PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study

Delphi, consensus, paediatric, paediatric rheumatology, rheumatology, healthcare technologies, technology enabled care, digital ALL Metrics - Views Downloads How to cite this article Rostron H, Pini S, Galloway A et al. PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.14191.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol [version 1; peer review: 3 approved with reservations] Heather Rostron1,2, Simon Pini3, Adam Galloway1, Anthony Gilbert4, Polly Livermore5,6, Anthony Redmond1,7 Heather Rostron1,2, Simon Pini3, [...] Adam Galloway1, Anthony Gilbert4, Polly Livermore5,6, Anthony Redmond1,7 PUBLISHED 14 Jan 2026 Author details Author details 1 Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, England, LS7 4SA, UK 2 Children's Clinical Research Team, Leeds Teaching Hospitals NHS Trust, Leeds, England, LS1 3EX, UK 3 Psychological and Social Medicine, University of Leeds School of Healthcare, Leeds, England, LS1 3EX, UK 4 Therapies Department, Royal National Orthopaedic Hospital, London, England, HA7 4LP, UK 5 NIHR Great Ormond Street Hospital Biomedical Research Centre, London, England, WC1N 3JH, UK 6 Infection, Immunity & Inflammation Department, University College London, London, England, WC1E 6BT, UK 7 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, Please Select, LS7 4SA, UK 2 Children's Clinical Research Team, Leeds Teaching Hospitals NHS Trust, Leeds, England, LS1 3EX, UK 3 Psychological and Social Medicine, University of Leeds School of Healthcare, Leeds, England, LS1 3EX, UK 4 Therapies Department, Royal National Orthopaedic Hospital, London, England, HA7 4LP, UK 5 NIHR Great Ormond Street Hospital Biomedical Research Centre, London, England, WC1N 3JH, UK 6 Infection, Immunity & Inflammation Department, University College London, London, England, WC1E 6BT, UK 7 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, Please Select, LS7 4SA, UK Heather Rostron Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Simon Pini Roles: Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Adam Galloway Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Anthony Gilbert Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing Polly Livermore Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing Anthony Redmond Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS Children and young people (CYP) cared for in rheumatology services are largely managed in the outpatient environment. Conditions such as Juvenile Idiopathic Arthritis are usually chronic and complex in nature, necessitating input from a range of multidisciplinary healthcare professionals. Technology Enabled Care (TEC) practices in paediatric rheumatology can be varied and may have the potential to better support families and clinical teams in managing rheumatological conditions. CYP people are known to be able users of technology but evidence-driven guidance to maximise the potential for technology enabled care remains limited. Drawing on previous PhD work package findings, the aim of this current project is to develop guidance through a modified Delphi consensus exercise. Findings from previous PhD work packages will be synthesised into a list of statements around the concept of technology enabled care. Following assembly of a Study Advisory Group, stakeholders will be approached to undertake two online modified Delphi technique rounds. For Round 1, stakeholders will indicate their level of perceived importance using a Likert scale, for each statement. Statements not reaching consensus will be voted on again during a second Round. Stakeholders will then vote, in order of priority, on all statements reaching consensus. Descriptive quantitative analyses will be used to describe minimal stakeholder credentials and to demonstrate >75% consensus. The top 10-20 statements will be included in the final guidance. All project risks and benefits have been considered, minimised, and presented as part of the Research Ethics Committee (REC) application to the School of Medicine at the University of Leeds (REC project reference 2550). Project dissemination is planned for traditional routes through appropriate academic journals and paediatric specialty-specific conferences. Further dissemination will take place following ongoing collaboration with Patient and Public representatives. Not applicable Children and young people (CYP) with problems such as arthritis, are mainly cared for from the outpatient department. These CYP often need to be cared for by the multidisciplinary team (MDT) Eg. nurses, doctors, and physiotherapists etc. Technology Enabled Care (TEC) with these CYP can be very different. TEC may have the potential to better support CYP, parents and the MDT to manage CYP’s care better. CYP are known to be able to use technology well, but research to best guide TEC is limited. This is the final part of a PhD. It describes the use of previous results to ask stakeholders (CYP, parents, MDT healthcare professionals, and others), to vote on which results are the most important to be included in future TEC guidance. Previous PhD findings will be brought together into a list of TEC statements. A team representing each stakeholder as described above, will come together to agree which statements should be voted on. Next, a larger number of stakeholders will be asked to vote twice against each statement. For the first time, stakeholders will vote on how important each statement is using a number scale. Statements not reaching consensus will be voted on again for a second time. Finally stakeholders will vote on the priority of each statement that has reached consensus. Statistics will describe stakeholders and show the agreed consensus. The top 10-20 statements will make up the final guidance. All project risks and benefits have been considered, minimised, and given the go-ahead by the School of Medicine Research Ethics Committee at the University of Leeds (SoMREC 2550). The project results will be written up in scientific journals and talked about at conferences to share with colleagues. CYP will be asked how they would like the results to be shared. Delphi, consensus, paediatric, paediatric rheumatology, rheumatology, healthcare technologies, technology enabled care, digital Corresponding Author(s) Heather Rostron ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under a doctoral fellowship awarded to Heather Rostron (Grant Reference Number NIHR302999)]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2026 Rostron H et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Rostron H, Pini S, Galloway A et al. PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.14191.1) First published: 14 Jan 