A human-centered and evidence-informed development process of EPIO; An eHealth self- management intervention for people living with chronic pain

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A human-centered and evidence-informed development process of EPIO; An eHealth self-

management intervention for people living with chronic pain

Ingrid Konstanse Ledel Solem, MPhil

Faculty of Medicine, University of Oslo Department of Digital Health Research, Division of Medicine, Oslo University Hospital

2021

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© Ingrid Konstanse Ledel Solem, 2021

Series of dissertations submitted to the Faculty of Medicine, University of Oslo

ISBN 978-82-8377-899-1

reproduced or transmitted, in any form or by any means, without permission.

Cover: Hanne Baadsgaard Utigard.

Print production: Reprosentralen, University of Oslo.

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Acknowledgments

This doctoral project was carried out at the Department of Digital Health Research in the Division of Medicine at Oslo University Hospital. The study was funded by the Norwegian Research Council, grant # 256574: “Living well with chronic pain: Using person-centered e- health design to support self-management for patients with chronic pain”, also called the EPIO project. Clinical Psychologist and Head of Department Lise Solberg Nes was the Principal Investigator of this project.

This PhD project could not have been conducted without the support and contributions by numerous people. I would like to start by thanking the many people collaborating and contributing during the project.

First of all, I want to express my deepest gratitude to my main supervisor, and the Principle Investigator of the EPIO project, Lise Solberg Nes. Thank you for believing in me, and giving me the opportunity to take part in such an important and meaningful project. You have always gone to great lengths to give me constructive feedback, encouragement and support regardless of your many other commitments, and I truly want to thank you for this. I have learned so much from your skillful supervision, especially regarding the scientific writing process. Your efficiency, stamina and scientific eloquence are inspiring, and your guidance throughout this dissertation project has been invaluable to me!

I would also like to give a special thanks to my mentor, discussion partner and co-supervisor Cecilie Varsi. Thank you for your many hours of supervision, for always keeping your door open and for your immense patience with me and my many questions. Thank you also for sharing your experiences and knowledge from the qualitative research field with me, for all your advice and feedback, for our many great discussions, and for close collaboration in analyses and paper writings. I would also like to thank you for your continuous

encouragements, motivational pep-talks and support throughout this process.

I have been very lucky to have a solid and knowledgeable team of supervisors, and I am also very grateful to my two other co-supervisors Hilde Eide and Ólöf Birna Kristjansdottir. Hilde, thank you for sharing your expertise, for introducing me to your person-centered healthcare research course and for all your constructive feedback and support. Your knowledgeable inputs and suggestions combined with your ability to see possibilities have been very helpful throughout this process. Ólöf, I want to thank you for all your constructive input and

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motivational feedback. Your eye for detail and ability to bring alternative viewpoints and perspectives into discussions has been very valuable, particularly in the writing process.

Thank you for also sharing and recommending relevant and important scientific literature with me.

I would also like to thank all other previous and present members of the EPIO project team.

Thank you to Mette Haaland-Øverby, for sharing your experiences and expertise in pain management with me and the rest of the team, and to Jelena Mirkovic for sharing your competence within participatory- and service-design and for collaborating during the

development process. Thank you also to Karina Heldal, my EPIO PhD-buddy who in the later years has become a valuable and important friend, for sharing your expertise in the pain management field with me, for contributing with the data material in Study II and for your collaboration during stakeholder workshops. Thank you also to Katrine Bostrøm, a more recent PhD-student in the EPIO project team, for your positivity and encouragement, I always enjoy our talks. Thank you also to the departmental editorial group, especially Marianne Westeng, Hilde Renate Sætre Sleveland and Elanor Halvorsen Brendmo, who contributed greatly in the EPIO development process, sharing knowledge and long work hours in everything from persona development, co-design workshops and usability testing. Your abilities to juggle many tasks are inspiring, and the EPIO project team would not have managed without the editorial group! Thank you also to the departmental software

development team led by Per Tømmer, especially Stein Jakob Nordbø, Per Olav Flaten, and Daniel Sollie Hansen. Thank you for the collaboration in the development process and for making EPIO so seamless and flawless! Thank you also to designer Yizhak Itzchaki for your great animations and enjoyable design, your collaborations during the development process and participation in workshops. Thank you also for your help with figures from the EPIO intervention program in the published paper III.

I would also like to express my deepest gratitude to all the participants who contributed to this dissertation project. I’m particularly grateful to the people living with chronic pain and their spouses who put their trust in me and shared their experiences, ideas and opinions. Thank you also to the health care providers who shared their time, knowledge, ideas and input for this project, and thank you to all collaborating EPIO project partners for their input, help with participant recruitment, collaboration and input during the development and manuscript publication processes. I especially want to thank Katherine Bevan, for your extensive help

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Great thanks also to my fellow PhD-students at the Department of Digital Health Research for academic discussions, feedback and support. In addition to Karina Heldal and Katrine

Bostrøm, I would like to thank Stian Jessen for sharing your knowledge on design research and participatory design, for always answering my questions with great enthusiasm, for sharing literature when needed, for general technical support and last but not least for our many inspiring discussions. I would also like to thank Berit Seljelid, who has been much more than a PhD-colleague, and with whom I have shared many laughs and (some) tears with.

Thank you for our many fruitful discussions, for all the brainstorming sessions and for sharing your wisdom with me.

I have been lucky to be a part of a knowledgeable, social, creative and supportive work environment, and I would like to thank all previous and present colleagues at the Department of Digital Health Research for this. A special thanks to Elin Børøsund, for sharing your knowledge and expertise from the eHealth research field, and for your input and collaboration on the published papers. I would also like to thank Cecilie Linnea Ellefsen for all the help with figures in this dissertation thesis.

Finally, I would also like to thank my family and friends for all your love and support, and for being so patient and understanding with me during this period. A special thanks to my mother Gerd, Terje and sister Trine for all our talks, for always listening to me and for giving your support. I am also deeply grateful to Kanutte, for always cheering me on and for loving my dad the way you do, which has made this intense dissertation writing process so much easier to handle for me. And thank you to my loving dad, Bjørn. Even though the disease makes it difficult for you to remember what I do, you always comfort me, laugh with me and say that you love me.

Last but not least, I am deeply grateful to my little tribe at home, Torgeir and Agnes (and the cat Kokos, when she is in the mood for it). This work would not be possible without your continuous love, help and support. Thank you for (almost) always being patient with me and for always encouraging and believing in me. And to Torgeir, thank you for all our discussions and your questions, which have been so important in this reflective process. Coming home to the two of you has given me motivation beyond anything!

