Funded by the VA HSR&D (Project# SDR 10-012)

Spotlight on Women Cyberseminar Series
Women’s Health

Research: ProgrPitfalls and Prom

Committee on Wome

Health Research, BPopulation Health Public Health Prac

Institute of Medicine 

N ti l a ona Ad i ca

demies

National Academy Press,

Washington, DC, 2010

Reviewed by Robert B

Wallace, MD, MSc

University of Iowa
Agenda for Today

• Discuss Discuss the genesis genesis of the report• Outline the structure of the report

• Discuss Discuss some of the key findings findings

• Provide comment on the nature and success 

report in meeting meeting its goals

• Suggest some additional directions for Wome

Health Research
Source of the Study and Fundin

Fundin

• Consolidated App p ro riations Act of 2008 (PL 110‐161• Department of Health and Human Services

• Office of Women’s Health

“To conduct a comprehensive review of the status of w

health research....

....summarize what has been learned about how diseas

sp y ecifically affect women....

....report to the Congress on suggestions for the directio

future research.
Committee Committee s’ Approach Approach to the Issue

....focused on health conditions that:

‐are specific specific to women‐are more common or more serious in women

‐have distinct causes or manifestations in women, o

‐have high morbidity or mortality in women

(Forms a definition of women’s health research)

N t o all conditions could be eval td ua e , so examp

‐specific to women‐differences differences in prevalence prevalence or severity severity, preferred preferred trea

trea

understanding among women

‐special research needs, whether or not there are s

differences
General Questions Posed by the Comm

On Women s’ Health Research Research

1. The most app p ro riate and relevant determinants of h2. Focus on the most appropriate and relevant conditio

end points?

3. Are the most relevant groups of women being studie

SES groups at highest risk of various diseases)

4. Are the most appropriate appropriate research research methods methods being us

study women’s health?

5. Are the research findings being translated in a away t

affects practice?

6. Are the research findings being communicated effect

women?
Substantive Chapters

A. Administrative history of major agencies and

p g ro rams related to women’s health (Intro ch

B. Research on Determinants of Women’s HealtC. Research Research on Conditions Conditions with Particular Particular Relev

Relev

Women’s Health

D. Methodologic Issues in Women’s Health Rese

E. Transforming Discovery to Impact: Translatio

Communication of Findings of Women’s Heal

Research

F. Recommendations

‐Appendix C: Selected Studies of Women’s Heal
A. Administrative History of Women’s H

Issues

Useful US federal regulatory and agency history;

congressional actions; major studies studies

Begins with 1977 FDA regulation banning clinical re

on pregnant women, due to thalidomide and

diethylstilbestrol experience (and the backlash)

Some issues (and scholarship needs):

‐Omits the history history and role of the women s’ movement movement a

on policy and politics

‐Over the centuries, were women’s diseases less attende

medical research?

‐If so, two major reasons: 1) military role in health scie

2) the 20th Cent. coronary e

(How do you study gender bias in health research?)
B. Research on Determinants of Wom

H lh ea t (Risk Factors)

‐ Most (or a )o ll f the risk fac o s t r a er re a ed l t to co 

con

affecting both men and women

‐ Takes a behavioral as well as physiological appro

‐ Vulnerable populations

‐ Diet, exercise, blood pressure

‐ Sexual risk behaviors

‐ Evaluates interventions on risk factors

‐ Social connectedness; exposure to violence, sub‐ Access to health care as a “risk factor”
Risk Factors Responsible for Attributable De

Women (Figure (Figure 2‐2 in Report) Report)
Prevalence of Obesity in the US

(Figure 2‐3 in the Report)
Some Important Areas Not Well Covere

Disease Ri ks Factors

• Physio‐chemical environment environment in general general• Genetic/ biological mediation of general

environments

• Public health programs and policies

• Effects of workplace workplace on health
C. Research on Conditions with Partic

R l e evance to W ’ omen s H lh ea t

The Report s’ Approach:

‐Occurrence/ mortality ‐Disparities in g‐Advances in prevention ‐Advances in di‐Advances in treatment ‐Knowledge gap
Progress in Surmounting Surmounting Medical Medical Cond

Cond

Research has contributed to Conditions with little 

major progress

‐Breast cancer

Cardiovascular disease

‐Unintended preg‐Maternal morbid

‐Cardiovascular disease mortality‐Cervical cancer

Research has lead to some

mortality

‐Autoimmune dis‐Alcohol & drug a

progress

‐Depression‐HIV/ AIDS

‐Lung cancer‐Other gynecolog

‐HIV/ AIDS cancers‐Osteoporosis

cancers

‐Non‐malignant g

cond.

