Design

Our review follows the five steps outlined by Arksey and O’Malley in their methodological framework for designing a scoping review to ensure an explicit approach to conducting the review and allow for the identification of all relevant literature, thus producing in-depth and broad results [20]. As described by Levac [21], we will include the additional step of consultation with stakeholders to help ground the work in routine practice and provide useful insights into applicability of findings. We will use the PRISMSA ScR checklist to ensure the reporting of our findings is transparent and comprehensive [22] (S1 Appendix). PROSPERO does not accept registration of scoping reviews, so our review will be registered on the CONNECT CRC website with reference to the published protocol.

Stage 1: Identifying the research question

The review aim was discussed at a CONNECT CRC meeting at the ERS Congress 2023, and the questions refined in discussion with multidisciplinary volunteers from the CONNECT network (including clinicians, researchers, and industry from 83 countries) in a video meeting and by email. S1 Fig shows the world map of CONNECT network as of August 2024.

Our finalised research questions are:

1. What are the characteristics of respiratory digital health that have been implemented in routine clinical practice in the last 10 years?
2. What frameworks were used to develop and evaluate the implementation strategies?
3. What population level outcomes were used in the evaluation?
4. What strategies were used, and which barriers and enablers to implementation were identified?
5. What (if any) insights were described relevant to the CONNECT overarching themes of reducing inequity, enhancing patient/professional relationships, supporting the patient journey, and reducing adverse environmental impact?

Stage 2: Identifying relevant studies

We adopted the PICO (Population, Intervention, Comparison, and Outcome) framework to define the search strategy for the scoping review. Some of the broader concepts required explanation in order for them to be operationalised during the selection process. We are using Covidence software to manage the studies for this review, from identification and de-duplication through to screening and data extraction [23]. We developed search strategies with support from a librarian and consulted previously published reviews for their key search terms [24, 25]. We used search terms for “respiratory condition” AND “digital technology” AND “implementation”. See S1 Table for the exemplar search strategies used in MEDLINE, which utilises comprehensive keywords and subheading structures; and S2 Table for the exemplar search strategies used in CABI, which utilises a simple search engine structure. The data range was from 2013–2023. We limited to the last decade because of the rapid evolution of digital healthcare and the recent acceleration of implementation with the COVID-19 pandemic. We therefore anticipated that older studies would be less relevant. We did not exclude by language. CONNECT is a global network with members fluent in most major languages.

A forward search will be performed on included studies using the International Statistical Institute Proceedings [26]. The reference lists of all included studies will be scrutinised to identify possible additional studies. We have also set up a cloud data repository for CONNECT network collaborators to record any relevant published studies that they know of through their professional and organisation networks, and the conferences they have attended. Suggested papers will be checked against the final list of included studies to ensure none are missed.

Stage 3: Study selection

Covidence automatically removes duplicates from multiple searches, during the importing process. Volunteers from the CONNECT network who expressed interest in contributing to the study selection, were invited to attend a two stage online training programme comprising an initial training session to explain the inclusion/exclusion criteria and processes, a pilot test screening of approximately 100 titles and abstracts followed a week later by a ‘troubleshooting’ (Q&A) session where discrepancies were discussed, questions answered and agreement reached on conventions to operationalise the inclusion/exclusion criteria for the remaining studies. Following training, each study is being independently screened by two reviewers randomly selected by Covidence from the twenty-seven volunteers. This process is being closely observed by lead researchers (CYH and AHYC) who are monitoring the performance of the individual volunteer reviewers and identifying any divergent decisions. Disagreements will be discussed within the core team (CYH, AC and HP) who will then direct conflict resolution within Covidence by 3 or 4 selected volunteers.

Twenty-seven volunteers are actively involved in undertaking the title and abstract screening but it is already clear that most volunteers will only contribute small numbers. We will select a sub-group of volunteers who have contributed extensively and accurately to undertake conflict resolution, full text screening, and data extraction.

We are including any digital health interventions implemented to support routine patient care. Patient care includes but is not limited to digital support for diagnosis, self-management, monitoring, medication adherence/compliance, education, psychological support, social support, remote consultation, or health professional facing interventions. For example, a decision support system that was designed to support delivery of care would be included, but an administrative system for scheduled appointments would be excluded.

Implementation studies are not always accurately indexed [27], so we have defined the key features of ‘implementation’ to guide the selection process.

• The intervention should be available to all clinically-eligible individuals (specifically not only to people who consent to the research).
• Outcomes should reflect the uptake and impact of the intervention within the population (e.g. using routine data).
• The intervention should be delivered within the existing service. Existing staff may be upskilled for the purpose, but interventions that require additional staff/resources for day-to-day delivery are unlikely to be sustained beyond the end of the project and therefore excluded.
• We did not specify a duration for the evaluation, but only included studies in which the intervention was (or was intended to be) embedded for the long term in routine care.

