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2005-2010 Extension
• Outcomes through September 2010,
adjudications through March 2011
– Tables in your packet, data on website soon
• Status of ―other‖ cancer coding
– 9,161 of 11,091 have been SEER coded
• NDI search identified ~3800 deaths through
December 2008 among former WHI ppts
Outcomes tasks yet to do
• Stroke case adjudication
– 1,000 DM and 2,000 OS
• SEER Coding
– 1,135 other cancers
• Heart Failure (HF) adjudication
– 4,700 retrospective cases among MRC
Pharmacopia
From the British Museum, photos courtesy of June Campbell
2009-2010 Medications Inventory
Form # Mailed or
on Call List
Total
Response
% Total
Response
Response
Response
Phone
Response
% Phone
Response
153 108296 97349 89.9 93574 86.4 3775 3.5
154 6584 5791 88.0 5632 85.5 159 2.4
Prevalence (%) of medication use
Top therapeutic classes reported
Top Therapeutic Classes of Use %*
CALCIUM COMBINATIONS 59
MULTIPLE VITAMINS W/
MINERALS 58
SALICYLATES 51
HMG COA REDUCTASE INHIBITORS
(STATINS) 40
NONSTEROIDAL ANTI-
INFLAMMATORY AGENTS (NSAIDS) 30
VITAMIN D 28
THYROID HORMONES 25
PROTON PUMP INHIBITORS 23
Top Therapeutic Classes of Use %*
BETA BLOCKERS CARDIO-SELECTIVE 23
CALCIUM CHANNEL BLOCKERS 18
BISPHOSPHONATES 18
ACE INHIBITORS 17
THIAZIDES AND THIAZIDE-LIKE
DIURETICS 12
ANGIOTENSIN II RECEPTOR
ANTAGONISTS 11
ANALGESICS OTHER 9
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) 9
Barriers to taking prescription
meds
No barriers to taking prescription medications 68.1
My health insurance would not cover the medication 3.7
The medication or copayment cost too much 4.4
It is a problem for me to get to the medical facility/physician 0.4
Taking the medication would be inconvenient 0.3
Concerned about possible side effects/complications from medication 7.2
Concerned about missing work due to taking the medication 0.1
My family discouraged me from taking the medication 0.3
My friends discouraged me from taking the medication 0.2
I am taking too many medications 1.8
I don't like taking medications 5.9
Over the Counter
Medication Type
%*
Reporting
Use
% Reporting
<= 1 year of
use
% Reporting
>1 year of
use
Aspirin 55 14 81
Anti-Inflammatory 1 31 29 65
Anti-Inflammatory 2 9 24 63
Antacid 1 22 25 61
Antacid 2 9 19 65
Natural Hormone 1 4 21 65
Natural Hormone 2 1 19 56
OTC Insulin <1 18 52
Multi-Vitamin 65 10 82
Calcium/Vitamin D 60 12 78
Calcium 10 15 66
Vitamin D 27 46 41
% of breast cancer cases
reporting ever use
• Tamoxifen, 44%
– 22% for 5+ years
• Raloxifene, 6%
• Anastrozole, 28%
• Exemestane, 6%
• Letrozole, 14%
CMS data
• CCC purchased CMS data for 1991-2007– MedPar
• Inpatient Standard Analytical File (SAF)
• Skilled Nursing Facility SAF
– Outpatient SAF
– Home Health SAF
– Hospice SAF
– Carrier SAF
– Durable Medical Equipment
– Denominator
• Ongoing linkages planned
Linking details
WHI 161,808 % of total
Submitted to CMS 151,116 93%
Perfectly matched 132,685 82%
Fuzzy matched 2305 1%
Deleted 150 <1%
Valid links 135,740 84%
Linkage by demographics
Age at
screening
%
50-59 70.6
60-69 90.5
70-79 90.4
Race/ethnicity %
White 85.6
African American 76.0
Hispanic 72.3
American Indian 74.6
Asian/Pac Islander 80.0
Other/Unknown 80.2
Region %
NE 86.3
SE 81.8
MW 84.3
W 83.5
Study %
CT 86.7
OS 81.9
Highly statistically significant differences in probability of
linkage by age, race, BMI, region, and study components
CMS Medicare Provider Analysis and
Review (Med PAR)
• Inpatient hospital or skilled nursing facility (SNF) includes
– admission and discharge dates
– diagnosis and procedure codes
– costs
• 63,840 women are in the Med PAR file
– 63,552 have at least one inpatient stay.
– 56,996 have 1+ inpatient stay of 2+ days.