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Sammendrag

Bakgrunn: Langvarige smerter er et stort folkehelseproblem som rammer omtrent 30% av den norske voksne befolkningen. Å leve med langvarige smerter kan være svært utfordrende, og påvirker som regel flere aspekter av den rammedes liv. God behandling krever ofte en tverrfaglig tilnærming, inkludert psykologisk støtte. Slik behandling er imidlertid ikke alltid tilgjengelig, og alternative måter å tilby behandling på er nødvendig. Et økende antall studier støtter opp under bruken av e-helse i behandling og som hjelp til egenmestring, også for langvarige smerter. Litteraturen er derimot sprikende, og en rekke utfordringer har blitt knyttet til eksisterende løsninger, inkludert manglende kunnskapsgrunnlag i løsningene, mangel på bruker- og helsepersonellinvolvering i utviklingsprosessen, høyt

intervensjonsfrafall, manglende effekttesting samt implementeringsutfordringer. Det er derfor behov for løsninger som imøtekommer disse utfordringene.

Mål: Målet med dette doktorgradsprosjektet var å utvikle en kunnskapsbasert og

personsentrert e-helseintervensjon for personer med langvarige smerter. Spesifikke mål som ble utforsket igjennom tre studier var å:

1) Utforske pasienters erfaringer og holdninger til e-helse, utforske hvordan en e-helseløsning kan imøtekomme brukernes behov og utfordringer samt utforske mulige fasilitatorer og barrierer for bruk av en slik løsning.

2) Utforske helsepersonells erfaringer med smertebehandling, deres erfaringer og holdninger til e-helse og deres forslag til innhold- og designelementer i en potensiell e-helseintervensjon for langvarige smerter.

3) Designe og utvikle en kunnskapsbasert og brukersentrert e-helseintervensjon som brukere kan finne akseptabel, brukervennlig og meningsfull, med potensiale til å forbedre brukernes livskvalitet.

Metode: Et kvalitativ og eksplorerende forskningsdesign ble benyttet i denne avhandlingen.

Datainnsamlingsmetoder inkluderte semistrukturerte intervju (Studie I og II), observasjon, workshop og brukertesting (Studie III). Data ble analysert ved hjelp av tematisk analyse (Studie I og II) og innholdsanalyse (Studie III). I tillegg ble en «rapid analysis» tilnærming benyttet i alle tre studier for å kunne gi fortløpende tilbakemelding og innspill til den pågående innholds- og softwareutviklingen. Utviklingsprosessen fulgte en iterativ og brukersentrert tilnærming basert på eksisterende designrammeverk og anbefalte

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tilnærmingsmetoder for design og utvikling av e-helseløsninger. Brukere og andre interessenter deltok aktivt i alle faser fra prosjektutvikling til ferdig utviklet løsning.

Resultater: I første fase av utviklingsprosessen deltok 20 personer med langvarige smerter og 5 pårørende (Studie I) samt 12 helsepersonell (Studie II) i individuelle intervju. Resultatene støttet eksisterende litteratur som viser at det er svært krevende å leve med langvarige smerter, og pekte på et tydelig behov for en mer helhetlig behandlingstilnærming og økt daglig støtte for personer med langvarige smerter. Til tross for positive holdninger knyttet til bruken av e- helse, hadde få deltakere erfaring med slike løsninger. Deltakerne pekte på en rekke

utfordringer og bidro med forslag og innspill som til sammen ga et helhetlig bilde av hvordan en e-helseløsning kan utvikles for å imøtekomme brukernes behov og hverdag.

Studie III bygget videre på resultatene fra studie I og II, og inkluderte en rekke interessenter, inkludert 17 personer med langvarige smerter, to pårørende og 14 smerte/e-helsespesialister, i tillegg til 20 interessenter fra prosjektteamet (dvs. forskere, innholdskonsulenter, software- team og brukerrepresentant). Resultatene pekte på behovet for en troverdig og

kunnskapsbasert e-helseløsning med kartleggingsfunksjonalitet, personalisering og muligheter for tilbakemeldinger. Designelementer som påminnelser, integrering av en «buddy» eller avatar, visualisering og muligheter for å skreddersy løsningen ble ansett viktig for å kunne bygge opp under motivasjon og bruk. Iterasjoner med brukertesting ga videre innsikt i hvordan designe og optimalisere løsningen på en best mulig måte slik at brukere vil kunne finne den akseptabel, brukervennlig og meningsfylt.

Det endelige resultatet, smertemestringsprogrammet EPIO (etter den greske gudinnen for smertelindring), er en evidensbasert og brukersentrert e-helse løsning, en applikasjon (app), som skal støtte personer som lever med langvarige smerter. Selve programmet er bygget opp basert på prinsipper fra kognitiv atferdsterapi (CBT) med elementer fra aksept- og

forpliktelsesterapi (ACT), og intervensjonen inneholder ett ansikt-til-ansikt

introduksjonsmøte, 1-2 oppfølgingssamtaler pr. telefon og ni app-baserte CBT/ACT moduler.

Programmet har som mål å gi brukere tilgang til kunnskapsbasert psykoedukasjon og relaterte øvelser for å gi støtte i hverdagen med langvarige smerter.

Konklusjon: Denne avhandlingen gir et eksempel på hvordan en e-helseintervensjon kan utvikles slik at den inkorporerer eksisterende kunnskap samtidig som den imøtekommer brukernes behov. Avhandlingen bidrar spesifikt med kunnskap om pasienters, pårørende og helsepersonells teknologierfaringer, holdninger, behov og forslag til en e-helseintervensjon

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Abbreviations & definitions

Abbreviations

ACT Acceptance and commitment therapy CBT Cognitive behavioral therapy

eHealth Electronic health

GP General practitioner

QoL Quality of life

RCT Randomized controlled trial SUS System usability scale

Frequently used/most relevant definitions

eHealth “The use of technology to support health, well-being and healthcare”

(L. van Gemert-Pijnen, Kelders, et al., 2018, p. 7)

eHealth

intervention The use of eHealth technology aiming to “intervene in an existing context by changing behavior and/or cognitions”

(L. van Gemert-Pijnen, Kelders, et al., 2018, p. 7)

eHealth solution Broader term, as it does not need to be an intervention (i.e., focus on changing behavior), although more specific than eHealth as it refers to a specific solution

Human-centered

design Design approach used as a foundation for the development process in this dissertation project. Refers to an approach that “ensures that the designs match the needs and capabilities of the people for whom they are intended” (D. Norman, 2013b, p. 9)

Stakeholder(s) Anyone who may influence or be influenced by the eHealth solution(s) either directly (i.e., potential end-user) or indirectly (e.g., health care providers and researchers). In this dissertation key stakeholders refer to patients, spouses and health care providers participating in the studies.

The term specialist stakeholders refer to pain management specialists and eHealth specialists from collaborating partners in the larger research

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project. Internal stakeholders refer to the multidisciplinary project team (i.e., researchers, editors, designer, software developers and user

representative)

User Intended end-users of the final eHealth solution. In this dissertation project intended end-users were people living with chronic pain

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List of papers

Paper I

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Børøsund E, Haaland- Øverby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L.

Patients’ Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. Journal of Medical Internet Research 2019;21(4):e13205.

