WOMEN S INTERAGENCY HIV STUDY LABORATORY - PELVIC EXAM STUDIES COLPOSCOPY RESULTS FORM L4 ID LABEL HERE ---> - - - VISIT #: FORM COMPLETED BY: VERSION DATE: 0 / 0 / 6 ANY MISSING OR INCOMPLETE TEST RESULTS MUST BE EXPLAINED ON THIS FORM. A. COLPOSCOPY: DONE... T DONE... (Ad) PARTICIPANT REFUSED...3 (END) Aa. DATE OF PROCEDURE: / / M D Y Ab. COLPOSCOPY PERFORMED BY: (ENTER INITIALS OF COLPOSCOPIST/S) i ii Ac. WAS COLPOSCOPY PERFORMED BY A WIHS COLPOSCOPIST?... (A)... (PROMPT) PROMPT: IF QUESTION Ac = (I.E., COLPOSCOPY WAS PERFORMED BY A N-WIHS COLPOSCOPIST), THEN COMPLETE ACSR ATC FORM AND PROCEED TO QUESTION A. WIHS Laboratory Form L4: Pelvic Exam Studies (Colposcopy Results) 0/0/6 Page of 4
Ad. REASON COLPO T DONE: PROMPT: Unable to contact participant (e.g., no phone, homeless, no response to attempts)... Participant was no show for multiple appointments... Participant was too ill to be scheduled at this time... 3 Participant s work/school schedule prevented her from coming... 4 Participant moved out of area / too difficult to travel... 5 Participant is incarcerated... 6 Staff unable to obtain colpo results from primary care OB/GYN for L4 completion... 7 Other... 8 END FORM AFTER COMPLETING QUESTION Ad. A. INDICATION FOR COLPOSCOPY (CIRCLE OR FOR EACH OF THE FOLLOWING) a. Prior history of Dysplasia... b. ASCUS, AGUS, Koilocytosis or SIL on recent WIHS Pap Smear... c. Presence of visible cervical or vaginal lesions... d. Presence of visible vulvar or perianal lesions... e. Post coital bleeding when not menstruating... f. Positive HPV detection test... g. Research only... h. Other... Page of 4
A3. TYPE OF COLPOSCOPY PERFORMED: a. Cervical b. Vaginal c. Vulvar d. Perianal e. Anal (anoscopy) PROMPT: IF RESPONSES TO QUESTIONS A3a AND A3b ARE BOTH, SKIP TO QUESTION A0. A4. WAS CERVIX PRESENT?...... (SKIP TO A0) COLPOSCOPY RESULTS: A5. CERVICAL EXAM ADEQUACY: SATISFACTORY... ENDOCERVICAL SPECULUM USED TO VISUALIZE SQUAMOCOLUMNAR JUNCTION... SQUAMOCOLUMNAR JUNCTION T VISUALIZED... 3 A6. GENERAL CATEGORIZATION OF CERVICAL COLPOSCOPY: WITHIN RMAL LIMITS... (A0) ABRMAL FINDINGS... A7. ABRMAL COLPOSCOPIC FINDINGS FOUND T FOUND a. Keratosis (leukoplakia) b. Aceto-White Epithelium c. Punctation d. Mosaicism e. Atypical Vessels f. Other Page 3 of 4
A8. WHAT PERCENT (%) OF TRANSFORMATION ZONE WAS ABRMAL? 0%... < 5%... 5% - < 50%...3 50% - < 75%...4 75% - 00%...5 A9. What quadrants are abnormal? a. Endocervix (#8)... b. Inner upper left quadrant (#9)... c. Inner lower left quadrant (#0)... d. Inner lower right quadrant (#)... e. Inner upper right quadrant (#)... f. Outer upper left quadrant (#3)... g. Outer lower left quadrant (#4)... 6 3 5 9 8 0 4 h. Outer lower right quadrant (#5)... i. Outer upper right quadrant (#6)... OTHER FINDINGS FOUND T FOUND LOCATION IF FOUND A0. Inflammation (A) a. Vaginal b. Cervical c. Vulvar d. Perianal e. Anal A. Polyp/Papilloma (A) a. Vaginal b. Cervical c. Vulvar d. Perianal e. Anal A. Condyloma acuminatum (A3) a. Vaginal b. Cervical c. Vulvar d. Perianal e. Anal Page 4 of 4
