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A Rapid Review for Developing a Co-Design Framework for a Pediatric Surgical Communication Application

  • Michelle Cwintal
    Affiliations
    Faculty of Dental Medicine and Oral Health Sciences, McGill University, 2001 McGill College Ave, Montreal, Quebec, H3A 1G1, Canada
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  • Hamed Ranjbar
    Affiliations
    Faculty of Medicine and Health Sciences, McGill University, 3605 Rue de La Montagne, Montréal, Quebec, H3G 2M1, Canada
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  • Parsa Bandamiri
    Affiliations
    Faculty of Medicine and Health Sciences, McGill University, 3605 Rue de La Montagne, Montréal, Quebec, H3G 2M1, Canada
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  • Elena Guadagno
    Affiliations
    Harvey E. Beardmore Division of Pediatric Surgery, The Montreal Children's Hospital, McGill University Health Centre, 1001 Decarie Blvd, Room B04.2028, Montreal, Quebec H4A 3J1, Canada
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  • Esli Osmanlliu
    Affiliations
    Department of Pediatrics, Division of Emergency Medicine, Montreal Children’s Hospital, 1001 Decarie Blvd, Montreal, Quebec, H4A 3J1, Canada
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  • Dan Poenaru
    Correspondence
    Corresponding author. , Harvey E. Beardmore Division of Pediatric Surgery, The Montreal Children's Hospital, McGill University Health Centre, 1001 Decarie Blvd, Room B04.2028, Montreal, Quebec H4A 3J1, Canada. Tel.: +1 514 412 4497; fax: +1 514 412 4289.
    Affiliations
    Faculty of Medicine and Health Sciences, McGill University, 3605 Rue de La Montagne, Montréal, Quebec, H3G 2M1, Canada

    Harvey E. Beardmore Division of Pediatric Surgery, The Montreal Children's Hospital, McGill University Health Centre, 1001 Decarie Blvd, Room B04.2028, Montreal, Quebec H4A 3J1, Canada
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Open AccessPublished:January 19, 2023DOI:https://doi.org/10.1016/j.jpedsurg.2023.01.030

      Highlights of Paper

      • What is currently known about this topic?
      Although co-design is slowly becoming more popular in the development of mHealth interventions, it lacks standardized guidelines and evaluation.
      • 2.
        What new information is contained within this article?
      This review provides a summary of what pre-existing frameworks may be used to inform co-design, the steps of co-design most commonly used, and the strengths and limitations co-design brings.

      Summary

      Background

      The exponential growth in the use of mobile health (mHealth) applications in patient care has highlighted the importance of understanding end-users’ needs for successful interventions, achievable through the process of co-design. This review aims to summarize previously published uses of co-design in mHealth applications. It will inform the development of a local mHealth tool in pediatric surgery.

      Methods

      The rapid review was conducted following Cochrane Rapid Review guidelines. We searched four databases from inception until August 2021 for collaborative design in mHealth apps. Two reviewers independently screened titles and abstracts using Rayyan, with a third reviewer resolving any conflicts. Studies were excluded if they were non-empirical or in other languages than English.

      Results

      Out of 984 records screened, 175 were included for full-text screening, and 27 met all eligibility criteria. The purpose of the studies related to care support, communication, self-management or information management. All interventions involved their target audience in the co-design process, and 85% included healthcare professionals for expert opinion. Stakeholder participation was solicited via interviews, surveys, focus groups, design sessions, and prototype evaluation. To initiate the process, 15 studies included needs identification, 8 did background research, and 7 performed literature reviews.

      Conclusion

      Co-design has a positive impact on mHealth development, research processes and outcomes. Its success relies on a clearly identified framework of terminology, activities involved, and evaluation techniques. The findings of this review will be integrated into a novel co-design framework, which will be used to inform the development of a pediatric surgery mHealth application.

      Keywords

      List of Abbreviations

      CASP
      Critical Appraisal Skills Programme
      mHealth
      mobile health
      HCP
      healthcare provider
      MRC
      Medical Research Council
      PD
      Participatory design
      RITE
      rapid iterative testing and evaluation

      Declarations of Interest

      Michelle Cwintal, Hamed Ranjbar, Parsa Bandamiri, Elena Guadagno and Dan Poenaru are co-founders of and hold intellectual property right for the future pediatric surgical communication application, whose development will be informed by this review.

      Funding

      This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

      Introduction

      There has been a rapid increase in the use of mobile health (mHealth) applications in patient care [
      • Cao J.
      • Lim Y.
      • Sengoku S.
      • et al.
      Exploring the Shift in International Trends in Mobile Health Research From 2000 to 2020: Bibliometric Analysis.
      ]. mHealth is defined as the use of mobile devices (e.g., smartphones, personal digital assistant tools, and other wireless devices) to support the health-related services provided to patients, enhancing delivery of care and improving patient health outcomes [

      eHealth WHOGOf. mHealth: new horizons for health through mobile technologies: second global survey on eHealth. Geneva: World Health Organization; 2011.

