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03 Asc H Medicolegal Austin

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A potpourri of ASC-H and related interpretations- …

A potpourri of ASC-H and related interpretations-
(Part III)

Published in: Health & Medicine, Technology

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  • Transcript

    • 1. ASC-H: Quality Improvement, Ancillary HPV testing, and Medicolegal aspects 1) Highlight blinded review quality improvement technique employed at MWH to enhance ASC-H detection 2) medicolegal ramifications of disputed retrospective ASC-H interpretations. 3) Unpublished data on the usefulness of HPV testing in the largest series reported to date from MWH
    • 2. Multiple Slide Blinded Reviews as a Quality Improvement Tool
      • Identify Pap tests screened as negative or equivocally abnormal preceding subsequent diagnoses of CIN2/3, AIS, or cervical cancer.
      • Insert Pap tests of interest into 10-20 slide cytology challenge sets.
      • Ask staff cytotechnologists to rescreen and interpret all cases on anonymous answer sheets.
      • Review rescreening findings with staff along with histologic and cytologic follow-up.
    • 3. Paps #1 and 2 Two Negative Paps Preceding CIN2 Biopsy Result
    • 4. Original Review Pap#1
      • Date: 4/7/03
      • Diagnosis
        • Negative for intraepithelial lesion or malignancy.
        • Inflammatory changes.
    • 5.  
    • 6. What do you think?
      • Negative
      • Cancer
      • Suspicious for cancer
      • HSIL
      • AGC (Atypical glandular cells)
      • ASC-H
      • LSIL
      • ASCUS
    • 7. Blinded Cytotechnologist Review Results
      • Negative: 9
      • LSIL: 1
      • ASC-US: 4
      Retro-review Diagnosis knowing outcome: Atypical Squamous Cells cannot exclude HSIL (ASC-H)
    • 8. Original Review Pap #2
      • Date: 3/26/04
      • Diagnosis
        • Negative for intraepithelial lesion or malignancy.
        • Inflammatory changes.
    • 9.  
    • 10.  
    • 11.  
    • 12.  
    • 13.  
    • 14.  
    • 15. What do you think?
      • Negative
      • Cancer
      • Suspicious for cancer
      • HSIL
      • AGC (Atypical glandular cells)
      • ASC-H
      • LSIL
      • ASCUS
    • 16. Blinded Cytotechnologist Review Results
      • Negative: 9
      • ASC-US: 4
      Retro-review Diagnosis knowing outcome: Atypical Squamous Cells cannot exclude HSIL (ASC-H)
    • 17. Subsequent Surgical Pathology Result
      • Date: 1/4/07
      • Diagnosis:
        • Cervical intraepithelial neoplasia 2 (CIN 2)
    • 18. Paps #3 and 4 Two Negative Paps Preceding CIN2 Biopsy Result
    • 19. Original Review Pap #3
      • Date: 4/21/05
      • Diagnosis
        • Negative for intraepithelial lesion or malignancy.
        • Repair.
    • 20.  
    • 21.  
    • 22.  
    • 23. What do you think?
      • Negative
      • Cancer
      • Suspicious for cancer
      • HSIL
      • AGC (Atypical glandular cells)
      • ASC-H
      • LSIL
      • ASCUS
    • 24. Blinded Cytotechnologist Review Results
      • Negative: 8
      • Atypical glandular cells: 1
      • ASC-H: 2
      • ASC-US: 2
      Retro-review Diagnosis knowing outcome: Atypical Squamous Cells cannot exclude HSIL (ASC-H)
    • 25. Original Review Pap #4
      • Date: 6/1/06
      • Diagnosis
        • Negative for intraepithelial lesion or malignancy.
        • Adequate with cocci partially obscuring 50-75% of epithelial cells.
    • 26.  
    • 27.  
    • 28.  
    • 29.  
    • 30.  
    • 31.  
    • 32.  
    • 33. What do you think?
      • Negative
      • Cancer
      • Suspicious for cancer
      • HSIL
      • AGC (Atypical glandular cells)
      • ASC-H
      • LSIL
      • ASCUS
    • 34. Blinded Cytotechnologist Review Results
      • Negative: 2
      • HSIL: 4
      • ASC-H: 5
      • ASC-US: 2
      Retro-review Diagnosis knowing outcome: High-grade squamous intraepithelial lesion (HSIL)
    • 35. Subsequent Surgical Pathology Result
      • Date: 1/4/07
      • Diagnosis:
        • Cervical intraepithelial neoplasia 2 (CIN 2)
    • 36. Multiple Slide Blinded Review (MSBR) Conclusions
      • Difficult to diagnose ASC-H cases may be best recognized only with the hindsight bias of later known histologic outcome.
      • Standard of practice- what a reasonable peer who do under similar circumstances- is different from hindsight bias-influenced retrospective review.
      • ASC Pap Litigation Guidelines state that a violation of the standard of practice can ONLY be confirmed with MSBR.
    • 37. ASC-H and HPV Testing MWH Experience
    • 38.
      • Atypical squamous cells, cannot exclude HSIL ( ASC-H ) subcategory was introduced in the 2001 Bethesda System.
      • “ Atypical (immature) Metaplasia” : small cells with high N/C ratios.
      • “ Crowded Sheet Pattern”
    • 39. Background
      • Mimics :
          • Atrophy
          • Reactive/reparative change
          • Naked nuclei
          • Parakeratosis
          • Immature metaplastic cells
