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Ann Am Thorac Soc. 2019 Jul 17. doi: 10.1513/AnnalsATS.201903-268SD. [Epub ahead of print]

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

Author information

1
Kaiser Permanente Southern California, Research and Evaluation, Pasadena, California, United States ; michael.k.gould@kp.org.
2
University of California San Francisco, 8785, Department of Radiology and Biomedical Imaging, Department of Epidemiology and Biostatistics, Philip R. Lee Institute for Health Policy Studies, San Francisco, California, United States.
3
University of California Davis School of Medicine, 12218, Department of Medicine, Sacramento, California, United States.
4
Kaiser Permanente Southern California, Research and Evaluation, Pasadena, California, United States.
5
University of California Los Angeles David Geffen School of Medicine, 12222, Department of Medicine, Los Angeles, New York, United States.
6
University of California Davis School of Medicine, 12218, Department of Public Health Sciences, Sacramento, California, United States.
7
Kaiser Permanente Washington Health Research Institute, 343041, Seattle, Washington, United States.
8
National Jewish Health, 2930, Department of Radiology, Denver, Colorado, United States.
9
University of Pennsylvania Perelman School of Medicine, 14640, Department of Radiology, Philadelphia, Pennsylvania, United States.
10
Kaiser Permanente Northwest, 160623, The Center for Health Research, Portland, Oregon, United States.
11
UC Davis, 8789, Davis, California, United States.
12
Mayo Clinic Arizona, 23387, Department of Medicine, Scottsdale, Arizona, United States.
13
UCSF, 8785, San Francisco, California, United States.

Abstract

Small pulmonary nodules are most often managed by surveillance imaging with chest computed tomography (CT), but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multi-center, pragmatic, comparative effectiveness trial with cluster randomization by hospital or health system that compares more vs. 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, 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 7th edition (AJCC 7) stage T1aN0M0. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care utilization, 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 non-patient stakeholders in the design and execution of the study.

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