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Algorithm for the evaluation of therapeutic failure reports—proposal and pilot analysis
Author(s) -
González Claudia Patricia Vaca,
Martínez Roxana Patricia De las salas,
Gutiérrez José Julián López,
Pedraza Ricardo Sánchez,
Figueras Albert
Publication year - 2013
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3355
Subject(s) - medicine , inter rater reliability , reliability (semiconductor) , pharmacovigilance , intra rater reliability , delphi , delphi method , kappa , reliability engineering , data mining , drug , statistics , computer science , artificial intelligence , confidence interval , psychiatry , mathematics , power (physics) , rating scale , physics , geometry , quantum mechanics , engineering , operating system
Purpose To propose and validate an algorithm to analyze the reports of suspected therapeutic failure (TF) received in pharmacovigilance programs. Methods A Delphi consensus method with a group of 12 international experts was used to identify the different causes that prompt TF and to propose an algorithm to analyze reports of suspected lack of efficacy of medicines. A pilot analysis of 50 reports was the basis to evaluate the interrater and intrarater validity of the algorithm. Results A 10‐question algorithm was proposed. The evaluation of 50 reports of suspected TF showed that only 8% could be actually attributed to a manufacturing quality problem, whereas the real reason underlying the alleged TF was the inappropriate use of the prescribed drug in 28%. Minimum information to attribute the cause to a TF was lacking in 31% of these reports. The interrater reliability was “moderate” (kappa coefficient = 0.55), and the intrarater reliability ranged from 0.732 to 0.908 (“substantial” to “almost perfect”). Conclusions The proposed TF algorithm is a valid, reliable, and reproducible analysis tool that can help to disentangle the frequent and complex reports of suspected TF. Copyright © 2012 John Wiley & Sons, Ltd.