Clustering care pathways of people with alcohol dependence using a data linkage of routine data in Bremen, Germany.

BACKGROUND: Although many individuals with alcohol dependence (AD) are recognized in the German healthcare system, only a few utilize addiction-specific treatment services. Those who enter treatment are not well characterized regarding their prospective pathways through the highly fragmented German healthcare system. This paper aims to (1) identify typical care pathways of patients with AD and their adherence to treatment guidelines and (2) explore the characteristics of these patients using routine data from different healthcare sectors. METHODS: We linked routinely collected register data of individuals with a documented alcohol-related diagnosis in the federal state of Bremen, Germany, in 2016/2017 and their addiction-specific health care: two statutory health insurance funds (outpatient pharmacotherapy for relapse prevention and inpatient episodes due to AD with and without qualified withdrawal treatment (QWT)), the German Pension Insurance (rehabilitation treatment) and a group of communal hospitals (outpatient addiction care). Individual care pathways of five different daily states of utilized addiction-specific treatment following an index inpatient admission due to AD were analyzed using state sequence analysis and cluster analysis. The follow-up time was 307 days (10 months). Individuals of the clustered pathways were compared concerning current treatment recommendations (1: QWT followed by postacute treatment; 2: time between QWT and rehabilitation). Patients' characteristics not considered during the cluster analysis (sex, age, nationality, comorbidity, and outpatient addiction care) were then compared using a multinomial logistic regression. RESULTS: The analysis of 518 individual sequences resulted in the identification of four pathway clusters differing in their utilization of acute and postacute treatment. Most did not utilize subsequent addiction-specific treatment after their index inpatient episode (n = 276) or had several inpatient episodes or QWT without postacute treatment (n = 205). Two small clusters contained pathways either starting rehabilitation (n = 26) or pharmacotherapy after the index episode (n = 11). Overall, only 9.3% utilized postacute treatment as recommended. CONCLUSIONS: A concern besides the generally low utilization of addiction-specific treatment is the implementation of postacute treatments for individuals after QWT.

Case-control study developing Scottish Epilepsy Deaths Study Score to predict epilepsy-related death.

This study aimed to develop a risk prediction model for epilepsy-related death in adults. In this age- and sex-matched case-control study, we compared adults (aged ≥16 years) who had epilepsy-related death between 2009 and 2016 to living adults with epilepsy in Scotland. Cases were identified from validated administrative national datasets linked to mortality records. ICD-10 cause-of-death coding was used to define epilepsy-related death. Controls were recruited from a research database and epilepsy clinics. Clinical data from medical records were abstracted and used to undertake univariable and multivariable conditional logistic regression to develop a risk prediction model consisting of four variables chosen a priori. A weighted sum of the factors present was taken to create a risk index-the Scottish Epilepsy Deaths Study Score. Odds ratios were estimated with 95% confidence intervals (CIs). Here, 224 deceased cases (mean age 48 years, 114 male) and 224 matched living controls were compared. In univariable analysis, predictors of epilepsy-related death were recent epilepsy-related accident and emergency attendance (odds ratio 5.1, 95% CI 3.2-8.3), living in deprived areas (odds ratio 2.5, 95% CI 1.6-4.0), developmental epilepsy (odds ratio 3.1, 95% CI 1.7-5.7), raised Charlson Comorbidity Index score (odds ratio 2.5, 95% CI 1.2-5.2), alcohol abuse (odds ratio 4.4, 95% CI 2.2-9.2), absent recent neurology review (odds ratio 3.8, 95% CI 2.4-6.1) and generalized epilepsy (odds ratio 1.9, 95% CI 1.2-3.0). Scottish Epilepsy Deaths Study Score model variables were derived from the first four listed before, with Charlson Comorbidity Index ≥2 given 1 point, living in the two most deprived areas given 2 points, having an inherited or congenital aetiology or risk factor for developing epilepsy given 2 points and recent epilepsy-related accident and emergency attendance given 3 points. Compared to having a Scottish Epilepsy Deaths Study Score of 0, those with a Scottish Epilepsy Deaths Study Score of 1 remained low risk, with odds ratio 1.6 (95% CI 0.5-4.8). Those with a Scottish Epilepsy Deaths Study Score of 2-3 had moderate risk, with odds ratio 2.8 (95% CI 1.3-6.2). Those with a Scottish Epilepsy Deaths Study Score of 4-5 and 6-8 were high risk, with odds ratio 14.4 (95% CI 5.9-35.2) and 24.0 (95% CI 8.1-71.2), respectively. The Scottish Epilepsy Deaths Study Score may be a helpful tool for identifying adults at high risk of epilepsy-related death and requires external validation.

