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Currently, there are no adequate methods for dealing with changes in the healthcare system brought about by electronic health applications (eHealth) or the associated ethical implications in practice. This can be attributed to the lack of comprehensive interdisciplinary approaches that could support teams in integrating ethical considerations into the agile software development process. To close this gap, the DARE approach has been developed and tested in interdisciplinary collaborative research. The DARE method is a modular system designed to improve the development of ethically sound software in a deliberative, agile, and responsive manner.

Background: The field of eHealth is growing rapidly and chaotically. Health care professionals need guidance on reviewing and assessing health-related smartphone apps to propose appropriate ones to their patients. However, to date, no framework or evaluation tool fulfills this purpose., Objective: Before developing a tool to help health care professionals assess and recommend apps to their patients, we aimed to create an overview of published criteria to describe and evaluate health apps., Methods: We conducted a systematic review to identify existing criteria for eHealth smartphone app evaluation. Relevant databases and trial registers were queried for articles. Articles were included that (1) described tools, guidelines, dimensions, or criteria to evaluate apps, (2) were available in full text, and (3) were written in English, French, German, Italian, Portuguese, or Spanish. We proposed a conceptual framework for app evaluation based on the dimensions reported in the selected articles. This was revised iteratively in discussion rounds with international stakeholders. The conceptual framework was used to synthesize the reported evaluation criteria. The list of criteria was discussed and refined by the research team., Results: Screening of 1258 articles yielded 128 (10.17%) that met the inclusion criteria. Of these 128 articles, 30 (23.4%) reported the use of self-developed criteria and described their development processes incompletely. Although 43 evaluation instruments were used only once, 6 were used in multiple studies. Most articles (83/128, 64.8%) did not report following theoretical guidelines; those that did noted 37 theoretical frameworks. On the basis of the selected articles, we proposed a conceptual framework to explore 6 app evaluation dimensions: context, stakeholder involvement, features and requirements, development processes, implementation, and evaluation. After standardizing the definitions, we identified 205 distinct criteria. Through consensus, the research team relabeled 12 of these and added 11 more-mainly related to ethical, legal, and social aspects-resulting in 216 evaluation criteria. No criteria had to be moved between dimensions., Conclusions: This study provides a comprehensive overview of criteria currently used in clinical practice to describe and evaluate apps. This is necessary as no reviewed criteria sets were inclusive, and none included consistent definitions and terminology. Although the resulting overview is impractical for use in clinical practice in its current form, it confirms the need to craft it into a purpose-built, theory-driven tool. Therefore, in a subsequent step, based on our current criteria set, we plan to construct an app evaluation tool with 2 parts: a short section (including 1-3 questions/dimension) to quickly disqualify clearly unsuitable apps and a longer one to investigate more likely candidates in closer detail. We will use a Delphi consensus-building process and develop a user manual to prepare for this undertaking., Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021227064; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021227064., (©Janette Ribaut, Annette DeVito Dabbs, Fabienne Dobbels, Alexandra Teynor, Elisabeth Veronica Mess, Theresa Hoffmann, Sabina De Geest. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 15.01.2024.)

Background: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders)., Methods: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods)., Discussion: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations., Trial Registration: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021., (© 2022. The Author(s).)

Purpose: Allogeneic stem cell transplantation would benefit from re-engineering care towards an integrated eHealth-facilitated care model. With this paper we aim to: (1) describe the development of an integrated care model (ICM) in allogeneic SteM-cell-transplantatIon faciLitated by eHealth (SMILe) by combining implementation, behavioral, and computer science methods (e.g., contextual analysis, Behavior Change Wheel, and user-centered design combined with agile software development); and (2) describe that model's characteristics and its application in clinical practice., Methods: The SMILe intervention's development consisted of four steps, with implementation science methods informing each: (1) planning its set-up within a theoretical foundation; (2) using behavioral science methods to develop the content; (3) choosing and developing its delivery method (human/technology) using behavioral and computer science methods; and (4) describing its characteristics and application in clinical practice., Results: The SMILe intervention is embedded within the eHealth enhanced Chronic Care Model, entailing four self-management intervention modules, targeting monitoring and follow-up of important medical and symptom-related parameters, infection prevention, medication adherence, and physical activity. Interventions are delivered partly face-to-face by a care coordinator embedded within the transplant team, and partly via the SMILeApp that connects patients to the transplant team, who can monitor and rapidly respond to any relevant changes within 1 year post-transplant., Conclusion: This paper provides stepwise guidance on how implementation, behavioral, and computer science methods can be used to develop interventions aiming to improve care for stem cell transplant patients in real-world clinical settings. This new care model is currently being tested in a hybrid I effectiveness-implementation trial., (© 2021. The Author(s).)

