Baseline and Follow-Up Variables
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- Johnathan Howard
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1 Baseline and Follow-Up Variables Form and variables Additional Timing and Subsample Notes 1 Form 2 - Eligibility Screen -- name; mailing address; telephone numbers and best times to call; date of birth; residing in area for next three years; current involvement in other research studies; history of cancer (site, diagnosis in past 10 years); ethnicity; recruitment source; hormone use (present, in last three months); osteoporosis-related fracture and hormone use as treatment; hysterectomy history; last menstrual bleeding; number of meals prepared away from home; special diets (type); history of diabetes, deep vein thrombosis, pulmonary embolus, stroke, transient ischemic attack, myocardial infarction; history of sickle cell anemia, heart failure, liver disease, bleeding problem; loss of 15 pounds in last six months; renal failure requiring hemodialysis; other chronic illness; emotional or mental problems; ability to get to clinical center; interest in DM; interest in HRT (willingness to stop current hormone medications). Form 4 - HRT Washout -- date stopped hormones; assessment of symptoms after stopping (HT for those on hormones at initial contact). Form 10 - HRT Management and Safety Interview -- presence and amount of vaginal bleeding; changes in breasts; currently taking medications, or have symptoms, worries, or health changes that might require stopping study pills; pill-taking behaviors. Form 17 - CaD Management and Safety Interview -- presence of gastrointestinal symptoms, currently taking medications, or have symptoms, concerns, or health changes that might require stopping study pills; pill-taking behaviors. Form 20 - Personal Information --education; employment status; occupation; marital status; partner s education, employment status, occupation; total family income; recent history of mammogram, pelvic exam, endometrial aspiration; insurance coverage; serve in armed services. Form 25 Participant Treatment Assignment: Estrogen plus Progesterone/E-Alone date stopped study pills; symptoms when stopped; guess on treatment assignment and reasons. Form 28 Participant Treatment Assignment CaD -- when stopped study pills, guess on treatment assignment and reasons. Form 30 - Medical History Questionnaire -- hospitalization history; history of medical conditions; history of heart, circulatory, or coagulation problems; history of arthritis, gallbladder disease, thyroid disease, hypertension, angina, peripheral arterial disease and related procedures, colonoscopy or sigmoidoscopy, stool guaiac; history of cancers (site, age at diagnosis); recent history of falls or syncopal episodes; history of fractures (site, age, number). Form 31 - Reproductive History -- age at menarche; history of menstrual irregularity and amenorrhea; history of menopausal symptoms; history of pregnancy, pregnancy outcomes, infertility; history of breast Updated at final screening contact. Also at non-routine contracts initiated by participant while HT participants were taking study pills, and for two semi-annual contacts after stopping study pills. Also at non-routine contracts initiated by participant while CaD participants were taking study pills, and for one semi-annual contact after stopping study pills. For E+P, when intervention stopped July 9, For E-Alone, when intervention stopped in February At CaD study close-out October 2004 to March 2005.
2 feeding; history of gynecologic and breast surgeries. Form 32 - Family History Questionnaire -- number of full-blooded sisters and brothers, daughters, and sons; parental age or date of death; relatives' history of' diabetes, myocardial infarction, stroke, cancers; fractures in parents (site, age). Form 33 - Medical History Update -- hospitalization since last contact; hospitalization for heart, circulatory, or coagulation problems; stroke or transient ischemic attack, number of falls or syncopal episodes, fractures update; cancer (type, where diagnosed, hospitalization); mammogram; breast biopsy, needle aspiration, or lumpectomy; tests and procedures; electrocardiogram; diagnosis of new conditions; hip or other joint replacement. Form 34 - Personal Habits Questionnaire -- coffee consumption; smoking history; alcohol history; weight change; special diets; history of physical activity and exercise (frequency, duration). Form 35 - Personal Habits Update physical activity and exercise; alcohol consumption; current cigarette smoking. Form 37 - Thoughts and Feelings -- social support; social integration; care giving; social strain; optimism; negative emotional