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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open Qual . 2024 Jul 15;13(3):e002626. doi: 10.1136/bmjoq-2023-002626 Search in PMC Search in PubMed View in NLM Catalog Add to search Service development project to pilot a digital technology innovation for video direct observation of therapy in adult patients with asthma Katherine O’Neill Katherine O’Neill 1 Medicines Optimisation Innovation Centre, Northern Health and Social Care Trust, Antrim, UK Find articles by Katherine O’Neill 1 , Cairine Gormley Cairine Gormley 2 Department of Respiratory Medicine, Western Health and Social Care Trust, Derry, UK Find articles by Cairine Gormley 2 , Martin G Kelly Martin G Kelly 2 Department of Respiratory Medicine, Western Health and Social Care Trust, Derry, UK Find articles by Martin G Kelly 2 , Rachel Huey Rachel Huey 1 Medicines Optimisation Innovation Centre, Northern Health and Social Care Trust, Antrim, UK Find articles by Rachel Huey 1 , Glenda Fleming Glenda Fleming 1 Medicines Optimisation Innovation Centre, Northern Health and Social Care Trust, Antrim, UK Find articles by Glenda Fleming 1, ✉ , Michael Scott Michael Scott 1 Medicines Optimisation Innovation Centre, Northern Health and Social Care Trust, Antrim, UK Find articles by Michael Scott 1 , Michael Shields Michael Shields 3 Centre for Experimental Medicine, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK 4 Continga, Belfast, UK Find articles by Michael Shields 3, 4 , James C McElnay James C McElnay 4 Continga, Belfast, UK 5 School of Pharmacy, Queen's University Belfast, Belfast, UK Find articles by James C McElnay 4, 5 Author information Article notes Copyright and License information 1 Medicines Optimisation Innovation Centre, Northern Health and Social Care Trust, Antrim, UK 2 Department of Respiratory Medicine, Western Health and Social Care Trust, Derry, UK 3 Centre for Experimental Medicine, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK 4 Continga, Belfast, UK 5 School of Pharmacy, Queen's University Belfast, Belfast, UK ✉ Correspondence to Dr Glenda Fleming; [email protected] ✉ Corresponding author. Received 2023 Sep 28; Accepted 2024 May 30; Collection date 2024. © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13078356 PMID: 39009461 Abstract Background Adherence to pharmacotherapy and use of the correct inhaler technique are important basic principles of asthma management. Video- or remote-direct observation of therapy (v-DOT) could be a feasible approach to facilitate monitoring and supervising therapy, supporting the delivery of standard care. Objective To explore the utility and the feasibility of v-DOT to monitor inhaler technique and adherence to treatment in adults attending the asthma outpatient service in a tertiary hospital in Northern Ireland. Method The project evaluated use of the technology with 10 asthma patients. Patient and clinician feedback was obtained, in addition to measures of patient engagement and disease-specific clinical markers to assess the feasibility and utility of v-DOT technology in this group of patients. Results The engagement rate with v-DOT for participating patients averaged 78% (actual video uploads vs expected video uploads) over a median 7 week usage period. Although 50% of patients reported a technical issue at some stage during the usage period, all patients and clinicians reported that the technology was easy to use and that they were satisfied with the outcomes. A range of positive impacts were observed, including optimised inhaler technique and an observed improvement in lung function. An increase in asthma control test scores aligned with clinical aims to promote adherence and alleviate symptoms. Conclusion The v-DOT technology was shown to be a feasible method of assessing inhaler technique and monitoring adherence in this small group of adult asthma patients. A range of positive impacts for participating patients and clinicians were observed. Not all patients invited to join the project agreed to participate or engage with using the technology, highlighting that in this setting, digital modes of delivering care provide only one of the approaches in the necessary “tool kit” for clinicians and patients. Keywords: Asthma, Medication reconciliation, Chronic disease management WHAT IS ALREADY KNOWN ON THIS TOPIC Video direct observation of therapy (v-DOT) has previously been shown to be an effective tool for improving medication adherence in patients with conditions such as tuberculosis. The authors of this article have previously reported on the feasibility and impact of v-DOT in children with asthma, showing improvements in inhaler technique and asthma control. The topic has yet to be explored with adult asthma patients. WHAT THIS STUDY ADDS This pilot project explores the aspects of feasibility, utility, acceptability and satisfaction with using v-DOT as a tool in the mangement of asthma form both a clinician and patient perspective. Although a number of positive outcomes were reported, aspects for further consideration were identified to support future implementation of v-DOT within healthcare systems. HOW THIS STUDY MIGHY AFFECT RESEARCH, PRACTICE OR POLICY The project findings are informative to clinicians managing adult asthma patients who are considering utilising digital technology as a tool to augment the delivery of standard care. Introduction Asthma affects approximately 262 million people worldwide. 