2026, 6:10 (https://doi.org/10.3310/nihropenres.14191.1) Latest published: 14 Jan 2026, 6:10 (https://doi.org/10.3310/nihropenres.14191.1) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Children and young people (CYP) cared for in paediatric rheumatology services often experience inflammatory conditions, with up to two-thirds of these CYP remaining in adult services1,2. Other CYP experience a range of non-inflammatory musculoskeletal conditions. Consequently, CYP can have varying, chronic, painful symptoms, requiring ongoing outpatient management. Often with no cure, many CYP need long-term management with cytotoxic disease-modifying antirheumatic drugs and multi-disciplinary specialist input. CYP’s management can necessitate long travel distances and lead to reduced school and work attendance. One potential method of increasing service efficiencies and decreasing the burden for families within paediatric rheumatology may be to provide more services using technology enabled care (TEC). Although some clinical teams were providing TEC Eg. remote services prior to COVID-193, the pandemic forced a steep rise in using TEC for remote management4,5. National Health Service (NHS) Trusts in the UK strived to reduce face-to-face appointments to 20%6. Furthermore, stipulations within NHS England required healthcare providers to minimise routine visits, resulting in a rapid move to remote management with limited training for safe implementation using TEC7. Therefore, there has been considerable variability in TEC to support such rapid changes8. There is a firm commitment in the UK to drive TEC9–12. UK national plans are outlined in the NHS Blueprint and built into the NHS Long Term Plan to ensure TEC is provided in a ‘modern way’ to retain what is argued to be valuable adaptations to NHS services for some patients during COVID-19. A change in UK government in 2024 continued to highlight the need for change in the NHS, by launching a ‘rallying cry’ for members of the public and NHS staff to share thoughts about the future of the NHS. This exercise was underpinned by three big shifts, of which ‘analogue to digital’ was one13, and was incorporated into the 10-year Health Plan for England14. Furthermore, an independent investigation of the NHS found that while there is great potential for TEC to transform NHS services, there is much more work to do to realise its full potential13. As highlighted by the NHS Federated Data Platform, there has been minimal change over the last two decades, specifically with CYP and how their care is co-managed with parents15. Looking further afield, there is a drive to lead, retain and streamline healthcare technology innovations across Europe16 and to work together globally17. CYP are known to be avid, proficient users of all things technology-related, seen by the increased use of smartphone technologies18. Examples of TEC in action may include wearable technologies, e-patient reported outcome questionnaires, web-based tools for peer support, or the use of various online applications for provision of virtual clinics and medication reminders19. With these considerations in mind, it would therefore seem logical that TEC should be used routinely to support CYP, by empowering them to use their technological skills to develop self-management skills and to support their care decisions20. For the purposes of this study, Technology Enabled Care is used as a collective term and is defined here by Norwegian colleagues: “Telecare, telehealth, telemedicine, mobile (m)-, digital- and electronic (e) health services21.” There has been some empirical work published describing the changing landscape of TEC with CYP in cardiology22, those with complex needs23, and palliative care24. Focusing on paediatric rheumatology, one survey found face-to-face consults more acceptable to parents25, with other findings reporting on financial cost-savings for patients but not necessarily for healthcare providers when using TEC for remote services26. Two systematic reviews have been published on the usability and effectiveness of electronic (e)-health27 and mobile (m)-health28 interventions for patients with juvenile idiopathic arthritis; these reviews were limited to studies only reporting on empirical research using quantitative methodologies. This protocol paper sets out the process for a consensus study, linked to a wider PhD-related project (PeRFekT study), where the overall focus is on providing evidence-based guidance for TEC in paediatric rheumatology. This present protocol is intended to fulfil the final work package of the wider PhD programme. Previous work packages entailed the following: • WP1 – a mixed methods systematic review (PROSPERO number: CRD42023443058; published protocol: https://bmjopen.bmj.com/content/14/2/e082515)29. Aim: To provide a comprehensive understanding and evaluation of the adoption of TEC by patients in paediatric rheumatology services, to establish best practices. Status: Completed • WP2 – an e-survey with industry partners. Aim: To explore innovative technologies being developed for CYP’s healthcare to support TEC across the UK. Status: Completed • WP3 – a mixed methods study with rheumatology healthcare professionals, CYP and parents. Aim: To investigate what Technology Enabled Care practices are taking place and how Technology Enabled Care can be used to support and improve the management of Children and Young People across UK paediatric rheumatology departments. Status: Analysis almost complete What this study will bring This consensus study will bring together all previous work package findings, from which the consensus statements are currently being generated. The project is based upon the results of a large mixed methods systematic review. Although included papers in the review did not provide the opportunity to undertake a full quantitative analysis due to a lack of randomised controlled trials, a full narrative analysis has been performed inclusive of all types of paper. Furthermore, WP2 and 3 provide further robust evidence in generating consensus statements. Rather than relying solely on the literature, patients, parents, healthcare professionals or the lead author, this study will incorporate the views of a wide range of invested stakeholders for consensus input into a guidance framework. The process to be used will follow similar principles to a recent clinical consensus format30. The current, consensus project aim, is to agree upon, by multi stakeholder consensus, the strongest 10–20 Technology Enabled Care statements for inclusion into the final framework for use as guidance in paediatric rheumatology services. This study is the 4th and final PhD work package, and NPT has been used