expressiveness; hostility; Form 38 Daily Life items: quality of life; symptoms; life events; depression; sleep disturbance; urinary incontinence; sexual functioning. Form 38 - Daily Life -- quality of life; symptoms; life events; depression; sleep disturbance; urinary incontinence; sexual functioning. Form 39 - Cognitive Assessment -- expanded mini mental status examination. Form 40 - Addendum to Medical History Update -- family history of DVT and PE. (2002) Form 41 - Addendum to Personal Information -- racial/ethnic background using 2000 Census questions. (2002) Form 42 - Observational Study Questionnaire -- birth weight, birth status, breast feeding at birth; coffee/tea consumption; alcohol history; smoking history; history of breast examination, history of benign breast disease, recent history of mammogram; history of the use of powders in genital area or on sanitary napkins; history of diaphragm; history electric blanket use; religious affiliation; recent history of physical activity and exercise (frequency, duration); occupational history; height and weight history, weight change; state of residence history. Form 43 - Hormone Use Interview current and past hormone replacement (duration, frequency); history of oral contraceptive, diethylstilbestrol, depo-provera use. Form 44 Current Medications.current medication name, form, strength, duration. Form 45 Current Supplements.current supplement name; vitamin and mineral type, dose, frequency, duration. See Self Report Outcomes table for changes in self-report questions over time. Initiated in 2002, collected once from all CT and OS participants at next routine contact. Initiated in 2002, collected once from all CT and OS participants at next routine contact. Form 48 OS Follow-up Questionnaire (Year 1) -- current weight, recent weight change; current food and beverage consumption at meal or snack times, recent use of fats or oils, recent wine consumption; current smoking habits; recent history of hormone replacement; history of insecticide exposure; history of
3 living with pets; history of computer use (frequency, duration); history of hand-held hair dryer use (frequency, duration). Form 49 - Estrogen Plus Progestin Survey date stopped; take hormones since stopped and reasons; take hormones now; current symptoms and severity; how manage symptoms; depression scale; sexual functioning; current medications, natural hormones; quality of life. Form 55 - Estrogen-Alone Survey current symptoms; how manage symptoms; sexual functioning; current medications, natural hormones; take hormones since stopped and reasons; take hormones or SERMS now. For E+P participants on study through July 8, 2002, when intervention was stopped; administration began in March For all E-Alone participants; administered twice: first in Jan before the intervention was stopped on February 28, 2004, and again at closeout visit. Form 60 Food Questionnaire item Food Frequency Questionnaire. Year 2: 30% cross sectional. Year 3,6: 4.3% cohort (same as blood subsample) and 5.7% repeated cross-sectional; Year 4,5,7: 10% crosssectional. In 2000 implemented rotating crosssectional subsample so each DM participant received a FFQ at least once every 3 years. Form 62 Four-Day Food Record Form 80 - Physical Measurements resting pulse and blood pressure; height, weight; waist and hip circumference. Form 81 - Pelvic Exam physical exam results; presence of cystocele, rectocele; uterine presence, size, prolapse; adnexae; follow-up results. Form 82 - Endometrial Aspiration uterine depth; aspiration results; follow-up results. Form 83 Transvaginal Uterine Ultrasound endometrial thickness; pathology results; endometrial cavity fluid; follow-up results. Form 84 - Clinical Breast Exam nipple discharge; skin, axillary, or breast mass; mass size, mobility, number; follow-up results. Form 85 - Mammogram -- summary results, follow-up results. Form 86 ECG 12 lead ECG Form 87 Bone Density Scan hip, spine, and whole body scan 4.6% DM cohort in years 0 and 1. Overlap with Form 100 Blood subsample in year 1 and same as Form 62-4DFR subsample. Waist and hip measurements at Year 3, 6, and 9 in 6% CT cohort subsample. Same as Form 38- Daily Life and Form 100-Blood cohort). For BD sites, height at OS Year 6. Not required for E+P participants after July 9, 2002, when intervention was stopped. In additional to routine collection, collected at other contacts to manage unexpected bleeding. Not required after July 9, 2002, when intervention was stopped. Done only if endometrial aspiration could not be done or was refused. Optional for DM participants. Not required on enhanced recruitment participants. Collected at close-out if did not reach Year 9.
