Background About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many do not take their medication as prescribed. To address this problem, we need scalable interventions. Objective To develop a scalable low-cost intervention to support medication adherence in people prescribed medication for hypertension in primary care, and to obtain precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care. Design Systematic reviews and meta-analyses; qualitative meta-synthesis; interviews and focus groups; expert consultations; pre-testing study; randomised feasibility trial; randomised controlled trial of effectiveness and cost-effectiveness; economic modelling. Setting and participants Primary care practices in England and Wales. Patients prescribed medication for hypertension with poorly controlled blood pressure. Interventions Very brief intervention delivered by a practice nurse or healthcare assistant followed by a digital intervention (text messaging programme or smartphone app). Main outcome measures Acceptability, feasibility, fidelity and cost of the interventions. Systolic blood pressure. Biochemical and self-reported measures of medication adherence. Results Our systematic reviews showed that both app-based and face-to-face interventions in patients with long-term conditions have a positive effect on medication adherence. The meta-synthesis of published qualitative studies showed that: digital interventions to support medication use were perceived as acceptable and useful; a digital intervention would be more effective if it was personalised and tailored; barriers to using digital interventions included lack of interest, lack of confidence and lack of proficiency and experience in using the technology; digital interventions should be simple, easy to navigate and age-appropriate; patients wanted accurate information on their health condition, potential side effects of medication and health consequences of non-adherence; reminder notifications and a self-monitoring feature were perceived as helpful by some patients; some patients suggested that a digital intervention should enable them to communicate with pharmacies, but practitioners were concerned that this would increase their workload. The interview and focus group study identified several barriers to adherence, including forgetting, unpleasant side effects and reluctance to medicate. A digital intervention to support medication adherence was acceptable to patients if it was user-friendly, the content was tailored to the user, and the privacy of user data was protected. Simple reminder messages for taking medication and reordering prescriptions were considered more useful by patients than those providing information on the benefits of medication or the consequences of non-adherence. Patients preferred to receive feedback on their adherence levels in the form of a simple graph, percentage score or statistic. Practitioners thought that it would be feasible to introduce a digital intervention to patients in a very brief face-to-face consultation. In the pre-testing study, participants reported that the interventions we developed were easy to use and that they would recommend them to others. The feasibility trial showed that the combined intervention was acceptable and that a large cost-effectiveness trial was feasible. The main trial showed no difference between arms in systolic blood pressure or medication adherence at 12-month follow-up. The estimate (95% confidence interval) for the difference in means between arms in self-measured systolic blood pressure at 12 months was −0.61 mmHg (−3.05 to 1.82), p = 0.62 [for intervention vs. control (reference group)]. In the base case analysis, the intervention had a mean incremental cost-effectiveness ratio below the usual willingness-to-pay thresholds in the National Health Service in the United Kingdom. The probability of cost-effectiveness was between 77% and 80% at willingness-to-pay thresholds of £15,000, £20,000 and £30,000 per quality-adjusted life-year, but the confidence intervals are wide and cross zero, indicating some chance that the intervention could be less effective and more costly. Limitations The effectiveness trial was conducted during the COVID-19 pandemic. To reduce the risk of infection, the very brief intervention was delivered by telephone instead of face-to-face, and all study measurements were conducted remotely. This may have led to lower response rates and data quality and lower effectiveness of the intervention. A significant proportion (24%) of participants did not have raised blood pressure at baseline, and self-reported medication adherence was high at baseline, which reduced the possible scope for an intervention effect. Conclusions The findings on effectiveness do not support the commissioning of the intervention in United Kingdom primary care. The cost-effectiveness findings are more equivocal, showing a high probability of being cost-effective at standard United Kingdom willingness-to-pay thresholds, but with some uncertainty. Future work Future research should address the challenge of identifying and recruiting people who are poorly adherent and have raised blood pressure and test the intervention in this group. Variants such as face-to-face delivery, adding a follow-up consultation or a purely digital version could also be investigated. Study registration This study is registered as CRD42017080150; CRD42020164049; ISRCTN12805654; ISRCTN74504989; ISRCTN82013652. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20013) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 18. See the NIHR Funding and Awards website for further award information. Plain language summary About 15% of people (10 million) registered with primary care practices in England and Wales are prescribed medication for hypertension (high blood pressure). However, many do not take their medication as prescribed, which may harm their health and increases health service costs. To address this problem, we need low-cost interventions that can reach all the people who need them. This research programme aimed to develop a new intervention to support people with poorly controlled blood pressure to take their hypertension medication as prescribed and to assess how well it worked and how much it cost compared with usual care only. The findings would inform a decision on whether to introduce the intervention in primary care practices in the United Kingdom. We used a range of different research methods, including literature reviews, interviews and focus groups, and randomised controlled trials. The intervention we developed has two parts: a very brief intervention delivered by a practice nurse or healthcare assistant by telephone, followed by a digital intervention (individually tailored text messages for up to 420 days or a smartphone app). In the main trial, 537 participants received either the intervention or just usual care and were followed up 12 months later. The intervention was low cost, but it was not effective: the results showed no difference in blood pressure or medication adherence between the two groups at 12 months. Not all participants had raised blood pressure at the start of the study, and many were already taking their medication as prescribed; this may explain why the intervention did not work. The findings suggest that the intervention should not be introduced in United Kingdom primary care practices before showing that it works in patients who do not take their medication as prescribed and have raised blood pressure. Scientific summary Background Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension do not take their medications as prescribed – 42% in the UK according to one study. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. Primary care practitioners have an important role in supporting patients to adhere to their prescribed medication. However, they lack time to provide ongoing support for adherence, and their time is expensive. A potential solution is for a practitioner such as a practice nurse to deliver a very brief intervention (VBI) during a consultation and to use a digital intervention such as text messaging or a smartphone app to support subsequent adherence. About 96% of UK adults use a mobile phone, and in 93% of cases, this is a smartphone; the corresponding figures for those aged 65 and above are 88% and 77%. This suggests that digital interventions have the potential to reach the majority of this population. Digital interventions have several other advantages over traditional interventions: they can be fully automated; provide information that is highly tailored to the individual; be interactive; be available at any time; deliver support in real time; deliver support with high fidelity; and be easily updated. Recent meta-analyses have reported promising findings for the effectiveness of nurse-led and digital interventions to improve medication adherence and reduce BP in people with hypertension. The interventions examined in these reviews varied widely in content and delivery, and the digital interventions that have been evaluated to date have not made full use of individual tailoring, interactivity and other features that may increase user engagement and potential effectiveness. Objectives The PAM programme (Programme on Adherence to Medication) aimed to develop and evaluate an intervention to support medication adherence that combines a VBI from a practice nurse or healthcare assistant with a digital intervention (text messaging programme or smartphone app). Such an intervention would be inexpensive to deliver, scalable and potentially cost-effective. The objectives were: To develop a scalable low-cost intervention to support medication adherence in people prescribed treatment for hypertension in primary care. To evaluate the acceptability and feasibility of the intervention and the feasibility of conducting a (cost-)effectiveness trial. To provide precise and robust estimates of the effectiveness and cost-effectiveness of the intervention compared with usual care (UC). To develop an economic model of the cost-effectiveness of medication adherence interventions. To inform a decision on whether to implement the intervention in primary care. Methods The target group is patients in primary care practices in England and Wales who do not take their antihypertensive medication as prescribed and have raised BP. Methods used were: Systematic reviews of randomised controlled trials of app-based (9 trials) and face-to-face interventions (20 trials) to support medication adherence, with random-effects meta-analyses. A meta-synthesis of 30 published qualitative studies of adults taking medication for cardiovascular-related long-term health conditions (e.g. type 2 diabetes, hypertension) and/or healthcare practitioners who treat patients with cardiovascular conditions who were asked about their views and experiences of digital interventions to support medication adherence. Interviews with 11 healthcare practitioners [6 practice nurses, 2 healthcare assistants, 2 practice pharmacists, 1 general practitioner (GP)] and 6 patients, and 4 focus groups, with a total of 14 patients, to gather views on the acceptability and content of digital interventions for medication adherence. Expert consultations with 2 commissioners, 2 academics, 2 nurses, 2 patients and 10 GPs. Participants were e-mailed a description of the proposed intervention, a description of the proposed design of the randomised feasibility study and a link to an online questionnaire that asked their views on the delivery mode and content of the intervention and on the proposed feasibility study. Commissioners were asked about the evidence needed to inform a decision whether to commission the intervention. Pre-testing study of early versions of the digital interventions to assess acceptability. The text messaging intervention was used by 22 patients with hypertension for 28 days, and four of them also used the smartphone app for an additional 28 days. Data were collected by weekly telephone interviews, questionnaires and log files showing how they had used the interventions. Randomised feasibility trial to assess the feasibility and acceptability of the PAM intervention and the feasibility of conducting a large cost-effectiveness trial. Patients with hypertension who had raised BP and were non-adherent to their prescribed medication as indicated by their practice records and practice GP assessment were eligible for the study. One hundred and one