The electronic frailty index and outcomes in patients with myocardial infarction.

BACKGROUND: Frailty is increasingly present in patients with acute myocardial infarction. The electronic Frailty Index (eFI) is a validated method of identifying vulnerable older patients in the community from routine primary care data. Our aim was to assess the relationship between the eFI and outcomes in older patients hospitalised with acute myocardial infarction. STUDY DESIGN AND SETTING: Retrospective cohort study using the DataLoch Heart Disease Registry comprising consecutive patients aged 65 years or over hospitalised with a myocardial infarction between October 2013 and March 2021. METHODS: Patients were classified as fit, mild, moderate, or severely frail based on their eFI score. Cox-regression analysis was used to determine the association between frailty category and all-cause mortality. RESULTS: In 4670 patients (median age 77 years [71-84], 43% female), 1865 (40%) were classified as fit, with 1699 (36%), 798 (17%) and 308 (7%) classified as mild, moderate and severely frail, respectively. In total, 1142 patients died within 12 months of which 248 (13%) and 147 (48%) were classified as fit and severely frail, respectively. After adjustment, any degree of frailty was associated with an increased risk of all-cause death with the risk greatest in the severely frail (reference = fit, adjusted hazard ratio 2.87 [95% confidence intervals 2.24 to 3.66]). CONCLUSION: The eFI identified patients at high risk of death following myocardial infarction. Automatic calculation within administrative data is feasible and could provide a low-cost method of identifying vulnerable older patients on hospital presentation.

Understanding Pathways into Care-homes using Data (UnPiCD study): a two-part model to estimate inpatient and care-home costs using national linked health and social care data.

BACKGROUND: Pathways into care-homes have been under-researched. Individuals who move-in to a care-home from hospital are clinically distinct from those moving-in from the community. However, it remains unclear whether the source of care-home admission has any implications in term of costs. Our aim was to quantify hospital and care-home costs for individuals newly moving-in to care homes to compare those moving-in from hospital to those moving-in from the community. METHODS: Using routinely-collected national social care and health data we constructed a cohort including people moving into care-homes from hospital and community settings between 01/04/2013-31/03/2015 based on records from the Scottish Care-Home Census (SCHC). Individual-level data were obtained from Scottish Morbidity Records (SMR01/04/50) and death records from National Records of Scotland (NRS). Unit costs were identified from NHS Scotland costs data and care-home costs from the SCHC. We used a two-part model to estimate costs conditional on having incurred positive costs. Additional analyses estimated differences in costs for the one-year period preceding and following care-home admission. RESULTS: We included 14,877 individuals moving-in to a care-home, 8,472 (57%) from hospital, and 6,405 (43%) from the community. Individuals moving-in to care-homes from the community incurred higher costs at £27,117 (95% CI £ 26,641 to £ 27,594) than those moving-in from hospital with £24,426 (95% CI £ 24,037 to £ 24,814). Hospital costs incurred during the year preceding care-home admission were substantially higher (£8,323 (95% CI£8,168 to £8,477) compared to those incurred after moving-in to care-home (£1,670 (95% CI£1,591 to £1,750). CONCLUSION: Individuals moving-in from hospital and community have different needs, and this is reflected in the difference in costs incurred. The reduction in hospital costs in the year after moving-in to a care-home indicates the positive contribution of care-home residency in supporting those with complex needs. These data provide an important contribution to inform capacity planning on care provision for adults with complex needs and the costs of care provision.

Use of proxy indicators for automated surveillance of severe acute respiratory infection, the Netherlands, 2017 to 2023: a proof-of-concept study.

