CONTEMPORARY GUIDELINES
Educational Objectives
| The goal of this program is to improve the quality of the periodic well-woman visit and the management of women with
malignant gynecologic conditions. After hearing and assimilating this program, the clinician will be better able to:
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 | 1. Discuss how evidence-based medicine affects health care.
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| 2. Counsel patients about evidence supporting new recommendations for the periodic well-woman visit.
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| 3. Identify the appropriate screening tests and test intervals for women.
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| 4. Discuss the evidence supporting referral guidelines published by the American College of Obstetricians and
Gynecologists and the Society of Gynecologic Oncologists.
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| 5. Identify women with pelvic masses who would benefit from referral to a gynecologic oncologist.
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Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning
committee to disclose relevant financial relationships within the past 12 months that might create any personal conflicts of interest.
Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary
business or commercial interest. For this program,the faculty and planning committee reported nothing to disclose.
Acknowledgments
Dr. Policar was recorded at the 2008 Annual Women’s Health Care Seminar, held February 29 to March 1, 2008, in Albuquerque,
NM, and sponsored by the University of New Mexico, Health Sciences Center, School of Medicine, Department
of Obstetrics and Gynecology, and Office of Continuing Medical Education. Dr. Dowdy was recorded at
OB/GYN Clinical Reviews, held November 8-9, 2007, in Rochester, MN, and sponsored by the Mayo Clinic and
Mayo Foundation. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooperation in the
production of this program.
| WELL-WOMAN VISIT: RETHINKING OUR ROUTINES —Michael S. Policar, MD, MPH, Associate Clinical Professor
of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, School of Medicine, and
Medical Director, UCSF/Family PACT Program Support and Evaluation, California Office of Family Planning, Sacramento,
CA
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| Evidence-based medicine: provides patients with services that work and avoids services that do not work; reduces
morbidity, mortality, and economic costs resulting from unnecessary tests; provides more time to take care of patients
who are sick; integrates preventive health messages between clinicians and health educators; helps consumer avoid hazards
of false-positive test results, and time lost from visits and services of limited or no benefit; saves on out-of-pocket
costs; important to communicate to patients that screening tests important, but only small part of preventive health
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| United States Preventive Services Task Force (USPSTF): committee of Agency for Healthcare Research and
Quality; rigorous evidence-based review process; multidisciplinary nonindustry expert panel; screening recommendations
categorized by disease (eg, osteoporosis, cancer, diabetes) and by 4 age groups and pregnancy; supports opportunistic
prevention model (integrating preventive services with other office visits); strength of recommendation—A, strongly
recommends routine provision; B, recommends routine provision; C, no recommendation for or against; D, recommends
against routine provision; I, insufficient evidence to recommend for or against routine provision
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| USPSTF recommendations for women 25 to 64 yr of age: anticipatory guidance (counseling)—substance
abuse; diet and exercise; injury prevention; sexual behavior; dental health; immunizations—current recommendations
tetanus, diphtheria, pertussis (TDaP) booster every 10 yr, and rubella vaccine (for women of childbearing age) and influenza
vaccine annually; chemoprophylaxis—multivitamin with folate for women planning pregnancy; physical
examination—height, weight, and body mass index (BMI), blood pressure (BP), Papanicolaou (Pap) test (at least every
3 yr), and clinical breast examination (CBE); special testing for high-risk patients; American College of Physicians
(ACP) and American Academy of Family Physicians (AAFP) have adopted same recommendations; general prevention
guidelines—endorsed by American Cancer Society (ACS), American Diabetes Association and American Heart Association;
calculate BMI at every visit; BP at least every 2 yr or at every health visit; lipid screening starts at 24 yr of age, performed
every 5 yr; blood glucose testing starts at 45 yr of age (earlier if patient high risk), performed every 3 yr; CBE
every 3 yr between 20 and 40 yr of age; CBE and mammography annually, beginning at 40 yr of age; Pap testing annually
if <30 yr of age, every 1 to 3 yr if ≥30 yr of age; colorectal cancer screening starting at 50 yr of age
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| American College of Obstetricians and Gynecologists (ACOG) Primary and Preventive Care: recommends
