Patient-Specific QA & QA Process. Sasa Mutic, Ph.D. Washington University School of Medicine

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1 Patient-Specific QA & QA Process Sasa Mutic, Ph.D. Washington University School of Medicine

2 Outline of Presentation QA and QC in RT Safety vs. quality Patient specific QM program

3 Learning Objectives Describe safety and quality goals in RT Describe the benefits of delineating between QA and QC Describe approaches to design of patient specific QC procedures

4 Patient Specific QA SRS/SBRT more risky than conventional RT How does higher risk translate to patient specific QA/QC procedures? Literature and recommendations quite general (generic) Combinations of procedures and equipment quite diverse QA/QC procedures unique True understanding of QM principles more important than in almost any other area of RT

5 Quality\Safety in RT? Benefit Underdose Target Dose Overdose Is this distribution realistic: most patients receive acceptable treatments acceptable with treatments? a minority being harmed? Courtesy:

6 Quality\Safety in RT? Benefit Underdose Target Dose Overdose Or is this more realistic: there s a continuous distribution from acceptable treatments to harmful treatments? Courtesy:

7 Quality\Safety in RT? High-quality means minimizing process variation and moving the average closer to the optimum value - Med. Phys., (5): p Stable and well defined processes enable Standardization Quantification Benchmarking Improvements Quality Control Courtesy:

8 Quality\Safety in RT? Benefit Harm Uncertainty Uncertainty Harm Underdose Target Dose Overdose Courtesy:

9 Reducing Variability Treatment Selection Imaging Contour Approval Contouring Plan Creation The Goal Physics Approval MD Approval Physics Checks Treatment and Ongoing QA Completion Normative decision theory: Start with Work - Value added efficiency 1) move Timeline to efficacy Wait No value 2) Uncertainty

10 QA and QC in RT There are numerous definitions and approaches For purposes of this presentation QA: ensuring quality in the process QC: ensuring quality in products QC: quality of individual patient treatments

11 When QC in RT? Just before treatment? At every step? At critical steps? Consultation Simulation Contouring Planning Treatment

12 When QC in RT? Ford et al. Int J Rad Onc Biol Phys 74 (2009)

13 When QC in RT? QC potentially resource intensive Balance between rework and unnecessary QC If QC is not catching anything question its utility If QC is catching many things question QA and QM Every patient or a sampling of patients In RT tendency is to QA/QC everything

14 QC possibilites Plan of treatment Peer review Simulation MD, physics, therapy, etc. reviews Image registration - MD, physics, dosimetry, etc. reviews Contouring - MD, physics, dosimetry, etc. reviews Planning - MD, physics, dosimetry, etc. reviews Data export - Physics, dosimetry, therapy, etc. reviews Data - Physics Patient setup - MD, physics, therapy, etc. reviews Overall treatment - MD, physics, therapy, peer review, etc...

15 When QC in RT? It is difficult for individual clinics to prioritize their QA/QC/QM activities if the broader field and community is still struggling with what to prioritize Prioritization requires data Evidence based medicine is becoming mainstream, RT QA/QC need to embrace the same approach

16 Example: QA\QC Check Effectiveness An analysis of the effectiveness of common QA/QC checks IRB between Johns Hopkins University & Washington University Both institutions started incident learning systems (ILS) at the same time Data: o Incident reports: o 4,407 reports o 292 (7%) high potential severity Ford et al Int. J. Radiat. Oncol. Biol. Phys., 84(3), , (2012).

17 Physics chart review Therapist chart review Physics weekly chart check Physician chart review EPID dosimetry Port films: check by therapist Timeout by the therapist Port films: check by physician In vivo diode measurements Checklist Chart rounds Online CT: check by therapist SSD check Online CT: check by physician Pre treatment IMRT QA Sensitivity (%)

18 Literature Search May 2013 pubmed.org search on: (Quality Assurance) AND (Radiation Therapy) AND (IMRT) Results: 463 (Chart Checks) Results: 7 (Chart Review) - Results: 34 An order of magnitude difference

19 How would investors use this data? Physics chart review Therapist chart review Physics weekly chart check Physician chart review EPID dosimetry Port films: check by therapist Timeout by the therapist Port films: check by physician In vivo diode measurements Checklist Chart rounds Online CT: check by therapist SSD check Online CT: check by physician Pre treatment IMRT QA Returns Sensitivity (%)

20 Current IMRT QA Paradigm We are pretty good at making sure that we can treat a phantom correctly at ~7:00 pm WashU Physicist Transfer patient plan to a QA phantom Dose recalculated (homogeneous) on phantom any dose calculation errors would not be revealed 2. Perform QA prior to treatment Subsequent data changes/corruption may result in systematic errors for all subsequent patients 3. The volume of data impossible to monitor and verify manually Manual checks do reveal data changes/corruptions, but not reliably 4. The process too laborious with questionable benefits A systematic analysis and redesign demonstrates possibility of a much more robust and automated process