eligible patients from nine general practices in the East of England and London were randomised to receiving the PAM intervention (N = 61) or UC only (N = 40). Randomised controlled trial to estimate the effectiveness and cost-effectiveness of the PAM intervention to improve medication adherence and reduce BP compared with UC only, to inform a decision on whether to implement the intervention in primary care (‘main trial’). A total of 573 eligible patients from 57 practices in England and Wales were individually randomised, stratified by practitioner, to the PAM intervention or control (UC only) and followed up at 12 months. The primary outcome was systolic blood pressure (SBP). The analysis was based on 537 participants. Within-trial economic analysis of the cost-effectiveness of the PAM intervention compared with UC alone. The main cost-effectiveness measure was the incremental cost per quality-adjusted life-year (QALY) gained, and the analysis included extensive deterministic and probabilistic sensitivity analyses. Results Systematic reviews The findings from the meta-analysis of app-based interventions showed that, at follow-up, patients in the intervention groups were more likely to self-report adherence to medication than those in the comparator groups [odds ratio 2.12, 95% confidence interval (CI) 1.64 to 2.75, n = 988, p < 0.0005]. None of the behaviour change techniques (BCTs) used in the interventions was significantly associated with intervention effect size. In the meta-analysis of face-to-face interventions, statistically significant pooled effects were found favouring the intervention arm over the control arm for several Medication Event Monitoring System measures of adherence, for example, percentage of prescribed doses taken on time over a period of 3 weeks to 2 months [mean difference (MD) 9.34, 95% CI 4.36 to 14.33, n = 3,667, p = 0.0002]. We also found significant between-arm effects for a self-report measure of adherence (Morisky scale). The impact of BCTs on intervention effectiveness could not be estimated as the analyses were underpowered. Taken together, these reviews supported our proposal to use face-to-face and digital components in the PAM intervention. However, we were unable to identify promising BCTs for potential inclusion in the proposed intervention. Meta-synthesis of previous qualitative studies The main findings from the meta-synthesis of published qualitative studies were: digital interventions to support medication use were perceived as acceptable and useful; a digital intervention would be more effective if it was personalised and tailored; barriers to using digital interventions included lack of interest, lack of confidence and lack of proficiency and experience in using the technology; digital interventions should be simple, easy to navigate and age-appropriate; patients wanted accurate information on their health condition, potential side effects of medication and health consequences of non-adherence; reminder notifications and a self-monitoring feature were perceived as helpful by some patients but unnecessary by others; some patients suggested that a digital intervention should enable them to communicate with pharmacies, but practitioners were concerned that this would increase their workload. Interviews and focus groups with practitioners and patients This study identified several barriers to adherence, including forgetting, unpleasant side effects and reluctance to medicate. A digital intervention to support medication adherence, either via text messages or smartphone app, was acceptable to patients, provided that it was user-friendly, the content was tailored to the user and the privacy of user data was protected. Simple reminder messages for taking medication and reordering prescriptions were considered more useful by patients than those providing information on the benefits of medication or the consequences of non-adherence, which were favoured by practitioners. Rather than messages of encouragement, patients preferred to receive feedback on their adherence levels in the form of a simple graph, percentage score or statistic. All the practitioners thought that it would be feasible to introduce a digital intervention to patients in a very brief face-to-face discussion during a primary care consultation. Expert consultations There was substantial similarity of views between the different stakeholders. They found the concept of a VBI delivered face-to-face by a healthcare practitioner acceptable. However, they felt that it was not feasible to address possible reasons for medication non-adherence in a VBI, and that the intervention should be limited to emphasising the importance of taking medication as prescribed and signposting the patient to a digital intervention. Pre-testing study Participants reported that the interventions were easy to use and that they would recommend them to other people. They were satisfied with the frequency of the messages and the content of the daily reminder and weekly query messages, but they were somewhat less satisfied with the content of the daily non-reminder (advice) messages. The response rate to the query messages was 100%, indicating a high degree of engagement. Randomised feasibility trial All 101 participants had their BP measured at baseline, and the vast majority provided a urine sample for chemical adherence testing. Participants were on average 65.8 years of age, 54% male, with a substantial minority (35%) from the most deprived areas, based on practice postcode. Baseline characteristics were similar in the two arms. At 3-month follow-up, 83% of participants had their BP measured and provided a urine sample, and the percentage was similar in the two arms. Ninety-two per cent of participants randomised to the intervention arm opted to receive text messages, and 8% opted to use the app. Ninety per cent responded to the tailoring questions which were administered digitally. Four intervention participants actively disengaged from the digital intervention by sending a STOP message. Seventy-two per cent continued to use the digital intervention for at least 1 month. The post-trial interviews showed that intervention participants found the intervention to be acceptable. Participants were satisfied with the baseline and follow-up consultations and the study procedures, and there were no concerns among control participants about being randomised to this arm. Practitioners also confirmed that the study procedures and intervention were acceptable. From baseline to follow-up, mean SBP reduced from 146.9 mmHg to 136.9 mmHg in the intervention arm compared with no change in the control arm (adjusted MD 9.2 mmHg, 95% CI 5.7 to 12.6), and biochemically measured adherence increased to a greater extent in the intervention arm than in the control arm, suggesting that the intervention was potentially effective. The findings from this trial showed that the intervention was acceptable to participants and that most offered the digital intervention used it, at least in the short term. The trial procedures were demonstrated to be practicable. Together with the findings on trial uptake and retention rates, this suggested that a large cost-effectiveness trial was feasible. Main trial Baseline characteristics were similar in the two arms. The majority of participants were recruited from practices in the East of England. Similar to the feasibility trial, 56% were male and mean age was 66.5 years. The vast majority categorised themselves as being of White ethnicity, but there was a range of deprivation levels, based on participant home postcode. Mean BP, obtained from practice records before randomisation, was 145/82 mmHg, again similar to the sample in the feasibility trial. Of participants, 75.8% had a BP reading above the accepted cut-off of 140/90 mmHg and 71.7% had a SBP reading above 140. We were, therefore, partially successful in recruiting a sample of participants who had a raised BP even though they were prescribed antihypertensive medication. The estimate (95% CI) for the difference in means between arms in the primary outcome of self-measured SBP at 12 months was −0.61 mmHg (−3.05 to 1.82), p = 0.62 [for intervention vs. control (reference group)]. Thus, the estimated effect was very small, and the detectable effect size of 5 mmHg did not fall within the CI. The estimate for the difference in means between arms for SBP obtained from practice records was 1.04 mmHg (−1.56 to 3.65), p = 0.43. Thus, the intervention appeared to have no effect on SBP. There was also no effect of the intervention on biochemically measured adherence. Of the 392 participants who provided a urine sample at follow-up, 388 (99.0%) were found to have at least one antihypertensive medication (or metabolite) in their urine. Based on the urinalysis, 94.3% of participants were categorised as ‘fully adherent’, 4.8% as ‘partially adherent’ and only 0.9% as ‘non-adherent’. There was no difference in these percentages between trial arms. Self-reported adherence at 12 months was also high, with no difference between trial arms. The mean score on the five-item Medication Adherence Report Scale questionnaire was 23.8 [standard deviation 1.7] out of a maximum score of 25 (based on 387 participants who provided 12-month data on this scale). Of the intervention participants, 212 (77.9%) opted to receive text messages; 60 (22.1%) opted to use the app, and 39 of these became active users. On average, participants were satisfied with the combined intervention (VBI plus digital intervention) and thought that it was acceptable and effective. However, 61.0% used the digital intervention for less than 3 months, with the main reasons being not needing any further support and finding the messages annoying. Economic analysis The total mean intervention cost per patient was £30. In the base case analysis, the intervention was found to be cost-effective compared with UC, with a mean estimated incremental cost-effectiveness ratio (ICER) of £1231 per QALY gained (95% CI −£13,156 to £19,535) and mean incremental net monetary benefit (INMB) of £289 (95% CI −£498 to £1026) at a willingness-to-pay (WTP) threshold of £15,000/QALY. The INMB rose to £400 (95% CI −£643 to £1383) and £621 (95% CI −£933 to £2104) for £20,000/QALY and £30,000/QALY, respectively. The probability that the intervention is cost-effective was between 77% and 80% for these WTP thresholds. Limitations The effectiveness trial was conducted during the COVID-19 pandemic. To reduce the risk of infection, the VBI was delivered by telephone instead of face-to-face, and all study measurements were conducted remotely. This may have led to lower response rates and data quality and lower effectiveness of the intervention. A significant proportion (24%) of participants did not have raised BP at baseline, and self-reported medication adherence was high at baseline, which reduced the possible scope for an intervention effect. Conclusions The combination of a VBI delivered by a practice nurse or healthcare assistant and a digital intervention was acceptable to both patients and practitioners. However, although the feasibility trial showed promising results, the main trial showed no effect of the intervention on medication adherence or SBP at 12 months. The cost-effectiveness findings showed a mean ICER below the usual WTP thresholds, but the CIs are wide and cross zero, indicating some chance that the intervention could be less effective and more costly compared with UC only. The effectiveness findings do not support the commissioning of the intervention in UK primary care. Future research should address the challenge of identifying and recruiting people who are poorly adherent. If it is feasible to recruit patients who are non-adherent to their prescribed antihypertensive medication and have raised BP, the intervention could be tested with the VBI delivered remotely or face-to-face. Variants such as adding a follow-up consultation or testing a purely digital version could also be investigated. The economic model developed for this programme can provide the basis for future economic evaluations of similar interventions across a range of different conditions. Study registration This study is registered as CRD42017080150; CRD42020164049; ISRCTN12805654; ISRCTN74504989; ISRCTN82013652. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20013) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 18. See the NIHR Funding and Awards website for further award information.

