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The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade.
BMC Med Res Methodol
December 2024
Janssen Research & Development LLC, Global Epidemiology Organization, Raritan, NJ, USA.
Background: Autoimmune disorders have primary manifestations such as joint pain and bowel inflammation but can also have secondary manifestations such as non-infectious uveitis (NIU). A regulatory health authority raised concerns after receiving spontaneous reports for NIU following exposure to Remicade, a biologic therapy with multiple indications for which alternative therapies are available. In assessment of this clinical question, we applied validity diagnostics to support observational data causal inferences.
View Article and Find Full Text PDFReal-world efficacy of transfusion with liberal or restrictive strategy in traumatic brain injury.
Ann Clin Transl Neurol
December 2024
Department of Critical Care Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Objective: The short-term efficacy of red blood cell (RBC) transfusion among general traumatic brain injury (TBI) patients is unclear.
Methods: We used the MIMIC database to compare the efficacy of liberal (10 g/dL) versus conservative (7 g/dL) transfusion strategy in TBI patients. The outcomes were neurological progression (decrease of Glasgow coma scale (GCS) of at least 2 points) and death within 28 days of ICU admission.
Health Utility of Pain Response Versus Nonresponse to Palliative Radiation Therapy for Symptomatic Bone Metastases: Analyses Based on Real-World Data from 26 Centers.
J Palliat Med
December 2024
Department of Radiation Oncology, Saitama Medical center, Saitama, Japan.
Utility values of responders and nonresponders are essential inputs in cost-effectiveness studies of radiation therapy for painful bone metastases but, to our knowledge, they have not been reported separately. We sought to determine the utility values of responders and nonresponders using data from a prospective observational study on bone metastases. The original prospective observational study was conducted at 26 centers in Japan.
View Article and Find Full Text PDFIsatuximab plus pomalidomide and dexamethasone in frail individuals with relapsed/refractory multiple myeloma in Japan.
Int J Hematol
December 2024
Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Kawasaki 1, Mizuno-cho, Mizuno-ku, Nagoya, Aichi, 467-8601, Japan.
This post-marketing surveillance (PMS) assessed the safety and effectiveness of isatuximab plus pomalidomide and dexamethasone (Isa-Pd) for relapsed or refractory multiple myeloma (RRMM) in frail individuals during real-world use in Japan. Data from all individuals with RRMM treated with Isa-Pd in Japan between October 2020 and October 2021 were collected, with follow-up continued up to 12 months after starting Isa-Pd or until discontinuation. In the overall PMS population, 40 participants were classified as frail (33.
View Article and Find Full Text PDFLimited Efficacy of Anti-EGFR Monoclonal Antibodies in Colorectal Cancer Patients with Rare RAS Variants: Analysis of the C-CAT Database.
Curr Issues Mol Biol
December 2024
Department of Clinical Oncology, School of Medicine, Yamagata University, 2-2-2 Iida-Nishi, Yamagata 990-9585, Japan.
Epidermal growth factor receptor (EGFR) inhibition is crucial in treating RAS wild-type metastatic colorectal cancer, yet current testing methods may miss rare RAS variants affecting treatment efficacy. We analyzed 4122 colorectal cancer patients receiving anti-EGFR antibodies from the Center for Cancer Genomics and Advanced Therapeutics database, identifying 54 patients (1.3%) with rare RAS variants undetectable by standard testing.
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