throughout. NPT is a middle-range, evidence-based, consistent framework used to explain implementation factors when considering the late stage of adoption of innovations in healthcare31. As part of the wider programme of work the statements will be mapped to NPT. The current, consensus project aim, is to agree upon, by multi stakeholder consensus, the strongest 10–20 Technology Enabled Care statements for inclusion into the final framework for use as guidance in paediatric rheumatology services. The study design takes a consensus-based approach, by undertaking an online modified Delphi study, with various stakeholders. Characteristics of participants Healthcare Professionals: Healthcare Professionals from the multidisciplinary team in paediatric rheumatology departments (including but not limited to: Clinical Nurse Specialists, Consultants, Registrars, Youth Workers, Research Nurses, Psychologists and Allied Healthcare Professionals). Families: CYP aged 11–17 years cared for within acute paediatric rheumatology services and their parents. Other Stakeholders: A range of other stakeholders: NHS Commissioners and Business Managers (working within general paediatric or paediatric rheumatology services), charity workers and industry partners (working in the health tech or digital health space). Previous Delphi studies have reported varying sample sizes from less than 20 and up to 80+32,33, often based on sparse robust evidence and dependent perhaps upon diversity of participants and the project undertaken34. Due to the lack of standardised approach, no formal sample size has been calculated. Drawing on previous PhD work packages and speaking with participants, as well as available literature, 16 participants from each of the above stakeholder groups (total 64) are anticipated to be recruited to allow for drop out between Rounds and to answer the research question. Inclusion criteria Healthcare Professionals: Multidisciplinary Team staff members who support the care of Children and Young People aged 11 – 17 years of age in paediatric rheumatology services in the UK. CYP and their parents/guardians: CYP aged 11 – 17 years inclusive who are cared for (regardless of diagnosis and length of time from diagnosis) in paediatric rheumatology services in the UK. Other stakeholders: NHS Commissioners and Business Managers, charity workers and industry partners. All participants having the ability to read and understand the English language. Exclusion criteria There are no specific exclusion criteria, other than not being able to meet the above inclusion criteria. Healthcare Professionals, CYP, parents/guardians and other stakeholders either taking part in the earlier stages of the PhD project or who have offered contact details to take part in further work, will be invited to take part during previous study interactions with the lead author. HCP participants will also be approached via national paediatric rheumatology professional groups, namely: Clinical Nurse Specialists, Clinical Psychology Network, Trainee Network, Allied Health Professionals Network, and the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR). Recruitment materials will be sent to professionals (Eg. commissioners) to share across their networks. Social media (X – formerly Twitter, Facebook and LinkedIn) will be used to maximise awareness, with the study link to the Participant Information Sheet and Consent Statement being made available via the study link. CYP in the Patient and Public Involvement group ‘Your Rheum’35 will be approached by the group’s coordinator. Three charities have agreed to share the study on their social media channels +/- approach via official charity emails (Children's Chronic Arthritis Association – CCAA36, National Rheumatoid Arthritis Society – NRAS37, and Lupus UK38). A purposive sampling approach39 will be used to target a range of participants Eg. in terms of professional background, age of CYP, CYP diagnosis, location and whether participants have taken part in previous PhD work packages (a mixture of both will be targeted). Please see Table 1–Table 4 for the Sampling Frameworks. | Main sampling Category | ||| |---|---|---|---| | 1. Gender | Female | Male | Other | | 2. Ethnicity | White | Ethnic minority background | | | 3. Participated in previous PhD work package | Yes | No | All potential participants will first be asked to assess their eligibility within Online Surveys (a web-based platform to distribute electronic questionnaires). Next, study documents will include a participant-specific Participant Information Sheet (PIS) and a Consent Statement (CS) and will be available within Online Surveys for all participants to read. Once the PIS and CS have been read, participants will enter their name and date, indicating their informed, digital consent to take part and providing contact details for the lead author to follow up with them. The lead author’s contact details will be provided within the study documents if any participants would like to discuss the study directly with a member of the research team. All CYP aged 16 years and over will provide informed consent for themselves following the above method and using separate PIS’s and CS’s. Parents of CYP less than 16 years will provide consent on behalf of their child following the above method and using separate PIS’s and CS’s. As is best practice, CYP less than 16years will also be required to provide assent, or their agreement to take part, again following the above method and using separate PIS’s and CS’s. If electronic consent +/- assent is difficult for a participant or would result in them being excluded in taking part, then every effort will be made to accommodate individual requirements (Eg. by collecting a wet ink signature via paid postage of the appropriate documents). All consent discussions, recruitment etc will be carried out according to Good Clinical Practice principles. CYP and parents taking part in the study will be provided with a £20 voucher per completion of each of the online modified Delphi rounds (£40 total) to thank them for their time and providing their perspectives. CYP will also receive a certificate. The Study Advisory Group and Participant Flow chart are included as Figure number 1. Data collection will take place using an online modified Delphi technique40. The format of the Delphi Rounds will follow a similar method used recently by the Study Advisory Group’s methodologist, Adam Galloway (AG)30. Study Advisory Group A Study advisory group (SAG) has been convened, consisting of the lead author, the academic supervisory team, 2 PPI representatives (1 young person and 1 parent) and an experienced appropriate methodologist (AG). The SAG will meet