Background: Salbutamol is the most commonly prescribed inhaler for adults discharged from the Emergency Department (ED) with uncontrolled asthma. However newer options, e.g. Maintenance and Reliever Therapy (MART), are now recommended due to growing concerns over risks linked to salbutamol over-prescription. Transitioning to new inhalers requires support for both patients and healthcare professionals (HCP). This paper outlines how we developed an implementation package based on evidence, theory and the person based approach to support asthma medication optimisation in the ED. Methods: The purpose of this study was to use person based intervention development methods in a three phase process: (1) understanding behaviour, collating and synthesising evidence from in depth interviews with the target population (patients and HCPs); secondary deductive analysis using the theoretical domains framework (TDF) to understand barriers and facilitators to prescribing; developing guiding principles and logic model based on underlying theory (2) identifying behavioural content and implementation options, behaviour change techniques were selected and translated into intervention content (3) intervention materials developed and refined with input of stakeholders. Results: We identified modifiable target behaviours for HCPs to support guideline based care in the ED. These included identifying eligible patients, communicating rationale, providing patients with inhaler and resources, and communicating changes to primary care. Key theoretical domains included knowledge, skills, addressing beliefs about consequences, and targeting professional role perceptions. These domains were targeted through a clinical decision aid and training materials for ED HCP, template discharge summary for primary care, and visual and written materials for patients. Minor refinements were made based on stakeholder feedback (six ED doctor think-aloud interviews; two patient workshops with eight and five participants respectively; and 12 survey responses to final draft of video). Conclusion: We developed an intervention grounded in theory, evidence, and stakeholder feedback aimed at promoting and supporting delivery of guideline recommendation. ### Competing Interest Statement IS has given lectures at meetings with honoraria supported by AstraZeneca, is conducting quality improvement activity at their institution supported by AstraZeneca. IS received a PhD studentship from AUKCAR which supported the initial work including the systematic review and data collection for the interviews from patients and healthcare professionals. BB is conducting quality improvement activity at their institution supported by AstraZeneca. KP has given lectures at meetings/webinars, with/without honoraria, supported by Sanofi; has taken part in clinical trials sponsored by AstraZeneca. PEP has attended advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi; has given lectures at meetings/webinars, with/without honoraria, supported by AstraZeneca, Chiesi and GlaxoSmithKline; has attended international conferences with AstraZeneca; has taken part in clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Regeneron and Sanofi; is conducting research funded by GlaxoSmithKline for which his institution receives remuneration and quality improvement activity at his institution supported by AstraZeneca. ### Funding Statement The AMEND quality improvement project was funded by AstraZeneca through an Education Grant and AstraZeneca was not involved in the development of the programme educational materials. The views expressed are those of the authors and not necessarily those of AstraZeneca. The AMEND project builds upon IS PhD studentship from AUKCAR which was funded by Asthma+Lung UK as part of the Asthma UK Centre for Applied Research [AUK-AC-2012-01 and AUK-AC-2018-01]. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The qualitative research in phase 1 and 2 was conducted in accordance with the Declaration of Helsinki and ethical approval was obtained from Camden and Kings Cross Research Ethics Committee HRA Approval [REC Reference 21/LO/0665]. The study received NHS governance approval from Barts Health NHS Trust. All participants provided written informed consent. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. The materials in the AMEND implementation package are available from the corresponding author on reasonable request

