Objective: To assess the performance characteristics of the Institute for Healthcare Improvement Global Trigger Tool (GTT) to determine its reliability for tracking local and national adverse event rates.
Data Sources: Primary data from 2008 chart reviews.
Study Design: A retrospective study in a stratified random sample of 10 North Carolina hospitals. Hospital-based (internal) and contract research organization-hired (external) reviewers used the GTT to identify adverse events in the same 10 randomly selected medical records per hospital in each quarter from January 2002 through December 2007.
Data Collection/extraction: Interrater and intrarater reliability was assessed using κ statistics on 10 percent and 5 percent, respectively, of selected medical records. Additionally, experienced GTT users reviewed 10 percent of records to calculate internal and external teams' sensitivity and specificity.
Principal Findings: Eighty-eight to 98 percent of the targeted 2,400 medical records were reviewed. The reliability of the GTT to detect the presence, number, and severity of adverse events varied from κ=0.40 to 0.60. When compared with a team of experienced reviewers, the internal teams' sensitivity (49 percent) and specificity (94 percent) exceeded the external teams' (34 and 93 percent), as did their performance on all other metrics.
Conclusions: The high specificity, moderate sensitivity, and favorable interrater and intrarater reliability of the GTT make it appropriate for tracking local and national adverse event rates. The strong performance of hospital-based reviewers supports their use in future studies.
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http://dx.doi.org/10.1111/j.1475-6773.2010.01156.x | DOI Listing |
Trials
January 2025
Department of Neurology, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany.
Background: Postoperative delirium (POD) is the most common neurological adverse event among elderly patients undergoing surgery. POD is associated with an increased risk for postoperative complications, long-term cognitive decline, an increase in morbidity and mortality as well as extended hospital stays. Delirium prevention and treatment options are currently limited.
View Article and Find Full Text PDFJ Transl Med
January 2025
Department of Hematology Oncology, Affiliated Hospital of Guizhou Medical University, No. 4 Bei Jing Road, Yunyan District, Guiyang, 550004, Guizhou, China.
Background: Anti-CD19 chimeric antigen receptor (CAR) T cell therapy is a common, yet highly efficient, cellular immunotherapy for lymphoma. However, many recent studies have reported on its cardiovascular (CV) toxicity. This study analyzes the cardiotoxicity of CD19 CAR T cell therapy in the treatment of lymphoma for providing a more valuable reference for clinicians.
View Article and Find Full Text PDFExp Hematol Oncol
January 2025
Bone Marrow Transplantation Center of The First Affiliated Hospital Liangzhu Laboratory, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Zhejiang, China.
Background: Sequential CD19 and CD22 chimeric antigen receptor (CAR)-T cell therapy offers a promising approach to antigen-loss relapse in relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL); however, research in adults remains limited.
Methods: This study aimed to evaluate the efficacy and safety of sequential CD19 and CD22 CAR-T cell therapy in adult patients with R/R B-ALL between November 2020 and November 2023 (ChiCTR2100053871). Key endpoints included the adverse event incidence, overall survival (OS), and leukemia-free survival (LFS).
BMC Cancer
January 2025
Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310003, China.
Background: To date, there remains a paucity of comparative investigations pertaining to preoperative immunochemotherapy and conventional chemotherapy in the context of limited-stage small-cell lung cancer (LS-SCLC) patients. This study conducted a comprehensive comparative assessment concerning the safety and efficacy profiles of preoperative immunochemotherapy and chemotherapy in individuals diagnosed with stage I-IIIB SCLC.
Methods: This investigation collected 53 consecutive patients diagnosed with LS-SCLC spanning stage I to IIIB who underwent preoperative immunochemotherapy or conventional chemotherapy at our hospital from January 2019 to July 2021.
BMC Neurol
January 2025
Department of Neurosurgery, Gifu University Graduate School of Medicine, 1-1, Yanagido, Gifu, 501-1194, Japan.
Background: Tyrosine kinase inhibitors (TKIs) improve prognosis in chronic myeloid leukemia (CML). Nilotinib and ponatinib, second- and third-generation TKIs, respectively, have been reported to cause adverse vascular occlusive events such as myocardial infarction and peripheral arterial disease. However, little is known about the risk of cerebral infarction associated with severe cerebrovascular stenosis, which is a late complication of TKIs.
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