Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study.

Background: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. Methods: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. Findings: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. Interpretation: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. Funding: None.

Psychosocial factors in adherence to pharmacological treatment and diabetes mellitus control in patients over 65.

AIM: To explore the influence of anxiety/depression symptoms and social risk in patients older than 65 years with type 2 diabetes mellitus (T2DM) both in non-adherence to pharmacological treatment (Non-AdhT) and in poor control of T2DM. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Adults over 65 years of age with T2DM treated at the Madrid Primary Care Service. MAIN MEASUREMENTS: Data collection: Electronic Health Record database. VARIABLES: Poor control of T2DM (HBA1c) and Non-AdhT (Morisky-Green test); main clinical variables: symptoms of depression/anxiety and social risk. Global multivariate logistic regression models and disaggregated by sex were used to Non-AdhT and poor T2DM control. RESULTS: Data were obtained on 884 subjects. Non-AdhT prevalence: 4.4%; prevalence of poor T2DM control: 37.2%. Multivariate logistic regression models for No-AdhT in men showed a higher risk if they had symptoms of anxiety/depression (OR: 3.88; 95%CI: 1.15-13.07); and in women, if they had social risk (OR: 5.61; 95%CI: 1.86-16.94). Multivariate logistic regression models for poor control of T2DM in men revealed a higher risk if they did not have AdhT (OR: 3.53; 95%CI: 1.04-12.02). CONCLUSIONS: In people over 65 years with T2DM, although Non-AdhT is low, the prevalence of poor T2DM control is high. Symptoms of depression or anxiety are a risk factor to Non-AdhT in men, while social risk has the same effect in women. Non-AdhT in men increases the risk of poor T2DM control. From a gender perspective, it is important to detect social and mental health problems in older adults with diabetes and to reinforce strategies to improve their adherence to drug treatment in these patients.

Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study.

INTRODUCTION: Breast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors. METHODS AND ANALYSIS: Population-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations. TRIAL REGISTRATION NUMBER: This protocol is registered in Clinical Trials.gov (identifier: NCT03846999).

[Nursing Workforce Characteristics and Control of Diabetes Mellitus in Primary Care: a Multilevel Analysis]. / Control de la diabetes mellitus en población adulta según las características del personal de enfermería de atención primaria de la comunidad de Madrid: análisis multinivel.

OBJECTIVE: Nurse activity is determined by the characteristics of nursing staff. The objective was to determine the impact of Primary Health Care (PHC) nursing workforce characteristics on the control of Diabetes Mellitus (DM) in adults. METHODS: Cross-sectional analytical study. Administrative and clinical registries and questionnaire PES-Nursing Work Index from PHC nurses. Participants 44.214 diabetic patients in two health zones within the Community of Madrid, North-West Zone (NWZ) with higher socioeconomic situation and South-West Zone (SWZ) with lower socioeconomic situation, and their 507 reference nurses. Analyses were performed to multivariate multilevel logistic regression models. PRIMARY OUTCOME MEASURE: Poor DM control (figures equal or higher than 7% HbA1c). RESULTS: The prevalence of poor DM control was 40.1% [CI95%: 38.2-42.1]. There was a risk of 25% more of poor control if the patient changed centre and of 27% if changed of doctor-nurse pair. In the multilevel multivariate regression models: in SWZ increasing the ratio of patients over 65 years per nurse increased the poor control (OR=1.00008 [CI95%:1.00006-1.001]); and higher proportion of patients whose Hb1Ac was not measured at the centre contributed to poor DM control (OR=5.1 [CI95%:1.6-15.6]). In two models for health zone, the economic immigration condition increased poor control, in SWZ (OR=1.3 [CI95%:1.03-1.7]); and in NWZ (OR=1.29 [CI95%:1.03-1.6]). CONCLUSIONS: Higher 65 years old patients ratio per nurse, economic immigration condition and a higher proportion of patients whose Hb1Ac was not measured contribute to worse DM control.