1 Adherence to pharmacotherapy, including inhaler therapies, is a central part of asthma management. Use of an inhaler at the dosage prescribed and correct inhaler technique is crucial to ensuring that the medicine is deposited deep within the lungs. However, poor adherence to prescribed therapy is common, that is, the patient can fail to use inhaler(s) at the frequency prescribed. Furthermore, many studies have reported that the majority of patients (50%–80%) fail to use effective inhaler technique. 2 Poor adherence to inhaled therapies and/or incorrect inhaler use are major causes of uncontrolled asthma and increased healthcare utilisation. 3 Adherence to medication can be complex and multifactorial. Interventions to promote adherence must focus on issues important to the patient. From the perspective of the person with asthma, adherence to prescribed therapy can relate to poor understanding of the need for treatment, lack of involvement in decision-making about their inhaler device and low motivation to change behaviour. 4 From the clinician’s perspective, there can also be barriers to facilitating good adherence practices including difficulty in scheduling, treatment by different healthcare providers and time constraints. 5 There is a need for a feasible method of monitoring and supervising therapy, which supports the delivery of standard care which includes provision of advice, education and empowerment of patients in the self-management of their condition. Approaches to enhance patient motivation can include thorough patient and caregiver education and more frequent patient contact. 6 Digital devices offer the potential to support the delivery of best practices, optimise adherence and direct decision-making in asthma, thereby helping clinicians and empowering patients Direct observation of therapy (DOT) is the viewing by a clinician of a patient’s medication administration, to ensure adherence (medicine is used as prescribed) and effective technique (medicine is administered appropriately). 7 In tuberculosis (TB), there is strong evidence that DOT allows assessment of correct self-administration of medication and course completion. 8 As a result, DOT has been promoted by the World Health Organisation (WHO) to enhance medication adherence in patients with TB. 9 However, DOT can be labour intensive and inconvenient to both patients and healthcare workers, making it difficult for healthcare services to sustain. 10 The use of video DOT (v-DOT) or remote DOT, where patients submit ‘selfie’ videos of their administration of medicines for assessment by a healthcare professional, has the potential to increase flexibility and reduce the costs associated with traditional DOT while meeting patient-specific needs for treatment. Significantly, v-DOT has been shown to be effective in patients with TB in whom good medication adherence is imperative. 11 Emerging evidence from feasibility studies in children with asthma have demonstrated high levels of acceptability and improvement in inhaler technique using v-DOT. 5 12 13 The effect of v-DOT in the adult asthma service has not yet been explored. There are significant differences in the type of therapies and the method of therapy administration in adults compared with children. Aims and objectives The aim of this service development project was to explore the use of the v-DOT platform to monitor inhaler technique and adherence to inhaler treatment in patients in an adult asthma outpatient service in a tertiary hospital in the Western Health and Social Care Trust, Northern Ireland. The primary objective was to explore the utility and the feasibility of using the v-DOT platform to monitor inhaler technique and adherence to inhaler treatment in adult outpatients and to explore patient and clinician ease of use and satisfaction with the v-DOT platform. A secondary objective was to explore if treatment improvement had been achieved as measured using patient clinical markers (lung function and asthma control test scores). Methodology The technology The v-DOT platform (provided and supported by Continga), which operates on mobile phones and other portable devices, involved the patient making a short ‘selfie’ video of their medication administration, which was automatically encrypted and uploaded onto a secure website for viewing by a healthcare professional. Design The project delivered a service development evaluation using the technology with 10 patients from the adult asthma outpatient service, Altnagelvin Area Hospital, Northern Ireland, with each patient being asked to use the v-DOT platform for a period of 6 weeks. There was no change to any part of patient standard care, and the v-DOT technology was to be used only in the tracking of adherence and inhaler technique. Information governance and information technology communications governance processes were completed before using the technology on Trust computer systems. Patients were selected based on convenience sampling of those already attending the asthma outpatient clinic within the study time frame. Between December 2021 and October 2022, patients were invited to use the technology by the clinical pharmacist who managed the asthma outpatient clinic. Patients were invited to review and consider an information and consent form (explaining how the video was used, how the results