    • 40. Background
      • Incidence of ASC-H: 0.22% - 1.09%
      • Reported rate of CIN 2/3 on histologic follow-up: 12.2% - 68.2%
      • Reported rates of high-risk HPV + in ASC-H: 33.3% - 85.6%
    • 41. Background
      • 2006 Consensus Follow-up Guidelines from the American Society for Colposcopy and Cervical Pathology (ASCCP)
        • ASC-H go to colposcopy
        • Based on data from the ASCUS / LSIL Triage Study (ALTS)
    • 42. Background on ALTS
      • All patients had previous ASC-US or LSIL pap on conventional smears based on 1991 Bethesda terminology.
      • Participants had liquid-based Pap and HPV testing.
      • Diagnosis was made by 4 pathologists
          • 110 ASC-H cases; 84% + hrHPV
      • Younger than average patient population. - Median age 24 years old.
    • 43. Background
      • 2001 ASCCP guidelines for ASC-US recommend “reflex” HPV DNA testing when liquid-based cytology is used.
        • ~ 85% of ASC-US paps get reflex HPV testing .
      • Some studies suggest that HPV testing may help triage ASC-H patients and reduce the number of colposcopies.
    • 44. GOALS
      • Evaluate:
        • ASC-H paps
        • High-risk HPV (hrHPV) DNA test results
        • Histologic follow-up
        • Presence or absence of endocervical/ transformation zone (EC / TZ)
          • Affect on detection of CIN
          • Affect on hrHPV detection
    • 45. Materials and Methods
      • July 1, 2005 – December 31, 2007
      • ThinPrep Imaging System (TIS) was used
        • ASC-H called when small, rounded, squamous cells with dense limited cytoplasm, enlarged and euchromatic or hyperchromatic nuclei and some degree of nuclear membrane irregularities were identified
        • EC/TZ status based on Bethesda 2001.
      • High-risk HPV DNA testing via Hybrid Capture II (HC2)
        • Ordered by clinicians as reflex for ASC pap, women > 30 y.o., or HPV regardless.
    • 46. Materials and Methods
      • Histologic follow-up
        • Endocervical curettage
        • Cervical biopsy
        • Cervical conization (loop or cold knife cone)
      • Two surgical pathologists confirmed CIN diagnoses.
        • CIN1
        • CIN 2 or higher (CIN2/3)
      • Stratified according to age and EC/TZ status.
    • 47. Results
      • ASC-H interpretations
        • 1646 (1619 ThinPrep, 27 conventional)
        • 0.59% of all paps
          • 0.60% in TP, 0.38% in conv.
        • 1187 (of TP) 73.3% had hrHPV testing done
      • Presence or absence of EC/TZ made no difference with regard to hrHPV DNA detection or detection of CIN 2/3
    • 48.  
    • 49. Results The difference in hrHPV + was significant between women <40 y.o. and women > 40 y.o.
    • 50. Results 926 with ASC-H & hrHPV testing 421 No histology 505 w/ at least 1 cervical bx * 257 (50.9%) hrHPV + 248 (49.1%) hrHPV - * 101 women had two or more biopsies
    • 51. Results 257 (50.9%) HPV + 248 (49.1%) HPV - 160 (62.3%) CIN 35 (14.1%) CIN
    • 52. Results
      • Cumulative CIN detection rate was 38.6% (195/505)
      • CIN 2/3 in 87 (17.2%) of 505 ASC-H & hrHPV tested patients
    • 53. Results
      • Statistical difference (P < .001) between hrHPV+ w/ CIN 2/3 and hrHPV – w/ CIN 2/3.
      • Women 30 -39 y.o. w/ + hrHPV had the greatest risk.
      • 4 women had AIS; all were hrHPV +
    • 54. Results (Table 4)
      • 35.8% of HPV+ women < 40 y.o. had CIN 2/3;
      • 20.8% of HPV+ women > 40 y.o. had CIN 2/3
    • 55. Results
      • ASC-H PPV of CIN2/3 = 17.2%
      • ASC-H and + hrHPV PPV of CIN2/3 = 32.7%
      • ASC-H and – hrHPV NPV of no CIN2/3 = 98.8%
    • 56. ASC-H w/ reflex hrHPV Testing
      • < 40 y.o.
      • Sensitivity 96.1%
      • Specificity 54%
      • PPV 35.8%
      • NPV 98.1%
      • < 40 y.o .
      • 100%
      • 68.4%
      • 20.8%
      • 100%
    • 57. Comment CAP interlaboratory comparison program
    • 58. Comment
      • Some abstracts report increased ASC-H reporting with the use of the ThinPrep Imaging System (TIS)
        • Decreased detection of hr HPV
        • Decreased detection of CIN 2/3
    • 59. Comment ALTS
    • 60. Why so much variability in hrHPV detection rates?
      • Differences in cytologic interpretation threshold for ASC-H
      • Undercalling of HSIL
      • Overcalling of ASC-H as HSIL
      • Overcalling metaplastic cells as ASC-H
      • Different patient populations
        • Rate of hrHPV + varies from 2.9% (current study) - 32.7% (ALTS)
        • ALTS median age 24 y.o.; this study median age 30 y.o.
    • 61. Summary of this study
      • Significant difference in detection of CIN in + hrHPV than negative.
      • The negative predictive value of – hrHPV in ASC-H was 100% in women > 40 y.o.
      • Highest CIN 2/3 detection rate was in women 30-39 y.o. with ASC-H and + hrHPV
    • 62. Conclusions
      • Using both Pap test and high-risk HPV DNA testing allows for effective risk stratification of patients:
        • HPV + to colposcopy
        • HPV – to follow-up with regular Pap and hrHPV testing.