Availability of large-scale evidence on specific harms from systematic reviews of randomized trials
Φόρτωση...
Ημερομηνία
Συγγραφείς
Papanikolaou, P. N.
Ioannidis, J. P. A.
Τίτλος Εφημερίδας
Περιοδικό ISSN
Τίτλος τόμου
Εκδότης
Περίληψη
Τύπος
Είδος δημοσίευσης σε συνέδριο
Είδος περιοδικού
peer reviewed
Είδος εκπαιδευτικού υλικού
Όνομα συνεδρίου
Όνομα περιοδικού
American Journal of Medicine
Όνομα βιβλίου
Σειρά βιβλίου
Έκδοση βιβλίου
Συμπληρωματικός/δευτερεύων τίτλος
Περιγραφή
PURPOSE: To assess how frequently systematic reviews of randomized controlled trials convey large-scale evidence on specific, well-defined adverse events. METHODS: We searched the Cochrane Database of Systematic Reviews for reviews containing quantitative data on specific, well-defined harms for at least 4000 randomized subjects, the minimum sample required for adequate power to detect an adverse event due to an intervention in 1% of subjects. Main outcome measures included the number of reviews with eligible large-scale data on adverse events, the number of ineligible reviews, and the magnitude of recorded harms (absolute risk, relative risk) based on large-scale evidence. RESULTS: Of 1727 reviews, 138 included evidence on greater than or equal to4000 subjects. Only 25 (18%) had eligible data on adverse events, while 77 had no harms data, and 36 had data on harms that were nonspecific or pertained to <4000 subjects. Of 66 specific adverse events for which there were adequate data in the 25 eligible reviews, 25 showed statistically significant differences between comparison arms; most pertained to serious or severe adverse events and absolute risk differences <4%. In 29% (9/31) of a sample of large trials in reviews with poor reporting of harms, specific harms were presented adequately in the trial reports but were not included in the systematic reviews. CONCLUSION: Systematic reviews can convey useful large-scale information on adverse events. Acknowledging the importance and difficulties of studying harms, reporting of adverse effects must be improved in both randomized trials and systematic reviews. (C) 2004 by Elsevier Inc.
Περιγραφή
Λέξεις-κλειδιά
clinical-trials, safety, metaanalyses, methodology, women, drugs
Θεματική κατηγορία
Παραπομπή
Σύνδεσμος
<Go to ISI>://000224439300007
http://ac.els-cdn.com/S0002934304004942/1-s2.0-S0002934304004942-main.pdf?_tid=a64471ecf8c6139cfbe7c7331a14733d&acdnat=1334231157_07e2e16cf0acae469a6e6a1c63c3e797
http://ac.els-cdn.com/S0002934304004942/1-s2.0-S0002934304004942-main.pdf?_tid=a64471ecf8c6139cfbe7c7331a14733d&acdnat=1334231157_07e2e16cf0acae469a6e6a1c63c3e797
Γλώσσα
en
Εκδίδον τμήμα/τομέας
Όνομα επιβλέποντος
Εξεταστική επιτροπή
Γενική Περιγραφή / Σχόλια
Ίδρυμα και Σχολή/Τμήμα του υποβάλλοντος
Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών και Τεχνολογιών. Τμήμα Βιολογικών Εφαρμογών και Τεχνολογιών