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BACKGROUND: Comparing causal effect estimates obtained using observational data to those obtained from the gold standard (i.e., randomized controlled trials [RCTs]) helps assess the validity of these estimates. However, comparisons are challenging due to differences between observational data and RCT generated data. The unknown treatment assignment mechanism in the observational data and varying sampling mechanisms between the RCT and the observational data can lead to confounding and sampling bias, respectively. AIMS: The objective of this study is to propose a two-step framework to validate causal effect estimates obtained from observational data by adjusting for both mechanisms. MATERIALS AND METHODS: An estimator of causal effects related to the two mechanisms is constructed. A two-step framework for comparing causal effect estimates is derived from the estimator. An R package RCTrep is developed to implement the framework in practice. RESULTS: A simulation study is conducted to show that using our framework observational data can produce causal effect estimates similar to those of an RCT. A real-world application of the framework to validate treatment effects of adjuvant chemotherapy obtained from registry data is demonstrated. CONCLUSION: This study constructs a framework for comparing causal effect estimates between observational data and RCT data, facilitating the assessment of the validity of causal effect estimates obtained from observational data.
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Causalidad , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Estudios Observacionales como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Simulación por Computador , Factores de Confusión Epidemiológicos , Proyectos de Investigación , Sistema de Registros/estadística & datos numéricos , Reproducibilidad de los Resultados , Sesgo , Sesgo de Selección , Interpretación Estadística de Datos , Farmacoepidemiología/métodosRESUMEN
PURPOSE: Pregnancies ending before gestational week 12 are common but not notified to the Medical Birth Registry of Norway. Our goal was to develop an algorithm that more completely detects and dates all possible pregnancy outcomes (i.e., miscarriages, elective terminations, ectopic pregnancies, molar pregnancies, stillbirths, and live births) by using diagnostic codes from primary and secondary care registries to complement information from the birth registry. METHODS: We used nationwide linked registry data between 2008 and 2018 in a hierarchical manner: We developed the UiO pregnancy algorithm to arrive at unique pregnancy outcomes, considering codes within 56 days as the same event. To estimate the gestational age of pregnancy outcomes identified in the primary and secondary care registries, we inferred the median gestational age of pregnancy markers (45 ICD-10 codes and 9 ICPC-2 codes) from pregnancies registered in the medical birth registry. When no pregnancy markers were available, we assigned outcome-specific gestational age estimates. The performance of the algorithm was assessed by blinded clinicians. RESULTS: Using only the medical birth registry, we identified 649 703 pregnancies, including 1369 (0.2%) miscarriages and 3058 (0.5%) elective terminations. With the new algorithm, we detected 859 449 pregnancies, including 642 712 live-births (74.8%), 112 257 miscarriages (13.1%), 94 664 elective terminations (11.0%), 6429 ectopic pregnancies (0.7%), 2564 stillbirths (0.3%), and 823 molar pregnancies (0.1%). The median gestational age was 10+1 weeks (IQR 10+0-12+2) for miscarriages and 8+0 weeks (IQR 8+0-9+6) for elective terminations. Gestational age could be inferred using pregnancy markers for 66.3% of miscarriages and 47.2% of elective terminations. CONCLUSION: The UiO pregnancy algorithm improved the detection and dating of early non-live pregnancy outcomes that would have gone unnoticed if relying solely on the medical birth registry information.
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Aborto Espontáneo , Algoritmos , Edad Gestacional , Resultado del Embarazo , Sistema de Registros , Humanos , Femenino , Embarazo , Sistema de Registros/estadística & datos numéricos , Noruega/epidemiología , Resultado del Embarazo/epidemiología , Aborto Espontáneo/epidemiología , Adulto , Aborto Inducido/estadística & datos numéricos , Mortinato/epidemiología , Nacimiento Vivo/epidemiologíaRESUMEN
BACKGROUND: Data monitoring and surveillance systems are the cornerstone for governance and regulation, planning, and policy development for chronic disease care. Our study aims to evaluate health systems capacity for data monitoring and surveillance for kidney care. METHODS: We leveraged data from the third iteration of the International Society of Nephrology Global Kidney Health Atlas (ISN-GKHA), an international survey of stakeholders (clinicians, policymakers and patient advocates) from 167 countries conducted between July and September 2022. ISN-GKHA contains data on availability and types of kidney registries, the spectrum of their coverage, as well as data on national policies for kidney disease identification. RESULTS: Overall, 167 countries responded to the survey, representing 97.4% of the global population. Information systems in forms of registries for dialysis care were available in 63% (n = 102/162) of countries, followed by kidney transplant registries (58%; n = 94/162), and registries for non-dialysis chronic kidney disease (19%; n = 31/162) and acute kidney injury (9%; n = 14/162). Participation in dialysis registries was mandatory in 57% (n = 58) of countries; however, in more than half of countries in Africa (58%; n = 7), Eastern and Central Europe (67%; n = 10), and South Asia (100%; n = 2), participation was voluntary. The least-reported performance measures in dialysis registries were hospitalization (36%; n = 37) and quality of life (24%; n = 24). CONCLUSIONS: The variability of health information systems and early identification systems for kidney disease across countries and world regions warrants a global framework for prioritizing the development of these systems.