Purpose: To describe a process of creating eHealth components for an integrated care model using an agile software development approach, user-centered design and, via the Behavior Change Wheel, behavior theory-guided content development. Following the principles of implementation science and using the SMILe project (integrated care model for allogeneic stem cell transplantation facilitated by eHealth) as an example, this study demonstrates how to narrow the research-to-practice gap often encountered in eHealth projects., Methods: We followed a four-step process: (a) formation of an interdisciplinary team; (b) a contextual analysis to drive the development process via behavioral theory; (c) transfer of content to software following agile software development principles; and (d) frequent stakeholder and end user involvement following user-centered design principles., Findings: Our newly developed comprehensive development approach allowed us to create a running eHealth component and embed it in an integrated care model. An interdisciplinary team's collaboration at specified interaction points supported clear, timely communication and interactions between the specialists. Because behavioral theory drove the content development process, we formulated user stories to define the software features, which were prioritized and iteratively developed using agile software development principles. A prototype intervention module has now been developed and received high ratings on the System Usability Scale after two rounds of usability testing., Conclusions: Following an agile software development process, structured collaboration between nursing scientists and software specialists allowed our interdisciplinary team to develop meaningful, theory-based eHealth components adapted to context-specific needs., Clinical Relevance: The creation of high-quality, accurately fitting eHealth components specifically to be embedded in integrated care models should increase the chances of uptake, adoption, and sustainable implementation in clinical practice., (© 2020 The Authors. Journal of Nursing Scholarship published by Wiley Periodicals LLC on behalf of Sigma Theta Tau International.)

Background: Medication adherence to immunosuppressants in allogeneic stem cell transplantation (alloSCT) is essential to achieve favorable clinical outcomes (e.g. control of Graft-versus-Host Disease). Over 600 apps supporting medication adherence exist, yet they lack successful implementation and sustainable use likely because of lack of end-user involvement and theoretical underpinnings in their development and insufficient attention to implementation methods to support their use in real-life settings. Medication adherence has three phases: initiation, implementation and persistence. We report the theory-driven development of an intervention module to support medication adherence (implementation and persistence phase) in alloSCT outpatients as a first step for future digitization and implementation in clinical setting within the SMILe project (Development, implementation and testing of an integrated care model in allogeneic SteM cell transplantatIon faciLitated by eHealth)., Methods: We applied Michie's Behavior Change Wheel (BCW) and the Capability-Opportunity-Motivation and Behavior (COM-B) model using three suggested stages followed by one stage added by our team regarding preparation for digitization of the intervention: (I) Defining the problem in behavioral terms; (II) Identifying intervention options; (III) Identifying content and implementation options; (IV) SMILe Care Model Prototype Development. Scientific evidence, data from a contextual analysis and patients'/caregivers' and clinical experts' inputs were compiled to work through these steps., Results: (I) Correct immunosuppressant taking and timing were defined as target behaviors. The intervention's focus was determined within the COM-B dimensions Capability (lack of knowledge, lack of routine), Opportunity (lack of cues, interruptions in daily routine) and Motivation (lack of problem solving, trivialization). (II) Five intervention functions were chosen, i.e. education, training, modelling, persuasion and enablement. (III) Twenty-four behavior change techniques were selected, e.g., goal setting, action planning and problem solving. (IV) Finally, seventeen user stories were developed to guide the SMILeApp's software development process., Conclusion: Our example on the theory-driven development of an intervention module in alloSCT delivered by eHealth and transplant team using a rigorous 3 + 1-stage approach based on BCW, COM-B and agile software development techniques, can be used as methodological guidance for other eHealth intervention developers. Our approach has the potential to enhance successful implementation and sustained use of eHealth solutions in real-life settings.

Purpose: We report on our contextual analysis's methodology, as a first step of an implementation science project aiming to develop, implement, and test the effectiveness of an integrated model of care in SteM-cell transplantatIon faciLitated by eHealth (SMILe)., Methods: We applied an explanatory sequential mixed-methods design including clinicians and patients of the University Hospital Freiburg, Germany. Data were collected from 3/2017 to 1/2018 via surveys in 5 clinicians and 60 adult allogeneic stem-cell transplantation patients. Subsequently, we conducted 3 clinician focus groups and 10 patient interviews. Data analysis followed a 3-step process: (1) creating narrative descriptions, tables, and maps; (2) mapping key observational findings per dimension of the eHealth-enhanced Chronic-Care Model; (3) reflecting on how findings affect our choice of implementation strategies., Results: Current clinical practice is mostly acute care driven, with no interdisciplinarity and weak chronic illness management. Gaps were apparent in the dimensions of self-management support and delivery-system design. Health behaviors that would profit from support include medication adherence, physical activity and infection prevention. The theme "being alone and becoming an expert" underpinned patients need to increase support in hospital-to-home transitions. Patients reported insecurity about recognizing, judging and acting upon symptoms. The theme "eHealth as connection not replacement" underscores the importance of eHealth augmenting, not supplanting human contact. Synthesis of our key observational findings informed eight implementation strategies., Conclusion: Stakeholders are willing towards a chronic care-focused approach and open for eHealth support. The contextual information provides a basis for the SMILe model's development and implementation., Competing Interests: Declaration of competing interest No conflict of interest apply to this study. This preparatory part of the SMILe project did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., (Copyright © 2020 Elsevier Ltd. All rights reserved.)