Early adversity and emotional awareness: A partial confirmation and extension of their relationship.

Early adversity has been consistently linked to mental health outcomes, but the underlying pathways remain unclear. One previous study found an association between early adversity and trait emotional awareness (EA), which has itself been linked to health outcomes, but links to mental health were not explicitly examined. The aim of the current study was to test the hypothesis that the association between early adversity and health can be partially accounted for by differences in EA within a large student sample (n = 196). Participants completed measures of early adversity, EA, and current emotional functioning (i.e., depression, anxiety, somatization, positive/negative affect). Bayesian analyses found the most evidence for models with an interaction between sex and early adversity in predicting emotional functioning - revealing the expected negative relationship between early adversity and EA in females, but a positive relationship in males. Early adversity, but not EA, was associated with depression, anxiety, and implicit negative affect. Only explicit positive affect was associated with both early adversity and EA, and EA partially mediated the negative association between early adversity and positive affect. These results provide limited support for EA as a mediating pathway for the effects of early adversity on mental health.

The FRESHAIR4Life study: Global implementation research on non-communicable disease prevention targeting adolescents' exposure to tobacco and air pollution in disadvantaged populations.

The FRESHAIR4Life study aims to reduce the non-communicable disease (NCD) burden by implementing preventive interventions targeting adolescents' exposure to tobacco use and air pollution (AP) worldwide. This paper presents the FRESHAIR4Life methodology and initial rapid review results. The rapid review, using various databases and PubMed, aimed to guide decision-making on risk factor focus, target areas, and populations. It showed variable NCD mortality rates related to tobacco use and AP across the participating countries, with tobacco as the main risk factor in the Kyrgyz Republic, Greece, and Romania, and AP prevailing in Pakistan and Uganda. Adolescent exposure levels, sources, and correlates varied. The study will continue with an in-depth situational analysis to guide the selection, adaptation, and integration of evidence-based interventions into the FRESHAIR4Life prevention package. This package will be implemented, evaluated, assessed for cost-effectiveness, and iteratively refined. The research places a strong emphasis on co-creation, capacity building, and comprehensive communication and dissemination.

Participatory Development of an Integrated, eHealth-Supported, Educational Care Pathway (Diabetes Box) for People With Type 2 Diabetes: Development and Usability Study.

BACKGROUND: Type 2 diabetes (T2D) tremendously affects patient health and health care globally. Changing lifestyle behaviors can help curb the burden of T2D. However, health behavior change is a complex interplay of medical, behavioral, and psychological factors. Personalized lifestyle advice and promotion of self-management can help patients change their health behavior and improve glucose regulation. Digital tools are effective in areas of self-management and have great potential to support patient self-management due to low costs, 24/7 availability, and the option of dynamic automated feedback. To develop successful eHealth solutions, it is important to include stakeholders throughout the development and use a structured approach to guide the development team in planning, coordinating, and executing the development process. OBJECTIVE: The aim of this study is to develop an integrated, eHealth-supported, educational care pathway for patients with T2D. METHODS: The educational care pathway was developed using the first 3 phases of the Center for eHealth and Wellbeing Research roadmap: the contextual inquiry, the value specification, and the design phase. Following this roadmap, we used a scoping review about diabetes self-management education and eHealth, past experiences of eHealth practices in our hospital, focus groups with health care professionals (HCPs), and a patient panel to develop a prototype of an educational care pathway. This care pathway is called the Diabetes Box (Leiden University Medical Center) and consists of personalized education, digital educational material, self-measurements of glucose, blood pressure, activity, and sleep, and a smartphone app to bring it all together. RESULTS: The scoping review highlights the importance of self-management education and the potential of telemonitoring and mobile apps for blood glucose regulation in patients with T2D. Focus groups with HCPs revealed the importance of including all relevant lifestyle factors, using a tailored approach, and using digital consultations. The contextual inquiry led to a set of values that stakeholders found important to include in the educational care pathway. All values were specified in biweekly meetings with key stakeholders, and a prototype was designed. This prototype was evaluated in a patient panel that revealed an overall positive impression of the care pathway but stressed that the number of apps should be restricted to one, that there should be no delay in glucose value visualization, and that insulin use should be incorporated into the app. Both patients and HCPs stressed the importance of direct automated feedback in the Diabetes Box. CONCLUSIONS: After developing the Diabetes Box prototype using the Center for eHealth and Wellbeing Research roadmap, all stakeholders believe that the concept of the Diabetes Box is useful and feasible and that direct automated feedback and education on stress and sleep are essential. A pilot study is planned to assess feasibility, acceptability, and usefulness in more detail.

