Construction of the whole-process nursing service system for day surgery patient based on the Kano model: A pilot cluster randomized controlled trial.

Objective: The types and number of day surgeries have significantly increased, but the construction of the whole process nursing service system (WPNSS) for preoperative education, intraoperative cooperation, postoperative knowledge, and follow-up for day surgery patients is still in the exploratory stage. The aim of this study is to establish the WPNSS for day surgery patients using the Kano model and to preliminarily assess its efficacy. Methods: WPNSS for day surgery was devised leveraging Internet hospital information systems and patient mobile terminals (WeChat), guided by the World Health Organization's conceptual framework for scaling-up strategies. The system was methodically developed, progressing from defining the overall framework to delineating modular functions and developing specific educational materials and tools. A pilot test was conducted in a hospital in China. Results: WPNSS, a patient-centric remote education and monitoring system, seamlessly amalgamates health education, online consultations, and follow-up functionalities; offering semi-automated surgical consultations, inquiry services, and postoperative follow-ups, as well as autonomously disseminating perioperative health education content. Comprising both client and server components, patients utilizing the system are inclined to recommend day surgery at the hospital to others. Conclusions: WPNSS delivers personalized and precise health education, consultation, and postoperative follow-up services for day surgery patients. Current results suggest that the WPNSS may improve patients' experience. Trial Registration: Chinese Clinical Trial Register (ChiCTR2200066782).

Implementation of a Clinical Decision Support System for Antimicrobial Prescribing in Sub-Saharan Africa: Multisectoral Qualitative Study.

BACKGROUND: Suboptimal use of antimicrobials is a driver of antimicrobial resistance in West Africa. Clinical decision support systems (CDSSs) can facilitate access to updated and reliable recommendations. OBJECTIVE: This study aimed to assess contextual factors that could facilitate the implementation of a CDSS for antimicrobial prescribing in West Africa and Central Africa and to identify tailored implementation strategies. METHODS: This qualitative study was conducted through 21 semistructured individual interviews via videoconference with health care professionals between September and December 2020. Participants were recruited using purposive sampling in a transnational capacity-building network for hospital preparedness in West Africa. The interview guide included multiple constructs derived from the Consolidated Framework for Implementation Research. Interviews were transcribed, and data were analyzed using thematic analysis. RESULTS: The panel of participants included health practitioners (12/21, 57%), health actors trained in engineering (2/21, 10%), project managers (3/21, 14%), antimicrobial resistance research experts (2/21, 10%), a clinical microbiologist (1/21, 5%), and an anthropologist (1/21, 5%). Contextual factors influencing the implementation of eHealth tools existed at the individual, health care system, and national levels. At the individual level, the main challenge was to design a user-centered CDSS adapted to the prescriber's clinical routine and structural constraints. Most of the participants stated that the CDSS should not only target physicians in academic hospitals who can use their network to disseminate the tool but also general practitioners, primary care nurses, midwives, and other health care workers who are the main prescribers of antimicrobials in rural areas of West Africa. The heterogeneity in antimicrobial prescribing training among prescribers was a significant challenge to the use of a common CDSS. At the country level, weak pharmaceutical regulations, the lack of official guidelines for antimicrobial prescribing, limited access to clinical microbiology laboratories, self-medication, and disparity in health care coverage lead to inappropriate antimicrobial use and could limit the implementation and diffusion of CDSS for antimicrobial prescribing. Participants emphasized the importance of building a solid eHealth ecosystem in their countries by establishing academic partnerships, developing physician networks, and involving diverse stakeholders to address challenges. Additional implementation strategies included conducting a local needs assessment, identifying early adopters, promoting network weaving, using implementation advisers, and creating a learning collaborative. Participants noted that a CDSS for antimicrobial prescribing could be a powerful tool for the development and dissemination of official guidelines for infectious diseases in West Africa. CONCLUSIONS: These results suggest that a CDSS for antimicrobial prescribing adapted for nonspecialized prescribers could have a role in improving clinical decisions. They also confirm the relevance of adopting a cross-disciplinary approach with participants from different backgrounds to assess contextual factors, including social, political, and economic determinants.

Telehealth for Rare Disease Care, Research, and Education Across the Globe: A Review of the Literature by the IRDiRC Telehealth Task Force.

