protocol describes the development and pilot evaluation of SerenApp. By integrating the perspectives of survivors, health care professionals, researchers, and technology developers, the study seeks to develop an intervention that is relevant, acceptable, and feasible within real-world health care settings. The findings generated through the cocreation process, usability evaluation, and pilot randomized controlled trial are expected to contribute to the evidence base on participatory approaches in digital mental health and inform the future refinement, implementation, and large-scale evaluation of SerenApp. Trial Registration: ClinicalTrials.gov NCT07169539; https://clinicaltrials.gov/study/NCT07169539 International Registered Report Identifier (IRRID): DERR1-10.2196/87151

Purpose Long-term breast cancer survivors experience permanent effects of cancer treatment such as reduced strength, aerobic capacity, and mobility, as well as cognitive, cardiac, or neurotoxic complications. This study aims to characterise the experience and needs of breast cancer survivorship care and to examine its alignment with the person-centred care model, based on the perspectives of long-term breast cancer survivors and the multidisciplinary professionals involved in their care. Methods This study co-created, with long-term breast cancer survivors and healthcare professionals, a patient journey map to visually describe their experiences. Healthcare-related needs were also prioritised, and solutions to improve health services were proposed. Results Person-centred care in breast cancer survivorship is yet to be fully implemented. Five relevant areas of care were identified through independent focus groups and workshops: early recurrence detection, monitoring of potential physical consequences, psychological health, employment-related aspects, and healthy lifestyles. Being involved in the decision-making process and being listened to were identified as priority needs by patients. Meanwhile, healthcare professionals stressed the importance of improving communication with patients. Psychological support and care coordination were among the most important needs for both patients and healthcare professionals. Conclusion Potential solutions to address these needs included improving access to information and communication channels, increasing resources (such as rehabilitation, psychotherapy, case managers, and direct scheduling), and strengthening support for healthy lifestyle and employment, as well as creating specific training for healthcare professionals. Experiences and care needs of long-term breast cancer survivors were visualised in the patient journey map, which can be used for service redesign.

BACKGROUND Survivors of breast cancer frequently experience anxiety, stress, and depression during the follow-up and survivorship phases, when access to psychosocial support is often limited. Although psychological interventions have demonstrated effectiveness, their implementation in routine clinical practice remains challenging. Digital mental health interventions offer a promising alternative. However, many existing solutions show limited personalization, engagement, and long-term adherence, partly due to insufficient involvement of end users in their design. OBJECTIVE This study aims to develop and pilot-test a cocreated digital psychological intervention (SerenApp) aimed at improving psychological well-being among women during breast cancer follow-up and to evaluate its feasibility, usability, and preliminary effectiveness. METHODS This mixed methods study adopts a participatory cocreation approach structured into 3 phases. Phase 1 focuses on identifying unmet psychosocial needs and co-designing the app’s content and functionalities through workshops involving patients and health care professionals, applying design thinking principles and the Cocre-Ar-E (cocreate, assemble, and evaluate) framework. Phase 2 involves the technical development of the intervention using an agile scrum framework methodology, followed by usability and technical validation (alpha testing). Phase 3 consists of a pilot randomized controlled trial (n=90; 45 participants in each of the intervention and control groups) conducted in Andalusia and the Canary Islands, Spain. Outcomes include acceptability, usability, adherence, psychological well-being, and cost-effectiveness. Validated instruments include the Cancer Patients’ Stress Coping Questionnaire (CAEPO), Patient Health Questionnaire-9 (PHQ-9), Hospital Anxiety and Depression Scale (HADS), EQ-5D-5L, System Usability Scale (SUS), Client Satisfaction Questionnaire-8 (CSQ-8), Client Service Receipt Inventory (CSRI), and Mobile App Rating Scale (MARS). Quantitative analyses will include ANOVA, multilevel regression models, and cost-effectiveness analyses (incremental cost-effectiveness ratio and incremental cost-utility ratio), whereas qualitative data will be analyzed using reflexive thematic analysis supported by NVivo software. RESULTS Funding was awarded by the Instituto de Salud Carlos III (PI24/01193) in 2024. The SerenApp project began in January 2025 with an exploratory phase and a comprehensive literature review. The cocreation phase was conducted between September 2025 and May 2026, involving 24 breast cancer survivors and 15 multidisciplinary health care professionals. Development and alpha testing are ongoing, with recruitment expected to begin in 2027. Data analysis has not yet started, and the main study findings are expected to be published in 2028. CONCLUSIONS This protocol describes the development and pilot evaluation of SerenApp. By integrating the perspectives of survivors, health care professionals, researchers, and technology developers, the study seeks to develop an intervention that is relevant, acceptable, and feasible within real-world health care settings. The findings generated through the cocreation process, usability evaluation, and pilot randomized controlled trial are expected to contribute to the evidence base on participatory approaches in digital mental health and inform the future refinement, implementation, and large-scale evaluation of SerenApp. CLINICALTRIAL ClinicalTrials.gov NCT07169539; https://clinicaltrials.gov/study/NCT07169539 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/87151