Facilitators of and Barriers to the Use of a Digital Self-Management Service for Diagnostic Testing: Focus Group Study With Potential Users.

BACKGROUND: Health care lags in digital transformation, despite the potential of technology to improve the well-being of individuals. The COVID-19 pandemic has accelerated the uptake of technology in health care and increased individuals' willingness to perform self-management using technology. A web-based service, Directlab Online, provides consumers with direct digital access to diagnostic test packages, which can digitally support the self-management of health. OBJECTIVE: This study aims to identify the facilitators, barriers, and needs of Directlab Online, a self-management service for web-based access to diagnostic testing. METHODS: A qualitative method was used from a potential user's perspective. The needs and future needs for, facilitators of, and barriers to the use of Directlab Online were evaluated. Semistructured focus group meetings were conducted in 2022. Two focus groups were focused on sexually transmitted infection test packages and 2 were focused on prevention test packages. Data analysis was performed according to the principles of the Framework Method. The Consolidated Framework for Implementation Research was used to categorize the facilitators and barriers. RESULTS: In total, 19 participants, with a mean age of 34.32 (SD 14.70) years, participated in the focus groups. Important barriers were a lack of privacy information, too much and difficult information, and a commercial appearance. Important facilitators were the right amount of information, the right kind of tests, and the involvement of a health care professional. The need for a service such as Directlab Online was to ensure its availability for users' health and to maintain their health. CONCLUSIONS: According to the participants, facilitators and barriers were comprehension of the information, the goal of the website, and the overall appearance of the service. Although the service was developed in cocreation with health care professionals and users, the needs did not align. The users preferred understandable and adequate, but not excessive, information. In addition, they preferred other types of tests to be available on the service. For future research, it would be beneficial to focus on cocreation between the involved medical professionals and users to develop, improve, and implement a service such as Directlab Online.

Evaluation of completely online psychotherapy with app-support versus therapy as usual for clients with depression or anxiety disorder: A retrospective matched cohort study investigating the effectiveness, efficiency, client satisfaction, and costs.

INTRODUCTION: Depressive and anxiety disorders are common mental disorders ranking among the leading causes of global disease burden. Not all clients currently benefit from therapy and clients are looking for modern ways of therapy. Online psychotherapy is a promising option for better meeting clients' needs. Recently, a new psychotherapy concept has emerged that combines videoconferencing sessions with support through a mobile application. The latter allows for ecological momentary assessments and interventions, facilitates communication between patients and therapists in between sessions through chat, and allows for incorporating feedback-informed treatment principles. MATERIAL AND METHODS: The study was a retrospective observational matched cohort study, comparing online psychotherapy with Therapy As Usual (TAU) for clients with depressive or anxiety disorders. Data were obtained via questionnaires, which are part of standard clinical care. Primary outcomes included general mental functioning, and symptoms of depression and anxiety. Secondary outcomes were efficiency, client satisfaction, and therapy costs. Primary endpoints were analyzed using linear mixed models analysis, with an interaction term between time and group. Secondary outcomes were analyzed using linear regression. RESULTS: Larger improvements were observed in the online compared to the TAU group for general mental functioning and depressive disorder (i.e., General mental functioning: B = -8.50, 95 CI: -15.01 - -1.97, p = 0.011; Depressive disorder: B = - 3.66, 95 % CI: -5.79 - -1.54p < 0.01). No significant differences in change over time between the two groups were observed for anxiety disorder (B = -3.64, 95 % CI: (-13.10 - 5.82) p = 0.447). The total number of sessions was significantly higher in the online psychotherapy group than in TAU (B = 3.71, p < 0.01), although clients were matched on treatment time in weeks. Treatment session duration in minutes was comparable across the groups. DISCUSSION: Online psychotherapy with app support showed to be a promising alternative to TAU for depressive and anxiety disorders. More research is needed to evaluate the effectiveness, cost-effectiveness and client satisfaction of online psychotherapy compared to TAU, such as randomized controlled trials or studies multiple baseline series designs, and in-depth qualitative research.

