Introduction There is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. Methods and analysis PANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). Eligibility criteria: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18–49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial. Ethics and dissemination Ethical approval granted by South Central–Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals. Trial registration number ISRCTN30448031 ; EudraCT number: 2021-005748-31.

Background: The COVID-19 pandemic has accelerated adoption of remote consulting in healthcare. Despite opportunities posed by telemedicine, most hypertension services in Europe have suspended ambulatory blood pressure monitoring (ABPM). Methods: We examined the process and performance of remotely delivered ABPM using two methodologies: firstly, a Failure Modes and Effects Analysis (FMEA) and secondly, a quantitative analysis comparing ABPM data from a subgroup of 65 participants of the Screening for Hypertension in the INpatient Environment (SHINE) diagnostic accuracy study. The FMEA was performed over seven sessions from February to March 2021, with a multidisciplinary team comprising a patient representative, a research coordinator with technical expertise and four research clinicians. Results: The FMEA identified a single high-risk step in the remote ABPM process. This was cleaning of monitoring equipment in the context of the COVID-19 pandemic, unrelated to the remote setting. A total of 14 participants were scheduled for face-to-face ABPM appointments, before the UK March 2020 COVID-19 lockdown; 62 were scheduled for remote ABPM appointments since emergence of the COVID-19 pandemic between November 2020 and August 2021. A total of 65 (88%) participants completed ABPMs; all obtained sufficient successful measurements for interpretation. For the 10 participants who completed face-to-face ABPM, there were 402 attempted ABPM measurements and 361 (89%) were successful. For the 55 participants who completed remote ABPM, there were 2516 attempted measurements and 2214 (88%) were successful. There was no significant difference in the mean per-participant error rate between face-to-face (0.100, SD 0.009) and remote (0.143, SD 0.132) cohorts (95% CI for the difference -0.125 to 0.045 and two-tailed P-value 0.353). Conclusions: We have demonstrated that ABPM can be safely and appropriately provided in the community remotely and without face-to-face contact, using video technology for remote fitting appointments, alongside courier services for delivery of equipment to participants.

Background: The safety, effectiveness and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, in patients in the community who are multiply-vaccinated and at increased risk of morbidity and mortality from COVID-19, has not been established. We aimed to determine whether molnupiravir added to usual care reduced hospital admissions/deaths among people at higher risk from COVID-19, and here report our preliminary analyses.Methods: Participants in this UK multicentre, open-label, adaptive, multi-arm, platform, randomised controlled trial were aged ≥50, or ≥18 years with comorbidities, and unwell ≤5 days with confirmed COVID-19 in the community, and were randomised to usual care or usual care plus molnupiravir (800mg twice daily for 5 days). The primary outcome measure was all-cause hospitalisation/death within 28 days, analysed using Bayesian models. The main secondary outcome measure was time to first self-reported recovery. A sub-set of participants in each group were assessed for the virology primary outcome measure of day seven SARS-CoV-2 viral load. Trial registration: ISRCTN30448031Findings: Between December 8, 2021 and April 27, 2022, 25783 participants were randomised to molnupiravir plus usual care (n=12821) or usual care alone (n=12962). Mean (range) age of participants was 56·6 years (18 to 99), 58·6% were female, and 99% had at least one dose of a SARS-CoV-2 vaccine. The median duration of symptoms prior to randomisation was two days (IQR 1 – 3), the median number of days from symptom onset to starting to take the medication was three days (IQR 3 – 4), 87% (11109/11997) received their medication within five days of symptom onset, and 95·4% (n=11857) of participants randomised to molnupiravir reported taking molnupiravir for five days. Primary outcome measure data were available in 25000 (97%) participants and included in this analysis. 103/12516 (0·8%) hospitalisations/deaths occurred in the molnupiravir group versus 96/12484 (0·8%) in usual care alone with a posterior probability of superiority of 0·34 (adjusted odds ratio 1·061 (95% Bayesian credible interval [BCI]) 0·80 to 1·40). Estimates were similar for all subgroups. The observed median (IQR) time-to-first-recovery from randomisation was 9 (5–23) days in molnupiravir and 15 (7–not reached) days in usual care. There was an estimated benefit of 4·2 (95% BCI: 3·8 – 4·6) days in time-to-first-recovery (TTR) giving a posterior probability of superiority of >0·999 (estimated median TTR 10·3 [10·2 – 10·6] days vs 14·5 [14·2 – 14·9] days respectively; hazard ratio [95% BCI], 1·36 [1·3–1·4] days), which met the pre-specified superiority threshold. On day 7, SARS-CoV-2 virus was below detection levels in 7/34 (21%) of the molnupiravir group, versus 1/39 (3%) in the usual care group (p=0.039), and mean viral load was lower in the molnupiravir group compared with those receiving usual care [(SD) of log10(viral load) 3·82 (1·40) in the molnupiravir group and 4.93 (1·38) in the usual care group, (P<0·001)]. 59 (0·4%) participants experienced serious adverse events in the molnupiravir group and 52 (0·4%) in usual care. Interpretation: In this preliminary analysis, we found that molnupiravir did not reduce already low hospitalisations/deaths among higher risk, vaccinated adults with COVID-19 in the community, but resulted in faster time to recovery, and reduced viral detection and load.Funding: This project is funded by the NIHR (NIHR135366). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Background Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone–based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. Objective The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. Methods The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4–percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. Results The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. Conclusions This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. Trial Registration ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379 International Registered Report Identifier (IRRID) DERR1-10.2196/32918