BackgroundEffective pandemic preparedness requires robust severe acute respiratory infection (SARI) surveillance. However, identifying SARI patients based on symptoms is time-consuming. Using the number of reverse transcription (RT)-PCR tests or contact and droplet precaution labels as a proxy for SARI could accurately reflect the epidemiology of patients presenting with SARI.AimWe aimed to compare the number of RT-PCR tests, contact and droplet precaution labels and SARI-related International Classification of Disease (ICD)-10 codes and evaluate their use as surveillance indicators.MethodsPatients from all age groups hospitalised at Leiden University Medical Center between 1 January 2017 up to and including 30 April 2023 were eligible for inclusion. We used a clinical data collection tool to extract data from electronic medical records. For each surveillance indicator, we plotted the absolute count for each week, the incidence proportion per week and the correlation between the three surveillance indicators.ResultsWe included 117,404 hospital admissions. The three surveillance indicators generally followed a similar pattern before and during the COVID-19 pandemic. The correlation was highest between contact and droplet precaution labels and ICD-10 diagnostic codes (Pearson correlation coefficient: 0.84). There was a strong increase in the number of RT-PCR tests after the start of the COVID-19 pandemic.DiscussionAll three surveillance indicators have advantages and disadvantages. ICD-10 diagnostic codes are suitable but are subject to reporting delays. Contact and droplet precaution labels are a feasible option for automated SARI surveillance, since these reflect trends in SARI incidence and may be available real-time.

[Establishment of the new "Health Data Lab" to provide data for science]. / Aufbau des neuen "Forschungsdatenzentrums Gesundheit" zur Datenbereitstellung für die Wissenschaft.

The analysis of real-world data (RWD) has become increasingly important in health research in recent years. With the BfArM Health Data Lab (HDL), which is currently being set up, researchers will in future be able to gain access to routine data from the statutory health insurance of around 74 million people in Germany. Data from electronic patient records can also be made available for research prospectively. In doing so, the Health Data Lab guarantees the highest data protection and IT security standards. The digital application process, the provision of data in secure processing environments as well as the features supporting the analyses such as catalogues of coding systems, a point-and-click analysis tool and predefined standard analyses increase user-friendliness for researchers. The use of the extensive health data accessible at HDL will open a wide range of future possibilities for improving the health system and the quality of care. This article begins by highlighting the advantages of the HDL and outlining the opportunities that the RWD offers for research in healthcare and for the population. The structure and central aspects of the HDL are explained afterwards. An outlook on the opportunities of linking different data is given. What the application and data usage processes at the HDL will look like is illustrated using the example of fictitious possibilities for analysing long COVID based on the routine data available at the HDL in the future.

[Health and climate change-what is the potential of real-world data?] / Gesundheit und Klimawandel ­ welche Potenziale haben versorgungsnahe Daten?

This article addresses the question of how climate change may affect health and to what extent real-world data can contribute to research in this topic area. Climate change is altering the environmental and living conditions of humankind, and has thus also become a relevant health problem. The increase in extreme weather events, changes in exposure to UV and air pollution, and the climate-associated spread of allergens or novel pathogens are significantly changing the spectrum of diseases and the need for medical care in the population. However, in Germany, only few findings on the consequences for the healthcare system and on particularly affected population groups exist so far. Real-world data (primary data, register data, and administrative data) in combination with environmental exposure data and other relevant data (e.g., socio-economic data) have the potential to significantly advance research on the health consequences of climate change. This paper identifies changes in environmental and living conditions and associated health risks. It describes the databases that are generally available for analysing health effects of climate change. A concrete example is used to show how individual health data (in this case claims data of the statutory health insurance), environmental exposure data and other data can be successfully combined. Finally, the article offers a comprehensive overview of open research questions that can be answered with real-world data.

Healthcare use attributable to COVID-19: a propensity-matched national electronic health records cohort study of 249,390 people in Wales, UK.

BACKGROUND: To determine the extent and nature of changes associated with COVID-19 infection in terms of healthcare utilisation, this study observed healthcare contact 1 to 4 and 5 to 24 weeks following a COVID-19 diagnosis compared to propensity-matched controls. METHODS: Two hundred forty nine thousand three hundred ninety Welsh individuals with a positive reverse transcription-polymerase chain reaction (RT-PCR) test were identified from data from national PCR test results. After elimination criteria, 98,600 positive individuals were matched to test negative and never tested controls using propensity matching. Cohorts were split on test location. Tests could be taken in either the hospital or community. Controls were those who had tested negative in their respective environments. Survival analysis was utilised for first clinical outcomes which are grouped into primary and secondary. Primary outcomes include post-viral-illness and fatigue as an indication of long-COVID. Secondary outcomes include clinical terminology concepts for embolism, respiratory conditions, mental health conditions, fit notes, or hospital attendance. Increased instantaneous risk for positive individuals was quantified using hazard ratios (HR) from Cox regression, while absolute risk (AR) and relative risk were quantified using life table analysis. RESULTS: Analysis was conducted using all individuals and stratified by test location. Cases are compared to controls from the same test location. Fatigue (HR: 1.77, 95% CI: 1.34-2.25, p = < 0.001) and embolism (HR: 1.50, 95% CI: 1.15-1.97, p = 0.003) were more likely to occur in all positive individuals in the first 4 weeks; however, anxiety and depression (HR: 0.83, 95% CI: 0.73-0.95, p = 0.007) were less likely. Positive individuals continued to be more at risk of fatigue (HR: 1.47, 95% CI: 1.24-1.75, p = < 0.001) and embolism (HR: 1.51, 95% CI: 1.13-2.02, p = 0.005) after 4 weeks. All positive individuals are also at greater risk of post-viral illness (HR: 4.57, 95% CI: 1.77-11.80, p = 0.002). Despite statistical association between testing positive and several conditions, life table analysis shows that only a small minority of the study population were affected. CONCLUSIONS: Community COVID-19 disease is associated with increased risks of post-viral-illness, fatigue, embolism, and respiratory conditions. Despite elevated risks, the absolute healthcare burden is low. Subsequently, either very small proportions of people experience adverse outcomes following COVID-19 or they are not presenting to healthcare.

