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 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 7 th 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.

Association of the Intensity of Diagnostic Evaluation With Outcomes in Incidentally Detected Lung Nodules

“…We believe that the findings in this study will complement the forthcoming results of the noninferiority Watch the Spot Trial . The Watch the Spot Trial compares 2 different guideline-concordant nodule evaluation strategies, whereas the present study compared more extreme deviations from guideline-concordant care that can only be observed in actual clinical practice.…”

Patient characteristics associated with adherence to pulmonary nodule guidelines

“…Further studies are needed to assess patient-oriented outcomes at various nodule follow-up intervals in order to provide clarity about the optimal follow-up strategy. In fact, an ongoing multi-center trial is currently comparing varying intervals of follow-up to address these questions [33].…”

Clinical Equipoise and Shared Decision-making in Pulmonary Nodule Management. A Survey of American Thoracic Society Clinicians

“…Our survey identified three potential trials for which respondents acknowledged clinical equipoise and a willingness to enroll patients. The Patient-Centered Outcomes Research Institute (PCORI) has recognized pulmonary nodule evaluation as a priority area and funded a $14.5 million multicenter pragmatic effectiveness trial comparing algorithms for pulmonary nodule surveillance (34). The need for such trials is particularly acute in light of the ongoing widespread adoption of lung cancer screening, which will further increase the number of pulmonary nodules detected.…”