OTHER FINDINGS FOUND T FOUND LOCATION IF FOUND A3. Other: a. (A5) b. Vaginal c. Cervical d. Vulvar e. Perianal f. Anal A4. Other: a. (A5) b. Vaginal c. Cervical d. Vulvar e. Perianal f. Anal A5. WAS PAP SMEAR PERFORMED WITH THIS COLPOSCOPY? A6. CERVICAL BIOPSY TAKEN? a. ECC Performed............ (SKIP TO A7) DELAYED...3 (SKIP TO A7) REFUSED... <-7> (SKIP TO A7)...... DELAYED...3 REFUSED... <-7> b. Colposcopically Directed Punch Biopsy... (c) i) Number of punch biopsies taken: ii) Location(s) taken: (round to nearest o'clock) a. o'clock b. o'clock c. o'clock d. o'clock Page 5 of 4
c. Cervical Excisional Biopsy (other than punch biopsy)... (d) i) Location taken: o'clock to o'clock d. Loop Excision of Transformation Zone (LLETZ, LETZ, LEEP)... (e) i. ectocervical passes... (a) a. enter # of passes e. Cervical Cone Biopsy... (A7) (CIRCLE ONE TYPE) Laser... (A7) Cold Knife... (A7) Loop... 3 i. ectocervical passes (a) (ii) a. enter # of passes ii. endocervical core A7. Overall impression of Cervix (Circle the highest grade lesion). RMAL... ABRMAL, BUT SIL... LOW GRADE... 3 HIGH GRADE... 4 INVASIVE... 5 CERVIX T PRESENT... 6 (A8) Page 6 of 4
a. TOTAL NUMBER OF CERVICAL LESIONS: none... one... two... 3 three... 4 four... 5 five to nine... 6 > ten... 7 A8. OTHER N-CERVICAL BIOPSIES TAKEN?...... (SKIP TO A6) DELAYED...3 (SKIP TO A6) REFUSED... <-7> (SKIP TO A6) TYPE BIOPSIES TAKEN ENTER UP TO LOCATION CODES FOR EACH TYPE A9. Vaginal... (A0) a) b) A0. Vulvar... (A) a) b) A. Perianal... (A) a) b) A. Anal (Anoscopy)*... (A3) a) b) A3. Endometrial... A4. Other... (A6) b) c) a. A5. Other... (A6) b) c) a. LOCATION CODES ARE LOCATED ON PAGES 0- * COMPLETE SECTION B ON PAGES - 4 OF THIS FORM Page 7 of 4
A6. a. TOTAL NUMBER OF VAGINAL LESIONS: none... one... two... 3 three... 4 four... 5 five to nine... 6 > ten... 7 b. TOTAL NUMBER OF VULVAR LESIONS: none... one... two... 3 three... 4 four... 5 five to nine... 6 > ten... 7 c. TOTAL NUMBER OF PERIANAL LESIONS: A7. MAXIMUM LESION SIZE: IF LESION PRESENT, CODE AS - none... one... two... 3 three... 4 four... 5 five to nine... 6 > ten... 7 a. vaginal. cm b. vulvar. cm c. perianal. cm d. anal. cm e. Other. cm (SPECIFY LOCATION) Page 8 of 4
A8. TOTAL NUMBER OF DIAGSTIC BIOPSIES TAKEN (Include both cervical and non-cervical biopsies that will be reported on L5 forms when pathology reports are available): a. TOTAL NUMBER OF BIOPSIES DELAYED OR REFUSED (Include both cervical and non-cervical): A9. OVERALL IMPRESSION: (CIRCLE THE HIGHEST N-CERVICAL GRADE LESION) RMAL... (A33) ABRMAL, BUT SIL... LOW GRADE... 3 HIGH GRADE... 4 INVASIVE... 5 A30. LOCATION OF THE HIGHEST GRADE N-CERVICAL LESION: a) Vagina... b) Vulva... c) Perianal... d) Anal... e) Other... Page 9 of 4