When Type 1 diabetes mellitus (T1DM) patients transition from paediatric to adult healthcare providers, the risk of deteriorating health outcomes rises. The aim of this study is to integrate the experiences and perspectives regarding interventions for the management of T1DM during the transition from paediatric to adult care, from a patient and professional perspective. A systematic review was conducted 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 available in English or Spanish. Twenty-five references met the inclusion criteria of the study and were included. Four main themes were identified: (a) teen experience, (b) acceptability, (c) implementation considerations and (d) equity. Conclusion: During the care transition, adolescents with T1DM undergo a critical phase of increasing care independence in which fostering autonomy and strengthening continuity of care may achieve a more satisfying care. What is Known: • Transitions from pediatric to adult healthcare providers are associated with an increased risk of adverse health outcomes. What is New: • This study highlights that enhancing the transition process requires improved information transfer, reinforced continuity of care, and effective coordination among healthcare providers.

BACKGROUND Despite a lack of evidence relating to effectiveness and safety, the use of apps in the field of mental health is increasing due to their ease of use and accessibility. The aim of the EvalDepApps project is to develop and validate an assessment tool for evaluating depression management apps based on scientific evidence, expert judgment, and end-user needs. OBJECTIVE The purpose of this study was to determine the most relevant criteria for evaluating apps intended to manage depression through consensus-based assessment. METHODS A total of 43 individuals (22 health professionals, 4 health technology experts, and 17 individuals diagnosed with depression) were invited to participate in an online modified Delphi study of 51 criteria identified from the literature. In Round 1, participants rated criteria according to relevance (0="Not at all important" to 6="Very important") and 3 levels of consensus were defined: high level when ≥ 80% of respondents scored the criterium at 5 or 6; medium when 60-79% of respondents scored the criterium at 5 or 6; and low when < 60% of respondents scored the criterium at 5 or 6. In Round 2, participants were asked to re-rate criteria that had achieved the medium level of consensus in Round 1 under the same parameters. Comments by participants were collected and analyzed. The final assessment list consisted of those criteria that had attained the maximum consensus in either Round. RESULTS The response rate was 59.0% (26/43) in Round 1 and 53.4% (23/43) in Round 2. In Round 1, 24 criteria (47.1%) attained the maximum level of consensus, 20 (39.2%) the medium level, and 7 (13.7%) the lowest level. In Round 2, 4 out of 20 criteria (20.0%) attained the maximum consensus. Participant comments reinforced the relevance of the selected criteria. The final list consisted of 28 criteria, the majority relating to Safety and Privacy, and Clinical Effectiveness (25.0% each), followed by Usability and Functionality (17.9%). CONCLUSIONS By prioritizing criteria relating to data security and clinical effectiveness, participants in this study emphasized that the assessment of apps for depression management must take both these aspects into full consideration. The results of this study will enable the EvalDepApps project to develop an assessment tool for depression management apps that incorporates the most relevant criteria.

This work provides a synthesis of the perceptions of people with type 1 diabetes mellitus (T1DM) and healthcare professionals about the acceptability, implementation, and equity of continuous subcutaneous insulin infusion (CSII). A qualitative evidence synthesis was carried out. Three online databases (Medline, Embase, and Web of Science) were searched. Qualitative articles which were available in Spanish or English were included. A descriptive thematic synthesis was conducted according to PRISMA and ENTREQ guidelines. Thirty‐two references met the inclusion criteria of the study and were included out of an initial 345 identified references. Seven main themes were identified: (a) acceptability, (b) adaptation to the insulin pump, (c) facilitators for the adequate use of insulin pump, (d) variability of acceptability, (e) barriers for the use of insulin pump, (f) feasibility and implementation considerations, and (g) equity. CSII is well accepted by most people with T1DM, with some exceptions. CSII can relieve management burden, increase autonomy and flexibility and improve family relationships. There were multiple perceived barriers to its continued use. Future studies should continue to analyze inequalities in access and use of the CSII.