The International Rare Diseases Research Consortium (IRDiRC) Telehealth (TH) Task Force explored the use of TH for improving diagnosis, care, research, and education for rare diseases (RDs). The Task Force reviewed related literature published from January 2017 to August 2023, and identified various models and implementation strategies of TH for RD. The Task Force highlighted the reported values and benefits of using TH for RDs, along with the limitations and opportunities. The number of publications sharply increased since 2021, coinciding with the onset of the COVID-19 pandemic, which forced the rapid adoption of TH in many healthcare settings. One of the major benefits of TH for RDs lies in its capacity to surmount geographical barriers, which helps in overcoming the constraints posed by limited numbers and geographical dispersion of specialists. This was evident during the pandemic when TH was used to maintain a level of continued medical care and research when face-to-face visits were severely restricted. TH, through which clinical research can be decentralized, can also facilitate and enhance RD research by decreasing burden, expanding access, and enhancing efficiency. This will be especially beneficial when coupled with the adoption of digital health technologies, such as mobile health (mHealth) and wearable devices for remote monitoring (i.e., surveillance of outpatient data transmitted through devices), along with big data solutions. TH has also been shown to be an effective means for RD education and peer mentoring, enabling local health care providers (HCPs) to care for RD patients, which indirectly ensures that RD patients get the expertise and multidisciplinary care they need. However, limitations and weaknesses associated with using TH for RD care and research were also identified, including the inability to perform physical examinations and build relationships with HCPs. Therefore, TH has been recommended as a complement to, rather than substitute for, face-to-face consultations. There is also a concern that TH may lead to an amplification of health disparities and inequities related to social determinants of health for those with RDs due to lack of access to TH technologies, inadequate digital literacy, and geographical, socio-cultural, and linguistic barriers. Finally, the Task Force also discussed evidence and knowledge gaps that will benefit from future research efforts to help advance and expand the use of TH for RD care, research, and education.

Virtual simulation for teaching cardiology in nursing: a scoping review protocol.

INTRODUCTION: Virtual simulation (VS) can be an effective learning strategy in the context of nursing education on cardiovascular disease; however, its use in teaching cardiology in nursing is less studied. The objective of this scoping review is to map the use of VS for teaching cardiology in nursing. METHODS AND ANALYSIS: This scoping review will be conducted according to the Joanna Briggs Institute methods, and the results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Eight databases will be searched: MEDLINE (NCBI/PubMed), Cumulative Index to Nursing and Allied Health Literature, Web of Science, Latin American and Caribbean Literature in Health Sciences, Spanish Bibliographic Index of Health Sciences, Database of Nursing, EMBASE and Google Scholar from inception to 31 July 2024. This study will include any existing peer-reviewed literature and grey literature. There will be no time or language restrictions. Two reviewers will screen and select the articles independently, and when there are differences, they will be resolved with a third opinion. When appropriate, broad themes and categories derived from the review questions will be accompanied by other illustrative formats (eg, tables or graphs, word clouds and infographics). ETHICS AND DISSEMINATION: This research project does not require ethical committee approval. The study is part of a cooperative research project between researchers from the Federal University of Piauí, Northeast of Brazil, and Queen's University, Ontario, Canada, to develop and seek evidence of content validity of a VS game about valvular heart disease. The protocol and review will be published in peer-reviewed journals. REGISTRATION DETAILS: Open Science Framework (https://doi.org/10.17605/OSF.IO/S3UMH).

What does it mean to be engaged with digital health interventions? A qualitative study into the experiences of engaged users and the views of professionals.

Objective: Digital health interventions (DHIs) hold promise for influencing health behaviors positively, but their widespread implementation and effectiveness remain limited. Engagement is crucial for DHI effectiveness, yet its conceptualization is debated. This qualitative study explores engagement from user and professional perspectives. Methods: Twenty self-proclaimed engaged health app users participated in semistructured interviews, and 13 professionals working with DHIs completed an online survey. Results: Interviews with health app users revealed three key components of their sense of engagement: behavioral, cognitive, and affective. Behavioral engagement includes routine, effortless, and dynamic usage; emphasizing the importance of the quality of fit between user and technology over frequency of use. Cognitive engagement encompasses the technology's utility as a tool for supporting behavior change, providing new insights, and enhancing motivation. Affective engagement involves enjoying progress, deriving pleasure from using the technology, and identifying with the technology. Notably, participants exhibited varying emphasis on these components. Professionals, in a parallel inquiry, agreed on the relevance of behavior, cognition, and affect in defining engagement. In their understanding, behavioral engagement is often associated with adherence and frequency of use, while cognitive engagement emphasizes understanding, motivation, and achieving cognitive outcomes. Affective engagement, although diverse, is recognized as a critical dimension. In addition, it was noticeable that users and professionals perceived microengagement (with the DHI) and macroengagement (with the target behavior) as interconnected. Conclusion: To conclude, this study contributes a nuanced understanding of the multifaceted nature of engagement, informing future measurement of the concept, DHI design, and implementation strategies for improved user experiences and outcomes.