Paper II

Varsi C, Ledel SolemIK, Eide H, BørøsundE, Kristjansdottir OB, Heldal K, Waxenberg LB, Weiss KE, SchreursKMG, Morrison EJ, Stubhaug A, Solberg Nes L. Health care providers’

experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: A qualitative study. Under review, BMC Health Services Research, submitted 02/07/2020, revised and resubmitted 21/12/2020 and 02/03/2021.

Paper III

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Børøsund E, Schreurs KMG,

Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Øverby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People with Chronic Pain: Design and Development of EPIO.

Journal of Medical Internet Research 2020;22(1):e15889

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1. Introduction

Chronic pain conditions are common, complex and difficult to manage, constituting a significant impact on those affected (Breivik et al., 2006; Dueñas et al., 2016; Rice et al., 2016). Traditional medical treatments with surgery and/or pain medications are often unable to address all symptoms and meet all needs of people living with chronic pain, and increased use of interdisciplinary care approaches and inclusion of psychological self-management components, such as cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) have been recommended (Borsook et al., 2018; Dansie & Turk, 2013; Ehde et al., 2014; Flink et al., 2020; Gatchel et al., 2014; Kress et al., 2015; Landmark et al., 2013;

Mills et al., 2016; Schatman, 2012). Such treatment is for a number of reasons unfortunately not widely available however, and despite the high population prevalence, accompanying challenges and negative impacts of chronic pain, treatment and health care support for people living with chronic pain is rarely optimal and chronic pain often even considered undertreated (Breivik et al., 2006; Ehde et al., 2014; Gatchel et al., 2014; Kress et al., 2015; Urits et al., 2019). Given the challenges and limitations of existing treatment, the need for alternative and innovative treatment options within chronic pain management is evident.

Electronic health (eHealth) has the potential to provide patients with easier access to self- management support, and a growing body of research points to the potential of eHealth interventions in chronic pain management (Bender et al., 2011; Buhrman et al., 2016; Du et al., 2019; Eccleston et al., 2014; Heapy et al., 2015; Thurnheer et al., 2018). Findings are still mixed however, and there are a number of challenges related to existing eHealth self-

management solutions for chronic pain, including limited theoretical/evidence-based content and self-management aspects, limited or lack of stakeholder (e.g., patients and health care providers) involvement in the design and development process, low adherence and high attrition, and there also seems to be a gap between the anticipated benefits, evidence of efficacy and the actual implementation into clinical use (Black et al., 2011; Buhrman et al., 2016; Dario et al., 2017; de la Vega & Miro, 2014; Devan, Farmery, et al., 2019; Du et al., 2019; Eccleston et al., 2014; Granja et al., 2018; Lalloo et al., 2015; Machado et al., 2016;

Salazar et al., 2018; Thurnheer et al., 2018; J. E. van Gemert-Pijnen et al., 2011; Wallace &

Dhingra, 2014).

In Norwegian context, the interest in and considered potential of eHealth have grown in recent years, with the Norwegian government acknowledging eHealth as a prerequisite to

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ensure sustainable and high quality health care services (The Norwegian Directorate of eHealth, 2019a). Governmental reports state that eHealth should be viewed as an important asset to health care services, having the potential to empower- and increase individuals’

ability to self-manage when living with health issues (The Norwegian Directorate of eHealth, 2019a, 2019b; The Norwegian Ministry of Health and Care Services, 2013b, 2013a, 2015;

The Norwegian Ministry of Local Government and Modernisation, 2016). Research

examining the potential of eHealth within chronic pain management in Norway is still at an early stage however, and availability of evidence-based eHealth pain management solutions in the Norwegian context remains at best scarce.

Designing and developing eHealth interventions for sustained use and support. The identified challenges related to existing eHealth interventions for chronic pain call for further research and new approaches. Human/user-centered and/or person-centered design

approaches have been suggested in this process, emphasizing the importance of focusing on user needs and requirements (Baker et al., 2014; Cranen et al., 2017; Keogh et al., 2010; J. E.

van Gemert-Pijnen et al., 2011; Yardley et al., 2015). Depending on solution purpose (e.g., self-management), the incorporation and combination of theoretically based content,

stakeholder involvement, motivational and persuasive design elements and functionalities and aspects to plan and prepare for efficacy testing and implementation are considered vital (Asbjørnsen et al., 2019, 2020; DeMonte et al., 2015; Fry & Neff, 2009; Granja et al., 2018;

Kelders et al., 2012; Ludden et al., 2015; Varsi et al., 2019; Webb et al., 2010).

1.1 This dissertation

This dissertation seeks to contribute to a better understanding of how an eHealth self- management intervention for chronic pain can be developed to potentially support self- management for people living with chronic pain. The dissertation centers around the initial processes, design and development phases of a larger research project aiming to design, develop and efficacy test a user-centered, evidence-based eHealth self-management intervention for adults with chronic pain (Norwegian Research Council, grant # 25657).

Specifically, this dissertation explores how an eHealth self-management intervention, based on existing evidence and targeting chronic pain, could be designed and developed to best support the needs and challenges of potential Norwegian users in an effective, meaningful and useful way.

The specific aims investigated in three studies for the dissertation were:

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3 I. To advance the knowledge regarding the needs and requirements for eHealth pain

management interventions through 1) explore patients with chronic pain’s experiences with information and communication technology (ICT), 2) explore how an e-health intervention can support the everyday needs and challenges of patients with chronic pain, and 3) identify possible facilitators and barriers for patients’ use of an eHealth pain management intervention.¹

II. To examine health care providers’ experiences of treating patients with chronic pain, their attitudes towards, and use of, digital solutions in pain management, and their suggestions for content and design elements for a potential digital pain self- management intervention for people living with chronic pain.

III. To develop an evidence-based intervention that was acceptable to users (i.e., well received, suitable, user friendly, attractive, and meeting needs) and had the potential to produce changes in quality of life for people with chronic pain.

1.2 Dissertation structure

In this dissertation, the introduction (1) is followed by the background (2), which provides an overview of the state of the literature within the research areas and topics included. As such, the background provides the rationale for the studies and work included in this dissertation. In the design and development of eHealth interventions: conceptual frameworks and design methodology (3), the conceptual frameworks and design approaches that inspired the development processes in this dissertation are presented. In primary objective and specific aims of the dissertation (4), aims and research questions addressed in this dissertation are presented. Methods (5) present the research design and specific methods, including ethical considerations, for the three studies included in this dissertation. Results (6) presents a summary of findings from each of the three studies, while the discussion (7) discusses methodological considerations, synthesizes findings and discusses them in light of existing research and recommendations for the development, uptake and impact of eHealth

technology. The section ends with the dissertation’s implications for practice research and recommendations for future research. Finally, the conclusion (8) concludes the dissertation findings.

