TY - JOUR
T1 - Methods for the watch the spot trial
T2 - A pragmatic trial of more-versus less-intensive strategies for active surveillance of small pulmonary nodules
AU - Watch the Spot Trial Investigators
AU - Gould, Michael K.
AU - Smith-Bindman, Rebecca
AU - Kelly, Karen
AU - Altman, Danielle E.
AU - Barjaktarevic, Igor
AU - Creekmur, Beth
AU - De Bie, Evan
AU - Dyer, Debra S.
AU - Barbosa, Eduardo J.Mortani
AU - Mularski, Richard A.
AU - Qi, Lihong
AU - Vaszar, Laszlo T.
AU - Yu, Sophronia
AU - Miglioretti, Diana L.
N1 - Publisher Copyright:
Copyright © 2019 by the American Thoracic Society.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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, comparativeeffectiveness 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.
AB - 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, comparativeeffectiveness 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.
KW - Lung cancer
KW - Pragmatic trial
KW - Pulmonary nodule
KW - Screening
KW - Surveillance
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U2 - 10.1513/AnnalsATS.201903-268SD
DO - 10.1513/AnnalsATS.201903-268SD
M3 - Article
C2 - 31314549
AN - SCOPUS:85075812668
VL - 16
SP - 1567
EP - 1576
JO - Annals of the American Thoracic Society
JF - Annals of the American Thoracic Society
SN - 2325-6621
IS - 12
ER -