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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 127   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. J NIH Power Calculations 1 1 Reprinted with permission from the June 28, 1993 WHI Protocol, pages 77-83. Page 127 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 127
An Assessment of the NIH Women's Health Initiative J NIH Power Calculations 1 1 Reprinted with permission from the June 28, 1993 WHI Protocol, pages 77-83.

OCR for page 128
An Assessment of the NIH Women's Health Initiative (i) ERT versus Control: Coronary Heart Disease.   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control ERT (or PERT) 20,000 25,000 30,000 6 25 3.26 2.71 50 59 67 30 3.26 2.62 66 76 83 35 3.25 2.49 80 88 93 9 25 5.03 4.16 69 79 86 30 5.02 3.97 85 92 96 35 5.01 3.79 94 98 99 (ia) PERT versus Control: Coronary Heart Disease.   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control PERT 20,000 25,000 30,000 6 25 3.26 2.71 48 57 65 30 3.26 2.60 64 74 82 35 3.25 2.49 79 87 92 9 25 5.03 4.16 67 77 84 30 5.02 3.97 84 91 95 35 5.01 3.79 94 97 99 (ii) ERT versus Control: Combined Fractures. (The percentage of cases and the powers in this table are based upon our original age distribution assumptions, i.e., 50-59, 60-69, 70-79 year olds enter in the ratio 2:2:1, and hence are conservative estimates.)   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control ERT 20,000 25,000 30,000 6 25 5.84 4.86 79 87 92 30 5.84 4.66 92 96 98 35 5.83 4.46 98 99 >99 9 25 8.85 7.31 94 97 99 30 8.84 6.99 99 >99 >99 35 8.82 6.66 >99 >99 >99

OCR for page 129
An Assessment of the NIH Women's Health Initiative (iia) ERT versus Control: Combined Fractures. (The percentage of cases and the powers in this table are based upon our original age distribution assumptions, i.e., 50-59, 60-69, 70-79 year olds enter in the ratio 2:2:1, and hence are conservative estimates.)   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control PERT 20,000 25,000 30,000 6 25 5.84 4.86 77 85 91 30 5.84 4.66 90 95 98 35 5.83 4.46 98 99 >99 9 25 8.85 7.31 93 97 99 30 8.84 6.99 99 >99 >99 35 8.82 6.66 >99 >99 >99 (iii) ERT versus Control: Hip Fractures.   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control ERT 20,000 25,000 30,000 6 25 2.34 1.94 41 49 56 30 2.34 1.86 55 65 73 35 2.33 1.77 70 79 86 9 25 3.91 3.22 62 71 79 30 3.90 3.07 78 87 92 35 3.89 2.92 90 95 98 (iiia) PERT versus Control: Hip Fractures.   Power (%)   Percentage cases Total sample size Average follow-up (y) Intervention effect (%) Control PERT 20,000 25,000 30,000 6 25 2.34 1.94 39 47 54 30 2.34 1.86 54 63 71 35 2.33 1.77 68 77 84 9 25 3.91 3.22 60 69 77 30 3.90 3.07 76 85 91 35 3.89 2.92 88 94 97

OCR for page 130
An Assessment of the NIH Women's Health Initiative (iv) ERT versus Control: Breast Cancer.   Power (%)   Percentage Cases Total Sample Size Average follow-up (y) Increase due to ERT (%) Control ERT 20,000 25,000 30,000 6 20 2.07 2.25 13 15 17 30 2.08 2.35 23 28 32 9 20 3.04 3.40 27 33 38 30 3.05 3.60 52 61 69 14 20 4.5 5.17 52 62 70 30 4.53 5.54 85 92 96 (iva) PERT versus Control: Breast Cancer.   Power (%)   Percentage Cases Total Sample Size Average follow-up (y) Increase due to PERT (%) Control 20,000 ERT 25,000 30,000 6 20 2.07 2.25 12 14 16 30 2.08 2.35 22 27 31 9 20 3.04 3.40 26 32 37 30 3.05 3.60 50 60 67 14 20 4.50 5.17 51 60 68 30 4.53 5.54 83 91 95

OCR for page 131
An Assessment of the NIH Women's Health Initiative (i) Dietary Modification: Breast Cancer.   Power (%)   Percentage of cases Sample size Average follow-up (y) Intervention effect (%) Control Intervention 42,000 48,000 54,000 6 11 2.05 1.89 25 28 31 12 2.05 1.87 32 35 39 14 2.05 1.85 39 44 48 9 11 2.92 2.61 58 63 69 12 2.92 2.57 70 75 80 14 2.92 2.52 81 86 89 (ii) Dietary Modification: Colorectal Cancer.   Power (%)   Percentage of cases Sample size Average follow-up (y) Intervention effect (%) Control Intervention 42,000 48,000 54,000 6 18 1.07 0.93 33 37 41 20 1.07 0.92 40 45 49 22 1.07 0.91 47 52 57 9 18 1.61 1.32 77 83 87 20 1.61 1.29 86 90 93 22 1.60 1.25 92 95 97 (iii) Dietary Modification: Coronary Heart Disease.   Power (%)   Percentage of cases Sample size Average follow-up (y) Intervention effect Control Intervention 42,000 48,000 54,000 6 11 3.04 2.72 48 53 58 12 3.03 2.67 58 64 69 14 3.02 2.63 68 74 79 9 11 4.62 4.15 62 67 72 12 4.60 4.08 72 78 83 14 4.58 4.00 82 86 90

OCR for page 132
An Assessment of the NIH Women's Health Initiative (i) Calcium/Vitamin D versus Control: Hip Fractures   Power (%)   Percentage cases Total sample size Average Follow-up (y) Intervention effect (%) Control ERT (or PERT) 20,000 25,000 30,000 5 25 1.88 1.58 53 67 78   30 1.88 1.51 69 83 91   35 1.88 1.45 83 93 97 8 25 3.35 2.76 81 92 97   30 3.34 2.64 93 98 >99   35 3.34 2.51 98 >99 >99 (ii) Calcium/Vitamin D versus Control: Combined Fractures (The percentages of cases and powers in this table are based upon our original age distribution assumptions i.e., 50-59, 60-69, 70-79 year olds enter in the ratio 2.2.1 and hence are conservative estimates.)   Power (%)   Percentage cases Total sample size Average Follow-up (y) Intervention effect (%) Control Calcium/ Vitamin D 25,000 35,000 45,000 5 25 4.84 4.07 90 97 99   30 4.84 3.91 98 >99 >99   35 4.83 3.75 >99 >99 >99 8 25 7.85 6.49 99 >99 >99   30 7.83 6.20 >99 >99 >99   35 7.82 5.91 >99 >99 >99 (iii) Calcium/Vitamin D versus Control: Colorectal Cancer   Power (%)   Percentage cases Total sample size Average Follow-up (y) Intervention effect (%) Control Calcium/ Vitamin D 25,000 35,000 45,000 5 18 0.86 0.76 17 23 28   20 0.86 0.75 20 27 33   22 0.86 0.74 24 31 38 8 25 1.42 1.17 52 66 77   30 1.42 1.15 60 75 85   35 1.42 1.12 69 83 91

Representative terms from entire chapter:

coronary heart