{Reference Type}: Journal Article
{Title}: Modelling the impact of bias in fecal immunochemical testing on long-term outcomes of colorectal cancer screening.
{Author}: de Jonge L;Toes-Zoutendijk E;Koopmann BDM;van Schrojenstein Lantman M;Franken-van Vorsselen B;Speijers C;van Ingen H;Humer E;van der Groep P;Thelen M;Lansdorp-Vogelaar I; ;
{Journal}: Clin Chim Acta
{Volume}: 561
{Issue}: 0
{Year}: 2024 Jul 15
{Factor}: 6.314
{DOI}: 10.1016/j.cca.2024.119809
{Abstract}: <B>BACKGROUND: </B>As the impact of unmanaged bias (i.e. systematic source of inaccuracy) in fecal immunochemical test (FIT) analytical performance on long-term colorectal cancer (CRC) outcomes is unknown, we assessed the impact bias in FIT performance in an ongoing FIT-based CRC screening program.<BR><B>METHODS: </B>This study consisted of two parts: cross-sectional observational data analysis to estimate change in short-term outcomes and microsimulation modelling to estimate change in long-term outcomes assuming different levels of bias by assuming 15 % lower up to 15 % higher Hemoglobin detected in the stool compared to observed. Two scenarios were considered: bias occurring 1) one-time only, due to the occasional bias associated with the FIT kits used in 2020 and 2) consistently due to a constant bias associated with the FIT kits used from 2020 onwards.<BR><B>RESULTS: </B>With a hypothetical bias of -15 % to +15 %, we observed a positivity rate ranging from 6.7 % to 7.8 %, and a detection rate for CRC between 0.65 % and 0.68 %. Single biases in FIT performance resulted in less than 0.1 % change in long-term CRC screening outcomes, while consistent biases resulted in a much larger change (up to 1.4 % in CRC cases and CRC-related deaths and up to 2.07 % in total costs). Detecting lower Hemoglobin concentrations resulted in a relatively larger change on long-term CRC outcomes in comparison to positive bias.<BR><B>CONCLUSIONS: </B>Because of the substantial impact of consistent FIT bias, it is important to set evidence-based acceptance criteria of bias on long-term CRC screening outcomes and in particular, the introduction of an asymmetrical or upward shifted tolerance interval for FIT bias.