Introduction Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension and associated conditions do not take their medications as prescribed. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. The Programme on Adherence to Medication (PAM) trial will estimate the effectiveness and cost-effectiveness of a medication adherence intervention in patients prescribed medication for hypertension with poorly controlled blood pressure in primary care. Methods A two-arm multicentre individually randomised controlled parallel group superiority trial recruiting patients prescribed medication for hypertension with poorly controlled BP in primary care practices in England and Wales. The target sample size is 542. Participants in the Intervention group will receive a very brief intervention delivered remotely (by telephone or video call) by a practice nurse or healthcare assistant followed by a digital intervention (text messaging or smartphone app) in addition to usual care; control group participants will receive usual care alone. The primary outcome is systolic BP measured at 12 months. Medication adherence will be measured by chemical adherence testing of urine samples and self-report. An economic evaluation and a process evaluation will be undertaken. Ethics and dissemination The Cambridge East Independent Research Ethics Committee (REC reference 19/EE/0354), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approved the trial. The findings will be disseminated to the scientific community, participating practitioners and patients, relevant patient groups and the public using a range of methods, including journal articles, conference presentations, newsletters and the Programme website. Trial registration number The UK’s Clinical Trial Registry ISRCTN82013652

For the last 40 years, the first line of asthma treatment has been short-acting beta2 agonists (SABA) used as symptom relief alongside daily inhaled corticosteroids (ICS) as preventers. New guidelines recommend replacing SABA relievers with ICS-based relievers (ICS-formoterol) because of clear risks from excess and sole use of SABA. This study aimed to explore patient perceptions of SABA, ICS and ICS-formoterol, with a focus on identifying barriers to adherence to new recommended treatments. A qualitative study was carried out investigating UK asthma online community forum posts using keyword searches between July 2021 and March 2025. Inductive thematic analysis was used to analyze the data, informed by the Necessity Concerns Framework. 326 posts were identified across 206 adults with asthma. Thematic analysis highlighted that many people remained attached to their SABA and viewed it as a key element of their treatment. They appeared unconvinced by warnings around SABA over-use and were dissatisfied with the quality of advice from health care professionals (HCPs). In contrast, they raised a range of concerns about ICS and ICS-formoterol, and had reservations about replacing SABA with these treatments. A common objection to replacing SABA was that ICS-formoterol does not provide the same symptom relief. Results highlight a perceived lack of individualized care from HCPs and insufficient explanation and justification of treatment changes. This analysis highlights several potential barriers to adherence to recommended asthma treatment. Strategies to support the implementation of asthma treatment guidelines should include addressing patients' treatment beliefs and educating clinicians to better communicate treatment changes.

