Comparative effectiveness of second line oral antidiabetic treatments among people with type 2 diabetes mellitus: emulation of a target trial using routinely collected health data.

OBJECTIVE: To compare the effectiveness of three commonly prescribed oral antidiabetic drugs added to metformin for people with type 2 diabetes mellitus requiring second line treatment in routine clinical practice. DESIGN: Cohort study emulating a comparative effectiveness trial (target trial). SETTING: Linked primary care, hospital, and death data in England, 2015-21. PARTICIPANTS: 75 739 adults with type 2 diabetes mellitus who initiated second line oral antidiabetic treatment with a sulfonylurea, DPP-4 inhibitor, or SGLT-2 inhibitor added to metformin. MAIN OUTCOME MEASURES: Primary outcome was absolute change in glycated haemoglobin A1c (HbA1c) between baseline and one year follow-up. Secondary outcomes were change in body mass index (BMI), systolic blood pressure, and estimated glomerular filtration rate (eGFR) at one year and two years, change in HbA1c at two years, and time to ≥40% decline in eGFR, major adverse kidney event, hospital admission for heart failure, major adverse cardiovascular event (MACE), and all cause mortality. Instrumental variable analysis was used to reduce the risk of confounding due to unobserved baseline measures. RESULTS: 75 739 people initiated second line oral antidiabetic treatment with sulfonylureas (n=25 693, 33.9%), DPP-4 inhibitors (n=34 464 ,45.5%), or SGLT-2 inhibitors (n=15 582, 20.6%). SGLT-2 inhibitors were more effective than DPP-4 inhibitors or sulfonylureas in reducing mean HbA1c values between baseline and one year. After the instrumental variable analysis, the mean differences in HbA1c change between baseline and one year were -2.5 mmol/mol (95% confidence interval (CI) -3.7 to -1.3) for SGLT-2 inhibitors versus sulfonylureas and -3.2 mmol/mol (-4.6 to -1.8) for SGLT-2 inhibitors versus DPP-4 inhibitors. SGLT-2 inhibitors were more effective than sulfonylureas or DPP-4 inhibitors in reducing BMI and systolic blood pressure. For some secondary endpoints, evidence for SGLT-2 inhibitors being more effective was lacking-the hazard ratio for MACE, for example, was 0.99 (95% CI 0.61 to 1.62) versus sulfonylureas and 0.91 (0.51 to 1.63) versus DPP-4 inhibitors. SGLT-2 inhibitors had reduced hazards of hospital admission for heart failure compared with DPP-4 inhibitors (0.32, 0.12 to 0.90) and sulfonylureas (0.46, 0.20 to 1.05). The hazard ratio for a ≥40% decline in eGFR indicated a protective effect versus sulfonylureas (0.42, 0.22 to 0.82), with high uncertainty in the estimated hazard ratio versus DPP-4 inhibitors (0.64, 0.29 to 1.43). CONCLUSIONS: This emulation study of a target trial found that SGLT-2 inhibitors were more effective than sulfonylureas or DPP-4 inhibitors in lowering mean HbA1c, BMI, and systolic blood pressure and in reducing the hazards of hospital admission for heart failure (v DPP-4 inhibitors) and kidney disease progression (v sulfonylureas), with no evidence of differences in other clinical endpoints.

The impact of collaborative organisational models and general practice size on patient safety and quality of care in the English National Health Service: A systematic review.

Collaborative primary care has become an increasingly popular strategy to manage existing pressures on general practice. In England, the recent changes taking place in the primary care sector have included the formation of collaborative organisational models and a steady increase in practice size. The aim of this review was to summarise the available evidence on the impact of collaborative models and general practice size on patient safety and quality of care in England. We searched for quantitative and qualitative studies on the topic published between January 2010 and July 2023. The quality of articles was assessed using the Newcastle-Ottawa Scale and the Critical Appraisal Skills Programme checklist. We screened 6533 abstracts, with full-text screening performed on 76 records. A total of 29 articles were included in the review. 19 met the inclusion criteria following full-text screening, with seven identified through reverse citation searching and three through expert consultation. All studies were found to be of moderate or high quality. A predominantly positive impact on service delivery measures and patient-level outcomes was identified. Meanwhile, the evidence on the effect on pay-for-performance outcomes and hospital admissions is mixed, with continuity of care and access identified as a concern. While this review is limited to evidence from England, the findings provide insights for all health systems undergoing a transition towards collaborative primary care.