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Salud Global , Enfermedades Renales , Sistema de Registros , Humanos , Sistema de Registros/estadística & datos numéricos , Enfermedades Renales/diagnóstico , Enfermedades Renales/terapia , Enfermedades Renales/epidemiología , Diagnóstico PrecozRESUMEN
BACKGROUND: Worldwide, the uptake of peritoneal dialysis (PD) compared with hemodialysis remains limited. This study assessed organizational structures, availability, accessibility, affordability and quality of PD worldwide. METHODS: This cross-sectional study relied on data from kidney registries as well as survey data from stakeholders (clinicians, policymakers and advocates for people living with kidney disease) from countries affiliated with the International Society of Nephrology (ISN) from July to September 2022. RESULTS: Overall, 167 countries participated in the survey. PD was available in 79% of countries with a median global prevalence of 21.0 [interquartile range (IQR) 1.5-62.4] per million population (pmp). High-income countries (HICs) had an 80-fold higher prevalence of PD than low-income countries (LICs) (56.2 pmp vs 0.7 pmp). In 53% of countries, adults had greater PD access than children. Only 29% of countries used public funding (and free) reimbursement for PD with Oceania and South East Asia (6%), Africa (10%) and South Asia (14%) having the lowest proportions of countries in this category. Overall, the annual median cost of PD was US$18 959.2 (IQR US$10 891.4-US$31 013.8) with full private out-of-pocket payment in 4% of countries and the highest median cost in LICs (US$30 064.4) compared with other country income levels (e.g. HICs US$27 206.0). CONCLUSIONS: Ongoing large gaps and variability in the availability, access and affordability of PD across countries and world regions were observed. Of note, there is significant inequity in access to PD by children and for people in LICs.
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Salud Global , Diálisis Peritoneal , Humanos , Diálisis Peritoneal/estadística & datos numéricos , Diálisis Peritoneal/economía , Estudios Transversales , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Fallo Renal Crónico/terapia , Fallo Renal Crónico/economía , Fallo Renal Crónico/epidemiología , Sistema de Registros/estadística & datos numéricosRESUMEN
BACKGROUND: Too high or too low patient volumes and work amounts may overwhelm health care professionals and obstruct processes or lead to inadequate personnel routine and process flow. We sought to evaluate, whether an association between current caseload, current workload, and outcomes exists in intensive care units (ICU). METHODS: Retrospective cohort analysis of data from an Austrian ICU registry. Data on patients aged ≥ 18 years admitted to 144 Austrian ICUs between 2013 and 2022 were included. A Cox proportional hazards model with ICU mortality as the outcome of interest adjusted with patients' respective SAPS 3, current ICU caseload (measured by ICU occupancy rates), and current ICU workload (measured by median TISS-28 per ICU) as time-dependent covariables was constructed. Subgroup analyses were performed for types of ICUs, hospital care level, and pre-COVID or intra-COVID period. RESULTS: 415 584 patient admissions to 144 ICUs were analysed. Compared to ICU caseloads of 76 to 100%, there was no significant relationship between overuse of ICU capacity and risk of death [HR (95% CI) 1.06 (0.99-1.15), p = 0.110 for > 100%], but for lower utilisation [1.09 (1.02-1.16), p = 0.008 for ≤ 50% and 1.10 (1.05-1.15), p < 0.0001 for 51-75%]. Exceptions were significant associations for caseloads > 100% between 2020 and 2022 [1.18 (1.06-1.30), p = 0.001], i.e., the intra-COVID period. Compared to the reference category of median TISS-28 21-30, lower [0.88 (0.78-0.99), p = 0.049 for ≤ 20], but not higher workloads were significantly associated with risk of death. High workload may be associated with higher mortality in local hospitals [1.09 (1.01-1.19), p = 0.035 for 31-40, 1.28 (1.02-1.60), p = 0.033 for > 40]. CONCLUSIONS: In a system with comparably high intensive care resources and mandatory staffing levels, patients' survival chances are generally not affected by high intensive care unit caseload and workload. However, extraordinary circumstances, such as the COVID-19 pandemic, may lead to higher risk of death, if planned capacities are exceeded. High workload in ICUs in smaller hospitals with lower staffing levels may be associated with increased risk of death.
