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Janette Ribaut,1,2 Sabina De Geest,1,3 Lynn Leppla,1,4 Sabine Gerull,2,5 Alexandra Teynor,6 Sabine Valenta1,2 On behalf of the SMILe study team1Institute of Nursing Science, Department Public Health, Faculty of Medicine, University of Basel, Basel, Switzerland; 2Department of Theragnostic, Hematology, University Hospital of Basel, Basel, Switzerland; 3Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium; 4Departments of Hematology, Oncology and Stem Cell Transplantation, Medical Center University of Freiburg, Freiburg, Germany; 5Department of Hematology, Cantonal Hospital of Aarau, Aarau, Switzerland; 6Department of Computer Science, University of Applied Sciences, Augsburg, GermanyCorrespondence: Sabine ValentaInstitute of Nursing Science, Department Public Health, Faculty of Medicine, University of Basel, Bernoullistrasse 28, Basel, CH-4056, SwitzerlandTel +41 61 32 85275Email sabine.valenta@unibas.chPurpose: Little is known about allogeneic stem cell transplant (alloSCT) patients’ medication adherence strategies. Acceptability and preferences regarding electronic monitoring (EM) systems to assess all three phases of medication adherence (ie, initiation, implementation, persistence) are crucial to allow their successful implementation in clinical or research settings but have not yet been evaluated. We therefore aimed to explore: 1) alloSCT patients’ medication adherence and self-management strategies; and 2) their acceptability and preferences of three different EM systems (MEMS Cap, Helping Hand, Button) as part of the Swiss SMILe study.Patients and Methods: Respecting anti-pandemic measures, we used a purposive sample of six adult alloSCT patients from the University Hospital Basel, Switzerland (USB)— 6 weeks to 2 years post-alloSCT—to conduct three focus group sessions with two patients each. Using a semi-structured outline, we explored 1) patients’ medication adherence strategies and medication self-management; and 2) their acceptance and preferences regarding EM use. The three tested EM systems were available for testing during each session. Discussions were audio-recorded, visualized using mind-mapping and analyzed using Mayring’s qualitative content analysis.Results: Patients (33% females; mean age 54.6± 16.3 years; 10.4± 8.4 months post-alloSCT) used medication adherence enhancing strategies (eg, preparing pillbox, linking intake to a habit). Still, they indicated that post-alloSCT medication management was challenging (eg, frequent schedule changes). All participants preferred the MEMS Button. Participants said its small size and the possibility to combine it with existing pillboxes (eg, putting it into/next to them) made them more confident about implementing it in their daily lives.Conclusion: Regarding EM systems for medication adherence, end-user preferences and acceptability influence adoption and fidelity. Of the three systems tested, our sample found the MEMS Button most acceptable and most preferable. Therefore, we will use it for our USB SMILe study.Keywords: allogeneic hematopoietic stem cell transplantation, medication adherence, electronic monitoring, patient empowerment, focus groups

BackgroundDigitization is vital for data management, especially in health care. However, problems still hinder health care stakeholders in their daily work while collecting, processing, and providing health data or information. Data are missing, incorrect, cannot be collected, or information is inadequately presented. These problems can be seen as data or information problems. A proven way to elicit requirements for (software) systems is by using creative frameworks (eg, user-centered design, design thinking, lean UX [user experience], or service design) or creative methods (eg, mind mapping, storyboarding, 6 thinking hats, or interaction room). However, to what extent they are used to solve data or information-related problems in health care is unclear. ObjectiveThe primary objective of this scoping review is to investigate the use of creative frameworks in addressing data and information problems in health care. MethodsFollowing JBI guidelines and the PRISMA-ScR framework, this paper analyzes selected papers, answering whether creative frameworks addressed health care data or information problems. Focusing on data problems (elicitation or collection, processing) and information problems (provision or visualization), the review examined German and English papers published between 2018 and 2022 using keywords related to “data,” “design,” and “user-centered.” The database SCOPUS was used. ResultsOf the 898 query results, only 23 papers described a data or information problem and a creative method to solve it. These were included in the follow-up analysis and divided into different problem categories: data collection (n=7), data processing (n=1), information visualization (n=11), and mixed problems meaning data and information problem present (n=4). The analysis showed that most identified problems fall into the information visualization category. This could indicate that creative frameworks are particularly suitable for solving information or visualization problems and less for other, more abstract areas such as data problems. The results also showed that most researchers applied a creative framework after they knew what specific (data or information) problem they had (n=21). Only a minority chose a creative framework to identify a problem and realize it was a data or information problem (n=2). In response to these findings, the paper discusses the need for a new approach that addresses health care data and information challenges by promoting collaboration, iterative feedback, and user-centered development. ConclusionsAlthough the potential of creative frameworks is undisputed, applying these in solving data and information problems is a minority. To harness this potential, a suitable method needs to be developed to support health care system stakeholders. This method could be the User-Centered Data Approach.

