Evaluation of lung cancer early detection offered by the German Social Accident Insurance for formerly asbestos-exposed employees using low-dose computed tomography - setting and study design.

Background: Clinical trials have shown the benefits of lung cancer screening (LCS) in certain high-risk groups using low-dose high-resolution computed tomography (LDCT). Risk groups are usually defined by age and tobacco use. Exposure to asbestos dust is an important occupational risk factor for lung cancer. Since 2014, the German Social Accident Insurance (DGUV) has introduced annual LCS for high-risk groups (EVA-LCS). In addition to occupational asbestos dust exposure, the population at risk is defined by age (≥ 55 years) and tobacco consumption (≥ 30 pack-years). The health services research project EVALUNG aims to evaluate the EVA-LCS using a combination of quantitative and qualitative methods.

Methods: The quantitative part will be based on a secondary data analysis of routine administrative and medical data from the EVA-LCS. The results of the individual screening rounds will be analysed in a cross-sectional design. Primary endpoints are participation patterns, the rate of findings requiring further diagnostic investigation, the detection of lung cancer including tumour stage and characteristics, and the notification and recognition of asbestos-related occupational diseases. Secondary endpoints include false-positive and false-negative findings, incidence of other cancers, and all-cause and cancer-related mortality. To avoid selection bias, a complete set of anonymised data (approximately 22,200 individuals as of 12/2021) from the EVA-LCS will be transmitted for use in EVALUNG. A sub-sample will be used to perform longitudinal analyses and explore a linkage with cancer registry data. Another component is the development and piloting of quality indicators. Qualitative interviews will be conducted to analyse the perceptions, satisfaction, and potential psychological effects of EVA-LCS participants. Interviews with participating physicians will focus on their attitudes and knowledge regarding LCS. A further aim is to develop an evidence-based decision aid.

Discussion: The EVALUNG concept is based on various complementary approaches, enabling a comprehensive evaluation of the EVA-LCS and the identification of optimization potentials. The quality of the data is crucial for the validity of the quantitative analyses. One way to address potential limitations is to link the data with cancer registry data. The results may contribute to the planning and development of a national LDCT lung cancer screening programme in Germany.