Original Articles
Baseline Characteristics and Mortality Outcomes of Control Group Participants and Eligible Non-Responders in the NELSON Lung Cancer Screening Study

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Introduction

Individuals who are younger, have a high socioeconomic background and/or have a healthy lifestyle are more inclined to participate in screening trials. This form of bias may affect the generalizability of study results to the target population. This study aimed to investigate the generalizability of the NELSON lung cancer screening trial to the Dutch population.

Methods

People at high risk for developing lung cancer were identified by sending a health questionnaire to 606,409 persons aged 50–74 years, based on population registries. Eligible subjects received an invitation to participate (n = 30,051). 15,822 subjects agreed to participate and were randomized, whereas 15,137 did not respond (so-called eligible nonresponders). Baseline characteristics and mortality profiles were compared between control group participants and eligible nonresponders.

Results

Participants had better self-reported health (p = 0.02), were younger, more physically active, higher educated, and more often former smokers compared with eligible nonresponders (all p < 0.001). No differences were seen in self-reported outcomes of pulmonary tests, history of lung cancer, and smoked pack-years. Mortality due to all-causes (p < 0.001) and mortality classification separately was lower among participants. However, the proportion of subjects death due to cancer was higher among participants (62.4% vs. 54.9%).

Conclusion

Modest differences in baseline characteristics between participants and eligible nonresponders, led to minor differences in mortality profiles. However, group sizes were large and therefore it seems unlikely that these small differences will influence the generalizability of the NELSON trial. Results of the NELSON trial can roughly be used to predict the effect of population-based lung cancer screening.

Key Words

Selection bias
Refusal to participate
Mass screening and Lung cancer

Cited by (0)

The NELSON trial is financially supported by “ZonMW: the Netherlands Organisation for Health Research and Development” (grant number 120610015), “KWF: Dutch Cancer Society” (grant number EMCR 2007–3857), “Erasmus MC trust fund”, “Health Insurance Innovation Foundation”, “G. Ph. Verhagen Stichting”, “Rotterdam Oncologic Thoracic Steering committee” (ROTS), Roche for providing a grant for the performance of proteomics-research, Siemens Germany for providing four digital workstations, “Stichting tegen Kanker” and “Vlaamse Liga tegen kanker”. The funding sources had only financial roles.

The NELSON trial is registered under registration number ISRCTN63545820 at www.trialregister.nl.

Disclosure: The authors declare no conflict of interest.