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Association between maternal body mass index and hospital admissions for infection in offspring: longitudinal cohort study.
OBJECTIVE: To investigate the relation between maternal body mass index and hospital admissions for infections in their offspring, and to identify potentially modifiable mediators. DESIGN: Longitudinal cohort study. SETTING: Born in Bradford longitudinal, multi-ethnic birth cohort, Bradford, UK. Secondary analysis linked to routine hospital admission data, January 2007 to 3 October 2022. PARTICIPANTS: 9540 singleton births between 2007 and 2011, born to 9037 mothers, followed up from birth to about age 15 years. MAIN OUTCOME MEASURES: Total number of hospital admissions related to infections, between birth and age 15 years, in age categories <1 year, 1-4 years, and 5-15 years. RESULTS: The main study cohort comprised 9540 children and 9037 mothers. About 56% of mothers were overweight or obese. First trimester maternal body mass index was positively associated with rates of hospital admissions for infection across all ages, but associations were significant (P<0.05) only for children born to women with the highest body mass index (obesity grades 2-3). Compared with women with a healthy body mass index, children born to women with obesity grades 2-3 had an adjusted rate ratio of 1.41 (95% confidence interval 1.13 to 1.77) at <1 year and an adjusted rate ratio of 1.53 (1.19 to 1.98) for hospital admissions for infection by age 5-15 years. Similar trends were seen for respiratory and gastrointestinal infections, and multisystem viral infections. Being born by caesarean section and child obesity at aged 4-5 years accounted for 21% and 26% of the association, respectively. CONCLUSIONS: In this study, a modest but consistent association between maternal obesity (grades 2-3) and hospital admissions for infection throughout childhood was found. Healthcare professionals and public health campaigns should continue to support mothers to achieve and maintain a healthy body weight before conception and during the postpartum period.
Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa.
INTRODUCTION: Point-of-care (POC) urine tenofovir (TFV) tests can provide timely information regarding antiretroviral therapy (ART) adherence to support management of HIV treatment in clinics. However, there are limited data on the costs and feasibility of integrating POC testing into HIV clinics in sub-Saharan Africa. We characterized clinic flow and implementation costs of POC adherence testing for persons initiating ART in HIV care clinics in South Africa. METHODS: We conducted a microcosting within a randomized controlled implementation trial of POC TFV test in government clinics in Durban, South Africa (STREAM HIV). Time-and-motion observation was conducted between 1st March and 31st December 2022, to assess staff and client time needed for POC TFV testing and counselling. We estimated both financial and economic costs for capital, clinic consumables and personnel using a provider (national government) perspective. RESULTS: The estimated cost of POC TFV was USD $13 per client, assuming a clinic volume of 20 individuals initiating ART per month. The largest component costs of POC TFV testing were the test strip consumables, which accounted for 53% of the test cost. The median total time of a clinic visit with a POC TFV test, starting from client registration, was 49:19 (minutes: seconds) (IQR: 29:19-89:35). TFV testing took 9:22 (IQR: 7:35-14:11), taking up 19% of the total clinic visit time, including sample collection, sample loading, TFV test processing and counselling provision based on test results. Overall, 29% of the clinic visit time included direct clinical care and assessment with a provider, with clients spending a median 14:09 (IQR: 10:35-21:22) getting vitals checked, receiving adherence monitoring via POC TFV testing, and collecting their ART refill. Waiting in line for ART took most (48%) of the clinic visit time. CONCLUSIONS: POC TFV testing can be administered at reasonable costs, requires less than 10 minutes of healthcare provider time, and, therefore, may be feasible to implement in South African clinics. Findings can inform policy and budgetary planning for ART monitoring in South Africa and future cost-effectiveness analyses of POC TFV testing. CLINICAL TRIAL NUMBER: NCT04341779.
