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The Evolving Well

Woman Visit

Michael Policar, MD, MPH

www.PolicarLectures.com


EBM: What Is It?

“Evidence based medicine is the conscientious,

explicit, and judicious use of current best evidence

in making decisions about the care of individual

patients.

The practice of EBM means integrating individual

clinical expertise with the best available external

clinical evidence from systematic research.”

–David Sackett, MD

Sackett DL et al. BMJ. 1996;312:71–72.


Why Is This An Important Issue?

• EBM provides an opportunity to impact quality

– Provide patients with services that work

– Avoid the provision of services that don’t t work

• Reduce the morbidity, mortality, and economic

cost resulting from unnecessary tests

• Reduce “demand pressures” on clinics, offices

• Integrate “preventive health messages” between

clinicians and health educators


Why Is This Important

to Providers?

•The time and resources consumed

by unnecessary health screening

visits and tests (and resultant false

positives) can be redirected to

more useful purposes


Why Is This Important to

Consumers?

• Avoid the hazards of false positive test

results

• Avoid time lost for visits and services of

limited or no benefit

• Save on out-of

of-pocket costs

• Understand that screening tests are only

a small part of “prevention”


Traditional Periodic Health Screening

• Pre-1920

1920’s: “check-up” visit did not exist

• 1922: : American Medical Association

• Advised “annual exam” of healthy persons

• 1922 to mid-1990s

ü Check-ups done annually or more often

ü“Routine” panel of tests often done for each

patient regardless of age, risk factors, or

underlying medical conditions

ü Screening intervals often arbitrary

ü Inconsistent patterns of adoption of new tests


Where Does “The Evidence” Come From?

US Preventive Services Taskforce

• Agency for Healthcare

Research and Quality

• Rigorous evidence-based review process

• Multidisciplinary, non-industry expert panel

• Screening recommendations by disease and by

four age groups + pregnancy

• Supported “opportunistic prevention” model

• Web site: www.ahrq.gov/clinic/uspstfix.htm


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


USPSTF: 25-64 Age Band

• Anticipatory Guidance (counseling)

– Substance abuse; tobacco; avoid alcohol while driving

– Diet, exercise: limit fat and cholesterol; adequate Ca

– Injury prevention: seat belts, helmets, smoke detector

– Sexual behavior: contraception, STDs

– Dental health

• Immunizations

– Tetanus-diptheria booster; Rubella (childbearing age)

– Influenza vaccine

• Chemoprophylaxis

– Multivitamin with folate (women planning pregnancy)


USPSTF: 25-64 Age Band

• Physical exam, lab, and imaging tests

– Height and weight

Physical

– Blood pressure

exam

– Pap smear (at least every 3 years)

– Clinical breast exam (starting at 40 yo)

– Mammography (starting at 40 yo)

– Lipid screening (starting at 45)

– Bowel cancer screening ( starting at 50 yo)

– Rubella serology or history (childbearing age)


USPSTF: 25-64 Age Band

• High risk sexual behavior RPR, GC, Ct, HIV

Hepatitis A, B vaccine

• Injection drug use

RPR, HIV; hep A,B vaccine

• Low income, TB contacts

PPD

• Native Americans

Hepatitis A vaccine, PPD,

pneumococcal vaccine

• Travelers to dev countries Hepatitis A,B vaccine

• Blood product recipients

HIV, hepatitis B vaccine

• Health care workers

Hepatitis A,B vaccine; PPD;

influenza vaccine

• Family h/o skin cancer

Avoid sun; protective clothing


Preventing Cancer,

CVD, and Diabetes:

A Common Agenda of

the ACS, ADA, AHA

2004

• Implied “disappointing

results” of opportunistic

prevention

• No recommendation for

screening intervals

• “Time has come for new

models of periodic health

maintenance visits and

schedules”