      ,
      • McCurdie T.
      • Taneva S.
      • Casselman M.
      • et al.
      mHealth consumer apps: the case for user-centered design.
      ]. Developing and implementing successful mHealth applications requires an in-depth comprehension of the end-users’ needs and experiences, as well as their feedback on the utility they receive from the application [
      • Slater H.
      • Campbell J.M.
      • Stinson J.N.
      • et al.
      End User and Implementer Experiences of mHealth Technologies for Noncommunicable Chronic Disease Management in Young Adults: Systematic Review.
      ,
      • Farao J.
      • Malila B.
      • Conrad N.
      • et al.
      A user-centred design framework for mHealth.
      ]. This can be achieved through co-design with patients and other key stakeholders.
      Co-design in healthcare is an approach that promotes collective creativity across all phases of the design process, resulting in increased uptake of the mHealth interventions [
      • Thabrew H.
      • Fleming T.
      • Hetrick S.
      • et al.
      Co-design of eHealth Interventions With Children and Young People.
      ,
      • Goodyear-Smith F.
      Use of codesign in primary care research: real-life examples.
      ]. The end goal of co-design is to leverage the experiential knowledge and diverse socio-cultural background of patients and healthcare staff to create a clinical intervention, such as an mHealth application, which improves quality of care [
      • Donetto S.
      • Pierri P.
      • Tsianakas V.
      • et al.
      Experience-based Co-design and Healthcare Improvement: Realizing Participatory Design in the Public Sector.
      ]. Co-design introduces many benefits, including the generation of more ideas, better understanding of user’s needs, reduction in development in cost and time, reporting of higher satisfaction by patients, and higher quality of service [
      • Thabrew H.
      • Fleming T.
      • Hetrick S.
      • et al.
      Co-design of eHealth Interventions With Children and Young People.
      ].
      Effective implementation of co-design in mHealth development faces significant challenges. Not only is the process variable, requiring adaptation to the unique context surrounding the mHealth intervention, but very few guidelines exist on how to achieve this [
      • Eyles H.
      • Jull A.
      • Dobson R.
      • et al.
      Co-design of mHealth Delivered Interventions: A Systematic Review to Assess Key Methods and Processes.
      ,
      • Noorbergen T.J.
      • Adam M.T.P.
      • Teubner T.
      • et al.
      Using Co-design in Mobile Health System Development: A Qualitative Study With Experts in Co-design and Mobile Health System Development.
      ,

      Noorbergen T, Adam M, Teubner T, et al. Using Co-Design in mHealth Systems Development: A Qualitative Study with Experts in Co-design and mHealth System Development (Preprint). 2021.

      ]. These challenges are further amplified in pediatric care, a field which is often neglected in novel technology design [
      • Niksch A.L.
      mHealth in pediatrics-finding healthcare solutions for the next generation.
      ]. Pediatric care, and more specifically, pediatric surgery, has the potential to benefit immensely from mHealth interventions, through a variety of implementations in the perioperative period [
      • Rantala A.
      • Pikkarainen M.
      • Miettunen J.
      • et al.
      The effectiveness of web-based mobile health interventions in paediatric outpatient surgery: A systematic review and meta-analysis of randomized controlled trials.
      ,
      • Nguyen N.
      • Leveille E.
      • Guadagno E.
      • et al.
      Use of mobile health technologies for postoperative care in paediatric surgery: A systematic review.
      ]. Co-design of a pediatric mHealth intervention includes an additional layer of complexity, which accounts for the evolving psychosocial demand of the pediatric population, while maintaining translatability for caregivers and clinicians utilizing the application [
      • Niksch A.L.
      mHealth in pediatrics-finding healthcare solutions for the next generation.
      ]. How to meaningfully engage different populations to create a seamless application that meets end-users’ needs remains a challenge.
      Thus, this rapid review aims to provide an overview and synthesis of how co-design has been previously used in the development of mHealth applications. This will consolidate best practices in a framework which can be referenced in future co-design attempts, taking into account specific considerations for the field of pediatric care. This rapid review will also inform the co-design protocol for the future development of a pediatric surgery mHealth application.

      Methods

      This study followed the Cochrane Rapid Review Guidelines [
      • Garritty C.
      • Gartlehner G.
      • Nussbaumer-Streit B.
      • et al.
      Cochrane Rapid Reviews Methods Group offers evidence-informed guidance to conduct rapid reviews.
      ] and methodological guidance from the Virginia Commonwealth University [

      Rapid Review Protocol. VCU Libraries Research Guides.

      ]. Our protocol included the following steps: 1) identifying a research question, 2) setting eligibility criteria, 3) designing and executing a search strategy, 4) screening and selecting studies using an iterative team approach, 5) data extraction, and 6) data synthesis.
      Studies were included if they described:
      • The development of an mHealth intervention, allowing for collaboration of care between patient/caregiver and members of the clinical team.
      • The process of co-design for the development of the mHealth intervention, and/or its benefits and limitations
      • The involvement of patients undergoing care, their caregivers or parents, or members of their clinical team in the process of co-design.
      Only studies written in English were included. All empirical studies were included.
      A senior medical librarian comprehensively searched the following databases from inception until August 6, 2021: Medline (Ovid), Embase (Ovid), Cochrane (Wiley), Web of Science (Clarivate Analytics). The search strategy used variations in text words found in the title, abstract or keyword fields, and relevant subject headings to retrieve articles looking at collaborative design in mobile health apps. The full search strategy can be found in the Supplementary Material 1. Additional papers were identified through “snowballing”, using the included studies.
      References found were imported into EndNote X9 [

      Team TE. EndNote. EndNote X9 ed. Philadelphia, PA: Clarivate; 2013.

