The importance of the regimen of screening in maximizing the benefit and minimizing the harms.

BACKGROUND In CT screening for lung cancer, the regimen of screening is critical in diagnosing lung cancer early while limiting unnecessary tests and invasive procedures. The International Early Lung Cancer Action Program (I-ELCAP) has developed a regimen based on evidence collected in the I-ELCAP cohort of more than 70,000 participants. METHODS Important in the development of the regimen is the recognition of the profound difference between the first, baseline round of screening and all subsequent rounds of repeat screening. For each person undergoing screening, the baseline round happens only once while repeat rounds will be performed annually for many years. This difference needs to be clearly recognized as it is these annual rounds which allow for identification of small, early, yet aggressive, lung cancers which have high cure rates despite their aggressiveness. The importance of nodule consistency and size are key factors in the regimen. The regimen needs to be continuously updated by incorporating advances in technology and knowledge. RESULTS The use of the I-ELCAP regimen reduces the workup of participants in the screening program to less than 10% in the baseline round and less than 6% in the annual repeat rounds. By use of this regimen, estimated cure rate of lung cancers diagnosed under screening is 80% or higher in both baseline and annual repeat rounds. CONCLUSIONS The I-ELCAP collaboration provides a new paradigm that answers the 2002 NCI call for multiple approaches to address relevant questions about screening and the Institute of Medicine (IOM) Roundtable on Evidence-based Medicine from the National Academy of Science's call for a "new clinical research paradigm that takes better advantage of data generated in the course of healthcare delivery would speed and improve the development of evidence for real-world decision making".