Aspects of this proposal need to be better clarified.
First, what additional data will be used (the “existing real-life HCV-4 cohorts”)? The purpose of the study is to use pooled estimates to better understand efficacy and safety of Sofosbuvir + Simeprevir +/- ribavirin, but what efficacy data is available from the existing real-life cohorts? What safety data? What covariates of interest (since the stated goal is to use logistic regression methods to identify patient predictors of efficacy and safety, such as within demographic sub-groups)? Right now, without knowing which data sources will be merged in, it’s not possible for the proposal to clearly pre-specify the outcomes of interest and the analytic approach.
Second, and related to this, the statistical analysis plan is not sufficiently explained – more detail is provided in the statistical analysis section of the scientific abstract (please define F4, is this Fibrosis staging or HCV genotype 4?) than in the main text of the proposal.
Third, one point of clarity, the covariates of interest section suggested that HCV genotype (4a or not) would be examined, but I had thought all patients had been diagnosed with HCV4 – is this for patients will multiple HCV genotypes?