      ], where duplicates were removed. They were imported into the online Rayyan platform [
      • Ouzzani M.
      • Hammady H.
      • Fedorowicz Z.
      • et al.
      Rayyan—a web and mobile app for systematic reviews.
      ] for the screening and selection process. Level 1 and level 2 screening were performed by two independent reviewers (HR, PB). Any disagreements were resolved by a third reviewer (MC).
      HR, PB and MC extracted and verified data on: study characteristics (year published, country of publication, study type), mHealth intervention characteristics (target audience, platform of intervention, clinical field of intervention, purpose of intervention), co-design characteristics (whether a specific approach or framework was used, who was involved in co-design, methods used during the co-design process, which steps of intervention development used co-design) and co-design outcomes (impact of co-design, evaluation of the process of co-design – benefits and limitations).
      Critical appraisal tools from the Joanna Briggs Institute were inspected and the checklist for qualitative research was selected to evaluate the quality of each included study [

      Critical Appraisal Tools. JBI.

      ]. The Critical Appraisal Skills Programme (CASP) checklist [

      Brice R. CASP CHECKLISTS. CASP - Critical Appraisal Skills Programme.

      ] was used to complement the quality appraisal of the selected studies. The quality appraisal can be found in Supplementary Table 1.
      Data was analyzed qualitatively summarized narratively. Key, recurring steps described in the co-design process of each of the included studies were identified and categorized.

      Results

      Study Selection

      In total, 1048 records were retrieved, with 984 remaining for level 1 screening after duplicate removal. Twenty-seven records were included after level 2 screening (Figure 1). Records were primarily excluded due to incorrect use of the mHealth application (not collaborative care), or focussing on the wrong construct (e.g., not mHealth, not patient care, not co-design). A list of level 2 exclusions can be found in Supplementary Table 2. The full list of included studies, and their details, can be found in Supplementary Table 3. The included studies were published between 2007 and 2021. Most of the studies were published after 2018.

      mHealth Intervention Characteristics

      The purpose of the mHealth interventions were categorized care support, decision support, self-management support, information management and communication.
      The majority (59%) of the designed mHealth interventions supported disease self-management [
      • Woods L.
      • Duff J.
      • Roehrer E.
      • et al.
      Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart.
      ,
      • Woods L.
      • Cummings E.
      • Duff J.
      • et al.
      Conceptual Design and Iterative Development of a mHealth App by Clinicians, Patients and Their Families.
      ,

      Vilarinho T, Floch J, Stav E. Co-designing a mHealth Application for Self-management of Cystic Fibrosis. In: Bernhaupt R, Dalvi G, Joshi A, K. Balkrishan D, O'Neill J, Winckler M, eds. Human-Computer Interaction – INTERACT 2017. Cham: Springer International Publishing; 2017:3-22.