BACKGROUND:Overprescribing of short-acting beta-agonist (SABA) inhalers is a worldwide problem. OBJECTIVES:To evaluate the impact of a system-wide quality improvement programme on SABA overprescribing, and to identify the most effective strategies. METHODS:All general practices within one East London borough received the intervention between October 2020 and March 2023. Practices in two neighbouring boroughs acted as comparators. Intervention practices engaged in quality improvement activities including: electronic alerts flagging patients prescribed ≥12 SABA inhalers/year; generating lists of patients overprescribed SABA to call for review; a summary guideline for clinicians; electronic patient information leaflets. All practices were offered webinar coaching. Prescribing data were collected from electronic health records, and SABA overprescription evaluated through interrupted times series analysis. Content analysis was applied to survey data and conversations with staff. RESULTS:During the three-year study period all localities introduced programmes to reduce SABA prescribing. We observed a significant decrease in the proportion of asthma patients prescribed more than 6 SABA/year in the study practices. The COVID pandemic triggered a temporary increase in patients on asthma registers, which persisted for 6 months. When implemented by practices the electronic prescribing alerts were effective: 50% of patients who received an active response reduced to <12 SABA in the following year. CONCLUSIONS:This quality improvement programme was associated with a reduction in SABA overuse, which could also decrease hospital admissions. Practices required individual coaching to use the electronic tools effectively. Integrated prescribing alerts reduced overprescribing, and collaborative practice cultures supported faster implementation of improvement strategies.

Abstract Background Randomised implementation trials evaluate the effects of implementation strategies on implementation outcomes and may also monitor clinical effectiveness. Routine healthcare data are used in implementation trials for participant identification, intervention delivery, and/or outcome ascertainment. Trial efficiency (scientific, operational, statistical, and economic) is operationalised across trial design, processes, superstructure, infrastructure, and stakeholder engagement (the Trial Efficiency Pentagon). Despite frequent usage, the contribution of routine data to implementation trial efficiency remains underexplored. We aimed to investigate how the use of routine healthcare data affects trial efficiency in two implementation trials. Methods We conducted a qualitative comparative case study of two implementation trials, one UK-based and one US-based. Participants were purposively sampled from trial teams involved in the use and management of routine healthcare data. Data were collected through semi-structured interviews, document analysis, and feedback workshops. Framework analysis guided by the Trial Efficiency Pentagon was used to analyse the data, and data flow diagrams were developed to visualise routine data pathways within each trial. Results The two trials (DIGITS and IMP2ART) used routine data to characterise the practice population of eligible patients, support clinical and economic outcome evaluation, facilitate audit and feedback, and assist in intervention delivery. Common facilitators that supported the use of routine data included sufficient IT and hardware capacity, relatively low cost, centralised regulatory approval for multi-site studies, and strong collaboration and partnerships. Common barriers included administrative complexity, redundant bureaucratic processes, and challenges with data sharing requirements. Key differences included the DIGITS trial’s in-house data warehouses within an integrated healthcare system ensured high data quality and enabled preliminary analyses. In contrast, the IMP2ART trial, managing a larger national sample, employed an external research database to integrate data from various EHR systems but faced challenges such as legacy systems, diverse coding practices and site-specific approvals. Data quality can act as either a facilitator or a barrier. Conclusions Routine data has an impact on implementation trial efficiency across trial design, processes, superstructure, infrastructure, and stakeholder engagement. To improve trial efficiency in public healthcare systems, researchers must address technological and regulatory barriers to accessing data. In private healthcare systems, data use and access hinges on investing in robust IT infrastructure and ensuring comprehensive organisational commitment. Trial registration IMP2ART trial registration: ISRCTN15448074; DIGITS trial Clinicaltrials.gov Identifier: NCT05160233.

Background:Reduced social engagement is associated with increased risk of incident Parkinson's disease (PD). Online peer support provides opportunities to develop new social connections. A digital social forum was recently embedded within PREDICT-PD, an online UK cohort study that stratifies participants for risk of future PD, to explore the feasibility of digital social engagement as an intervention to modify PD risk. Objective:This study reports on the content of messages exchanged on the forum to better understand how this was used and experienced. Methods:364 public posts from 218 distinct users were analysed using thematic analysis. Results:Members created a sense of community through disclosing personal information and reaching out to others. Experiences were shared in relation to symptom appraisal, emotional impacts and routes to diagnosis. Practical advice, resources and information were exchanged to aid symptom management and proactive lifestyle changes. Users discussed their aspirations for timely diagnosis and treatment within healthcare, further research funding to aid prevention and treatment, and greater awareness of PD within society. Technical issues with the forum were reported, and accessibility was viewed as a potential barrier. Conclusions:The online forum provided a peer support environment for people with similar health experiences to connect, exchange information and emotional support, and engage in discussions around political and social issues unique to PD. This highlights the potential of leveraging online peer support to promote social engagement in prodromal PD. Further research is needed to examine the effect on PD risk and develop accessible technologies.

BackgroundOnline health communities (OHCs) enable people with long-term conditions (LTCs) to exchange peer self-management experiential information, advice, and support. Engagement of “superusers,” that is, highly active users, plays a key role in holding together the community and ensuring an effective exchange of support and information. Further studies are needed to explore regular users’ interactions with superusers, their sentiments during interactions, and their ultimate impact on the self-management of LTCs. ObjectiveThis study aims to gain a better understanding of sentiment distribution and the dynamic of sentiment of posts from 2 respiratory OHCs, focusing on regular users’ interaction with superusers. MethodsWe conducted sentiment analysis on anonymized data from 2 UK respiratory OHCs hosted by Asthma UK (AUK), and the British Lung Foundation (BLF) charities between 2006-2016 and 2012-2016, respectively, using the Bio-Bidirectional Encoder Representation from Transformers (BioBERT), a pretrained language representation model. Given the scarcity of health-related labeled datasets, BioBERT was fine-tuned on the COVID-19 Twitter Dataset. Positive, neutral, and negative sentiments were categorized as 1, 0, and –1, respectively. The average sentiment of aggregated posts by regular users and superusers was then calculated. Superusers were identified based on a definition already used in our previous work (ie, “the 1% users with the largest number of posts over the observation period”) and VoteRank, (ie, users with the best spreading ability). Sentiment analyses of posts by superusers defined with both approaches were conducted for correlation. ResultsThe fine-tuned BioBERT model achieved an accuracy of 0.96. The sentiment of posts was predominantly positive (60% and 65% of overall posts in AUK and BLF, respectively), remaining stable over the years. Furthermore, there was a tendency for sentiment to become more positive over time. Overall, superusers tended to write shorter posts characterized by positive sentiment (63% and 67% of all posts in AUK and BLF, respectively). Superusers defined by posting activity or VoteRank largely overlapped (61% in AUK and 79% in BLF), showing that users who posted the most were also spreaders. Threads initiated by superusers typically encouraged regular users to reply with positive sentiments. Superusers tended to write positive replies in threads started by regular users whatever the type of sentiment of the starting post (ie, positive, neutral, or negative), compared to the replies by other regular users (62%, 51%, 61% versus 55%, 45%, 50% in AUK; 71%, 62%, 64% versus 65%, 56%, 57% in BLF, respectively; P<.001, except for neutral sentiment in AUK, where P=.36). ConclusionsNetwork and sentiment analyses provide insight into the key sustaining role of superusers in respiratory OHCs, showing they tend to write and trigger regular users’ posts characterized by positive sentiment.