Using qualitative research and the person-based approach to coproduce an inclusive intervention for postpartum blood pressure self-management
Objective To coproduce an inclusive intervention for blood pressure (BP) self-management post partum. Design Using the person-based approach, an intervention was coproduced in three phases. Phase 1 entailed intervention coproduction with a diverse patient and public involvement panel and stakeholders (clinical, academic, government and third sector-based). Phase 2 involved intervention optimisation through think-Aloud interviews with former patients and clinicians. Phase 3 was user-Testing followed by semistructured interviews with current patients and their clinicians. Setting Patients and clinicians from primary and secondary care drawn from Southern and Northern England. Participants Seven former patients and 11 clinicians participated in think-Aloud interviews to provide their views of intervention prototypes (phase 2). Additionally, 23 patients and 9 of their clinicians participated in semistructured interviews after using the intervention for 2 weeks (phase 3). Intervention An interactive patient app-My BP Care-and accompanying leaflet to support BP self-monitoring. These were linked to a clinician dashboard with alerts and an emailing system to facilitate appropriate titration of patient medication. Results The intervention was codeveloped following these guiding principles to ensure it was accessible and inclusive: easily comprehensible, motivating, simple and quick to use. Interview findings indicated that patient adherence to the intervention was promoted by the initial patient training conducted by the midwives, the enhanced clinical oversight they felt they received as a result of the intervention, the free BP monitor they received, reassurance they received of the medication safety for them and their baby, the intervention's simplicity and the motivating reminders they received. Conclusions Through coproduction with a diverse group of patients and stakeholders, and optimisation through testing among further diverse patients and clinicians, we developed a multicomponent intervention that is accessible and engaging for diverse patients, compatible with prevailing clinical practice and adaptable to different clinical contexts.
Chronicity rhetoric in health and welfare systems inhibits patient recovery: a qualitative, ethnographic study of fibromyalgia care
Fibromyalgia is a leading cause of disability in the UK and worldwide, but is difficult to diagnose and treat due to unclear pathogenesis and diverse and fluctuating symptoms. Although various treatment modalities are recommended, no treatments have been proven to effect sustainable improvement or recovery, and patients are typically dissatisfied with their care. Increasingly, biopsychosocial services are being developed, that aim to take a multifaceted, holistic approach. In this paper, we draw on a qualitative, ethnographic study of biopsychosocial services in the UK (including 59 interviews, 200 h observation, document review, and stakeholder workshops), that are providing new and promising forms of support. Drawing on Smith's Sociology for People as our analytic framework, we explore the work that is undertaken in these services. We discover chronicity rhetoric that interrupts practitioners' and patients' efforts to promote healing and recovery. We show that chronicity rhetoric is produced and reinforced through Biomedical Research and Welfare Benefits systems. Our findings are likely to have wider applicability to services for other difficult-to-treat conditions that are having increasingly problematic impacts on health, wellbeing and economic productivity worldwide (e.g., chronic pain, Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME)).
The potential health impact and healthcare cost savings of different sodium reduction strategies in Canada.
BackgroundHigh dietary sodium is the main dietary risk factor for non-communicable diseases due to its impact on cardiovascular diseases, the leading cause of death globally. The objective of the study was to estimate the number of avoidable ischemic heart disease (IHD) and stroke incidence cases, and their associated healthcare cost and Quality-Adjusted Life Year (QALY) savings resulting from different sodium reduction strategies and recommendations in Canada.MethodsWe used the PRIMEtime model, a proportional multi-state lifetable model. Outcomes were modeled over the lifetime of the population alive in 2019, at a 1.5% discount rate, and from the public healthcare system perspective. Nationally representative data were used as inputs for the model.ResultsFully meeting Health Canada's sodium reduction targets was estimated to prevent 219,490 (95% UI (Uncertainty Interval), 73,409-408,630) cases of IHD, and 164,435 (95% UI, 56,121-305,770) strokes. This led to a gain of 276,185 (95% UI, 85,414-552,616) QALYs, and healthcare costs savings of CAD 4,212 (95% UI, 1,303-8,206) million over the lifetime of the 2019 cohort. Sodium reduction intake through front-of-package labeling (FOPL) regulations has the potential to prevent between 35,930 (95% UI, 8,058-80,528) and 124,744 (95% UI, 40,125-235,643) cases of IHD, and between 26,869 (95% UI, 5,235-61,621) and 93,129 (95% UI, 30,296-176,014) strokes. This results in QALY gains ranging from 45,492 (95% UI, 10,281-106,579) to 157,628 (95% UI, 46,701-320,622), and healthcare costs savings ranging from CAD 695 (95% UI, 160-1,580) to CAD 2,415 (95% UI, 722-4,746) million over the lifetime of the 2019 Canadian cohort. All sodium reduction strategies tested were cost saving.ConclusionsReducing population-level sodium intakes is feasible and has the potential to improve health outcomes and save healthcare costs in Canada. From interventions tested, most health and healthcare costs gains were attributed to fully meeting sodium reduction targets, which highlights the importance of changing the voluntary nature of these targets to mandatory. A combination of strategies, mandatory sodium reduction targets and implementation of the 'high in' FOPL symbol would provide the most benefit from a public health standpoint.