      ,
      • Thirumalai M.
      • Rimmer J.H.
      • Johnson G.
      • et al.
      TEAMS (Tele-Exercise and Multiple Sclerosis), a Tailored Telerehabilitation mHealth App: Participant-Centered Development and Usability Study.
      ,
      • Song T.
      • Yu P.
      • Bliokas V.
      • et al.
      A Clinician-Led, Experience-Based Co-Design Approach for Developing mHealth Services to Support the Patient Self-management of Chronic Conditions: Development Study and Design Case.
      ,
      • Siek K.A.
      • Ross S.E.
      • Khan D.U.
      • et al.
      Colorado Care Tablet: the design of an interoperable Personal Health Application to help older adults with multimorbidity manage their medications.
      ,
      • Siek K.A.
      • Khan D.U.
      • Ross S.E.
      • et al.
      Designing a personal health application for older adults to manage medications: a comprehensive case study.
      ,
      • Ravn Jakobsen P.
      • Hermann A.P.
      • Søndergaard J.
      • et al.
      Development of an mHealth Application for Women Newly Diagnosed with Osteoporosis without Preceding Fractures: A Participatory Design Approach.
      ,
      • Neuhauser L.
      • Kreps G.L.
      • Morrison K.
      • et al.
      Using design science and artificial intelligence to improve health communication: ChronologyMD case example.
      ,
      • Fiordelli M.
      • Zanini C.
      • Amann J.
      • et al.
      Selecting Evidence-Based Content for Inclusion in Self-Management Apps for Pressure Injuries in Individuals With Spinal Cord Injury: Participatory Design Study.
      ,
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Birnie K.A.
      • Nguyen C.
      • Do Amaral T.
      • et al.
      A parent–science partnership to improve postsurgical pain management in young children: Co-development and usability testing of the Achy Penguin smartphone-based app.
      ,
      • Austin L.
      • Sharp C.
      • Veer S.V.D.
      • et al.
      Providing 'the bigger picture': benefits and feasibility of integrating remote monitoring from smartphones into the electronic health record: Findings from the Remote Monitoring of Rheumatoid Arthritis (REMORA) study.
      ,
      • Anderson J.N.
      • Krukowski R.A.
      • Paladino A.J.
      • et al.
      THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care.
      ,
      • Amann J.
      • Fiordelli M.
      • Scheel-Sailer A.
      • et al.
      Opportunities and Challenges of a Self-Management App to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Qualitative Study.
      ,
      • Amann J.
      • Fiordelli M.
      • Brach M.
      • et al.
      Co-designing a Self-Management App Prototype to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Mixed Methods Study.
      ]; 44% were designed for care support [
      • Woods L.
      • Cummings E.
      • Duff J.
      • et al.
      Conceptual Design and Iterative Development of a mHealth App by Clinicians, Patients and Their Families.
      ,
      • Neuhauser L.
      • Kreps G.L.
      • Morrison K.
      • et al.
      Using design science and artificial intelligence to improve health communication: ChronologyMD case example.
      ,
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Birnie K.A.
      • Nguyen C.
      • Do Amaral T.
      • et al.
      A parent–science partnership to improve postsurgical pain management in young children: Co-development and usability testing of the Achy Penguin smartphone-based app.
      ,
      • Strand A.S.
      • Johnsson B.
      • Hena M.
      • et al.
      Developing eHealth in neonatal care to enhance parents' self-management.
      ,
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ,
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ,
      • Ruland C.M.
      • Slaughter L.
      • Starren J.
      • et al.
      Children's contributions to designing a communication tool for children with cancer.
      ,
      • Nielsen C.
      • Agerskov H.
      • Bistrup C.
      • et al.
      User involvement in the development of a telehealth solution to improve the kidney transplantation process: A participatory design study.
      ,
      • Mueller E.L.
      • Cochrane A.R.
      • Moore C.M.
      • et al.
      Title: The Children's Oncology Planning for Emergencies (COPE) Tool: Prototyping with Caregivers of Children with Cancer.
      ,
      • Miller M.
      • Roxburgh C.S.
      • McCann L.
      • et al.
      Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery.
      ,
      • Davies A.
      • Mueller J.
      • Hennings J.
      • et al.
      Recommendations for Developing Support Tools With People Suffering From Chronic Obstructive Pulmonary Disease: Co-Design and Pilot Testing of a Mobile Health Prototype.
      ]; 37% for communication [
      • Fiordelli M.
      • Zanini C.
      • Amann J.
      • et al.
      Selecting Evidence-Based Content for Inclusion in Self-Management Apps for Pressure Injuries in Individuals With Spinal Cord Injury: Participatory Design Study.
      ,
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Amann J.
      • Fiordelli M.
      • Scheel-Sailer A.
      • et al.
      Opportunities and Challenges of a Self-Management App to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Qualitative Study.
      ,
      • Amann J.
      • Fiordelli M.
      • Brach M.
      • et al.
      Co-designing a Self-Management App Prototype to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Mixed Methods Study.
      ,
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ,
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ,
      • Ruland C.M.
      • Slaughter L.
      • Starren J.
      • et al.
      Children's contributions to designing a communication tool for children with cancer.
      ,
      • Davies A.
      • Mueller J.
      • Hennings J.
      • et al.
      Recommendations for Developing Support Tools With People Suffering From Chronic Obstructive Pulmonary Disease: Co-Design and Pilot Testing of a Mobile Health Prototype.
      ,
      • Lipson-Smith R.
      • White F.
      • White A.
      • et al.
      Co-Design of a Consultation Audio-Recording Mobile App for People With Cancer: The SecondEars App.
      ,
      • Harding R.
      • Carrasco J.M.
      • Serrano-Pons J.
      • et al.
      Design and Evaluation of a Novel Mobile Phone Application to Improve Palliative Home-Care in Resource-Limited Settings.
      ]; 19% for information management [
      • Woods L.
      • Duff J.
      • Roehrer E.
      • et al.
      Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart.
      ,
      • Neuhauser L.
      • Kreps G.L.
      • Morrison K.
      • et al.
      Using design science and artificial intelligence to improve health communication: ChronologyMD case example.
      ,
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Austin L.
      • Sharp C.
      • Veer S.V.D.
      • et al.
      Providing 'the bigger picture': benefits and feasibility of integrating remote monitoring from smartphones into the electronic health record: Findings from the Remote Monitoring of Rheumatoid Arthritis (REMORA) study.
      ,
      • Kildea J.
      • Battista J.
      • Cabral B.
      • et al.
      Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design.
      ]; 7% were for decision support [
      • Ravn Jakobsen P.
      • Hermann A.P.
      • Søndergaard J.
      • et al.
      Development of an mHealth Application for Women Newly Diagnosed with Osteoporosis without Preceding Fractures: A Participatory Design Approach.
      ,
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ].
      The majority of the mHealth interventions were designed for adult patients to use. Four were designed for pediatric patients only [
      • Birnie K.A.
      • Nguyen C.
      • Do Amaral T.
      • et al.
      A parent–science partnership to improve postsurgical pain management in young children: Co-development and usability testing of the Achy Penguin smartphone-based app.
      ,
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ,
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ,
      • Ruland C.M.
      • Slaughter L.
      • Starren J.
      • et al.
      Children's contributions to designing a communication tool for children with cancer.
      ], three were designed for parents/caregivers of pediatric patients [
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Strand A.S.
      • Johnsson B.
      • Hena M.
      • et al.
      Developing eHealth in neonatal care to enhance parents' self-management.
      ,
      • Mueller E.L.
      • Cochrane A.R.
      • Moore C.M.
      • et al.
      Title: The Children's Oncology Planning for Emergencies (COPE) Tool: Prototyping with Caregivers of Children with Cancer.
      ], and one was designed for caregivers of adult patients [
      • Harding R.
      • Carrasco J.M.
      • Serrano-Pons J.
      • et al.
      Design and Evaluation of a Novel Mobile Phone Application to Improve Palliative Home-Care in Resource-Limited Settings.
      ].
      All of the interventions included their target audience in the co-design process, and 85% included healthcare professionals to provide either their expert opinion and/or feedback on the intervention that was being developed [
      • Woods L.
      • Duff J.
      • Roehrer E.
      • et al.
      Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart.
      ,
      • Woods L.
      • Cummings E.
      • Duff J.
      • et al.
      Conceptual Design and Iterative Development of a mHealth App by Clinicians, Patients and Their Families.
      ,

      Vilarinho T, Floch J, Stav E. Co-designing a mHealth Application for Self-management of Cystic Fibrosis. In: Bernhaupt R, Dalvi G, Joshi A, K. Balkrishan D, O'Neill J, Winckler M, eds. Human-Computer Interaction – INTERACT 2017. Cham: Springer International Publishing; 2017:3-22.

