Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study

Abstract

IntroductionIn Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population.Methods and analysisA decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population’s preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data.Ethics and disseminationEthical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences.Trial registration numberDRKS00019010.

Screening Implications for Distribution of Colorectal Cancer Subsite by Age and Role of Flexible Sigmoidoscopy

“…While screening compliance in the NordICC study with invitation to colonoscopy was 42%, adherence to flexible sigmoidoscopy was reportedly higher in prior randomized controlled trials, ranging from 58 to 83% [ 23 ]. The role of sigmoidoscopy as an acceptable alternative for colonoscopy in patient preference continues to be further explored, and our study contributes to characterizing the utility of sigmoidoscopy in a more personalized screening process [ 24 ].…”