BACKGROUND: The escalating global prevalence of type 2 diabetes and prediabetes presents a major public health challenge. Physical activity plays a critical role in managing (pre)diabetes; however, adherence to physical activity recommendations remains low. The ENERGISED trial was designed to address these challenges by integrating mHealth tools into the routine practice of general practitioners, aiming for a significant, scalable impact in (pre)diabetes patient care through increased physical activity and reduced sedentary behaviour.
METHODS: The mHealth intervention for the ENERGISED trial was developed according to the mHealth development and evaluation framework, which includes the active participation of (pre)diabetes patients. This iterative process encompasses four sequential phases: (a) conceptualisation to identify key aspects of the intervention; (b) formative research including two focus groups with (pre)diabetes patients (n = 14) to tailor the intervention to the needs and preferences of the target population; (c) pre-testing using think-aloud patient interviews (n = 7) to optimise the intervention components; and (d) piloting (n = 10) to refine the intervention to its final form.
RESULTS: The final intervention comprises six types of text messages, each embodying different behaviour change techniques. Some of the messages, such as those providing interim reviews of the patients\' weekly step goal or feedback on their weekly performance, are delivered at fixed times of the week. Others are triggered just in time by specific physical behaviour events as detected by the Fitbit activity tracker: for example, prompts to increase walking pace are triggered after 5 min of continuous walking; and prompts to interrupt sitting following 30 min of uninterrupted sitting. For patients without a smartphone or reliable internet connection, the intervention is adapted to ensure inclusivity. Patients receive on average three to six messages per week for 12 months. During the first six months, the text messaging is supplemented with monthly phone counselling to enable personalisation of the intervention, assistance with technical issues, and enhancement of adherence.
CONCLUSIONS: The participatory development of the ENERGISED mHealth intervention, incorporating just-in-time prompts, has the potential to significantly enhance the capacity of general practitioners for personalised behavioural counselling on physical activity in (pre)diabetes patients, with implications for broader applications in primary care.

A healthy lifestyle may improve mental health. It is yet not known whether and how a mobile intervention can be of help in achieving this in adolescents. This study investigated the effectiveness and perceived underlying mechanisms of the mobile health (mHealth) intervention #LIFEGOALS to promote healthy lifestyles and mental health. #LIFEGOALS is an evidence-based app with activity tracker, including self-regulation techniques, gamification elements, a support chatbot, and health narrative videos.
A quasi-randomized controlled trial (N = 279) with 12-week intervention period and process evaluation interviews (n = 13) took place during the COVID-19 pandemic. Adolescents (12-15y) from the general population were allocated at school-level to the intervention (n = 184) or to a no-intervention group (n = 95). Health-related quality of life (HRQoL), psychological well-being, mood, self-perception, peer support, resilience, depressed feelings, sleep quality and breakfast frequency were assessed via a web-based survey; physical activity, sedentary time, and sleep routine via Axivity accelerometers. Multilevel generalized linear models were fitted to investigate intervention effects and moderation by pandemic-related measures. Interviews were coded using thematic analysis.
Non-usage attrition was high: 18% of the participants in the intervention group never used the app. An additional 30% stopped usage by the second week. Beneficial intervention effects were found for physical activity (χ21 = 4.36, P = .04), sedentary behavior (χ21 = 6.44, P = .01), sleep quality (χ21 = 6.11, P = .01), and mood (χ21 = 2.30, P = .02). However, effects on activity-related behavior were only present for adolescents having normal sports access, and effects on mood only for adolescents with full in-school education. HRQoL (χ22 = 14.72, P < .001), mood (χ21 = 6.03, P = .01), and peer support (χ21 = 13.69, P < .001) worsened in adolescents with pandemic-induced remote-education. Interviewees reported that the reward system, self-regulation guidance, and increased health awareness had contributed to their behavior change. They also pointed to the importance of social factors, quality of technology and autonomy for mHealth effectiveness.
#LIFEGOALS showed mixed results on health behaviors and mental health. The findings highlight the role of contextual factors for mHealth promotion in adolescence, and provide suggestions to optimize support by a chatbot and narrative episodes.
ClinicalTrials.gov [NCT04719858], registered on 22/01/2021.