      ,
      • Song T.
      • Yu P.
      • Bliokas V.
      • et al.
      A Clinician-Led, Experience-Based Co-Design Approach for Developing mHealth Services to Support the Patient Self-management of Chronic Conditions: Development Study and Design Case.
      ,
      • Siek K.A.
      • Ross S.E.
      • Khan D.U.
      • et al.
      Colorado Care Tablet: the design of an interoperable Personal Health Application to help older adults with multimorbidity manage their medications.
      ,
      • Siek K.A.
      • Khan D.U.
      • Ross S.E.
      • et al.
      Designing a personal health application for older adults to manage medications: a comprehensive case study.
      ,
      • Ravn Jakobsen P.
      • Hermann A.P.
      • Søndergaard J.
      • et al.
      Development of an mHealth Application for Women Newly Diagnosed with Osteoporosis without Preceding Fractures: A Participatory Design Approach.
      ,
      • Neuhauser L.
      • Kreps G.L.
      • Morrison K.
      • et al.
      Using design science and artificial intelligence to improve health communication: ChronologyMD case example.
      ,
      • Fiordelli M.
      • Zanini C.
      • Amann J.
      • et al.
      Selecting Evidence-Based Content for Inclusion in Self-Management Apps for Pressure Injuries in Individuals With Spinal Cord Injury: Participatory Design Study.
      ,
      • Cheng C.F.
      • Werner N.E.
      • Doutcheva N.
      • et al.
      Codesign and Usability Testing of a Mobile Application to Support Family-Delivered Enteral Tube Care.
      ,
      • Birnie K.A.
      • Nguyen C.
      • Do Amaral T.
      • et al.
      A parent–science partnership to improve postsurgical pain management in young children: Co-development and usability testing of the Achy Penguin smartphone-based app.
      ,
      • Austin L.
      • Sharp C.
      • Veer S.V.D.
      • et al.
      Providing 'the bigger picture': benefits and feasibility of integrating remote monitoring from smartphones into the electronic health record: Findings from the Remote Monitoring of Rheumatoid Arthritis (REMORA) study.
      ,
      • Anderson J.N.
      • Krukowski R.A.
      • Paladino A.J.
      • et al.
      THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care.
      ,
      • Amann J.
      • Fiordelli M.
      • Scheel-Sailer A.
      • et al.
      Opportunities and Challenges of a Self-Management App to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Qualitative Study.
      ,
      • Amann J.
      • Fiordelli M.
      • Brach M.
      • et al.
      Co-designing a Self-Management App Prototype to Support People With Spinal Cord Injury in the Prevention of Pressure Injuries: Mixed Methods Study.
      ,
      • Strand A.S.
      • Johnsson B.
      • Hena M.
      • et al.
      Developing eHealth in neonatal care to enhance parents' self-management.
      ,
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ,
      • Nielsen C.
      • Agerskov H.
      • Bistrup C.
      • et al.
      User involvement in the development of a telehealth solution to improve the kidney transplantation process: A participatory design study.
      ,
      • Mueller E.L.
      • Cochrane A.R.
      • Moore C.M.
      • et al.
      Title: The Children's Oncology Planning for Emergencies (COPE) Tool: Prototyping with Caregivers of Children with Cancer.
      ,
      • Miller M.
      • Roxburgh C.S.
      • McCann L.
      • et al.
      Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery.
      ,
      • Lipson-Smith R.
      • White F.
      • White A.
      • et al.
      Co-Design of a Consultation Audio-Recording Mobile App for People With Cancer: The SecondEars App.
      ,
      • Harding R.
      • Carrasco J.M.
      • Serrano-Pons J.
      • et al.
      Design and Evaluation of a Novel Mobile Phone Application to Improve Palliative Home-Care in Resource-Limited Settings.
      ,
      • Kildea J.
      • Battista J.
      • Cabral B.
      • et al.
      Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design.
      ]. Figure 2 describes the relationship between the target audience of the mHealth intervention, and which stakeholders were included in the co-design process. Although healthcare professionals were not meant to be the primary users of an intervention, they were always involved in collaborating with patients in their care via the mHealth designed, thus considered as users of the intervention to different extents.
      Fig. 2
      Fig. 2Target audiences of mHealth intervention vs. stakeholders involved in co-design
      The cells highlighted in green correspond to those studies where the target users were included as stakeholders in the process of co-design. The cells highlighted in yellow indicate other stakeholders included in the process of co-design, who were not the target audience. Cells highlighted in red show target audience that were not included in co-design. Studies demarcated by an asterisk are those that focused on pediatric populations.
      Fig. 2
      Fig. 2Target audiences of mHealth intervention vs. stakeholders involved in co-design
      The cells highlighted in green correspond to those studies where the target users were included as stakeholders in the process of co-design. The cells highlighted in yellow indicate other stakeholders included in the process of co-design, who were not the target audience. Cells highlighted in red show target audience that were not included in co-design. Studies demarcated by an asterisk are those that focused on pediatric populations.