to organise and streamline all TEC implementation factors and previous PhD work package findings prior to undertaking the consensus exercise. The streamlined statements/factors will be piloted on Online Surveys to check accessibility and formatting. The SAG will meet again following Round 1 of the online modified Delphi exercise (see below) to discuss the outcomes of Round 1, incorporate any additional comments (by agreement with the SAG), and plan for Round 2. Subsequent SAG meeting(s) will remain flexible and essentially used for discussion and agreement regarding any outliers or cases of uncertainty. Study introduction video All participants will be asked to view a short (10–15 mins) recorded introduction video made by the lead author. The video will introduce all previous related work to date and explain what is expected from participants during the online modified Delphi rounds and prioritisation ratings undertaken via email. Online modified Delphi rounds There will be 2 Rounds of online modified Delphi consensus exercises for all recruited and consented participants. Both Rounds will be conducted using Online Surveys. Round 1 is planned to take place during November/December 2025 and Round 2 at the start of 2026. Round 1 Online modified Delphi consensus exercise All participants will be asked to undertake an online consensus exercise. All streamlined statements agreed by the SAG will be listed within Online Surveys and participants will indicate their level of perceived importance using a 5-point Likert scale (1=very important – 5=very unimportant. A free text space will be available for each statement to suggest new statements/clarification. All statements reaching >75% level of consensus will be removed prior to Round 2 to reduce the burden on participants during Round 2. The exercise will remain open online for up to a month afterwards for pragmatic reasons, to give more opportunity for participants to complete it on their own. Round 2 Online modified Delphi consensus exercise All participants will be sent a summary of the Round 1 results prior to the Round 2 exercise. Only those statements not meeting consensus, plus any new considerations suggested by participants from Round 1, will be included in Round 2. There will be no free text options during Round 2 and the same Likert scale (1–5) will be used again. Otherwise, the exercise will follow the same format as Round 1. All factors rated as ‘Important’ or ‘Very important’ by at least 75% of all respondents in Round 1 & Round 2 will be included in a prioritisation exercise. Prioritisation Ten to twenty statements are planned to be included in the final framework. Regardless of how many statements meet the >75% inclusion threshold, all participants will be asked to complete a prioritisation exercise. The exercise will indicate priority to implement statements into practice, based on importance, level of agreement, and perceived priority. The prioritisation exercise will be completed via email after Round 2. The top 10–20 prioritised statements will be included in the final framework guidance. The timescale for completing the prioritisation exercise is January 2026. Data analysis Free text responses offered during Round 1 of the online modified Delphi exercise will be analysed using content analysis41 and added to the comprehensive list of statements (if agreed by the SAG) either as a new statement in its own right or as a sub-factor within a broader theme. Quantitative analysis will be used to describe minimal non-identifiable participant details and for Round 1 to report the level of consensus, to remove those factors >75% consensus from the Round 2 exercise. Quantitative analysis will then be used for Round 2 to identify >75% consensus, then all those factors reaching >75% consensus from both Round 1 and Round 2 will be included for the prioritisation exercise, again using quantitative analysis. Normalisation Process Theory As alluded to in the introduction, NPT is a sociological theory that can be used flexibly to explain implementation factors when integrating innovative interventions into healthcare settings31. It provides a framework as a tool using the domains ‘Coherence (understanding), Cognitive Participation (relational work that builds a community of practice around an intervention), Collective Action (operational work that people need to do to make an intervention successful), and Reflexive Monitoring (appraisal work). NPT also considers the context of implementation and outcomes. Patients and the public have been involved with the PhD at numerous stages, including overall design, data collection, and previous publication29. For this specific sub-project, eligible PPI contributors will be invited to take part as participants in order for their views and opinions to be taken into account when providing guidance on TEC. Study design and concept April 2024-January 2025; REC approval received April 2025; Participant approaches and consents received from June 2025 (ongoing); Data collection planned from October-February 2025/26; Data analysis planned for February 2026; Dissemination planned for submission March 2026. The range of different participants, inclusive of patients and parents, is viewed as a strength of the study Consensus statements are based upon comprehensive evidence-based PhD project findings Involvement of patients and the public throughout the project and earlier PhD findings has increased relevancy of the outcomes Consensus is limited at the outset to two adapted Delphi rounds to incorporate a pragmatic approach, which may be seen as a study limitation BANNAR: Barbara Ansell National Network for Adolescent Rheumatology CCAA: Children's Chronic Arthritis Association CS: Consent Statement CYP: Children and Young People PeRFekT: PaEdiatric Rheumatology FramEworK for Technology enabled care PIS: Participant Information Sheet PPI: Patient and Public Involvement NHS: National Health Service NPT: Normalisation Process Theory NRAS: National Rheumatoid Arthritis Society REC: Research Ethics Committee SAG: Study Advisory Group TEC: Technology Enabled Care WP: Work Package This consensus project has received ethical approval from the University of Leeds (School of Medicine ethical approval number 2550), with full consideration of ethical and safety implications outlined within the REC application. All participants will provide digitally recorded consent to take part. A full outcome report will be produced and published in a leading journal in this field. The review report will also be submitted to the British Society for Rheumatology conference and/or Paediatric Rheumatology European Society conference. Members of Your Rheum and Barbara Ansell