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PAPERBACK list:$25.00 Web:$22.50 add to cart PDF BOOK your price: $19.50 add to cart Rights & Permissions Free Resources PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) From Cancer Patient to Cancer Survivor: Lost in Transition Other Related Titles An Assessment of the NIH Women's Health Initiative (1993) Institute of Medicine (IOM) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 117   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. H NIH-Sponsored Women's Health Studies The committee asked NIH to provide information about other studies of women's health within NIH. The following charts were developed from the documents provided by the various institutes. Two charts were developed. The first contains those studies that are funded by more than one institute; the second includes those studies that are single-institute funded. Those studies marked with an asterisk (*) do not necessarily focus on women, however NIH included them in the response regarding “Women 's Health Studies.” Abbreviations are as follows: NHLBI National Heart, Lung, and Blood Institute NCI National Cancer Institute NIDDK National Institute of Diabetes and Digestive and Kidney Diseases NINDS National Institute of Neurological Disorders and Stroke NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases NIDR National Institute Dental Research NIAAA National Institute on Alcohol Abuse and Alcoholism ORMH Office for Research on Minority Health Page 117 Front Matter (R1-R16) Executive Summary (1-18) Introduction (19-24) Clinical Trial (25-76) Observational Study (77-80) Community Prevention Study (81-84) Concluding Remarks (85-90) References (91-94) Appendix A: Clinical Trial Exclusion Criteria (95-100) Appendix B: U.S. House of Representatives Appropriations COmmittee (101-102) Appendix C: Statement of Task (103-104) Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health (105-108) Appendix E: Meeting Participants June, July, and August 1993 (109-112) Appendix F: Primary and Subsidiary Hypotheses of the Women's Health Initiative Clinical Trial (113-114) Appendix G: Women's Health Initiative Committees (115-116) Appendix H: NIH-Sponsored Women's Health Studies (117-122) Appendix I: NIH Cost and FTE Summary for Vanguard Clinical Centers (123-126) Appendix J: NIH Power Calculations (127-132) Appendix K: Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators (133-134) Appendix L: Abbreviations and Acronyms (135-136) Appendix M: Committee and Staff Biographies (137-142)

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OCR for page 117
An Assessment of the NIH Women's Health Initiative H NIH-Sponsored Women's Health Studies The committee asked NIH to provide information about other studies of women's health within NIH. The following charts were developed from the documents provided by the various institutes. Two charts were developed. The first contains those studies that are funded by more than one institute; the second includes those studies that are single-institute funded. Those studies marked with an asterisk (*) do not necessarily focus on women, however NIH included them in the response regarding “Women 's Health Studies.” Abbreviations are as follows: NHLBI National Heart, Lung, and Blood Institute NCI National Cancer Institute NIDDK National Institute of Diabetes and Digestive and Kidney Diseases NINDS National Institute of Neurological Disorders and Stroke NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases NIDR National Institute Dental Research NIAAA National Institute on Alcohol Abuse and Alcoholism ORMH Office for Research on Minority Health

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An Assessment of the NIH Women's Health Initiative TABLE H-1 WOMEN'S HEALTH STUDIES WITH MULTI-INSTITUTE FUNDING Study Title Contributing Institutes Estimate of Costs by Institute ($) Period of Study Number of Subjects Women's Health Trial: Feasibility Study in Minority Populations NCI NHLBI NIDR 12,300,000 1,106,000 300,000 13,706,000 2 years 2,250 WHT Feasibility Study in Minority Populations: Salivary Study NIDR (same as above) 300,000 (part of above) 2 years (same as above period) 200 (part of above sample) Postmenopausal Estrogen/Progestin Interventions (PEPI) NHLBI NICHD NIAMS NIA NIDDK 15,187,000 3,535,355 2,025,000 578,000 535,000 21,860,355 10 years 875 Breast Cancer Prevention Trial - Tamoxifen NCI NHLBI NIAMS 65,820,000 7,931,000 2,136,000 75,887,000 7 years 16,000 Study of Osteoporotic Fractures NIAMS NIA 32,489,000 14,615,191 47,104,191 11 years 9,700 Efficacy of Estrogen in Hyperprolactinemic Amenorrhea NIDDK ORWH 1,043,032 NA 1,043,032 5 years 100 Membrous Lupus Nephropathy NIDDK NCI 1,257,000 NA 1,257,000 9 years 16 to date (75% female) Combination Radioiodine and Adriamycin for Follicular Thyroid Carcinoma NIDDK NCI 1,499,000 NA 1,499,000 6 years 22 to date (75% female) Vitamin E, Betacarotene and Aspirin in Women NCI NHLBI 8,474,728 8,348,000 16,822,728 5 years 40,000 Long-Term Outcome of Obesity Treatment in Minority Women NIDDK ORMH 3,534,011 6 years 600