Dark patterns, dark nudges, sludge and misinformation: alcohol industry apps and digital tools.

Many alcohol-industry-funded (AIF) organizations disseminate eHealth/mHealth tools that claim to assist users in making health decisions by monitoring alcohol consumption, e.g. blood alcohol calculators, AUDIT scores, consumption trackers. Previously, AIF materials were found to contain health misinformation that could increase consumption (dark nudges) or make healthy behaviour change more difficult (sludge). The accuracy and functionality of AIF tools have never been analysed, and given the history of AIF materials it is possible they contain misinformation and function as covert marketing channels to promote alcohol-industry-friendly narratives on the causes and possible solutions of alcohol-related harms. We evaluated the information accuracy and framing, behaviour change techniques (BCTs), and functions of AIF digital tools (n = 15, from the UK, Ireland, the USA, Canada, New Zealand, Australia; including Drinkaware, Drinkwise, Educ'alcool and others), compared to a non-industry-funded independent sample (n = 10). We identified misinformation and 'dark patterns' (interface design strategies for influencing users against their interest) throughout AIF tools; significantly fewer provided accurate feedback (33% vs 100%), and significantly more omitted information on cancer (67% vs 10%) and cardiovascular disease (80% vs 30%) and promoted industry-friendly narratives (47% vs 0%). AIF tools encouraged consumption through priming nudges (53%) and social norming (40%). AIF tools utilized fewer BCTs, provided users with more limited pre-set options (54%), and fewer drink choices (mean 24 vs 275). Their input structure often impeded their ability to provide guideline advice. We conclude that AIF tools contain pro-industry misinformation strategies and dark patterns that misinform users about their consumption and could 'nudge' them towards continuing to drink alcohol-characteristics of 'Dark Apps' designs.

A Digital Health Model for School-Based Implementation to Improve Parent and Child Outcomes: Comparison of Active Versus Light-Touch Coaching Effects.

Online or app-based parenting interventions have become more widely available in recent years. However, challenges related to poor engagement and high attrition have been noted in the literature, and there are important questions regarding ways to enhance parental engagement and improve treatment outcomes through digital health, including through the addition of therapeutic coaches. The current study evaluated differences in the effects of active versus "light-touch" coaching implementations of an enhanced version of Family Check-Up Online (FCU-O) on parent/family and child-level outcomes from pre-treatment to 2-month follow-up assessments. The enhanced version of the FCU-O was adapted to support families in coping with pandemic-related stressors to prevent youth behavioral and emotional problems during middle school and included app-based modules designed to support effective parenting practices as well as virtual coaching. In the "active-coach" condition, parenting coaches were active in efforts to arrange coaching sessions with parents as they worked through the app-based modules, while in the light-touch intervention, parent-coaches enrolled participants in the context of a one-time support session but did not actively pursue families to schedule additional sessions. Parents in the active-coach condition exhibited greater engagement with both the app and coaching sessions than parents in the light-touch condition. Further, stronger improvements in several aspects of parenting and child functioning were observed in the active-coach versus light-touch conditions. However, parents in the light-touch condition showed reductions in stress and comparable levels of dosage when using the app. Implications for prevention and accessibility of digital health interventions are discussed.

Co-Designing a Conversational Agent With Older Adults With Chronic Obstructive Pulmonary Disease Who Age in Place: Qualitative Study.