National Network for Adolescent Rheumatology (BANNAR) will be invited to share their creative dissemination ideas. This consensus paper and overall PhD results are part of a wider programme of work aiming to create guidelines for implementing future TEC approaches. Not applicable. Repository name: Figshare Persistent Identifier: https://www.doi.org/10.6084/m9.figshare.30862478 Description: The dataset contains all Participant Information Sheets and Consent Statements for the project Licence: Creative Commons Attribution 4.0 International (CC-BY 4.0) The authors wish to thank all stakeholders for their support of the project, particularly the charities listed under the ‘Recruitment’ section. Faculty Opinions recommendedReferences - 1. Stringer G: Musculoskeletal conditions. Why is it important? NHS England, 2019; [Accessed 3 May 2020]. Reference Source - 2. Selvaag AM, Aulie HA, Lilleby V, et al.: Disease progression into adulthood and predictors of long-term active disease in juvenile idiopathic arthritis. Ann Rheum Dis. 2016; 75(1): 190–195. PubMed Abstract | Publisher Full Text - 3. Healy P, McCrone L, Tully R, et al.: Virtual outpatient clinic as an alternative to an actual clinic visit after surgical discharge: a randomised controlled trial. 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PubMed Abstract | Publisher Full Text | Free Full Text Author details Author details 1 Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, England, LS7 4SA, UK 2 Children's Clinical Research Team, Leeds Teaching Hospitals NHS Trust, Leeds, England, LS1 3EX, UK 3 Psychological and Social Medicine, University of Leeds School of Healthcare, Leeds, England, LS1 3EX, UK 4 Therapies Department, Royal National Orthopaedic Hospital, London, England, HA7 4LP, UK 5 NIHR Great Ormond Street Hospital Biomedical Research Centre, London, England, WC1N 3JH, UK 6 Infection, Immunity & Inflammation Department, University College London, London, England, WC1E 6BT, UK 7 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, Please Select, LS7 4SA, UK 2 Children's Clinical Research Team, Leeds Teaching Hospitals NHS Trust, Leeds, England, LS1 3EX, UK 3 Psychological and Social Medicine, University of Leeds School of Healthcare, Leeds, England, LS1 3EX, UK 4 Therapies Department, Royal National Orthopaedic Hospital, London, England, HA7 4LP, UK 5 NIHR Great Ormond Street Hospital Biomedical Research Centre, London, England, WC1N 3JH, UK 6 Infection, Immunity & Inflammation Department, University College London, London, England, WC1E 6BT, UK 7 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, Please Select, LS7 4SA, UK Heather Rostron Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing Simon Pini Roles: Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Adam Galloway Roles: Methodology, Writing – Review & Editing Roles: Methodology, Writing – Review & Editing Anthony Gilbert Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing Polly Livermore Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing Anthony Redmond Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) under a doctoral fellowship awarded to Heather Rostron (Grant Reference Number NIHR302999)]. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright © 2026 Rostron H et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Rostron H, Pini S, Galloway A et al. PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.14191.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE 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 Jan 2026 Views 0 How to cite this report: Huang B. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39356) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39356 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39356 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 09 Mar 2026 Bin Huang, University of Cincinnati College of Medicine (Ringgold ID: 12303), Cincinnati, Ohio, USA Approved with Reservations VIEWS 0 The manuscript presents a study protocol for a consensus‑building project designed to understand technology‑enabled care (TEC) by engaging a broad community of stakeholders through an online modified Delphi process. The study builds on findings from three previous PhD work packages ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close The manuscript presents a study protocol for a consensus‑building project designed to understand technology‑enabled care (TEC) by engaging a broad community of stakeholders through an online modified Delphi process. The study builds on findings from three previous PhD work packages that examined different aspects of TEC adoption across stakeholder groups. The expected output is a set of 10–20 high‑priority statements on TEC‑enabled care from a wide range of stakeholders, including peadiatric rheumatology multidisciplinary team members, CYP, parents, and representatives from regulatory, business, and industry sectors. Overall, the manuscript does a good job outlining key components of the protocol; however, additional detail would strengthen the work.

The introduction provides relevant literature and effectively highlights the timeliness of investigating TEC in CYP. It would benefit, however, from a clearer articulation of research gaps, challenges in TEC adoption, and how this study advances current knowledge. Focusing on peadiatric rheumatology is a strength. These conditions are highly heterogeneous and dynamic, and current practice relies heavily on in‑person assessments, physical examinations, and high‑quality patient–provider communication. The manuscript would be improved by discussing field‑specific challenges identified by previous work and clarifying how this study will advance TEC implementation in peadiatric rheumatology.

The use of Normalization Process Theory (NPT) is appropriate given the complexity and variety of TEC modalities. However, more detail is needed to make the protocol operationally clear and reproducible. For instance, elaborating on how coherence will be established across stakeholder groups with potentially competing interests, anticipated challenges, and planned mitigation strategies would strengthen the methodological rigor. Without this detail, a theoretically sound protocol may still encounter implementation difficulties or lack reproducibility across contexts. The manuscript currently focuses on process description but offers limited rationale explaining how new practices, technologies, or ways of working will become—or fail to become—embedded (“normalized”) into routine practice. The data collection section should be expanded to specify what data will be collected, how it will be obtained, managed, processed, and reported, and how data sharing will be handled.

