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Study Protocol

Design and development of an eHealth intervention to support self-management in people with musculoskeletal disorders - ‘eHealth: It’s TIME’: a study protocol

[version 1; peer review: 2 approved with reservations]
PUBLISHED 14 Nov 2022
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Abstract

Background: Musculoskeletal disorders (MSDs) are a leading cause of global morbidity, with the burden expected to increase in the near future. Self-management, with the support of healthcare professionals, is recommended for many MSDs. However, frequent clinical contact is not feasible. Previous research has highlighted the need for a co-designed eHealth-mediated self-management follow-up support intervention which integrates remote monitoring and behavioural change. Thus, the current study aims to develop and design a user-centred, eHealth-mediated self-management support prototype for people with MSDs.
Methods: A three-step, iterative system development cycle will be utilised to develop and design the “eHealth: It’s TIME prototype”. The three-step process will include creating website features and content using two sequential focus groups with people with MSDs (n = 6 – 8); heuristic testing using the 10 heuristic principles of Nielsen (n = 5); and usability testing through in-person 60-minute interviews with people with MSDs (n = 3 – 5) and musculoskeletal physiotherapists (n = 3 – 5).
Conclusion: The eHealth: It’s TIME prototype will be a systematically developed, follow-up self-management support intervention guided by behavioural change theory and the preferences of end users.

Keywords

eHealth, self-management, intervention development, musculoskeletal pain, user-centred design approach

Introduction

Globally, musculoskeletal disorders (MSDs) are the leading contributor to the need for rehabilitation1, with this intervention essential in maximising a person’s function and quality of life2. Despite these individual and societal benefits, rehabilitation services remain under-resourced, and this, together with the high demand for such services, has created an enormous musculoskeletal (MSK) care gap1. While this divide continues to widen, solutions to this challenge are urgently needed3; solutions which deliver person-centred care and empower people with MSDs to self-manage their condition are critical3.

eHealth interventions are increasingly being viewed as the answer to improving MSK care access and supporting self-management46. However, while their use has been growing, with the coronavirus disease 2019 (COVID-19) pandemic being seen as a significant catalyst7, sustaining this has remained elusive8. A lack of user (i.e. people with MSDs) involvement is considered a major contributing factor to this9, resulting in usability issues and high dropout rates, and ultimately eHealth interventions that are “high tech-with-a-low impact”1014.

A recent scoping review reported only 22% (14/63) of the 63 eHealth-mediated self-management support interventions were co-designed15, despite numerous calls to utilise a more user-centred design approach1618. User-centred design is an approach that involves users in the development and decision-making process19, resulting in interventions which demonstrate greater effectiveness, satisfaction and usability than traditionally developed (i.e., linear, often top-down) interventions20.

This study is part of a larger project, ‘eHealth: It’s TIME’, which aims to develop an eHealth-mediated self-management support intervention for people with MSDs. For development processes and eHealth interventions to be successful, a holistic focus, encompassing the habits and rituals of the end users, intervention setting and context, is required14,21. This involves identifying barriers and facilitators and exploring implementation challenges at the intervention planning stage22,23. Hence, this study is informed by our earlier research utilising a systematic scoping approach to chart the current literature base15 and establish stakeholder perceptions towards eHealth-mediated self-management support for people with MSDs24. People with MSDs and MSK physiotherapists reported concerns about assessment and diagnosis and establishing a therapeutic relationship and felt that eHealth interventions may be best reserved for follow-up care24. Considering these findings, this study in the ‘eHealth: IT’s TIME’ project aims to co-develop and design a prototype of an intervention that facilitates follow-up self-management support via integrated remote monitoring and behavioural change. This work will likely contribute to the development and design of a more easy-to-use, worthwhile intervention that can potentially improve treatment outcomes for people living with MSDs14,17,25. The ‘eHealth: It’s TIME’ project is guided by the Medical Research Council (MRC) framework26 and the CeHReS (Center for eHealth Research) Roadmap14,27.

