Asynchronous digital health interventions for reviewing asthma: a mixed-methods systematic review protocol

INTRODUCTION: People living with asthma require regular reviews to address their concerns and questions, assess control, review medication, and support self-management. However, practical barriers to attending face-to-face consultations might limit routine reviews. Reviewing asthma using asynchronous digital health interventions could be convenient for patients and an efficient way of maintaining communication between patients and healthcare professionals and improving health outcomes. We, therefore, aim to conduct a mixed-methods systematic review to assess the effectiveness of reviewing asthma by asynchronous digital health interventions and explore the views of patients and healthcare professionals about the role of such interventions in delivering asthma care. METHODS: We will search MEDLINE, Embase, Scopus, PsycInfo, CINAHL, and Cochrane Library from 2001 to present without imposing any language restrictions. We are interested in studies of asynchronous digital health interventions used either as a single intervention or contributing to mixed modes of review. Two review authors will independently screen titles and abstracts, and retrieve potentially relevant studies for full assessment against the eligibility criteria and extract data. Disagreements will be resolved by discussion with the review team. We will use 'Downs and Black' checklist, 'Critical Appraisal Skills Programme', and 'Mixed Methods Appraisal Tool' to assess methodological quality of quantitative, qualitative, and mixed-methods studies respectively. After synthesising quantitative (narrative synthesis) and qualitative (thematic synthesis) data separately, we will integrate them following methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions. CONCLUSION: The findings of this review will provide insights into the role of asynchronous digital health interventions in the routine care of people living with asthma. TRIAL REGISTRATION: Systematic review registration: PROSPERO registration number: CRD42022344224

Examining the effectiveness of telemonitoring with routinely acquired blood pressure data in primary care: challenges in the statistical analysis

BackgroundScale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data.MethodsFour different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, “regression adjustment for propensity score” and “random coefficient modelling”. The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6–12 months follow-up prior to analysis. The fourth analysis used linear mixed modelling based on all available data.ResultsThe standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6–12 months follow-up (-4.06, 95% CI -6.30 to -1.82, p

Telemonitoring at scale for hypertension in primary care: An implementation study

BackgroundWhile evidence from randomised controlled trials shows that telemonitoring for hypertension is associated with improved blood pressure (BP) control, healthcare systems have been slow to implement it, partly because of inadequate integration with existing clinical practices and electronic records. Neither is it clear if trial findings will be replicated in routine clinical practice at scale. We aimed to explore the feasibility and impact of implementing an integrated telemonitoring system for hypertension into routine primary care.Methods and findingsThis was a quasi-experimental implementation study with embedded qualitative process evaluation set in primary care in Lothian, Scotland. We described the overall uptake of telemonitoring and uptake in a subgroup of representative practices, used routinely acquired data for a records-based controlled before-and-after study, and collected qualitative data from staff and patient interviews and practice observation. The main outcome measures were intervention uptake, change in BP, change in clinician appointment use, and participants’ views on features that facilitated or impeded uptake of the intervention. Seventy-five primary care practices enrolled 3,200 patients with established hypertension. In an evaluation subgroup of 8 practices (905 patients of whom 427 [47%] were female and with median age of 64 years [IQR 56–70, range 22–89] and median Scottish Index of Multiple Deprivation 2012 decile of 8 [IQR 6–10]), mean systolic BP fell by 6.55 mm Hg (SD 15.17), and mean diastolic BP by 4.23 mm Hg (SD 8.68). Compared with the previous year, participating patients made 19% fewer face-to-face appointments, compared with 11% fewer in patients with hypertension who were not telemonitoring. Total consultation time for participants fell by 15.4 minutes (SD 68.4), compared with 5.5 minutes (SD 84.4) in non-telemonitored patients. The convenience of remote collection of BP readings and integration of these readings into routine clinical care was crucial to the success of the implementation. Limitations include the fact that practices and patient participants were self-selected, and younger and more affluent than non-participating patients, and the possibility that regression to the mean may have contributed to the reduction in BP. Routinely acquired data are limited in terms of completeness and accuracy.ConclusionsTelemonitoring for hypertension can be implemented into routine primary care at scale with little impact on clinician workload and results in reductions in BP similar to those in large UK trials. Integrating the telemonitoring readings into routine data handling was crucial to the success of this initiative

Are self-reported telemonitored blood pressure readings affected by end-digit preference: a prospective cohort study in Scotland