1 Please note that the wording of the original aims in Paper I were slightly altered by the Journal of Medical Internet Research, post proof reading. There is therefore a small difference in how the aims for this paper are described in this dissertation versus the published paper.

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2. Background

Chronic pain, defined as any type of pain lasting for more than 3 months (World Health Organization, 2020), is common, complex and difficult to alleviate (Borsook et al., 2018;

Breivik et al., 2006; Clauw et al., 2019; Dueñas et al., 2016). Prevalence varies greatly depending on definition and geographical area, but recent research estimates that an average of 20-30% of the adult population in the Western world suffers from chronic pain (Breivik et al., 2006; Landmark et al., 2013; Langley, 2011; Nahin et al., 2019), with numbers continuing to increase in parallel with a growing, more sedentary and aging population (Nahin et al., 2019; Rice et al., 2016). Societal impact is also substantial, with chronic pain being a major reason why people seek health care services (Blyth et al., 2004; Breivik et al., 2006; Kress et al., 2015; Langley, 2011) and a considerable contributor to sick leave and disability (Dueñas et al., 2016; Langley, 2011; Rice et al., 2016).

While the nature and consequences of chronic pain may vary depending on pain condition, degree and other related circumstances, multiple aspects of life are usually impacted for the people living with chronic pain (Borsook et al., 2018; Breivik et al., 2006; Flink et al., 2020).

Physical pain, symptoms and limitations are main aspects recognized, but chronic pain conditions are frequently also accompanied by psychological challenges such as emotional distress, symptoms of anxiety and depression, and an overall reduced quality of life (QoL) (Breivik et al., 2013; Clauw et al., 2019; Hooten, 2016; Solberg Nes et al., 2009; Turk &

Okifuji, 2002). Social and economic concerns and difficulties are often also involved (Breivik et al., 2013; Dueñas et al., 2016). Given the high population prevalence and significant

potential for negative impact, effective and accessible treatment options for people living with chronic pain conditions are vital.

2.1 Chronic pain management: An interdisciplinary approach in progress Recent decades have shown a shift from mainly biomedical approaches such as surgery and opioid medication towards a more comprehensive interdisciplinary and biopsychosocial approach to understanding, managing and treating chronic pain conditions (Borsook et al., 2018; Dansie & Turk, 2013; Flink et al., 2020; Gatchel et al., 2014; Kress et al., 2015;

Landmark et al., 2013; Mills et al., 2016). Such approaches vary, but may include multi- faceted treatment and follow-up with a combination of traditional medication management, physical therapy/exercise and cognitive behavioral techniques for pain self-management (Okifuji et al., 1999; Turk et al., 2011). Active self-management is in fact increasingly

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considered to be a focal part of successful pain management, and current international clinical guidelines recommend the inclusion of self-management interventions in the treatment

approaches for people living with chronic pain conditions (Mills et al., 2016).

2.1.1 Self-management

Self-management in dealing with illness refers to a person’s own ability to manage the many emotional, cognitive, behavioral and medical aspects and consequences of a chronic health condition. This includes maintaining, changing and creating new and meaningful behaviors or life roles in order to maintain acceptable health, well-being and QoL (Barlow et al., 2002;

Lorig & Holman, 2003). While strategies, delivery mode and even the definition of self- management may vary, self-management interventions tend to place great emphasis on patients’ active role in the treatment, commonly include educational information and skills training, and aim to facilitate self-efficacy and problem-solving (Creer & Holroyd, 2006;

Nicholas & Blyth, 2016).

2.1.2 Psychological interventions to support self-management of chronic pain

The effects and benefits of psychological chronic pain self-management interventions are well documented, with cognitive behavioral therapy (CBT; A. T. Beck, 1976) and more recently also acceptance and commitment therapy (ACT; Hayes et al., 1999) representing the most used and recognized complex self-management approaches in support of people living with chronic pain (Mann et al., 2013).

CBT for pain self-management, aiming to challenge and change unhelpful thoughts and behaviors and enhance adaptive coping skills and strategies (J. S. Beck, 2011), including components such as: a) psychoeducation on the nature of pain and pain physiology, b)

strategies for emotional regulation and coping, c) problem-solving skills training, d) cognitive restructuring (i.e., identifying and challenging maladaptive thoughts), e) behavioral activation, relaxation skill training and guidance in activity-pacing, and f) communication skills training (McCracken & Turk, 2002; Thorn, 2004; Williams et al., 2020) has shown the most

promising effects so far (Eccleston et al., 2013; Morley et al., 1999; Nicholas & Blyth, 2016;

Williams et al., 2020). Positive outcomes have been demonstrated across a broad spectrum of chronic pain conditions, including low back pain, fibromyalgia, rheumatoid arthritis and osteoarthritis (Ehde et al., 2014; Urits et al., 2019; Williams et al., 2020), and have been associated with improved coping and social functioning (Morley et al., 1999), improved mood

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7 and level of emotional distress (Williams et al., 2012), reduced self-reported level of pain (Morley et al., 1999; Williams et al., 2012, 2020) and reduced disability (Williams et al., 2012, 2020). Overall effect sizes have been consistent, although relatively small and often primarily significant immediately post-treatment (Ehde et al., 2014; Williams et al., 2012, 2020), with the complex nature of chronic pain likely contributing to this issue (Eccleston et al., 2013). Small statistical effect sizes do not preclude the potential for significant clinical impact, however, and sufficient evidence exists to conclude that the use of CBT in chronic pain management can be of significant benefit to people living with chronic pain. (Ehde et al., 2014; Vlaeyen & Morley, 2005; Williams et al., 2012, 2020).

Psychological interventions in support of people living with chronic pain are nonetheless continuously evolving (Eccleston & Crombez, 2017; McCracken & Vowles, 2014; Morley et al., 2013; Sturgeon, 2014; Vlaeyen & Morley, 2005; Williams et al., 2020). For example, the complex nature of chronic pain makes complete pain relief challenging, sometimes even impossible (Eccleston et al., 2013), and a move towards focusing more on “accepting” and living with the pain has recently emerged (McCracken & Vowles, 2014; Turk et al., 2011) through the concept of ACT (Hayes et al., 1999). ACT for pain management aims to increase psychological flexibility through accepting the pain, rather than trying to control or struggle with the pain, as well as identifying, committing to and behaving in accordance with personal values (Hayes et al., 1999).

Research examining the potential impact of ACT in chronic pain management is still at an early stage, and the evidence base for positive impact still somewhat limited and inconclusive (Hann & McCracken, 2014; Hughes et al., 2017; Veehof et al., 2016; Williams et al., 2020).

There are however indications that ACT may be associated with significant improvement in pain acceptance/psychological flexibility (Hann & McCracken, 2014; Hughes et al., 2017), pain intensity (Veehof et al., 2016), disability/physical functioning (Hann & McCracken, 2014; Hughes et al., 2017; Veehof et al., 2016), depression and/or anxiety (Hann &

McCracken, 2014; Hughes et al., 2017; Veehof et al., 2016) and QoL (Hughes et al., 2017).