OBJETIVO: La actividad de enfermería está condicionada por las características de la plantilla. El objetivo fue determinar cómo afectan las características de la plantilla de enfermería de atención primaria (AP) al control de la diabetes mellitus (DM) en personas adultas. METODOS: Estudio analítico transversal. Instrumentos para la recogida de datos: sistemas de información de AP y cuestionario PES-Nursing Work Index. Participantes: 44.214 pacientes diabéticos en dos zonas de salud de la Comunidad de Madrid: Zona Noroeste (ZNO) con mejor situación socioeconómica y Zona Suroeste (ZSO) con peor situación socioeconómica y los 507 profesionales de enfermería de referencia. Se realizaron análisis multivariantes multinivel de regresión logística. La variable dependiente fue la DM estaba mal controlada (cuando los valores de Hb1Ac eran igual o mayor que 7%). RESULTADOS: La prevalencia DM mal controlada fue de 40,1% (IC95%:38,2-42,1). Existía un riesgo de un 25% más de peor control si el paciente cambiaba de centro de salud y de un 27% si cambiaba de pareja médico de cabaecera y enfermera. En los modelos de regresión logística multivariante multinivel: para la ZSO a mayor ratio de pacientes mayores de 65 años aumentaba el riesgo de mal control (OR=1,00008 [IC95%:1,00006-1,001]); a mayor proporción de pacientes sin seguimiento por centro de salud peor control (OR=5,1 [IC95%:1,6-15,6]). En los dos modelos por zona de salud, la condición de ser inmigrante económico aumentó el riesgo de mal control, ZSO (OR=1,3 [IC95%:1,03-1,7]); y ZNO (OR=1,29 [IC95%:1,03-1,6]). CONCLUSIONES: Son factores de riesgo de tener mal controlada la diabetes mellitus la mayor proporción de pacientes mayores de 65 años por enfermera, ser inmigrante y la proporción de pacientes sin seguimiento.

Impact of primary care nursing workforce characteristics on the control of high-blood pressure: a multilevel analysis.

OBJECTIVE: To determine the impact of Primary Health Care (PHC) nursing workforce characteristics and of the clinical practice environment (CPE) perceived by nurses on the control of high-blood pressure (HBP). DESIGN: Cross-sectional analytical study. SETTING: Administrative and clinical registries of hypertensive patients from PHC information systems and questionnaire from PHC nurses. PARTICIPANTS: 76,797 hypertensive patients in two health zones within the Community of Madrid, North-West Zone (NWZ) with a higher socioeconomic situation and South-West Zone (SWZ) with a lower socioeconomic situation, and 442 reference nurses. Segmented analyses by area were made due to their different socioeconomic characteristics. PRIMARY OUTCOME MEASURE: Poor HBP control (adequate figures below the value 140/90 mm Hg) associated with the characteristics of the nursing workforce and self-perceived CPE. RESULTS: The prevalence of poor HBP control, estimated by an empty multilevel model, was 33.5% (95% CI 31.5% to 35.6%). In the multilevel multivariate regression models, the perception of a more favourable CPE was associated with a reduction in poor control in NWZ men and SWZ women (OR=0.99 (95% CI 0.98 to 0.99)); the economic immigration conditions increased poor control in NWZ women (OR=1.53 (95% CI 1.24 to 1.89)) and in SWZ, both men (OR=1.89 (95% CI 1.43 to 2.51)) and women (OR=1.39 (95% CI 1.09 to 1.76)). In all four models, increasing the annual number of patient consultations was associated with a reduction in poor control (NWZ women: OR=0.98 (95% CI0.98 to 0.99); NWZ men: OR=0.98 (95% CI 0.97 to 0.99); SWZ women: OR=0.98 (95% CI 0.97 to 0.99); SWZ men: OR=0.99 (95% CI 0.97 to 0.99). CONCLUSIONS: A CPE, perceived by PHC nurses as more favourable, and more patient-nurse consultations, contribute to better HBP control. Economic immigration condition is a risk factor for poor HBP control. Health policies oriented towards promoting positive environments for nursing practice are needed.

Use of health care resources and loss of productivity in patients with depressive disorders seen in Primary Care: INTERDEP Study.

INTRODUCTION: The InterDep Study analyzes the characteristics of patients with a depressive disorder who, in the last years, have received health services at Primary Care in an specific health care area. The InterDep Study evaluates the use of heath care resources attributable to depression (direct costs) and loss of productivity (indirect costs). It also analyzes these patients' referral to the specialist. METHODS: A retrospective, multicenter observational study was conducted using computerized medical records collected in an anonymized database of 22,795 patients who received health care services between 2005 and 2009 for a new episode of depressive disorder in a specific Primary Care Area of the Madrid Health Service (Community of Madrid) (former Area 6). RESULTS: A 74.5% of the patients with depressive disorders were women, mean age 54 years (SD 17.7). According to the ICPC classification, depression was the most frequently diagnosed disorder (48.4%), followed by anxiety (35.4%) and adjustment disorder (16.2%). A 88.5% were treated with selective serotonin reuptake inhibitors (SSRIs) (N06AB). The average total annual cost (both direct and indirect costs) was 725.2 Euros. Loss of productivity was the major cost in depressed patients treated in primary care (501.0 Euros), especially among those patients on disability. A 29.7% of the patients were referred to specialized care. CONCLUSIONS: The prevalence and the socio-sanitary impact of depressive disorders in primary care require adequate clinical competence from the physician to guarantee proper disease management thus, minimizing the significant direct (health care resources) and indirect (loss of productivity) cost.