PMID- 19477890
OWN - NLM
STAT- MEDLINE
DCOM- 20090916
LR  - 20220321
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 64
IP  - 2
DP  - 2009 Aug
TI  - Reporting of adverse events in randomized controlled trials of highly active 
      antiretroviral therapy: systematic review.
PG  - 239-50
LID - 10.1093/jac/dkp191 [doi]
AB  - OBJECTIVES: Our objectives were to systematically assess the quality of reporting 
      of adverse events (AEs) in publications of randomized trials of highly active 
      antiretroviral therapy (HAART), and to examine whether reporting quality affects 
      the effect estimates reported for AEs. METHODS: We searched the PubMed, Cochrane 
      library and EMBASE electronic databases up to December 2008. We included all 
      published randomized controlled trials assessing HAART for treatment-naive adult 
      HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting 
      was extracted according to CONSORT guidelines. We pooled the relative risks for 
      AEs and compared results by sponsorship and different reporting methods. RESULTS: 
      Forty-nine trials, including 19 882 patients, published between 2000 and 2008, 
      met the inclusion criteria. Only one of the trials reported on AE collection 
      methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did 
      not refer to the attribution methods. AE reporting was nearly always selective 
      and selection criteria were highly variable, based on severity grading or 
      occurrence threshold. Presentation of AEs above an occurrence threshold was more 
      common in studies sponsored by industry (30/31) than in studies sponsored by 
      non-profit organizations (3/18). Moreover, we showed that differences in the 
      methods of reporting AEs may affect the results reported for AEs. No significant 
      improvement in AE reporting was seen over this period. CONCLUSIONS: We found 
      substantial variability in AE reporting. Variability was influenced by sponsor 
      identity and affected outcomes. These facts obstruct our ability to choose HAART 
      based on currently published data.
FAU - Chowers, Michal Y
AU  - Chowers MY
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 
      chowersm@post.tau.ac.il
FAU - Gottesman, Bat Sheva
AU  - Gottesman BS
FAU - Leibovici, Leonard
AU  - Leibovici L
FAU - Pielmeier, Ulrike
AU  - Pielmeier U
FAU - Andreassen, Steen
AU  - Andreassen S
FAU - Paul, Mical
AU  - Paul M
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20090528
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Antiretroviral Therapy, Highly Active/*adverse effects
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - Publications/*statistics & numerical data
MH  - Randomized Controlled Trials as Topic
RF  - 72
EDAT- 2009/05/30 09:00
MHDA- 2009/09/17 06:00
CRDT- 2009/05/30 09:00
PHST- 2009/05/30 09:00 [entrez]
PHST- 2009/05/30 09:00 [pubmed]
PHST- 2009/09/17 06:00 [medline]
AID - dkp191 [pii]
AID - 10.1093/jac/dkp191 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2009 Aug;64(2):239-50. doi: 10.1093/jac/dkp191. Epub 2009 
      May 28.