Using Critical Success Index or Gilbert Skill Score as composite measures of positive predictive value and sensitivity in diagnostic accuracy studies: Weather forecasting informing epilepsy research.

The Critical Success Index (CSI) and Gilbert Skill score (GS) are verification measures that are commonly used to check the accuracy of weather forecasting. In this article, we propose that they can also be used to simplify the joint interpretation of positive predictive value (PPV) and sensitivity estimates across diagnostic accuracy studies of epilepsy data. This is because CSI and GS each provide a single measure that takes the weather forecasting equivalent of PPV and sensitivity into account. We have re-analysed data from our recent systematic review of diagnostic accuracy studies of administrative epilepsy data using CSI and GS. We summarise the results and benefits of this approach.

Prostate cancer outcomes following whole-gland and focal high-intensity focused ultrasound.

OBJECTIVE: To report the 5-year failure-free survival (FFS) following high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS: This observational cohort study used linked National Cancer Registry data, radiotherapy data, administrative hospital data and mortality records of 1381 men treated with HIFU for clinically localised prostate cancer in England. The primary outcome, FFS, was defined as freedom from local salvage treatment and cancer-specific mortality. Secondary outcomes were freedom from repeat HIFU, prostate cancer-specific survival (CSS) and overall survival (OS). Cox regression was used to determine whether baseline characteristics, including age, treatment year, T stage and International Society of Urological Pathology (ISUP) Grade Group were associated with FFS. RESULTS: The median (interquartile range [IQR]) follow-up was 37 (20-62) months. The median (IQR) age was 65 (59-70) years and 81% had an ISUP Grade Group of 1-2. The FFS was 96.5% (95% confidence interval [CI] 95.4%-97.4%) at 1 year, 86.0% (95% CI 83.7%-87.9%) at 3 years and 77.5% (95% CI 74.4%-80.3%) at 5 years. The 5-year FFS for ISUP Grade Groups 1-5 was 82.9%, 76.6%, 72.2%, 52.3% and 30.8%, respectively (P < 0.001). Freedom from repeat HIFU was 79.1% (95% CI 75.7%-82.1%), CSS was 98.8% (95% CI 97.7%-99.4%) and OS was 95.9% (95% CI 94.2%-97.1%) at 5 years. CONCLUSION: Four in five men were free from local salvage treatment at 5 years but treatment failure varied significantly according to ISUP Grade Group. Patients should be appropriately informed with respect to salvage radical treatment following HIFU.

National routine data for low birthweight and preterm births: Systematic data quality assessment for United Nations member states (2000-2020).

