Smith‐Bindman, Rebecca

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.

ABSTRACTObjectivesIdentifying the distributions and determinants of fluoroscopy time for invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI).BackgroundICA and PCI are significant contributors to radiation exposure from medical imaging in the US. Fluoroscopy time is a potentially modifiable determinant of radiation exposure for these procedures, but has not been well characterized in contemporary practice.MethodsWe evaluated the distribution of fluoroscopy time in patients undergoing ICA and/or PCI in the CathPCI Registry®, stratifying patients by numerous clinical scenarios. Hierarchical models were used to determine patient, procedure, operator and hospital‐level factors associated with fluoroscopy time for these procedures.ResultsOur study included a total of 3,295,348 ICA and PCI procedures performed by 9,600 operators from January 2005 through June 2009. There was wide variation in fluoroscopy times for these procedures with median [IQR] fluoroscopy times of 2.6 [1.7–4.5] minutes for ICA, 6.7 [4.2–10.8] minutes for ICA in patients with prior coronary artery bypass grafting (CABG), 10.1 [6.0–17.4] minutes for PCI, 10.7 [7.0–16.9] minutes for PCI with ICA, and 16.0 [10.6–24.0] minutes for PCI and ICA in patients with prior CABG. Prolonged fluoroscopy times (>30 minutes) were rare for ICA, but occurred in 6.7% of PCIs and 14.7% of PCIs in patients with prior CABG. After accounting for patient characteristics and procedure complexity, operator and hospital‐level factors explained nearly 20% of the variation in fluoroscopy time.ConclusionsFluoroscopy times vary widely during ICA and PCI with operator and hospital‐level factors contributing substantially to these differences. A better understanding of potentially modifiable sources of this variation will elucidate opportunities for enhancing the radiation safety of these procedures. © 2013 Wiley Periodicals, Inc.