      Frameworks Used to Inform the Process of Co-Design

      A number of pre-existing frameworks or methods were used across the studies to inform their co-design protocols (Table 1).
      Table 1Frameworks used to inform co-design protocols
      FrameworkDescriptionStudies Referencing
      Medical Research Council (MRC) framework for developing and evaluating complex interventions (Skivington et al., (2021))Consists of four phases: 1) development or identification of the intervention, 2) feasibility, 3) evaluation and 4) implementation. A list of core elements (considering context, developing and refining programme theory, engaging stakeholders, identifying key uncertainties, refining the intervention and economic considerations) require consideration at each of the phases, prior to moving onto the next.Miller et al. (2020)

      Strand et al. (2021)

      Song et al. (2021)

      Harding et al. (2021)
      Participatory design (PD) method (Clemensen et al., (2016))Nielsen et al. present PD as consisting of three phases: 1) Identification of needs, 2) Design and Development and 3) Testing and evaluation in clinical practice. PD is iterative, and depends on reflection of previous phases. Jakobsen et al. present PD as consisting of four ongoing and parallel activities: literature search, design and development, user activities and field studies.Nielsen et al. (2020)

      Ravn Jakobsen et al. (2018)
      Design Council’s Double Diamond Model

      28. Framework for Innovation: Design Council's evolved Double Diamond [

      Framework for Innovation: Design Council's evolved Double Diamond.

      ].
      This model consists of four phases: 1) Discover, 2) Define, 3) Develop and 4) Deliver. The double diamond depicts the design process to consist of divergent thinking, in order to generate more ideas, followed by convergent thinking, to synthesize the ideas that were generated. The first diamond corresponds to exploring and defining the problem or challenge that is being tackled, and the second relates to exploring and refining a solution. The design process described by the Double Diamond Model is iterative and encourages collaboration.Miller et al. (2020)
      Hevner’s Design Science Research Cycles (Hevner, (2007))Consist of three cycles: 1) design, 2) relevance (consisting of context-specific inputs from the environment), and 3) rigor (incorporating theories and methods from existing knowledge base). Relevance and rigor cycle results are then incorporated into and refined iteratively in the design cycle.Woods et al. (2019)
      Stanford University’s Design Thinking Process of InnovationA 5-stage process, consisting of 1) empathizing with stakeholders, 2) defining healthcare challenges, 3) ideating possible solutions, 4) creating a rapid prototype and 5) testing with end-users.Woods et al. (2019)
      Other studies mentioned being guided by theory in design science [
      • Neuhauser L.
      • Kreps G.L.
      • Morrison K.
      • et al.
      Using design science and artificial intelligence to improve health communication: ChronologyMD case example.
      ], rapid iterative testing and evaluation (RITE) (discussing problems and fixing them between sessions) [
      • Siek K.A.
      • Ross S.E.
      • Khan D.U.
      • et al.
      Colorado Care Tablet: the design of an interoperable Personal Health Application to help older adults with multimorbidity manage their medications.
      ,
      • Siek K.A.
      • Khan D.U.
      • Ross S.E.
      • et al.
      Designing a personal health application for older adults to manage medications: a comprehensive case study.
      ], immediate data analysis (similar to RITE, but problems being fixed at the end of the day, potentially after a few sessions) [
      • Siek K.A.
      • Ross S.E.
      • Khan D.U.
      • et al.
      Colorado Care Tablet: the design of an interoperable Personal Health Application to help older adults with multimorbidity manage their medications.
      ,
      • Siek K.A.
      • Khan D.U.
      • Ross S.E.
      • et al.
      Designing a personal health application for older adults to manage medications: a comprehensive case study.
      ] and consensus methods [
      • Fiordelli M.
      • Zanini C.
      • Amann J.
      • et al.
      Selecting Evidence-Based Content for Inclusion in Self-Management Apps for Pressure Injuries in Individuals With Spinal Cord Injury: Participatory Design Study.
      ]. Ruland et al. [
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ,
      • Ruland C.M.
      • Slaughter L.
      • Starren J.
      • et al.
      Children's contributions to designing a communication tool for children with cancer.
      ] informed their protocol with Druin’s “The design of children’s technology” [

      The design of children's technology. Morgan Kaufmann Publishers Inc.; 1998.

      ].

      Steps and Methods of Co-Design

      The big “principal” steps that were recurrent among the included studies were: needs identification via stakeholder interviews, background research, literature review, prototype design, feedback and testing. Studies presented different methods for each of these steps, and the feedback and testing step was often iterative, occurring in multiple rounds of back and forth feedback between stakeholders and developers. Figure 3 shows the key recurrent steps, as well as the predominant methods employed to solicit stakeholder participation, together with the quality appraisal score of the study.
      Fig. 3
      Fig. 3Stakeholder Participation across the different steps and methods used in co-design
      Heat map of the most common steps of co-design observed across studies along with the quality appraisal score of each study. Dark green indicates steps that were commonly used in studies with high quality appraisal scores. Red indicates steps that were uncommon, with a low quality appraisal score. Studies marked with an asterisk correspond to those with pediatric focus.
      Fig. 3
      Fig. 3Stakeholder Participation across the different steps and methods used in co-design
      Heat map of the most common steps of co-design observed across studies along with the quality appraisal score of each study. Dark green indicates steps that were commonly used in studies with high quality appraisal scores. Red indicates steps that were uncommon, with a low quality appraisal score. Studies marked with an asterisk correspond to those with pediatric focus.

      mHealth Intervention Outcomes

      Several strengths and limitations were identified throughout the included studies, relating to the use of co-design in mHealth development.
      Co-designed mHealth interventions empowered end-users, increasing their satisfaction, ability to manage the condition the intervention related to, and amplifying their participation in their care. Those considering the diversity of end-users conceived results that are more representative of the general public.
      However, the process of co-design highlighted the need for a facilitator due to several limitations, as well as potential challenges to generalizability due to small sample sizes.
      The distribution of studies and the strengths and limitations identified through the process of co-design can be found in Figure 4 and 5.
      Fig. 4
      Fig. 4Strengths of co-design reported across the included studies
      Green highlighted cells correspond to strengths. Blank boxes indicate that a given item was not reported. Studies demarcated by an asterisk are those that focused on pediatric populations.
      Fig. 4
      Fig. 4Strengths of co-design reported across the included studies
      Green highlighted cells correspond to strengths. Blank boxes indicate that a given item was not reported. Studies demarcated by an asterisk are those that focused on pediatric populations.
      Fig. 5
      Fig. 5Limitations of co-design reported across the included studies. Red highlighted cells correspond to limitations reported in each study. Blank boxes that a given item was not reported. Studies demarcated by an asterisk are those that focused on pediatric populations.
      Fig. 5
      Fig. 5Limitations of co-design reported across the included studies. Red highlighted cells correspond to limitations reported in each study. Blank boxes that a given item was not reported. Studies demarcated by an asterisk are those that focused on pediatric populations.