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COVID-19 , Enfermedad Crítica , Unidades de Cuidados Intensivos , Sistema de Registros , Carga de Trabajo , Humanos , Carga de Trabajo/estadística & datos numéricos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Unidades de Cuidados Intensivos/organización & administración , Masculino , Femenino , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Austria/epidemiología , Enfermedad Crítica/terapia , Enfermedad Crítica/epidemiología , Enfermedad Crítica/mortalidad , COVID-19/epidemiología , COVID-19/mortalidad , COVID-19/terapia , Estudios de Cohortes , Mortalidad Hospitalaria/tendencias , AdultoRESUMEN
BACKGROUND: Clinical trials play a crucial role in biomedical research, and it is important to register them in public registries to ensure transparency and prevent research waste. In this study, we wished to determine what steps need to be taken to identify every clinical trial run in India that has been registered in any of the (non-Indian) World Health Organization-recognised primary registries. Of the 16 registries, we studied all except that of the European Union, which will be studied separately. METHODS: Two methodologies were employed for each registry, except for four that did not facilitate one or the other method. Methodology A involved downloading all the records in a registry and querying them. Methodology B involved conducting a search via the registry website. RESULTS: Only four registries provided consistent results with both methodologies. Seven registries had different results from the two methodologies. Of these, in four cases, in Methodology A one field indicated that the study ran in India, while another indicated otherwise. CONCLUSIONS: The above-mentioned ambiguities should be addressed by the concerned registries. Overall, this study reinforces the need for improved data accuracy and transparency in clinical trial registries and emphasizes the importance of resolving complications faced by users while navigating the registries. Ensuring accurate and comprehensive registration of clinical trials is essential for meta-research and the use of such data by a variety of stakeholders.
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Ensayos Clínicos como Asunto , Sistema de Registros , Sistema de Registros/estadística & datos numéricos , India , Humanos , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/estadística & datos numéricos , Ensayos Clínicos como Asunto/normas , Estudios Transversales , Investigación Biomédica/estadística & datos numéricos , Investigación Biomédica/métodos , Investigación Biomédica/normas , Exactitud de los DatosRESUMEN
BACKGROUND: The number of living kidney donors in the United States has declined since 2005, with variations based on the donor-recipient relationship. The reasons for this decline are unclear, and strategies to mitigate declined donations remain elusive. We examined the change in donor number monthly (within-year) versus annually (between-years) to inform potentially modifiable factors for future interventions. METHODS: In this registry-based cohort analysis of 141 759 living kidney donors between 1995 and 2019, we used linear mixed-effects models for donor number per month and year to analyze between-year and within-year variation in donation. We used Poisson regression to quantify the change in the number of donors per season before and after 2005, stratified by donor-recipient relationship and zip-code household income tertile. RESULTS: We observed a consistent summer surge in donations during June, July, and August. This surge was statistically significant for related donors (incidence rate ratio [IRR] range: 1.12-1.33) and unrelated donors (IRR range: 1.06-1.16) across donor income tertiles. CONCLUSION: Our findings indicate lower rates of living kidney donation in non-summer months across income tertiles. Interventions are needed to address barriers to donation in non-summer seasons and facilitate donations throughout the year. Since the Organ Donor Leave Law provides a solid foundation for supporting year-round donation, extending the law's provisions beyond federal employees may mitigate identified seasonal barriers.
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Trasplante de Riñón , Donadores Vivos , Estaciones del Año , Obtención de Tejidos y Órganos , Humanos , Donadores Vivos/estadística & datos numéricos , Masculino , Femenino , Estados Unidos , Trasplante de Riñón/estadística & datos numéricos , Persona de Mediana Edad , Adulto , Estudios de Seguimiento , Obtención de Tejidos y Órganos/estadística & datos numéricos , Obtención de Tejidos y Órganos/tendencias , Sistema de Registros/estadística & datos numéricos , Pronóstico , Nefrectomía/estadística & datos numéricosRESUMEN