‐Alzheimer’s disea
Occurrence of Breast Cancer‐United Stat
Comments on this Approach Approach

1. Information on disease control is widely available a

understood among clinicians

2. Applaud some representation of mental illness, but 

not enough

3. Some conflating of social with medical issues (e.g.

unintended p g y) re nancy)

4. The largest group of medical conditions in women (

is “Other,” e.g.:

‐Skin conditions  ‐Other mental illnesses ‐Degenerativ

‐Neurological cond. ‐Gastrointestinal cond. ‐Endocrine c

5. No particular particular attention attention to public health or aging
D. Methodologic Issues in Women’s H

R h esearch

• Short chapter; technical study designs not re• Some general issues usefully characterized:

– Inclusion of women in studies of men and women

women‐only studies

– Sampling– Statistical power for subgroup analysis– Routine sex‐specific analysis of data– Revisiting the fetal harm issue– Female‐appropriate appropriate endpoints endpoints (e g. ., unstable unstable ang

ang

– Quality‐of‐life endpoints that are women‐oriente– Composite outcomes (e.g., WHI’s Global Health In
E. Translating and Communicating Wom

H lh ea t R h esearch

• VA given credit for maintaining women’s hea

research centers!

• Who should translate? Gov’t; investigators; m

ind ? ustry Not sol l e y a women’s issue

• Social and cultural issues in translation

• S il pec a issues in communi ti ca on

• Barriers in patient decision‐making (Building 

decision aids into the system) system)

• Barriers associated with health care provider

health plans and providers
A Case History of Prevention in Women

Mammography

Number of News Items on Mammography, by Y

Lexus‐Nexus Database (Figure 5‐2 in the Report)
New York Times Article Article‐‐2002

A Missed Opportunity for Scholarship 

P i revention R h) esearch)

• Why doesn t doesn’t this uproar occur among men fo

prostate cancer?

• Why doesn’t this happen among women con

lung or colon cancer?

• What drives the culture of prevention?

• How do women, and the public in general, de

ambiguous, controversial science?
Gender Concordance and Physician

P i erceptions of Th i e r P i at ents [Women & Health 

Physician Physician s’ Perceptions Perceptions of Their Patients Patients – Odds 

Disease uncertainty Hidden Agenda R

Fem. Pt/ 1.3* 2.2** 0

Male MD

Fem. Pt/ 0.6* 2.1 1

Fem. MD
Appendix C: Information/ Findings on 

M j a or S di tu es of W ’ omen s H lh ea t

• Women s’ Health Initiative Initiative (WHI)

• Women’s Health Study (WHS)• S d tu y of Women Across the Nation (S 

W

• Black Women’s Health Study (BWHS)• Nurses’ Health Study (NHS)
F. Recommendations to the Office of Wo

H lh ea t ( di d) (edited)

1. US government should sustain and increase focus o

women’s health

2. Target research initiatives that increase research on 

popul ti a ons with hi h t g es disease b d ur en

3. Research should include prevention and attention t

q y ualit of life

4. Adequate participation of women in all relevant res5. Better research translation of women’s health resea

issues

6. Develop evidence‐based strategies for communicat

research findings to women
A Proposal For Moving Forward on Wo

H lh ea t R h esearch: Some S d uggested A 

ppro

1. Assess the biology of the condition in terms of uniq

or sex genetics or molecular biology.

2. Use research precedent to estimate how much of to

k ld now e ge on a women’s condition was creat de by

“genderless” research and/ or research on males.

3. For translational therapeutic research on conditions 

occur in both women and men, identify those situat

where clear differential approaches are needed, wh

clinicians really need prompting prompting.

4. Research the clinical environments that uniquely en

the clinical outcomes of women, and adjust accordi
A Proposal For Moving Forward on Wo

H lh ea t R h esearch: Some S d uggested A 

ppro

5. Use personalized medicine to surmount som

gender differences in prevention and treatme

6. Above all else, don’t confuse advocacy or

uncorrectable disparities with the imperative

responsibilities of high quality science
Gender and the Diagnostic, Management, 

Surveillance of Chronic Obstructive Pulmo

Disease [Proc Am Thor Soc 4:686]

Symptom Gender DifferencesDyspnea Women have greater seve

Chronic cough Women more likely to be

awakened by cough

Sputum production Men have more

Depression High in men and women; 

have more

A it/ nx e y/ f ti a gue Ditto