Back to basics: A mediation analysis approach to addressing the fundamental questions of integrated care evaluations.

Health systems around the world are aiming to improve the integration of health and social care services to deliver better care for patients. Existing evaluations have focused exclusively on the impact of care integration on health outcomes and found little effect. That suggests the need to take a step back and ask whether integrated care programmes actually lead to greater clinical integration of care and indeed whether greater integration is associated with improved health outcomes. We propose a mediation analysis approach to address these two fundamental questions when evaluating integrated care programmes. We illustrate our approach by re-examining the impact of an English integrated care program on clinical integration and assessing whether greater integration is causally associated with fewer admissions for ambulatory care sensitive conditions. We measure clinical integration using a concentration index of outpatient referrals at the general practice level. While we find that the scheme increased integration of primary and secondary care, clinical integration did not mediate a decrease in unplanned hospital admissions. Our analysis emphasizes the need to better understand the hypothesized causal impact of integration on health outcomes and demonstrates how mediation analysis can inform future evaluations and program design.

Ethnic and socioeconomic disparities in initiation of second-line antidiabetic treatment for people with type 2 diabetes in England: A cross-sectional study.

AIMS: To assess any disparities in the initiation of second-line antidiabetic treatments prescribed among people with type 2 diabetes mellitus (T2DM) in England according to ethnicity and social deprivation level. MATERIALS AND METHODS: This cross-sectional study used linked primary (Clinical Practice Research Datalink) and secondary care data (Hospital Episode Statistics), and the Index of Multiple Deprivation (IMD). We included people aged 18 years or older with T2DM who intensified to second-line oral antidiabetic medication between 2014 and 2020 to investigate disparities in second-line antidiabetic treatment prescribing (one of sulphonylureas [SUs], dipeptidyl peptidase-4 [DPP-4] inhibitors, or sodium-glucose cotransporter-2 [SGLT2] inhibitors, in combination with metformin) by ethnicity (White, South Asian, Black, mixed/other) and deprivation level (IMD quintiles). We report prescriptions of the alternative treatments by ethnicity and deprivation level according to predicted percentages derived from multivariable, multinomial logistic regression. RESULTS: Among 36 023 people, 85% were White, 10% South Asian, 4% Black and 1% mixed/other. After adjustment, the predicted percentages for SGLT2 inhibitor prescribing by ethnicity were 21% (95% confidence interval [CI] 19-23%), 20% (95% CI 18-22%), 19% (95% CI 16-22%) and 17% (95% CI 14-21%) among people with White, South Asian, Black, and mixed/other ethnicity, respectively. After adjustment, the predicted percentages for SGLT2 inhibitor prescribing by deprivation were 22% (95% CI 20-25%) and 19% (95% CI 17-21%) for the least deprived and the most deprived quintile, respectively. When stratifying by prevalent cardiovascular disease (CVD) status, we found lower predicted percentages of people with prevalent CVD prescribed SGLT2 inhibitors compared with people without prevalent CVD across all ethnicity groups and all levels of social deprivation. CONCLUSIONS: Among people with T2DM, there were no substantial differences by ethnicity or deprivation level in the percentage prescribed either SGLT2 inhibitors, DPP-4 inhibitors or SUs as second-line antidiabetic treatment.

Framework for identification and measurement of spillover effects in policy implementation: intended non-intended targeted non-targeted spillovers (INTENTS).