BACKGROUND: The prognosis, recurrence rates, and secondary prevention strategies varied significantly among different subtypes of acute ischemic stroke (AIS). Machine learning (ML) techniques can uncover intricate, non-linear relationships within medical data, enabling the identification of factors associated with etiological classification. However, there is currently a lack of research utilizing ML algorithms for predicting AIS etiology. OBJECTIVE: We aimed to use interpretable ML algorithms to develop AIS etiology prediction models, identify critical factors in etiology classification, and enhance existing clinical categorization. METHODS: This study involved patients with the Third China National Stroke Registry (CNSR-III). Nine models, which included Natural Gradient Boosting (NGBoost), Categorical Boosting (CatBoost), Extreme Gradient Boosting (XGBoost), Random Forest (RF), Light Gradient Boosting Machine (LGBM), Gradient Boosting Decision Tree (GBDT), Adaptive Boosting (AdaBoost), Support Vector Machine (SVM), and logistic regression (LR), were employed to predict large artery atherosclerosis (LAA), small vessel occlusion (SVO), and cardioembolism (CE) using an 80:20 randomly split training and test set. We designed an SFS-XGB with 10-fold cross-validation for feature selection. The primary evaluation metrics for the models included the area under the receiver operating characteristic curve (AUC) for discrimination and the Brier score (or calibration plots) for calibration. RESULTS: A total of 5,213 patients were included, comprising 2,471 (47.4%) with LAA, 2,153 (41.3%) with SVO, and 589 (11.3%) with CE. In both LAA and SVO models, the AUC values of the ML models were significantly higher than that of the LR model (P < 0.001). The optimal model for predicting SVO (AUC [RF model] = 0.932) outperformed the optimal LAA model (AUC [NGB model] = 0.917) and the optimal CE model (AUC [LGBM model] = 0.846). Each model displayed relatively satisfactory calibration. Further analysis showed that the optimal CE model could identify potential CE patients in the undetermined etiology (SUE) group, accounting for 1,900 out of 4,156 (45.7%). CONCLUSIONS: The ML algorithm effectively classified patients with LAA, SVO, and CE, demonstrating superior classification performance compared to the LR model. The optimal ML model can identify potential CE patients among SUE patients. These newly identified predictive factors may complement the existing etiological classification system, enabling clinicians to promptly categorize stroke patients' etiology and initiate optimal strategies for secondary prevention.
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Algoritmos , Accidente Cerebrovascular Isquémico , Aprendizaje Automático , Humanos , Accidente Cerebrovascular Isquémico/clasificación , Accidente Cerebrovascular Isquémico/etiología , Accidente Cerebrovascular Isquémico/diagnóstico , Estudios Prospectivos , Femenino , Masculino , Persona de Mediana Edad , Anciano , China/epidemiología , Pronóstico , Máquina de Vectores de Soporte , Isquemia Encefálica/clasificación , Isquemia Encefálica/etiología , Sistema de Registros/estadística & datos numéricos , Modelos LogísticosRESUMEN
As of now, a model for predicting the survival of patients with out-of-hospital cardiac arrest has not been established. This study aimed to develop a model for identifying predictors of survival over time in patients with out-of-hospital cardiac arrest during their stay in the emergency department, using ensemble-based machine learning. A total of 26 013 patients from the Korean nationwide out-of-hospital cardiac arrest registry were enrolled between January 1 and December 31, 2019. Our model, comprising 38 variables, was developed using the Survival Quilts model to improve predictive performance. We found that changes in important variables of patients with out-of-hospital cardiac arrest were observed 10 minutes after arrival at the emergency department. The important score of the predictors showed that the influence of patient age decreased, moving from the highest rank to the fifth. In contrast, the significance of reperfusion attempts increased, moving from the fourth to the highest rank. Our research suggests that the ensemble-based machine learning model, particularly the Survival Quilts, offers a promising approach for predicting survival in patients with out-of-hospital cardiac arrest. The Survival Quilts model may potentially assist emergency department staff in making informed decisions quickly, reducing preventable deaths.
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Aprendizaje Automático , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/mortalidad , Paro Cardíaco Extrahospitalario/terapia , Masculino , Femenino , República de Corea , Anciano , Persona de Mediana Edad , Servicio de Urgencia en Hospital/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Análisis de SupervivenciaRESUMEN
Cardiogenic shock (CS) is a serious complication of heart attack and constitutes one of its main causes of death. To date, there is no data on its treatment and evolution in Latin America. OBJECTIVES: To know the clinical characteristics, treatment strategies, evolution and in-hospital mortality of CS in Latin America. MATERIALS AND METHODS: This is a prospective, multicenter registry of patients hospitalized with CS in the context of acute coronary syndromes (ACS) with and without ST segment elevation for 24 months. RESULTS: 41 Latin American centers participated incorporating patients during the period between October 2021 and September 2023. 278 patients were included. Age: 66 (59-75) years, 70.1 % men. 74.8 % of the cases correspond to ACS with ST elevation, 14.4 % to ACS without ST elevation, 5.7 % to right ventricular infarction and 5.1 % to mechanical complications. CS was present from admission in 60 % of cases. Revascularization: 81.3 %, inotropic use: 97.8 %, ARM: 52.5 %, Swan Ganz: 17 %, intra-aortic balloon pump: 22.2 %. Overall in-hospital mortality was 52.7 %, with no differences between ACS with or without ST. CONCLUSIONS: Morbidity and mortality is very high despite the high reperfusion used.