The Asthma App as a New Way to Promote Responsible Short-Acting Beta2-Agonist Use in People With Asthma: Results of a Mixed Methods Pilot Study.

BACKGROUND: Approximately 262 million people worldwide are affected by asthma, and the overuse of reliever medication-specifically, short-acting beta2-agonist (SABA) overuse-is common. This can lead to adverse health effects. A smartphone app, the Asthma app, was developed via a participatory design to help patients gain more insight into their SABA use through monitoring and psychoeducation. OBJECTIVE: This pilot study aims to evaluate the feasibility and usability of the app. The preliminary effects of using the app after 3 months on decreasing asthma symptoms and improving quality of life were examined. METHODS: A mixed methods study design was used. Quantitative data were collected using the app. Asthma symptoms (measured using the Control of Allergic Rhinitis and Asthma Test) and the triggers of these symptoms were collected weekly. Quality of life (36-Item Short-Form Health Survey) was assessed at baseline and after 3, 6, and 12 months. User experience (System Usability Scale) was measured at all time points, except for baseline. Furthermore, objective user data were collected, and qualitative interviews, focusing on feasibility and usability, were organized. The interview protocol was based on the Unified Theory of Acceptance and Use of Technology framework. Qualitative data were analyzed using the Framework Method. RESULTS: The baseline questionnaire was completed by 373 participants. The majority were female (309/373, 82.8%), with a mean age of 46 (SD 15) years, and used, on average, 10 SABA inhalations per week. App usability was rated as good: 82.3 (SD 13.2; N=44) at 3 months. The Control of Allergic Rhinitis and Asthma Test score significantly improved at 3 months (18.5) compared with baseline (14.8; ß=.189; SE 0.048; P<.001); however, the obtained score still indicated uncontrolled asthma. At 3 months, there was no significant difference in the quality of life. Owing to the high dropout rate, insufficient data were collected at 6 and 12 months and were, therefore, not further examined. User data showed that 335 users opened the app (250/335, 74.6%, were returning visitors), with an average session time of 1 minute, and SABA registration was most often used (7506/13,081, 57.38%). Qualitative data (from a total of 4 participants; n=2, 50% female) showed that the participants found the app acceptable and clear. Three participants stated that gaining insight into asthma and its triggers was helpful. Two participants no longer used the app because they perceived their asthma as controlled and, therefore, did not use SABA often or only used it regularly based on the advice of the pulmonologist. CONCLUSIONS: The initial findings regarding the app's feasibility and usability are encouraging. However, the notable dropout rate underscores the need for a cautious interpretation of the results. Subsequent studies, particularly those focusing on implementation, should explore the potential integration of the app into standard treatment practices.

Digital Triage Tools for Sexually Transmitted Infection Testing Compared With General Practitioners' Advice: Vignette-Based Qualitative Study With Interviews Among General Practitioners.

BACKGROUND: Digital triage tools for sexually transmitted infection (STI) testing can potentially be used as a substitute for the triage that general practitioners (GPs) perform to lower their work pressure. The studied tool is based on medical guidelines. The same guidelines support GPs' decision-making process. However, research has shown that GPs make decisions from a holistic perspective and, therefore, do not always adhere to those guidelines. To have a high-quality digital triage tool that results in an efficient care process, it is important to learn more about GPs' decision-making process. OBJECTIVE: The first objective was to identify whether the advice of the studied digital triage tool aligned with GPs' daily medical practice. The second objective was to learn which factors influence GPs' decisions regarding referral for diagnostic testing. In addition, this study provides insights into GPs' decision-making process. METHODS: A qualitative vignette-based study using semistructured interviews was conducted. In total, 6 vignettes representing patient cases were discussed with the participants (GPs). The participants needed to think aloud whether they would advise an STI test for the patient and why. A thematic analysis was conducted on the transcripts of the interviews. The vignette patient cases were also passed through the digital triage tool, resulting in advice to test or not for an STI. A comparison was made between the advice of the tool and that of the participants. RESULTS: In total, 10 interviews were conducted. Participants (GPs) had a mean age of 48.30 (SD 11.88) years. For 3 vignettes, the advice of the digital triage tool and of all participants was the same. In those vignettes, the patients' risk factors were sufficiently clear for the participants to advise the same as the digital tool. For 3 vignettes, the advice of the digital tool differed from that of the participants. Patient-related factors that influenced the participants' decision-making process were the patient's anxiety, young age, and willingness to be tested. Participants would test at a lower threshold than the triage tool because of those factors. Sometimes, participants wanted more information than was provided in the vignette or would like to conduct a physical examination. These elements were not part of the digital triage tool. CONCLUSIONS: The advice to conduct a diagnostic STI test differed between a digital triage tool and GPs. The digital triage tool considered only medical guidelines, whereas GPs were open to discussion reasoning from a holistic perspective. The GPs' decision-making process was influenced by patients' anxiety, willingness to be tested, and age. On the basis of these results, we believe that the digital triage tool for STI testing could support GPs and even replace consultations in the future. Further research must substantiate how this can be done safely.