ACOG: Interventions Beyond USPSTF

• PHS visit should be done annually

• Physical examination

– Height, weight, BP, neck, breasts, abdomen, pelvic

– >40 yo: oral cavity, axillae; ; skin if high risk

• Lab

– TSH > 50 yo (Q5 yrs); 19-49: if increased risk

– FBG (Q 3 years) @ 45 years old

– Mammography starting at 40 years old

– Bone density, Q2 yrs @ 65 yo; > 50 increased risk


Periodic Health Screening Visits

• Mid-1990s

1990s-present

ü EBM review led to rejection of the “periodic

health screening” visit

ü“Opportunistic prevention” model widely

adopted

ü Currently there is no national benchmark

recommendation regarding either the need for or

frequency of periodic health screening visits


Cancer Deaths in Women, 2006

Female deaths

% Dths Screening Test

• Lung 27% None

• Breast 15% Yes

• Bowel, Rectum 10% Yes

• Lymphoma/Leuk

Leuk 7 % None

• Pancreas 6 % None

• Ovary 6 % None (low risk woman)

• Uterus 3 % None

• Cervix (3,710) 1 % Yes

Screening tests available to prevent 26% of cancer deaths


SBE: Recommendations

• USPSTF 2002:[ I ] recommendation

• Canadian TF 2001: [ D ] recommendation

• American Cancer Society (ACS) 2003

– At > 20 years old, inform of benefits, limitations

– If SBE chosen, provide instruction in use

– Report new findings to health care provider

– Acceptable not to do SBE or to do irregularly

– Goal of SBE is “increased breast awareness”


Clinical Breast Exam (CBE)

• Most studies evaluate MG + CBE, not CBE alone

• Accuracy of CBE:

– Sensitivity: 54%, specificity: 93-94%

94%

• 5-15% of breast cancers detected on CBE alone,

especially in younger women

• Most bodies recommend starting at 40 years old;

perform annually, concurrent with mammogram

– USPSTF: [ I ] recommendation

– ACS: 20-39 every 3 years, then annually


Why Are SBE, CBE Poor Screening Tests?

• Breast cancer is a systemic disease, with spread to

local and distant sites at the same time

• Breast cancer is best viewed as occultly metastatic

at the time of presentation

• By the time that breast cancer is large enough to be

palpated, it’s s potential for spread has been manifest

• Improved survival for women with small lesions

applies mainly to pre-clinical lesions


Screening Mammography: Benefits

• Sensitivity (positive when cancer present): 80-95 %

– False negative (neg(

if cancer present): 5-205

%

• Specificity: (negative when cancer absent): 94-97 97 %

– False positive (pos in absence of cancer): 3-63

6 %

• Likelihood of breast ca death after >10 yrs screening

– Overall:

RR= 0.85 (15 % reduction)

– Women>50:

RR =0.78 (22% reduction)

• ACS Meta-analysis: analysis: 24% reduction in mortality


Screening Mammography Periodicity

• 40-49 49 years old: annually

– Cancer uncommon, but grows more rapidly

– With lower sensitivity, more frequent screening

improves accuracy

• 50-69 years old: every other year

– Cancers easier to detect with surrounding fat

– Cancers grow more slowly in this age group

– USPSTF: in women > 50, no benefit to annual

over biennial (every 2 years) screening


Screening for Cervical Cancer

ACS, USPSTF 2002, ACOG 2003

Historical

Current

Initiate Paps* 18 or SD 21 or SD + 3 years

Discontinue Paps

- Total hyster’my

Q3-5 5 years Not recommended [D]

- Upper age limit none [D] if >65 (or 70)&WS

Pap interval

- < 30 years old annually annually

[A]

- > 30 years old annually

if WS, Q2-3 3 years [A]

* Whichever is first SD= sexual debut

WS= well screened


Post-Hysterectomy Pap Smears

• There is no reason to screen for

(cervical) cancer in an organ which is

no longer present

• Yet, 60% of women with a

hysterectomy for benign disease are

still receiving “cuff” Pap smears!!


CIN and Adolescents

• High grade lesions take years to develop

– Earliest HSILS are 3 years after sexual debut

• High grade lesions are rare

– CIN 3 annual incidence 15-19 19 yo: 3/10,000

– 4 years after HPV infection, rate CIN 2/3 is


Pap Smears and Adolescents

• More harm than benefit within 3 years of sexual

debut… stop doing them!!!