interventions beyond USPSTF; recommends annual periodic health screening visit; physical examination—
height, weight, BMI, BP, neck, breasts, abdomen, pelvic region, oral cavity, and axillae; laboratory and imaging—
thyrotropin every 5 yr, starting at 50 yr of age; fasting plasma glucose at 45 yr of age; lipid testing at 45 yr of age; recommendations
nonevidence-based and controversial; only group recommending pelvic examination to screen for ovarian
cancer; cancer deaths in women—3 screening tests available to prevent 26% of cancer deaths (eg, breast, cervical, colon);
no screening tests for 74% of cancers that cause mortality in women
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| Breast cancer screening: previous guidelines—self breast examination (SBE) monthly; CBE annually; baseline
mammography at 35 yr of age; from 40 to 49 yr of age, mammography every 2 yr; at 50 yr of age, annual mammography;
SBE—according to USPSTF, insufficient evidence to support monthly examinations; according to ACS, optional;
CBE—according to USPSTF, insufficient evidence to support; ACS recommends every 3 yr until 40 yr of age,
then annually; mammography—USPSTF recommends baseline at 40 yr of age, then every 1 to 2 yr; ACS recommends
baseline at 40 yr of age, then annually; baseline at 35 yr of age no longer recommended
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| SBE: data show mortality and survival equal among women performing SBE and those coincidentally discovering mass;
ACS recommendation—inform women 20 yr of age of benefit and limitations (provide instruction, if SBE chosen); instruct
patient to report new findings to health care provider; goal increased breast awareness, not reduction of breast
cancer mortality
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| CBE: most studies evaluate mammography in conjunction with CBE, not CBE alone; sensitivity ≈50%; abnormalities in
6 or 7 of every 100 CBEs; most organizations recommend performing annually (concurrent with mammography) starting
at 40 yr of age; evidence does not support CBE alone for woman <40 yr of age; ACS does not provide evidence to
support CBE every 3 yr for women 20 to 39 yr of age; breast cancer systemic disease (spreads locally and distantly at
same time); viewed as occultly metastatic at time of presentation; potential for spread by time breast cancer large
enough to palpate; improved survival for women with small lesions applies mainly to preclinical lesions
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| Mammography: sensitivity ≈90%; fairly good specificity; false-positive rate, 3% to 6%; more false-positive results in
younger women; ACS meta-analysis showed ≈25% reduction in mortality among women who have annual mammography
(up to 10 yr); recommendations—annually, in women 40 to 49 yr of age (cancer uncommon, but grows rapidly); every
other year (biennially), in women 50 to 69 yr of age (cancers easier to detect with surrounding fat, and cancers grow
more slowly in this age group); USPSTF—no benefit to annual (vs biennial) screening in women ≥50 yr of age
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| Cervical cancer screening: when to initiate—3 yr after sexual debut, or at age 21 yr; when to discontinue—screening
not recommended posthysterectomy for benign disease; ACS guidelines recommend 70 yr of age, USPSTF recommends 65
yr of age (if 3 negative tests in previous 10 yr); screening interval—ACS recommends biennially for women <30 yr of age,
if using liquid-based cytology; ACOG recommends annually for women <30 yr of age, regardless of technology used; 2- or
3-yr interval for women >30 yr of age with history of normal tests; posthysterectomy—no reason to screen (squamous cell
cancer of vagina rare); radical hysterectomy for invasive cervical cancer exception; woman with cervical squamous intraepithelial
neoplasia (CIN) III needs 3 negative Pap tests at ≥6-mo intervals until discontinuing; virginal women—screening
not recommended (discuss benefits and risks); immunocompromised women—annual screening recommended; women
with multiple sexual partners or women using hormonal contraceptives or hormone replacement therapy—no difference
in screening interval recommendations; pregnant women—if Pap test shows low-grade squamous intraepithelial lesion,
wait until delivery to perform colposcopy; lesbian women—no definitive recommendation (lack of data)
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| Human papillomavirus (HPV) plus Pap test: indications— immunocompetent women ≥30 yr of age with cervix;
inform women in advance of HPV screening; management of women who are Pap-negative and HPV-positive uncertain;
women who are Pap- and HPV-negative should be screened no earlier than 3 yr after tests (false-positive tests can lead to
unnecessary interventions); data show improved sensitivity has potential to drastically increase screening costs; most
health care systems have no mechanism to enforce guidelines; liquid-based cytology vs conventional cervical cytology—
data show no substantial benefit of liquid cytology over conventional cervical cytology in detecting high-grade CIN