BACKGROUND: As a reaction to the global demographic increase in older adults (aged 60+ years), policy makers call for initiatives to enable healthy aging. This includes a focus on person-centered care and access to long-term care for older adults, such as developing different services and digital health technologies. This can enable patients to engage in their health and reduce the burden on the health care systems and health care professionals. The European Union project Smart Inclusive Living Environments (SMILE) focuses on well-being and aging in place using new digital health technologies. The novelty of the SMILE project is the use of a cocreational approach focused on the needs and preferences of older adults with chronic obstructive pulmonary disease (COPD) in technology development, to enhance access, adaptation, and usability and to reduce stigma. OBJECTIVE: The study aimed to describe the perspective, needs, and preferences of older adults living with COPD in the context of the design and development of a conversational agent. METHODS: This study carried out a data-driven thematic analysis of interview data from 11 cocreation workshops with 33 older adults living with COPD. RESULTS: The three particular features that the workshop participants wanted to implement in a new technology were (1) a "my health" function, to use technology to manage and learn more about their condition; (2) a "daily activities" function, including an overview and information about social and physical activities in their local area; and (3) a "sleep" function, to manage circadian rhythm and enhance sleep quality, for example, through online video guides. In total, 2 overarching themes were identified for the 3 functions: measurements, which were actively discussed and received mixed interest among the participants, and health literacy, due to an overall interest in learning more about their condition in relation to everyday life. CONCLUSIONS: The future design of digital health technology must embrace the complexities of the everyday life of an older adult living with COPD and cater to their needs and preferences. Measurements should be optional and personalized, and digital solutions should be used as a supplement to health care professionals, not as substitute.

A public value-based model to understand patients' adoption of eHealth: Theoretical underpinnings and empirical application.

Objective: The main objective of this study is to develop an eHealth adoption model based on patients' perceptions of public value dimensions and empirically apply the model to understand the adoption of a governmental health app by Jordanian patients. The study attempts to contribute to overcoming the narrow focus of contemporary theories such as UTAUT and, ultimately, to designing more effective implementation strategies in order to address the current delays in global eHealth adoption. Methods: We conducted a quantitative survey of 430 Jordanian patients, utilizing structural equation modeling (SEM) to process the empirical data. Specifically, we applied an SEM two-step approach that involved (a) evaluating the model-data fit through a review of the measurement model(s) and common method bias; and (b) analyzing the structural model. Results: Our findings confirm that the proposed patients' value scale is valid and reliable. Its five dimensions (hedonistic motivation, utilitarian motivation, social value, ethical public value, and public trust value) significantly correlate with patients' public value, and the latter directly affects their use of eHealth apps, with habits mediating this relationship. Among the dimensions, hedonistic motivations tend to be prioritized over utilitarian ones. Ethical and trust values also play an essential role, particularly in how health technology handles patients' data and upholds their dignity and self-esteem. Conclusions: This study highlights the holistic nature of eHealth adoption by patients and the crucial role of public values in their use behavior. It provides useful insights for policymakers and developers.

The Triple E project: a factorial randomised controlled trial to enhance engagement with eHealth approaches to improve health risk behaviours among adolescents.

BACKGROUND: Digital, or eHealth, interventions are highly promising approaches to help adolescents improve their health behaviours and reduce their risk of chronic disease. However, they often have low uptake and retention. There is also a paucity of high-quality research into the predictors of eHealth engagement, and a lack of studies that have systematically evaluated existing engagement strategies in adolescent populations. This paper describes the protocol for a randomised controlled trial which primarily aims to assess the effectiveness of different strategies in increasing engagement with a healthy lifestyles app, Health4Life. Associations between the engagement strategies and improvements in adolescent health behaviours (healthy eating, physical activity, sleep, recreational screen time, smoking, alcohol use) will also be examined, along with potential predictors of adolescents' intentions to use health apps and their use of the Health4Life app. METHODS: The current study will aim to recruit 336 adolescent and parent/guardian dyads (total sample N = 672) primarily through Australia wide online advertising. All adolescent participants will have access to the Health4Life app (a multiple health behaviour change, self-monitoring mobile app). The trial will employ a 24 factorial design, where participants will be randomly allocated to receive 1 of 16 different combinations of the four engagement strategies to be evaluated: text messages, access to a health coach, access to additional gamified app content, and provision of parent/guardian information resources. Adolescents and parents/guardians will both complete consent processes, baseline assessments, and a follow-up assessment after 3 months. All participants will also be invited to complete a qualitative interview shortly after follow-up. The primary outcome, app engagement, will be assessed via an App Engagement Index (Ei) using data collected in the Health4Life app and the Mobile App Rating Scale - User version. DISCUSSION: This research will contribute significantly to building our understanding of the types of strategies that are most effective in increasing adolescents' engagement with health apps and which factors may predict adolescents' use of health apps. TRIAL REGISTRATION: The trial is registered at the Australian New Zealand Clinical Trials Registry (ACTRN12623000399695). Date registered: 19/04/2023.