The discussion would benefit from further development. Potential points to address include: This is a timely and important topic with strong potential to inform TEC implementation in pediatric rheumatology. However, the current manuscript would benefit from substantial revision to provide greater methodological clarity, ensure rigor, and enhance interpretability. The expected output is a set of 10–20 high‑priority statements on TEC‑enabled care from a wide range of stakeholders, including peadiatric rheumatology multidisciplinary team members, CYP, parents, and representatives from regulatory, business, and industry sectors. Overall, the manuscript does a good job outlining key components of the protocol; however, additional detail would strengthen the work.

The introduction provides relevant literature and effectively highlights the timeliness of investigating TEC in CYP. It would benefit, however, from a clearer articulation of research gaps, challenges in TEC adoption, and how this study advances current knowledge. Focusing on peadiatric rheumatology is a strength. These conditions are highly heterogeneous and dynamic, and current practice relies heavily on in‑person assessments, physical examinations, and high‑quality patient–provider communication. The manuscript would be improved by discussing field‑specific challenges identified by previous work and clarifying how this study will advance TEC implementation in peadiatric rheumatology.

The use of Normalization Process Theory (NPT) is appropriate given the complexity and variety of TEC modalities. However, more detail is needed to make the protocol operationally clear and reproducible. For instance, elaborating on how coherence will be established across stakeholder groups with potentially competing interests, anticipated challenges, and planned mitigation strategies would strengthen the methodological rigor. Without this detail, a theoretically sound protocol may still encounter implementation difficulties or lack reproducibility across contexts. The manuscript currently focuses on process description but offers limited rationale explaining how new practices, technologies, or ways of working will become—or fail to become—embedded (“normalized”) into routine practice. The data collection section should be expanded to specify what data will be collected, how it will be obtained, managed, processed, and reported, and how data sharing will be handled.

The discussion would benefit from further development. Potential points to address include: - Generalizability: How will recruitment be documented? Will reasons for refusal be captured? How will the sample characteristics be assessed relative to the target population, and how might this influence interpretation of findings? - Operational considerations: With 16 participants per stakeholder group (64 total), it is unclear whether Delphi rounds will be conducted jointly or separately across groups. The manuscript should explain how the team will manage challenges specific to conducting an online Delphi study. - Digital literacy: While CYP may be digitally proficient, this may not hold for other stakeholders. The protocol should consider how differences in digital literacy might affect participation, data quality, and interpretation. - Limitations and future directions, specific to the field of paediatric rheumatology. This is a timely and important topic with strong potential to inform TEC implementation in pediatric rheumatology. However, the current manuscript would benefit from substantial revision to provide greater methodological clarity, ensure rigor, and enhance interpretability. - Is the rationale for, and objectives of, the study clearly described? Partly - Is the study design appropriate for the research question? Partly - Are sufficient details of the methods provided to allow replication by others? Partly - Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Biostatistician and Pediatric Rheumatology researcher CITE HOW TO CITE THIS REPORT Huang B. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39356) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39356 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39356 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: McGagh D. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39563) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39563 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39563 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 06 Mar 2026 Approved with Reservations VIEWS 0 This manuscript presents the protocol for a modified Delphi consensus study aiming to develop guidance for the use of Technology Enabled Care (TEC) in paediatric rheumatology services. The topic is timely and relevant. Digital health technologies (DHTs) represent a ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close This manuscript presents the protocol for a modified Delphi consensus study aiming to develop guidance for the use of Technology Enabled Care (TEC) in paediatric rheumatology services. The topic is timely and relevant. Digital health technologies (DHTs) represent a disparate collection of tools include telehealth / eHealth, remote monitoring, clinical informatics tools (e.g. EHR integration) and digital therapeutics (e.g. lifestyle app, self-help). The range of these tools require a wide scope to both design and implement in practice. DHTs are increasingly used to support outpatient care for chronic conditions, and the integration of perspectives from clinicians, children and young people, families, and other stakeholders is an important strength of the proposed work. The protocol is written well overall and the Delphi approach is appropriate for developing consensus guidance in an area where practice is heterogeneous. There are, however, several areas where the protocol could be strengthened to improve the clarity of the study rationale and the conceptual framing of the work. Clarity in introduction / rationale I think the introduction, whilst including lots of interesting references and points would benefit from a change in structure. It currently covers several themes, including the paediatric rheumatology care context, the expansion of digital health technologies during the COVID-19 pandemic, broader policy developments relating to digital healthcare within the NHS and NPT. While these elements are relevant, the overall narrative would benefit from a clearer structure that explicitly articulates the research gap. The current sub headings interrupt the flow for the reader. The rationale could be strengthened by structuring the introduction more explicitly around the following arc (as a suggestion): NHS policy documents There appears to be some misalignment between several statements in the introduction and the policy references used to support them. In particular, the sentence referring to the NHS Federated Data Platform does not clearly correspond to the claim being made in the surrounding text around a lack of change to CYP care over the past 20 years. It would be helpful for the authors to review these citations to ensure that each policy reference directly supports the statement it is intended to substantiate. More broadly, the introduction currently includes a substantial number of references to policy initiatives and strategic documents relating to digital transformation of the NHS. While this context helps demonstrate the relevance