OBJECTIVE: Low birthweight (<2500 g) and preterm birth (<37 weeks) are markers of newborn vulnerability. To facilitate informed decisions about investments in prevention and care, it is imperative to enhance data quality and use. Hence, the objective of this study is to systematically assess the quality of data concerning low birthweight and preterm births within routine administrative data sources. DESIGN: Systematic data quality assessment by adopting the WHO Data Quality Framework. SETTING: National routine data system from UN member states. POPULATION: Livebirths. METHODS: National routine administrative data on low birthweight and preterm births for 195 countries from 2000 to 2020 were systematically collated, totalling >700 million live births. The WHO data quality framework was adapted to undertake standardised data quality assessments. MAIN OUTCOME MEASURES: Availability, reporting quality, internal and external consistency of low birthweight and preterm data. RESULTS: Most United States Member States (64%: 124/195) had national data on low birthweight and (40%: 82/195) had data on preterm birth. Routine data system reporting was highest in North America, Australasia and Europe, where more than 95% live births had data on low birthweight and over 75% had data preterm births. In contrast, data reporting was lowest in sub-Saharan Africa (13% for low birthweight, 8% for preterm births) and Southern Asia (16% for low birthweight, 5% for preterm births). Most countries collect individual-level data; but, aggregate data reporting from hospital-based systems remain common in sub-Saharan Africa and Southern Asia. While data quality was generally high in North America, Australasia and Europe, gaps remain in the availability of gestational age metadata. Consistency between low birthweight and preterm rates were poor in Southern Asia and sub-Saharan Africa regions across time. There was high external consistency between low birthweight rates obtained from routine administrative data compared with low birthweight rates obtained from survey data for countries with high data quality. CONCLUSIONS: Sub-Saharan Africa and South Asia countries have data gaps but also opportunities for rapid progress. Most births occure in facilities, electronic health information systems already include low birthweight, and adding accurate gestational age including with ultrasound assessment is becoming increasingly attainable. Moving toward the collection of individual level data would enable monitoring of quality of care and longer-term outcomes. This is crucial for every child and family and essential for measuring progress towards relevant sustainable development goals. The assessment will inform countries' actions for data quality improvement at national level and use of data for impact.

Diffusion of a new drug among ambulatory physicians-The impact of patient pathways.

When drugs enter the market, physicians' prescribing behavior plays a crucial role in the diffusion process. Although regulations to foster economically efficient prescribing exist, physicians have some degree of freedom in choosing medication and are subject to various influencing factors. The aim of the present analysis is to investigate how interaction among patients and physicians affects the diffusion. We look at two different ways that patient pathways might influence physicians and examine these effects for Sacubitril/Valsartan (S/V), a new drug for patients with heart failure. Using administrative data from Germany, we identify physicians who prescribed S/V in the first 2 years of its availability. We apply survival models to estimate the impact of the patient-physician interaction on the physicians' adoption time. To this end, we determine whether individual physicians treated patients that had been prescribed S/V, and how many other physicians already prescribing S/V were connected in patient-sharing networks. Our main findings are that patients with a previous prescription seem to induce adoption by demanding repeat prescriptions. Moreover, patients establish connections between physicians that may lead to prescriptions for new patients. Our results therefore suggest that patient pathways play a significant role in the diffusion of a new drug.

The extent of anticholinergic burden across an older Welsh population living with frailty: cross-sectional analysis of general practice records.

BACKGROUND: Anticholinergic medicines are associated with adverse outcomes for older people. However, little is known about their use in frailty. The objectives were to (i) investigate the prevalence of anticholinergic prescribing for older patients, and (ii) examine anticholinergic burden according to frailty status. METHODS: Cross-sectional analysis of Welsh primary care data from the Secure Anonymised Information Linkage databank including patients aged ≥65 at their first GP consultation between 1 January and 31 December 2018. Frailty was identified using the electronic Frailty Index and anticholinergic burden using the Anticholinergic Cognitive Burden (ACB) scale. Descriptive analysis and logistic regression were conducted to (i) describe the type and frequency of anticholinergics prescribed; and (ii) to estimate the association between frailty and cumulative ACB score (ACB-Sum). RESULTS: In this study of 529,095 patients, 47.4% of patients receiving any prescription medications were prescribed at least one anticholinergic medicine. Adjusted regression analysis showed that patients with increasing frailty had higher odds of having an ACB-Sum of >3 compared with patients who were fit (mild frailty, adj OR 1.062 (95%CI 1.061-1.064), moderate frailty, adj OR 1.134 (95%CI 1.131-1.136), severe frailty, adj OR 1.208 (95%CI 1.203-1.213)). CONCLUSIONS: Anticholinergic prescribing was high in this older population. Older people with advancing frailty are exposed to the highest anticholinergic burden despite being the most vulnerable to the associated adverse effects. Older people with advancing frailty should be considered for medicines review to prevent overaccumulation of anticholinergic medications, given the risks of functional and cognitive decline that frailty presents.

Survival and critical care use among people with dementia in a large English cohort.

