Table 2. . Synthetic control quality checklist – external control data source questions.
Item number | Key question | Criteria for judgement |
---|---|---|
1 | Was the original data collection process similar to that of the clinical trial? | State whether patients are from large, well-conducted randomized controlled trials or high-quality prospective cohort studies, and whether patient characteristics are similar to the target population |
2 | Was the external control population sufficiently similar to the clinical trial population? | State how the external population is similar with regard to key characteristics, such as (but not limited to): age, geographic distribution, performance status, treatment history, and sex |
3 | Did the outcome definitions of the external control match those of the clinical trial? | State whether the outcomes are measured similarly or not |
4 | Was the synthetic control dataset sufficiently reliable and comprehensive? | State whether there are sufficient sample sizes and covariates that can create comparable control groups |
5 | Were there any other major limitations to the dataset? | State any other aspects of the dataset that would limit the reliability and validity of comparisons |
Adapted with permission from [10].