A preventive integrated eHealth approach for individuals with a low socioeconomic position: protocol for a realist evaluation.

BACKGROUND: Adoption of standalone eHealth tools is low among persons in lower socioeconomic groups. The preventive integrated eHealth approach combines blended care with an active and personal approach to facilitate access to local care, tailored to the needs of the participant. We describe the four step preventive integrated eHealth approach for individuals with a low socioeconomic position and the realist evaluation protocol of the intervention and implementation. The realist evaluation centers around the question, 'what works for whom in what circumstances and why'. METHODS: The study population will consist of adult individuals with a low socioeconomic position, who participate in the preventive integrated eHealth approach in one of the participating locations in the Netherlands. The four-step intervention consists of: (1) a proactive invitation of participants by care professionals, (2) the use of an eHealth tool that produces a personalized health report, (3) a personal consultation with a care professional to discuss the personalized health report and set a goal to work on, and (4) active referral to local social and health care. An initial program theory theorized from literature and stakeholder involvement is presented. Qualitative and quantitative data collection and analysis with participants (survey at zero, three and twelve months and focus groups at six months) and professionals (interviews at three months) will inform the realist evaluation and serves to test and refine the initial program theory. DISCUSSION: Our mixed-methods realist evaluation on the effect and implementation of a personal and active blended care approach will elucidate what elements trigger the mechanisms and responses of how individuals with a low socioeconomic position experience the preventive integrated eHealth approach. This will inform the way a preventative health check incorporating eHealth can be used to its full potential for low socioeconomic positioned groups to help close the digital divide and contribute to reduce health disparities.

Positive experiences with the use of an eHealth smartphone application during the treatment of an abdominal aortic aneurysm.

OBJECTIVE: To evaluate the patient perceived satisfaction and feasibility of a personalized eHealth application (app) for abdominal aortic aneurysm (AAA) patients undergoing surgery. METHODS: Patients were offered to download the app prior to undergoing AAA surgery, in a prospective single centre cohort study, using a mixed methods sequential explanatory design. It offers information via the timely delivery of push notifications with text, images, and videos. The information includes chapters regarding the AAA, surgical techniques (endovascular aneurysm repair and open surgical repair), and perioperative lifestyle advice such as; physical exercise programmes, healthy and protein rich diet, geriatric care, and to stop smoking or drinking alcohol. RESULTS: The app was installed by 59/65 patients (91%). After installation, six patients deactivated the app (10%). The mean age was 74 years (SD = 7) and 85% of patients were male. The app was opened a median of 67 times (interquartile range [IQR] 33-127) and with a median time interval of 50 hours (IQR 28-74). Overall, 90% (53/59) completed a satisfaction questionnaire. On a numeric rating scale from 0 to 10, the median scored satisfaction for guidance was 8 (IQR 6-8), provided information was 8 (IQR 6-8), usefulness was 7 (IQR 6-8.5), and for recommending it to others 8 (IQR 6-9). Using purposeful sampling, seven patients underwent a semi-structured interview on user-experience of the app. They described experiencing positive changes to lifestyle habits, and appreciating the ability to share it with loved ones or informal caregivers. Several areas of improvement were reported. CONCLUSION: The personalized eHealth app is feasible in older AAA patients and valued as a useful supplement to the standard of care. We argue that the app aids in managing a prehabilitation programme, aids in the digital transformation of healthcare, and thereby decreases the workload of hospital staff.

Scaling up! Staff e-learning for a national take-home naloxone program.