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Síndrome Coronario Agudo , Mortalidad Hospitalaria , Sistema de Registros , Choque Cardiogénico , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome Coronario Agudo/epidemiología , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/diagnóstico , Mortalidad Hospitalaria/tendencias , Contrapulsador Intraaórtico/estadística & datos numéricos , Contrapulsador Intraaórtico/métodos , América Latina/epidemiología , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Choque Cardiogénico/epidemiología , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Infarto del Miocardio con Elevación del ST/epidemiología , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/complicaciones , Infarto del Miocardio con Elevación del ST/mortalidadRESUMEN
PURPOSE: Patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia. METHODS: In this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO2 92-96%) or to a liberal oxygen strategy (target SaO2 97-100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months. RESULTS: From September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0-13.7] versus liberal: 0 days [IQR 0-13.7], median treatment effect: 0 days [95% confidence interval (CI) - 3.1 to 3.1]). Mortality at day 28 (59/159 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001). CONCLUSIONS: In adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.
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Oxigenación por Membrana Extracorpórea , Humanos , Oxigenación por Membrana Extracorpórea/métodos , Oxigenación por Membrana Extracorpórea/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Adulto , Unidades de Cuidados Intensivos/estadística & datos numéricos , Saturación de Oxígeno/fisiología , Sistema de Registros/estadística & datos numéricos , Oxígeno , Choque Cardiogénico/terapia , Choque Cardiogénico/mortalidad , Paro Cardíaco/terapia , Paro Cardíaco/mortalidadRESUMEN
BACKGROUND: The majority of palliative care patients express a preference for remaining at home for as long as possible. Despite progression of disease there is a strong desire to die at home. Nonetheless, there are transfers between care settings, demonstrating a discrepancy between desired and actual place of death. AIM: To map the prevalence of patients near death undergoing specialized palliative home care and being transferred to inpatient care in Sweden. METHODS: A national retrospective cross-sectional study based on data from the Swedish Register of Palliative Care. Patients ≥ 18 years of age enrolled in specialized palliative home care with dates of death between 1 November 2015 and 31 October 2022 were included (n = 39,698). Descriptive statistics were used. RESULTS: Seven thousand three hundred eighty-three patients (18.6%), approximately 1,000 per year, were transferred to inpatient care and died within seven days of arrival. A considerable proportion of these patients died within two days after admission. The majority (73.6%) were admitted to specialized palliative inpatient care units, 22.9% to non-specialized palliative inpatient care units and 3.5% to additional care units. Transferred patients had more frequent dyspnoea (30.9% vs. 23.2%, p < 0.001), anxiety (60.2% vs. 56.5%, p < 0.001) and presence of several simultaneous symptoms was significantly more common (27.0% vs. 24.8%, p 0.001). CONCLUSION: The results show that patients admitted to specialized palliative home care in Sweden are being transferred to inpatient care near death. A notable proportion of these patients dies within two days of admission. Common features, such as symptoms and symptom burden, can be observed in the patients transferred. The study highlights a phenomenon that may be experienced by patients, relatives and healthcare personnel as a significant event in a vulnerable situation. A deeper understanding of the underlying causes of these transfers is required to ascertain whether they are compatible with good palliative care and a dignified death.
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Servicios de Atención de Salud a Domicilio , Cuidados Paliativos , Transferencia de Pacientes , Sistema de Registros , Humanos , Suecia , Masculino , Cuidados Paliativos/métodos , Cuidados Paliativos/estadística & datos numéricos , Femenino , Anciano , Servicios de Atención de Salud a Domicilio/estadística & datos numéricos , Servicios de Atención de Salud a Domicilio/normas , Sistema de Registros/estadística & datos numéricos , Estudios Transversales , Estudios Retrospectivos , Anciano de 80 o más Años , Persona de Mediana Edad , Transferencia de Pacientes/estadística & datos numéricos , Transferencia de Pacientes/métodos , Transferencia de Pacientes/normas , Adulto , Pacientes Internos/estadística & datos numéricos , Pacientes Internos/psicología , Hospitalización/estadística & datos numéricosRESUMEN
BACKGROUND: The National Cancer Institute funds many large cohort studies that rely on self-reported cancer data requiring medical record validation. This is labor intensive, costly, and prone to underreporting or misreporting of cancer and disparity-related differential response. US population-based central cancer registries identify incident cancer within their catchment area, yielding all malignant neoplasms and benign brain and central nervous system tumors with standardized data fields. This manuscript describes the development, implementation, and features of a system to facilitate linkage between cohort studies and cancer registries and the release of cancer registry data for matched cohort participants. METHODS: The Virtual Pooled Registry-Cancer Linkage System (VPR-CLS) provides an online system to link cohorts with multiple state cancer registries by 1) securely transmitting a study file to registries, 2) providing an optimized linkage algorithm to generate preliminary match counts, and 3) providing a streamlined process and templated forms for submitting and tracking data requests for cohort participants who matched with registries. RESULTS: In 2022, the VPR-CLS launched with 45 registries, covering 95% of the US state populations and Puerto Rico. Registries have linked with 15 studies having 14â273-10.9 million participants. Except in 1 study, linkage sensitivity ranged from 87.0% to 99.9%. Numerous registries have adopted the VPR-CLS templated institutional review board-registry application (n = 39), templated data use agreement (n = 25), and central institutional review board (n = 16). CONCLUSIONS: The VPR-CLS markedly improves ascertainment of cancer outcomes and is the preferred approach for determination of outcomes from cohort studies, postmarketing surveillance, and clinical trials.