Methods

Study aims

The present study aims to systematically develop and design a user-centred web-based prototype for adults with MSDs to enhance follow-up self-management support via integrated remote monitoring and behavioural change

Study design

The eHealth: It's TIME prototype will be co-developed and designed using a three-step system development cycle28,29 which includes the creation of website features and content (Step 1); heuristic testing (Step 2); and usability testing (Step 3) (Figure 1). The CeHRes Roadmap14 will inform the development and design process of the eHealth-mediated follow-up self-management support intervention. This evidence-based roadmap14 provides practical guidance on how to execute the participatory eHealth development process, fulfilling the MRC framework criteria26, with the latter framework providing limited information on how to design complex interventions30.

8ae2a451-f247-4848-bcd1-bb617bee6f59_figure1.gif

Figure 1. Study overview.

The CeHRes Roadmap has been utilised for eHealth development in numerous settings3134 and complex contexts14, such as MSK healthcare. This study relates to the development and design of an eHealth intervention, with emphasis on the first three phases of the Roadmap: contextual inquiry, value specification and design.

Ethical approval has been granted by the Clinical Research Ethics Committee (CREC) of the Cork Teaching Hospitals (REF: ECM 4 (f) 20/09/2022). The study will be performed in accordance with the Declaration of Helsinki.

Step 1: Creation of website features and content

Study participants

Using purposive sampling, individuals with a MSD will be eligible to participate in this study if they are English speaking (judged by researcher MK during pre-interview communication); 18 years or older; and able to provide informed consent. Participants with pain of specific pathological origin (e.g. infection, malignancy, inflammatory disease or fracture); those that are pregnant; or have had surgery within the past six months; will be excluded. Initial eligibility screening for individuals with a MSD will be undertaken through the online platform Qualtrics. For those that do not have access to a computer or the internet, the screening will be conducted via post.

Recruitment

Individuals with MSDs will be recruited through various methods:

  • Primary and secondary care: The researcher MK will email physiotherapy managers and General Practices in Cork City outlining the details of the study and request that information about the study be circulated to all their staff to distribute to their patients with a MSD. A poster for display in waiting rooms will be included. At one hospital site (Mercy University Hospital), potential participants will be identified by MSK physiotherapy staff. Eligibility screening will be completed by the researcher (MK). Potentially eligible participants will be informed about the study by the lead researcher (MK) and will receive a participant information leaflet. Following a reflection period of 24h, the researcher will telephone the individual with the MSD to confirm their interest in participation.

  • Professional Organisation: The call for participants along with the poster will be sent to physiotherapists via the Irish Society of Chartered Physiotherapists (ISCP) mailing list.

  • Patient support groups: An email request will also be sent out to people with MSDs via gatekeepers in Arthritis Ireland and Chronic Pain Ireland.

  • University staff: An email request will also be sent out to all academic, research and administrative staff in UCC, targeting those with a MSD via a gatekeeper.

  • Social media: The study will also be advertised on social media (Twitter). Interested participants will be asked to contact the researcher MK.

Those with access to email that express interest in the study will be sent a participant information leaflet, and a Qualtrics link to the Consent form. For those that do not have access to a computer or the internet, the participant information leaflet and consent form will be sent via post with a prepaid return envelope.

Procedures

Questionnaires

Before the focus group, participants with a MSD will complete two questionnaires via Qualtrics: (1) demographic details and (2) the eHealth Literacy Scale (eHEALS). The eHEALS is an eight-item self-report measure assessing individuals’ perceived ability to locate, evaluate, and apply eHealth information35. The overall scores range from 8 to 40, with higher scores indicating higher self-perceived levels of eHealth literacy35.

Focus Groups

Two sequential focus groups, involving between six and eight participants, will be facilitated by MK (lead researcher) to elicit users’ views and preferences regarding the proposed features. Focus groups are considered an appropriate method for informing intervention development36. The focus groups will take place in person but can be held remotely if necessary (e.g., for COVID health and safety reasons) via Microsoft Teams. Each focus group is expected to last 60 minutes. In situations where non-attendance or scheduling difficulties occur, one-to-one interviews will be conducted utilising the same topic guide. At the outset of each focus group interview, informed consent will be re-confirmed orally, and audio-recorded digitally.

Following the scoping review15 and qualitative study24, a list of the individual with a MSD’s needs and requirements was formulated. Proposed eHealth intervention prototype elements to meet these needs will be built prior to the first focus group. While building these elements, the Web Content Accessibility Guidelines37 will be followed, making content accessible to a wider range of people with disabilities38. Microsoft Office software will be utilised to ensure readability recommendations are met (i.e., grade 6 or less on the Flesch-Kincaid Grade Level)39.

