Top Women’s Health Articles of 2016-17

Rebecca Jackson, MDObstetrics, Gynecology and Reproductive SciencesUCSF

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Articles that might change practice or topics in the newsRoutine pelvic examUterine fibroid embolizationHSV screeningOCP’s and cancerOverdiagnosis of breast cancerThreats to reproductive health

No more Pelvic Exams?

Pelvic Exam Potential Benefits

Can detect numerous conditions (Ca, vaginitis, warts, STI, fibroids, ov cysts, polyps, prolapse)

What is the accuracy of detecting these before symptoms occur? UNKNOWN

What is the benefit of detecting these before symptoms occur (rather than waiting for sx)? UNKNOWN

Pelvic Exam Potential Harms

False positives: For ovarian cancer: 1.2-8.6%; False negative (ie false reassurance): 0-100%May lead to unnecessary and sometimes

invasive work-ups5-36% went on to have surgery

Psychological harms, pain, discomfort: 11-80%, median 35%, all of which may be a barrier to receiving healthcareWomen who experienced pain or discomfort less

likely to have a return visit

Pelvic Exam Conclusion

“In the absence of clear evidence on the balance of benefits and harms of using pelvic examination to screen for asymptomatic gynecologic conditions, clinicians are encouraged to consider the patient's risk factors for various gynecologic conditions and the patient's values and preferences, and engage in shared decision making with the patient to determine whether to perform a pelvic examination.”

What do patients think?

Mixed cross-sectional study and RCT of 452 women undergoing cervical cancer screening

Preference for pelvic exam when given info about ACOG guidelines vs ACP guidelines

Phase 1 (baseline): 262 women asked about desire to have an exam, without being given information

Phase 2: RCT: 190 got randomized to review ACOG vs ACP guidelines and rationale

ACOG: recommends annual pelvic exams in women >21 yo:

ACP: strongly recommends against routine pelvic exam

What do patients think?

Results: In phase 1 (baseline): 79% wanted routine examACOG group: 82% ACP group: 39%94% believed potential benefits and harms

should be discussed prior to the exam

ACOG: recommends annual pelvic exams in women >21 yo:

ACP: strongly recommends against routine pelvic exam

Sushi? Monstera

At the Shops at Muana Lani (1 resort down the road). Sit at sushi bar if you can. Go early (6pm ish)

OCP and Cancer…. Again OCP Safety…. Again

Prospective cohort study of 46K women in 1968 for up to 44 years. Ever vs Never use of OCP. Adjustment for age, parity, SES, smoking. Outcome: Cancer incidence (15 types)

Of 15 cancer sites, none had increased risk assocwith ever use of OCP including breast and melanoma

Decreased risk seen for:1. CRC 0.81 (0.66-0.99) Attrib risk: -11%2. EmCa 0.66 (0.48-0.89) Attrib risk: -10%3. Ov 0.67 (0.5-0.89) Attrib risk: -11%4. Blood Ca 0.74 (0.58-0.94) Attrib Risk: -11%

There is increased incidence in current and recent use (<5yrs) for:

Breast 1.48 (1.1-2.0)Cervical 2.3 (1.2-4.3)

These disappear by 5 to 15 years after stopping

3 questions: 1. How long do EmCa, OvCa and CRC benefits

persist2. Does OCP use in repro years produce new

cancer risks later in life3. What is the overall balance of cancer among

past users as they enter later stages of life

3 questions: 1. How long do EmCa, OvCa and CRC benefits

persist- >35 years2. Does OCP use in repro years produce new cancer

risks later in life NO3. What is the overall balance of cancer among past

users as they enter later stages of life lower risk of Ovarian, endometrial, CRC and blood cancers

How do these studies compare with past evidence?