Evidence‐Based Approaches to Quality Improvement: A Narrative Review of Integrating Bayesian Adaptive Trials Into Health Services
ABSTRACTRationaleQuality improvement (QI) in health service programmes aims to make small, incremental changes to increase reach and efficiency. Simple, low‐risk programmatic changes can improve services, particularly when supported by robust evidence. However, in health service contexts, there is tension between the need for swift decision‐making and the high research standards for conducting methodologically rigorous trials. Randomized trials are rarely used to evaluate these changes due to high costs and long timelines, especially when the changes are expected to result in marginal improvements. Instead, health service programmes frequently introduce changes informed by anecdotal evidence or less robust evaluation methods such as before‐and‐after comparisons.AimsIn this paper, we present a narrative review of the concepts underlying Bayesian adaptive trial designs for conducting QI research, highlighting their use in the commercial sector and exploring opportunities for cross‐industry learning and future application in healthcare settings.MethodsRelevant studies were selected based on their contextual relevance to the topic, in keeping with the narrative review approach.ResultsGiven that programmatic changes typically yield modest improvements, we recommend that adaptive trial designs can strike a balance between obtaining reliable results and avoiding overly large sample sizes. We review how interim analysis and early stopping can be integrated into trials, allowing the level of rigour to be adjusted according to the proramme specifications.ConclusionAdaptive trial designs hold significant promise for enhancing the QI efforts. To ensure that adaptive trial designs can be successfully integrated into health service contexts, tradeoffs should be made between methodological rigour and resource constraints.
AZD1222 effectiveness against severe COVID-19 in individuals with comorbidity or frailty: The RAVEN cohort study
Objectives: Despite being prioritized during initial COVID-19 vaccine rollout, vulnerable individuals at high risk of severe COVID-19 (hospitalization, intensive care unit admission, or death) remain underrepresented in vaccine effectiveness (VE) studies. The RAVEN cohort study (NCT05047822) assessed AZD1222 (ChAdOx1 nCov-19) two-dose primary series VE in vulnerable populations. Methods: Using the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub, linked to secondary care, death registration, and COVID-19 datasets in England, COVID-19 outcomes in 2021 were compared in vaccinated and unvaccinated individuals matched on age, sex, region, and multimorbidity. Results: Over 4.5 million AZD1222 recipients were matched (mean follow-up ∼5 months); 68% were ≥50 years, 57% had high multimorbidity. Overall, high VE against severe COVID-19 was demonstrated, with lower VE observed in vulnerable populations. VE against hospitalization was higher in the lowest multimorbidity quartile (91.1%; 95% CI: 90.1, 92.0) than the highest quartile (80.4%; 79.7, 81.1), and among individuals ≥65 years, higher in the ‘fit’ (86.2%; 84.5, 87.6) than the frailest (71.8%; 69.3, 74.2). VE against hospitalization was lowest in immunosuppressed individuals (64.6%; 60.7, 68.1). Conclusions: Based on integrated and comprehensive UK health data, overall population-level VE with AZD1222 was high. VEs were notably lower in vulnerable groups, particularly the immunosuppressed.
