Methodological Quality Evaluation on Studies Related to Whether Statins Should be Discontinued in Patients with Intracerebral Hemorrhage by Using Target Trial Emulation Framework
Methodological Quality Evaluation on Studies Related to Whether Statins Should be Discontinued in Patients with Intracerebral Hemorrhage by Using Target Trial Emulation Framework
OBJECTIVE:By using target trial emulation(TTE)framework,to perform methodological quality evaluation on observational studies related to whether statins should be discontinued in patients with intracerebral hemorrhage(ICH),so as to summarize common methodological deficiency that can be avoided and provide methodological references for subsequent study design.METHODS:Literature research method was used to screen the studies that meet the inclusion and exclusion criteria,the TTE framework was used tot evaluate the methodological quality of the enrolled studies,including seven aspects of inclusion and exclusion criteria,treatment strategy,random allocation method,start and end of follow-up,outcome indicator,causal comparison and statistical analysis protocols.RESULTS:A total of 8 cohort studies were enrolled,and the patients were divided into two groups,with patients in the exposed group discontinuing statins and patients in the non-exposed group continuing to use statins.The methodological evaluation presented the following problems,2 studies used post-baseline information as an exclusion criterion;4 studies did not specifically describe the treatment strategy;4 studies had no simulate random allocation method;3 studies had no clear literature basis for the selection of covariates;1 study did not describe the time points of follow-up;and none of the studies explicitly stated that an intention-to-treat(ITT)analysis or a protocol-conformant(PP)analysis was used.Only 2 studies described the method of handling missing data,by choosing to directly delete patients with missing data.CONCLUSIONS:Future similar studies on the clinical prognostic impact of discontinuing statins after ICH should avoid using post-baseline information to define inclusion and exclusion criteria,define causal inferences(ideally including both ITT and PP analyses),and consider to use literature reviews or clinical experience for covariate screening(preferably using directed acyclic graphs).
维普
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