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Registro Médico Coordinado , Neoplasias , Sistema de Registros , Humanos , Sistema de Registros/estadística & datos numéricos , Neoplasias/epidemiología , Neoplasias/diagnóstico , Estados Unidos/epidemiología , Registro Médico Coordinado/métodos , Estudios de Cohortes , National Cancer Institute (U.S.)RESUMEN
BACKGROUND: Precision medicine has become a mainstay of cancer care in recent years. The National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Program has been an authoritative source of cancer statistics and data since 1973. However, tumor genomic information has not been adequately captured in the cancer surveillance data, which impedes population-based research on molecular subtypes. To address this, the SEER Program has developed and implemented a centralized process to link SEER registries' tumor cases with genomic test results that are provided by molecular laboratories to the registries. METHODS: Data linkages were carried out following operating procedures for centralized linkages established by the SEER Program. The linkages used Match*Pro, a probabilistic linkage software, and were facilitated by the registries' trusted third party (an honest broker). The SEER registries provide to NCI limited datasets that undergo preliminary evaluation prior to their release to the research community. RESULTS: Recently conducted genomic linkages included OncotypeDX Breast Recurrence Score, OncotypeDX Breast Ductal Carcinoma in Situ, OncotypeDX Genomic Prostate Score, Decipher Prostate Genomic Classifier, DecisionDX Uveal Melanoma, DecisionDX Preferentially Expressed Antigen in Melanoma, DecisionDX Melanoma, and germline tests results in Georgia and California SEER registries. CONCLUSIONS: The linkages of cancer cases from SEER registries with genomic test results obtained from molecular laboratories offer an effective approach for data collection in cancer surveillance. By providing de-identified data to the research community, the NCI's SEER Program enables scientists to investigate numerous research inquiries.
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Genómica , Neoplasias , Sistema de Registros , Programa de VERF , Humanos , Programa de VERF/estadística & datos numéricos , Estados Unidos/epidemiología , Neoplasias/genética , Neoplasias/epidemiología , Neoplasias/diagnóstico , Genómica/métodos , Sistema de Registros/estadística & datos numéricos , Femenino , Masculino , Pruebas Genéticas/métodos , Pruebas Genéticas/estadística & datos numéricos , Registro Médico Coordinado/métodos , National Cancer Institute (U.S.)RESUMEN
BACKGROUND: Veterans have unique military risk factors and exposures during deployment that may augment their risk of post-acute sequelae of SARS-CoV-2 (PASC). The purpose of this study is to identify potential risk factors for PASC among Veterans in the national Airborne Hazards and Open Burn Pit Registry (AHOBPR). METHODS: This prospective observational study consisted of a semi-structured interview conducted via phone or videoconference from November 2021 to December 2022 among a stratified random sample of deployed Veterans nested within the national AHOBPR with laboratory-confirmed SARS-CoV-2 infection. PASC was defined as persistent new-onset symptoms lasting more than 2 months after initial SARS-CoV-2 infection. Deployment history, airborne hazards exposure and symptoms were obtained from the AHOBPR self-assessment questionnaire completed prior to SARS-CoV-2 infection (past). Post-infection symptoms and health behaviors obtained at study interview (present) were used to test the hypothesis that deployment experience and exposure increases the risk for PASC. RESULTS: From a sample of 212 Veterans, 149 (70%) met criteria for PASC with a mean age of 47 ± 8.7 years; 73 (49%) were women and 76 (51%) were men, and 129 (82.6%) continued to experience persistent symptoms of SARS-CoV-2 (596.8 ± 160.4 days since initial infection). Neither exposure to airborne hazards (OR 0.97, CI 0.92-1.03) or to burn pits (OR 1.00, CI 0.99-1.00) augmented risk for PASC. CONCLUSIONS: PASC is highly common among Veterans enrolled in the AHOBPR, but we did not observe any unique military risk factors (e.g., airborne hazards exposure) that augmented the risk of PASC. Our findings may provide guidance to clinicians in the VHA network to administer appropriate care for Veterans experiencing PASC.