COVID-19 vaccine effectiveness against hospitalisation and death of people in clinical risk groups during the Delta variant period: English primary care network cohort study
Background: COVID-19 vaccines have been shown to be highly effective against hospitalisation and death following COVID-19 infection. COVID-19 vaccine effectiveness estimates against severe endpoints among individuals with clinical conditions that place them at increased risk of critical disease are limited. Methods: We used English primary care medical record data from the Oxford-Royal College of General Practitioners Research and Surveillance Centre sentinel network (N > 18 million). Data were linked to the National Immunisation Management Service database, Second Generation Surveillance System for virology test data, Hospital Episode Statistics, and death registry data. We estimated adjusted vaccine effectiveness (aVE) against COVID-19 infection followed by hospitalisation and death among individuals in specific clinical risk groups using a cohort design during the delta-dominant period. We also report mortality statistics and results from our antibody surveillance in this population. Findings: aVE against severe endpoints was high, 14–69d following a third dose aVE was 96.4% (95.1%–97.4%) and 97.9% (97.2%–98.4%) for clinically vulnerable people given a Vaxzevria and Comirnaty primary course respectively. Lower aVE was observed in the immunosuppressed group: 88.6% (79.1%–93.8%) and 91.9% (85.9%–95.4%) for Vaxzevria and Comirnaty respectively. Antibody levels were significantly lower among the immunosuppressed group than those not in this risk group across all vaccination types and doses. The standardised case fatality rate within 28 days of a positive test was 3.9/1000 in people not in risk groups, compared to 12.8/1000 in clinical risk groups. Waning aVE with time since 2nd dose was also demonstrated, for example, Comirnaty aVE against hospitalisation reduced from 96.0% (95.1–96.7%) 14–69days post-dose 2–82.9% (81.4–84.2%) 182days+ post-dose 2. Interpretation: In all clinical risk groups high levels of vaccine effectiveness against severe endpoints were seen. Reduced vaccine effectiveness was noted among the immunosuppressed group.
Implementation of chronic kidney disease guidelines for sodium-glucose co-transporter-2 inhibitor use in primary care in the UK: a cross-sectional study
Background: The cardiovascular and kidney benefits of sodium-glucose co-transporter-2 (SGLT2) inhibitors in people with chronic kidney disease (CKD) are well established. The implementation of updated SGLT2 inhibitor guidelines and prescribing in the real-world CKD population remains largely unknown. Methods: A cross-sectional study of adults with CKD registered with UK primary care practices in the Oxford-Royal College of General Practitioners Research and Surveillance Centre network on the 31st December 2022 was undertaken. Pseudonymised data from electronic health records held securely within the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) were extracted. An update to a previously described ontological approach was used to identify the study population, using a combination of Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) indicating a diagnosis of CKD and laboratory confirmed CKD based on Kidney Disease: Improving Global Outcomes (KDIGO) diagnostic criteria. We examined the extent to which SGLT2 inhibitor guidelines apply to and are then implemented in adults with CKD. A logistic regression model was used to identify factors associated with SGLT2 inhibitor prescribing, reported as odds ratios (ORs) with 95% confidence intervals (CI). The four guidelines under investigation were the United Kingdom Kidney Association (UKKA) Clinical Practice Guideline SGLT2 Inhibition in Adults with Kidney Disease (October 2021), American Diabetes Association (ADA) and KDIGO Consensus Report on Diabetes Management in CKD (October 2022), National Institute for Health and Care Excellence (NICE) Guideline Type 2 Diabetes in Adults: Management (June 2022), and NICE Technology Appraisal Dapagliflozin for Treating CKD (March 2022). Findings: Of 6,670,829 adults, we identified 516,491 (7.7%) with CKD, including 32.8% (n = 169,443) who had co-existing type 2 diabetes (T2D). 26.8% (n = 138,183) of the overall CKD population had a guideline directed indication for SGLT2 inhibitor treatment. A higher proportion of people with CKD and co-existing T2D were indicated for treatment, compared to those without T2D (62.8% [n = 106,468] vs. 9.1% [n = 31,715]). SGLT2 inhibitors were prescribed to 17.0% (n = 23,466) of those with an indication for treatment, and prescriptions were predominantly in those with co-existing T2D; 22.0% (n = 23,464) in those with T2D, and <0.1% (n = 2) in those without T2D. In adjusted multivariable analysis of people with CKD and T2D, females (OR 0.69, 95% CI 0.67–0.72, p <0.0001), individuals of Black ethnicity (OR 0.84, 95% CI 0.77–0.91, p <0.0001) and those of lower socio-economic status (OR 0.72, 95% CI 0.68–0.76, p <0.0001) were less likely to be prescribed an SGLT2 inhibitor. Those with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 had a lower likelihood of receiving an SGLT2 inhibitor, compared to those with an eGFR ≥60 mL/min/1.73 m2 (eGFR 45–60 mL/min/1.73 m2 OR 0.65, 95% CI 0.62–0.68, p <0.0001, eGFR 30–45 mL/min/1.73 m2 OR 0.73, 95% CI 0.69–0.78, p <0.0001, eGFR 15–30 mL/min/1.73 m2 OR 0.52, 95% CI 0.46–0.60, p <0.0001, eGFR <15 mL/min/1.73 m2 OR 0.03, 95% CI 0.00–0.23, p = 0.0037, respectively). Those with albuminuria (urine albumin-to-creatinine ratio 3–30 mg/mmol) were less likely to be prescribed an SGLT2 inhibitor, compared to those without albuminuria (OR 0.78, 95% CI 0.75–0.82, p <0.0001). Interpretation: SGLT2 inhibitor guidelines in CKD have not yet been successfully implemented into clinical practice, most notably in those without co-existing T2D. Individuals at higher risk of adverse outcomes are paradoxically less likely to receive SGLT2 inhibitor treatment. The timeframe between the publication of guidelines and data extraction may have been too short to observe changes in clinical practice. Enhanced efforts to embed SGLT2 inhibitors equitably into routine care for people with CKD are urgently needed, particularly in those at highest risk of adverse outcomes and in the absence of T2D. Funding: None.