We are including studies involving patients with any respiratory conditions (short or long-term) of all ages. Where there is doubt about whether a condition is ‘respiratory’, we are including those conditions covered by the Assemblies and Groups of the ERS. If there is a comparator, it is likely to be usual care, but we expect many studies to be ‘before and after’ observational designs.

We are excluding:

• Digital health interventions that do not directly involve patient care (e.g. interventions such as workflow managements, appointments or triage systems with exclusively administrative purposes).
• Health professional education (e.g. online conferences, online courses).
• Population level initiatives to manage the COVID-19 pandemic (such as contact tracing, vaccination programmes). However, COVID-19 is a respiratory disease so we are including studies investigating initiatives at an individual level (for example, ‘hospital at home’ or management of COVID-19 in people with CRD).
• Grey literature, unpublished interventions, conference abstracts and reviews. We are tagging potentially relevant abstracts and will check for a subsequent publication. Potentially useful papers that do not meet the inclusion criteria (e.g. systematic reviews) will be retrieved for background literature and reference lists checked for relevant publications.

Conflict resolution will be undertaken by a small team of five reviewers who made the largest contributions to the review process in terms of number of titles and abstracts reviewed and availability to engage in the conflict resolution discussions with CYH and AHYC. The reviewers will be trained in a similar two-stage process to perform the full text reviews, followed by conflict resolution. CYH and AHYC will oversee quality control.

Stage 4: Data charting, extraction and management

The data will be extracted manually in Covidence. We will develop and pilot a data extraction sheet to record the data that we require to answer the five research questions.

1. Characteristics of the respiratory digital health implemented in the included study (citation, intervention, targeted population and their respiratory condition(s), country/healthcare system)
2. The frameworks (if any) that were used to develop and evaluate the implementation strategies. Examples of likely frameworks include the Non-Adoption, Abandonment, Scale-Up, Spread and Sustainability (NASSS), Normalisation Process Theory (NPT), Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, Behavioural Intervention Technology (BIT) model and reporting standards (StaRI), Expert Recommendations for Implementing Change (ERIC) and Theoretical Domains Framework (TDF) [28–34]. Key domains from the most commonly used frameworks will be collated and used to tailor the data extraction form.
3. Population level outcomes used in the evaluation.
4. Implementation strategies used and identified barriers and enablers.
5. Insights (if any) relevant to the CONNECT overarching themes of reducing inequity, enhancing patient/professional relationships, supporting the patient journey, and reducing adverse environmental impact.

Volunteers (n≈4) who have contributed substantially to the review process will extract data independently for two or three studies to pilot the form and as a training exercise. Following this pilot process the extraction form will be discussed within the core team (CYH, CYP, HP) and revised for use with the rest of the studies. CYH and AHYC will oversee the data extraction process, resolve conflicts between the volunteers and check the accuracy of the data prior to charting.

We will contact the corresponding authors of the included studies for missing information. If no response is received within two weeks after the first contact; we will recontact the author once, as well as the lead or senior author of the publication, depending on who the initial contact was. If we do not receive a response within a week, we will report the data as "missing" in the publication.

Stage 5: Collating, summarising and reporting the results

We will use a PRISMA diagram to report the review process and the number of studies in each stage. As appropriate to answer the five research questions, a narrative summary of qualitative data will be collated with the charted results from the quantitative data. More specifically, we will:

1. Describe the studies’ characteristics in a table and collate the types of digital health implemented.
2. Describe the implementation frameworks used in the included studies and, if a specific framework is not used explicitly, report the domains of most commonly used frameworks that were assessed, potentially illustrating findings graphically to highlight the outcomes that are used (or not).
3. Tabulate the outcomes assessed, with a primary focus on the population-level implementation outcomes used in quantitative studies.
4. Use thematic analysis to synthesise qualitative data and authors’ observations on strategies used, and barriers and enablers to implementation identified by the authors. Use thematic analysis to synthesise qualitative data and authors’ observations on insights that address the CONNECT over-arching themes.

We will consider categorising the studies into subgroups, such as digital health before/during/after the COVID period; settings such as high, middle, low resource settings, or disease area.

Stage 6: Consultation exercise

We will engage with a network of colleagues from the CONNECT collaboration (i.e. who expressed interest in the review, but did not contribute to screening or specific review tasks and are thus not authors), and maintain ongoing interaction with them throughout the review process. Their roles include joining stakeholder panels to advise on interpretation of findings and suggesting any potentially relevant papers of which they were aware. This group consists of academic researchers and clinicians who have experience or interest in implementing real-life respiratory digital health as well as volunteers with a technology background. They represent both high-income countries and Low- and Middle-Income Countries (LMICs), and we will invite them to contribute to online video workshops in which we will explore themes from the review and request feedback from their diverse perspectives. As appropriate, we will use digital interactive tools to facilitate interaction.