BACKGROUND: Admitting people with dementia to critical care units may not always lead to a clear survival benefit. Critical care admissions of people with dementia vary across countries. Little is known about the use and trends of critical care admissions of people with dementia in England. OBJECTIVE: To investigate critical care use and survival among people with dementia in a large London catchment area. METHODS: A retrospective cohort study using data from dementia assessment services in south London, UK (2007-20) linked with national hospitalisation data to ascertain critical care admissions. Outcomes included age-sex-standardised critical care use and 1-year post-critical care admission survival by dementia severity (binary: mild versus moderate/severe). We used logistic regression and Kaplan-Meier survival plots for investigating 1-year survival following a critical care admission and linear regressions for time trends. RESULTS: Of 19,787 people diagnosed with dementia, 726 (3.7%) had ≥1 critical care admission at any time after receiving their dementia diagnosis. The overall 1-year survival of people with dementia, who had a CCA, was 47.5% (n = 345). Dementia severity was not associated with 1-year survival following a critical care admission (mild dementia versus moderate-severe dementia odds of 1-year mortality OR: 0.90, 95% CI [0.66-1.22]). Over the 12-year period from 2008 to 2019, overall critical care use decreased (ß = -0.05; 95% CI = -0.01, -0.0003; P = 0.03), while critical care admissions occurring during the last year of life increased (ß = 0.11, 95% CI = 0.01, 0.20, P = 0.03). CONCLUSIONS: In this cohort, while critical care use among people with dementia declined overall, its use increased among those in their last year of life. Survival remains comparable to that observed in general older populations.

Does previous asbestos exposure increase the risk of a post coronary artery bypass graft (CABG) pleural effusion - a routine data study?

BACKGROUND: Development of pleural effusion (PE) following CABG is common. Post-CABG PE are divided into early- (within 30 days of surgery) and delayed-onset (30 days-1 year) which are likely due to distinct pathological processes. Some experts suggest asbestos exposure may confer an independent risk for late-onset post-CABG PE, however no large studies have explored this potential association. RESEARCH QUESTION: To explore possible association between asbestos exposure and post-CABG PE using routine data. METHODS: All patients who underwent CABG 01/04/2013-31/03/2018 were identified from the Hospital Episode Statistics (HES) Database. This England-wide population was evaluated for evidence of asbestos exposure, pleural plaques or asbestosis and a diagnosis of PE or PE-related procedure from 30 days to 1 year post-CABG. Patients with evidence of PE three months prior to CABG were excluded, as were patients with a new mesothelioma diagnosis. RESULTS: 68,150 patients were identified, of whom 1,003 (1%) were asbestos exposed and 2,377 (3%) developed late-onset PE. After adjusting for demographic data, Index of Multiple Deprivation and Charlson Co-morbidity Index, asbestos exposed patients had increased odds of PE diagnosis or related procedure such as thoracentesis or drainage (OR 1.35, 95% CI 1.03-1.76, p = 0.04). In those with evidence of PE requiring procedure alone, the adjusted OR was 1.66 (95% CI 1.14-2.40, p = 0.01). Additional subgroup analysis of the 518 patients coded for pleural plaques and asbestosis alone revealed an adjusted OR of post-CABG PE requiring a procedure of 2.16 (95% CI 1.38-3.37, p = 0.002). INTERPRETATION: This large-scale study demonstrates prior asbestos exposure is associated with modestly increased risk of post-CABG PE development. The risk association appears higher in patients with assigned clinical codes indicative of radiological evidence of asbestos exposure (pleural plaques or asbestosis). This association may fit with a possible inflammatory co-pathogenesis, with asbestos exposure 'priming' the pleura resulting in greater propensity for PE evolution following the physiological insult of CABG surgery. Further work, including prospective studies and clinicopathological correlation are suggested to explore this further.

Protocol for the effectiveness evaluation of an antenatal, universally offered, and remotely delivered parenting programme 'Baby Steps' on maternal outcomes: a Born in Bradford's Better Start (BiBBS) study.

