Research Recommendations from a Lung Cancer Screening Workshop

The National Cancer Institute and the American Cancer Society cosponsored a workshop on March 7–8, 2001, in Rockville, Md, to discuss rapidly emerging technology used in screening for lung cancer; the various research methods that can be used to evaluate performance of the screening technology; and the data systems, infrastructure needs, and mechanisms for facilitating such research activities. The conclusions and recommendations from that workshop are given herein. Group 1 was asked to examine the impact of technology changes on screening studies. For example, how can the presumed future changes in low-dose helical computed tomographic technology be most effectively managed in the clinical trials setting? How do we deal, from a scientific and research point of view, with the fact that technology is changing faster than we can study it? What are the potential issues associated with the integration of computer-aided diagnosis into screening technologies. Group 1’s conclusions and recommendations were as follows: (a) Investigators should explore and develop clinical trial designs that can adapt to changing information. For example, draw sequential statistical methods and Bayesian methods from the existing statistical literature on adaptive designs. Plan for changing technology during the course of a trial, and characterize technology in an ongoing way. (b) Observer performance may dominate technology differences and the effects of screening. Therefore, measure early and train observers appropriately. (c) Consider modest, shortterm, intermediate end points to allow cutting losses early. (d) Researchers should do modeling for overall evaluation at variable times depending on goal and with detailed data on lead time, length time, and survival characteristics by cell type for patients treated and not treated. (e) Trialists should consider measuring costs during screening trials; cost-effectiveness analysis will be worthwhile if effects are present and “large.” (f) Investigators must be aggressive about quality assurance. Group 2 was asked to assess the various methodologic approaches to evaluating screening performance, efficacy, and other aspects of new screening technologies in trials and observational data. Their conclusions and recommendations were as follows: (a) Studies should be designed and performed to answer practice-relevant questions (eg, What should be done with small lesions?). (b) Models need to be developed to evaluate varying screening and treatment strategies and risk/outcome in terms of cost and effectiveness. (c) There is a need for coordinated and standardized surveillance of both screening and treatment in the community with emphasis on quality assurance. (d) All prospective studies of lung cancer screening should be organized to achieve a multidisciplinary, stateof-the-art approach to detection, treatment, and follow-up. (e) Screening programs provide a unique opportunity to educate patients on risk factors such as smoking. There is a need to evaluate different strategies to reduce smoking. Group 3 was charged with evaluating issues of data standardization and informatics. The type of comparisons to be made across studies will dictate the degree of data standardization required for various factors, such as study population, criteria for entry, follow-up, and intervention. What types of comparisons are feasible across studies? What will be the influence of rapidly evolving use of computerized systems for management of data in research and in clinical practice? Group 3’s conclusions and recommendations were as follows: (a) Support is needed for the development of a repository of standard data elements with an explicit data dictioAcad Radiol 2001; 8:942–943