PMID- 29344371
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210112
IS  - 2053-3624 (Print)
IS  - 2053-3624 (Electronic)
IS  - 2053-3624 (Linking)
VI  - 4
IP  - 2
DP  - 2017
TI  - Accrual monitoring in cardiovascular trials.
PG  - e000720
LID - 10.1136/openhrt-2017-000720 [doi]
LID - e000720
AB  - OBJECTIVE: To provide brief guidance on how to design accrual monitoring 
      activities in a clinical trial protocol. SETTING: Two completed clinical trials 
      that did not achieve the planned sample size, the Cost of Strategies After 
      Myocardial Infarction (COSTAMI) trial and the Biventricular Pacing After Cardiac 
      Surgery (BiPACS) trial. DESIGN: A Bayesian monitoring tool, the constant accrual 
      model, is applied retrospectively to accrual data from each case study to 
      illustrate how the tool could be used to identify problems with accrual early in 
      the trial period and to frame the conditions in which the approach can be used in 
      practice. RESULTS: After 312 days and 155 patients enrolled in the COSTAMI trial, 
      accrual could be classified as 'off target' on the basis of statistical criteria 
      outlined in the protocol. As for the BiPACS trial, after 2 years, it was already 
      evident that the accrual was 'considerably off target'. CONCLUSIONS: Prompt 
      awareness of a high risk of accrual failure could trigger different interventions 
      to overcome protocol-related, patient-related or investigator-related barriers to 
      recruitment or ultimately contribute to an early stopping decision due to 
      recruitment futility.Accrual prediction models should be included as standard 
      tools for routine monitoring activities in cardiovascular research. Among them, 
      methods relying on the Bayesian approach are particularly attractive, as they can 
      naturally update past evidence when actual accrual data becomes available.
FAU - Baldi, Ileana
AU  - Baldi I
AUID- ORCID: 0000-0002-8578-9164
AD  - Department of Cardiac, Thoracic and Vascular Sciences, Unit of Biostatistics, 
      Epidemiology and Public Health, University of Padova, Padova, Italy.
FAU - Gregori, Dario
AU  - Gregori D
AD  - Department of Cardiac, Thoracic and Vascular Sciences, Unit of Biostatistics, 
      Epidemiology and Public Health, University of Padova, Padova, Italy.
FAU - Desideri, Alessandro
AU  - Desideri A
AD  - Cardiovascular Research Foundation, San Giacomo Hospital, Castelfranco Veneto, 
      Italy.
FAU - Berchialla, Paola
AU  - Berchialla P
AD  - Department of Clinical and Biological Sciences, University of Torino, Torino, 
      Italy.
LA  - eng
PT  - Journal Article
DEP - 20171217
PL  - England
TA  - Open Heart
JT  - Open heart
JID - 101631219
PMC - PMC5761309
OTO - NOTNLM
OT  - bayesian monitoring
OT  - clinical trial
OT  - poor accrual
COIS- Competing interests: None declared.
EDAT- 2018/01/19 06:00
MHDA- 2018/01/19 06:01
PMCR- 2017/12/17
CRDT- 2018/01/19 06:00
PHST- 2017/09/07 00:00 [received]
PHST- 2017/11/08 00:00 [revised]
PHST- 2017/11/18 00:00 [accepted]
PHST- 2018/01/19 06:00 [entrez]
PHST- 2018/01/19 06:00 [pubmed]
PHST- 2018/01/19 06:01 [medline]
PHST- 2017/12/17 00:00 [pmc-release]
AID - openhrt-2017-000720 [pii]
AID - 10.1136/openhrt-2017-000720 [doi]
PST - epublish
SO  - Open Heart. 2017 Dec 17;4(2):e000720. doi: 10.1136/openhrt-2017-000720. 
      eCollection 2017.