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. 2024 Jan 4;13(2):e230140. doi: 10.57264/cer-2023-0140

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].