| A survey of inclusion of the time element when reporting adverse effects in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor alpha inhibitors. | |
| | |
MedLine Citation:
|
PMID: 16831828 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: The adequacy of reporting the time element in adverse effects in articles on randomised clinical trials of cyclo-oxygenase-2 and tumour necrosis factor (TNF)alpha antagonists was surveyed. METHODS: Prominent rheumatology and general/internal medicine journals were searched for all randomised controlled trials published about cyclo-oxygenase-2 and TNFalpha inhibitor use in rheumatological diseases up to November 2005. Reporting of time to the occurrence of the adverse effects, the use of patient years as the time frame of the reported adverse effects and the use of annual standard incidence ratios based on the surveillance, epidemiology and end-results (SEER) programme when reporting neoplasms as potential adverse effects of TNFalpha antagonists were specifically tabulated. RESULTS: Only 23 of 70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient years to report the adverse effects and six studies used annual standard incidence ratios, using SEER, as the comparator. CONCLUSION: In reporting of adverse effects in randomised clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects. |
| | |
Authors:
|
Y Yazici; H Yazici |
Related Documents
:
|
15368038 - Efficacy of heat and moisture exchangers in preventing ventilator-associated pneumonia:... 16624388 - What is the best protocol of single-agent methotrexate chemotherapy in nonmetastatic or... 19588428 - Pharmacologic interventions for pregnant women enrolled in alcohol treatment. 11399238 - A rapid and systematic review of the clinical effectiveness and cost-effectiveness of o... 7931858 - Cocaine abuse in methadone maintenance programs: integrating pharmacotherapy with psych... 19721108 - Adverse reactions to antidepressants. |
Publication Detail:
|
Type: Journal Article Date: 2006-07-10 |
Journal Detail:
|
Title: Annals of the rheumatic diseases Volume: 66 ISSN: 0003-4967 ISO Abbreviation: Ann. Rheum. Dis. Publication Date: 2007 Jan |
Date Detail:
|
Created Date: 2006-12-20 Completed Date: 2007-01-30 Revised Date: 2010-09-15 |
Medline Journal Info:
|
Nlm Unique ID: 0372355 Medline TA: Ann Rheum Dis Country: England |
Other Details:
|
Languages: eng Pagination: 124-7 Citation Subset: IM |
Affiliation:
|
New York University, Hospital for Joint Diseases, New York, New York, USA. yusuf.yazici@nyumc.org |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Antirheumatic Agents
/
adverse effects*,
therapeutic use Arthritis, Rheumatoid / complications, drug therapy Cyclooxygenase 2 Inhibitors / adverse effects*, therapeutic use Follow-Up Studies Humans Incidence Neoplasms / etiology* Randomized Controlled Trials as Topic Research Design / standards* SEER Program Time* Treatment Outcome Tumor Necrosis Factor-alpha / antagonists & inhibitors* |
| Chemical | |
Reg. No./Substance:
|
0/Antirheumatic Agents; 0/Cyclooxygenase 2 Inhibitors; 0/Tumor Necrosis Factor-alpha |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Evidence for efficacy of the Italian national pre-participation screening programme for identificati...
Next Document: Signs of inflammation in both symptomatic and asymptomatic muscles from patients with polymyositis a...