PMID- 30473787
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2049-1573 (Print)
IS  - 2049-1573 (Electronic)
IS  - 2049-1573 (Linking)
VI  - 6
IP  - 1
DP  - 2017
TI  - Bias and estimation under misspecification of the risk period in self-controlled 
      case series studies.
PG  - 373-389
LID - 10.1002/sta4.166 [doi]
AB  - The self-controlled case series (SCCS) method is useful for estimating the 
      relative incidence (RI) of acute events, such as adverse events (AEs) during a 
      specified risk period following an exposure (e.g., 6-week period after 
      vaccinations or 30-day period after infection-related hospitalizations). In 
      practice, the "optimal" risk period is unknown and must be specified. To date, 
      two approaches are available to guide the specification of the risk period. Both 
      methods do not fully utilize the nature of the bias due to misspecification, 
      which to date has not been characterized. Thus, we elucidate the bias of SCCS 
      estimate of the RI when the risk period is misspecified. We then propose a novel 
      method that more effectively estimates the optimal risk period and the associated 
      RI of AEs. The new method incorporates information on the functional form of the 
      bias. Efficacy of the proposed approach is illustrated with substantial reduction 
      in bias and variance in simulation studies. The proposed method is illustrated 
      with two SCCS studies to determine the (1) risk of idiopathic thrombocytopenic 
      purpura after measles-mumps-rubella vaccination in children and (2) risk of 
      cardiovascular events after infection-related hospitalizations in older patients 
      on dialysis.
FAU - Campos, Luis Fernando
AU  - Campos LF
AD  - Department of Statistics, Harvard University, Cambridge, MA 02138, USA.
FAU - Senturk, Damla
AU  - Senturk D
AD  - Department of Biostatistics, University of California, Los Angeles, CA 90095, 
      USA.
FAU - Chen, Yanjun
AU  - Chen Y
AD  - Institute for Clinical and Translational Science, Irvine, CA 92617, USA.
FAU - Nguyen, Danh V
AU  - Nguyen DV
AD  - Department of Medicine, University of California Irvine, Orange, CA 92868, USA.
LA  - eng
GR  - R01 DK092232/DK/NIDDK NIH HHS/United States
PT  - Journal Article
DEP - 20171020
PL  - United States
TA  - Stat (Int Stat Inst)
JT  - Stat (International Statistical Institute)
JID - 101661793
PMC - PMC6249026
MID - NIHMS914901
OTO - NOTNLM
OT  - case series analysis
OT  - dialysis
OT  - idiopathic thrombocytopenic purpura
OT  - infection
OT  - maximum likelihood
OT  - measles-mumps-rubella
OT  - non-homogeneous Poisson process
OT  - risk length
OT  - vaccination
EDAT- 2017/01/01 00:00
MHDA- 2017/01/01 00:01
PMCR- 2018/11/21
CRDT- 2018/11/27 06:00
PHST- 2018/11/27 06:00 [entrez]
PHST- 2017/01/01 00:00 [pubmed]
PHST- 2017/01/01 00:01 [medline]
PHST- 2018/11/21 00:00 [pmc-release]
AID - 10.1002/sta4.166 [doi]
PST - ppublish
SO  - Stat (Int Stat Inst). 2017;6(1):373-389. doi: 10.1002/sta4.166. Epub 2017 Oct 20.