Presentation of B-cell lymphoma in childhood and adolescence: a systematic review and meta-analysis
Background: The diagnosis of B-cell lymphoma, one of the commonest cancers seen in childhood and adolescence, is challenging. There is a crucial need to identify and delineate the prevalence of associated symptoms in order to improve early diagnosis. Aims: To identify clinical presentations associated with childhood and adolescent B-cell lymphomas and estimate symptom prevalence. Methods: A systematic review of observational studies and meta-analysis of proportions was carried out. Medline and EMBASE were systematically searched, with no language restrictions, from inception to 1st August 2022. Observational studies with at least 10 participants, exploring clinical presentations of any childhood and adolescent lymphoma, were selected. Proportions from each study were inputted to determine the weighted average (pooled) proportion, through random-effects meta-analysis. Results: Studies reported on symptoms, signs and presentation sites at diagnosis of 12,207 children and adolescents up to the age of 20. Hodgkin’s lymphoma most frequently presented with adenopathy in the head-and-neck region (79% [95% CI 58%-91%]), whilst non-Hodgkin’s lymphoma presented abdominally (55% [95% CI 43%-68%]). Symptoms associated with lymphoma included cervical lymphadenopathy (48% [95% CI 20%-77%]), peripheral lymphadenopathy (51% [95% CI 37%-66%]), B-symptoms (40% [95% CI 34%-44%]), fever (43% [95% CI 34%-54%]), abdominal mass (46% [95% CI 29%-64%]), weight loss (53% [95% CI 39%-66%]), head-and-neck mass (21% [95% CI 6%-47%]), organomegaly (29% [95% CI 23%-37%]), night sweats (19% [95% CI 10%-32%]), abdominal pain (28% [95% CI 15%-47%]), bone pain (17% [95% CI 10%-28%]) and abnormal neurology (11% [95% CI 3%-28%]). Conclusion: This systematic review and meta-analysis of proportions provides insight into the heterogeneous clinical presentations of B-cell lymphoma in childhood and adolescence and provides estimates of symptom prevalence. This information is likely to increase public and clinical awareness of lymphoma presentations and aid earlier diagnosis. This review further highlights the lack of studies exploring childhood and adolescent lymphoma presentations in primary care, where patients are likely to present at the earliest stages of their disease.
Identifying early symptoms associated with a diagnosis of childhood, adolescent and young adult cancers: a population-based nested case-control study
Background: Childhood, teenage and young adult (CTYA, 0–24 years) cancers are rare and diverse, making timely diagnosis challenging. We aim to explore symptoms and symptom combinations associated with a subsequent cancer diagnosis and to establish their timeframe. Methods: Using the QResearch Database, we carried out a matched nested case-control study. Associations between pre-specified symptoms encountered in primary care and a subsequent diagnosis of any cancer were explored using conditional logistic regression. Median diagnostic intervals were used to split symptoms into “late” and “early” timeframes to identify relevant early symptoms. Results: 3186 cases and 50,576 controls were identified from a cohort of 3,424,771 CTYA. We identified 12 novel associations, of which hemiparesis [OR 90.9 (95%CI 24.7-335.1), PPV = 1.6%], testicular swelling [OR 186.7 (95%CI 86.1-404.8), PPV = 2.4%] and organomegaly [OR 221.6 (95%CI 28.3-1735.9), PPV = 5.4%] had significant positive predictive values (PPV). Limb pain, a known marker of serious illness in children, was a recurrent early symptom across cancer subtypes. Similar clinical presentations were observed across childhood and TYA cancers. Discussion: Using the largest cohort to date, we provide novel information on the time-varying predictive utility of symptoms in the diagnosis of CTYA cancers. Our findings will help to raise clinical and public awareness of symptoms, stratify those at higher-risk and ultimately aid earlier diagnosis.