21 Error spectrum Publicized - One side of the spectrum, usually large dosimetric errors NY Times Articles Semi-publicized RPC data Approximately 20% of participating institutions fail the credentialing test at 7% or 4mm* Approximately 30% fail at 5%* Unpublicized/unnoted everyday occurrences Small dosimetric errors and geographic misses Suboptimal treatment plans (contouring and dose distributions) Care coordination issues Unnecessary treatment delays *Molineu et al, Credentialing results from IMRT irradiations of an anthropomorphic head and neck, Med Phys, 40, 2013.

22 QM Tools

23 Patient Specific QM Program Focus Imaging and target delineation TG66, TG76, TG132 Treatment planning Dosimetry Localization on treatment machine Treatment delivery Overall patient management

24 Example: Imaging and Target Delineation

25 Average Motion and Maximum Intensity Projection (MIP) 4D motion Time-Average MIP Maximum Intensity Projection

26 Image review and artifacts Dangers of MIP

27 Image review and artifacts Dangers of MIP

28 Breathing Rate Difference 9 bpm 14 bpm

29 9 bpm Breathing Rate Difference (MIP) 14 bpm 9 mm difference

30 Phase vs. Amplitude Smaller tumor size on Amplitude-MIP Green contour: ITV based on Phase-MIP Yellow contour: ITV based on Amplitude-MIP Phase-MIP Amplitude-MIP

31 CT Dataset Type for Contouring 1. ITV AllPhases : GTV on each of 10 respiratory phases and combining these GTVs Can use for everything 2. ITV 2Phase : contouring GTV on peak inhale (0% phase) and the peak exhale phase (nominally - 50%) and then combining the two Generally used for abdomen 3. ITV MIP : contouring GTV on MIP with modifications based on physician's visual verification of contours in each respiratory phase Use for hyperdense tissues with caveats 4. ITV MinIP : contouring GTV on MinIP with modification by physician Use for hypodense tissues with caveats 5. ITV 2M : combining ITV MIP and ITV MinIP. Use for tissues exhibiting hypo and hyper density

32 CT Dataset Type for Contouring a) GTV (green contour), b) ITV AllPhases, c) ITV 2Phase, d) ITV MIP, e) ITV MinIP and f) ITV 2M -ITV MIP and ITV MinIP coutours are as they appear on the intensity projection data set; all others are registered to the 0% phase of the 4D CT data set. Use of combined maximum and minimum intensity projections to determine internal target volume in 4-dimensional CT scans for hepatic malignancies, Liu et al, Radiation Oncology 2012, 7:11

33 CT Dataset Type for Contouring Use of combined maximum and minimum intensity projections to determine internal target volume in 4- dimensional CT scans for hepatic malignancies, Liu et al, Radiation Oncology 2012, 7:11

34 Multiple Targets Stats: RML PTV_RLL 50Gy CI= & R50 = 5.4 Stats: RLL PTV_RML 54Gy CI= &R50 = 4.9

35 Multiple Targets Matching target and Rx during planning Matching target and treatment calendar during delivery Localization Reviewing individual as well as composite plans (dose per fraction and total dose matter)

36 Summary Conclusion Patient specific QA/QC critical in stereotactic and hypofractionated procedures QM program design largely dependent on local medical physicist Understanding of technologies, procedures, and critical failure points crucial for safe and quality treatments

37 References 1. Ford et al Int. J. Radiat. Oncol. Biol. Phys., 84(3), , (2012). 2. Ford et al Int J Rad Onc Biol Phys 74 (2009) SRT and SBRT: Current practices for QA dosimetry and 3D 4. S H Benedict1, Journal of Physics:ConferenceSeries 250 (2010) doi: / /250/1/ Solberg, Timothy D., et al. "Quality assurance of immobilization and target localization systems for frameless stereotactic cranial and extracranial hypofractionated radiotherapy." International Journal of Radiation Oncology* Biology* Physics 71.1 (2008): S131-S Solberg, Timothy D., et al. "Quality and safety considerations in stereotactic radiosurgery and stereotactic body radiation therapy: executive summary." Practical radiation oncology 2.1 (2012): Galvin, James M., and Greg Bednarz. "Quality assurance procedures for stereotactic body radiation therapy." International Journal of Radiation Oncology* Biology* Physics 71.1 (2008): S122-S Use of combined maximum and minimum intensity projections to determine internal target volume in 4-dimensional CT scans for hepatic malignancies, Liu et al, Radiation Oncology 2012, 7:11

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