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| Ovarian cancer screening: USPSTF—screening asymptomatic women with transvaginal ultrasonography (US), tumor
markers, or examination not recommended; insufficient evidence to recommend for or against in asymptomatic
women at increased risk; ACOG—“data suggest currently available screening tests do not appear beneficial for screening
low-risk asymptomatic women”; ACOG fails to provide evidence supporting annual gynecologic examination with
pelvic examination (except for preventive health care)
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| Sexually transmitted disease (STD) screening: screen for Chlamydia annually in sexually active women <25 yr of
age; screen for gonorrhea annually in sexually active women <25 yr of age, if rate in patient population ≥1%;
chlamydia—rate low in women ≥25 yr of age; as prevalence decreases, positive predictive value declines, making incorrect
diagnoses more likely; likelihood of chlamydia in woman 39 yr of age same as in girl 12 yr of age; most common in
teens and early 20s; nevertheless, women 40 yr of age being screened at same rate as women 18 yr of age; gonorrhea and
chlamydia screening recommendations—history of gonorrhea, chlamydia, or pelvic inflammatory disease in past 2 yr;
>1 sexual partner in past year; new sexual partner within previous 90 days; screen if patient has reason to believe sexual
partner has other partners; screening not recommended if patient >26 yr of age and does not believe sexual partner has
other partner; screening for gonorrhea and chlamydia can be done using nucleic acid amplification test (urine test)
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| Other screening tests: lipid screening—begin at 20 yr of age, with 5-yr intervals; diabetes screening—begin at 45 yr
of age, with 3-yr intervals; fasting plasma glucose recommended; 2-hr glucose load test recommended if woman has
polycystic ovary syndrome (PCOS); begin screening at 20 yr of age if patient high risk; thyroid disease screening—
endocrine organizations recommend initial screening at 60 yr of age, and only with specified reasons (ACOG recommends
starting at 50 yr of age)
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| Obstacles to adopting new guidelines: booming market in new screening technologies; government more interested
in political expediency than evidence-based medicine; cancer screening seen as marketing opportunity; difficult for clinicians
to change status quo; consumer demand; steps in changing practice—avoid duplication of services; if patient has
primary care provider (PCP), collaborate with colleague to determine screening policies for practice; offer women who
do not have PCP periodic health screening services; inform patients of changes that apply to them; keep track of benefit
changes made by your payors
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| WHEN TO REFER YOUR PATIENT TO A GYNECOLOGIC ONCOLOGIST —Sean C. Dowdy, MD, Associate Professor
of Gynecologic Oncology, May Clinic, Rochester, MN
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| Endometrial cancer: “patients with primary diagnosis of endometrial cancer or with recurrent disease could benefit
from pretreatment consultation or evaluation by gynecologic oncologist to assist in determining most appropriate surgical
approach, as well as extent of surgery and potential benefit of adjuvant therapy”; most patients with endometrial cancer
have disease limited to uterus; ≈70% stage I; many patients cured with hysterectomy; common misperceptions—“all patients
with grade 1 endometriosis do well”; data show ≈20% of patients with grade 1 endometriosis upgraded at time of
hysterectomy; nearly 20% have deep myometrial invasion; data show patients with deep myometrial invasion have ≈28%
risk for hematogenous recurrence; “the nodes feel OK”; only 10% of involved nodes palpable; evidence shows lymphadenectomy
therapeutic; data show 77% of patients with positive para-aortic (PA) nodes have disease above inferior
mesenteric artery (IMA); stopping lymphadenectomy at IMA will miss 46% of patients with positive PA metastases;
thorough lymph node dissection important; “we’ll give some irradiation”; no justification for routine use of preoperative
irradiation; routine postoperative irradiation results in over- and undertreatment in most patients; ≈50% of patients with
positive pelvic nodes have recurrence in PA lymph nodes or have positive PA lymph nodes; routine postoperative irradiation
undertreats 8% to 16% of patients; >33% of patients overtreated; “it’s only a hysterectomy”; possibility reoperation
necessary; patients often have significant comorbidities (eg, obesity, diabetes); consider referral to tertiary care center;
laparoscopy—performed at Mayo Clinic since 2005; to date, no conversions and no intraoperative transfusions; median
hospital stay 3 days; refer to gynecologic oncologist to determine need for chemotherapy, irradiation, or vaginal brachytherapy
to prevent vaginal vault recurrences; appropriate adjuvant treatment based on appropriate staging