This article discusses an approach to translational bioethics (TB) that is concerned with the adaptation-or \'translation\'-of concepts, theories and methods from bioethics to practical contexts, in order to support \'non-bioethicists\', such as researchers and healthcare practitioners, in dealing with their ethical issues themselves. Specifically, it goes into the participatory development of clinical ethics support (CES) instruments that respond to the needs and wishes of healthcare practitioners and that are tailored to the specific care contexts in which they are to be used. The theoretical underpinnings of this participatory approach to TB are found in hermeneutic ethics and pragmatism. As an example, the development of CURA, a low-threshold CES instrument for healthcare professionals in palliative care, is discussed. From this example, it becomes clear that TB is a two-way street. Practice may be improved by means of CES that is effectively tailored to specific end users and care contexts. The other way around, ethical theory may be enriched by means of the insights gained from engaging with practice in developing CES in a process of co-creation. TB is also a two-way street in the sense that it requires collaboration and commitment of both bioethicists and practitioners, who engage in a process of mutual learning. However, substantial challenges remain. For instance, is there a limit to the extent to which a method of moral reasoning can be adapted in order to meet the constraints of a given healthcare setting? Who is to decide, the bioethicist or the practitioners?

Digital assistive technologies have the potential to address the pressing need for adequate therapy options for patients with long COVID (also known as post-COVID-19 condition) by enabling the implementation of individual and independent rehabilitation programs. However, the involvement of the target patient group is necessary to develop digital devices that are closely aligned to the needs of this particular patient group.
Participatory design approaches, such as cocreation, may be a solution for achieving usability and user acceptance. However, there are currently no set methods for implementing cocreative development processes incorporating patients. This study addresses the following research questions: what are the tasks and challenges associated with the involvement of patient groups? What lessons can be learned regarding the adequate involvement of patients with long COVID?
First, a literature review based on a 3-stage snowball process was conducted to identify the tasks and challenges emerging in the context of the cocreation of digital assistive devices and services with patient groups. Second, a qualitative analysis was conducted in an attempt to extract relevant findings and criteria from the identified studies. Third, using the method of theory adaptation, this paper presents recommendations for the further development of the existing concepts of cocreation in relation to patients with long COVID.
The challenges of an active involvement of patients in cocreative development in health care include hierarchical barriers and differences in the levels of specific knowledge between professionals and patients. In the case of long COVID, patients themselves are still inexperienced in dealing with their symptoms and are hardly organized into established groups. This amplifies general hurdles and leads to questions of group identity, power structure, and knowledge creation, which are not sufficiently addressed by the current methods of cocreation.
The adaptation of transdisciplinary methods to cocreative development approaches focusing on collaborative and inclusive communication can address the recurring challenges of actively integrating patients with long COVID into development processes.

The use of eHealth is more challenging for people with intellectual disabilities (IDs) than for the general population because the technologies often do not fit the complex needs and living circumstances of people with IDs. A translational gap exists between the developed technology and users\' needs and capabilities. User involvement approaches have been developed to overcome this mismatch during the design, development, and implementation processes of the technology. The effectiveness and use of eHealth have received much scholarly attention, but little is known about user involvement approaches.
In this scoping review, we aimed to identify the inclusive approaches currently used for the design, development, and implementation of eHealth for people with IDs. We reviewed how and in what phases people with IDs and other stakeholders were included in these processes. We used 9 domains identified from the Centre for eHealth Research and Disease management road map and the Nonadoption, Abandonment, and challenges to the Scale-up, Spread, and Sustainability framework to gain insight into these processes.
We identified both scientific and gray literature through systematic searches in PubMed, Embase, PsycINFO, CINAHL, Cochrane, Web of Science, Google Scholar, and (websites of) relevant intermediate (health care) organizations. We included studies published since 1995 that showed the design, development, or implementation processes of eHealth for people with IDs. Data were analyzed along 9 domains: participatory development, iterative process, value specification, value proposition, technological development and design, organization, external context, implementation, and evaluation.
The search strategy resulted in 10,639 studies, of which 17 (0.16%) met the inclusion criteria. Various approaches were used to guide user involvement (eg, human or user-centered design and participatory development), most of which applied an iterative process mainly during technological development. The involvement of stakeholders other than end users was described in less detail. The literature focused on the application of eHealth at an individual level and did not consider the organizational context. Inclusive approaches in the design and development phases were well described; however, the implementation phase remained underexposed.
The participatory development, iterative process, and technological development and design domains showed inclusive approaches applied at the start of and during the development, whereas only a few approaches involved end users and iterative processes at the end of the process and during implementation. The literature focused primarily on the individual use of the technology, and the external, organizational, and financial contextual preconditions received less attention. However, members of this target group rely on their (social) environment for care and support. More attention is needed for these underrepresented domains, and key stakeholders should be included further on in the process to reduce the translational gap that exists between the developed technologies and user needs, capabilities, and context.