Background Azithromycin, an antibiotic with potential antiviral and anti-inflammatory properties, has been used to treat COVID-19, but evidence from community randomised trials is lacking. We aimed to assess the effectiveness of azithromycin to treat suspected COVID-19 among people in the community who had an increased risk of complications. Methods In this UK-based, primary care, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in people at increased risk of an adverse clinical course (PRINCIPLE), we randomly assigned people aged 65 years and older, or 50 years and older with at least one comorbidity, who had been unwell for 14 days or less with suspected COVID-19, to usual care plus azithromycin 500 mg daily for three days, usual care plus other interventions, or usual care alone. The trial had two coprimary endpoints measured within 28 days from randomisation: time to first self-reported recovery, analysed using a Bayesian piecewise exponential, and hospital admission or death related to COVID-19, analysed using a Bayesian logistic regression model. Eligible participants with outcome data were included in the primary analysis, and those who received the allocated treatment were included in the safety analysis. The trial is registered with ISRCTN, ISRCTN86534580. Findings The first participant was recruited to PRINCIPLE on April 2, 2020. The azithromycin group enrolled participants between May 22 and Nov 30, 2020, by which time 2265 participants had been randomly assigned, 540 to azithromycin plus usual care, 875 to usual care alone, and 850 to other interventions. 2120 (94%) of 2265 participants provided follow-up data and were included in the Bayesian primary analysis, 500 participants in the azithromycin plus usual care group, 823 in the usual care alone group, and 797 in other intervention groups. 402 (80%) of 500 participants in the azithromycin plus usual care group and 631 (77%) of 823 participants in the usual care alone group reported feeling recovered within 28 days. We found little evidence of a meaningful benefit in the azithromycin plus usual care group in time to first reported recovery versus usual care alone (hazard ratio 1.08, 95% Bayesian credibility interval [BCI] 0.95 to 1.23), equating to an estimated benefit in median time to first recovery of 0.94 days (95% BCI -0.56 to 2.43). The probability that there was a clinically meaningful benefit of at least 1.5 days in time to recovery was 0.23. 16 (3%) of 500 participants in the azithromycin plus usual care group and 28 (3%) of 823 participants in the usual care alone group were hospitalised (absolute benefit in percentage 0.3%, 95% BCI -1.7 to 2.2). There were no deaths in either study group. Safety outcomes were similar in both groups. Two (1%) of 455 participants in the azothromycin plus usual care group and four (1%) of 668 participants in the usual care alone group reported admission to hospital during the trial, not related to COVID-19. Interpretation Our findings do not justify the routine use of azithromycin for reducing time to recovery or risk of hospitalisation for people with suspected COVID-19 in the community. These findings have important antibiotic stewardship implications during this pandemic, as inappropriate use of antibiotics leads to increased antimicrobial resistance, and there is evidence that azithromycin use increased during the pandemic in the UK. Copyright (C) 2021 The Author(s). Published by Elsevier Ltd.