• Management of ASC-US and LSIL

– Preferred approach is repeat Pap at 6,12 months or

HPV test at 12 months

– Do not request “reflex HPV” for women under 21

– If ASC-US and HPV+, use approaches above

• CIN 2’s 2 s can be managed like CIN 1’s 1 s (and observed)

• Avoid “see and treat” LEEPs

ACOG Committee Opinion, 4/2006


Caveats

HPV+Pap

Wright, Obstet Gynecol

2004;103:304

Indications

• Women 30 years old

and older

• Immunocompetent

• Cervix in place

• Inform women in advance of HPV screening

• Mgt of Pap neg/ / HPV pos women is uncertain

• Women who are Pap negative, HPV negative

should be screened no earlier than 3 years


So Now You’re Thinking…

•O.K….I.I understand that women over

30 years old may need Pap smears

only every couple of years

•But don’t t they need to come in one a

year for a pelvic exam to screen for

ovarian cancer?


Ovarian Cancer Screening

• Options for screening

–(Bimanual) Pelvic examination

– Transvaginal pelvic ultrasound (TVS)

– Serum Tumor Marker: CA-125

• None are recommended for low risk

asymptomatic women

– Low sensitivity, specificity for early disease

– Low prevalence of disease

– High cost of evaluation


Ovarian Cancer Screening

USPSTF (2004)

• Screening asymptomatic women with

ultrasound, tumor markers, or exam is

not recommended [D]

• Insufficient evidence to recommend for

or against in asymptomatic women at

increased risk [I]


EBM vs. “The Conventional Wisdom”

• ACOG (Committee Opinion, 12/2002)

–“Data suggest that currently available

(ovarian cancer) screening tests do not

appear to be beneficial for screening low

risk, asymptomatic women.”

– An annual gynecological examination with

an annual pelvic examination is

recommended for preventive health care.”


“Routine” STI Screening

• Cervical Chlamydia (in women)

– Annually in sexually active women thru 25 yo

• Cervical gonorrhea (in women)

– Annually in sexually active women thru 25 yo

– Only if practice-site prevalence is at least 1%

• Pregnant women

– Syphilis, HIV, Chlamydia

– Hepatitis B antigen (newborn treatment)


2.8%

2.6%

35-39

39 yo: : 0.15%

1.0%

CDC,2005


Targeted Screening: GC+Ct Risk Factors

GC + Ct screening

• History of gonorrhea, chlamydia, or PID in the past

2 years

• More than 1 sexual partner in the past year

• New sexual partner within 90 days

• Sexual partner who has other partners

GC screening

• African American women 26-30 years old, especially

in urban areas


Contact Testing for STI Exposure

• Test asymptomatic persons with high risk sexual

exposure (new or multiple sexual partners) for

– Gonorrhea

– Chlamydia

– Syphilis

– HIV

• No contact testing for

– HSV (culture), HPV (DNA)

– HBV, HBC (strategy for HBV is vaccination)

• Maybe: HSV-2 2 serology


Is the “Screening Pelvic Exam”

Outdated?

Screen for

Preferred test

GC, Ct

Use NAAT with urine sample

Cervical cancer Not within 3 years of sexual debut

Pap every 2-32

3 yrs afterward

None if total hyst for benign dz

Ovarian cancer USPSTF rec. against bimanual exam

Vulvar lesions

Unnecessary if asymptomatic

Vaginal infxn

Unnecessary if asymptomatic

Myomas

Unnecessary if asymptomatic


Obstacles to Adoption

• Industry

– Booming market in new screening technologies

– Most achieve marginal improvements

• Government

– Major objective is political expediency, not EBM

– Example: 1997 NCI panel on Mammography

• Health systems

– NCQA: measure what’s s measurable

– Cancer screening as “good marketing”

• Consumers

• Clinicians


Women’s s Perceptions of Pap Screening

Smith M, Ann Fam Med 2003; 1: 203

Focus groups with 812 Michigan women

• Believe that Paps are highly effective in prevention

of cervical cancer…“

…“set against” a change in GL

• Women should be screened annually (or more

often), starting with menses or sexual activity

• Believe that Paps check for a variety of conditions

• Believe that efforts to reduce Pap frequency are

economically motivated by health plan

• “Annual Pap smears are firmly entrenched”


Obstacles to Clinician Adoption

• Rejection of evidence based findings

– “These are wrong and I won’t t change my

practice”

• Impact of professional experience and culture

– “I I once saw a patient where a test found...”

– “It may not help, but I want to offer something”

– “I I don’t t want to miss a cancer and have someone

else find it”

– Bragging rights: “I I snagged one!”