BACKGROUND: There is increasing awareness among researchers and policymakers of the potential for healthcare interventions to have consequences beyond those initially intended. These unintended consequences or "spillover effects" result from the complex features of healthcare organisation and delivery and can either increase or decrease overall effectiveness. Their potential influence has important consequences for the design and evaluation of implementation strategies and for decision-making. However, consideration of spillovers remains partial and unsystematic. We develop a comprehensive framework for the identification and measurement of spillover effects resulting from changes to the way in which healthcare services are organised and delivered. METHODS: We conducted a scoping review to map the existing literature on spillover effects in health and healthcare interventions and used the findings of this review to develop a comprehensive framework to identify and measure spillover effects. RESULTS: The scoping review identified a wide range of different spillover effects, either experienced by agents not intentionally targeted by an intervention or representing unintended effects for targeted agents. Our scoping review revealed that spillover effects tend to be discussed in papers only when they are found to be statistically significant or might account for unexpected findings, rather than as a pre-specified feature of evaluation studies. This hinders the ability to assess all potential implications of a given policy or intervention. We propose a taxonomy of spillover effects, classified based on the outcome and the unit experiencing the effect: within-unit, between-unit, and diagonal spillover effects. We then present the INTENTS framework: Intended Non-intended TargEted Non-Targeted Spillovers. The INTENTS framework considers the units and outcomes which may be affected by an intervention and the mechanisms by which spillover effects are generated. CONCLUSIONS: The INTENTS framework provides a structured guide for researchers and policymakers when considering the potential effects that implementation strategies may generate, and the steps to take when designing and evaluating such interventions. Application of the INTENTS framework will enable spillover effects to be addressed appropriately in future evaluations and decision-making, ensuring that the full range of costs and benefits of interventions are correctly identified.

How do patients pass through stroke services? Identifying stroke care pathways using national audit data.

OBJECTIVE: To map and describe how patients pass through stroke services. METHODS: Data from 94,905 stroke patients (July 2013-July 2015) who were still inpatients 72 hours after hospital admission were extracted from a national stroke register and were used to identify the routes patients took through hospital and community stroke services. We sought to categorize these routes through iterative consultations with clinical experts and to describe patient characteristics, therapy provision, outcomes and costs within each category. RESULTS: We identified 874 routes defined by the type of admitting stroke team and subsequent transfer history. We consolidated these into nine distinct routes and further summarized these into three overlapping 'pathways' that accounted for 99% of the patients. These were direct discharge (44%), community rehabilitation (47%) and inpatient transfer (19%) with 12% of the patients receiving both inpatient transfer and community rehabilitation. Patients with the mildest and most severe strokes were more likely to follow the direct discharge pathway. Those perceived to need most therapy were more likely to follow the inpatient transfer pathway. Costs were lowest and mortality was highest for patients on the direct discharge pathway. Outcomes were best for patients on the community rehabilitation pathway and costs were highest where patients underwent inpatient transfers. CONCLUSION: Three overarching stroke care pathways were identified which differ according to patient characteristics, therapy needs and outcomes. This pathway mapping provides a benchmark to develop and plan clinical services, and for future research.

Variations in hospital resource use across stroke care teams in England, Wales and Northern Ireland: a retrospective observational study.

OBJECTIVE: To identify the main drivers of inpatient stroke care resource use, estimate the influence of stroke teams on the length of stay (LoS) of its patients and analyse the variation in relative performance across teams. DESIGN: For each of four types of stroke care teams, a two-level count data model describing the variation in LoS and identifying the team influence on LoS purged of patient and treatment characteristics was estimated. Each team effect was interpreted as a measure of stroke care relative performance and its variation was analysed. SETTING: This study used data from 145 396 admissions in 256 inpatient stroke care teams between June 2013 and July 2015 included in the national stroke register of England, Wales and Northern Ireland-Sentinel Stroke National Audit Programme. RESULTS: The main driver of LoS, and thus resource use, was the need for stroke therapy even after stroke severity was taken into account. Conditional on needing the therapy in question, an increase in the average amount of therapy received per inpatient day was associated with shorter LoS. Important variations in stroke care performance were found within each team category. CONCLUSIONS: Resource use was strongly associated with stroke severity, the need for therapy and the amount of therapy received. The variations in stroke care performance were not explained by measurable patient or team characteristics. Further operational and financial analyses are needed to unmask the causes of this unexplained variation.

The impact of a combinatorial digital and organisational intervention on the management of long-term conditions in UK primary care: a non-randomised evaluation.