of the project were to be used, stored and subsequently deleted). If agreeable, the patient completed the written informed consent form. For patients who agreed, the v-DOT app was set up on the patient’s smartphone, tablet or other mobile device to allow video capture and encrypted transmission. The patient was instructed on correct inhaler use and asked to capture and upload the video recordings of their daily inhaler use over a period of 6 weeks. The clinician could then review video uploads on a daily basis, accessed through the password-protected repository, and could contact a patient by telephone or text message if the inhaler technique required adjustment. The clinician rated the inhaler technique in submitted videos as ‘good’ (ie, all the steps performed correctly), ‘partial’ (if the patient missed out step(s), but some medicine was likely to be delivered to the lungs) or ‘poor’ (the patient missed steps critical to medicine delivery to lungs). Data collected Daily adherence data, utility and feasibility measures on the use of the v-DOT platform were collected. Specifically: Patient engagement with v-DOT The length of time that patients used the technology for (recommended period was 6 weeks). The proportion (%) of v-DOT videos successfully uploaded (actual number vs expected number). The proportion (%) of patient inhaler videos where technique was rated ‘good’ as assessed by the clinician. Record of technical and/or feasibility issues raised during the project and action taken to resolve. Ease of use and satisfaction with use of the v-DOT platform (clinicians and patients ) using Likert scales and open-ended questions. Lung function spirometry, fractional exhaled nitric oxide (FeNO) and asthma control test scores were also collected at the start and end of the project to explore if treatment improvement had been achieved in the participating patients. All quantitative data were summarised using descriptive statistics. Results Patients Between December 2021 and October 2022, 19 patients were offered the use of the v-DOT platform to help optimise inhaler use and monitor adherence to inhaler therapy. 10 patients agreed to participate and 9 declined. Reasons for declining included no interest in using technology (n=2; 11%), no interest generally (n=3; 16%) and did not feel that using the v-DOT platform would benefit them (n=4; 21%). For the 10 patients who used the technology, characteristics are presented in table 1 . The mean age of patients was 47 years and there were an equal number of men and women. Most patients had used oral steroids in the last year with a median of 3 courses in the previous year and experienced shortness of breath related to exercise. While lung function as measured by spirometry was generally normal, FeNO results indicated active airway inflammation in the participating patients. They were prescribed a median of 5 asthma medications and the median asthma control test result of 12 indicated suboptimal asthma control (score≥20 suggestive of acceptable, good control). The participating patients had a median of 2 other comorbidities and were prescribed a median of 3 other medications for conditions other than asthma. Table 1. Patient characteristics Characteristics Median (IQR) age 44 (33–65) N (%) M 5 (50%) F 5 (50%) N (%) patients hospitalised due to asthma in previous year 1 (10%) N (%) used oral steroids in last year 9 (90%) Median (IQR) (range) oral steroid courses in last year 2 (2–3) (0–5) N (%) patients off work due to asthma in the last year 1 (10%) N (%) patients with exercise related shortness of breath 8 (80%) Median (IQR) number of asthma medications 4.5 (3–5) Median (IQR) FEV1 % predicted 79 (75–81) Median (IQR) FVC % predicted 104 (101–111) Median (IQR) FEV1/FVC % predicted 81 (70–88) Median (IQR) FeNO (ppm) 55 (45–60) Median (IQR) asthma control test 12 (10–14) Median (IQR) number of comorbidities 2 (1–3) Median (IQR) number of other medications 3 (1–4) Baseline therapy as defined by GINA* Step 4: Moderate-to-high dose ICS-LABA maintenance treatment, medium dose ICS formoterol as maintenance or reliever, high dose ICS plus second controller 3 (30%) Step 4 or 5: 3 (30%) Step 5: High dose ICS-LABA plus oral corticosteroids, high dose ICS-LABA plus other add-on agents 4 (40%) Open in a new tab * https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf . .F, female; FeNO, fractional exhaled nitric oxide; FEV 1 , forced expiratory volume in one second; FVC, forced vital capacity; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; M, male. Patient engagement with the V-DOT platform The median (IQR) length of time that patients used the technology was 7 (6-7) weeks. An equal number of patients (5/10; 50%) used the v-DOT platform with 1 or 2 asthma inhalers. The devices monitored were dry powder inhalers (DPIs) (73%), Softmist inhalers (20%) and pressurised metered-dose inhalers (7%). Each individual had an expected number of videos to be uploaded (according to their individual inhaler treatment regimen and number of monitored days). Over each individual’s duration of time using the technology, the proportion of the actual number of videos uploaded/expected number of videos uploaded was as summarised in figure 1 . The median (IQR) proportion of videos submitted over a median 7-week period was 78% (66%–92%). Two patients requested to continue using the technology after the 6-week project period, as they found the reminder function on the v-DOT platform useful (platform sent a text message reminder to use their inhalers). Figure 1. Open in a new tab The proportion of actual number of videos/expected number of videos uploaded to video direct observation of therapy platform for each patient. For those videos not uploaded by the patient, the reasons given included technical issues (video would not upload, app not working), patient issues (trial run, patient forgot, patient did not upload video of adequate quality for review) or unknown (no reason given). 