2.1.3 Availability of psychological interventions for chronic pain self-management Even though the potential for positive impact is significant, access to psychological self- management interventions such as CBT for chronic pain remains a challenge (Ehde et al., 2014; Urits et al., 2019), and if available, such interventions are usually only provided within

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secondary or tertiary care settings, and often only considered after pharmacological treatment has failed (Kress et al., 2015).

Potential reasons for the underutilization of psychological self-management interventions are many, including health care system barriers such as lack of pain management specialty services, geographical limitations in health care services and long waiting lists (Breivik et al., 2006; Ehde et al., 2014; Kress et al., 2015), reimbursement issues, time constraints related to individual in person or group therapy follow up, limited formal chronic pain treatment training or providers being unfamiliar with self-management interventions for chronic pain (Ehde et al., 2014; Johnson et al., 2013; Kress et al., 2015). Challenges with stigma associated with the use of psychological care may also be an issue (Ehde et al., 2014) and pain in itself may be another barrier as some patients may find it challenging to physically attend

appointments (Ehde et al., 2014). The numerous barriers to the availability and use of psychological self-management support means that many patients only see their general practitioner (GP) for pain management support (Breivik et al. 2006; Schulte et al. 2010). This despite the fact that GPs tend to find chronic pain challenging to treat (Johnson et al., 2013) and that patients have reported skepticism about GPs’ competence and ability to understand and treat pain (Kress et al., 2015).

Considering the recommendations for interdisciplinary and biopsychosocial approaches to the understanding, treatment and management of chronic pain conditions (Dansie & Turk, 2013;

Gatchel et al., 2014; Kress et al., 2015; Landmark et al., 2013; Mills et al., 2016), current inadequate and limited treatment of chronic pain can have significant consequences for the individual, the health care system and for the health care providers (Eccleston et al., 2020).

Waiting for treatment may even be associated with increased symptoms of depression, of suicidal thinking and an overall deterioration in psychological well-being and QoL for the person living with chronic pain (Choinière et al., 2010; Lynch et al., 2008). The situation is also alarming considering the anticipated increase in chronic pain prevalence (Nahin et al., 2019; Rice et al., 2016) and the need for alternative and innovative solutions is evident.

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9 2.2 The potential of eHealth in chronic pain management

2.2.1 What is eHealth

eHealth is a broad term often used to define a combination of technology, health and health services, delivered through information and communication technologies (Eysenbach, 2001;

Shaw et al., 2017; J. E. van Gemert-Pijnen, 2013). In this dissertation, eHealth refers to “the use of technology to support health, well-being and healthcare” as defined by van Gemert- Pijnen and colleagues (2018, p. 7). eHealth technology refers to the actual technological

”instrument” used (e.g., mobile phone, computer, tablet), while eHealth interventions refer more specifically to the use of eHealth technology aiming to “intervene in an existing context by changing behavior and/or cognitions” (L. van Gemert-Pijnen, Kip, et al., 2018, p. 7).

eHealth solution is used as a broader term, as it does not need to be an intervention (i.e., focus on changing behavior), although more specific than eHealth as it refers to a specific solution, such as a step counter.

The emergence of eHealth as a field reflects the substantial and ever-growing influence of technology in society today. Research examining the actual effect, impact and implementation of eHealth is still at an early stage, but with technology being a natural part of many people’s lives (e.g., 92% of Norwegians between 16-79 years used the internet daily or almost daily in 2020; Statistics Norway (SSB)), eHealth solutions and interventions have the potential to make health care more accessible and widely distributed (World Health Organization, 2016), with promising indications of greater efficiency, outcome and cost reductions (Andersson et al., 2017; European Comission, 2018; Eysenbach, 2001; IMS Institute for Healthcare Informatics, 2015; Kreps & Neuhauser, 2010; Rogers et al., 2017; J. E. van Gemert-Pijnen, 2013; L. van Gemert-Pijnen, Kelders, et al., 2018; Webb et al., 2010).

2.2.2 eHealth in support of chronic pain self-management

Considering the limited availability and outreach of in-person psychological interventions for the self-management of chronic pain (Ehde et al., 2014; Urits et al., 2019), eHealth solutions may offer innovative new ways to promote such support (Andersson, 2014; Eccleston et al., 2014; Eccleston & Crombez, 2017; Ehde et al., 2014; Keogh, 2013; Keogh et al., 2010; L. van Gemert-Pijnen, Kip, et al., 2018; Vardeh et al., 2013). eHealth interventions not only have the potential to promote evidence-based content, knowledge and strategies to people living with chronic pain, but also to reinforce intervention delivery, uptake and use through continuous, tailored and personalized follow-up and feedback (Asbjørnsen et al., 2019; Kelders et al.,

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2012; Kelders & Howard, 2018; Rogers et al., 2017). As such, eHealth interventions may promote active coping, empowerment and potentially also behavior change (Asbjørnsen et al., 2019, 2020; Garg et al., 2016; Michie et al., 2017; Rosser & Eccleston, 2011; L. van Gemert- Pijnen, Kelders, et al., 2018; Webb et al., 2010).

2.2.3 eHealth and support of chronic pain self-management in the Norwegian context

The interest in and considered potential of eHealth has grown rapidly in recent years, also in the Norwegian context. Following the “One citizen - one record - Digital services in the health and care sector” governmental publication (The Norwegian Ministry of Health and Care Services, 2013b) a number of governmental reports have been published emphasizing the expected important societal role of eHealth and welfare technology (The Norwegian Ministry of Health and Care Services, 2013a, 2015; The Norwegian Ministry of Local

Government and Modernisation, 2016). A national eHealth strategy also describes eHealth as a prerequisite to sustainable and high quality health care services (The Norwegian Directorate of eHealth, 2019a), and as a means to better utilization of health care resources (The

Norwegian Ministry of Local Government and Modernisation, 2016). eHealth, and particularly mobile health technology and applications (apps), have also been considered important assets to the Norwegian health care services, potentially increasing patient

participation in health care treatment, empowering and increasing individuals’ ability to self- manage (The Norwegian Ministry of Health and Care Services, 2013b, 2013a, 2015; The Norwegian Ministry of Local Government and Modernisation, 2016).

Despite these distinct calls, and a goal for welfare technology to be an integral part of Norwegian health care services by 2020 (The Norwegian Ministry of Health and Care Services, 2013a), research focusing on eHealth within chronic pain management and

availability of eHealth pain management solutions in the Norwegian context, remain scarce.

