EULAR Points to consider for the development evaluation

EULAR Points to consider for the development, evaluation and implementation of mobile health applications aiding self-management in people living with rheumatic and musculoskeletal diseases.

Target population/question • Apps users, including patients, parents/carers, health professionals, rheumatologists, patient organizations, scientific societies, app developers and regulatory agencies. • To assist in evaluating the quality of existing apps, while guiding the development, evaluation and implementation of future apps aiding self-management among people living with RMDs. 2 20/02/2021

Methods I • Development according to the 2014 EULAR standardized operating procedures 1 • Task Force § • Systematic Literature Review (SLR) § • 19 members from 10 countries across Europe, including 15 rheumatologists, 2 patient research partners, 2 healthcare professionals. Detailed information on existing m. Health apps to aid self-management among people living with RMDs, focusing on content and development methods. Patient focus group and patient survey § Gain insights into the needs, views, experiences and preferences in m. Health apps to aid selfmanagement among people living with RMDs. 1 van der Heijde D, et al. Ann Rheum Dis 2015; 74: 8– 13. 3 20/02/2021

Methods II • One-day Task Force meeting § § § Results of SLR, patient focus group and survey presented to Task Force Group discussion led to formulation of 3 overarching principles and 10 points to consider Voting on agreement for every proposed statement. • Level of evidence and strength of recommendation judged according to Oxford Centre for Evidence Based Medicine standards 2 • Level of agreement allocated by online voting to each point to consider by Task Force members (anonymously) 2 http: //www. cebm. net/index. aspx? o=5653 4 20/02/2021

Identification Methods III 435 abstracts form Pubmed 97 abstracts from Embase 1 abstract from Cochrane 1 abstract from Psych. Info 25 abstract from 3 abstract from Web of Science manual search 87 duplicates excluded. 562 abstracts identified 418 excluded: Screening 475 abstracts screened -173 not in Rheumatology and not generic. -95 not a m. Health intervention. -92 m. Health intervention but not an App. -13 m. Health App for m. Health intervention but not for self-management purposes. -74 reviews. 56 selected for full-text screening 24 excluded: 5 Eligibility - 13 m. Health intervention but not an App. -10 m. Health intervention with connected device but not connected to an App. -1 full-text non accessible. 32 full-text articles included 20/02/2021

Overarching prinicples A. Apps* for self-management support the health, wellbeing and empowerment of people living with RMDs. B. Apps* require an overarching conceptual framework, which defines the target population and purpose of the app. C. User privacy and safety are fundamental considerations for all apps* aimed at people living with RMDs. *An app is a small programme that can be downloaded and installed on a mobile device. For the purpose of these Pt. C, the definition takes a focus on self-management of RMDs. 6 20/02/2021

Points to consider 1 • The information content in self-management apps should be up-to-date, scientifically justifiable, user-acceptable and evidence-based where applicable. § Any medical content provided by self-management apps should be validated by appropriate experts § A previous review of existing rheumatology apps highlighted that the source of medical information was lacking in 40% of the screened apps. § Sources should be cited whenever possible. § Lo. E: 5 7 20/02/2021

Points to consider 2 • Apps should be relevant and tailored to the individual needs of people with RMDs. § Largely based on expert opinion and the results of the patients’ survey. § Patient priorities, for example, pain, function and fatigue, should be taken into account when designing apps. § Lo. E: 5 8 20/02/2021

Points to consider 3 • The design, development and validation of self-management apps should involve people with RMDs and relevant health care providers. § Health professionals and patients were rarely involved in every stage of app development (SLR). § Since patients are the target users, app development should be patient-centered, and driven directly by the needs and priorities of people living with RMDs. § As medical content is provided and medical data are usually collected in such apps, health care providers, in particular rheumatologists, should be involved in the development phase. § Lo. E: 5 9 20/02/2021

Points to consider 4 • There should be transparency on an app’s developer, funding source, content validation process, version updates and data ownership. § Important information such as the developer, funding source(s), advertisement and promotion, conflict of interest, or date of last update were missing from the description of a significant number of apps. § Such information should be made publicly available for any app. § Lo. E: 5 10 20/02/2021

Points to consider 5 • Data collection as part of an app must adhere to all applicable regulatory frameworks, particularly data protection. § Mostly based on expert opinion after discussion of existing regulatory documents. § European Union’s General Data Protection Regulation (GDPR), 1996 US Health Insurance Portability and Accountability Act (HIPAA) and national regulatory documents (UK, Spain). § Applicable regulations and ethical principles should be followed if medical-related data are collected as part of apps, to ensure that appropriate data protection regulations are adhered to, while promoting patient safety. § Lo. E: 5 11 20/02/2021

Points to consider 6 • Apps must not result in physical or emotional harm to people with RMDs. § The content and functionalities of apps should consider the wellbeing of people living with RMDs as a priority. § Content that could potentially cause emotional distress or suicidal ideation must be avoided. § Lo. E: 5 12 20/02/2021

Points to consider 7 • Apps could facilitate patient-health care provider communication and contribute to electronic health records or research. § The lack of feedback on data collected by apps seems to affect app use and its cessation in other diseases. § There is a need for health professionals and regulators to acknowledge the use and capacity of apps to enhance patient-health care provider communication § Lo. E: 5 13 20/02/2021