BACKGROUND: Reporting individual clinical and patient-reported outcomes to patients during consultations may add to patients\' disease knowledge and activation and stimulate Shared Decision Making (SDM). These outcomes can be presented over time in a clear way by the means of dashboarding. We aimed to systematically develop a Chronic Kidney Disease (CKD) dashboard designed to support consultations, test its usability and explore conditions for optimal use in practice.
METHODS: For development a participatory approach with patients and healthcare professionals (HCPs) from three hospitals was used. Working groups and patient focus groups were conducted to identify needs and inform the dashboard\'s design. Usability was tested in patient interviews. A focus group with HCPs was held to identify conditions for optimal use of the dashboard in daily practice.
RESULTS: A dashboard was developed for CKD patients stage 3b-4 visualizing both clinical and patient-reported outcomes over time for use during consultations and accessible for patients at home. Both HCPs and patients indicated that the dashboard can: motivate patients in their treatment by providing feedback on outcomes over time; improve consultation conversations by enhanced preparation of both HCPs and patients; better inform patients, thereby facilitating shared decision making. HCPs and patients both stated that setting a topic agenda for the consultation together is important in effectively discussing the dashboard during consultations. Moreover, the dashboard should not dominate the conversation. Lastly, findings of the usability tests provided design requirements for optimal user-friendliness and clarity.
CONCLUSIONS: Dashboarding can be a valuable way of reporting individual outcome information to patients and their clinicians as findings suggest it may stimulate patient activation and facilitate decision making. Co-creation with patients and HCPs was essential for successful development of the dashboard. Gained knowledge from the co-creation process can inform others wishing to develop similar digital tools for use in clinical practice.

UNASSIGNED: Returning to work often fails due to conflicting expectations and goals of the stakeholders involved. Due to their medical expertise and workplace-related knowledge, occupational physicians could effectively promote mutual understanding and cooperation between the stakeholders. The study aimed to develop a manual and training session for its application that will support occupational physicians to assume a mediating role in the integration of employees with a mental illness.
UNASSIGNED: Based on a literature review and extensive qualitative preliminary work on the expectations of the stakeholders, the manual and training materials were developed, discussed and revised in several consecutive steps based on a participatory approach with occupational physicians and other experts. Finally, occupational physicians were trained to use the manual during their specialization training in order to subsequently test its practicability in everyday work.
UNASSIGNED: The manual presents information on the potentially different expectations of the actors for the return process and offers comprehensive advice for the mediating work of the occupational physicians. After a manualized training of approximately 2h, 9 out of 37 participants used the manual for return interviews within 4 months and 6 out of 9 rated it as helpful.
UNASSIGNED: The first positive experiences of using the material developed with the target group justify a larger interventional study to investigate the presumed beneficial effects on the success of reintegration.

