Assessment of therapeutic safety in systematic reviews: literature review

Safety Time period Source Efficacy or effectiveness Safety Category A Safety Category B 1966-70 Medline 0 0 0 - Cochrane Library 1 0 0 1971-75 Medline 0 0 0 - Cochrane Library 0 0 0 1976-80 Medline 1 0 1 (100) - Cochrane Library 2 0 0 1981-85 Medline 11 0 0 - Cochrane Library 12 0 0 1986-90 Medline...

Full description

Saved in:
Bibliographic Details
Published in:BMJ 2001-09, Vol.323 (7312), p.546-546
Main Authors: Ernst, Edzard, Pittler, Max H
Format: Article
Language:English
Subjects:
Abstracting
Analysis
Assessment
Biological and medical sciences
Clinical trials
Effectiveness
Evidence based medicine
Evidence-Based Medicine - methods
General pharmacology
Health care
Health Policy
Humans
Information Storage and Retrieval
Intervention
Libraries
Literature reviews
Medical sciences
Medical treatment
Meta analysis
Meta-Analysis as Topic
Miscellaneous
Pharmacology. Drug treatments
Randomized Controlled Trials as Topic
Safety
Studies
Systematic reviews
Systematic Reviews as Topic
Treatment
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Safety Time period Source Efficacy or effectiveness Safety Category A Safety Category B 1966-70 Medline 0 0 0 - Cochrane Library 1 0 0 1971-75 Medline 0 0 0 - Cochrane Library 0 0 0 1976-80 Medline 1 0 1 (100) - Cochrane Library 2 0 0 1981-85 Medline 11 0 0 - Cochrane Library 12 0 0 1986-90 Medline 103 10 (10) 5 (5) - Cochrane Library 71 8 (11) 3 (4) 1991-95 Medline 431 60 (14) 19 (4) - Cochrane Library 406 61 (15) 12 (3) 1996-December 2000 Medline 1005 259 (26) 41 (4) - Cochrane Library 1462 398 (27) 54 (4) Comment Systematic reviews and meta-analyses provide little information on the safety aspects of therapeutic interventions. Randomised clinical trials are usually of short duration and thus cannot identify delayed adverse events. 2 The assessment of safety has to go far beyond randomised clinical trials and should use various methods, including post-marketing surveillance studies, spontaneous reporting schemes, and epidemiological investigations. 3 Systematic reviews on the safety of therapeutic interventions should take these considerations into account and should combine data from various types of studies. 4 Safety aspects have so far not been adequately investigated by systematic reviews.
ISSN:0959-8138
0959-8146
0959-535X
1468-5833
1756-1833
DOI:10.1136/bmj.323.7312.546