Kristjánsdóttir and colleagues examined the use of smartphone diaries in fibromyalgia, concluding that such an intervention was well accepted by the participants with significant results on catastrophizing immediate and at mid-term follow-up. However, the results were not sustained at long term, potentially indicating a need for more continuity and longer intervention durations (Kristjánsdóttir et al., 2011; Kristjánsdóttir, Fors, Eide, Finset, Stensrud, van Dulmen, Hørven Wigers, et al., 2013; Kristjánsdóttir, Fors, Eide, Finset,

Stensrud, van Dulmen, Wigers, et al., 2013). More recently, Grasaas and colleagues examined

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11 the potential of an eHealth app for adolescents with chronic pain. Translating and adapting the eHealth self-management app iCanCope with Pain^TM into Norwegian, results revealed high user satisfaction and ease of use (Grasaas et al., 2019), but also high attrition rates and low engagement (Grasaas, 2020). Apart from these studies, however, research exploring the development and/or evaluation of eHealth pain management interventions remains to be conducted and/or published in Norway, and evidence-based eHealth interventions to support self-management of chronic pain have yet to be implemented.

2.2.4 The potential effects, quality and challenges associated with existing eHealth self-management solutions

While research examining eHealth pain management interventions in Norway is still scarce, a growing body of international research have reported on the potential of eHealth in chronic pain management, including self-management over the past decade, the extent, efficacy and quality of which have been examined in reviews and meta-analyses (Bender et al., 2011;

Bhattarai et al., 2018; Buhrman et al., 2016; Dario et al., 2017; de la Vega & Miro, 2014;

Devan, Farmery, et al., 2019; Du et al., 2019; Eccleston et al., 2014; Garg et al., 2016; Heapy et al., 2015; Lalloo et al., 2015; Machado et al., 2016; Mcgeary et al., 2012; Moman et al., 2019; Portelli & Eldred, 2016; Rosser & Eccleston, 2011; Slattery et al., 2019; Thurnheer et al., 2018; Wallace & Dhingra, 2014). Findings indicate that eHealth solutions for the

management of chronic pain may be associated with improved pain related outcomes, including reduced pain intensity (Bender et al., 2011; Buhrman et al., 2016; Du et al., 2019;

Eccleston et al., 2014; Martorella et al., 2017; Mehta et al., 2019; Moman et al., 2019;

Thurnheer et al., 2018) and reduced disability (Bender et al., 2011; Buhrman et al., 2016; Du et al., 2019; Eccleston et al., 2014; Martorella et al., 2017). eHealth solutions for chronic pain management have also been associated with improved psychological outcomes, including reduced depression and anxiety (Buhrman et al., 2016; Garg et al., 2016; Moman et al., 2019), reduced pain catastrophizing (Buhrman et al., 2016; Moman et al., 2019), improved self- efficacy (Mehta et al., 2019; Moman et al., 2019) and improved QoL (Dario et al., 2017;

Thurnheer et al., 2018). However, despite promising indications from the use of eHealth in chronic pain management so far, findings are still mixed and inconclusive, and a number of limitations and challenges have been identified.

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2.2.4.1 Theoretical/evidence-based foundation and self-management aspects

Reviews have pointed to an alarming lack of theoretical foundation and evidence-based intervention content (Eccleston et al., 2014; Lalloo et al., 2015; Machado et al., 2016; Portelli

& Eldred, 2016; Salazar et al., 2018; Thurnheer et al., 2018; Wallace & Dhingra, 2014), as well as a lack of incorporation of comprehensiveness and self-management functionality in existing eHealth chronic pain management solutions (Bhattarai et al., 2018; de la Vega &

Miro, 2014; Devan, Farmery, et al., 2019; Eccleston et al., 2014; Lalloo et al., 2015; Wallace

& Dhingra, 2014). For instance, one review found that none of the 279 apps identified and included in the review provided a theoretical rationale, and none were comprehensive in terms of self-management, with the majority of the apps only including one or two self-management components (i.e., self-care skills training, education, self-monitoring, social support and goal setting) (Lalloo et al., 2015). Another review found a strong emphasis on pharmacological therapy and natural remedies among the identified and included apps, however, only six out of 195 apps included endorsed theoretical reference to CBT principles (Portelli & Eldred, 2016). An even more recent review included only 19 out of 939 apps identified, as the majority of identified apps failed to meet the inclusion criteria of providing information on included pain management strategies (Devan, Farmery, et al., 2019). When researchers, developers or marketing agents claim eHealth apps to be effective or therapeutic, yet fail to consider and/or identify theoretical foundation, existing evidence or even intervention content, the risk of people being misled is significant (Rosser & Eccleston, 2011), which could subsequently do more harm than good (Portelli & Eldred, 2016).

2.2.4.2 Stakeholder involvement

Multiple reviews have pointed to the limited involvement of patients/users (Bender et al., 2011; Bhattarai et al., 2018; Buhrman et al., 2016; Devan, Farmery, et al., 2019; Eccleston et al., 2014; Heapy et al., 2015; Mcgeary et al., 2012; Sundararaman et al., 2017) and the limited or even lack of involvement of health care providers (Bhattarai et al., 2018; Devan, Farmery, et al., 2019; Lalloo et al., 2015; Mcgeary et al., 2012; Portelli & Eldred, 2016; Rosser &

Eccleston, 2011; Wallace & Dhingra, 2014; Zhao et al., 2019) in the design and development processes of eHealth pain management interventions. There are also indications that existing eHealth solutions for chronic pain may have been developed in response to technological advances rather than as a result of user needs (de la Vega & Miro, 2014; Keogh et al., 2010;

Mcgeary et al., 2012). In response to the apparent user involvement deficiency, reviews have

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13 called for the inclusion of stakeholders in all design and development processes to gain more knowledge related to usability (Bender et al., 2011; Bhattarai et al., 2018; Salazar et al., 2018;

Sundararaman et al., 2017), user satisfaction (Eccleston et al., 2014; Heapy et al., 2015;

Thurnheer et al., 2018) and user needs (Bender et al., 2011; Buhrman et al., 2016; Heapy et al., 2015; Sundararaman et al., 2017; Thurnheer et al., 2018) in the development of eHealth pain management solutions.

2.2.4.3 Attrition/adherence

High attrition rates and low adherence have occurred as major challenges to the use and potential impact of eHealth interventions (Buhrman et al., 2016; Kelders et al., 2012; Lin et al., 2018; Rosser et al., 2009). Attrition refers to study drop-out and/or no longer using an intervention (i.e., “nonusage attrition”) (Eysenbach, 2005; Sieverink et al., 2017), while adherence refers to adherence or compliance to a study or protocol (e.g., number of completed modules within an intervention) (Lin et al., 2018). Within the field of eHealth, adherence has also been referred to as “use as intended” (Kelders et al., 2012; Sieverink et al., 2017).

Reported attrition/adherence rates in eHealth pain self-management interventions vary greatly ((e.g., attrition; 0-84% (Rosser et al., 2009), 4-54% (Buhrman et al., 2016) and 17.4%

(Eccleston et al., 2014)), with single study attrition (i.e., treatment dropout) even as high as 96.5% reported (Lin et al., 2018). Adherence for eHealth interventions in terms of “use as intended” has yielded a 50% average adherence rate (Kelders et al (2012). With the large variety in eHealth attrition/adherence rates, researchers may be tempted to accept sub-optimal rates. However, with use being a natural prerequisite for effect, users are unlikely to benefit from eHealth interventions if not using, engaging in, or adhering to the intervention (Michie et al., 2017). The attrition/adherence issue in eHealth interventions subsequently calls for substantial problem-solving approaches.

