- ... patient satisfaction and im- personal care,'*"” iatrogenesis (negligent adverse events),'® diagnostic errors,” unnecessary procedures/surgery,’® sub- optimal medication prescribing/usage, ! and neglect of quality- ...
- NLM Digital Collections - Technical specifications for submitting clinical trial data sets for treatment of ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022... should include death information are the Disposition (DS) domain that records the death as a disposition event, Adverse Events (AE), and Demographics (DM) to populate the ...
- NLM Digital Collections - Modulator treatments for cystic fibrosis : effectiveness and valuePublication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, April 27, 2020... on lung function, nutritional status, and CFQR respiratory domain scores. Safety was assessed based on the occurrence of adverse events and the number of AEs that led to ...
- NLM Digital Collections - Adverse events toolkit. Clinical guidance for identifying harmPublication: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, July 2023... believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0 ... believes this item to be in the public domain. ... Events Toolkit: Clinical Guidance for Identifying Harm Ann Maxwell ...
- NLM Digital Collections - PCSK9 inhibitors for treatment of high cholesterol : effectiveness, value, and value-based ...Publication: [Boston, MA] : Institute for Clinical and Economic Review, November 24, 2015... events, discontinuations due to adverse events, and common adverse events. The quality of individual studies was assessed by considering the domains listed below, which are adapted from the methods ...
- NLM Digital Collections - Safer technologies program for medical devices : guidance for industry and Food and Drug ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021... 9 Contains Nonbinding Recommendations of the following four sub-parts. a. A reduction in the occurrence of a known serious adverse event FDA recognizes that, while some medical products do ...
- NLM Digital Collections - Insulin degludec (Tresiba??, Novo Nordisk A/S) for the treatment of diabetes : effectiveness, ...Publication: [Boston, MA] : Institute for Clinical and Economic Review, March 14, 2016... differences in QOL were observed, the individual QOL domains showing benefit were not consistent across trials. Harms The total number of all adverse events was similar in the degludec groups and the ...
- NLM Digital Collections - Vesicular monoamine transporter 2 inhibitors for tardive dyskinesia : effectiveness and value ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, December 22, 2017... data on discontinuation of TD medication due to adverse events beyond the first year, • lack of robust data on non-drug costs of TD, • inability to include sub-populations that may differ from the average TD ...
- NLM Digital Collections - Modulator treatments for cystic fibrosis : effectiveness and value : final evidence report ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, June 7, 2018... open-label studies was based on treatment-emergent adverse events and other ... respiratory domain, and number or rate of pulmonary exacerbations. See ...
- NLM Digital Collections - Technology assessment. Vaccine development : capabilities and challenges for addressing ...Publication: Washington, DC : United States Government Accountability Office, November 2021... from EHRs for analysis. other sources to detect adverse events and study specific safety Interoperable systems allow clinical care staff to enter data into questions for vaccines including for sub-populations such as patient records during the patient's ...
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