BACKGROUND: Better management of long-term conditions remains a policy priority, with a focus on improving outcomes and reducing use of expensive hospital services. A number of interventions have been tested, but many have failed to show benefit in rigorous comparative research. In 2016, the NHS Test Beds scheme was launched to implement and test interventions combining digital technologies and pathway redesign in routine health care settings, with each intervention comprising multiple innovations to better realise benefit from their 'combinatorial' effect. We present the evaluation of one of the NHS Test Beds, which combined risk stratification algorithms, practice-based quality improvement and health monitoring and coaching to improve management of long-term conditions in a single health economy in the north-west of England. METHODS: The NHS Test Bed was implemented in one clinical commissioning group in the north-west of England (patient population 235,800 served by 36 general practices). Routine administrative data on hospital use (the primary outcome) and a selection of secondary outcomes (data from both hospital and primary care) were collected in the intervention site, and from a comparator area in the same region. We used difference-in-differences analysis to compare outcomes in the NHS Test Bed area and the comparator after initiation of the combinatorial intervention. RESULTS: Tests confirmed the existence of parallel trends in the intervention and comparator sites for hospital outcomes for the period April 2016 to March 2017, and for some of the planned primary care outcomes. Based on 10 months of post-intervention secondary care data and 13 months post-intervention primary care data, we found no significant impact on primary outcomes between the intervention and comparator site, and a significant impact on only one secondary outcome. CONCLUSION: A combinatorial digital and organisational intervention to improve the management of long-term conditions was implemented across a whole health economy, but we found no evidence of a positive impact on health care utilisation outcomes in hospital and primary care.

[The effect of Seguro Popular de Salud on catastrophic and impoverishing expenditures in Mexico, 2004-2012]. / Efecto del Seguro Popular de Salud sobre los gastos catastróficos y empobrecedores en México, 2004-2012.

OBJECTIVE: To determine the impact of Seguro Popular (SPS) on catastrophic and impoverishing household expenditures and on the financial protection of the Mexican health system. MATERIAL AND METHODS: The propensity score matching (PSM) method was applied to the population affiliated to SPS to determine the program's attributable effect on health expenditure. This analysis uses the National Household Income and Expenditure Survey (ENIGH) during 2004-2012, conducted by Mexico's National Institute of Statistics andGeography (INEGI). RESULTS: It was found that SPS has a significant effect on reducing the likelihood that households will incur impoverishing expenditures. A negative effect on catastrophic expenditures was also found, but it was not statistically significant. CONCLUSIONS: This paper shows the effect that SPS, in particular health insurance, has as an instrument of financial protection. Future studies using longer periods of ENIGH data should analyze the persistence of high out-of-pocket expenditure.

OBJETIVO: Determinar el impacto del Seguro Popular (SPS) en los gastos catastróficos y empobrecedores de los hogares y la protección financiera del sistema de salud en México. MATERIAL Y MÉTODOS: Se aplicó el método de pareo por puntaje de propensión sobre la afiliación al SPS y se determinó el efecto atribuible en el gasto en salud. Se hizo uso de la Encuesta Nacional de Ingresos y Gastos de los Hogares (ENIGH) de 2004 a 2012, del Instituto Nacional de Estadística y Geografía. RESULTADOS: El SPS tiene un efecto significativo reductor en la probabilidad de sufrir gastos empobrecedores. En lo que respecta a los gastos catastróficos hubo reducción sin ser significativa entre grupos. CONCLUSIONES: Este estudio demuestra el efecto que el SPS, y en particular el aseguramiento en salud, tiene como un instrumento de protección financiera. Para futuros estudios se propone analizar la persistencia del alto porcentaje del gasto de bolsillo aprovechando series de tiempo más largas de la ENIGH.