Objective Simple forms of blood pressure (BP) telemonitoring require patients to text readings to central servers creating an opportunity for both entry error and manipulation. We wished to determine if there was an apparent preference for particular end digits and entries which were just below target BPs which might suggest evidence of data manipulation. Design Prospective cohort studySetting 37 socio-economically diverse primary care practices from South East NHS Lothian, Scotland.Participants Patients were recruited with hypertension to a telemonitoring service in which patients submitted home BP readings by manually transcribing the measurements into text messages for transmission (‘patient-texted system’). These readings were compared to those from primary care patients with uncontrolled hypertension using a system in which readings were automatically transmitted, eliminating the possibility of manipulation of values (‘automatic-transmission system’).Methods A Generalised Estimating Equations method was used to compare BP readings between the patient-texted and automatic-transmission systems, while taking into account clustering of readings within patients.Results A total of 44,150 BP readings were analysed on 1,068 patients using the patient-texted system compared to 20,705 readings on 199 patients using the automatic-transmission system. Compared to the automatic-transmission data, the patient-texted data showed a significantly higher proportion of occurrences of both systolic and diastolic BP having a zero end digit (OR 2.1, 95% CI 1.7 to 2.6) although incidence was less than 2% of readings. Similarly, there was a preference for systolic 134 and diastolic 84 (the threshold for alerts was 135/85) (134 systolic BP OR 1.52, 95% CI 1.28 to 1.82; 84 diastolic BP OR 1.54, 95% CI 1.28 to 1.86). Conclusion End-digit preference for zero numbers and specific value preference for readings just below the alert threshold exists among patients self-reporting their BP using telemonitoring. However, the proportion of readings affected is small and unlikely to be clinically important

Prevalence and risk factors for long COVID among adults in Scotland using electronic health records : a national, retrospective, observational cohort study

Acknowledgements This work was supported by the Chief Scientist Office, grant number COV/LTE/20/15. EAVE II is supported by a grant (MC_PC_19075) from the Medical Research Council; and a grant (MC_PC_19004) from BREATHE–The Health Data Research Hub for Respiratory Health, funded through the UK Research and Innovation Industrial Strategy Challenge Fund. LD was supported by a post-doctoral clinical fellowship from the Asthma UK Centre for Applied Research. SVK acknowledges funding from a NRS Senior Clinical Fellowship (SCAF/15/02), the Medical Research Council (MC_UU_00022/2) and the Scottish Government Chief Scientist Office (SPHSU17). The authors would like to acknowledge the support of Dave Kelly and Lamorna Brown of Albasoft Ltd., and Sharon Kennedy, Mike Birnie, Safraj Shahul Hameed and Elliott Hall of Public Health Scotland for their involvement in obtaining approvals, provisioning, and linking data and the use of the secure analytical platform within the National Safe Haven. Funding Chief Scientist Office (Scotland), Medical Research Council, and BREATHE.Peer reviewe

Impact of COVID-19 lockdown on the incidence and mortality of acute exacerbations of chronic obstructive pulmonary disease: national interrupted time series analyses for Scotland and Wales

The COVID-19 pandemic and ensuing national lockdowns have dramatically changed the healthcare landscape. The pandemic’s impact on people with chronic obstructive pulmonary disease (COPD) remains poorly understood. We hypothesised that the UK-wide lockdown restrictions were associated with reductions in severe COPD exacerbations. We provide the first national level analyses of the impact of the COVID-19 pandemic and first lockdown on severe COPD exacerbations resulting in emergency hospital admissions and/or leading to death as well as those recorded in primary care or emergency departments

Prevalence and risk factors for long COVID among adults in Scotland using electronic health records : a national, retrospective, observational cohort study

