Abstract
Introduction
Over recent years there has been growing evidence of increased risk of mortality associated with hemorrhagic stroke among older patients. The main objective of this study is to propose and validate a prognostic life table for complex chronic patients after an intracerebral hemorrhage (ICH) episode in primary care settings.
Methods
This was a multicenter and retrospective study (April 1, 2006–December 31, 2016) of a cohort from the general population presenting an episode of ICH from which a predictive model of mortality was obtained using a Cox proportional hazards regression model. In addition, Kaplan–Meier survival curves, the log-rank test, receiver operating characteristic (ROC) curves, and area under the ROC curve (AUC) were used to evaluate the ability to stratify patients according to vital prognosis. We proceeded to external validation of the model through prospective monitoring (January 1, 2013–December 31, 2017) of the population of complex chronic patients with an episode of ICH.
Results
A total of 3594 people aged ≥ 65 years were identified as complex chronic patients (women 55.9%; mean age, 86.1 ± 8.4 years) of whom 161 suffered hemorrhagic stroke during the study period (January 1, 2013–December 31, 2017). The primary outcome was death from any cause within 5 years of follow-up after an ICH episode. The independent prognostic factors of mortality were age > 80 years (HR 1.048, 95% CI 1.021–1.076, p < 0.001) and HAS-BLED score (HR 1.369, 95% CI 1.057–1.774, p = 0.017). Compared to the general population, the incidence density/1000 person per year (15 vs 0.22) was significantly higher with a significantly lower annual lethality rate (17% vs 49.2%); and both the prognostic factors and the risk of stratified mortality showed different epidemiological patterns. The internal validation of the model was optimal (log-rank < 0.0001) in the general population, but its external validation was not significant in the complex chronic patient population (log-rank p = 0.104).
Conclusions
The ICH-AP is a clinical scale that can improve the prognostic prediction of mortality in primary care after an episode of ICH in the general population, but it was not significant in its external validation in a population of complex chronic patients.
Trial Registration
ClinicalTrials.gov ID: NCT03247049.
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Acknowledgements
The authors wish to thank the research group Ebrictus for providing assistance and support to this manuscript; as well as Jesus Carot Domenech for his technical support from Information and Communication Technology.
Funding
No funding or sponsorship was received for this study or publication of this article. The Rapid Service Fee was funded by the authors.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for.
Disclosures
Maria Antonia González-Henares, Jose Luis Clua-Espuny, Blanca Lorman-Carbo, Jose Fernández-Saez, Lluisa Queralt-Tomas, Eulalia Muria-Subirats, Juan Ballesta-Ors and Jose Vincente Gil-Guillen have nothing to disclose.
Compliance with Ethics Guidelines
Ethics approval was granted by the Ethics Committee at the Research Institute of Primary Care Jordi Gol i Gurina (IDIAP), Health Department, Generalitat de Cataluña, code P16/087 and complies with the Helsinki Declaration and the local ethics committee requirements for clinical research. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in the county without contact with participants in order to gather data from the study. Records of inpatient care after baseline assessment with International Classification of Diseases (10th version; ICD-10) code prefixes I60, I61, I63, I64 and H34, I67, and G45 were compiled for all participants. All other diagnoses were based on information from assessments conducted during home visits and records from hospitals, general practitioners, and institutional care facilities. Given each study site belongs to Catalonian Health Institute–Public Health Govern, an ethical approval was not obtained from each one.
Data Availability
Currently the datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. All data generated or analyzed during this study will be shared in ClinicalTrials.gov ID: NCT03247049, Unique Protocol ID: IDIAP Jordi Gol code P16/087. Title: Prognosis in Intracerebral Hemorrhage. The ICH-AP Score in Primary Care. Official Title: Predicting Long Term Survival in Patients with Primary Intracerebral Hemorrhage. Development and Validation of the ICH-AP in Primary Care.
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González-Henares, M.A., Clua-Espuny, J.L., Lorman-Carbo, B. et al. Risk of Long-Term Mortality for Complex Chronic Patients with Intracerebral Hemorrhage: A Population-Based e-Cohort Observational Study. Adv Ther 37, 833–846 (2020). https://doi.org/10.1007/s12325-019-01206-y
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DOI: https://doi.org/10.1007/s12325-019-01206-y