None listed
Conditions
Brief summary
This prospective, multi-centre quality improvement study will assess whether introducing synoptic procedural reporting improves the quality and consistency of endobronchial ultrasound (EBUS) procedures that are used to determine cancer stages in patients with suspected or confirmed non-small cell lung cancer (NSCLC). This study will include both historical (pre-intervention) and prospective (post-intervention) phases and involves 25 international sites. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have known or suspected non-small cell lung cancer (NSCLC) and you are planned to undergo an endobronchial ultrasound (EBUS) assessment at a participating hospital. Study details Participants who choose to enrol in the prospective part of this study will undergo their EBUS procedure per the standard protocols. The procedure itself won't change for cancer patients, the intervention will be ensuring that the doctors conducting the EBUS procedure use a structured reporting document (called a synoptic reporting template) to capture specific characteristics during the procedure. Characteristics collected using the synoptic reporting template will then be compared to historical data that were collected without the structured guidelines. Doctors completing the new structured reporting template will also be asked to provide feedback on the template and reporting procedure. It is hoped this research will demonstrate that using a synoptic reporting template is easy and acceptable for doctors who are conducting EBUS for cancer staging in patients with NSCLC. It is also hoped that using the synoptic reporting template will enable doctors to consistently collect relevant details regarding a person's cancer that can then be used to choose the best treatment option for each person.
Interventions
Synoptic Procedural Report for Endobronchial Ultrasound (EBUS)
Intervention: Proceduralists complete a structured, electronic synoptic EBUS report within existing reporting software. The template contains mandatory fields (e.g., indication, lymph node stations examined, number of biopsies, use of ROSE, complications).
For clinicians: Instead of a free-text narrative, data must be structured and simplified
Time required: Approximately 5 minutes per report (the same as existing time, no additio
Synoptic Procedural Report for Endobronchial Ultrasound (EBUS) Intervention: Proceduralists complete a structured, electronic synoptic EBUS report within existing reporting software. The template contains mandatory fields (e.g., indication, lymph node stations examined, number of biopsies, use of ROSE, complications). For clinicians: Instead of a free-text narrative, data must be structured and simplified Time required: Approximately 5 minutes per report (the same as existing time, no additional time required) Duration of intervention: Implemented for 3 months post-go-live at each participating site. Training: Proceduralists receive a brief online orientation session covering the template layout, required data fields, and rationale for quality indicators. Administered by: Interventional pulmonologists performing staging EBUS procedures. Adherence monitoring: At the end of the study period, review of submitted reports to assess completeness and compliance will be performed
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hospital level: - Able to nominate a lead EBUS proceduralist (interventional pulmonologist or thoracic surgeon) - Systematic staging EBUS procedures routinely performed at institution for Stage Ib-IIIA NSCLC - Institution volume such that site expects to be able to contribute a minimum 20 cases (systematic staging EBUS) within 4 month prospective study period - Anticipate able to obtain Institutional Review Board (IRB) approval without alteration to study protocol (will be shared) - Anticipate able to obtain necessary IRB/Governance approvals to permit commencement of data for prospective phase of study - Able to maintain prospective data entry into Redcap database - Willingness of proceduralists to complete synoptic reports with standardized reporting for all 5 mediastinal lymph node stations in patients undergoing systematic mediastinal lymph node staging for patients with cStage Ib-IIIA. - Able to provide via RedCap findings on a per-nodal station basis of PET report, EBUS procedural findings, EBUS pathology/cytology report for all prospective EBUS systematic mediastinal lymph node staging procedures performed for 5mths from the time of study commencement. - Able to provide via RedCap findings on a per-nodal station basis of PET report, EBUS procedural findings, EBUS pathology/cytology report for retrospective component for pre-interventional period for procedures for EBUS-TBNA mediastinal staging for patients with cStage Ib-IIIA. Patient level: - Adult patients with known/suspected non-small cell lung cancer (NSCLC) clinical stage Ib – IIIC undergoing systematic staging EBUS for evaluation of curative-intent treatment.
Exclusion criteria
Hospital level: Hospitals will be excluded from the study if there is an insufficient number of procedures conducted at pre- or post-test stages of the study, are unable to introduce synoptic reporting at their centre, are unable to obtain necessary IRB approvals, are unable to commence synoptic reporting on the anticipated commencement date. Patient level - Medical co-morbidities preclude bronchoscopy - Medical co-morbidities or known pathologic extent of disease preclude consideration of curative-intent therapy - Age < 18 years
Outcome results
None listed