The COVID–19 pandemic has created unprecedented challenges for health care systems globally. This study aimed to explore the presence of mental illness in a Spanish cohort of COVID-19-infected population and to evaluate the association between the presence of specific mental health conditions and the risk of death and hospitalization. This is a retrospective cohort study including all individuals with confirmed infection by SARS-CoV-2 from the PRECOVID (Prediction in COVID–19) Study (Aragon, Spain). Mental health illness was defined as the presence of schizophrenia and other psychotic disorders, anxiety, cognitive disorders, depression and mood disorders, substance abuse, and personality and eating disorders. Multivariable logistic regression models were used to examine the likelihood of 30-day all-cause mortality and COVID–19 related hospitalization based on baseline demographic and clinical variables, including the presence of specific mental conditions, by gender. We included 144,957 individuals with confirmed COVID–19 from the PRECOVID Study (Aragon, Spain). The most frequent diagnosis in this cohort was anxiety. However, some differences were observed by sex: substance abuse, personality disorders and schizophrenia were more frequently diagnosed in men, while eating disorders, depression and mood, anxiety and cognitive disorders were more common among women. The presence of mental illness, specifically schizophrenia spectrum and cognitive disorders in men, and depression and mood disorders, substance abuse, anxiety and cognitive and personality disorders in women, increased the risk of mortality or hospitalization after COVID–19, in addition to other well-known risk factors such as age, morbidity and treatment burden. Identifying vulnerable patient profiles at risk of serious outcomes after COVID–19 based on their mental health status will be crucial to improve their access to the healthcare system and the establishment of public health prevention measures for future outbreaks.

BACKGROUND The COVID-19 pandemic has created unprecedented challenges for health care systems globally. The identification of risk factors is crucial when optimizing medical resources for specific vulnerable population groups such as patients with mental disorders, who are specially at risk of poor COVID-19 outcomes. OBJECTIVE We aimed at evaluating the associated risk of hospitalization and mortality in infected individuals based on the presence of specific mental disorders. METHODS Retrospective cohort study including all individuals with confirmed infection by SARS-CoV-2 from the PRECOVID Study (Aragon, Spain). Mental health illness was defined as the presence of schizophrenia and other psychotic disorders, anxiety, cognitive disorders, depression and mood disorders, substance abuse, and personality and eating disorders. Multivariable logistic regression models were used to examine the likelihood of 30-day all-cause mortality and COVID-19 related hospitalization based on baseline demographic and clinical variables, including the presence of specific mental conditions, by gender. RESULTS In this cohort study including 144,957 individuals with confirmed COVID-19 from the PRECOVID Study (Aragon, Spain), anxiety was the most frequent diagnosis. However, some differences were observed by sex: substance abuse, personality disorders and schizophrenia were more frequently diagnosed in men, while eating disorders, depression and mood, anxiety and cognitive disorders were more common among women. Of the total number of patients with mental illness and COVID-19 infection, 4.7% died and 13.8% were hospitalized during the follow-up period. The presence of mental illness, specifically schizophrenia spectrum and cognitive disorders in men, and depression and mood disorders, substance abuse, anxiety and cognitive and personality disorders in women, increased the risk of mortality or hospitalization after COVID-19, in addition to other well-known risk factors such as age, morbidity and treatment burden. CONCLUSIONS Identifying vulnerable patient profiles at risk of serious outcomes after COVID-19 based on their mental health status will be crucial to improve their access to the healthcare system and implement targeted public health prevention measures.

Functional performance in older adults is a predictor of survival and other health outcomes and its measurement is highly recommended in primary care settings. Functional performance and frailty are closely related concepts, and frailty status is associated with the use of health care services. However, there is insufficient evidence on the utilization of services profile according to the functional performance of older adults. The aim of this study was to assess the relationship between functional performance and the use of a wide range of health services in community-dwelling older adults. Generalized additive models for location, scale and shape were used to study these complex data of services utilization, from primary to hospital care. A total of 749 participants from two Spanish regions were followed up for 2 years. Of those, 276 (37%) presented low functional performance and 473 (63%) normal performance according to the Timed Up and Go test. The results showed that even after adjusting for burden of comorbidity and polypharmacy, participants with low functional performance used primary and secondary care health services more intensively, visited emergency rooms more often, and were hospitalized more frequently and for longer periods of time. A negative binomial distribution and a variant thereof were found to be the best models to describe health service utilization data. In conclusion, functionality should be considered as an important health indicator for tailoring the provision of health services for older adults.