Ovarian cancer meta-analysis 2013: OR 0.73 (0.66-0.81)

Meta-analysis of 4 major cancersBreast: 1.08 (1.00-1.17) p<0.05

(higher risk in more recent users)CRC: 0.86 (0.79-0.95)Cervix: Higher risk in women with

HPV, but significant heterogeneity so no meta-analysis done

Endometrial 0.57 (0.43-0.77)

Havrilesky, ObGyn 2013

Gierisch, Ca EpidBiomarkers Prev, 2013

What about breast cancer mortality?Meta-analysis of OCP

and all-cause and specific-cause death

9 prospective cohort studies

No difference in all cause mortality or breast cancer mortality

Reduction in ovarian cancer mortality: OR 0.58 (0.34-0.94)

Zhong, Int J Gyn Ob, 2015

Breast Cancer Mortality, n=199K

OR 1.0 (0.95-1.06

Quantifying overdiagnosis in mammography screening

Quantifying ^ overdiagnosis in mammography screening

over-treatment

Overdiagnosis/Overtreatment—we know is exists—how do we quanitify it? Effective screening program should lead to an

increase in smaller tumors at time of diagnosis and, over time, a concordant decrease in larger tumors. Should also see a decrease in mortality (although that

could also be due to better treatments)

In Walsh paper, approximates overdiagnosis as the extent to which diagnosis of smaller tumors exceeds the decrease in larger tumors If no over-diagnosis: small tumor increase=large tumor

decreaseOver-diagnosis = small tumor increase - large tumor

decrease

Shift in size distribution over time. Note in early period, large tumors predominated and over time, small tumors predominate. Screening works?

Modest decrease in larger tumors (30/100K)

Very large increase in smaller tumors (162/100K)

Conclusion: 30/100K were destined to become large tumors but detected earlier by screening. 132/100K=over-diagnosis

162-30=132

Women in some areas offered screening, and in other areas, not.

Allows adjustment for change in incidence over time in unscreened vs in screened population

With screening: found substantial increase in small tumors and no difference in large tumors

Estimated overdiagnosis as 15-39% if exclude DCIS and 24-48% if include it

What to do about over-diagnosis?

Its not the over-diagnosis that’s the problem…. Its over treatment

Better biomarkers and prognostic prediction methods

Encourage ourselves and patients that less aggressive treatment is acceptable

Change terminology: For DCIS, move away from “carcinoma” to IDLE: indolent lesions of epithelial origin

Hike: White Road—Upper HamakuaDitch Trail

Kapu??Very muddy/wet2 miles to cliff (45 min)Extremely lush, lots of

birds singingEnd of White Road—on

left as you leave last Waimea subdivision—mile 54

HSV Screening and Serotyping Genital Herpes

Very Common: 1 in 6 adults. Morbid though not mortal Increases risk of HIV transmissionNeonatal HSV, though rare, has substantial

morbidity and mortality

WHY NOT SCREEN FOR IT?

For screening:HSV infection may not have a long symptomatic

period during which screening, early identification, and treatment may alter its course.

Benefits: No cure so “small” benefit at bestHarms: False Positives and associated labelling!

50% false positives, no confirmatory test availableRecommend against screening of

asymptomatic people, even pregnant women

With population prevalence of 15%, screening 10,000 would result in 1485 true positive, 1445 false positive.

What about serotyping? NO role!HSV2 tests have low specificity and high false

positive rateHSV1, which is an increasingly common cause of

genital herpes, cannot differentiate oral from genital infections

What about pregnant women?No screening recommended. If h/o HSV: observe carefully for outbreaks.

Alternatives to hysterectomy Uterine Fibroid Embolization

Alternative to hysterectomy or myomectomy for select women with fibroids and heavy bleeding and dysmenorrhea in women who don’t desire future fertility

Mixed findings related to improvement in bulk symptoms

5 year results in meta-analysis of 7 studies showed similar satisfaction and long-term major complications but higher rate of minor complications, readmissions and reoperation in the UAE arm

EMMY Trial at 10 years

RCT of UAE vs Hysterectomy in 156 women, at 10yrs, 84% follow-up

At 10yrs: 90% improved/acceptable bldingRate of reoperation: 2 yrs- 24%, 5 years-28%;

10years-35%Both groups had significantly improved QOL

compared to baseline and high overall satisfaction (78% UAE, 87% hyst)

UAE is contraindicated in women desiring fertility due to unknown effect on fertility and on pregnancy outcomes

Meta-analysis of 227 pregnancies (observational studies) showed increased SAB (35% vs 17%) and C/S (66% vs 49%). Underpowered to examine PTB, IUGR, placental issues