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Síndrome Post Agudo de COVID-19 , Sistema de Registros , Veteranos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Quema de Residuos al Aire Libre/efectos adversos , Síndrome Post Agudo de COVID-19/epidemiología , Prevalencia , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Factores de Riesgo , SARS-CoV-2 , Estados Unidos/epidemiología , Veteranos/estadística & datos numéricosRESUMEN
Chronic ulcer patients form a heterogenous group of patients with various medical backgrounds. Cost-effective targeted treatment necessitates more knowledge about specific features related to different subgroups of ulcer patients. Hence, this study aimed to characterize ulcer patients according to gender and ulcer aetiology. A total of 946 consecutively recorded chronic ulcer patients in the Tampere Wound Registry (TWR) were included and data were gathered from the TWR and patient medical records. Comparisons were made between males and females and patients with venous-, arterial or mixed-, diabetic foot-, pressure- and atypical ulcers. Male patients were found to have diabetes, hypercholesterolemia and obesity significantly more often than females (59.2% vs. 39.6%; p < 0.001, 46.5% vs. 33.3%; p = 0.001, 42.7% vs. 35.9%; p = 0.017 respectively), whereas autoimmune diseases were more common among females (30.6% vs. 15.6%; p < 0.001). Recurrence of ulcers was most common among patients with venous ulcers (p < 0.001) and multimorbidity among those with diabetic foot ulcers (p < 0.001). To conclude, males with chronic ulcers would benefit particularly from lifestyle advice, multidisciplinary treatment should be targeted specifically at those with diabetic and arterial or mixed ulcers and preventive measures at those with venous ulcers.
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Pie Diabético , Humanos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Enfermedad Crónica , Factores Sexuales , Anciano de 80 o más Años , Pie Diabético/epidemiología , Pie Diabético/terapia , Finlandia/epidemiología , Úlcera Varicosa/terapia , Úlcera Varicosa/epidemiología , Adulto , Sistema de Registros/estadística & datos numéricosRESUMEN
The Surveillance, Epidemiology, and End Results (SEER) Program established in 1973 was the first laboratory for experimenting with new methods for cancer data collection and translating the data into population-based cancer statistics. The SEER Program staff have been instrumental in the development of the International Classification of Disease-Oncology and successfully implemented the routine collection of anatomic and prognostic cancer stage at diagnosis. Currently the program consists of 21 central registries that generate cancer statistics covering more than 48% of the US population and an additional 10 research support registries contributing to certain research projects, such as the National Childhood Cancer Registry. In parallel with the geographical expansion, the program built an architecture of methods and tools for population-based cancer statistics, with SEER*Explorer as the most recent online tool for descriptive statistics. In addition, SEER releases annual updates for a comprehensive data product line, which includes SEER*Stat databases with an annual caseload of more than 800â000 incident cases. Furthermore, the program developed a full suite of analytical applications for population-based cancer statistics that include Joinpoint (regression-based trend analysis), DevCan (risk of diagnosis and death), CanSurv (survival models), and ComPrev and PrejPrev (cancer prevalence), among others. The future of the SEER Program is closely aligned to the overall goals of the "war on cancer." The program aims to release longitudinal treatment data coupled with a comprehensive genomic characterization of cancers with a declared goal of decreasing the cancer burden and disparities across a wide spectrum of diseases and communities.
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Neoplasias , Programa de VERF , Humanos , Programa de VERF/estadística & datos numéricos , Neoplasias/epidemiología , Neoplasias/diagnóstico , Estados Unidos/epidemiología , Historia del Siglo XX , Historia del Siglo XXI , Sistema de Registros/estadística & datos numéricosRESUMEN
BACKGROUND: The effectiveness of generalist palliative care interventions in hospitals is unknown. AIM: This study aimed to explore the impact of a palliative care case management intervention for patients with gastrointestinal cancer (PalMaGiC) on hospital admissions, healthcare use, and place of death. DESIGN: This was a register-based cohort study analyzing data from the Danish Register on Causes of Death, the Danish National Patient Register, and the Danish Palliative Database. SETTING/PARTICIPANTS: Deceased patients with gastrointestinal cancer from 2010 to 2020 exposed to PalMaGiC were compared over three periods of time to patients receiving standard care. RESULTS: A total of 43,969 patients with gastrointestinal cancers were included in the study, of whom 1518 were exposed to PalMaGiC. In the last 30 days of life, exposed patients were significantly more likely to be hospitalized (OR of 1.62 (95% CI 1.26-2.01)), spend more days at the hospital, estimate of 1.21 (95% CI 1.02-1.44), and have a higher number of hospital admissions (RR of 1.13 (95% CI 1.01-1.27)), and were more likely to die at the hospital (OR of 1.94 (95% CI 1.55-2.44)) with an increasing trend over time. No differences were found for hospital healthcare use. CONCLUSION: Patients exposed to the PalMaGiC intervention had a greater likelihood of hospitalizations and death at the hospital compared to unexposed patients, despite the opposite intention. Sensitivity analyses show that regional differences may hold some of the explanation for this. Future development of generalist palliative care in hospitals should focus on integrating a home-based approach, community care, and PC physician involvement.