      Discussion

      This review highlights that co-design is heterogenous and there is no “one size fits all” approach. A diversity of methods and strategies should be adopted that are best suited for a given project, population or goal of co-design, to ensure maximum participation from stakeholders.
      User empowerment, increased stakeholder diversity, addressing the needs of all users and leveraging their experiences allow researchers to gather unique insights and address limitations of the mHealth intervention. Co-design promotes patient engagement, which is especially important for intervention usability. Involving stakeholders throughout the entire design process yields mHealth interventions that have high uptake and usability. The inclusion of a facilitator (e.g., lead user, patient partner, or physician-patient liaison) throughout the co-design process resulted in significant improvement in collaboration and helped alleviate limitations by reducing hierarchy between patients and physicians. Despite this, limitations do remain and need to be addressed independently.
      This rapid review is a first step in understanding how co-design is currently used in the development of mHealth applications that promote collaborative care. More interestingly, the review has also provided insight into how children are being engaged into co-designing pediatric mHealth interventions. The results from the review will be used to develop a framework to guide the co-design of a pediatric mHealth intervention.

      The Rise of Co-Design in mHealth

      Co-design and the use of mHealth interventions in healthcare have become areas of increased interest and research [
      • Cao J.
      • Lim Y.
      • Sengoku S.
      • et al.
      Exploring the Shift in International Trends in Mobile Health Research From 2000 to 2020: Bibliometric Analysis.
      ,
      • Ward M.E.
      • De Brún A.
      • Beirne D.
      • et al.
      Using Co-Design to Develop a Collective Leadership Intervention for Healthcare Teams to Improve Safety Culture.
      ]. The earliest included study was published in 2007, but most studies included in this review were published after 2018, paralleling the increased popularity and prioritization of patient-centered care [
      • Engle R.L.
      • Mohr D.C.
      • Holmes S.K.
      • et al.
      Evidence-based practice and patient-centered care: Doing both well.
      ,
      • Sanz M.F.
      • Acha B.V.
      • García M.F.
      Co-Design for People- Centred Care Digital Solutions: A Literature Review.
      ]. Engaging patients, their caregivers, and healthcare professionals through co-design will create mHealth solutions that address their needs and are acceptable to them, promoting a patient-centered approach [
      • Butler J.M.
      • Gibson B.
      • Patterson O.V.
      • et al.
      Clinician documentation of patient centered care in the electronic health record.
      ].

      Reporting Guidelines and Systematic Evaluation of Co-Design Studies

      A recurrent theme in the included studies was the lack of published guidelines to inform the process of co-design. Although some studies were informed by previously described frameworks, none of them were specific to the co-design of an mHealth intervention. This resulted in variable protocols employing different methods for co-design. The process of co-design needs more standardization to improve reproducibility. This does not imply that there is a one-size fits all methodology to engaging in meaningful and effective co-design. A variety of methods should be employed to best achieve the goal, and to ensure meaningful engagement of all stakeholders.
      The reproducibility and standardization of co-design may be improved by systematic reporting and evaluation of co-design protocols. The current level of reporting on co-design processes is poor [
      • Eyles H.
      • Jull A.
      • Dobson R.
      • et al.
      Co-design of mHealth Delivered Interventions: A Systematic Review to Assess Key Methods and Processes.
      ]. Standardized reporting on the process of co-design, including elements such as how it was informed, the methods employed, and the outcomes of engaging in co-design, may be achieved through the development of reporting guidelines or checklists. Such tools may also result in easier evaluation of co-design, along with the use of validated evaluation tools. Despite growing in popularity, co-design strategies lack evaluation [
      • Slattery P.
      • Saeri A.K.
      • Bragge P.
      Research co-design in health: a rapid overview of reviews.
      ]. Evaluating the process of co-design is crucial in gauging what is effective and what may be omitted. This, in turn, may inform the development of evidence-based guidelines for how to efficiently engage in co-design.

