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Table 2 Study assessments

From: Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy

Subject demographics

 • Age

 • Sex

 • Ethnicity

 • Race

Subject medical history and baseline status

 • Prior invasive lung procedures and surgeries

 • Lung function and diffusing capacity

 • Antithrombotic medication current and prior status, including duration of any discontinuation

 • Subject risk factors

 • Pre-procedure probability of malignancy

 • Quality of life (EQ-5D)

Lesion characteristics

 • Size

 • Location

 • Presence of bronchus sign on computerized tomography (CT)

 • Lung zone (peripheral, middle, and proximal thirds)

 • Visibility on fluoroscopy (if applicable)

 • Positron emission tomography (PET)-positive (yes/no)

 • Associated lymphadenopathy

 • Distance to closest fissure

 • Distance from lesion to pleura

 • Preprocedure probability of malignancy (investigator assessment)

Procedural assessments

 • Indication for procedure

 • Anesthesia type

 • Catheter type

 • Procedure duration

 • Imaging used (fluoroscopy, PET, radial endobronchial ultrasound [EBUS])

 • Ability to successfully navigate to lesion

 • Use of associated tools and type (e.g., access tools, biopsy forceps, cytology brush, aspiration needle)

 • Number of lesions biopsied

 • Number of lymph nodes biopsied (if applicable)

 • Placement of fiducial markers (if applicable), type used, indication, and status at follow-up imaging

 • Surgical resection, including use of dye marker, type used, and adequacy for surgical resection

 • Diagnosis by both cytologic rapid on-site evaluation (ROSE) and pathology

 • Cancer type (primary or metastatic), if applicable

 • Cancer stage, if applicable

 • Adequacy of sample for molecular testing and mutation type (if applicable)

 • Lymph node number, station, size, and success in obtaining sample (if applicable)

 • Number and type of repeat electromagnetic navigational bronchoscopy (ENB) procedures or other biopsies

 • Other health services (e.g., imaging, transfusion, surgery, emergency room admission, prescriptions) received during admission for index procedure

 • Hospital admission duration

 • Adverse events, action taken, relationship to device, and outcome

Follow-up assessments

 • Subject satisfaction (at 1-month follow-up only)

 • Subject quality of life (EQ-5D) at all follow-up visits

 • ENB Productivity and Activity Questionnaire (ENB-PAQ) at 1 month visit

 • All health services (e.g., imaging, transfusion, surgery, emergency room admission, prescriptions) received since last visit

 • All healthcare services related to lung health since index procedure (e.g., primary care and specialist visits, hospital, emergency room, oncology, radiology, pain management).

 • All therapeutic and diagnostic procedures and diagnoses related to lung health since last visit

 • Adverse events, action taken, relationship to device, and outcome