4 Form 90 - Functional Status -- grip strength; chair stand; 6 meter timed walk. Form 92 - Pap Smear -- type cells present; pathology results; follow-up results. Form Blood Collection and Processing -- hematocrit, white blood cell count, platelet count, fasting triglycerides (for HT participants if serum lipemic); fasting serum, plasma (citrate and EDTA), buffy coat, RBCs for storage; time since ate; physical exercise and aspirin use before blood drawn; time drawn, centrifuged, removed from cells, frozen. Form Urine collection and Processing first morning void urine for storage; time collected, centrifuged, removed to vials, frozen. Form 134 Addendum to Medical History Update history of Parkinson s disease, diabetes Form OS Follow-Up Questionnaire (Year 3) -- recent weight change, figure (weight) identification; current physical activity and exercise (frequency, duration); usual activities; past strenuous physical activity by age (frequency); recent alcohol consumption, change in alcohol consumption habits; recent coffee/tea/water/diet drinks consumption; recent use of fats or oils; current smoking, current smoking exposure; current employment status, current marital status, partner s current employment status; total family income; existence and recent use of usual medical care provider, change in usual medical provider; choice options in current health insurance coverage, type(s) of current health insurance coverage and payment mechanism; recent use of hormone replacement therapy; diagnoses of new medical conditions. Form OS Follow-Up Questionnaire (Year 4) -- current weight, recent weight change; current physical activity and exercise (frequency, duration); exposure and sensitivity to sunlight; current smoking; past and present use of artificial sweeteners; recent use of hormone replacement therapy; diagnoses of new medical conditions; current marital status. Form 145 OS Follow-Up Questionnaire (Year 5) -- current weight, recent weight change; current physical activity and exercise (frequency, duration); current smoking; video, video display terminal exposure; depression scale; frequency religious practices; recent use of alternative medical treatments; current dental health, frequency of professional dental care; recent use of hormone replacement therapy; diagnoses of new medical conditions; current marital status. Form 146 OS Follow-Up Questionnaire (Year 6) -- current weight, recent weight change; current physical activity and exercise (frequency, duration); usual activities; coffee, tea, soft drink, alcohol consumption; current smoking; smoking exposure; existence and recent use of medical care provider, status and types of health insurance; use of natural hormones; use of osteoporosis prescription medications; recent use of hormone replacement therapy; diagnoses of new medical conditions; family history of Alzheimer s; current employment status; current marital status; family finances. Form 147 OS Follow-Up Questionnaire (Year 7) -- current weight; recent weight change; current physical activity and exercise (frequency, duration); use of weight loss medications; recent use of hormone replacement therapy; diagnoses of new medical conditions; family history of breast cancer; life events; parents birthplace; current marital status. HT women with cervix. Same as Form 38-Daily Life and Form 80 [for hip/waist] cohort). Hct, platelet count, WBC done only at screening on CT and OS participants; triglyceride done on HT participants if serum lipemic. Not required on enhanced recruitment participants.
5 Form 148 OS Follow-Up Questionnaire (Year 8) -- current weight; recent weight change; current physical activity and exercise (frequency, duration); current smoking status; use of weight loss medications; coffee, tea, soft drink consumption ; recent use SERMS, recent use of hormone replacement therapy; diagnoses of new medical conditions; family history of senile dementia; current marital status. Form 149 Supplement to OS Follow-Up Questionnaire (Year 9) -- care giving responsibilities; life events; breast cancer; use of weight loss medications; parents birthplace. Form 150 Hormone Use Update medications for osteoporosis; SERMs; natural hormones; estrogen or progesterone and reason; estrogen and progesterone together; estrogen and testosterone duration, type; estrogen, duration, kind, how adminietered; progesterone, duration, kind, how administered. Form 151 Activities of Daily Life (ADL) general health, quality of life, special services, nursing home, aid to walk, take calcium supplement, health limit list of usual daily activities, assistance needed for routine activities (included in Form 155 in Ext Study Form 153 Medication and Supplement Inventory prescription medications (name, strength, medication type, duration); barriers to get or take medications; non-prescritpion medications (aspirin, AINSM, antacid, natural female hormones, insulin; dietary supplements: multi-vitamin, calcium, vitamin D) Form 154 Breast Health Supplement to Medication Inventory SERMS (tamoxifen, raloxifene, toremilene) and duration; anti-estrogen therapries (anastrozole, exemestane, latrozole), barriers to get or take these medications Form 155 Lifestyle Questionnaire take hormones, weight loss, smoking, alcohol consumption, living conditions, physical activitiy, social activities, support available, everyday care needs, symptoms, outlook, resilience, energy level, sleep habits, anxiety, pain, emotions, spirituality, Form 151-Activities of Daily Life items. 25-Hour Recall For OS participants who did not reach Year 7 by time of closeout. 4.6% DM cohort at years 3, 6, and 9, same as Form 62-4DFR. Also al a repeated crosssectional 1% DM subsample, selected annually
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New Patient Questionnaire Name: Primary Care Physician: Date of Birth: / / Home Phone: ( ) Cell Phone: ( ) Why are you seeing a cardiologist? (please answer in detail) Have you ever seen a cardiologist
Last Name: First Name: MI: 1. Have you recently had any major family changes: If yes, please explain:
Adult Medical Questionnaire Our ability to draw effective conclusions about your present state of health and how to improve it depends, to a significant extent, on your ability to respond thoughtfully
Breast Cancer Risk Assessment and Prevention
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DEPARTMENT OF MEDICINE Outpatient Intake Form
NAME: Last First Middle Initial Date of Birth: ADDRESS: HOME PHONE: WORK PHONE: Did someone refer you here? Yes No If yes, please give name: Main reason for your visit today: MEDICAL HISTORY: (Please check
Genetic Risk Evaluation and Testing Program
INSTRUCTIONS: Please complete this form to the best of your ability PRIOR to your appointment. Please remember to list ALL relatives, both living and deceased, regardless of if they have had cancer or
Top Tier. Medical Breast Specialist, P.C.
