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Methods for the Watch the Spot Trial. A Pragmatic Trial of More- versus Less-Intensive Strategies for Active Surveillance of Small Pulmonary Nodules

Authors :
Danielle E. Altman
Lihong Qi
Sophronia Yu
Michael K. Gould
Rebecca Smith-Bindman
Beth Creekmur
Debra S. Dyer
Diana L. Miglioretti
Igor Barjaktarevic
Evan de Bie
Karen Kelly
Eduardo J. Mortani Barbosa
Laszlo T. Vaszar
Richard A. Mularski
Source :
Annals of the American Thoracic Society. 16:1567-1576
Publication Year :
2019
Publisher :
American Thoracic Society, 2019.

Abstract

Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include: 1) the pragmatic integration of study procedures into existing clinical workflow; 2) the use of cluster randomization by hospital or health system; 3) the implementation and evaluation of a system-level intervention for protocol-based care; 4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; 5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; 6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and 7) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study.

Details

ISSN :
23256621 and 23296933
Volume :
16
Database :
OpenAIRE
Journal :
Annals of the American Thoracic Society
Accession number :
edsair.doi.dedup.....e30c7c57e80a07454cb5f9f1a52ae945
Full Text :
https://doi.org/10.1513/annalsats.201903-268sd