of Technology Enabled Care to current health system priorities, some of these statements read as policy narrative rather than evidence-based justification for the study. The rationale could likely be presented more succinctly by highlighting the key structural shift that occurred during the COVID-19 pandemic, where many services moved rapidly toward remote and technology-enabled models of care. This shift continues to be reflected in current policy directions with the key example being the latest NHS 10-year plan emphasing the transitioning from “analogue to digital” as a key pillar. Use of evidence from existing systematic reviews The manuscript references two systematic reviews examining eHealth and mHealth interventions for children and young people with juvenile idiopathic arthritis. These reviews are currently presented primarily in terms of their limitations, specifically that they focused on empirical quantitative studies. While acknowledging methodological limitations is appropriate, these reviews also represent an important body of evidence within the field. The introduction would be strengthened by briefly summarising key findings from these reviews, for example, findings relating to usability, feasibility, or effectiveness of digital interventions before highlighting their limitations. Doing so would provide a clearer evidence base for the study rationale and demonstrate how the proposed Delphi exercise builds on existing knowledge. Positioning the work within wider DHT landscape A notable strength of this study is the use of a multi-stakeholder consensus approach that brings together clinicians, patients and families, commissioners, and other stakeholders. The development and implementation of TEC pathways is inherently complex, and successful interventions typically require input from multiple groups across clinical, technical, and service delivery domains. The proposed Delphi process therefore represents an appropriate and commendable approach for generating consensus in this area. It may further strengthen the manuscript to position this work more explicitly within the broader digital health methodological landscape. In recent years, several frameworks have emerged to guide the development and evaluation of digital health technologies and emphasise the importance of multi-stakeholder collaboration throughout the lifecycle of digital tools. For example, the V3 framework (verification, analytical validation, clinical validation) and its recent extension V3+ highlight structured approaches to developing and validating sensor-based digital health technologies (Bakker JP et al Npj Digital Medicine. 2025 Jan 24;8(1):51). Similarly, further work by the Digital Medicine Society (DiMe) has published evidence-based frameworks for evaluating digital health software products that emphasise stakeholder engagement, usability, and robust evidence generation (Goldsack JC et al. Scientific Reports. 2025 Oct 31;15(1):38150.) Although the present study focuses primarily on service design and implementation with a specific focus on UK / NHS rather than validation of a specific digital tool, briefly situating the proposed consensus framework within this wider digital health evidence ecosystem could strengthen the manuscript. Doing so may also enhance the international relevance and visibility of the resulting guidance beyond the immediate context of paediatric rheumatology services. This may be something you explore prior to the consensus exercise, or if the consensus exercise has happened that you integrate this perspective in post-hoc in the write up. Breadth of technologies Lastly, a broader conceptual issue relates to the wide range of technologies included under the TEC umbrella (this may be beyond the scope for the protocol but worth considering going forward). As currently defined, TEC encompasses a diverse set of tools, including “telecare, telehealth, telemedicine, mobile (m)-, digital- and electronic (e) health services”, essentially encompassing most if not all of the digital health sphere. These technologies differ substantially in their purpose, implementation requirements, regulatory considerations, and evaluation frameworks. Given this heterogeneity, it would be helpful for the authors to clarify whether the intention is to produce high-level implementation principles that apply across all forms of TEC, or whether different categories of technologies may require distinct considerations within the consensus framework being proposed. A single set of consensus statements may risk oversimplifying issues that differ significantly between, for example, design and delivery of telemed services versus wearable sensor-based DHTs. Providing greater clarity on the intended scope and level of abstraction of the guidance would strengthen the conceptual framing of the study and also it’s scope for researchers in digital health looking to develop patient-centred tools. There are, however, several areas where the protocol could be strengthened to improve the clarity of the study rationale and the conceptual framing of the work. Clarity in introduction / rationale I think the introduction, whilst including lots of interesting references and points would benefit from a change in structure. It currently covers several themes, including the paediatric rheumatology care context, the expansion of digital health technologies during the COVID-19 pandemic, broader policy developments relating to digital healthcare within the NHS and NPT. While these elements are relevant, the overall narrative would benefit from a clearer structure that explicitly articulates the research gap. The current sub headings interrupt the flow for the reader. The rationale could be strengthened by structuring the introduction more explicitly around the following arc (as a suggestion): - What are some the problem in paediatric rheumatology care that TEC might address? - e.g. Centralised, hyper specialist care - What is already known from existing research on digital health interventions in rheumatology (paediatric preferably but if total absence of literature then can borrow from adult population)? - I think this section is largely absent from the background and would be worth adding. - What remains uncertain or lacks consensus? - With specific use case examples - How will the proposed Delphi study address this gap? NHS policy documents There appears to be some misalignment between several statements in the introduction and the policy references used to support them. In particular, the sentence referring to the NHS Federated Data Platform does not clearly correspond to the claim being made in the surrounding text around a lack of change to CYP care over the past 20 years. It would be helpful for the authors to review these citations to ensure that each policy reference directly supports the statement it is intended to substantiate. More broadly, the introduction currently includes a substantial number of references to policy initiatives and strategic documents relating to digital transformation of the NHS. While this context helps demonstrate the relevance of Technology Enabled Care to current health system priorities, some of these statements read as policy narrative rather than evidence-based justification for the study. The rationale could likely be presented more succinctly by highlighting the key structural shift that occurred during the COVID-19 