50 Chapter 3 Ethical considerations For the analysis of summary hospital data, since only completely anonymous summary data were collected and shared, no ethical approval was needed. The openSAFELY study was approved by the Health Research Authority (REC reference 20/LO/0651). Given that only anonymous summary data of routine clinical results were used, there was no informed consent requirement. Results Between May 2022 and July 2022, 30 (88%) of 34 contacted hospitals contributed summary data. After data collection, preparing and aggregating the data using the script provided on the website typically took less than an hour, based on received feedback. To conduct the analysis, we selected July 2022 as the cutoff date because the majority of hospitals did not have data available beyond that time. The number of AST and ALT tests performed in 3-week to 5-year-olds at each site can be found in (Table 1). The change in the number of tests over time in 3-week to 5-year-olds in the UK, the Netherlands and overall can be seen in Supplementary Figure 1. In the UK, there is a gradual increase in the number of ALT tests over time, with a significant drop at the start of the COVID-19 pandemic early in 2020 (Supplementary Figure 1a). The sharp increase in 2018 is caused by data availability: both Edinburgh and the Highlands provided data from 2018 onwards. The number of tests in the Netherlands is relatively stable over time, with an increase for both AST and ALT in 2018 (Supplementary Figure 1b). When combining data for all available locations, there is an increase in the number of tests for both AST and ALT in 2014, because only data from the Netherlands was available for 2012-2014. The number of AST tests is relatively stable after 2014, while there is a strong increase in ALT tests over time, mostly caused by the increase in tests in the UK (Supplementary Figure 1c). Since ALT was measured more frequently than AST (see Table 1), the results for AST are presented in the supplementary material. Data from Ireland is presented in the results with all data combined, as not enough data were available to present results on a country level. A hospital in Willemstad, Curaçao also provided us with data, but because only a few years of data were available, there were no recorded cases of hepatitis and Curaçao is a geographical outlier compared to the other contributing locations, we present the results including the data from Curaçao in a sensitivity analysis that can be found in the supplementary material.
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