The Usability of Homelab, a Digital Self-service at a Dutch General Practice, for Diagnostic Tests: Pilot Study With a Questionnaire.

BACKGROUND: eHealth potentially can make health care more accessible and efficient and help reduce the workload in primary health care. Homelab is an eHealth tool implemented in a general practice environment, and it offers relatively simple laboratory diagnostic tests without the referral of the general practitioner. After logging in this eHealth tool, patients select and order a diagnostic test based on their symptoms. The test results are presented online to the general practitioner and the patient. OBJECTIVE: This study aims to evaluate the use, usability, and user characteristics of Homelab. Further, it aims to evaluate whether Homelab replaces an appointment with the general practitioner. METHODS: Homelab has been implemented since May 2021 as a pilot in a Dutch general practice. The number of requests and the ordered diagnostic packages are monitored. After using Homelab, patients are invited to complete a short questionnaire. The questionnaire contains demographic questions and assesses usability using the System Usability Scale (10 items). In addition, questions about requesting an appointment with the general practitioner without Homelab are included. All data were anonymous. RESULTS: The questionnaire was filled by 74 individual patients. The mean age of the patients was 40.33 (SD 12.11) years, and half of them were females (39/74, 53%). The majority of the patients were highly educated (56/74, 76%) and employed (53/74, 72%). Approximately 81% (60/74) of the patients reported that they would use Homelab again in the future and 66% (49/74) reported that they would have gone to the general practitioner if they had not used Homelab. The usability of Homelab was perceived higher by the younger age group (mean 73.96, SD 14.74) than by the older age group (mean 61.59, SD 14.37). In total, 106 test packages were ordered over 1 year, and the most requested diagnostic package was "Am I still healthy? I want to do my annual health checkup." Homelab was used the most during the months of the COVID-19 lockdown. CONCLUSIONS: The use of Homelab, a digital self-service for ordering diagnostic tests, was monitored in this study, and its usability was perceived as above average. Our findings showed that patients are willing to use Homelab in the future and they would use it most of the time as a replacement for regular consultations. Homelab offers opportunities for more accessible and efficient health care for both the patient and the general practitioner.

What Makes a Quality Health App-Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study.

BACKGROUND: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps. OBJECTIVE: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. METHODS: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS. RESULTS: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide. CONCLUSIONS: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps.

Illness Perceptions and Self-Management among People with Chronic Lung Disease and Healthcare Professionals: A Mixed-Method Study Identifying the Local Context.

Self-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context was identified in Chinese primary care (PC) and secondary care (SC). A mixed-method study using semi-structured interviews and quantitative surveys was conducted on people with CLD and healthcare professionals (HCPs). The qualitative data was collected until data saturation was reached, and participants were invited to complete the survey after the interview. The qualitative data-analyzed with the framework approach-was triangulated with the quantitative data. A total of 52 participants completed the interviews, and 48 also finished the survey. Four themes were identified; (a) illness perceptions (e.g., patients had poor CLD knowledge and SM, inadequate resources lead to suboptimal disease control in PC); (b) self-management skills (e.g., most patients delayed exacerbation recognition and action, and some were admitted at the crisis point); (c) factors influencing self-management skills (e.g., (in)adequate disease knowledge and medical expenditure affordability); and (d) needs for self-management (e.g., increased disease knowledge, individualized self-management plan, eHealth, (healthcare insurance) policy support). Identified themes were dependent on each other and should be leveraged when implementing SMIs. Ultimately, such SMIs can optimize patient health outcomes.