Efecto del Seguro Popular de Salud sobre los gastos catastróficos y empobrecedores en México, 2004-2012 / The effect of Seguro Popular de Salud on catastrophic and impoverishing expenditures in Mexico, 2004-2012

Resumen: Objetivos: Determinar el impacto del Seguro Popular (SPS) en los gastos catastróficos y empobrecedores de los hogares y la protección financiera del sistema de salud en México. Material y métodos: Se aplicó el método de pareo por puntaje de propensión sobre la afiliación al SPS y se determinó el efecto atribuible en el gasto en salud. Se hizo uso de la Encuesta Nacional de Ingresos y Gastos de los Hogares (ENIGH) de 2004 a 2012, del Instituto Nacional de Estadística y Geografía. Resultados: El SPS tiene un efecto significativo reductor en la probabilidad de sufrir gastos empobrecedores. En lo que respecta a los gastos catastróficos hubo reducción sin ser significativa entre grupos. Conclusión: Este estudio demuestra el efecto que el SPS, y en particular el aseguramiento en salud, tiene como un instrumento de protección financiera. Para futuros estudios se propone analizar la persistencia del alto porcentaje del gasto de bolsillo aprovechando series de tiempo más largas de la ENIGH.

Abstract: Objective: To determine the impact of Seguro Popular (SPS) on catastrophic and impoverishing household expenditures and on the financial protection of the Mexican health system. Materials and methods: The propensity score matching (PSM) method was applied to the population affiliated to SPS to determine the program's attributable effect on health expenditure. This analysis uses the National Household Income and Expenditure Survey (ENIGH) during 2004-2012, conducted by Mexico's National Institute of Statistics and Geography (INEGI). Results: It was found that SPS has a significant effect on reducing the likelihood that households will incur impoverishing expenditures. A negative effect on catastrophic expenditures was also found, but it was not statistically significant. Conclusion: This paper shows the effect that SPS, in particular health insurance, has as an instrument of financial protection. Future studies using longer periods of ENIGH data should analyze the persistence of high out-of-pocket expenditure.

Health care utilisation amongst older adults with sensory and cognitive impairments in Europe.

Worldwide, the high prevalence of multiple chronic conditions amongst older population has led to increased utilisation of health care and rising associated costs, becoming a major public health concern. Hearing, vision and cognitive disorders are common chronic conditions amongst older Europeans and recent studies have documented its high co-occurrence. While it has been shown separately that suffering either mental disorders or sensory (hearing and vision) impairments is associated with higher health care utilisation, the association between health care utilisation and the interaction of these conditions has received little attention in the literature. Therefore, using four waves of the Survey of Health, Ageing and Retirement in Europe (SHARE), this study applies the correlated random effects method to the negative binomial and finite mixture models to analyse the extent to which the interaction of cognitive and sensory impairments is associated with health care use. We found that individuals with cognitive impairment tend to have more hospitalisations. The finite mixture approach indicates a positive association between sensory impairment and the number of hospitalisations amongst low users of health care. Additionally, our findings suggest a positive association between suffering both impairments at the same time and the number of doctor and GP visits.

Measuring the burden of preventable diabetic hospitalisations in the Mexican Institute of Social Security (IMSS).

BACKGROUND: The prevalence of diabetes among adults in Mexico has increased markedly from 6.7 % in 1994 to 14.7 % in 2015. Although the main diabetic complications can be prevented or delayed with timely and effective primary care, a high percentage of diabetic patients have developed them imposing an important preventable burden on Mexican society and on the health system. This paper estimates the financial and health burden caused by potentially preventable hospitalisations due to diabetic complications in hospitals operated by the largest social security institution in Latin America, the Mexican Institute of Social Security (IMSS), in the period 2007-2014. METHODS: Hospitalisations in IMSS hospitals whose main cause was a diabetic complication were identified. The financial burden was estimated using IMSS diagnostic-related groups. To estimate the health burden, DALYs were computed under the assumption that patients would not have experienced complications if they had received timely and effective primary care. RESULTS: A total of 322,977 hospitalisations due to five diabetic complications were identified during the period studied, of which hospitalisations due to kidney failure and diabetic foot represent 78 %. The financial burden increased by 8.4 % in real terms between 2007 and 2014. However, when measured as cost per IMSS affiliate, it decreased by 11.3 %. The health burden had an overall decrease of 13.6 % and the associated DALYs in 2014 reached 103,688. CONCLUSIONS: Resources used for the hospital treatment of diabetic complications are then not available for other health care interventions. In order to prevent these hospitalisations more resources might need to be invested in primary care; the first step could be to consider the financial burden of these hospitalisations as a potential target for switching resources from hospital care to primary care services. However, more evidence of the effectiveness of different primary care interventions is needed to know how much of the burden could be prevented by better primary care.