Existing clinical ethics support (CES) instruments are considered useful. However, users report obstacles in using them in daily practice. Including end users and other stakeholders in developing CES instruments might help to overcome these limitations. This study describes the development process of a new ethics support instrument called CURA, a low-threshold four-step instrument focused on nurses and nurse assistants working in palliative care.
We used a participatory development design. We worked together with stakeholders in a Community of Practice throughout the study. Potential end users (nurses and nurse assistants in palliative care) used CURA in several pilots and provided us with feedback which we used to improve CURA.
We distinguished three phases in the development process. Phase one, Identifying Needs, focused on identifying stakeholder and end user needs and preferences, learning from existing CES instruments, their development and evaluation, and identify gaps. Phase two, Development, focused on designing, developing, refining and tailoring the instrument on the basis of iterative co-creation. Phase three, Dissemination, focused on implementation and dissemination. The instrument, CURA, is a four-step low-threshold instrument that fosters ethical reflection.
Participatory development is a valuable approach for developing clinical ethics support instruments. Collaborating with end users and other stakeholders in our development study has helped to meet the needs and preferences of end users, to come up with strategies to refine the instrument in order to enhance its feasibility, and to overcome reported limitations of existing clinical ethics instruments.

In the past two decades, religious leaders have garnered increased interest from health ministries and NGOs as promoters, educators, and implementers of sensitive health programs such as family planning in several African countries. While religious leaders\' role as public health actors has been well-documented, there are few ethnographic accounts of how religious leaders engage with public health programs, especially family planning. Informed by twelve months of ethnographic study in three rural and peri-urban locations in Kilombero district in 2014-2016, this article examines how Muslim religious leaders experienced and negotiated their role as implementers of family planning services. Governments and NGOs seek religious leaders\' social capital to increase community\'s knowledge of and demand for family planning as well as to diffuse the community\'s moral anxieties surrounding its use. Participant observation and interviews, however, show that religious leaders selectively engage with family planning projects, balancing project demands, their own interests and the existing norms and perceptions in the community. Religious leaders stood beside other team members promoting condoms, but they remained silent themselves on condom promotion selecting instead to speak on the dangers of teenage pregnancy. Tensions, power differentials and a mélange of interests, existing and emergent, set the stage for religious leaders to selectively engage with the family planning project. Selective engagement was beneficial for both parties. Religious leaders received training on modern family planning, gained symbolic capital by associating with a powerful NGO, and expanded their social networks while government officials and NGOs received indirect support for family planning programs.

BACKGROUND: Although eMental health interventions, especially when delivered in a blended way, have great potential to improve the quality and efficiency of mental health care, their use in practice lags behind expectations. The Fit for Blended Care (FfBC) instrument was developed to support therapists and clients in shaping blended care in a way that optimally fits their needs. However, this existing version cannot be directly applied to specific branches of mental health care as it is too broad and generic.
OBJECTIVE: The goal of this study is to adapt the existing FfBC instrument to fit a specific, complex setting-forensic mental health care-by means of participatory development with therapists.
METHODS: The participatory process was divided into 4 phases and was executed by a project team consisting of 1 manager, 3-5 therapists, and 1 researcher. In phase 1, general requirements for the adaptation of the existing instrument were discussed in 2 focus groups with the project team. In phase 2, patient-related factors that influence the use of an existing web-based intervention were elicited through semistructured interviews with all 18 therapists working at an outpatient clinic. In phase 3, multiple focus groups with the project teams were held to create the first version of the adapted FfBC instrument. In phase 4, a digital prototype of the instrument was used with 8 patients, and the experiences of the 4 therapists were discussed in a focus group.
RESULTS: In phase 1, it became clear that the therapists\' main requirement was to develop a much shorter instrument with a few items, in which the content was specifically tailored to the characteristics of forensic psychiatric outpatients. The interviews showed a broad range of patient-related factors, of which 5 were used in the instrument: motivation for blended treatment; writing about thoughts, feelings, and behavior; conscientiousness; psychosocial problems; and social support. In addition, a part of the instrument was focused on the practical necessary preconditions that patients should fill by themselves before the treatment was developed. The use of the web-based prototype of the instrument in treatment resulted in overall positive experiences with the content; however, therapists indicated that the items should be formulated in a more patient-centered way to encourage their involvement in discussing the factors.
CONCLUSIONS: The participatory, iterative process of this study resulted in an adapted version of the FfBC instrument that fits the specific forensic context and supports shared decision making. In general, the adaptiveness of the instrument is important: its content and implementation should fit the type of care, the organization, and eHealth intervention. To adapt the instrument to other contexts, the guidelines described in this paper can be followed.