Thrombocytopenic, thromboembolic and haemorrhagic events following second dose with BNT162b2 and ChAdOx1: self-controlled case series analysis of the English national sentinel cohort
Background: Thrombosis associated with thrombocytopenia was a matter of concern post first and second doses of BNT162b2 and ChAdOx1 COVID-19 vaccines. Therefore, it is important to investigate the risk of thrombocytopenic, thromboembolic and haemorrhagic events following a second dose of BNT162b2 and ChAdOx1 COVID-19 vaccines. Methods: We conducted a large-scale self-controlled case series analysis, using routine primary care data linked to hospital data, among 12.3 million individuals (16 years old and above) in England. We used the nationally representative Oxford-Royal College of General Practitioners (RCGP) sentinel network database with baseline and risk periods between 8th December 2020 and 11th June 2022. We included individuals who received two vaccine (primary) doses of the BNT162b2 mRNA (Pfizer-BioNTech) and two vaccine doses of ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccines in our analyses. We carried out a self-controlled case series (SCCS) analysis for each outcome using a conditional Poisson regression model with an offset for the length of risk period. We reported the incidence rate ratios (IRRs) and 95% confidence intervals (CI) of thrombocytopenic, thromboembolic (including arterial and venous events) and haemorrhagic events, in the period of 0–27 days after receiving a second dose of BNT162b2 or ChAdOx1 vaccines compared to the baseline period (14 or more days prior to first dose, 28 or more days after the second dose and the time between 28 or more days after the first and 14 or more days prior to the second dose). We adjusted for a range of potential confounders, including age, sex, comorbidities and deprivation. Findings: Between December 8, 2020 and February 11, 2022, 6,306,306 individuals were vaccinated with two doses of BNT162b2 and 6,046,785 individuals were vaccinated with two doses of ChAdOx1. Compared to the baseline, our analysis show no increased risk of venous thromboembolic events (VTE) for both BNT162b2 (IRR 0.71, 95% CI: 0.65–0.770) and ChAdOx1 (IRR 0.91, 95% CI: 0.84–0.98); and similarly there was no increased risk for cerebral venous sinus thrombosis (CVST) for both BNT162b2 (IRR 0.87, 95% CI: 0.41–1.85) and ChAdOx1 (IRR 1.73, 95% CI: 0.82–3.68). We additionally report no difference in IRR for pulmonary embolus, and deep vein thrombosis, thrombocytopenia, including idiopathic thrombocytopenic purpura (ITP), and haemorrhagic events post second dose for both BNT162b2. Interpretation: Reassuringly, we found no associations between increased risk of thrombocytopenic, thromboembolic and haemorrhagic events post vaccination with second dose for either of these vaccines. Funding: Data and Connectivity: COVID-19 Vaccines Pharmacovigilance study.
Integrating Mobile Health App Data Into Electronic Medical or Health Record Systems and Its Impact on Health Care Delivery and Patient Health Outcomes: Scoping Review
Background: Mobile health (mHealth) apps are increasingly being used to capture patient health data, provide information, and guide self-management, with reported improvements in health care service delivery and outcomes. However, the impact of integrating mHealth app data into electronic medical record or electronic health record (EMR/EHR) systems remains underexplored. Objective: This study aims to identify what is known about the impact of integrating mHealth app data into EMR/EHR systems on health care delivery and patient outcomes. Methods: A scoping review was conducted to identify original studies that investigated the integration of patient-facing mHealth app data into EMR/EHR systems and the impact on health care outcomes. The PubMed, Embase, Web of Science, Cochrane Library, CINAHL, ProQuest, and PsycINFO databases were searched for papers published between January 2014 and July 2024. Two authors independently screened and extracted data on study characteristics, mHealth app features, details of integration with EMR/EHR systems, and effects on health care delivery and patient outcomes. Results: Nineteen studies with 113,135 participants were included. Among these, 6 were randomized clinical trial studies, 8 were conducted in the United States, 12 occurred in hospital settings, 15 involved adult participants, and 6 targeted diabetes management. Main features of the apps and EMR/EHR systems can be categorized into tracking or recording health data (n=19), app data integrated into EMR/EHR systems (n=19), app data summarized or presented on EMR/EHR interface (n=19), communication with the health care team (n=12), reminders or alerts (n=10), synchronization with other apps or devices (n=8), educational information (n=4), and using existing portal credentials to app access (n=2). Most studies reported benefits of integrating the app and EMR/EHR, such as enhanced patient education and self-management (n=5), real-time data recorded and shared with clinicians (n=4), support for clinical decision-making (n=3), improved communication between patients and clinicians (n=7), and improved patient outcomes (n=13). Challenges identified included high drop-off rates in app usage (n=3), limited accessibility due to device restrictions (n=3), incompatibility between mHealth apps and EMR/EHR systems (n=3), increased clinical workload in response to additional information (n=3), data accuracy issues due to network connectivity (n=1), and data security concerns (n=1). Conclusions: Evidence suggests that the effective integration of mHealth app data into EMR/EHR systems can enhance both clinicians' health care delivery and patients' health outcomes. However, current literature is limited, and future opportunities remain to examine the impact on long-term outcomes, such as mortality, readmissions, and costs, and assess the scalability and sustainability of integration among more broader health conditions and disabilities across diverse health care settings.