Introduction There is an urgent need to idenfy treatments for COVID-19 that reduce illness duration and hospital admission in those at higher risk of a longer illness course and complications. Methods and analysis The Platform Randomised trial of INterventions against COVID-19 In older peoPLE trial is an open-label, multiarm, prospective, adaptive platform, randomised clinical trial to evaluate potential treatments for COVID-19 in the community. A master protocol governs the addition of new interventions as they become available, as well as the inclusion and cessation of existing intervention arms via frequent interim analyses. The first three interventions are hydroxychloroquine, azithromycin and doxycycline. Eligible participants must be symptomatic in the community with possible or confirmed COVID-19 that started in the preceding 14 days and either (1) aged 65 years and over or (2) aged 50–64 years with comorbidities. Recruitment is through general practice, health service helplines, COVID-19 ‘hot hubs’ and directly through the trial website. Participants are randomised to receive either usual care or a study drug plus usual care, and outcomes are collected via daily online symptom diary for 28 days from randomisation. The research team contacts participants and/or their study partner following days 7, 14 and 28 if the online diary is not completed. The trial has two coprimary endpoints: time to first self-report of feeling recovered from possible COVID-19 and hospital admission or death from possible COVID-19 infection, both within 28 days from randomisation. Prespecified interim analyses assess efficacy or futility of interventions and to modify randomisation probabilities that allocate more participants to interventions with better outcomes. Ethics and dissemination Ethical approval Ref: 20/SC/0158 South Central - Berkshire Research Ethics Committee; IRAS Project ID: 281958; EudraCT Number: 2020-001209-22. Results will be presented to policymakers and at conferences and published in peer-reviewed journals. Trial registration number ISRCTN86534580.

Background: Care homes are an increasingly important sector of care. Care home residents are particularly vulnerable to infections and are often prescribed antibiotics, driving antibiotic resistance. Probiotics may be a cheap and safe way to reduce antibiotic use. Efficacy and possible mechanisms of action are yet to be rigorously evaluated in this group. Objective: The objective was to evaluate efficacy and explore mechanisms of action of a daily oral probiotic combination in reducing antibiotic use and infections in care home residents. Design: This was a multicentre, parallel, individually randomised, placebo-controlled, double-blind trial, with qualitative evaluation and mechanistic studies. Setting: A total of 310 care home residents were randomised from 23 UK care homes (from December 2016 to May 2018). Participants: The participants were care home residents aged ≥ 65 years who were willing and able to give informed consent or, if they lacked capacity to consent, had a consultee to advise about participation on their behalf. Intervention: A daily capsule containing an oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 (n = 155) or matched placebo (n = 155) for up to 1 year. Main outcome measures: The primary outcome was cumulative systemic antibiotic administration days for all-cause infections. Secondary outcomes included incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations and the detection of resistant Enterobacterales cultured from stool samples (not exclusively). Methods: Participants were randomised (1 : 1) to receive capsules containing probiotic or matched placebo. Minimisation was implemented for recruiting care home and care home resident sex. Care home residents were followed up for 12 months with a review by a research nurse at 3 months and at 6–12 months post randomisation. Care home residents, consultees, care home staff and all members of the trial team, including assessors and statisticians, were blinded to group allocation. Results: Care home residents who were randomised to probiotic had a mean 12.9 cumulative systemic antibiotic administration days (standard error 1.49 days) (n = 152) and care home residents randomised to placebo had a mean 12.0 cumulative systemic antibiotic administration days (standard error 1.50 days) (n = 153) (adjusted incidence rate ratio = 1.13, 95% confidence interval 0.79 to 1.63; p = 0.495). There was no evidence of any beneficial effects on incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations, the detection of resistant Enterobacterales cultured from stool samples or other secondary outcomes. There was no evidence that this probiotic combination improved blood immune cell numbers, subtypes or responses to seasonal influenza vaccination. Conclusions: Care home residents did not benefit from daily consumption of a combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 to reduce antibiotic consumption. Limitations: Limitations included the following: truncated follow-up of some participants; higher than expected probiotics in stool samples at baseline; fewer events than expected meant that study power may have been lower than anticipated; standard infection-related definitions were not used; and findings are not necessarily generalisable because effects may be strain specific and could vary according to patient population. Future work: Future work could involve further rigorous efficacy, mechanisms and effectiveness trials of other probiotics in other population groups and settings regarding antibiotic use and susceptibility to and recovery from infections, in which potential harms should be carefully studied. Trial registration: Current Controlled Trials ISRCTN16392920. Funding: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

ImportanceProbiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.ObjectiveTo determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.Design, Setting, and ParticipantsPlacebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.InterventionsStudy participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.Main Outcomes and MeasuresThe primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.ResultsAmong 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.Conclusions and RelevanceAmong care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.Trial RegistrationISRCTN Identifier:16392920.

BackgroundRespiratory syncytial virus (RSV) infection in older adults is recognised as an important health issue. We aimed to assess the community burden of RSV in Europe in older adults aged ≥60 years.MethodsThis international, prospective, observational cohort study is part of work by the REspiratory Syncytial virus Consortium in EUrope (RESCEU). Participants were recruited through general practitioners' (GPs) offices before two independent RSV seasons. Participants reported weekly about symptoms of acute respiratory tract infection (ARTI) during one RSV season. ARTI patients were tested for RSV during home visits and completed a daily symptom diary. RSV illness included PCR-confirmed ARTI and those showing seroconversion over the season. RSV ARTI was based on PCR alone (ClinicalTrials.gov,NCT03621930).ResultsWe recruited 1040 participants (527 in season 2017–2018 and 513 in season 2018–2019) with a median age of 75 years (range 60–100 years). Of these, 1023 (99%) lived independently at home at baseline. RSV illness incidence was 22 out of 527 (4.2%) and 37 out of 513 (7.2%) in the respective seasons. RSV illness did not affect frailty or cardiopulmonary status during the course of the study. No patients were hospitalised or died from RSV illness. In the 36 patients with PCR confirmed RSV ARTI, symptom duration averaged 19 days, while a doctor's visit took place in 11 out of 36 cases (31%). RSV ARTI could not be differentiated clinically from all other ARTIs based on symptoms.ConclusionThis European study showed that RSV is prevalent in community-dwelling older adults and rarely causes severe disease. This suggests that watchful waiting, using a continuity of care approach to identify those who do need more intensive care, is often justified when RSV is suspected in family practice.

Background: Co-morbid anxiety and depression can add to the complexity of chronic obstructive pulmonary disease (COPD). While digital health technologies for people with COPD support monitoring of vital signs (including oxygen saturation and pulse), mood is not routinely monitored even though it could support self-management. Aim: To report adherence to mood self-monitoring and levels of anxiety and depression for people with COPD. Methods: The sElf-management anD support proGrammE (EDGE) was a 12-month randomised controlled trial involving people with COPD. Participants were asked to complete an anxiety (General Anxiety Disorder, GAD) and depression questionnaire (Patient Health Questionnaire, PHQ) every 4 weeks via a tablet computer. Health status (EuroQol 5 Dimensions, EQ5D), respiratory impairment (St George’s Respiratory Questionnaire-COPD, SGRQ-C) and smoking status were recorded. Answering ≥10 of 12 months was adherent and PHQ and GAD scores of ≥5 positive. Results: Of 106 (99%) participants entering mood data, 81 participants were adherent. There were more ex-smokers in the adherent participant pool (n=71 of 81) compared with the non-adherent participants (n=13 of 25); p<0.001. Participants with positive PHQ and GAD scores (n=56) compared with those without (n=22) had EQ5D scores of mean±SD 0.6±0.2 and 0.7±0.2, respectively, and SGRQ-C scores of 62±19 and 50±16, respectively; both p<0.05. Conclusions: People with COPD can self-monitor mood over 12 months. With >50% of participants suggesting an elevated risk of both anxiety and depression (associated with a lower health status and higher respiratory impairment), the opportunity to regularly monitor mood in this patient population could offer useful information for comorbidity management.