Comparing event rates
Eligibility:
• One CMS interval
– 73% have 1 interval
– 22% have 2 intervals
– 4% have 3 or more intervals (1 has 18)
• Enrolled in Medicare at the time of WHI
enrollment
• Not in an HMO since WHI enrollment
CMS Data
Outcome
WHI
Event
Total
Participants
Claims, Outpatient,
Inpatient
No Yes Kappa
MI No 36586 34283 2303 .51
Yes 1632 198 1434
Total 38218 34481 3737
CHF No 36615 28213 8402 .21
Yes 1603 59 1544
Total 38218 28272 9946
CABG/PTCA No 35633 35382 251 .85
Yes 2585 445 2140
Total 38218 35827 2391
Hip Fracture No 37047 35875 1172 .64
Yes 1171 16 1155
Total 38218 35891 2327
Colorectal
Cancer
No 37567 37033 534 .58
Yes 651 159 492
Total 38218 37192 1026
Atrial Fib No 34895 29248 5647 .47
Yes 3323 37 3286
Total 38218 29285 8933
Frequencies of WHI and CMS Events
WHI 1993-2005
DM HT
CaD
os
48,835 27,347
36,282
93,676
CT=68,132
WHI =161,808
Participation status at end of initial
WHI study (2005)
CEE E+P DM CaD OS
N(%) N(%) N(%) N(%) N(%)
Enrolled in WHI 10739 16608 48835 36282 93676
Absolutely no follow-up 300
(2.8)
375
(2.3)
1104
(2.3)
429
(1.2)
1472
(1.6)
Died 653
(6.1)
825
(5.0)
2171
(4.5)
1406
(3.9)
5460
(5.8)
Eligible for consent to
Extension 1
9786
(91.1)
15408
(92.8)
45560
(93.3)
34447
(94.9)
86744
(92.6)
WHI 2005-2010 Extension
os
48,835
63,231
CT=52,176
WHI =115,406
DM (37,858) HT (20,433)
CaD (29,862)
Participation status at end of WHI
2005-2010 Extension study
CEE E+P DM CaD OS
N(%) N(%) N(%) N(%) N(%)
Enrolled in Extension 1 7645 12788 37858 29862 63231
Absolutely no follow-up 79
(1.0)
143
(1.1)
217
(0.6)
203
(0.7)
348
(0.6)
Died 561
(7.3)
856
(6.7)
2047
(5.4)
1684
(5.6)
3874
(6.1)
Eligible for consent to
Extension 2 7005
(91.6)
11789
(92.2)
35594
(94.0)
27975
(93.7)
59008
(93.3)
Design of WHI 2010-2015
Extension
os
48,835
52,001
CT=41,453
WHI =93,454
DM (30,655) HT (15,568)
CaD (24,206)
OS WHI Extension 1 Extension 21
Baseline N % N % N %
Age at baseline
50-54 12381 13.2 8999 14.2 7990 15.8
55-59 17329 18.5 12733 20.1 11194 22.2
60-64 20354 21.7 14489 22.9 12121 24.0
65-69 20846 22.3 14097 22.3 10909 21.6
70-74 15643 16.7 9402 14.9 6379 12.6
75-79 7123 7.6 3511 5.6 1907 3.8
Race/Ethnicity
White 78016 83.3 55767 88.2 45078 89.3
Black 7635 8.2 3585 5.7 2496 4.9
Hispanic 3609 3.9 1598 2.5 1185 2.3
American Indian 421 0.4 217 0.3 159 0.3
Asian/Pac Islander 2671 2.9 1291 2.0 1008 2.0
Unknown 1324 1.4 773 1.2 574 1.1
OS WHI Extension 1 Extension 21
Baseline N % N % N %
Family Income
Less than $10,000 3917 4.5 1661 2.8 997 2.1
$10,000-$19,000 10101 11.6 5555 9.3 3746 7.9
$20,000-$34,999 20226 23.3 12997 21.9 9852 20.7
$35,000-$49,000 17430 20.1 12226 20.6 9860 20.7
$50,000-$74,999 17487 20.2 13019 21.9 10930 22.9
$75,000+ 17608 20.3 13981 23.5 12283 25.8
Smoking
Never Smoked 47021 50.9 31746 50.8 25590 51.2
Past Smoker 39514 42.8 27410 43.9 21980 44.0
Current Smoker 5790 6.3 3315 5.3 2372 4.7
OS WHI Extension 1 Extension 21
Baseline N % N % N %Alcohol Intake
Non drinker 10477 11.3 5853 9.3 4269 8.5
Past drinker 17555 18.9 10400 16.5 7709 15.3
<1 drink per month 10731 11.5 7232 11.5 5786 11.5
<1 drink per week 18700 20.1 13023 20.7 10546 21.0
1 - <7 drinks per week 23824 25.6 17585 28.0 14664 29.2
7+ drinks per week 11704 12.6 8807 14.0 7290 14.5
Hypertension
Never hypertensive 61196 66.5 43238 69.5 35658 71.6
Untreated hypertensive 7317 8.0 4701 7.6 3628 7.3
Treated hypertensive 23464 25.5 14311 23.0 10484 21.1
Diabetes
No 89653 95.8 61411 97.2 49365 97.8
Yes 3902 4.2 1752 2.8 1087 2.2
WHI 2010-2015 Extension Study
WHI=88,552
AA/Hispanic
MRC
22,283
SRC = 71,171
MRC: Medical Records Cohort
SRC: Self-Report Cohort
WHI =93,454 HT
2010-2015 Data collection
• Annual mailed follow-up for all participants– Self-reported health outcomes
– Aging related conditions
– Limited exposure updates
• One-time repeat of medications inventory in MRC
• CVD, Fractures, Deaths adjudicated only in MRC
• New outcomes
– Heart Failure—retroactive and prospective abstraction of records in MRC (UNC)
– Valvular disease
– Atrial Fibrillation—rely primarily on CMS
• Cancer outcomes for entire cohort
• Periodic NDI searches
In-person visit
• Eligibles: MRC 80+ years of age
• Data collection
– BP, Pulse
– Anthropometry
– Short Physical Performance Battery
– Blood Collection
• CBC, DNA/RNA extraction, selected CVD biomarkers
• Timeline Fall 2011-Dec 2012