      Addressing the Digital Divide

      Digital divide is an important factor to consider in mHealth, referring to the ability of an individual to access digital tools along with their ability to comprehend, navigate and utilize them [
      • Wang X.
      • Shi J.
      • Lee K.M.
      The Digital Divide and Seeking Health Information on Smartphones in Asia: Survey Study of Ten Countries.
      ]. Studies have previously found that despite higher rates of smartphone ownership across various demographics, disparities in digital literacy continue to exist, associated with social determinants of health such as a lower socioeconomic status [
      • Czaja S.J.
      • Sharit J.
      • Lee C.C.
      • et al.
      Factors influencing use of an e-health website in a community sample of older adults.
      ]. In the rising age of mHealth, it is important to design tools with widespread accessibility, to avoid increasing the disparity in access to evidence-based healthcare.
      Ensuring representative diversity in the stakeholders included in the co-design process is necessary to ensure a variety of perspectives throughout. Co-design, in itself, does not ensure diversity in participation. A variety of meaningful and varied engagement strategies should be employed, accounting for individual needs, to mitigate intervention-generated inequalities and loss of participation. It is also important to consider that despite engaging with a diverse group of stakeholders, the intervention will ultimately only reflect their preferences and opinions.
      In the context of mHealth, the development of tools and strategies to facilitate user onboarding should be a priority. A few of the studies recommended having a “lead end-user” that could guide others engaging in the process of co-designing or testing a co-designed mHealth intervention. Clear tutorials, included in the intervention or provided separately, may also help users orient themselves in the intervention. Designing interventions such that they may be available widely on a variety of platforms, or being able to provide patients with the necessary platform to access the intervention, are also possible solutions to combat digital divide [
      • Eyrich N.W.
      • Andino J.J.
      • Fessell D.P.
      Bridging the Digital Divide to Avoid Leaving the Most Vulnerable Behind.
      ].

      Sparsity of Pediatric Interventions

      This rapid review was performed to inform the future development of a pediatric surgery mHealth intervention. However, study selection criteria were not restricted to only include pediatric mHealth interventions, to increase the number of studies that would be included. Of the 27 included studies, only 7 were mHealth interventions designed either for pediatric patients, or their caregivers. Despite this scarcity, we found that both adult and pediatric populations shared the key steps involved in co-design. These include pre-design activities, such as needs identification, design and development activities which includes methods such as mock-ups and storyboarding, and feedback and testing. Co-design in pediatric populations is subject to unique considerations. These studies were unique, as they included children in co-design, resulting in idea generation that researchers of caregivers had not thought of. Children also changed the nature of interactions and development, sometimes lacking a feasible grasp on logical design. In these cases, caregivers, researchers and professional designers were able to determine feasibility.
      Despite an increase in the use of interactive technology amongst children, there is a lack of pediatric mHealth interventions [
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ]. Designing an mHealth intervention for pediatric populations remains a challenge [
      • Niksch A.L.
      mHealth in pediatrics-finding healthcare solutions for the next generation.
      ], even without the additional layer of complexity co-design brings. It is suggested that the process of co-design should remain flexible, especially in regards to content selection, to prevent children that are ill from facing the nature of their illness [
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ]. The developed mHealth intervention should be “easy to use, and not too cognitively or emotionally-demanding” [
      • Ruland C.M.
      • Starren J.
      • Vatne T.M.
      Participatory design with children in the development of a support system for patient-centered care in pediatric oncology.
      ]. In one of the included studies, where the participating children were not very verbal, observations made by the researchers working with the children were taken into account as feedback [
      • Birnie K.A.
      • Nguyen C.
      • Do Amaral T.
      • et al.
      A parent–science partnership to improve postsurgical pain management in young children: Co-development and usability testing of the Achy Penguin smartphone-based app.
      ]. This is an important consideration, as children need to adapt to the environment they are placed in, and to interactions with new facilitators [
      • Stålberg A.
      • Sandberg A.
      • Söderbäck M.
      • et al.
      The child's perspective as a guiding principle: Young children as co-designers in the design of an interactive application meant to facilitate participation in healthcare situations.
      ]. Building a relationship of trust and familiarity with facilitators, as well as engaging children in environments they are familiar with, may elicit more participation.
      The mHealth interventions described in the included studies focussed on collecting information from children in a manner that was translatable to the clinician or caregiver. Primarily, they provided a channel for the child to communicate their feelings (physical or cognitive). Tools like these allow children to express and interact with their healthcare providers, resulting in their empowerment in the context of their own care [
      • D'Alessandro D.M.
      • Dosa N.P.
      Empowering Children and Families With Information Technology.
      ]. To maintain translatability, the information that is intended to be collected from the interaction of a pediatric patient with the mHealth intervention should be simple.
      Future research involving children in co-design needs to ensure the content being co-designed is chosen with sensitivity to the child’s condition and developmental stage. Simple functions and plain language should be favored. Observation of children’s behavior and expression is also essential to capture feedback that is not expressed through words.

      Limitations

      These findings must be interpreted in the context of some limitations. We may have missed relevant non-English papers or those that were not available in the databases used for this review, although we employed snowballing to maximize the yield of informative papers. Moreover, the inclusion criteria were very specific, due to the overarching purpose of the review, which resulted in the exclusion of studies that described the co-design of mHealth interventions that did not actively allow for collaboration of care, as well as of general reviews on co-design. Given the variety of co-design applications that have been published, we deemed that focussing on a specific context would yield more significant results for the future development of a pediatric surgical intervention. The purpose of the intervention a study reported on was categorized based on the authors’ interpretation. To reduce risk of subjectivity during data extraction, the study relied on two independent reviewers and a third “tie-breaker”. Moreover, any developmental steps or frameworks that were mentioned in the results were concretely found in the studies themselves.

      Conclusion

      The use of co-design and the development of mHealth interventions are growing exponentially, with a focus on promoting patient-centered care. Co-design provides a multitude of benefits when designing, developing and implementing mHealth applications. However, it is important to find strategies to alleviate the limitations that come with it. Co-design is variable in nature and requires more standardization, reporting and evaluation. Although there is no “one-size fits all” solution, and methods should be tailored to the goal of co-design and stakeholders involved, future research, development of evaluation and reporting protocols needs to focus on specific applications of co-design. The results of this review demonstrate a clear need for more focus on research and mHealth development in the field of pediatrics, especially pediatric surgery.
      The results of this rapid review will guide the future development of a pediatric surgery mHealth intervention.

      Appendix A. Supplementary data

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