This document can be used to prepare or evaluate feasibility of ancillary study proposals and paper proposals, but is NOT intended for publication.

Form 81 - Pelvic Exam

File Name	Data as of	Population	Data collected	One row per	Rows
f81_ht_inv.dat	9/12/2005	HT	Baseline, Main	Form	123,002

ID - WHI Participant Common ID

Col 1

N	Missing
123,002	0

F81DAYS - F81 Days since randomization

Col 2

Days between randomization and the date the form was initiated

N	Missing	Min	Max	Mean	StdDev
123,002	0	-275	3,842	1,050.989	895.396

F81VTYP - Visit Type

Col 3

Value	Description	N	%
1	Screening	27,346	22.2
2	Semi-Annual visit	631	0.5
3	Annual visit	94,247	76.6
4	Non-Routine visit	778	0.6

F81VY - Visit year

Col 4

Visit year for which this form was collected.

N	Missing	Min	Max	Mean	StdDev
122,224	778	0	10	2.893	2.416

F81VCLO - Closest to visit within visit type and year

Col 5

For forms entered with the same visit type and year, indicates the one closest to that visit's target date. Valid for forms entered with an annual visit type.

Usage Notes:

See data preparation document.

Value	Description	N	%
0	No	1,219	1
1	Yes	121,783	99

F81EXPC - Expected for visit

Col 6

This form/data was expected for this visit. Form 81 (Pelvic Exam) was expected at Baseline for all HT participants, and at Annual Visits 1-9 for HT participants without a hysterectomy. Pelvic exams were not expected after E+P study closure on 07/08/2002.

Usage Notes:

This includes forms from the subsample of OS participants at year 6 that were enrolled in the three clinical centers participating in the WHI Osteoporosis sub study, as height and weight were collected on OS participants at year 6 by design; see table 16.1; on page 16-18b of volume 2.

Value	Description	N	%
0	No	19,890	16.2
1	Yes	103,112	83.8

PELVICDY - Days from randomization to pelvic exam

Col 7

N	Missing	Min	Max	Mean	StdDev
122,365	637	-275	3,842	1,044.409	895.042

PELVICBY - Pelvic exam performed by

Col 8

Value	Description	N	%
1	CC staff	112,609	91.6
2	Other	10,043	8.2
	Missing	350	0.3%

PLVABNRM - Doctor found anything wrong

Col 9

Were there any abnormal findings found during the pelvic exam?

Usage Notes:

Sub-question of F81 V6 Q6 "Pelvic exam performed by". Not collected on all versions of Form 81.

Value	Description	N	%
0	No	9,303	7.6
1	Yes	357	0.3
	Missing	113,342	92.1%

ADIPOSE - Loss of adipose tissue

Col 10

External genitalia (vulva): loss of adipose tissue

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	45,014	36.6
1	Yes, probably benign	64,502	52.4
2	Yes, possibly malignant	2	0
	Missing	13,484	11%

PLVHAIR - Thinning of hair

Col 11

External genitalia (vulva): thinning of hair

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	30,652	24.9
1	Yes, probably benign	78,875	64.1
2	Yes, possibly malignant	2	0
	Missing	13,473	11%

DISCVLVA - Genitalia - Abnormal discoloration

Col 12

External genitalia (vulva): abnormal discoloration

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	104,118	84.6
1	Yes, probably benign	5,389	4.4
2	Yes, possibly malignant	43	0
	Missing	13,452	10.9%

ULCERVLV - Genitalia - Ulceration

Col 13

External genitalia (vulva): ulceration

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	109,013	88.6
1	Yes, probably benign	509	0.4
2	Yes, possibly malignant	7	0
	Missing	13,473	11%

GROWVLVA - Genitalia - Growth

Col 14

External genitalia (vulva): growth

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	107,624	87.5
1	Yes, probably benign	1,679	1.4
2	Yes, possibly malignant	9	0
	Missing	13,690	11.1%

ATROPHY - Atrophy

Col 15

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	40,841	33.2
1	Yes, probably benign	68,678	55.8
2	Yes, possibly malignant	2	0
	Missing	13,481	11%

PLVSMTH - Smooth

Col 16

Usage Notes:

Not collected on all versions of Form 81 Not required if "Pelvic exam performed by" is "Other"..

Value	Description	N	%
0	No	37,675	30.6
1	Yes, probably benign	71,760	58.3
2	Yes, possibly malignant	3	0
	Missing	13,564	11%

PLVPALE - Pale

Col 17

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	58,498	47.6
1	Yes, probably benign	50,901	41.4
2	Yes, possibly malignant	2	0
	Missing	13,601	11.1%

FRIABVAG - Vagina - Friable with contact

Col 18

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	106,445	86.5
1	Yes, probably benign	2,931	2.4
2	Yes, possibly malignant	5	0
	Missing	13,621	11.1%

BLOODVAG - Blood present

Col 19

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	108,495	88.2
1	Yes, probably benign	890	0.7
2	Yes, possibly malignant	7	0
	Missing	13,610	11.1%

DISCVAG - Vagina - Abnormal discoloration

Col 20

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	107,863	87.7
1	Yes, probably benign	1,536	1.2
2	Yes, possibly malignant	9	0
	Missing	13,594	11.1%