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An Assessment of the NIH Women's Health Initiative TABLE H-2 WOMEN'S HEALTH STUDIES FUNDED BY SINGLE INSTITUTES Study Title Contributing Institute Estimate of Cost ($) Period of Study Number of Subjects Low Fat Diet and Breast Cancer Reccurrence NCI 6,729,000 9 years 2,000 Carotene and Retinol Efficiency Trial NCI 24,707,000+ 13 years 17,000 (45% female) A Dietary Study of the Recurrence of Large Bowel Adenomatoris Polyps NCI 35,025,000 7 years 2,000 (30% female) Screening Trial for Prostate, Lung, Colorectal, and Ovarian Cancer NCI 74,517,000 16 years 148,000 (50% female) Treatment Strategies for Osteoporosis NIDDK 380,370 3 years 80 Ursodeoxycholate-Methotrexate for Primary Biliary Cirrhosis Clinical Trial NIDDK 3,330,368 6 years NA Human Zinc Deficiency (MCH) NIDDK 2,804,751 14 years 80 Low Fat Ad Libitum Diet and Weight Loss NIDDK 617,246 3 years 118 Biosynthesis, Glycosylation, and Action of Thyrotropin: Clinical Trials of Recombinant TSH NIDDK 2,008,000 3 years 35 (% female NA) Obesity Treatment: Self-Management vs. Dependence Models NIDDK 653,062 3 years 240 Modification of Director and Renal Disease * NIDDK 59,020,000 10 years 855 Cardiovascular Health Study NHLBI 63,370,000 6 years 5,201 (43% female) Women's Health Study NHLBI 8,348,000 5 years 41,600 Trial of Antioxidant Therapy of Cardiovascular Disease in Women (part of WHS) NHLBI 3,122,000 5 years 8,000 Nurses's Health Study NHLBI 2,762,000 13 years 121,700 Calcium for Preeclampsia Prevention NHLBI 2,000,000 3 years 4,500 Cardiovascular Risk Factors and Menopause NHLBI 2,207,000 4 years 550 Maintenance Psychotherapy in Recurrent Depression NHLBI 3,800,000 5 years 180 Atherosclerosis Risk in Communities * NHLBI 102,689,000 14 years 16,000 (% female NA) NHLBI Growth and Health Study NHLBI 16,645,000 9 years 2,379 Estrogen Effects on Cognition in Turner Syndrome NINDS 1,209,014 9 years 2,379

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An Assessment of the NIH Women's Health Initiative Women's Estrogen for Stroke Trial NINDS 5,205,657 5 years 652 Genetic Epidemiology of Epilepsy * NINDS 600,000 6 years 2,501 (46% female) Incidence and Prevalence of Epilepsy * NINDS 800,000 6 years 3,000 (50% female) Rochester Diabetic Neuropathy Study NINDS 3,744,698 9 years 380 (50% female) Felbamage Concentration Response Trial * NINDS 3,922,358 2 years 140 (50% female) Genetic Epidemiology of Familial Epilepsy * NINDS 1,449,561 10 years 340 (50% female) Rectal Diazepam in Acute Repetitive Seizures * NINDS 3,034,621 3 years 144 (47% female) Remacemide Inpatience Seizure Evaluation Trial * (RISE) NINDS 1,741,641 3 years 60 (33% female) Control Study of Value of BMT for Storage Diseases * NINDS 2,196,210 5 years 165 (50% female) National Acute Spinal Cord Injury Study * NINDS 6,609,929 17 years 495 (15% female) Stroke Prevention in Atrial Fibrillation * NINDS 14,799,368 9 years 3,400 (35% female) Warfarin Aspirin Recurrent Stroke Study * NINDS 25,875,696 5 years 1,920 (% female NA) Brain Resuscitation Clinical Trial * NINDS 3,379,284 14 years 2,500 (33% female) North American Carotid Endarterectomy Trial * NINDS 22,461,790 11 years 2,800 (% female NA) Randomizes Trial of Tirilizad in Acute Stroke * NINDS 1,124,130 2 years 700 (% female NA) Phase II-B Randomized Controlled Study of Tissue Plasminogen Activator for Acute Ischemic Stroke * NINDS 6,921,909 4 years 400 (% female NA) Randomized Trial of ORG 10172 in Acute Ischemic Stroke and Data Management Center * NINDS 9,532,046 5 years 1,800 (40% female) Asymptomatic Carotid Artery Stenosis Collaborative Study * NINDS 13,389,265 11 years 1,500 (35% female) Studies of the Natural History and Response to Therapy in Multiple Sclerosis Using MRI * NINDS 2,408,919 NA 38 (66% female)