BACKGROUND:Comorbid anxiety and depression can add to the complexity of managing treatment for people living with chronic obstructive pulmonary disease (COPD). Monitoring mood has the potential to identify individuals who might benefit from additional support and treatment.OBJECTIVE:We used data from the sElf-management anD support proGrammE (EDGE) trial to examine: (1) the extent to which the mood-monitoring components of a mobile health system for patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring.METHODS:A total of 107 men and women with a clinical diagnosis of COPD, aged ≥40 years old, were recruited to the intervention arm of the EDGE trial. Participants were invited to complete the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 test every four weeks using a tablet computer. Mood disturbance based on these measures was defined as a score ≥5 on either scale. Participants reporting a mood disturbance were automatically directed (signposted) to a stress or mood management video. Study outcomes included measures of health status, respiratory quality of life, and symptoms of anxiety and depression.RESULTS:Overall, 94 (87.9%) participants completed the 12-month study. A total of 80 participants entered at least one response each month for at least ten months. On average, 16 participants (range 8-38 participants) entered ≥2 responses each month. Of all the participants, 47 (50%) gave responses indicating a mood disturbance. Participants with a mood disturbance score for both scales (n=47) compared with those without (n=20) had lower health status (P=.008), lower quality of life (P=.009), and greater anxiety (P<.001) and increased depression symptoms (P<.001). Videos were viewed by 64 (68%) people over 12 months. Of the 220 viewing visualizations, 70 (34.7%) began after being signposted. Participants signposted to the stress management video (100%; IQR 23.3-100%) watched a greater proportion of it compared to those not signposted (38.4%; IQR 16.0-68.1%; P=.03), whereas duration of viewing was not significantly different for the mood management video.CONCLUSIONS:Monitoring of anxiety and depression symptoms for people with COPD is feasible. More than half of trial participants reported scores indicating a mood disturbance during the study. Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video. The opportunity to elicit measures of mood regularly as part of a health monitoring system could contribute to better care for people with COPD.

Recent telehealth studies have demonstrated minor impact on patients affected by long-term conditions. The use of technology does not guarantee the compliance required for sustained collection of high-quality symptom and physiological data. Remote monitoring alone is not sufficient for successful disease management. A patient-centred design approach is needed in order to allow the personalisation of interventions and encourage the completion of daily self-management tasks.

Background We conducted a randomized controlled trial of a digital health system supporting clinical care through monitoring and self-management support in community-based patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Objective The aim of this study was to determine the efficacy of a fully automated Internet-linked, tablet computer-based system of monitoring and self-management support (EDGE‚ sElf-management anD support proGrammE) in improving quality of life and clinical outcomes. Methods We compared daily use of EDGE with usual care for 12 months. The primary outcome was COPD-specific health status measured with the St George’s Respiratory Questionnaire for COPD (SGRQ-C). Results A total of 166 patients were randomized (110 EDGE, 56 usual care). All patients were included in an intention to treat analysis. The estimated difference in SGRQ-C at 12 months (EDGE−usual care) was −1.7 with a 95% CI of −6.6 to 3.2 (P=.49). The relative risk of hospital admission for EDGE was 0.83 (0.56-1.24, P=.37) compared with usual care. Generic health status (EQ-5D, EuroQol 5-Dimension Questionnaire) between the groups differed significantly with better health status for the EDGE group (0.076, 95% CI 0.008-0.14, P=.03). The median number of visits to general practitioners for EDGE versus usual care were 4 versus 5.5 (P=.06) and to practice nurses were 1.5 versus 2.5 (P=.03), respectively. Conclusions The EDGE clinical trial does not provide evidence for an effect on COPD-specific health status in comparison with usual care, despite uptake of the intervention. However, there appears to be an overall benefit in generic health status; and the effect sizes for improved depression score, reductions in hospital admissions, and general practice visits warrants further evaluation and could make an important contribution to supporting people with COPD. Trial registration International Standard Randomized Controlled Trial Number (ISRCTN): 40367841; http://www.isrctn.com/ISRCTN40367841 (Archived by WebCite at http://www.webcitation.org/6pmfIJ9KK)