Background: A staff e-learning course was developed to prepare for scaling up a national take-home naloxone (THN) program in Norway. The aims of the study were to (a) describe participant characteristics for those that completed a THN e-learning course, (b) compare opioid overdose knowledge scores before and after e-learning course completion, and (c) to explore subsequent THN distribution by those trained. Methods: This was a quasi-experimental pre-test, post-test longitudinal cohort study of individuals completing a THN e-learning course from April 2021 to May 2022. Frequency analyses were performed for participant characteristics and subsequent naloxone distributions at 1-week and 1-month follow-up. The opioid overdose knowledge scale (OOKS) was used to measure pre-test-post-test knowledge among participants. Wilcoxon signed-rank test was performed for comparison between pre-test and post-test. Effect size was calculated using Cohen criteria. Results: In total, 371 individuals were included in this study. Most were either nurses or social workers (n = 277, 75%). Participant knowledge increased by medium or large effect for all items measured. At 1-month follow-up, 15% reported naloxone distribution. During the study period, 94 naloxone kits were distributed. Major reasons for not distributing were "clients not interested", "workplace not distributing" and "workplace in process of distributing". Conclusions: Our findings suggest that an e-learning course is equally effective in terms of knowledge transfer as an in-person classroom setting, and may provide engagement in terms of naloxone distribution. However, our findings also emphasize the importance of clear implementation routines, including support from central coordinators to optimize the implementation process.

Evaluation of health recommender systems: a scoping review protocol.

BACKGROUND: People increasingly rely on online health information for their health-related decision-making. Given the overwhelming amount of information available, the risk of misinformation is high. Health recommender systems, which recommend personalised health-related information or interventions using intelligent algorithms, have the potential to address this issue. Many such systems have been developed and evaluated individually, but there is a need to synthesise the evaluation findings to identify gaps and ensure that future recommender systems are designed to have a positive impact on health or target behaviours. OBJECTIVE: The purpose of this review is to provide an overview of the state of the literature evaluating health recommender systems and highlight lessons learnt, methodological considerations and gaps in current research. METHODS AND ANALYSIS: The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and the Population, Concept, and Context frameworks. Five databases (PubMED, ACM Digital Library Full-Text Collection, IEEE Xplore, Web of Science and ScienceDirect) will be searched for studies published in English that evaluate at least one health recommender system using search terms following the themes reflecting digital health, recommendation systems and evaluations of efficacy and impact. After using EndNote 21 for initial screening, two independent reviewers will screen the titles, abstracts and full texts of the references, and then extract data from included studies related to the recommender system characteristics, evaluation design and evaluation findings into a predetermined form. A descriptive analysis will be conducted to provide an overview of the literature; key themes and gaps in the literature will be discussed. ETHICS AND DISSEMINATION: Ethical approval is not required as data will be obtained from already published sources. Findings from this study will be disseminated via publication in a peer-reviewed journal.

Effectiveness of the MyDiaMate application in reducing diabetes distress in adults with type 1 diabetes: Study protocol of the multi-national, randomised-controlled MyREMEDY trial.

AIMS: Diabetes distress is common among people with type 1 diabetes (T1D), negatively affecting quality of life, self management, and diabetes outcomes. E-health-based interventions could be an effective and low-cost way to improve the psychological care for people with T1D experiencing diabetes distress. The MyREMEDY study aims to test the effectiveness of the online unguided self-help intervention MyDiaMate in decreasing diabetes distress in adults with T1D. MyDiaMate is based on Cognitive Behavioural Therapy and consists of eight modules, each focusing on a different aspect of living with T1D that is often experienced as burdensome (e.g. hypoglycaemia, fatigue). METHODS: The effectiveness of MyDiaMate will be tested through a randomised-controlled trial across four European countries (the Netherlands, Germany, Spain and the United Kingdom). Six hundred and sixty adults (N = 165 per country) with T1D will be recruited and randomised with a balance of 2:1 into the intervention and care as usual groups. Intervention group members receive access to MyDiaMate for 6 months, care as usual group members receive access after 3 months for 3 months. Participants fill in questionnaires at 0 (baseline), 3 (effectiveness) and 6 months (follow-up). Primary outcome is diabetes distress at 3 months. Secondary outcomes are emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, fatigue, and glycaemic outcomes. Moreover, logdata of MyDiaMate use is passively collected. Linear mixed model analyses will be used to test the effectiveness of MyDiaMate along with identifying which user subgroup benefits most from MyDiaMate use. TRIAL REGISTRATION: Clinicaltrials.gov NCT06308549.

The web-based Pleasure&Pregnancy programme in the treatment of unexplained infertility: a randomized controlled trial.