pandemic, where many services moved rapidly toward remote and technology-enabled models of care. This shift continues to be reflected in current policy directions with the key example being the latest NHS 10-year plan emphasing the transitioning from “analogue to digital” as a key pillar. Use of evidence from existing systematic reviews The manuscript references two systematic reviews examining eHealth and mHealth interventions for children and young people with juvenile idiopathic arthritis. These reviews are currently presented primarily in terms of their limitations, specifically that they focused on empirical quantitative studies. While acknowledging methodological limitations is appropriate, these reviews also represent an important body of evidence within the field. The introduction would be strengthened by briefly summarising key findings from these reviews, for example, findings relating to usability, feasibility, or effectiveness of digital interventions before highlighting their limitations. Doing so would provide a clearer evidence base for the study rationale and demonstrate how the proposed Delphi exercise builds on existing knowledge. Positioning the work within wider DHT landscape A notable strength of this study is the use of a multi-stakeholder consensus approach that brings together clinicians, patients and families, commissioners, and other stakeholders. The development and implementation of TEC pathways is inherently complex, and successful interventions typically require input from multiple groups across clinical, technical, and service delivery domains. The proposed Delphi process therefore represents an appropriate and commendable approach for generating consensus in this area. It may further strengthen the manuscript to position this work more explicitly within the broader digital health methodological landscape. In recent years, several frameworks have emerged to guide the development and evaluation of digital health technologies and emphasise the importance of multi-stakeholder collaboration throughout the lifecycle of digital tools. For example, the V3 framework (verification, analytical validation, clinical validation) and its recent extension V3+ highlight structured approaches to developing and validating sensor-based digital health technologies (Bakker JP et al Npj Digital Medicine. 2025 Jan 24;8(1):51). Similarly, further work by the Digital Medicine Society (DiMe) has published evidence-based frameworks for evaluating digital health software products that emphasise stakeholder engagement, usability, and robust evidence generation (Goldsack JC et al. Scientific Reports. 2025 Oct 31;15(1):38150.) Although the present study focuses primarily on service design and implementation with a specific focus on UK / NHS rather than validation of a specific digital tool, briefly situating the proposed consensus framework within this wider digital health evidence ecosystem could strengthen the manuscript. Doing so may also enhance the international relevance and visibility of the resulting guidance beyond the immediate context of paediatric rheumatology services. This may be something you explore prior to the consensus exercise, or if the consensus exercise has happened that you integrate this perspective in post-hoc in the write up. Breadth of technologies Lastly, a broader conceptual issue relates to the wide range of technologies included under the TEC umbrella (this may be beyond the scope for the protocol but worth considering going forward). As currently defined, TEC encompasses a diverse set of tools, including “telecare, telehealth, telemedicine, mobile (m)-, digital- and electronic (e) health services”, essentially encompassing most if not all of the digital health sphere. These technologies differ substantially in their purpose, implementation requirements, regulatory considerations, and evaluation frameworks. Given this heterogeneity, it would be helpful for the authors to clarify whether the intention is to produce high-level implementation principles that apply across all forms of TEC, or whether different categories of technologies may require distinct considerations within the consensus framework being proposed. A single set of consensus statements may risk oversimplifying issues that differ significantly between, for example, design and delivery of telemed services versus wearable sensor-based DHTs. Providing greater clarity on the intended scope and level of abstraction of the guidance would strengthen the conceptual framing of the study and also it’s scope for researchers in digital health looking to develop patient-centred tools. - Is the rationale for, and objectives of, the study clearly described? Partly - Is the study design appropriate for the research question? Partly - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Psoriatic disease, wearable sensors, epidemiology CITE HOW TO CITE THIS REPORT McGagh D. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39563) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39563 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39563 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: Tan TC. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39562) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39562 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39562 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 26 Feb 2026 Approved with Reservations VIEWS 0 1. Would suggest describing the number of initial statements anticipated by the Dephi statements; criteria for inclusion/ exclusion and if statements will be mapped to NPT domains. 2. Would suggest describing ranking or scoring method for prioritization ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close 2. Would suggest describing ranking or scoring method for prioritization ... Continue reading 1. Would suggest describing the number of initial statements anticipated by the Dephi statements; criteria for inclusion/ exclusion and if statements will be mapped to NPT domains. 2. Would suggest describing ranking or scoring method for prioritization process. 3. Would suggest being specific in the protocol, minimum acceptable response rates per round and whether only participants completing Round 1 may enter Round 2. 4. Would benefit from clarifying whether industry partners responses will be analyzed separately and conflict of interest declaration. 2. Would suggest describing ranking or scoring method for prioritization process. 3. Would suggest being specific in the protocol, minimum acceptable response rates per round and whether only participants completing Round 1 may enter Round 2. 4. Would benefit from clarifying whether industry partners responses will be analyzed separately and conflict of interest declaration. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Partly - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Digital Health CITE HOW TO CITE THIS REPORT Tan TC. Reviewer Report For: PaEdiatric Rheumatology FramEworK for Technology enabled care (PeRFekT): A protocol for a consensus study [version 1; peer review: 3 approved with reservations]. NIHR Open Res 2026, 6:10 (https://doi.org/10.3310/nihropenres.15448.r39562) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39562 https://openresearch.nihr.ac.uk/articles/6-10/v1#referee-response-39562 NOTE: 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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