5 out of the 10 (50%) patients reported a technical issue at some stage during the usage period, causing a barrier to video upload. Delays in accessing the videos (due to barriers to video upload) to evaluate the quality of inhaler technique were reported by the clinician in 4 out of 10 (40%) of cases. In the instances where there were technical issues uploading or accessing the videos by the patient and/or the clinician, the v-DOT platform vendor technical support was accessed to troubleshoot and resolve the matter ( table 2 ). Table 2. Feasibility and utility of the v-DOT platform across the project lifespan Issue raised Actions taken Duration of 6 weeks to optimise inhaler use and monitor adherence for this patient group may be too long. Clinicians report patients achieving optimal levels at 2–3 weeks. Team acknowledged that study period in project may not map to time required when technology fully operational in clinical practice. Agreement to keep 6-week period for the duration of project and reassess thereafter. Delays in patient video upload for some patients. Subsequent delay in clinician receiving videos for assessment of technique and adherence. Clarification on WiFi connection with the patient. Clarification with patient on network connectivity when moving between Northern Ireland and Ireland coverage. One-to-one technical support and assistance to support clinician to troubleshoot technical issues. Error with installation of/login to app on some patient devices. Technological support to install app/reinstall app/assist with logon on request. Clinician required to scroll down excessively to navigate to and view videos on the platform. Technological support to review the layout and format of the viewing page. Full patient name list on view on clinician interface when enrolling new patients, highlighting a potential confidentiality issue. Clarification on function to reduce page size in order to conceal name list. Technological support to review the layout and format of the clinician viewing page. Lack of hospital logo on report templates. Technological support to upload and embed HSC Trust logo onto report template in order to facilitate direct use of printed reports in patient medical records. Link to download software to convert PDF reports to word reports blocked on hospital computers. Technical troubleshooting. Open in a new tab HSC, Health and Social Care; v-DOT, video direct observation of therapy. Of the videos submitted to the v-DOT platform, each received a quality rating on the patient’s inhaler technique by the clinician ( figure 2 ). Overall, the majority of the patient videos submitted across the total time period were rated as demonstrating ‘good’ quality inhaler technique (96%). Figure 2. Open in a new tab Inhaler technique quality rating by clinician of submitted videos. This result indicated that when videos were uploaded, the clinician was able to determine that patients were adherent to their prescribed medication (used inhaler) and could also assess inhaler technique (technique evaluated using visual and audio aspects of the uploaded videos). In only a few cases was the inhaler technique judged partially effective and in no cases was the technique judged poor. In a very few cases, the videos were not of sufficient quality to judge inhaler technique (no rating category). Table 2 summarises the technical and/or feasibility issues raised during the pilot and the action required to resolve. Issues related mainly to technical troubleshooting on the patient and clinician interfaces of the v-DOT platform. Ease of use and satisfaction 10 out of 10 patients (100%) rated the v-DOT technology as ‘very easy’ or ‘easy’ to use and were ‘very satisfied’ or ‘satisfied’ with the technology. Table 3 summarises the positive and negative responses relating to ease of use and overall satisfaction with the v-DOT technology from both patients (n=10) and clinicians (n=2; 1 clinical pharmacist and 1 consultant physician). Technical issues were a theme emerging from both patient and clinician qualitative reports on ease of use. Clinicians also highlighted that a shorter engagement period with v-DOT would improve ease of use. Table 3. Summary of patient and clinician comments on the ease of use and overall satisfaction with the v-DOT platform Patients Clinicians On ease of use of v-DOT platform: App easy to use and understand. Was a good daily reminder to use inhaler at a particular time. Setting up the program/app was a challenge initially due to my own lack of knowledge in this area for example, sign in for apple phone etc. The video didn’t always upload. Connectivity issues a few times so had difficulty uploading some videos. On satisfaction with v-DOT platform: Corrected technique of using inhaler. Increased confidence and skill in administering my inhaler, had a