STUDY QUESTION: Does offering the Pleasure&Pregnancy (P&P) programme rather than expectant management improve naturally conceived ongoing pregnancy rates in couples diagnosed with unexplained infertility? SUMMARY ANSWER: The P&P programme had no effect on the ongoing pregnancy rates of couples with unexplained infertility. WHAT IS KNOWN ALREADY: Underpowered studies suggested that face-to-face interventions targeting sexual health may increase pregnancy rates. The impact of an eHealth sexual health programme had yet to be evaluated by a large randomized controlled trial. STUDY DESIGN, SIZE, DURATION: This is a nationwide multi-centre, unblinded, randomized controlled superiority trial (web-based randomization programme, 1:1 allocation ratio). This RCT intended to recruit 1164 couples within 3 years but was put on hold after having included 700 couples over 5 years (2016-2021). The web-based P&P programme contains psychosexual information and couple communication, mindfulness and sensate focus exercises aiming to help maintain or improve sexual health, mainly pleasure, and hence increase pregnancy rates. The P&P programme additionally offers information on the biology of conception and enables couples to interact online with peers and via email with coaches. PARTICIPANTS/MATERIALS, SETTING, METHODS: Heterosexual couples with unexplained infertility and a Hunault-prognosis of at least 30% chance of naturally conceiving a live-born child within 12 months were included, after their diagnostic work-up in 41 Dutch secondary and tertiary fertility centres. The primary outcome was an ongoing pregnancy, defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed by an ultrasound scan, conceived naturally within 6 months after randomization. Secondary outcomes were time to pregnancy, live birth, sexual health, and personal and relational well-being at baseline and after 3 and 6 months. The primary analyses were according to intention-to-treat principles. We calculated relative risks (RRs, pregnancy rates) and a risk difference (RD, pregnancy rates), Kaplan-Meier survival curves (live birth over time), and time, group, and interactive effects with mixed models analyses (sexual health and well-being). MAIN RESULTS AND THE ROLE OF CHANCE: Totals of 352 (one withdrawal) and 348 (three withdrawals) couples were allocated to, respectively the P&P group and the expectant management group. Web-based tracking of the intervention group showed a high attrition rate (57% of couples) and limited engagement (i.e. median of 16 visits and 33 min total visitation time per couple). Intention-to-treat analyses showed that 19.4% (n = 68/351) of the P&P group and 22.6% (n = 78/345) of the expectant management group achieved a naturally conceived ongoing pregnancy (RR = 0.86; 95% CI = 0.64-1.15, RD = -3.24%; 95% CI -9.28 to 2.81). The time to pregnancy did not differ between the groups (Log rank = 0.23). Live birth occurred in 18.8% (n = 66/351) of the couples of the P&P group and 22.3% (n = 77/345) of the couples of the expectant management group (RR = 0.84; 95% CI = 0.63-1.1). Intercourse frequency decreased equally over time in both groups. Sexual pleasure, orgasm, and satisfaction of women of the P&P group improved while these outcomes remained stable in the expectant management group. Male orgasm, intercourse satisfaction, and overall satisfaction decreased over time with no differences between groups. The intervention did not affect personal and relational well-being. Non-compliance by prematurely starting medically assisted reproduction, and clinical loss to follow-up were, respectively, 15.1% and 1.4% for the complete study population. Per protocol analysis for the primary outcome did not indicate a difference between the groups. Comparing the most engaged users with the expectant management group added that coital frequency decreased less, and that male sexual desire improved in the intervention group. LIMITATIONS, REASONS FOR CAUTION: The intended sample size of 1164 was not reached because of a slow recruitment rate. The achieved sample size was, however, large enough to exclude an improvement of more than 8% of the P&P programme on our primary outcome. WIDER IMPLICATIONS OF THE FINDINGS: The P&P programme should not be offered to increase natural pregnancy rates but may be considered to improve sexual health. The attrition from and limited engagement with the P&P programme is in line with research on other eHealth programmes and underlines the importance of a user experience study. STUDY FUNDING/COMPETING INTEREST(S): Funded by The Netherlands Organisation for Health Research and Development (ZonMw, reference: 843001605) and Flanders Research Foundation. C.B.L. is editor-in-chief of Human Reproduction. H.W.L. received royalties or licences from Prometheus Publishers Springer Media Thieme Verlag. J.B. received support from MercK for attending the ESHRE course 'The ESHRE guideline on ovarian stimulation, do we have agreement?' J.v.D. reports consulting fees and lecture payments from Ferring, not related to the presented work, and support for attending ESHRE from Goodlife and for attending NFI Riga from Merck. A.H. reports consulting fees by Ferring Pharmaceutical company, The Netherlands, paid to institution UMCG, not related to the presented work. H.V. reports consulting fees from Ferring Pharmaceutical company, The Netherlands, and he is a member of the ESHRE guideline development group unexplained infertility and Chair of the Dutch guideline on unexplained infertility (unpaid). M.G. declares unrestricted research and educational grants from Ferring not related to the presented work, paid to their institution VU Medical Centre. The other authors have no conflicts to declare. TRIAL REGISTRATION NUMBER: NTR5709. TRIAL REGISTRATION DATE: 4 February 2016. DATE OF FIRST PATIENT'S ENROLMENT: 27 June 2016.