2.2.4.4. Efficacy testing/Evidence of efficacy

While a number of studies have found indications that eHealth pain management solutions may have the potential for positive outcome associations such as reduced pain

intensity/catastrophizing and improved psychological well-being (Bender et al., 2011;

Buhrman et al., 2016; Du et al., 2019; Eccleston et al., 2014; Martorella et al., 2017; Mehta et al., 2019; Moman et al., 2019; Thurnheer et al., 2018), reviews examining existing eHealth solutions for chronic pain management have pointed to an overall lack of rigorous testing and subsequent scientific evidence of efficacy (Dario et al., 2017; de la Vega & Miro, 2014; Du et

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al., 2019; Lalloo et al., 2015; Machado et al., 2016; Mcgeary et al., 2012; Moman et al., 2019;

Rosser & Eccleston, 2011; Salazar et al., 2018; Thurnheer et al., 2018), including long-term efficacy. For instance, examining pain-related apps found in app stores, one review concluded that none of the 283 pain-related apps identified could be located in scientific databases or reported on actual program efficacy (de la Vega & Miro, 2014). Research investigating which type of intervention content and eHealth technology (i.e., type of delivery mode) can promote the most effective and beneficial outcomes also appears to be lacking so far (Dario et al., 2017; Du et al., 2019; Heapy et al., 2015; Mehta et al., 2019; Thurnheer et al., 2018).

2.2.4.5 Implementation

Finally, actual uptake and implementation of eHealth solutions into clinical practice appears to be a challenge (Varsi et al., 2019), and despite promising potential, the actual use of eHealth technology within chronic pain management is still limited (Devan, Godfrey, et al., 2019; Kong et al., 2020; Levine et al., 2014; Schneider & Hadjistavropoulos, 2014). A range of factors have been associated with eHealth implementation success and/or failure, including limited exposure to, or awareness of, eHealth solutions (Devan, Godfrey, et al., 2019),

clinicians’ acceptance (Varsi et al., 2015; Wade et al., 2014), questioning whether the solution contains trustworthy information (Devan, Godfrey, et al., 2019), privacy and security related challenges (Granja et al., 2018; Illiger et al., 2014), and skepticism towards replacing in- person treatment with digital interventions (Devan, Godfrey, et al., 2019; Sharma & Clarke, 2014). The importance of implementation planning at an early stage in the design and development phase of eHealth interventions must not be underestimated (Varsi et al., 2019).

2.3 Designing and developing eHealth interventions for sustained use and support in chronic pain management

The identified limitations and challenges with existing eHealth pain management solutions call for further research and new approaches. The identified issues of limited theoretical and evidence-based content, as well as the lack of comprehensive self-management aspects must be considered at an early stage in the design and development process. What is the current theoretical, clinical and research evidence to support self-management of chronic pain conditions, and how can it best be incorporated and presented in a digital solution? Over the past decade, the need for more attention to stakeholder input, including users’ (i.e., intended end-users of a solution/intervention) needs and requirements, in the design and development

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15 process have been increasingly emphasized, and recommendations for user/human- and/or person-centered design approaches/frameworks have been made to properly address this issue (Baker et al., 2014; Cranen et al., 2017; Keogh et al., 2010; J. E. van Gemert-Pijnen et al., 2011; Yardley et al., 2015).

Suggestions for the incorporation of motivational and persuasive design elements have been made to target the challenges with attrition and adherence. For example, research has

indicated that the use of design elements and functionalities such as personalization, tailoring, reminders, suggestions, praise, social support and gamifying elements (e.g., use of points, badges, avatar(s) and metaphors) may promote user engagement and adherence (Asbjørnsen et al., 2019; Fry & Neff, 2009; Kelders et al., 2012; Ludden et al., 2015; Webb et al., 2010).

Some research has also indicated that guidance/interaction with a counselor and blended care delivery can improve study outcomes, facilitate eHealth acceptance and promote engagement and adherence (Andersson, 2014; Baumeister et al., 2014; Currie et al., 2015; Kelders et al., 2020; Kleiboer et al., 2015; Richards & Richardson, 2012). However, decisions on which design elements to use and how to use them should include stakeholder input (G. D. Ludden, van Rompay, Kelders, & van Gemert-Pijnen, 2015), again illustrating the importance of involving stakeholders in the early design and development processes of eHealth

interventions.

While rigorous efficacy testing of the final solution is not necessarily a part of the design and development phase of the eHealth solution, and as such also not a part of this dissertation, preparing and planning for efficacy testing is a vital part of the larger processes preparing eHealth solutions for implementation. As such, future efficacy testing should be considered also in the design and development phases.

Given the significant implementation issues associated with eHealth solutions, the importance of identifying potential barriers and facilitators for uptake, implementation and use at an early stage in the planning and development of eHealth solutions has been emphasized (Granja et al., 2018; Varsi et al., 2019). With implementation in mind, stakeholder involvement in the design, development and user testing processes have again been emphasized, aiming to tailor eHealth solutions to match the technology skills and health-literacy levels of the intended users, adequately train health care providers and users, and provide important information about potential value of use (DeMonte et al., 2015; Parker et al., 2013; Sundararaman et al., 2017; The Norwegian Ministry of Health and Care Services, 2013b, 2013a).

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In order to design and develop eHealth interventions for sustained use and support, the identified challenges related to existing eHealth interventions for chronic pain must be addressed. To successfully do so, existing conceptual frameworks and design methodologies must be examined and serve as inspiration, but existing approaches must also be explored and expanded on in the pursuit of more complete approaches.

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3. Design and development of eHealth interventions:

Conceptual frameworks and design methodology

The increasing body of eHealth related research over the past decade has led to

recommendations for the employment of guideline(s) when designing and developing eHealth solutions and interventions (Baker et al., 2014; Cranen et al., 2017; Keogh et al., 2010; Shah et al., 2009; J. E. van Gemert-Pijnen et al., 2011; Yardley et al., 2015). Comprehensive, established and published guidelines for how to design and develop eHealth solutions that can be based on evidence and stakeholder input, can address issues related to attrition/adherence, show efficacy and also be prepared for implementation into clinical practice are however still limited. The design and development processes of this dissertation project therefore rests on aspects from more than one guideline, methodology and concept.