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Neoplasias Gastrointestinales , Cuidados Paliativos , Sistema de Registros , Humanos , Neoplasias Gastrointestinales/terapia , Cuidados Paliativos/métodos , Cuidados Paliativos/estadística & datos numéricos , Masculino , Femenino , Dinamarca , Anciano , Sistema de Registros/estadística & datos numéricos , Estudios de Cohortes , Anciano de 80 o más Años , Persona de Mediana Edad , Hospitalización/estadística & datos numéricosRESUMEN
BACKGROUND: Malignant pleural mesothelioma (MPM) is a rare thoracic malignancy with poor prognosis and limited treatment options. Immunotherapy shows potential for improved outcomes; however, real-world evidence on its use will take time to accumulate. This study examined patient characteristics, treatment patterns, overall survival (OS), and predictors of mortality among patients diagnosed with MPM in Denmark prior to the introduction of newer treatments. METHODS: This historical cohort study based on routinely collected Danish National Registry data included adults newly diagnosed with MPM between 01 January 2011 and 31 May 2018. Summary statistics were used to describe patient characteristics and initial treatment. OS was estimated using Kaplan-Meier methods; Cox regression was used to compare patient mortality against the (age/sex-matched) general population and to investigate mortality predictors. RESULTS: Overall, 880 patients were included; 44% had advanced MPM, 37% had non-advanced MPM, and 19% had unknown MPM stage. Median age at diagnosis was 71.9 years, and 82% of the patients were male. Within 180 days of diagnosis, no treatment was recorded for 215 patients (54%) with advanced MPM and 150 (46%) with non-advanced MPM. Median time-to-initial treatment (interquartile range) was 47 days (31-111) overall, 40 days (28-77) in patients with advanced MPM, and 53 days (35-121) with non-advanced MPM. Median OS was 13.7 months overall (non-advanced MPM: 18.0 months vs. advanced MPM: 10.0 months). Predictors of higher mortality were older age at diagnosis, histology, and advanced MPM stage. INTERPRETATION: These findings provide a baseline upon which to evaluate MPM epidemiology as newer treatments are adopted in routine practice.
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Mesotelioma Maligno , Neoplasias Pleurales , Sistema de Registros , Humanos , Dinamarca/epidemiología , Masculino , Anciano , Femenino , Mesotelioma Maligno/terapia , Mesotelioma Maligno/mortalidad , Mesotelioma Maligno/patología , Neoplasias Pleurales/mortalidad , Neoplasias Pleurales/terapia , Neoplasias Pleurales/patología , Persona de Mediana Edad , Sistema de Registros/estadística & datos numéricos , Estudios de Cohortes , Anciano de 80 o más Años , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/terapia , Neoplasias Pulmonares/patología , Tasa de SupervivenciaRESUMEN
PURPOSE: To analyze the survival outcomes of female patients with cervical, uterine, and ovarian cancers in Southeast China (Fujian Province) from 2011 to 2020 and to provide a reference basis for prognostic evaluation and prevention of gynecological malignancies. METHODS: The data of 5823 patients with cervical, uterine, and ovarian cancers registered in the Fujian Provincial Cancer Prevention and Control System from 2011 to 2020 were enrolled for survival analysis and further stratified by age at diagnosis and township. Survival time was calculated up to March 30, 2022, and relative survival (RS) and age-standardized RS were calculated according to the International Cancer Survival Standards (ICSS). RESULTS: During 2011-2015, the 5-year RS for cervical, uterine, and ovarian cancers were 64.3â¯%, 64.2â¯%, and 44.7â¯%, respectively, while the age-standardized 5-year RS were 56.8â¯%, 47.9â¯%, and 27.9â¯%, respectively. During 2016-2020, the 5-year RS for cervical, uterine, and ovarian cancers were 72.3â¯%, 78.9â¯%, and 50.8â¯%, respectively, while the age-standardized 5-year RS were 64.5â¯%, 54.6â¯%, and 34.2â¯%, respectively. The 5-year RS for cervical and ovarian cancer all declined with age, while the 5-year RS for uterine cancer was highest at 45-54 years and lowest at 75 years. In addition, survival rates were broadly higher in urban than rural areas. CONCLUSION: Survival rates for cervical, uterine, and ovarian cancers have generally increased in the population covered by the Fujian Cancer Registry. However, survival rates remain lower than in developed countries. Emphasis should be placed on gynecological cancer screening and the introduction of effective treatments to improve survival rates for gynecological cancers.