PMID- 30697486
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 2167-8359 (Print)
IS  - 2167-8359 (Electronic)
IS  - 2167-8359 (Linking)
VI  - 7
DP  - 2019
TI  - The use of one-stage meta-analytic method based on individual participant data 
      for binary adverse events under the rule of three: a simulation study.
PG  - e6295
LID - 10.7717/peerj.6295 [doi]
LID - e6295
AB  - OBJECTIVE: In evidence synthesis practice, dealing with binary rare adverse 
      events (AEs) is a challenging problem. The pooled estimates for rare AEs through 
      traditional inverse variance (IV), Mantel-Haenszel (MH), and Yusuf-Peto (Peto) 
      methods are suboptimal, as the biases tend to be large. We proposed the 
      "one-stage" approach based on multilevel variance component logistic regression 
      (MVCL) to handle this problem. METHODS: We used simulations to generate trials of 
      individual participant data (IPD) with a series of predefined parameters. We 
      compared the performance of the MVCL "one-stage" approach and the five classical 
      methods (fixed/random effect IV, fixed/random effect MH, and Peto) for rare 
      binary AEs under different scenarios, which included different sample size 
      setting rules, effect sizes, between-study heterogeneity, and numbers of studies 
      in each meta-analysis. The percentage bias, mean square error (MSE), coverage 
      probability, and average width of the 95% confidence intervals were used as 
      performance indicators. RESULTS: We set 52 scenarios and each scenario was 
      simulated 1,000 times. Under the rule of three (a sample size setting rule to 
      ensure a 95% chance of detecting at least one AE case), the MVCL "one-stage" IPD 
      method had the lowest percentage bias in most of the situations and the bias 
      remained at a very low level (<10%), when compared to IV, MH, and Peto methods. 
      In addition, the MVCL "one-stage" IPD method generally had the lowest MSE and the 
      narrowest average width of 95% confidence intervals. However, it did not show 
      better coverage probability over the other five methods. CONCLUSIONS: The MVCL 
      "one-stage" IPD meta-analysis is a useful method to handle binary rare events and 
      superior compared to traditional methods under the rule of three. Further 
      meta-analyses may take account of the "one-stage" IPD method for pooling rare 
      event data.
FAU - Cheng, Liang-Liang
AU  - Cheng LL
AD  - West China School of Public Health, Sichuan University, Chengdu, China.
AD  - West China Research Center for Rural Health Development, Sichuan University, 
      Chengdu, China.
FAU - Ju, Ke
AU  - Ju K
AUID- ORCID: 0000-0001-8040-8978
AD  - West China School of Public Health, Sichuan University, Chengdu, China.
FAU - Cai, Rui-Lie
AU  - Cai RL
AD  - West China School of Public Health, Sichuan University, Chengdu, China.
FAU - Xu, Chang
AU  - Xu C
AUID- ORCID: 0000-0002-2627-1250
AD  - Chinese Evidence Based Medicine Center, West China Hospital of Sichuan 
      University, Chengdu, China.
LA  - eng
PT  - Journal Article
DEP - 20190123
PL  - United States
TA  - PeerJ
JT  - PeerJ
JID - 101603425
PMC - PMC6347966
OTO - NOTNLM
OT  - Binary rare adverse event
OT  - Evidence synthesis methods
OT  - IPD meta-analysis
OT  - Multilevel logistic
OT  - Rule of three
COIS- The authors declare that they have no competing interests.
EDAT- 2019/01/31 06:00
MHDA- 2019/01/31 06:01
PMCR- 2019/01/23
CRDT- 2019/01/31 06:00
PHST- 2018/07/02 00:00 [received]
PHST- 2018/12/15 00:00 [accepted]
PHST- 2019/01/31 06:00 [entrez]
PHST- 2019/01/31 06:00 [pubmed]
PHST- 2019/01/31 06:01 [medline]
PHST- 2019/01/23 00:00 [pmc-release]
AID - 6295 [pii]
AID - 10.7717/peerj.6295 [doi]
PST - epublish
SO  - PeerJ. 2019 Jan 23;7:e6295. doi: 10.7717/peerj.6295. eCollection 2019.