BackgroundThe 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. ObjectiveBefore 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. MethodsWe 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. ResultsScreening 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. ConclusionsThis 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 RegistrationPROSPERO International Prospective Register of Systematic Reviews CRD42021227064; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021227064

Abstract Background Designing intervention and implementation strategies with careful consideration of context is essential for successful implementation science projects. Although the importance of context has been emphasized and methodology for its analysis is emerging, researchers have little guidance on how to plan, perform, and report contextual analysis. Therefore, our aim was to describe the Basel Approach for coNtextual ANAlysis (BANANA) and to demonstrate its application on an ongoing multi-site, multiphase implementation science project to develop/adapt, implement, and evaluate an integrated care model in allogeneic SteM cell transplantatIon facILitated by eHealth (the SMILe project). Methods BANANA builds on guidance for assessing context by Stange and Glasgow (Contextual factors: the importance of considering and reporting on context in research on the patient-centered medical home, 2013). Based on a literature review, BANANA was developed in ten discussion sessions with implementation science experts and a medical anthropologist to guide the SMILe project’s contextual analysis. BANANA’s theoretical basis is the Context and Implementation of Complex Interventions (CICI) framework. Working from an ecological perspective, CICI acknowledges contextual dynamics and distinguishes between context and setting (the implementation’s physical location). Results BANANA entails six components: (1) choose a theory, model, or framework (TMF) to guide the contextual analysis; (2) use empirical evidence derived from primary and/or secondary data to identify relevant contextual factors; (3) involve stakeholders throughout contextual analysis; (4) choose a study design to assess context; (5) determine contextual factors’ relevance to implementation strategies/outcomes and intervention co-design; and (6) report findings of contextual analysis following appropriate reporting guidelines. Partly run simultaneously, the first three components form a basis both for the identification of relevant contextual factors and for the next components of the BANANA approach. Discussion Understanding of context is indispensable for a successful implementation science project. BANANA provides much-needed methodological guidance for contextual analysis. In subsequent phases, it helps researchers apply the results to intervention development/adaption and choices of contextually tailored implementation strategies. For future implementation science projects, BANANA’s principles will guide researchers first to gather relevant information on their target context, then to inform all subsequent phases of their implementation science project to strengthen every part of their work and fulfill their implementation goals.

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. [ABSTRACT FROM AUTHOR]

Abstract 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 S te M cell transplantat I on faci L itated by e Health). 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.

Andrew J Lloyd,1 Robin Thompson,2 Katy Gallop,1 Megan Teynor3 1Acaster Lloyd Consulting Ltd., London, UK; 2Value and Access, Biogen, Baar, Switzerland; 3Value and Access, Biogen, Cambridge, MA, USACorrespondence: Andrew J LloydAcaster Lloyd Consulting Ltd., 16 Upper Woburn Place, London WC1H0BS, UKTel +44 20 3978 1681Email andrew.lloyd@acasterlloyd.comBackground: Spinal muscular atrophy (SMA) is a rare, genetic, progressive neuromuscular disorder characterized by severe muscle atrophy and weakness and is a leading genetic cause of death in infants and children. Nusinersen was the first treatment targeting the underlying cause of disease approved by the FDA, EMA and other countries for patients with SMA. There are currently very limited data available on the health-related quality of life (HRQoL) burden of SMA suitable for use in a cost-effectiveness analysis.Objective: This study was designed to estimate quality of life weights or utilities for different SMA states.Methods: SMA case studies were developed describing Type I (infantile onset) and Type II (later-onset) patients and different outcomes from treatment. These were developed so that quality of life weights or utilities (where the value of health ranges from 1 – full health to 0 – dead) could be estimated for cost-effectiveness analysis. Clinical experts (n=5) rated each of the case studies using standardized HRQoL instruments – the EQ-5D-Y and PedsQL-NMM (baseline states only).Results: The SMA Type I utilities ranged from −0.33 (requires ventilation) to 0.71 (Type I patient reclassified as Type III following treatment), with quite substantial differences between some states. Most Type I states had a utility score below zero indicating the severity of the states. The SMA Type II utilities ranged from −0.13 (worsened) to 0.72 (stands/walks unaided). In general, the results showed HRQoL improved in line with better health states.Conclusion: The utility scores obtained in this study highlight the very substantial burden experienced by SMA patients. Despite the limitations in the methods used, this study produced data with face validity and is a useful starting point for understanding the burden of SMA Types I and II in cost-effectiveness analysis.Keywords: spinal muscular atrophy, health-related quality of life, utility, EQ-5D, cost-effectiveness analysis