Background: Long COVID is a debilitating multisystem condition. The objective of this study was to estimate the prevalence of long COVID in the adult population of Scotland, and to identify risk factors associated with its development. Methods: In this national, retrospective, observational cohort study, we analysed electronic health records (EHRs) for all adults (≥18 years) registered with a general medical practice and resident in Scotland between March 1, 2020, and October 26, 2022 (98–99% of the population). We linked data from primary care, secondary care, laboratory testing and prescribing. Four outcome measures were used to identify long COVID: clinical codes, free text in primary care records, free text on sick notes, and a novel operational definition. The operational definition was developed using Poisson regression to identify clinical encounters indicative of long COVID from a sample of negative and positive COVID-19 cases matched on time-varying propensity to test positive for SARS-CoV-2. Possible risk factors for long COVID were identified by stratifying descriptive statistics by long COVID status. Findings: Of 4,676,390 participants, 81,219 (1.7%) were identified as having long COVID. Clinical codes identified the fewest cases (n = 1,092, 0.02%), followed by free text (n = 8,368, 0.2%), sick notes (n = 14,469, 0.3%), and the operational definition (n = 64,193, 1.4%). There was limited overlap in cases identified by the measures; however, temporal trends and patient characteristics were consistent across measures. Compared with the general population, a higher proportion of people with long COVID were female (65.1% versus 50.4%), aged 38–67 (63.7% versus 48.9%), overweight or obese (45.7% versus 29.4%), had one or more comorbidities (52.7% versus 36.0%), were immunosuppressed (6.9% versus 3.2%), shielding (7.9% versus 3.4%), or hospitalised within 28 days of testing positive (8.8% versus 3.3%%), and had tested positive before Omicron became the dominant variant (44.9% versus 35.9%). The operational definition identified long COVID cases with combinations of clinical encounters (from four symptoms, six investigation types, and seven management strategies) recorded in EHRs within 4–26 weeks of a positive SARS-CoV-2 test. These combinations were significantly (p < 0.0001) more prevalent in positive COVID-19 patients than in matched negative controls. In a case-crossover analysis, 16.4% of those identified by the operational definition had similar healthcare patterns recorded before testing positive. Interpretation:The prevalence of long COVID presenting in general practice was estimated to be 0.02–1.7%, depending on the measure used. Due to challenges in diagnosing long COVID and inconsistent recording of information in EHRs, the true prevalence of long COVID is likely to be higher. The operational definition provided a novel approach but relied on a restricted set of symptoms and may misclassify individuals with pre-existing health conditions. Further research is needed to refine and validate this approach

Prevalence and risk factors for long COVID among adults in Scotland using electronic health records: a national, retrospective, observational cohort study.

Background: Long COVID is a debilitating multisystem condition. The objective of this study was to estimate the prevalence of long COVID in the adult population of Scotland, and to identify risk factors associated with its development. Methods: In this national, retrospective, observational cohort study, we analysed electronic health records (EHRs) for all adults (≥18 years) registered with a general medical practice and resident in Scotland between March 1, 2020, and October 26, 2022 (98–99% of the population). We linked data from primary care, secondary care, laboratory testing and prescribing. Four outcome measures were used to identify long COVID: clinical codes, free text in primary care records, free text on sick notes, and a novel operational definition. The operational definition was developed using Poisson regression to identify clinical encounters indicative of long COVID from a sample of negative and positive COVID-19 cases matched on time-varying propensity to test positive for SARS-CoV-2. Possible risk factors for long COVID were identified by stratifying descriptive statistics by long COVID status. Findings: Of 4,676,390 participants, 81,219 (1.7%) were identified as having long COVID. Clinical codes identified the fewest cases (n = 1,092, 0.02%), followed by free text (n = 8,368, 0.2%), sick notes (n = 14,469, 0.3%), and the operational definition (n = 64,193, 1.4%). There was limited overlap in cases identified by the measures; however, temporal trends and patient characteristics were consistent across measures. Compared with the general population, a higher proportion of people with long COVID were female (65.1% versus 50.4%), aged 38–67 (63.7% versus 48.9%), overweight or obese (45.7% versus 29.4%), had one or more comorbidities (52.7% versus 36.0%), were immunosuppressed (6.9% versus 3.2%), shielding (7.9% versus 3.4%), or hospitalised within 28 days of testing positive (8.8% versus 3.3%%), and had tested positive before Omicron became the dominant variant (44.9% versus 35.9%). The operational definition identified long COVID cases with combinations of clinical encounters (from four symptoms, six investigation types, and seven management strategies) recorded in EHRs within 4–26 weeks of a positive SARS-CoV-2 test. These combinations were significantly (p &lt; 0.0001) more prevalent in positive COVID-19 patients than in matched negative controls. In a case-crossover analysis, 16.4% of those identified by the operational definition had similar healthcare patterns recorded before testing positive. Interpretation: The prevalence of long COVID presenting in general practice was estimated to be 0.02–1.7%, depending on the measure used. Due to challenges in diagnosing long COVID and inconsistent recording of information in EHRs, the true prevalence of long COVID is likely to be higher. The operational definition provided a novel approach but relied on a restricted set of symptoms and may misclassify individuals with pre-existing health conditions. Further research is needed to refine and validate this approach

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca