PMID- 36199040
OWN - NLM
STAT- MEDLINE
DCOM- 20221007
LR  - 20221015
IS  - 1471-2288 (Electronic)
IS  - 1471-2288 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Oct 5
TI  - Reporting of the safety from allergic rhinitis trials registered on 
      ClinicalTrials.gov and in publications: An observational study.
PG  - 262
LID - 10.1186/s12874-022-01730-6 [doi]
LID - 262
AB  - BACKGROUND: Incomplete and inconsistent reporting of adverse events (AEs) through 
      multiple sources can distort impressions of the overall safety of the medical 
      interventions examined as well as the benefit-risk relationship. We aimed to 
      assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov 
      for completeness and consistency of AEs reporting comparing ClinicalTrials.gov 
      and corresponding publications. METHODS: We retrospectively examined completed 
      randomised controlled trials on AR registered in ClinicalTrials.gov on or after 
      9/27/2009 to trials updated with results on or before 12/31/2021 along with any 
      corresponding publications. Complete reporting of AEs in ClinicalTrials.gov were 
      summarised in tables describing AE information, and complete reporting in 
      publications was an explicit statement of serious AE, death or other AE. 
      Difference in completeness, number, or description of AEs between 
      ClinicalTrials.gov and publication was classified as inconsistent reporting of 
      AEs. RESULTS: There were 99 registered trials with 45 (45.5%) available 
      publications. All published trials completely reported AEs in ClinicalTrials.gov, 
      and 21 (46.7%) in publications (P < .001). In 43 (95.6%) publications, there was 
      at least one inconsistency in the reporting of AEs (P < .001). 8 (17.8%) 
      publications had different number of serious AEs (P = .003), 36 (80.0%) of other 
      AEs (P < .001) while deaths reporting was inconsistent in 8 (57.1%) publications 
      (P = .127). CONCLUSION: The reporting of AEs from AR trials is complete in 
      ClinicalTrials.gov and incomplete and inconsistent in corresponding publications. 
      There is a need to improve the reporting of AEs from AR trials in corresponding 
      publications, and thus to improve patient safety.
CI  - (c) 2022. The Author(s).
FAU - Paladin, Ivan
AU  - Paladin I
AD  - Department of ENT and Head and Neck Surgery, University Hospital of Split, Split, 
      Croatia. ivan.paladin@gmail.com.
FAU - Pranic, Shelly Melissa
AU  - Pranic SM
AD  - Department of Public Health, University of Split School of Medicine, Split, 
      Croatia.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20221005
PL  - England
TA  - BMC Med Res Methodol
JT  - BMC medical research methodology
JID - 100968545
SB  - IM
MH  - Databases, Factual
MH  - Humans
MH  - Retrospective Studies
MH  - *Rhinitis, Allergic
PMC - PMC9533497
OTO - NOTNLM
OT  - Adverse events
OT  - Allergic rhinitis
OT  - ClinicalTrials.gov
OT  - Completeness
OT  - Randomised controlled trial
OT  - Safety
EDAT- 2022/10/06 06:00
MHDA- 2022/10/12 06:00
PMCR- 2022/10/05
CRDT- 2022/10/05 23:37
PHST- 2022/05/02 00:00 [received]
PHST- 2022/09/19 00:00 [accepted]
PHST- 2022/08/23 00:00 [revised]
PHST- 2022/10/05 23:37 [entrez]
PHST- 2022/10/06 06:00 [pubmed]
PHST- 2022/10/12 06:00 [medline]
PHST- 2022/10/05 00:00 [pmc-release]
AID - 10.1186/s12874-022-01730-6 [pii]
AID - 1730 [pii]
AID - 10.1186/s12874-022-01730-6 [doi]
PST - epublish
SO  - BMC Med Res Methodol. 2022 Oct 5;22(1):262. doi: 10.1186/s12874-022-01730-6.