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| Adnexal mass: “patients with masses clinically suspicious for cancer should be offered opportunity of preoperative consultation
with gynecologic oncologist”; risk for malignancy in postmenopausal woman with unilocular mass without
solid components <1%, multilocular <8%, and solid components 70%; referral criteria for premenopausal women—
cancer antigen (CA)-125 >200 U/mL; ascites, or abdominal or distant metastasis on physical examination or imaging;
family history (first-degree relative) of breast or ovarian cancer; only one criterion required to recommend referral; data
show significant increase in sensitivity, but no decrease in specificity if threshold for CA-125 lowered to 50 or 67 U/mL;
in absence of other criteria, referral for family history of breast or ovarian cancer not necessary, except for patient suspected
of familial cancer syndrome; evidence supporting referral guidelines—data show 70% of cancers captured in premenopausal
group, and 94% in postmenopausal group; positive predictive value 34% for premenopausal patients, and
60% for postmenopausal patients; negative predictive value 90% for both groups; referral criteria for postmenopausal
women—similar guidelines as for premenopausal women; refer postmenopausal woman with any elevation in CA-125;
“guidelines should be used in conjunction with careful medical judgment when evaluating patients with clinically suspect
findings that do not necessarily meet the criteria”
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| Ovarian cancer: “adequate and complete surgical intervention mandatory primary therapy for ovarian carcinoma, permitting
precise staging, accurate diagnosis, and optimal cytoreduction; all women with suspected ovarian cancer should
be offered preoperative consultation with gynecologic oncologist”; “in most instances, initial operation by gynecologic
oncologist should obviate morbidity and cost of reoperation when an unstaged or less than appropriately cytoreduced malignancy
is diagnosed”; data show 5-yr survival among early-stage ovarian cancer patients referred to gynecologic oncologist
86% (vs 70% for those referred to general gynecologist; difference 21% vs 13% for those with stage III cancer
[speaker acknowledges study biases]); 30% of patients upstaged (75% to stage III) on reoperation; complete lymphadenectomy
important; consequences of suboptimal cytoreduction—reduced survival (data show 40%-50% 5-yr survival
in patients with stage III cancer undergoing cytoreduction); no intraperitoneal (IP) chemotherapy (data show 12-17
mo increased survival in patients given IP chemotherapy); reoperation (morbidity and cost); data show ≈12-mo reduction
in survival with 3 cycles of chemotherapy before interval cytoreduction
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| Cervical/vaginal cancer: refer cases of biopsy-proven disease; decreased rate of urinary problems with less invasive
procedures (eg, laparoscopic radical hysterectomy, robotic radical hysterectomy); radical vaginal trachelectomy preserves
fertility; primary chemoirradiation for advanced disease
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| Vulvar cancer: refer patients with multifocal, complex, and/or recurrent high-grade preinvasive vulvar lesions; suspected
or diagnosed Paget’s disease of vulva or invasive cancer; inguinal lymphadenectomy required if >1-mm invasion;
metastatic groin nodes treatable, but recurrence or persistence in groin nodes universally fatal
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| Gestational trophoblastic disease (GTD): refer when US or histologic confirmation of molar pregnancy; persistent
GTD; choriocarcinoma; placental site trophoblastic disease; correct chemotherapy, with or without surgery, associated
with near 100% survival; preserved fertility in majority of patients; treatment of high-risk patients with monotherapy associated
with higher risk for failure and increased morbidity and treatment duration
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Editor’s Notes
Michael Policar, MD, MPH: www.PolicarLectures.com
United States Preventive Services Taskforce: www.ahrq.gov/clinic/uspstfix.htm
Suggested Reading
Aletti GD, Dowdy SC et al: Aggressive surgical effort and improved survival in advanced-stage ovarian cancer.
Obstet Gynecol 107:77, 2006; Arbyn M, Bergeron C et al: Liquid compared with conventional cervical cytology:
a systematic review and meta-analysis. Obstet Gynecol 111:167, 2008; Dearking AC, Aletti GD et al: How relevant
are ACOG and SGO guidelines for referral of adnexal mass? Obstet Gynecol 110:841, 2007; DeFrancesco
MS: Adapting to the changing environment: redefining the annual visit. Obstet Gynecol Surv 62:491, 2007; Hills
RK, Daniels J: Assessing new interventions in women’s health. Best Pract Res Clin Obstet Gynaecol 20:713, 2006;
Im SS et al: Validation of referral guidelines for women with pelvic masses. Obstet Gynecol 105:35, 2005; Shulman
LP: New recommendations for the periodic well-woman visit: impact on counseling. Contraception 73:319,
2006; Sawaya GF: Evidence-based medicine versus liquid-based cytology. Obstet Gynecol 111(1):2, 2008.
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