Target population/question

1. 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.

2. Targetpopulation/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.

3. Methods I • Development according to the 2014 EULAR standardized operating procedures1 • Task Force • 19 members from 10 countries across Europe, including 15 rheumatologists, 2 patient research partners, 2 healthcare professionals. • Systematic Literature Review (SLR) • Detailed information on existing mHealthapps 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 mHealth apps to aid self-management among people living with RMDs. 1van der Heijde D, et al. Ann Rheum Dis 2015;74:8–13.

4. 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 standards2 • Level of agreement allocated by online voting to each point to consider by Task Force members (anonymously) 2http://www.cebm.net/index.aspx?o=5653

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

6. Overarchingprinicples • Apps* for self-management support the health, wellbeing and empowerment of people living with RMDs. • Apps* require an overarching conceptual framework, which defines the target population and purpose of the app. • User privacy and safety are fundamental considerations for all apps* aimed at people living with RMDs. *An appis a small programme thatcanbedownloaded and installed on a mobile device. For the purpose of thesePtC, the definitiontakes a focus on self-management of RMDs.

7. 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. • LoE: 5

8. 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. • LoE: 5

9. 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. • LoE: 5

10. Points to consider4 • 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. • LoE: 5

11. Points to consider5 • 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. • LoE: 5

12. Points to consider6 • 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. • LoE: 5

13. Points to consider7 • 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 • LoE: 5

14. Points to consider8 • 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 • LoE: 5

15. Points to consider9 • 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 • LoE: 5

16. Points to consider10 • 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 • LoE: 5

17. SummaryTable Oxford Level of EvidenceOverarchingprinciples *An app is a small programme that can be downloaded and installed on a mobile device..

18. SummaryTable Oxford Level of EvidencePoints to consider *An app is a small programme that can be downloaded and installed on a mobile device.

19. Summaryof pointstoconsider in bulletpoint format

20. Summaryof Points to considerinlay format • Ongoing with PARE

21. 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.