Designing a Nurse-Led eHealth Cardiac Rehabilitation Program: Insights From Participant Experiences and Qualitative Feedback.

BACKGROUND: This study examines the perspectives of individuals with coronary heart disease (CHD) on a nurse-led eHealth cardiac rehabilitation (NeCR) program, which included a website, tele-monitoring device, and social media chatroom. METHODS: Using a descriptive qualitative approach, semi-structured interviews were conducted with 18 participants to capture their feedback and experiences with the NeCR program. RESULTS: Participants found the NeCR program valuable in addressing gaps in cardiac rehabilitation services in China, empowering them to make behavioral changes and enhancing their social motivation. However, they also highlighted the need for a more user-friendly website, better symptom management during exercise, and stronger privacy protections in the peer networking chatroom. The study concludes that the NeCR program is feasible in providing accessible rehabilitative services at home post-discharge. Recommendations include improving the self-monitoring platform for ease of use, incorporating immediate symptom management guidance during exercise, and ensuring a secure environment for online peer support. CONCLUSIONS: These findings offer crucial insights for developing patient-centered eHealth cardiac rehabilitation services, emphasizing the importance of user-friendly design, effective symptom management features, and privacy protection in promoting participant engagement with e-platforms. TRIAL REGISTRATION: ChiCTR1800020411 (http://www.chictr.org.cn/showprojen.aspx?proj=33906).

Protocol of a randomized controlled trial into guided internet-delivered cognitive behavioral therapy for insomnia in autistic adults (i-Sleep Autism).

BACKGROUND: Sleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population. METHODS: With this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (N = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators. CONCLUSION: This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention. TRIAL REGISTRATION: NL-OMON56692.

Evaluation of a digital patient education programme in patients with coronary artery disease, a survey-based study.

INTRODUCTION: Patient education programmes focusing on risk factor modification and lifestyle changes are well established as part of cardiac rehabilitation in patients with coronary artery disease (CAD). As participation rates are low, digital patient education programmes (DPE) are interesting alternatives to increase access. Understanding patients' perceptions of DPE are important in terms of successful implementation in clinical practice but are not well known. Therefore, the aim of this study was to assess patients' perceptions of using a DPE in terms of end-user acceptance and usability, perceived significance for lifestyle changes and secondary preventive goal fulfilment in patients with CAD. METHODS: This was a cross-sectional survey-based study. The survey was distributed to all 1625 patients with acute coronary syndrome or chronic CAD with revascularisation, who were registered users of the DPE between 2020 and 2022 as part of cardiac rehabilitation. The survey contained 64 questions about e.g., acceptance and usability, perceived significance for making lifestyle changes and secondary preventive goal fulfilment. Patients who had never logged in to the DPE received questions about their reasons for not logging in. Data were analysed descriptively. RESULTS: A total of 366 patients (mean age: 69.1 ± 11.3 years, 20% female) completed the survey and among those 207 patients (57%) had used the DPE. Patients reported that the DPE was simple to use (80%) and improved access to healthcare (67-75%). A total of 69% of the patients were generally satisfied with the DPE, > 60% reported that the DPE increased their knowledge about secondary preventive treatment goals and approximately 60% reported having a healthy lifestyle today. On the other hand, 35% of the patients would have preferred a hospital-based education programme. Among the 159 patients (43%) who had never used the DPE, the most reported reason was a perceived need for more information about how to use the DPE (52%). CONCLUSIONS: This study shows an overall high level of patient acceptance and usability of the DPE, which supports its continued development and long-term role in cardiac rehabilitation in patients with CAD. Future studies should assess associations between participation in the DPE and clinical outcomes, such as secondary preventive goal fulfilment and hospitalisation.