Health economic outcomes and national economic impacts associated with Long COVID in England and Scotland.
BackgroundTwo million people in the UK suffer from Long COVID (LC), imposing substantial health economic impacts. This study aimed to: 1) assess longitudinal changes in health utility scores and economic costs of LC, and number of services received at LC specialist clinics and clinic region to capture care intensity; 2) assess whether volume of services received responded to health needs; and 3) estimate the national economic impact of LC.MethodsLC patients from 10 specialist clinics participated in the LOCOMOTION study. Patient-reported outcomes measures (EQ-5D-5L, C19-YRS and Health Economics Questionnaire) were completed on a digital platform. Associations were assessed between changes in economic outcomes (EQ-5D-3L utility, health economic costs) and number/type of LC specialist services received and region. Per-person values of quality-adjusted life-year losses, public sector costs, productivity losses and informal care costs were multiplied by LC prevalence to estimate national economic impacts.ResultsThere was a statistically significant reduction in public sector costs over time. There was no significant association between the number of specialist services received and change in health utility scores. LC specialist clinic and outpatient service utilisation corresponded to health need and had significant regional variation after controlling for health need. LC is associated with a substantial economic impact nationally, estimated at £8.1 billion annually and £24.2 billion since its emergence, comparable to the annual cost of £9.4 billion for stroke.ConclusionThe effectiveness of LC specialist clinic services warrants further research. The substantial national economic impact of LC warrants a nationwide LC care strategy.
Enhancing global clinical trial transparency for better health outcomes for all
Background: In 2022, WHO’s World Health Assembly adopted resolution WHA75.8, emphasizing the critical role of clinical trials in generating high-quality evidence and promoting equitable access to health interventions globally. In response, rapid landscape reviews were conducted to assess global clinical trial regulations, capacities, and funding distribution. Methods The analysis synthesized regulatory frameworks from 94 countries, institutional capacity data from the WHO International Clinical Trial Registry Platform (ICTRP), and funding data from World RePORT for trials registered between 2018-2022. Gaps in data availability and quality were assessed. Results Most countries reference international ethical guidelines, with universal requirements for ethics approval and informed consent. However, only 66% mandate public trial registration, and 40% require results reporting, with stark disparities between high- and low-income countries. High-income countries host over half of global trials; low-income countries contribute less than 1% despite high disease burden. Clinical trials sponsored by non-commercial entities are particularly scarce in low- and middle-income countries. Funding remains concentrated in the Americas and European regions, primarily driven by major funders such as the National Institutes of Health in the United States of America and European Commission. Significant data accessibility challenges persist due to incomplete registry records, inconsistent standards, lack of harmonized identifiers, and limited bulk data access. Recommendations Urgent actions include reinforcing international standards for trial registries, harmonizing data fields, improving registry interoperability, leveraging unique identifiers, enhancing multilingual accessibility, auditing data quality, pooling analytical resources, promoting open data policies, and investing in registry infrastructure and trained personnel. Conclusion Addressing data gaps and inequities in clinical trial ecosystems requires concerted action by global stakeholders. Improved data transparency and interoperability are essential to guide equitable research investments, foster coordination, and strengthen clinical trial capacity worldwide.