Focus Group 1

This focus group will review paper prototypes of the visual feature concepts and the prioritised elements to be developed in further detail for the click-through prototype. Participants will utilise Monopoly Money to determine the value of the individual features. Questions will address adoption, accessibility, and overall strengths/weaknesses of the key features (Appendix A, Extended data).

Focus Group 2

This focus group will review the initial clickable prototype, with participants being asked to provide feedback on the proposed functional elements and website pages. Questions will focus on functional elements (e.g., checkboxes, drag and drop, and tailored features) and individual webpage presentation (e.g., missing items and clarity; Appendix B, Extended data). The interview guides for both focus groups will continue to be refined iteratively by research team members, software developers, and graphic designers.

Analysis

The focus groups will be audio recorded, transcribed verbatim and imported into NVivo40. The lead researcher (MK) will complete a descriptive synthesis of the monopoly activity and focus group transcripts. The research team (MK, BF, DM, CB, BO’M & JMcV) will then review these findings, and refine the prototype as indicated.

Step 2: Heuristic testing

Five reviewers (a panel composed of three research team members, one graphic designer and one software developer) will evaluate the refined prototype on a computer and mobile device based on the 10 heuristic principles of Nielsen41. The areas of focus will include search, navigation, forms and data entry, information architecture, writing and content quality, trust and credibility, page layout and visual design.

The reviewers will independently rate each website page using the following criteria: +1 (complies), -1 (does not comply), or 0 (partially complies). Reviewers will provide comments to justify their scoring. For items deemed not relevant, reviewers will be advised to note ‘not applicable’. The reviewers will meet to discuss the ratings and reach a consensus regarding the items to be addressed before usability testing.

Step 3: Usability testing

Study participants

Participants involved in one-to-one interviews will include both individuals with a MSD and MSK physiotherapists.

Individuals with a MSD: Purposive sampling, using the same eligibility criteria and recruitment strategy will be used as described in Step 1. Potential participants will be naïve to the development of the eHealth intervention. Given approximately 80% of usability problems can be identified using a sample of three to five users42, we will recruit this number of individuals with a MSD42.

MSK Physiotherapists: A purposive sampling strategy will also be utilised for MSK physiotherapists. Physiotherapist eligibility criteria include physiotherapists working predominantly in the area of MSK therapy (at least 50% of their time) in either the public or private health setting. To recruit MSK physiotherapists working in the public sector, the researcher MK will contact physiotherapy managers, gatekeepers at these sites, to outline the details of the study; provide a participant information leaflet; and request that an email invitation is sent to all their staff. Email invitations will also be sent out via the ISCP mailing list. The study will also be advertised on social media (Twitter).

Interested participants will be asked to contact the researcher (MK). Those with access to email will be sent a participant information leaflet and consent form. For those that do not have access to a computer or the internet, the participant information leaflet and consent form will be sent via post with a prepaid return envelope. Three to five MSK physiotherapists will be recruited42.

Procedures

Questionnaires

Prior to the interviews, participants will complete the two questionnaires as outlined in Step 1. At the end of the interview, participants will complete the System Usability Scale (SUS) to evaluate user satisfaction43, with this validated questionnaire the most frequently utilised within usability testing44.

Interviews

The lead researcher (MK) will conduct the in-person one-to-one 60-minute interviews to identify problems with the prototype interface and paths and strategies that participants utilise, including time spent completing tasks. Participants will be interviewed in a private room within the university using their preferred devices (i.e., mobile phone, tablet, laptop and desktop) to review the prototype. At the outset of each interview, informed consent will be re-confirmed orally, and audio-recorded digitally.

Five usability scenarios for both people with a MSD (Appendix C, Extended data) and MSK physiotherapists (Appendix D, Extended data) have been developed by the research team, software developer and graphic designer. These scenarios will continue to be refined iteratively, as the prototype itself is refined. During the interview, participants will review the relevant five scenarios utilising the think-aloud method (i.e. participants think out aloud while performing a given task)45 and will respond to a series of open-ended questions about the interface, content, features, and format46. The think-aloud method is the most commonly utilised qualitative method of usability testing in eHealth intervention development44, effective in exploring end-users' attitudes towards eHealth interventions29,47.