ULCERVAG - Vagina - Ulceration

Col 21

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	109,266	88.8
1	Yes, probably benign	148	0.1
2	Yes, possibly malignant	2	0
	Missing	13,586	11%

GROWVAG - Vagina - Growth

Col 22

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	108,757	88.4
1	Yes, probably benign	565	0.5
2	Yes, possibly malignant	9	0
	Missing	13,671	11.1%

CYSTOCEL - Cystocele

Col 23

Usage Notes:

Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	None	71,564	58.2
1	Grade 1 (in vagina)	34,842	28.3
2	Grade 2 (to introitus)	6,221	5.1
3	Grade 3 (outside vagina)	405	0.3
	Missing	9,970	8.1%

RECTOCEL - Rectocele

Col 24

Usage Notes:

Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	None	90,593	73.7
1	Grade 1 (in vagina)	18,043	14.7
2	Grade 2 (to introitus)	3,906	3.2
3	Grade 3 (outside vagina)	326	0.3
	Missing	10,134	8.2%

PLVCERVX - Cervix

Col 25

Usage Notes:

Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	Absent	14,011	11.4
1	Present	99,191	80.6
	Missing	9,800	8%

CRVFLUSH - Flush with vaginal vault

Col 26

Usage Notes:

Sub-question of F81 V6 Q9 "Cervix". Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	85,642	69.6
1	Yes, probably benign	10,479	8.5
2	Yes, possibly malignant	3	0
	Missing	26,878	21.9%

FRIABCRV - Cervix - Friable with contact

Col 27

Usage Notes:

Sub-question of F81 V6 Q9 "Cervix". Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	86,839	70.6
1	Yes, probably benign	9,218	7.5
2	Yes, possibly malignant	16	0
	Missing	26,929	21.9%

LESION - Surface lesion/growth

Col 28

Cervix: surface lesion/growth (other than ectopy, Nabothian cyst)

Usage Notes:

Sub-question of F81 V6 Q9 "Cervix". Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	94,684	77
1	Yes, probably benign	1,339	1.1
2	Yes, possibly malignant	29	0
	Missing	26,950	21.9%

POLYP - Polyp

Col 29

Usage Notes:

Sub-question of F81 V6 Q9 "Cervix". Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	92,881	75.5
1	Yes, probably benign	3,118	2.5
2	Yes, possibly malignant	8	0
	Missing	26,995	21.9%

PLVUTER - Uterus

Col 30

Uterus (absent/present/unable to palpate)

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	Absent	14,376	11.7
1	Present	85,000	69.1
9	Unable to palpate	13,742	11.2
	Missing	9,884	8%

PROLAPSE - Prolapse

Col 31

Usage Notes:

Sub-question of F81 V6 Q10 "Uterus". Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	None	72,426	58.9
1	Grade 1 (in vagina)	10,468	8.5
2	Grade 2 (to introitus)	731	0.6
3	Grade 3 (outside vagina)	226	0.2
	Missing	39,151	31.8%

UTERSIZE - Uterine size (weeks)

Col 32

Usage Notes:

Sub-question of F81 V6 Q10 "Uterus". Not required if "Pelvic exam performed by" is "Other".

N	Missing	Min	Max	Mean	StdDev
82,547	40,455	0	80	4.242	1.587

UTERENLR - Enlarged since last exam

Col 33

Usage Notes:

Sub-question of F81 V6 Q10 "Uterus". Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	No	66,997	54.5
1	Yes	820	0.7
	Missing	55,185	44.9%

ADNEXAE - Adnexae

Col 34

Adnexae (normal/mass present/unable to palpate)

Usage Notes:

Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
0	Normal	41,254	33.5
1	Mass present	391	0.3
9	Unable to palpate/absent	69,198	56.3
	Missing	12,159	9.9%

MASSLOC - Mass present

Col 35

Adnexae: location of mass

Usage Notes:

Sub-question of F81 V6 Q11 "Adnexae". Not collected on all versions of Form 81. Not required if "Pelvic exam performed by" is "Other".

Value	Description	N	%
1	Right	164	0.1
2	Left	144	0.1
3	Both	50	0
	Missing	122,644	99.7%

PAPSMEAR - Pap smear obtained

Col 36

Usage Notes:

Not collected on all versions of Form 81.

Value	Description	N	%
0	No, not done	26,615	21.6
1	No, send for outside report	3,687	3
2	Yes, vaginal smear	10,600	8.6
3	Yes, Pap smear	73,843	60
	Missing	8,257	6.7%

PLVREFER - Referral made for follow-up

Col 37

Was a referral made for follow-up care (pelvic exam)?

Value	Description	N	%
0	No	112,352	91.3
1	Yes	2,707	2.2
	Missing	7,943	6.5%

PLVREFDY - Days from randomiaztion to pelvic exam referral

Col 38

Usage Notes:

Sub-question of F81 V6 Q13 "Referral made for follow-up".

N	Missing	Min	Max	Mean	StdDev
2,397	120,605	-428	3,651	1,070.491	818.859

PLVFURES - Pelvic follow-up results

Col 39

Usage Notes:

Sub-question of F81 V6 Q13 "Referral made for follow-up". Not collected on all versions of Form 81.

Value	Description	N	%
0	Normal	539	0.4
1	Benign changes	824	0.7
2	Possibly malignant	29	0
	Missing	121,610	98.9%