BACKGROUND: Poor perinatal mental health and maternal sensitivity towards a child in the early years can carry a long-term cost to individuals and to society, and result in negative child outcomes such as poor mental health and social emotional issues. Despite the recognition of early intervention and prevention, there is mixed evidence regarding antenatal parenting interventions that aim to enhance perinatal mental health and maternal sensitivity to prevent negative child outcomes. 'Baby Steps' is a relationship-based antenatal and postnatal parenting programme. The service evaluated in this study is delivered in a low-income and ethnically diverse community via Better Start Bradford. This study aims to assess whether the universally, and remotely delivered Baby Steps programme is effective in improving postnatal maternal sensitivity (primary outcome) and postnatal maternal mental health (secondary outcome) when compared to services as usual 6-10 weeks post-birth. It will also assess differences in birth outcomes, and differences in the prevalence of poor perinatal mental ill health through routine data. The feasibility of collecting cost and health related resource use data for a future economic evaluation will be explored. METHODS: The study is a quasi-experimental evaluation in a single centre. All participants are drawn from Born in Bradford's Better Start (BiBBS) interventional family cohort study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. The required minimum sample is n = 130 (ratio 1:1) to detect a medium effect (± 2.35, d = .50) on the primary outcome-maternal-child sensitivity, using the Mothers Object Relations Scale Short Form (MORS-SF). Secondary outcomes include the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder assessment 7 (GAD-7), identification of poor perinatal mental health through routine data, and birth outcomes (delivery method, gestation period, low birth weight). Service delivery costs and health resource use will be gathered from routine data. DISCUSSION: This study will evaluate the effectiveness of Baby Steps for enhancing maternal-child sensitivity and maternal mental health when delivered universally and remotely. The findings regarding programme effectiveness, process, and costs will be relevant for researchers, service commissioners, and service staff. TRIAL REGISTRATION: This study was prospectively registered with ISRCTN (22/04/2022, ISRCTN12196131).

Sharing real-world data for public benefit: a qualitative exploration of stakeholder views and perceptions.

BACKGROUND: There has been an increasing interest in the use of "real-world" data to inform care decision making that could lead to public health benefit. Routinely collected service and activity data associated with the administration of care services and service-users (such as electronic health records or electronic social care records), hold potential to better inform effective and responsive decision-making about health and care services provided to national and local populations. This study sought to gain an in-depth understanding regarding the potential to unlock real world data that was held in individual organisations, to better inform public health decision-making. This included sharing data between and within health service providers and local governing authorities, but also with university researchers to inform the evidence base. METHODS: We used qualitative methods and carried out a series of online workshops and interviews with stakeholders (senior-level decision-makers and service leads, researchers, data analysts, those with a legal and governance role, and members of the public). We identified recurring themes in initial workshops, and explored these with participants in subsequent workshops. By this iterative process we further refined the themes identified, compared views and perceptions amongst different stakeholder groups, and developed recommendations for action. RESULTS: Our study identified key elements of context and timing, the need for a different approach, and obstacles including governmental and legal, organisational features, and process factors which adversely affect the sharing of real world data. The findings also highlighted a need for improved communication about data for secondary uses to members of the public. CONCLUSION: The Covid-19 pandemic context and changes to organisational structures in the health service in England have provided opportunities to address data sharing challenges. Change at national and local level is required, within current job roles and generating new jobs roles focused on the use and sharing of real-world data. The study suggests that actions can be taken to unlock the potential of real-world data for public health benefit, and provides a series of recommendations at a national level, for organisational leaders, those in data roles and those in public engagement roles.

Changes in emergency department utilisation in Germany before and during different phases of the COVID-19 pandemic, using data from a national surveillance system up to June 2021.

BACKGROUND: During the COVID-19 pandemic and associated public health and social measures, decreasing patient numbers have been described in various healthcare settings in Germany, including emergency care. This could be explained by changes in disease burden, e.g. due to contact restrictions, but could also be a result of changes in utilisation behaviour of the population. To better understand those dynamics, we analysed routine data from emergency departments to quantify changes in consultation numbers, age distribution, disease acuity and day and hour of the day during different phases of the COVID-19 pandemic. METHODS: We used interrupted time series analyses to estimate relative changes for consultation numbers of 20 emergency departments spread throughout Germany. For the pandemic period (16-03-2020 - 13-06-2021) four different phases of the COVID-19 pandemic were defined as interruption points, the pre-pandemic period (06-03-2017 - 09-03-2020) was used as the reference. RESULTS: The most pronounced decreases were visible in the first and second wave of the pandemic, with changes of - 30.0% (95%CI: - 32.2%; - 27.7%) and - 25.7% (95%CI: - 27.4%; - 23.9%) for overall consultations, respectively. The decrease was even stronger for the age group of 0-19 years, with - 39.4% in the first and - 35.0% in the second wave. Regarding acuity levels, consultations assessed as urgent, standard, and non-urgent showed the largest decrease, while the most severe cases showed the smallest decrease. CONCLUSIONS: The number of emergency department consultations decreased rapidly during the COVID-19 pandemic, without extensive variation in the distribution of patient characteristics. Smallest changes were observed for the most severe consultations and older age groups, which is especially reassuring regarding concerns of possible long-term complications due to patients avoiding urgent emergency care during the pandemic.