Analysis

Interviews will be audio recorded and transcribed verbatim. The interview transcripts will be analysed utilising directed content analysis by MK applying a deductive approach to categorise what was useful and the areas to enhance48. This list will then be utilised by software developers to further refine the eHealth: It’s TIME intervention prototype, with this iterative approach recommended49,50.

Conclusions

eHealth interventions show potential in supporting self-management of people with MSDs. This study aims to develop and design an eHealth-mediated follow-up self-management support prototype for this cohort. It will be guided by the preferences of end-users, utilising a systematic iterative process. Once developed, the next phase of this project will be to complete a feasibility study to identify preliminary patient-reported outcomes (e.g., self-efficacy), to evaluate engagement with and the acceptability of the prototype and potential implementation considerations.

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VERSION 2 PUBLISHED 14 Nov 2022
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Kelly M, Fullen B, Martin D et al. Design and development of an eHealth intervention to support self-management in people with musculoskeletal disorders - ‘eHealth: It’s TIME’: a study protocol [version 1; peer review: 2 approved with reservations]. HRB Open Res 2022, 5:73 (https://doi.org/10.12688/hrbopenres.13611.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 14 Nov 2022
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Reviewer Report 18 Jul 2023
Ingris Pelaez-Ballestas, Hospital General de Mexico Dr Eduardo Liceaga, Mexico City, Mexico City, Mexico 
Approved with Reservations
VIEWS 37
I appreciate the opportunity to review this interesting and novel protocol “Design and development of an eHealth intervention to support self-management in people with musculoskeletal disorders-eHealth: It´s TIME: a study protocol”. Its implementation will provide support to health professionals and ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Pelaez-Ballestas I. Reviewer Report For: Design and development of an eHealth intervention to support self-management in people with musculoskeletal disorders - ‘eHealth: It’s TIME’: a study protocol [version 1; peer review: 2 approved with reservations]. HRB Open Res 2022, 5:73 (https://doi.org/10.21956/hrbopenres.14880.r34398)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 29 Nov 2023
    Marie Kelly, Discipline of Physiotherapy, University College Cork, Cork, Ireland
    29 Nov 2023
    Author Response
    Thank you Ingris for your time in reviewing our protocol. We appreciate all your comments and suggested changes. We have addressed the points you raised and amended the protocol accordingly.
    ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 29 Nov 2023
    Marie Kelly, Discipline of Physiotherapy, University College Cork, Cork, Ireland
    29 Nov 2023
    Author Response
    Thank you Ingris for your time in reviewing our protocol. We appreciate all your comments and suggested changes. We have addressed the points you raised and amended the protocol accordingly.
    ... Continue reading
Views
54
Cite
Reviewer Report 27 Mar 2023
Sara Lundell, Department of Sociology, Umea Universitet, Umeå, Västerbotten County, Sweden 
Approved with Reservations
VIEWS 54
This is a well-written protocol for a study with the aim to develop and design an eHealth self-management support for people with musculoskeletal disorders. The study will be conducted in three steps; 1) creation of website features and content with ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Lundell S. Reviewer Report For: Design and development of an eHealth intervention to support self-management in people with musculoskeletal disorders - ‘eHealth: It’s TIME’: a study protocol [version 1; peer review: 2 approved with reservations]. HRB Open Res 2022, 5:73 (https://doi.org/10.21956/hrbopenres.14880.r33542)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 29 Nov 2023
    Marie Kelly, Discipline of Physiotherapy, University College Cork, Cork, Ireland
    29 Nov 2023
    Author Response
    Thank you Sara for your time in reviewing our protocol. We appreciate all your comments and suggested changes. We have addressed the points you raised and amended the protocol accordingly.
    ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 29 Nov 2023
    Marie Kelly, Discipline of Physiotherapy, University College Cork, Cork, Ireland
    29 Nov 2023
    Author Response
    Thank you Sara for your time in reviewing our protocol. We appreciate all your comments and suggested changes. We have addressed the points you raised and amended the protocol accordingly.
    ... Continue reading

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 14 Nov 2022
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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