BackgroundAmong 5.4 million people receiving treatment for asthma in the United Kingdom, more than 2 million experience suboptimal control, leading to the use of health care services and resulting costs as well as poorer quality of life. Online health communities (OHCs) are increasingly used as a source of lay health advice, providing opportunities for learning and mutual support and complementing information from “official” health sources. While engagement with OHCs has the potential to improve self-management, concerns remain about the reliability and usefulness of the information posted. Professional moderation of such communities is essential for supporting sensitive patients, ensuring adherence to forum guidelines, and maintaining clinical safety. ObjectiveThis study aims to examine the experiences of moderators in an asthma OHC, identifying challenges and possible areas to optimize the safety and effectiveness of patient engagement. MethodsAll 6 current moderators of a nationwide charity-hosted OHC participated in in-depth, semistructured, audio-recorded, remote interviews. Audio recordings were transcribed verbatim and qualitatively analyzed using reflexive inductive thematic analysis. ResultsThe 6 moderators interviewed comprised 4 (67%) specialist respiratory nurses, 1 (17%) volunteer patient ambassador, and 1 (17%) customer support manager (all female, with average age 45, SD 10.5 y). In total, 5 (83%) moderators had at least a year’s experience of OHC moderation. Three main themes were generated from data analysis: moderation processes, challenges to effective moderation, and OHC effectiveness. The first theme focused on the different moderator roles and tasks undertaken, including the application of OHC guidelines in dealing with inappropriate content. The second theme covered difficult issues, such as mental health, and practical challenges, including lack of time and concerns about missing problematic posts. The third theme focused on the factors that made the OHC effective and increased its effectiveness, including keeping users safe, generating more OHC activity, encouraging discussion, and raising awareness of the OHC. We found a contradiction in how the moderators perceived the OHC’s effectiveness and their role in moderating it. While they expressed concerns about having insufficient time to moderate the OHC, they also felt that it was underused and would be more effective if it were busier or more active. ConclusionsBuilding on the challenges experienced by the moderators, several recommendations were put forward to optimize the safety and effectiveness of the asthma OHC. Moderators often work in isolation without external training or interaction with others. More research into OHC moderation is needed. A continuous professional development framework could improve moderation quality and user support, aligning with the evolving needs of these communities. These results can be relevant to national and international policy, attempting to enhance the safety of patients’ engagement with OHCs.

Background Patients with long-term conditions take part in online health communities (OHCs) for advice and guidance from peers. Engagement with OHCs may prompt changes in self-management behavior. Limited information exists on determinants of behavioral change resulting from engagement with an OHC. Aims Firstly, to identify whether engagement with an OHC results in behaviour change. Secondly, to identify the behavior change outcomes, and whether specific behavior change techniques were used. Design & Setting Qualitative analysis of posts written between December 2022 and August 2023 in the asthma OHC of the Asthma + Lung UK (ALUK) charity. Method The search term helped was used in the Google search engine to highlight relevant posts and threads. Two researchers read through these posts to identify threads that described behavior change as a result of OHC engagement and classified them based on the specific actions taken or intentions expressed by users. Earlier posts in the same threads that encouraged behavior change were classified using the Michie Behavior Change Technique (BCT) Taxonomy to identify potential contributing techniques. Results Thirty-five threads were identified, with 703 posts contributed from 200 users. Users characteristics were mostly hidden. Seventeen (48.6%) of these threads included posts where the users who started the thread went back to it to describe their behavior change as a result of engaging with the OHC. Within these threads, 6 posts demonstrated actual behavior change, 32 posts intention to change behavior, and one post both intention and actual behavior change. Behavior change outcomes included: contacting primary care services; trying out other users recommendations; consulting a healthcare professional to change medication; and purchasing equipment. Fifty-two distinct posts (out of a total of 362 posts) by 32 users were identified as prompting behavior changes, through the use of 12 out of 96 available BCTs. Common BCTs employed by users were: Demonstration of behavior (n=30), Action planning (n = 26), Instruction on how to perform the behavior (n=17), Adding objects to the environment (n=15), and Pharmacological support (n= 10). All threads where a behavior change was prompted, contained 2 or more BCTs. Eighteen of the 200 users were very active (i.e., superusers), contributing at least 10 posts during the 9-month period of the study. 9/18 superusers were among the 32 users who posted in threads where actual behavior change or intention to change behavior was observed. Conclusion Engagement with an OHC can influence the self-management behavior of patients with long-term conditions. Recognized BCTs underpinned threads demonstrating self-management behavior change. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement VD was partly funded through Research Capability Funding. This study was partly funded by a Programme Grants for Applied Research Programme (grant number: NIHR202037). Views articulated are those of the authors and not necessarily those of the National Health Service, NIHR, or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study used only openly available posts written publicly in the ALUK asthma online health community located at: https://healthunlocked.com/asthmalunguk-asthma I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets generated or analyzed during this study are not publicly available as they can easily be used to identify the participants, but are available from the corresponding author upon reasonable request.

INTRODUCTION:In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention's effectiveness and cost-effectiveness. METHODS AND ANALYSIS:An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50-70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically. ETHICS AND DISSEMINATION:The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER:NCT06849245.