Karen S. Barbosa, D.O. Board Certified, Fellowship Trained Breast Surgeon Top Tier Medical Breast Specialist, P.C. 80 Maple Avenue Smithtown, NY 11787 Office: 631.870.8721 Fax: 631.870.8722 Office Visit
Patient Name Date of Birth Age. Other phone ( ) . Other
GASTROINTESTINAL & MINIMALLY INVASIVE SURGERY HEALTH HISTORY QUESTIONNAIRE Date Patient Name _ Date of Birth Age Daytime phone ( ) Other phone ( ) Email How did you hear about us? My doctor Yellow pages
Patient Name Date of Birth MALE / FEMALE Date. Left handed or Right handed. Marital Status: Single Married Divorced Widowed Children?
PH NEW PATIENT HISTORY Patient Name Date of Birth MALE / FEMALE Date Occupation: Left handed or Right handed Marital Status: Single Married Divorced Widowed Children? Y or N # Previous Treating Physician:
Creve Coeur Family Medicine, LLC
Creve Coeur Family Medicine, LLC Patient Name: Date of Birth: Medication List Medication Name (Over the counter medications too) Strength/ Dose (mg) Number of pills per dose Number of times per day Personal
RAJIV SOOD MD, FACS AESTHETIC AND RECONSTRUCTIVE PLASTIC SURGERY MEDICAL HISTORY Today s Date: Name Date of Birth
RAJIV SOOD MD, FACS AESTHETIC AND RECONSTRUCTIVE PLASTIC SURGERY MEDICAL HISTORY 317-880-6825 Today s Date: Date of Birth Phone # Alternate # Age Height Current weight Significant other Name: Reason for
Patient Profile Patient Name: DOB: Address: City: State: Zip: Spouse/Significant Other: Children's names and ages: Patient Employer: Address:
Patient Profile Patient Name: DOB: Address: City: State: Zip: Phone# (H): (W): Other: Email: May Dr. Strong to leave medical information on your answering machine/voicemail? YES NO May Dr. Strong to send
16 East 40 th St, 2 nd Fl, New York, NY Ph fax
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Other doctors to receive copies of records : Chief complaint / history of present illness (Describe why you have been referred here):
Patient Name: Date: Age: Date of Birth: Preferred Name: Preferred Language: Address: City: State: Zip: Phone: Cell Phone: Preferred Phone: Emergency Contact: Relationship: Email: If you would like to opt
Breast Care Patient Questionnaire. Name: Account: When did you first become aware of the problem with your breast?
Breast Care Patient Questionnaire Name: Account: Today s date: / / Height: ft in Weight: lbs. Birth date: / / Age BREAST HISTORY: Reason for visit: Symptoms (see list below), which I noted on routine exam
SURGICAL BREAST PRACTICE NEW PATIENT QUESTIONNAIRE
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Corinna Mosher, M.D. A Medical Corporation 415 E. Rolling Oaks Drive Suite #280 Thousand Oaks, CA (805) Fax (805)
Patient Registration: Corinna Mosher, M.D. A Medical Corporation 415 E. Rolling Oaks Drive Suite #280 Thousand Oaks, CA 91361 (805) 496-8522 Fax (805) 496-0469 Last Name: First Name: MI: Address: City:
New Patient Medical History
New Patient Medical History MR #: Initial Appointment Date: / / Name: Birth Date: / / Address: City: State: Zip: Best Phone # to reach you: ( ) Second contact #: ( ) Email Address: Occupation: Marital
Virginia Center for Reproductive Medicine
Virginia Center for Reproductive Medicine New Patient Questionnaire Date: Patient Name: Date of Birth: / / Age: Social Security #: Address: Phone: (H) ( ) (W) ( ) Cell Phone: ( ) Pharmacy: ( ) Partner
Medications: Prescription and Non-prescription medications, vitamins, home remedies, birth control pills, herbs.
Medical History PLEASE COMPLETE ALL PAGES Name: Date: DOB: Please be as specific as possible as this form will give us a better understanding of your medical concerns and conditions. If you are uncomfortable
743 Jefferson Avenue Suite 203 Scranton, Pennsylvania
743 Jefferson Avenue Suite 203 Scranton, Pennsylvania 18510 570.344.9997 Name: DOB: / / Age: Address: City: State: Zip: Home Phone: Work Phone: Cell Phone: Reason for your visit today: Who referred you
Fertility HEALTH HISTORY
Fertility HEALTH HISTORY Female Name: First Middle Initial Last Preferred name Male Name: First Middle Initial Last Preferred name Address: City: State: Zip code: Contact numbers: home work/cell: Please