Methods for the watch the spot trial: A pragmatic trial of more-versus less-intensive strategies for active surveillance of small pulmonary nodules

Watch the Spot Trial Investigators

Research output: Contribution to journalArticle

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, 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.

Original languageEnglish (US)
Pages (from-to)1567-1576
Number of pages10
JournalAnnals of the American Thoracic Society
Volume16
Issue number12
DOIs
StatePublished - Dec 1 2019

Fingerprint

Pragmatic Clinical Trials
Random Allocation
Lung
Registries
Thorax
Tomography
Neoplasms
Workflow
Electronic Health Records
Health
Anxiety
Outcome Assessment (Health Care)
Guidelines
Technology
Delivery of Health Care

Keywords

  • Lung cancer
  • Pragmatic trial
  • Pulmonary nodule
  • Screening
  • Surveillance

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Methods for the watch the spot trial : A pragmatic trial of more-versus less-intensive strategies for active surveillance of small pulmonary nodules. / Watch the Spot Trial Investigators.

In: Annals of the American Thoracic Society, Vol. 16, No. 12, 01.12.2019, p. 1567-1576.

Research output: Contribution to journalArticle

@article{e9b8680fe53e443b85b972db2f12c546,
title = "Methods for the watch the spot trial: A pragmatic trial of more-versus less-intensive strategies for active surveillance of small pulmonary nodules",
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, 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.",
keywords = "Lung cancer, Pragmatic trial, Pulmonary nodule, Screening, Surveillance",
author = "{Watch the Spot Trial Investigators} and Gould, {Michael K.} and Rebecca Smith-Bindman and Karen Kelly and Altman, {Danielle E.} and Igor Barjaktarevic and Beth Creekmur and {De Bie}, Evan and Dyer, {Debra S.} and Barbosa, {Eduardo J.Mortani} and Mularski, {Richard A.} and Lihong Qi and Vaszar, {Laszlo T.} and Sophronia Yu and Miglioretti, {Diana L.}",
year = "2019",
month = "12",
day = "1",
doi = "10.1513/AnnalsATS.201903-268SD",
language = "English (US)",
volume = "16",
pages = "1567--1576",
journal = "Annals of the American Thoracic Society",
issn = "2325-6621",
publisher = "American Thoracic Society",
number = "12",

}

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.

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

UR - http://www.scopus.com/inward/record.url?scp=85075812668&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85075812668&partnerID=8YFLogxK

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 -