Points to consider 8 • App design should consider accessibility of people with RMDs across ages and abilities. § The accessibility of apps and their ease of use is an important point towards their implementation and sustainability. § App design should follow the principle of universal design, and should be usable regardless of previous experience of mobile device use § Lo. E: 5 14 20/02/2021

Points to consider 9 • If a social network is an important component of an app, structures should be in place to ensure appropriate content moderation. § Like other forms of social media, if apps allow public communication between users, they should include a moderation component (for example, someone to moderate live communication/interaction on communication platforms, thus avoiding and/or removing inappropriate or harmful content) § The app developer should be responsible for ensuring such structures exist and are enforced § Lo. E: 5 15 20/02/2021

Points to consider 10 • The rheumatology community should consider the cost-benefit balance of apps before endorsement and/or promotion. § The majority of people living with RMDs did not wish to pay for the apps in the patient survey. § Cost should be limited as much as possible § Lo. E: 5 16 20/02/2021

Summary Table Oxford Level of Evidence Overarching principles Table 1. Three overarching principles and 10 points to consider for the development, evaluation and implementation of apps to aid self-management among people living with rheumatic and musculoskeletal diseases. Overarching principles Lo. E So. R Lo. A (0 -10) A. Apps* for self-management support the health, wellbeing and empowerment of 10 (0) people living with RMDs. B. Apps* require an overarching conceptual framework, which defines the target 10 (0) population and purpose of the app. C. User privacy and safety are fundamental considerations for all apps* aimed at 10 (0) people living with RMDs. EULAR, European League Against Rheumatism; S o. R, strengh of recommendation; Lo. A, level of agreement; Lo. E, level of evidence *An app is a small programme that can be downloaded and installed on a mobile device. . 17 20/02/2021

Summary Table Oxford Level of Evidence Points to consider Table 1. Three overarching principles and 10 points to consider for the development, evaluation and implementation of apps to aid self-management among people living with rheumatic and musculoskeletal diseases. Points to consider Lo. E So. R Lo. A (0 -10) 1. The information content in self-management apps should be up-to-date, scientifically Level 5 D 9. 8 (0. 4) justifiable, user-acceptable and evidence-based where applicable. 2. Level 5 D 9. 7 (0. 5) Apps should be relevant and tailored to the individual needs of people with RMDs. 3. The design, development and validation of self-management apps should involve people Level 5 D 9. 8 (0. 6) with RMDs and relevant health care providers. 4. There should be transparency on an app’s developer, funding source, content validation Level 5 D 9. 9 (0. 3) process, version updates and data ownership. 5. Data collection as part of apps must adhere to all applicable regulatory frameworks, Level 5 D 9. 9 (0. 3) particularly data protection. 6. Level 5 D 9. 3 (1) Apps must not result in physical or emotional harm to people with RMDs. 7. Apps could facilitate patient-health care provider communication and contribute to Level 5 D 9. 4 (0. 9) electronic health records or research. 8. App design should consider accessibility of people with RMDs across ages and abilities. Level 5 D 9. 4 (0. 9) 9. If a social network is an important component of an app, structures should be in place to ensure appropriate content moderation. 10. The rheumatology community should consider the cost-benefit balance of apps before endorsement and/or promotion. EULAR, European League Against Rheumatism; S o. R, strengh of recommendation; Lo. A, level of agreement; Lo. E, level of evidence; 18 Level 5 D 9. 5 (0. 6) Level 5 D 8. 9 (1. 3) *An app is a small programme that can be downloaded and installed on a mobile device. 20/02/2021

Summary of points to consider in bullet point format 1. The information content in self-management apps should be up-to-date, scientifically justifiable, user-acceptable and evidence-based where applicable. 2. 3. Apps should be relevant and tailored to the individual needs of people with RMDs. The design, development and validation of self-management apps should involve people with RMDs and relevant health care providers. 4. There should be transparency on an app’s developer, funding source, content validation process, version updates and data ownership. 5. Data collection as part of apps must adhere to all applicable regulatory frameworks, particularly data protection. 6. 7. Apps must not result in physical or emotional harm to people with RMDs. Apps could facilitate patient-health care provider communication and contribute to electronic health records or research. 8. 9. App design should consider accessibility of people with RMDs across ages and abilities. If a social network is an important component of an app, structures should be in place to ensure appropriate content moderation. 10. 19 The rheumatology community should consider the cost-benefit balance of apps before endorsement and/or promotion. 20/02/2021

Summary of Points to consider in lay format • 20 Ongoing with PARE 20/02/2021

Acknowledgements • Convenors: Aurélie Najm, Francis Berenbaum • Methodologists: Elena Nikiphorou, Laure Gossec • Fellow: Aurélie Najm • Members of the Task Force: M. Kostine, C. Richez, J. D. Pauling, A. Finckh, V. Ritschl, Y. Prior, P. Balazova, S. R. Stones, Z. Szekanecz, A. Iagnocco, S. Ramiro, F. Sivera, M. Dougados, L. Carmona, G. Burmeister. • We thank David Benoist and Catherine Weill (BU Santé Paris Descartes, Université de Paris, France) for their contribution to the systematic literature search. 21 20/02/2021