Transcript Document

BCSC as a Platform for Comparative
Effectiveness Research
Diana Buist, PhD, MPH
for the BCSC
Comparative Effectiveness Research definition*
Head-to-head comparisons of benefits and harms of different
interventions and strategies to prevent, diagnose, treat and monitor
health conditions in “real world” settings

To improve health outcomes by developing and disseminating evidencebased information

Which interventions are most effective for which patients under specific
circumstances
*Health and Human Services definition
Where BCSC started…
 Were still learning whether mammography was efficacious, much
less effective
 Did not know much about what influenced screening effectiveness
or efficacy
 Risk factors
 Intervals
 Providers
 Facilities
Why is CER possible in BCSC
 Real world settings– community practice screening facilities
 Real world women and radiologists – consent (mostly) not required
 Geographic and racial distribution
 Able to compare important differences in international screening
strategies
 Ability to conduct ancillary studies off BCSC infrastructure platform
International comparisons
Examples:
-UK vs. US
-Norway vs. US (Vermont & North Carolina)
Recall is lower at same cancer detection rate in
the UK vs. US
Smith-Bindman et al JAMA 2003
Recall
Cancer detection rate
UK
BCSC
U.K.
BCSC
50-54
7.6
14.6
6.3
5.8
55-59
7
13.7
9.2
7.4
60-64
6.7
12.6
11.9
10.1
“UK performs far fewer diagnostic tests and open surgical biopsies to
diagnose same number of cancers”
Norway vs. US
Hofvind JNCI 2008
Hofvind et al Med Screen. 2009
 Interval cancer rates significantly higher in Vermont & North
Carolina than in Norway
 But - diagnosed tumors in US tended to be at an earlier stage
Screening intervals
Late stage breast cancers are no more likely for women
on a 2 year screening intervals vs. 1 year, except for
younger women
White et al JNCI 2004
2.0
OR (95% CI)
1.5
1.0
0.5
0.0
40-49
50-59
60-69
70-89
All
Age at Index Mammogram, y
“ These findings may be useful for policy decisions about appropriate screening
intervals and for use in statistical models that estimate the costs and benefits of
mammography by age and screening interval”
Mammography does not work as well in younger women
because of higher density and faster growing tumors
Buist et al. JNCI 2004
 68% of interval cancers by 12 months in younger
women explained by higher mammographic breast
density
 31% of interval cancers at 24 months in younger women
because of higher mitotic figure count and Ki-67 & 38%
because of higher breast density
*Used tissue blocks from Group Health in collaboration
with Fred Hutchinson Cancer Research Center
CER studies to test ways of
improving screening

Outreach

Screening strategy

Changing risk factors

New technology
JNCI 2000
•Reminding women to schedule a mammogram is as
effective as addressing barriers
“Simple intervention groups need to be included as
comparison groups in randomized trials so that we
better understand more complex intervention effects”
Sensitivity
Specificity
PPV
Incremental CBE Effect (%)
10
5
0
-5
-10
-15
-20
-25
-30
-35
-40
40-49
50-59
60-69
70-79
Patient age, y
CBE had modest incremental benefit to invasive cancer detection
over mammography alone, but results in more false-positive results
80+
Randomized trial of short-term hormone therapy suspension
does not change mammography recall
Buist et al. Annals Intern Med 2009
16.0
Recall rate (95% CI)
15.0
14.0
13.0
12.0
11.0
10.0
9.0
8.0
7.0
6.0
None
1-month
2-months
Hormone therapy suspension
The Radiological Evaluation and Breast Density (READ) Randomized Trial
Dense
Specificity
Fatty
Dense
24 month Sensitivity
Fatty
Dense
12 month Sensitivity
Fatty
-2
-1
0
1
2
% Change in Performance with CAD
3
4
Local BCSC Research Resources that could be used to
expand CER capacity
 Biological specimens in well characterized samples
 Tissue, blood samples, medical records
 Health services data in fee for service and HMO
 Treatment, comorbidities
 Quality improvement
 Technical and clinical quality measures
 Radiologists’ interpretation, facility level data
 New technologies, including costs
 Risk factor data on women for improving risk assessment
Conducting CER within BCSC is
possible, but worth remembering…
 Takes time and funding to engage with facility leaders
• Integrating with the clinical flow
 Need to be clear on where research ends and clinical care begins
 Getting realistic budget estimates and TIME! for interactively
working with clinical systems
 Clinical priorities are often not aligned with research priorities –
particularly true for timelines
Some CER citations
1.
Buist DS, ML A, Reed SD, Aiello Bowles EJ, Fitzgibbons ED, Gandara JC, Seger D, Newton KM. Short-term
hormone therapy suspension and mammography recall: a randomized trial. Ann Intern Med.
2009;150(11):752-65. PMCID: PMC2803099.
2.
Buist DS, Porter PL, Lehman C, Taplin SH, White E. Factors contributing to mammography failure in women
aged 40-49 years. J Natl Cancer Inst. 2004;96(19):1432-40.
3.
Hofvind S, Vacek PM, Skelly J, Weaver DL, Geller BM. Comparing screening mammography for early breast
cancer detection in Vermont and Norway. J Natl Cancer Inst. 2008;100(15):1082-91. PMCID: PMC2720695.
4.
Hofvind S, Yankaskas BC, Bulliard JL, Klabunde CN, Fracheboud J. Comparing interval breast cancer rates
in Norway and North Carolina: results and challenges. J Med Screen. 2009;16(3):131-9. PMCID: journal in
process.
5.
Jensen A, Geller BM, Gard CC, Miglioretti DL, Yankaskas B, Carney PA, Rosenberg RD, Vejborg I, Lynge E.
Performance of diagnostic mammography differs in the United States and Denmark. Int J Cancer. 2010.
PMCID: journal in process.
6.
Oestreicher N, Lehman CD, Seger DJ, Buist DS, White E. The incremental contribution of clinical breast
examination to invasive cancer detection in a mammography screening program. Am J Roentgenol.
2005;184(2):428-32.
7.
Smith-Bindman R, Chu PW, Miglioretti DL, Sickles EA, Blanks R, Ballard-Barbash R, Bobo JK, Lee NC,
Wallis MG, Patnick J, Kerlikowske K. Comparison of screening mammography in the United States and the
United Kingdom. JAMA. 2003;290(16):2129-37.
8.
Taplin SH, Barlow WE, Ludman E, MacLehos R, Meyer DM, Seger D, Herta D, Chin C, Curry S. Testing
reminder and motivational telephone calls to increase screening mammography: a randomized study. J Natl
Cancer Inst. 2000;92(3):233-42.
9.
Taplin SH, Rutter CM, Lehman CD. Testing the effect of computer-assisted detection on interpretive
performance in screening mammography. AJR Am J Roentgenol. 2006;187(6):1475-82.
10. White E, Miglioretti DL, Yankaskas BC, Geller BM, Rosenberg RD, Kerlikowske K, Saba L, Vacek PM,
Carney PA, Buist DS, Oestreicher N, Barlow W, Ballard-Barbash R, Taplin SH. Biennial versus annual
mammography and the risk of late-stage breast cancer. J Natl Cancer Inst. 2004;96(24):1832-9.
Thank you!