Design and development of digital research projects at the Department of Digital Health Research at Oslo University Hospital, where this dissertation project was conducted, are executed in accordance with the department’s own project management guideline. The guideline is unpublished as per spring 2021, but the methods used have been developed through years of departmental research (Børøsund et al., 2018; Jessen et al., 2018; Mirkovic et al., 2014; Ruland et al., 2008, 2009; Ruland & Bakken, 2002; Seljelid et al., 2020). Given the early stage of eHealth design and development guidelines and processes, however, the

development process in this dissertation project was also inspired by the Center for eHealth Research and Disease Management comprehensive Roadmap (CeHRes; J. E. van Gemert- Pijnen et al., 2011; L. van Gemert-Pijnen, Kelders, et al., 2018) for the development, evaluation and implementation of eHealth. The design and development processes in this dissertation were also significantly inspired by human-centered design (Abras et al., 2004; D.

Norman, 2013b; D. A. Norman, 1988), with elements from participatory design (Simonsen &

Robertson, 2013) and collaborative working methods from service design (Stickdorn &

Schneider, 2012) as well.

The design approaches and conceptual frameworks inspiring this dissertation are briefly presented below. More details about the working methodologies and specific methods used in each of the three studies included in this dissertation are provided in the methods section (5).

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3.1 Human-centered design

Human-centered design² can be defined as “The process that ensures that the designs match the needs and capabilities of the people for whom they are intended” (D. Norman, 2013c, p.

9). At the core of human-centered design lies the emphasis on developing solutions that are usable, effective, reliable and understandable (Abras et al., 2004; D. Norman, 2013a).

Promoting positive and enjoyable experiences is also accentuated (D. Norman, 2013c). The emphasis in human-centered design focuses on “solving the right problem, and doing so in a way that meets human needs and capabilities” (D. Norman, 2013a, p. 219). Getting to understand the user and their individual context is emphasized, and the use of observations recommended (D. Norman, 2013a). The recommended development process further includes idea generation activities with the goal of generating numerous ideas, rapid and iterative prototyping with simple mock-ups (i.e., simple sketches illustrating ideas and/or parts of the solutions) and testing (i.e., have people similar to the target population test the prototypes) (D.

Norman, 2013a).

3.2 Participatory design

Participatory design can be defined as “a process of investigating, understanding, reflecting upon, establishing, developing, and supporting mutual learning between multiple participants in collective ‘reflection-in-action” (Simonsen & Robertson, 2013, p. 2). Similar to human- centered design, participatory design aims to ensure a fit between the solution and the context in which it is supposed to be used. However, participatory design places participation at the core and argues that all stakeholders, that is anyone who may influence or be influenced by the solution(s) either directly (i.e., potential end-user) or indirectly (e.g., health care providers, designers or researchers), should be actively involved in the entire development process (Simonsen & Robertson, 2013). The participatory design approach rests on an ethical stance that one should respect people`s rights to represent themselves, rather than having others do this for them (Simonsen & Robertson, 2013). Participatory design relies on mutual learning (i.e., sharing ones’ experiences and creating a mutual understanding) between stakeholders (Simonsen & Robertson, 2013), and often include workshops where mock-ups, scenarios,

2 Initially referred to as user-centered design in the larger project description and the published articles of this dissertation. However, as the term human-centered emerged, suggesting a broader focus on development processes, this term was chosen for the actual dissertation manuscript, in line with Norman (2016), Steen (2011) and van Gemert-Pijnen et al (2018)

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19 prototypes and various types of design games are used to facilitate collaboration between stakeholders (Simonsen & Robertson, 2013).

3.3 Service design

There is no single definition of service design (Stickdorn & Schneider, 2012). However, across definitions, service design can be referred to as an “interdisciplinary approach that combines different methods and tools from various disciplines” when designing and

developing a service (Stickdorn & Schneider, 2012, p. 29). Working with representatives of all stakeholders in a user/human-centered and co-creative perspective, the goal is to develop and/or improve services and provide a holistic service that is useful, usable, efficient and desirable to the end-user (Stickdorn & Schneider, 2012). Service design approaches propose a range of design methods that can be used to facilitate stakeholder engagement and/or to identify user needs. These methods include, but are not limited to, the development of

personas (i.e., fictive user representatives), journey maps (e.g., identifying touch-points where users interact with the service) and idea generation (i.e., structured brainstorming) (Stickdorn

& Schneider, 2012; Stinkdorn et al., 2018).

3.4 The Department of Digital Health Research’s Project Management Guideline

The Department of Digital Health Research’s project management guideline for the

development, evaluation and implementation of eHealth research projects and solutions has been developed, tested and refined through nearly 20 years of research (Børøsund et al., 2018;

Jessen et al., 2018; Mirkovic et al., 2014; Ruland et al., 2008, 2009; Ruland & Bakken, 2002;

Seljelid et al., 2020). The guideline itself is unpublished as per spring 2021, but includes a description of activities leading from idea generation, design/development and efficacy testing of eHealth interventions aimed at supporting patients with chronic and long-term conditions and their health care providers. The departmental guideline consists of six phases, including:

1) Idea Generation and Project Description, 2) Project Establishment, 3) Needs Assessment, 4) Digital Solution Design and Development, 5) Feasibility and Efficacy Testing, and 6) Project Completion and Implementation (Please see Figure 1 for a simple guideline illustration).

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Figure 1. Illustration of the Department of Digital Health Research’s Project Management Guideline

Phases 3 (i.e., Needs Assessment) and 4 (i.e., Digital Solution Design and Development) acted as contributing factors guiding the development processes of this dissertation. These two phases are therefore described below.

3.4.1 Needs Assessment

The needs assessment phase focuses on obtaining knowledge and insight from and about the intended users (e.g., the specific patient population) of the eHealth solution to be developed.

The phase builds on the model of Evidence-based practice (Satterfield et al., 2009), indicating that the solution to be developed should lean on best available research evidence, in

combination with insight from patients/clients and the health care practice (i.e., health care providers). The phase usually entails a combination of angles and approaches, examining relevant aspects, options and spaces of opportunity. First, existing research regarding evidence-based practice involving the target end-user group(s) and condition(s) should be examined. This should also include information regarding what is already known about the needs and preferences of the target group, as well as their needs and preferences for eHealth solutions, presented from a variety of perspectives (e.g., the perspectives of patients,

caregivers/spouses and health care providers). Next, direct contact with the intended users and their health care providers must be conducted to complement the first step. In this step, formal and informal interviews and meetings should be arranged with key stakeholders (e.g.,

patients, spouses, health care providers) to collect information and data material. Methods inspired from service design (e.g., personas, journey maps), user-centered design (e.g., user involvement, co-creation) and qualitative research methods (e.g., interviews, observations) can be utilized to inspire and elicit input in this step. In addition, clinical practice visits and observations could also be conducted to gain insight into the specific context(s) where the eHealth solution will eventually be tested (i.e., feasibility/efficacy) and implemented.

Implementability of the solution is important to consider at this early stage to inform the upcoming phases of development. Input obtained from research and this broad range of

A human-centered and evidence-informed development process of EPIO; An eHealth self- management intervention for people living with chronic pain