Availability of large-scale evidence on specific harms from systematic reviews of randomized trials
| dc.contributor.author | Papanikolaou, P. N. | en |
| dc.contributor.author | Ioannidis, J. P. | en |
| dc.date.accessioned | 2015-11-24T19:33:45Z | |
| dc.date.available | 2015-11-24T19:33:45Z | |
| dc.identifier.issn | 0002-9343 | - |
| dc.identifier.uri | https://olympias.lib.uoi.gr/jspui/handle/123456789/23568 | |
| dc.rights | Default Licence | - |
| dc.subject | Humans | en |
| dc.subject | Meta-Analysis as Topic | en |
| dc.subject | Randomized Controlled Trials as Topic/*adverse effects/methods | en |
| dc.subject | Sample Size | en |
| dc.title | Availability of large-scale evidence on specific harms from systematic reviews of randomized trials | en |
| heal.abstract | 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 > or =4000 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. | en |
| heal.access | campus | - |
| heal.fullTextAvailability | TRUE | - |
| heal.identifier.primary | 10.1016/j.amjmed.2004.04.026 | - |
| heal.identifier.secondary | http://www.ncbi.nlm.nih.gov/pubmed/15465507 | - |
| heal.identifier.secondary | http://ac.els-cdn.com/S0002934304004942/1-s2.0-S0002934304004942-main.pdf?_tid=19958c814562920b73265f754e35f8fa&acdnat=1333364408_d03b47e79f4b0d764d6fcab7d32210d3 | - |
| heal.journalName | American Journal of Medicine | en |
| heal.journalType | peer-reviewed | - |
| heal.language | en | - |
| heal.publicationDate | 2004 | - |
| heal.recordProvider | Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής | el |
| heal.type | journalArticle | - |
| heal.type.el | Άρθρο Περιοδικού | el |
| heal.type.en | Journal article | en |
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