The effectiveness of additional screening examinations for children and adolescents in Germany: a longitudinal retrospective cohort study.

BACKGROUND: Continuous medical care is particularly important in childhood and adolescence. Since there are gaps in regular care in Germany, various health insurance providers offer to cover additional examinations (e.g., U10, U11, J2) to ensure ongoing paediatrician visits. However, the question arises as to whether these examinations are effective. Thus, the main objective of this study is to determine whether participation in the U10, U11 or J2 examinations leads to more frequent and earlier diagnosis and treatment of age-specific diseases. METHODS: The analyses are based on administrative claims data from a statutory health insurance fund. For each examination, an intervention group (IG) is formed and matched with a corresponding control group (CG). Descriptive analyses include proportion with diagnosis and treatment, average age of diagnosis and treatment initiation. Hypothesis testing is performed using methods appropriate to each. In addition, subgroup analyses and binominal logistic regression models are conducted. RESULTS: More diagnoses are detected in IG, irrespective of subgroups. Additionally, diagnoses are made slightly earlier on average in IG. In the total samples, more therapies are initiated in IG, and slightly earlier. Considering only diagnosed cases, more therapies are initiated in CG but continue to be started earlier in IG. Regression models show that participation in the examinations has the highest predictive power for detecting a diagnosis. The presence of a chronic disease and sex - male at the U10 and U11 and female at the J2 - are also significantly associated. The models further show that nationality, unemployment of parents and region also have a significant influence in some cases, whereas school-leaving qualification, vocational qualification and income of parents do not. Considering the initiation of treatment in overall samples, the models show similar results, but here the presence of a chronic illness has the highest predictive power. CONCLUSION: The results indicate that participation in the examinations leads to significantly more diagnoses and, in the overall samples, significantly more treatments. In addition, diagnoses were made somewhat earlier and therapies were initiated somewhat earlier. In the future, it would be useful to investigate the U10, U11 and J2 examinations over a longer time horizon to determine whether the statistically significant difference found is also clinically relevant, i.e., earlier diagnosis and initiation of therapy lead to prevention of manifestation or progression of the diagnosed diseases and to avoidance of secondary diseases. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

Investigating rapid diagnostic testing in Kenya's health system, 2018-2020: validating non-reporting in routine data using a health facility service assessment survey.

BACKGROUND: Understanding the availability of rapid diagnostic tests (RDTs) is essential for attaining universal health care and reducing health inequalities. Although routine data helps measure RDT coverage and health access gaps, many healthcare facilities fail to report their monthly diagnostic test data to routine health systems, impacting routine data quality. This study sought to understand whether non-reporting by facilities is due to a lack of diagnostic and/or service provision capacity by triangulating routine and health service assessment survey data in Kenya. METHODS: Routine facility-level data on RDT administration were sourced from the Kenya health information system for the years 2018-2020. Data on diagnostic capacity (RDT availability) and service provision (screening, diagnosis, and treatment) were obtained from a national health facility assessment conducted in 2018. The two sources were linked and compared obtaining information on 10 RDTs from both sources. The study then assessed reporting in the routine system among facilities with (i) diagnostic capacity only, (ii) both confirmed diagnostic capacity and service provision and (iii) without diagnostic capacity. Analyses were conducted nationally, disaggregated by RDT, facility level and ownership. RESULTS: Twenty-one per cent (2821) of all facilities expected to report routine diagnostic data in Kenya were included in the triangulation. Most (86%) were primary-level facilities under public ownership (70%). Overall, survey response rates on diagnostic capacity were high (> 70%). Malaria and HIV had the highest response rate (> 96%) and the broadest coverage in diagnostic capacity across facilities (> 76%). Reporting among facilities with diagnostic capacity varied by test, with HIV and malaria having the lowest reporting rates, 58% and 52%, respectively, while the rest ranged between 69% and 85%. Among facilities with both service provision and diagnostic capacity, reporting ranged between 52% and 83% across tests. Public and secondary facilities had the highest reporting rates across all tests. A small proportion of health facilities without diagnostic capacity submitted testing reports in 2018, most of which were primary facilities. CONCLUSION: Non-reporting in routine health systems is not always due to a lack of capacity. Further analyses are required to inform other drivers of non-reporting to ensure reliable routine health data.