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An Assessment of the NIH Women's Health Initiative
Appendixes
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An Assessment of the NIH Women's Health Initiative
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An Assessment of the NIH Women's Health Initiative
A
Clinical Trial Exclusion Criteria (June 28, 1993, WHI Protocol)
Exclusion Criteria for All Components
Competing Risk: Any medical condition associated with predicted survival of less than three years in the judgment of a Clinic physician (e.g., class IV congestive heart failure, obstructive lung disease requiring long-term ventilation or supplemental oxygen in the past, severe chronic liver disease with jaundice or ascites, kidney failure requiring dialysis, sickle cell anemia)
Adherence or Retention Reasons
alcoholism
other drug dependency
mental illness, including severe depression
dementia
active participant in any other intervention trial where participants are individually randomized to an intervention or control group
Additional Exclusion Criteria for All Clinical Trial Components
Competing Risk
invasive cancer of any type in the past 10 years
breast cancer at any time (in situ or invasive)
any medical condition associated with predicted survival of less than five years in the judgment of a Clinic physician (e.g., class IV congestive heart failure, obstructive lung disease requiring long-term ventilation or supplemental oxygen in the past, severe chronic liver disease with jaundice or ascites, kidney failure requiring dialysis, sickle cell anemia)
SOURCE: Adapted from National Institute of Health's WHI Protocol, June 28, 1993, p.28.
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baseline mammogram or clinical breast examination findings suspicious of breast cancer (see MOOP for detailed criteria) *
acute myocardial infarction in past six months *
stroke or transient ischemic attack (TIA) within the past six months *
known chronic active hepatitis or severe cirrhosis
Safety reasons
severely underweight (BMI < 18 kg/m2 or loss of 15 or more pounds in previous six months)
hematocrit < 34% or hemoglobin < 11.5 gm/dl *
platelets < 75,000 cells/ml
severe hypertension (systolic BP > 200 mmHg or diastolic BP > 105 mmHg)*
current use of oral daily corticosteroids for more than six months
Adherence or retention reasons
BMI > 40 kg/m2
unwilling to participate in baseline or yearly examination components such as yearly mammograms, clinical breast exams, phlebotomy, electrocardiograms, questionnaires and forms; or unable to complete baseline study requirements
Additional Exclusion Criteria for Hormone Replacement Component
Safety reasons
endometrial cancer of any stage at any time
endometrial hyperplasia at baseline biopsy or endometrial thickness > 5mm via ultrasonography (no recycling)
malignant melanoma of any stage at any time
non-traumatic thromboembolic event or thromboembolic event associated with estrogen or oral contraceptive use
previous osteoporosis-related fracture being treated with hormone replacement therapy
history of bleeding disorder serious enough to require transfusion
known history of hypertriglyceridemia, or lipemic serum leading to diagnosis of hypertriglyceridemia on baseline blood draw
deep vein thrombosis or pulmonary embolism in past six months*
currently on anticoagulants *
currently on tamoxifen
*
Implies that a woman who is temporarily excluded may be reevaluated for eligibility as appropriate to the excluding condition. If more than six months have elapsed since the woman's first screening visit, however, all baseline and screening activities must be repeated.
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An Assessment of the NIH Women's Health Initiative
Adherence or retention reasons
severe menopausal symptoms that would make placebo therapy intolerable to the participant
inadequate adherence with placebo run-in (less than 80% of pills taken)
unable or unwilling to discontinue use of hormone replacement therapy (women must discontinue current replacement hormone therapy for at least three months in order to be eligible for the HRT)*
unwilling to have baseline or yearly endometrial aspirations*
Additional Exclusion Criteria for Dietary Modification Component
Adherence or retention reasons
special dietary requirements incompatible with the intervention diet (such as celiac sprue, other malabsorption syndromes, use of MAO inhibitors). Women will be eligible if they are following a diabetic diet or a low salt diet
colorectal cancer at any time
unable to complete Four-Day Food Record adequately
percent of calories from fat estimated to be 34 or less
number of main meals prepared out of home ≥ 10 per week
type I (insulin-requiring, ketosis-prone) diabetes mellitus
gastrointestinal conditions that contraindicate a high fiber diet
Additional Exclusion Criteria for Calcium/Vitamin D Component
Safety reasons
History of renal calculi
Adherence or retention reasons
unable or unwilling to discontinue use of calcium or vitamin D supplements
inadequate adherence with HRT and/or DM trial components during the first year of followup (see Manual of Operations and Procedures for detailed criteria)
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Representative terms from entire chapter:
exclusion criteria