The financial and health burden of diabetic ambulatory care sensitive hospitalisations in Mexico.

OBJECTIVE: To estimate the financial and health burden of diabetic ambulatory care sensitive hospitalisations (ACSH) in Mexico during 2001-2011. MATERIALS AND METHODS: We identified ACSH due to diabetic complications in general hospitals run by local health ministries and estimated their financial cost using diagnostic related groups. The health burden estimation assumes that patients would not have experienced complications if they had received appropriate primary care and computes the associated Disability-Adjusted Life Years (DALYs). RESULTS: The financial cost of diabetic ACSH increased by 125% in real terms and their health burden in 2010 accounted for 4.2% of total DALYs associated with diabetes in Mexico. CONCLUSION: Avoiding preventable hospitalisations could free resources within the health system for other health purposes. In addition, patients with ACSH suffer preventable losses of health that should be considered when assessing the performance of any primary care intervention.

The financial and health burden of diabetic ambulatory care sensitive hospitalisations in Mexico / La carga financiera y de salud de las hospitalizaciones sensibles a la atención ambulatoria relacionadas con diabetes en México

Objective. To estimate the financial and health burden of diabetic ambulatory care sensitive hospitalisations (ACSH) in Mexico during 2001-2011. Materials and methods. We identified ACSH due to diabetic complications in general hospitals run by local health ministries and estimated their financial cost using diagnostic related groups. The health burden estimation assumes that patients would not have experienced complications if they had received appropriate primary care and computes the associated Disability-Adjusted Life Years (DALYs). Results. The financial cost of diabetic ACSH increased by 125% in real terms and their health burden in 2010 accounted for 4.2% of total DALYs associated with diabetes in Mexico. Conclusion. Avoiding preventable hospitalisations could free resources within the health system for other health purposes. In addition, patients with ACSH suffer preventable losses of health that should be considered when assessing the performance of any primary care intervention.

Objetivos. Estimar la carga financiera y de salud de las hospitalizaciones relacionadas con diabetes sensibles a la atención ambulatoria (HSAA) en México durante 2001-2011. Material y métodos. Se identificaron HSAA relacionadas con complicaciones diabéticas en hospitales generales operados por los servicios estatales de salud y se estimó su costo financiero utilizando grupos relacionados por diagnóstico. Para estimar la carga de salud se supuso que los pacientes no hubieran sufrido complicaciones diabéticas si hubieran recibido atención primaria adecuada y se calcularon los años de vida ajustados por discapacidad (AVAD). Resultados. El costo financiero de las HSAA diabéticas aumentó 125% en términos reales y la carga de salud en 2010 representó 4.2% del total de AVAD asociados con la diabetes en México. Conclusiones. Evitar hospitalizaciones prevenibles libera recursos dentro del sistema de salud. Adicionalmente, pacientes con HSAA sufren pérdidas de salud prevenibles que deben tomarse en cuenta al evaluar el desempeño de la atención primaria.

Using ambulatory care sensitive hospitalisations to analyse the effectiveness of primary care services in Mexico.

Ambulatory care sensitive hospitalisations (ACSH) have been widely used to study the quality and effectiveness of primary care. Using data from 248 general hospitals in Mexico during 2001-2011 we identify 926,769 ACSHs in 188 health jurisdictions before and during the health insurance expansion that took place in this period, and estimate a fixed effects model to explain the association of the jurisdiction ACSH rate with patient and community factors. National ACSH rate increased by 50%, but trends and magnitude varied at the jurisdiction and state level. We find strong associations of the ACSH rate with socioeconomic conditions, health care supply and health insurance coverage even after controlling for potential endogeneity in the rolling out of the insurance programme. We argue that the traditional focus on the increase/decrease of the ACSH rate might not be a valid indicator to assess the effectiveness of primary care in a health insurance expansion setting, but that the ACSH rate is useful when compared between and within states once the variation in insurance coverage is taken into account as it allows the identification of differences in the provision of primary care. The high heterogeneity found in the ACSH rates suggests important state and jurisdiction differences in the quality and effectiveness of primary care in Mexico.