positive impact on my symptoms for example, less coughing/ shortness of breath. It was a reminder to use inhalers. I am sometimes forgetful. Felt very silly and didn’t want to do it. Didn’t like it. Not beneficial to me but might be to someone else. On ease of use of v-DOT platform: Being able to see patients taking their inhaler and correcting their technique. Many patients did not want to take part as they either were ‘not into technology’ or they stated that they felt they ‘had a good enough technique now they had been taught. Time consuming for reviewer- possibly a shorter course that is, 3 to 4 weeks review instead of 6 weeks review. Technical glitches and waiting call back from vendor’. On Satisfaction with v-DOT platform: Seeing improvement in some spirometry and ACT after 6 week programme. Some patients totally engaged and uploaded videos every day. I was able to prove to some patients that if they took their inhalers correctly and daily that their symptoms did improve. Insights I wouldn’t have otherwise gained. Better monitoring of patients, and therefore, ensure better compliance and better control of disease. Would like to see continued access to the platform. Not all patients were willing to engage, or actively disengaged – disheartening. Open in a new tab v-DOT, video direct observation of therapy. In terms of user satisfaction, a range of positive impacts were reported by patients and clinicians including corrected and optimised inhaler technique, increased confidence, increased understanding, benefit of reminders and benefits of monitoring and data collection for patient management. Negative feedback highlighted that while the v-DOT could be of benefit to some patients, it may not be a useful tool for all. Those patients with negative feedback were those who discontinued use of the platform before the end of the 6-week period. There was agreement from clinicians that using the technology was beneficial to their patients- one clinician highlighted that it would be useful for some patients, such as those proactively seeking health improvement or those more comfortable with using new technology. Overall, both clinicians agreed that having access to the v-DOT platform was beneficial to their service. Additionally, both patients and clinicians provided suggestions for improving the utility and/or feasibility of the technology. These comments are summarised in table 4 . Table 4. Suggestions for improving the utility and/or feasibility of the technology Patient Clinician Have a chatting platform on it to be able to communicate through app. If not already available, written instructions for setting up the app etc. would be helpful. Shorter video observation time. Ensuring connectivity is better across border regions. Patient video upload - automatic counting needed to reduce burden on clinician. Open in a new tab Lung function and asthma control Over the course of using the v-DOT technology, 7/10 patients had an increase in FEV 1 % predicted, 4/10 patients had an increase in FVC % predicted and 9/10 patients had an increase in FEV 1 /FVC % predicted. 3 out of 10 patients had a decrease in FeNO and 8/10 patients had an increase in their asthma control test. Individual level changes are presented in figure 3 (A–E) . Figure 3. Open in a new tab (A) FEV1 % predicted individual level changes from start to end. (B) FVC % predicted individual level changes from start to end. (C) FEV1/FVC % predicted individual level changes from start to end. (D) FENO (ppm) individual level changes from start to end. (E) Asthma Control Test individual level changes from start to end. FeNO, fractional exhaled nitric oxide; FEV 1 , forced expiratory volume in one second; FVC, forced vital capacity. Discussion Inhaled medication is a commonly prescribed pharmacotherapy in asthma. Adherence to prescribed pharmacotherapy and use of the correct inhaler technique are considered important basic principles of asthma management. However, poor adherence to prescribed therapy and incorrect inhaler technique are common. There is a need for a feasible method of monitoring and supervising therapy that supports the delivery of standard care. This project indicated that it was feasible for a proportion of patients with asthma managed in this outpatient setting to use v-DOT technology to take and upload videos of themselves using their inhaler therapy over a median 7-week period, 78% of the time. Furthermore, it was feasible for the clinicians in this setting to quality rate the inhaler technique and provide feedback to patients based on their video uploads. In this project, there was agreement that shorter periods or ‘bursts’ of using the technology to promote adherence and good inhaler technique when needed would be the most useful application of the technology for clinicians and patients. All patients and clinicians involved reported that they found the technology easy to use and were satisfied with the technology. A range of positive impacts with the v-DOT technology were reported by patients and clinicians including corrected and optimised inhaler technique, increased patient confidence and understanding, benefit of reminders and benefits of monitoring and data collection for patient management. However, it was clear that time, resource and clear communication channels to detect and resolve potential technical issues at all stages were essential, as half of