A3. CIRCLE THE NUMBERS FOR THE LESION LOCATIONS: LOCATION CODES. Labium Majus (left) 7. Perianus upper left. Labium Majus (right) 8. Perianus lower left 3. Labium Minus (left) 9. Perianus lower right 4. Labium Minus (right) 30. Perianus upper right 5. Introitus (left) 3. Internal Anus 6. Introitus (right) 7. Perineum (left) 8. Perineum (right) 9. Inguinal (left) 0. Inguinal (right). Thigh (left) Thigh (right) 3. Clitoris 4. Urethra 5. Pubis 5 0 9 3 4 3 4 6 5 8 7 30 7 9 8 Page 0 of 4
A3. CIRCLE THE NUMBERS FOR LESION LOCATIONS: LOCATION CODES. Anterior vaginal wall, proximal third.. Anterior vaginal wall, medial third 3. Anterior vaginal wall, distal third 4. Left lateral vaginal wall, proximal third 5. Left lateral vaginal wall, medial third 6. Left Lateral vaginal wall, distal third 7. Posterior vaginal wall, proximal third 8. Posterior vaginal wall, medial third 9. Posterior vaginal wall, distal third 0. Right lateral vaginal wall, proximal third. Right lateral vaginal wall, medial third. Right lateral vaginal wall, distal third 3 ANTERIOR R.L. 0 4 5 6 L.L. INTROITUS FORNIX 7 9 8 POSTERIOR VAGINA AND CERVIX (DRAW OS) Page of 4
A33. DID YOU KW THE HIV STATUS AT THE TIME OF THIS EXAM?...... A34. WAS FOLLOW-UP VISIT SCHEDULED FOR BIOPSY?...... a) SPECIFY WHERE SCHEDULED: (M.D. OR INSTITUTION) (ADDRESS) SECTION B. ANAL COLPOSCOPY B. ANAL COLPOSCOPY: DONE... T DONE... (END) PARTICIPANT REFUSED... 3 (END) Ba. DATE OF ANAL COLPOSCOPY: / / M D Y Bb. COLPOSCOPY PERFORMED BY: (ENTER INITIALS OF COLPOSCOPIST/S) i ii Page of 4
B. INDICATION FOR ANAL COLPOSCOPY: a. Prior history of anal dysplasia... B3. ARE LESIONS PRESENT? B4. LESIONS b. Abnormal anal cytology... c. Presence of visible perianal lesions... d. Positive anal HPV detection test... e. Research only... f. Other......... (B8) FOUND T FOUND a. Keratosis (leukoplakia) b. Aceto-White Epithelium c. Punctation d. Mosaicism e. Atypical Vessels f. Condyloma g. Other B5. TOTAL NUMBER OF LESIONS: none... (B8) one... two... 3 three... 4 four... 5 five to nine... 6 > ten... 7 Page 3 of 4
B6. MAXIMUM LESION SIZE: cm B7. LOCATION OF LESION: (REFER TO DEFINITIONS AND DIAGRAM BELOW) B8. WAS A BIOPSY TAKEN? a. Anterior... (b) i. o'clock b. Posterior... (c) i. o'clock c. Anus... d. Crypt/Columnar area... e. Rectum... f. Other......... (B0) DELAYED... 3 (B0) REFUSED... <-7> (B0) B9. NUMBER OF BIOPSIES TAKEN: B0. ASCOPIC IMPRESSION: (CIRCLE THE HIGHEST N-CERVICAL GRADE LESION) RMAL... ABRMAL, BUT SIL... LOW GRADE... 3 HIGH GRADE... 4 INVASIVE... 5 DEFINITIONS: Posterior Anterior ANUS: (Anal Canal) between Verge and Squamo-Columnar junction (Pectinate Line) CRYPT/COLUMNAR AREA: Between Squamo-Columnar junction and Ano-Rectal (AR) line AR Line Squamo - Columnar Junction A-RECTUM: Between Verge and Ano-Rectal line R L ANUS R L RECTUM: Beyond Ano-Rectal line Verge Page 4 of 4