Upper Bound for Performance of Incident Reporting Systems Based on Experience with Phase III Adverse Event Reporting

2002 ◽  
Vol 96 (Sup 2) ◽  
pp. A1089
Author(s):  
Michael OʼConnor ◽  
Avery Tung ◽  
Mark Nunnally ◽  
Suanne Daves ◽  
Richard Cook
2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kelly Estrada-Orozco ◽  
Francy Cantor Cruz ◽  
Johana Benavides Cruz ◽  
Miguel Angel Ruiz-Cardozo ◽  
Andrea Marcela Suárez-Chacón ◽  
...  

2014 ◽  
Vol 32 (2) ◽  
pp. 83-89 ◽  
Author(s):  
Shanthi Sivendran ◽  
Asma Latif ◽  
Russell B. McBride ◽  
Kristian D. Stensland ◽  
Juan Wisnivesky ◽  
...  

Purpose Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. Methods A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event–reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. Results A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Conclusion Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.


2007 ◽  
Vol 104 (2) ◽  
pp. 471-472 ◽  
Author(s):  
Paul M. Mertes ◽  
Anne B. Guttormsen ◽  
Torkel Harboe ◽  
S Gunnar O. Johansson ◽  
Erik Florvaag ◽  
...  

2022 ◽  
Vol 12 ◽  
Author(s):  
Lisiane Freitas Leal ◽  
Claudia Garcia Serpa Osorio-de-Castro ◽  
Luiz Júpiter Carneiro de Souza ◽  
Felipe Ferre ◽  
Daniel Marques Mota ◽  
...  

Background: In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR).Methods: The present study is part of the project entitled, “Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries.” A network of Brazilian health experts was assembled to map secondary administrative data from healthcare organizations that might provide information related to medication use. A multi-phase approach including internet search of institutional government websites, traditional bibliographic databases, and experts’ input was used for mapping the data sources. The reviewers searched, screened and selected the data sources independently; disagreements were resolved by consensus. Data sources were grouped into the following categories: 1) automated databases; 2) Electronic Medical Records (EMR); 3) national surveys or datasets; 4) adverse event reporting systems; and 5) others. Each data source was characterized by accessibility, geographic granularity, setting, type of data (aggregate or individual-level), and years of coverage. We also searched for publications related to each data source.Results: A total of 62 data sources were identified and screened; 38 met the eligibility criteria for inclusion and were fully characterized. We grouped 23 (60%) as automated databases, four (11%) as adverse event reporting systems, four (11%) as EMRs, three (8%) as national surveys or datasets, and four (11%) as other types. Eighteen (47%) were classified as publicly and conveniently accessible online; providing information at national level. Most of them offered more than 5 years of comprehensive data coverage, and presented data at both the individual and aggregated levels. No information about population coverage was found. Drug coding is not uniform; each data source has its own coding system, depending on the purpose of the data. At least one scientific publication was found for each publicly available data source.Conclusions: There are several types of data sources for DUR in Brazil, but a uniform system for drug classification and data quality evaluation does not exist. The extent of population covered by year is unknown. Our comprehensive and structured inventory reveals a need for full characterization of these data sources.


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