Digital health analytics face critical challenges nowadays. The sophisticated analysis of patient-generated health content, which contains complex emotional and medical contexts, requires scarce domain expertise, while traditional ML approaches are constrained by data shortage and privacy limitations in healthcare settings. Online Health Communities (OHCs) exemplify these challenges with mixed-sentiment posts, clinical terminology, and implicit emotional expressions that demand specialised knowledge for accurate Sentiment Analysis (SA). To address these challenges, this study explores how Large Language Models (LLMs) can integrate expert knowledge through in-context learning for SA, providing a scalable solution for sophisticated health data analysis. Specifically, we develop a structured codebook that systematically encodes expert interpretation guidelines, enabling LLMs to apply domain-specific knowledge through targeted prompting rather than extensive training. Six GPT models validated alongside DeepSeek and LLaMA 3.1 are compared with pre-trained language models (BioBERT variants) and lexicon-based methods, using 400 expert-annotated posts from two OHCs. LLMs achieve superior performance while demonstrating expert-level agreement. This high agreement, with no statistically significant difference from inter-expert agreement levels, suggests knowledge integration beyond surface-level pattern recognition. The consistent performance across diverse LLM models, supported by in-context learning, offers a promising solution for digital health analytics. This approach addresses the critical challenge of expert knowledge shortage in digital health research, enabling real-time, expert-quality analysis for patient monitoring, intervention assessment, and evidence-based health strategies.

Background Globally, there is a growing focus on efficient trials, yet numerous interpretations have emerged, suggesting a significant heterogeneity in understanding “efficiency” within the trial context. Therefore in this study, we aimed to dissect the multifaceted nature of trial efficiency by establishing a comprehensive conceptual framework for its definition. Objectives To collate diverse perspectives regarding trial efficiency and to achieve consensus on a conceptual framework for defining trial efficiency. Methods From July 2022 to July 2023, we undertook a literature review to identify various terms that have been used to define trial efficiency. We then conducted a modified e-Delphi study, comprising an exploratory open round and a subsequent scoring round to refine and validate the identified items. We recruited a wide range of experts in the global trial community including trialists, funders, sponsors, journal editors and members of the public. Consensus was defined as items rated “without disagreement”, measured by the inter-percentile range adjusted for symmetry through the UCLA/RAND approach. Results Seventy-eight studies were identified from a literature review, from which we extracted nine terms related to trial efficiency. We then used review findings as exemplars in the Delphi open round. Forty-nine international experts were recruited to the e-Delphi panel. Open round responses resulted in the refinement of the initial nine terms, which were consequently included in the scoring round. We obtained consensus on all nine items: 1) four constructs that collectively define trial efficiency containing scientific efficiency, operational efficiency, statistical efficiency and economic efficiency; and 2) five essential building blocks for efficient trial comprising trial design, trial process, infrastructure, superstructure, and stakeholders. Conclusions This is the first attempt to dissect the concept of trial efficiency into theoretical constructs. Having an agreed definition will allow better trial implementation and facilitate effective communication and decision-making across stakeholders. We also identified essential building blocks that are the cornerstones of an efficient trial. In this pursuit of understanding, we are not only unravelling the complexities of trial efficiency but also laying the groundwork for evaluating the efficiency of an individual trial or a trial system in the future.

BackgroundPediatric stroke is relatively rare and underresearched, and there is little awareness of its occurrence in wider society. There is a paucity of literature on the effectiveness of interventions to improve rehabilitation and the services available to survivors. Access to online health communities through the internet may be a means of support for patients with pediatric stroke and their families during recovery; however, little research has been done in this area. ObjectiveThis study aims to identify the types of social support provided by an online peer support group to survivors of pediatric stroke and their families. MethodsThis was a qualitative thematic analysis of posts from a pediatric stroke population on a UK online stroke community active between 2004 and 2011. The population was split into 2 groups based on whether stroke survivors were aged ≤18 years or aged >18 years at the time of posting. The posts were read by 2 authors who used the adapted Social Support Behavior Code to analyze the types of social support exchanged. ResultsA total of 52 participants who experienced a pediatric stroke were identified, who posted a total of 425 messages to the community. About 41 survivors were aged ≤18 years at the time of posting and were written about by others (31/35 were mothers), while 11 were aged >18 years and were writing about themselves. Survivors and their families joined together in discussion threads. Support was offered and received by all participants, regardless of age. Of all 425 posts, 193 (45.4%) contained at least 1 instance of social support. All 5 types of social support were identified: informational, emotional, network, esteem support, and tangible aid. Informational and emotional support were most commonly exchanged. Emotional support was offered more often than informational support among participants aged ≤18 years at the time of posting; this finding was reversed in the group aged >18 years. Network support and esteem support were less commonly exchanged. Notably, the access subcategory of network support was not exchanged with the community. Tangible aid was the least commonly offered type of support. The exchanged social support provided insight into rehabilitation interventions and the unmet needs of pediatric stroke survivors. ConclusionsWe found evidence of engagement of childhood stroke survivors and their families in an online stroke community, with peer support being exchanged between both long- and short-term survivors of pediatric stroke. Engagement of long-term survivors of pediatric stroke through the online community was key, as they were able to offer informational support from lived experience. Further interventional research is needed to assess health and rehabilitation outcomes from engagement with online support groups. Research is also needed to ensure safe, nurturing online communities.

Background There is evidence that social interaction has an inverse association with the development of neurodegenerative diseases. PREDICT-Parkinson Disease (PREDICT-PD) is an online UK cohort study that stratifies participants for risk of future Parkinson disease (PD). Objective This study aims to explore the methodological approach and feasibility of assessing the digital social characteristics of people at risk of developing PD and their social capital within the PREDICT-PD platform, making hypotheses about the relationship between web-based social engagement and potential predictive risk indicators of PD. Methods A web-based application was built to enable social interaction through the PREDICT-PD portal. Feedback from existing members of the cohort was sought and informed the design of the pilot. Dedicated staff used weekly engagement activities, consisting of PD-related research, facts, and queries, to stimulate discussion. Data were collected by the hosting platform. We examined the pattern of connections generated over time through the cumulative number of posts and replies and ego networks using social network analysis. We used network metrics to describe the bonding, bridging, and linking of social capital among participants on the platform. Relevant demographic data and Parkinson risk scores (expressed as an odd 1:x) were analyzed using descriptive statistics. Regression analysis was conducted to estimate the relationship between risk scores (after log transformation) and network measures. Results Overall, 219 participants took part in a 4-month pilot forum embedded in the study website. In it, 200 people (n=80, 40% male and n=113, 57% female) connected in a large group, where most pairs of users could reach one another either directly or indirectly through other users. A total of 59% (20/34) of discussions were spontaneously started by participants. Participation was asynchronous, with some individuals acting as “brokers” between groups of discussions. As more participants joined the forum and connected to one another through online posts, distinct groups of connected users started to emerge. This pilot showed that a forum application within the cohort web platform was feasible and acceptable and fostered digital social interaction. Matching participants’ web-based social engagement with previously collected data at individual level in the PREDICT-PD study was feasible, showing potential for future analyses correlating online network characteristics with the risk of PD over time, as well as testing digital social engagement as an intervention to modify the risk of developing neurodegenerative diseases. Conclusions The results from the pilot suggest that an online forum can serve as an intervention to enhance social connectedness and investigate whether patterns of online engagement can impact the risk of developing PD through long-term follow-up. This highlights the potential of leveraging online platforms to study the role of social capital in moderating PD risk and underscores the feasibility of such approaches in future research or interventions.