Fertility: 1 rct of UAE vs myomectomy: lower pregnancy rate (50% vs 78%) and delivery (19% vs 48%), higher SAB (64% vs 23%)

“Partial” UFE= only small arterial vessels feeding fibroids are embolized, leaving large vessels patent

Retrospective cohort: 359 women with fibroids or adenomyosis desiring pregnancy and 1 yr infertile

Age: avg 36yo, 22-52(!) (20% over 40yo) From 2005-9, full UAE -199 pts 2009-14: partial UAE-160 ptsMedian f/u: 69 months; 7.5% lost to f/u

Spontaneous Pregnancy at 2 yrs:Partial UFE; 45%Conventional UFE: 36%

Live Birth: Partial: 38%Conventional: 31%

SAB:Partial-10%Conventional-7.5%

Surprisingly high rate of pregnancy and live birth in women>40yo

Very low SAB rates: 13% in <40yo8% in >40yo!!!

Pregnancy Outcome (n=150)6.7% PTB5% malpresentation1 cesarean hysterectomy2 placenta previa (1.3%) and 1 accreta1 still birth

UFE as a treatment for infertility?Too good to be true?

… ProbablyNeed controlled studies

Reproductive Health Threatened?

Mexico City Policy aka “Global Gag Rule” Prohibits foreign NGOs that receive US funding from

using ANY of their own $ (regardless of source) to inform or advocate for access to abortion care in their countries

Trump’s executive order re-instated it and expanded scope to include not just USAID but also PEPFAR, NIH

Does it decrease abortion? In Africa, increased abortion likely due to lost funding for

contraception

Does it decrease abortion? No. In Africa, increased abortion was seen in

countries affected by the policy: OR 2.6 (1.8-3.7)Other likely effects

Crippling of long standing integrated programs for global maternal-child health, HIV prevention

Decreased access to condoms, HIV clinics, family planning counseling

Leading to: Increased maternal mortality due to pregnancy-related complications, unsafe abortion, HIV

Since 1976 it has been renewed yearly. One sentence: “None of the [Medicaid] funds

contained in this Act shall be used to perform abortions except where the life of the mother would be endangered if the fetus were carried to term.”

Expanded to all federal health programs: Peace Corps, Federal Employees Health Benefits Program,

Federal Prisons, Medicare, ICE, DC, DOD, HIS, VA, ChildrensHealth Insurance Program

More recently, extended to federally subsidized private insurance plans offered through the exchanges

Multiple states have emulated it: 32 now prohibit use of state funds for abortion care

Given these funding restrictions, abortion only available to those who can pay out of pocket for itAs Thurgood Marshall said in 1976: “the class burdened by

the Hyde Amendment consists of indigent women, a substantial proportion of whom are members of minority races” for whom “denial of a Medicaid-funded abortion is equivalent to denial of legal abortion altogether.”

Attempts underway to codify the amendment so that it won’t be necessary to renew it annuallyDemocratic filibuster possible

1. Re-instate and expand Global Gag Rule2. Supreme Court justice selections with intent to

overturn Roe v Wade Unlikely to be overturned…. Has stood for 44 years with

multiple re-affirmations But, real threat to abortion access in US as legislators feel

emboldened to pass restrictive legislation HR7: denial of insurance coverage of abortion Trump would sign a 20-week ban if passed by Congress

3. Limit Access to Contraception Elimination of Medicaid and Title X funding to Planned

Parenthood. In Texas, a similar policy led to substantial decline in use of LARC with

increase in unintended pregnancy in Medi-caid population

Repeal of ACA: ACA gives access to contraception without co-payment/deductible. With ACA, more women using BCM. Decline in national abortion rate may be partly due to this

4. Other losses related to ACA repeal Under ACA, insurance companies may not charge more for

plans that include maternity care ACA guarantees coverage of USPSTF A and B recommendations

without co-pay. These include well-woman visits for cervical cancer and STI screening

5. Decrease in federal funding for Medicaid to states disproportionately affect those with low income

6. Policies that allow discrimination and/or deportation will affect health of immigrants, LGBTQ etc.

“ In the face of this rhetoric, women’s health physicians have a critical role to play: we must be a loud voice in support of evidence-based health care that is unencumbered by political interference.”

Questions?