patients experienced technical issues at some time over the 6-week monitoring period. By the end of the pilot, the majority of the technical matters had been resolved for this patient group, however, some technical challenges remained. Some patients continued to have intermittent problems uploading video and further improvements in the layout and format of the clinician viewing page, on-boarding of patients to the app and the troubleshooting process to resolve technical issues would be required in order for the innovation to be assimilated more easily in future. When used correctly and consistently, inhaled asthma medications are designed to alleviate the symptoms by controlling inflammation and minimising exacerbations. The increase in lung function and asthma control test scores observed with some patients in this small patient group align with these clinical aims. There was, however, a median 6 ppm increase in FeNO levels. Elevated FeNO levels may be explained by the presence of other respiratory comorbidities, for example, nasal disease. While clinicians in this setting agreed that using the technology was beneficial to their service and would like to have continued access to the technology, information gathered from screening patients (for participation and feedback) indicated that it may not be a useful tool for all patients. For example, the older population was more reluctant to engage with the video recording aspect of the technology. Adherence to medication is a complex issue, influenced by multiple treatment, clinician and patient-related barriers. v-DOT in this outpatient asthma service was considered one of the ‘tools’ in the ‘toolkit’ in addressing non-adherence and poor inhaler technique. Digital modes of delivering care may support, rather than replace, patient facing strategies. A recent scoping review evaluating 121 studies of digital interventions in asthma reported on how study outcomes related to the level of interactivity with the patient. The review concluded that there was evidence of improvement in both adherence and impairment due to asthma with interactive interventions involving two-way responsive patient communication. 14 The review highlighted that the ability to personalise a digital intervention in asthma care is important for its success. This v-DOT platform facilitated interaction between clinician and patient in relation to feedback, as required, on inhaler technique. The feedback from some patients and clinicians (eg, inclusion of a chat function, shorter duration of time for some patients) may be important aspects of personalisation in ongoing development of v-DOT technology to promote correct inhaler technique and adherence. Further scale up and adoption of any technology in the National Health Service (NHS) requires evaluation of the available evidence and decisions on commissioning or purchasing. Digital health technologies evidence frameworks and guidelines 15 16 on the use of digital technologies within the NHS outline a range of standard categories against which technology should be evaluated to assess proposed digital health technologies. These categories include design factors, describing value, demonstrating performance, delivering value and deployment considerations. This project provides information on feasibility and acceptability of the v-DOT approach among a small group of patients and clinicians in an asthma outpatient service in a tertiary hospital in Northern Ireland. Obtaining a fuller understanding of the impact of the technology on clinical outcomes in this patient group would require a robust research methodology. In the evidence framework, 15 the ‘demonstrating performance’ category includes a standard to provide evidence of the technology effectiveness to support its claimed benefits. In order for the new digital health technology to claim an impact on clinically relevant outcomes, high-quality interventional studies are advised. While the framework outlines that randomised controlled trials would be preferable (where this study design is appropriate), high quality, comparative real-world study designs may also be acceptable. In the case of v-DOT, however, it may be argued that this is not a new digital technology, but rather simply an approach that harnesses a patient’s mobile phone to allow a more efficient delivery of the established DOT approach. Current clinical guidelines for DOT as part of the management of respiratory populations include National Institute for Health and Care Excellence (NICE) clinical guideline 33 on TB (NG33), which recommends DOT as part of enhanced case management for certain at-risk groups (eg, evidence of non-adherence to treatment, history of homelessness, multidrug resistant TB) and the children of these at-risk groups. 17 The American Thoracic Society (ATS)/Centers for Disease Control and Prevention (CDC)/Infectious Diseases Society of America (IDSA) guideline and the Singapore guideline also recommend DOT for TB. 18 19 Specifically linked to v-DOT, the WHO guideline recommends using v-DOT to replace DOT where the technology is available (a conditional recommendation based on evidence with low-certainty in the findings). 20 This demonstrates that a level of evidence to support the use of DOT and v-DOT interventions currently exists. Furthermore, the use of v-DOT internationally in TB management adds to that evidence on a daily basis. 