Obstacles to Clinician Adoption

• Unwillingness to reject prior guidelines

– “I I don’t t want to admit that the old guidelines have

been wrong all of these years”

• Loss of pretext for PHS visits

– “If she doesn’t t need a Pap, she won’t t come in”

• Clinician-patient relationship concerns

– “We can’t t have a relationship with q3 year visits”

• Time constraints

– “Takes less time to do it than to explain why not”


Obstacles to Clinician Adoption

• Medicolegal concerns

– “If I stop doing it, I’m I m more likely to be sued”

• Marketing concerns

– “If I offer less, patients will leave my practice”

• Economic benefits

– “I I need to pay off my in-office DEXA”

• Economic threats

– Check up visits are my “bread and butter”


Obstacles to Clinician Adoption

• “I’m m exhausted! I’ve got to worry about…

– Professional liability

– Coding, contracts, call, credentials, CME,

and competition

– HIPAA, CLIA, OSHA, HDHPs and HSAs

– Paying my staff…and and myself

• And I just don’t t have time for this!!


Obstacles to Clinician Adoption

• Reasons to continue the screening “status quo”

– My patients believe in it

– The legal system demands it

– My professional organization expects it

– Vendors are pressuring me to utilize it

– Payers still pay for it

– It keeps my office practice going

– Common sense tells me that it may help someone

• And there’s s little incentive to do less…just that

– The evidence says it’s s the right thing to do


NIH Expert Panel on PNC

Rosen, Obstet Gynecol 1991; 77:782

• Multidisciplinary panel to review quality and

quantity of prenatal care

• Lamented lack of good quality data for decisions

• Recommendations:

– Add preconception visit to PNC

– Address psychosocial, environmental, family needs

– Visit schedule for low risk women

»Multip:: 6 PNC + preconception visit

»Nullip:: 8 PNC + preconception visit


EBM and Periodic Health Screening

• Many traditional interventions do not result in

improved health outcomes

– Asymptomatic conditions rarely are found

– False positive tests lead to unnecessary interventions

– Huge economic costs for claims paid, productivity lost

• Many desirable tests done more often than needed

• Some public health messages of the last 80 years are

no longer applicable, or may be harmful

• Most PHS visits, if done at all, will no longer

require exam or screening tests beyond a BP check


What May Be the Real Value of PHS?

Laine, , Ann Intern Med 2002:136:701

• Opportunity for behavioral anticipatory guidance

• Establishment of the clinician-patient relationship

• Increased sense of patient well-being; positive action

toward self-maintenance of health

• More likely to seek care when a problem does occur

• Desirable tests more likely to be done than at PHS

visits than during problem-oriented oriented care

• “Carves out a time and a place for prevention”


APE: Needless Ritual or Necessary Routine?

Laine, , Ann Intern Med 2002:136:701

• Educate patients about preventive practices of

proven and unproven benefit

– If not checking annually, patients must know when to

check in, and for what

• Impact of PHS on health perceptions, behaviors

– Do those with PHS visits feel better, behave healthier,

have appropriate screening, trust providers more?

• How often do we need to see patients to “keep them

from falling through the system’s s cracks”

• If low tech maneuvers engender confidence, continue


What Is Future of the “Well

Woman Exam?”

Change is likely to evolve slowly, but….

• Women with a primary care provider will have less

incentive to visit OBG for “check-up” visits

• Breast exams, screening tests, and contraception or

menopause care can (and will) be provided by PCP

• Some women will choose to be seen by OBG only

as required for Pap smears (every 2-32

3 years)


What Is Future of the “Well

Woman Exam?”

• Women who do not have a PCP can be offered

periodic health screening services

– That focus on primary prevention and behavioral

risk reduction

– That provides the same (limited) screening

interventions offered by a PCP

– Either through “opportunistic screening” or

dedicated periodic health screening visits


How Can My Practice Prepare?

• Meet with your colleagues and determine the

screening policies for your practice

– Make sure that all staff are aware of your policy

• Inform your patients of changes that apply to them

– During transitional phase, leave decisions to the patient

– Consider informing patients thru a letter or newsletter

• Keep track of benefit changes made by your payers

– Few have changed screening benefits yet

• Use “Preventive Medicine” E/M codes for PHS visits

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