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An Assessment of the NIH Women's Health Initiative New alcohol problems and disorder: 11 year ECA follow-up * NIAAA 311,680 3 years 867 (62% female) Biological markers of alcohol consumption among women NIAAA 67,486 NA 60 Secondary prevention of alcohol problems in women NIAAA 147,259 2 years NA (100% female) Alcohol use among teenagers and infant outcome NIAAA 126,829 NA 600 Effect of prenatal alcohol use on pediatric outcome NIAAA 82,088 9 years 650 Neuroendocrine effects of alcohol on puberty * NIAAA 135,866 NA NA Alcohol effects in postmenopausal women NIAAA 240,368 NA NA Fetal alcohol exposure and female reproductive function * NIAAA 210,781 NA NA Impact of labeling and education on antenatal drinking NIAAA 169,689 NA 14,500 Fetal alcohol exposure --From mechanism to prevention: protecting the next pregnancy * NIAAA 186,102 NA NA Biological risk factors in relatives of alcoholic women NIAAA 328,648 NA NA Hb-associated acetaldehyde --A marker of fetal alcohol exposure * NIAAA 57,211 NA NA Alcoholism and family interaction * NIAAA 475,739 NA 300 (17% female) Hispanic drinking and intra-family violence * NIAAA 699,615 NA 800 (% female NA) Genetic epidemiology --Alcohol abuse in eating disorders NIAAA 399,993 NA 147 A twin/family study of alcohol dependence in women NIAAA 157,151 2 years 2,503 (app 70% female) Alcohol use and HIV-related risky sex among adolescents * NIAAA 110,486 2,676 (50% female) 5 years Frequent heavy drinking and marital violence in newlyweds * NIAAA 194,716 1 year 4,000 (50% female) Experimental study of alcohol and marital aggression * NIAAA 145,044 NA 440 (50% female) Alcoholism and family history in women NIAAA 174,599 NA 60 A twin study of female alcoholism and related disorders NIAAA 762,450 App 20 years 2,400 (75% female)

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An Assessment of the NIH Women's Health Initiative Family history of alcoholism and premenstrual symptoms NIAAA 165,104 1 year NA Biobehavioral studies of alcohol problems in women NIAAA 141,098 NA NA Alcohol and the menstrual cycle -- Biobehavioral studies NIAAA 355,400 NA NA Mother's alcohol problems and children's victimization * NIAAA 305,567 NA App 1,000 (50% female) Alcohol, breathing, and sleep -- Age and gender effects * NIAAA 166,745 NA NA Cognitive and psychosocial recovery in alcoholic subtypes * NIAAA 181,903 2 years 240 (50% female) Longitudinal twin-family studies -- Use and abuse of alcohol * NIAAA 298,897 12,500 5 years (% female NA) Problem drinking by future MDs * NIAAA 190,951 NA NA Drinking, drug use and unsafe sex among gay and bisexual couples * NIAAA 180,414 NA NA Maternal alcohol and lactational immune transfer NIAAA 194,052 NA NA Interpersonal skills of adult children of alcoholics * NIAAA 103,300 NA 240 (% female NA) Dietary ethanol and initiation of DMBA tumorigenesis NIAAA 124,602 NA NA (100% female) Characteristics of homeless women and their children * NIAAA 301,844 NA 1,200 (% female NA) Neurobehavioral aspects of fetal alcohol exposure * NIAAA 895,954 NA NA Health beliefs and alcohol use in pregnant women NIAAA 79,649 NA 200 Psychosocial correlates of adolescent driving behavior * NIAAA 225,156 NA 5,000 Alcohol and stress -- Interactive effects * NIAAA 123,328 NA NA Problem drinking in women --A national survey follow-up NIAAA 456,729 10 years NA Effects of alcohol in human ovarian cell function NIAAA 168,224 NA NA Time-dependent effect of alcohol on spontaneous abortion NIAAA 34,560 NA 5,300 Vulnerability factors and adolescent drinking * NIAAA 172,191 2 years 3,190 (% female NA) Behavioral risk for AIDS among alcoholics * NIAAA 215,327 NA 1,500 (% female NA) Children of alcoholics risk in young adults -- A longitudinal sibling design * NIAAA 143,713 NA 12,686 (% female NA) Primary care alcohol screens --Patient sex and ethnicity * NIAAA 74,750 2 years 1,350 (66% female)

Representative terms from entire chapter:

health studies