BACKGROUND:Self-management strategies have the potential to support patients with chronic obstructive pulmonary disease (COPD). Telehealth interventions may have a role in delivering this support along with the opportunity to monitor symptoms and physiological variables. This paper reports findings from a six-month, clinical, cohort study of COPD patients' use of a mobile telehealth based (mHealth) application and how individually determined alerts in oxygen saturation levels, pulse rate and symptoms scores related to patient self-initiated treatment for exacerbations.METHODS:The development of the mHealth intervention involved a patient focus group and multidisciplinary team of researchers, engineers and clinicians. Individual data thresholds to set alerts were determined, and the relationship to exacerbations, defined by the initiation of stand-by medications, was measured. The sample comprised 18 patients (age range of 50-85 years) with varied levels of computer skills.RESULTS:Patients identified no difficulties in using the mHealth application and used all functions available. 40% of exacerbations had an alert signal during the three days prior to a patient starting medication. Patients were able to use the mHealth application to support self- management, including monitoring of clinical data. Within three months, 95% of symptom reporting sessions were completed in less than 100 s.CONCLUSIONS:Home based, unassisted, daily use of the mHealth platform is feasible and acceptable to people with COPD for reporting daily symptoms and medicine use, and to measure physiological variables such as pulse rate and oxygen saturation. These findings provide evidence for integrating telehealth interventions with clinical care pathways to support self-management in COPD.

INTRODUCTION:The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. METHODS AND ANALYSIS:The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. ETHICS AND DISSEMINATION:The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations. TRIAL REGISTRATION:Current controlled trials ISRCTN40367841.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive chronic disease, predicted to become the third leading cause of death by 2030. COPD patients are at risk of sudden and acute worsening of symptoms, reducing the patient's quality of life and leading to hospitalization. We present the results of a pilot study with 18 COPD patients using an m-Health system, based on a tablet computer and pulse oximeter, for a period of six months. For prioritizing patients for clinical review, a data-driven approach has been developed which generates personalized alerts using the electronic symptom diary, pulse rate, blood oxygen saturation, and respiratory rate derived from oximetry data. This work examines the advantages of multivariate novelty detection over univariate approaches and shows the benefit of including respiratory rate as a predictor.

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease predicted to become the third leading cause of death by 2030. Patients with COPD are at risk of exacerbations in their symptoms, which have an adverse effect on their quality of life and may require emergency hospital admission. Using the results of a pilot study of an m-Health system for COPD self-management and tele-monitoring, we demonstrate a data-driven approach for computing personalised alert thresholds to prioritise patients for clinical review. Univariate and multivariate methodologies are used to analyse and fuse daily symptom scores, heart rate, and oxygen saturation measurements. We discuss the benefits of a multivariate kernel density estimator which improves on univariate approaches.

BackgroundTelehealth shows promise for supporting patients in managing their long-term health conditions, such as chronic obstructive pulmonary disease (COPD). However, it is currently unclear how patients, and particularly older people, may benefit from these technological interventions.AimTo explore patients' expectations and experiences of using a mobile telehealth-based (mHealth) application and to determine how such a system may impact on their perceived wellbeing and ability to manage their COPD.Design and settingEmbedded qualitative study using interviews with patients with COPD from various community NHS services: respiratory community nursing service, general practice, and pulmonary rehabilitation.MethodAn embedded qualitative study was conducted to which patients were recruited using purposive sampling to achieve maximum variation. Interviews were carried out prior to receiving the mHealth system and again after a 6-month period. Data were analysed using a grounded theory approach.ResultsThe sample comprised 19 patients (aged 50-85 years) with varied levels of computer skills. Patients identified no difficulties in using the mHealth application. The main themes encapsulating patients' experience of using the mHealth application related to an increased awareness of the variability of their symptoms (onset of exacerbation and recovery time) and reassurance through monitoring (continuity of care).ConclusionPatients were able to use the mHealth application, interpret clinical data, and use these within their self-management approach regardless of previous knowledge. Telehealth interventions can complement current clinical care pathways to support self-management behaviour.