17 The decision to use available v-DOT technology may therefore come down to aspects of access, utility and implementation, that is, the delivering value and deployment aspects as outlined by digital health technologies evidence frameworks and guidelines. 15 16 A next step to expedite general adoption of such an innovation within the NHS setting may be to implement further service development pilots, with the ongoing collection of implementation and cost-effectiveness data, as guided by the digital technology frameworks. Limitations and future considerations This project did not evaluate how much training and support was delivered to patients by the clinicians in order to achieve good inhaler technique, when beginning to use the app and during the course of the project. Future work should include a more detailed record of the frequency and time required to instruct and train patients on inhaler technique including refresher sessions and follow-up, in order to more fully support v-DOT implementation. Use of the technology was evaluated in a small group of patients (n=10) which represented 53% of those invited to participate (n=19) during the project time frame. The group of patients who engaged in this project may represent those who are already ‘engaged’ or likely to engage in such a digital intervention (ie, clinically stable, currently use a mobile device, younger in age) and the utility and feasibility outcomes evaluated may have been positively influenced by the patient’s pre-existing level of digital literacy, confidence and access to digital services. While the use of NHS digital services is increasing 21 , it may still be important that future projects consider these factors more closely. This approach would enable more involvement from patients with a range of digital enablement levels. If the technology is to be embedded successfully across the service, it will be important to consider how those less familiar with digital interventions can be supported. Conclusion The v-DOT technology was shown to be a feasible method of assessing inhaler technique and monitoring adherence to prescribed inhaler use in a small group of outpatient adult patients with asthma who engaged with the technology (n=10; 53% of those invited to join the project). A range of positive impacts for participating patients and clinicians were reported. Not all eligible patients invited to join the project agreed to participate and engage with using the technology, highlighting that in this setting, digital modes of delivering care provide only one of the approaches in the necessary ‘tool kit’ for clinicians and patients. Furthermore, v-DOT may be useful at certain points and/or for limited periods in the clinical pathway and may not be needed continuously. Although all participating patients reported that v-DOT was very easy or easy to use, technical issues were experienced by 5 out of the 10 participating patients and time, resource and clear communication channels were required to detect and resolve these. Acknowledgments We wish to thank the Western Health and Social Care Trust, Northern Ireland, for hosting the project and all patients who took part. We also wish to thank Queen’s University Belfast and Continga, a spin-out company of Queen’s University Belfast, for in kind support (including access to the v-DOT platform). Footnotes Contributors: KO'N, CG and MS and contributed to project conception and design. KO'N, CG, MS and MGK contributed to data collection, data management, data analysis and interpretation of data and preparation of manuscript. KO'N, CG, RH, GF, MS, MGK, MS and JCM were involved in revising the manuscript critically for important intellectual content. GF is acting guarantor for this publication. Funding: Continga and Queen’s University Belfast funded the Medicines Optimisation Innovation Centre to set up, plan and evaluate the service development project in collaboration with the Western Health and Social Care Trust (Northern Ireland) . Competing interests: None declared. Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Provenance and peer review: Not commissioned; externally peer reviewed. Data availability statement All data relevant to the study are included in the article or uploaded as online supplemental information. Ethics statements Patient consent for publication Consent obtained directly from patient(s). Ethics approval This study involves human participants. Prior to initiation of this project, Health Research Authority (HRA) advice and documentation ( https://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2022.pdf ) and web-based ethics screening tool ‘Is my study research?’ ( hra-decisiontools.org.uk ) were consulted to inform whether or not the project was research as defined by the UK Policy Framework for Health and Social Care Research. Screening indicated the study would not be considered research by the NHS and met the criteria of a service development project. As such, a formal research ethics board approval was not required. Local information governance and information communications technology governance was obtained for the use of the technology in the project. Participants gave informed consent to participate in the study before taking part. References 1. World health organization. 2021. Available: http://Asthma (who.int) 2. Bryant L, Bang C, Chew C, et al. 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