Background 5.4 million people in the UK have asthma, with one third experiencing suboptimal control, leading to co-morbidities and increased healthcare use. A quarter of people with long-term conditions informally access peer support through online health communities (OHCs). However, integrating online peer support into primary care services to facilitate self-management is a new concept.Objectives To develop together with stakeholders the content, delivery, and recruitment strategy of a digital social intervention to promote use of online peer support amongst asthma patients in primary care.Methods Data was collected by qualitative, audio-recorded, one-to-one interviews with clinicians, and focus groups with patients with asthma from East London general practices. The topic guide was informed by patient and public involvement work. Data collected was iterative (i.e. new ideas were added to subsequent interviews and focus groups). Verbatim transcripts were uploaded to NVivo12 and thematically analysed.Results Twenty patients from several ethnicities participated across five focus groups, and three general practitioners and three practice nurses were interviewed. The study’s outputs included: the intervention’s face-to-face content; content of clinician training; patient-facing leaflets/material; and a survey to recruit eligible patients. An intervention consisting of a structured consultation with a primary care clinician followed by OHC engagement, was developed based on three generated themes: ‘introducing OHCs’, describing how clinicians should introduce OHCs; ‘OHC engagement’, describing factors influencing OHC engagement; and ‘clinician training’.Conclusion Findings will assist clinicians in consultations about supporting self-management of patients through OHCs. Future research should evaluate feasibility, effectiveness, and cost-effectiveness of such support.

Background:Online health communities (OHCs) enable patients to create social ties with people with similar health conditions outside their existing social networks. Harnessing mechanisms of information diffusion in OHCs has attracted attention for its ability to improve illness self-management without the use of health care resources. Objective:We aimed to analyze the novelty of a metaphor used for the first time in an OHC, assess how it can facilitate self-management of post-stroke symptoms, describe its appearance over time, and classify its diffusion mechanisms. Methods:We conducted a passive analysis of posts written by UK stroke survivors and their family members in an online stroke community between 2004 and 2011. Posts including the term "legacy of stroke" were identified. Information diffusion was classified according to self-promotion or viral spread mechanisms and diffusion depth (the number of users the information spreads out to). Linguistic analysis was performed through the British National Corpus and the Google search engine. Results:Post-stroke symptoms were referred to as "legacy of stroke." This metaphor was novel and appeared for the first time in the OHC in the second out of a total of 3459 threads. The metaphor was written by user A, who attributed it to a stroke consultant explaining post-stroke fatigue. This user was a "superuser" (ie, a user with high posting activity) and self-promoted the metaphor throughout the years in response to posts written by other users, in 51 separate threads. In total, 7 users subsequently used the metaphor, contributing to its viral diffusion, of which 3 were superusers themselves. Superusers achieved the higher diffusion depths (maximum of 3). Of the 7 users, 3 had been part of threads where user A mentioned the metaphor, while 2 users had been part of discussion threads in unrelated conversations. In total, 2 users had not been part of threads with any of the other users, suggesting that the metaphor was acquired through prior lurking activity. Conclusions:Metaphors that are considered helpful by patients with stroke to come to terms with their symptoms can diffuse in OHCs through both self-promotion and social (or viral) spreading, with the main driver of diffusion being the superuser trait. Lurking activity (the most common behavior in OHCs) contributed to the diffusion of information. As an increasing number of patients with long-term conditions join OHCs to find others with similar health-related concerns, improving clinicians' and researchers' awareness of the diffusion of metaphors that facilitate self-management in health social media may be beneficial beyond the individual patient.

The incidence of stroke in children is low, and pediatric stroke rehabilitation services are less developed than adult ones. Survivors of pediatric stroke have a long poststroke life expectancy and therefore have the potential to experience impairments from their stroke for many years. However, there are relatively few studies characterizing these impairments and what factors facilitate or counteract recovery.This study aims to characterize the main barriers to and facilitators of recovery from pediatric stroke. A secondary aim was to explore whether these factors last into adulthood, whether they change, or if new factors impacting recovery emerge in adulthood.We performed a qualitative thematic analysis based on posts from a population of participants from a UK-based online stroke community, active between 2004 and 2011. The analysis focused on users who talked about their experiences with pediatric stroke, as identified by a previous study. The posts were read by 3 authors, and factors influencing recovery from pediatric stroke were mapped into 4 areas: medical, physical, emotional, and social. Factors influencing recovery were divided into short-term and long-term factors.There were 425 posts relating to 52 survivors of pediatric stroke. Some survivors of stroke posted for themselves, while others were talked about by a third party (mostly parents; 31/35, 89% mothers). In total, 79% (41/52) of survivors of stroke were aged ≤18 years and 21% (11/52) were aged >18 years at the time of posting. Medical factors included comorbidities as a barrier to recovery. Medical interventions, such as speech and language therapy and physiotherapy, were also deemed useful. Exercise, particularly swimming, was deemed a facilitator. Among physical factors, fatigue and chronic pain could persist decades after a stroke, with both reported as a barrier to feeling fully recovered. Tiredness could worsen existing stroke-related impairments. Other long-standing impairments were memory loss, confusion, and dizziness. Among emotional factors, fear and uncertainty were short-term barriers, while positivity was a major facilitator in both short- and long-term recovery. Anxiety, grief, and behavioral problems hindered recovery. The social barriers were loneliness, exclusion, and hidden disabilities not being acknowledged by third parties. A good support network and third-party support facilitated recovery. Educational services were important in reintegrating survivors into society. Participants reported that worrying about losing financial support, such as disability allowances, and difficulties in obtaining travel insurance and driving licenses impacted recovery.The lived experience of survivors of pediatric stroke includes long-term hidden disabilities and barriers to rehabilitation. These are present in different settings, such as health care, schools, workplaces, and driving centers. Greater awareness of these issues by relevant professional groups may help ameliorate them.