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Nelson HD, Fu R, Humphrey L, et al. Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Sep. (AHRQ Comparative Effectiveness Reviews, No. 17.)

Appendix ASearches

Appendix A-1. Search Strategies

MEDLINE Searches

Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3, 4, 5
Search Strategy:
1selective estrogen receptor modulators/or raloxifene/or tamoxifen
2exp Breast Neoplasms/pc [Prevention & Control]
31 and 2
4Primary Prevention
5(primar$ adj2 prevent$).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
6exp Breast Neoplasms
71 and 4 and 6
8Chemoprevention
9chemoprevent$.mp.
101 and 6 and 9
111 and 5 and 6
1210 or 11
13(prevent$ adj3 (breast$ adj2 (neoplas$ or tumor$ or cancer$ or malignan$))).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
141 and 13
156 and 14
1612 or 15
17limit 16 to humans
18limit 17 to english language
19limit 17 to abstracts
2018 or 19
Database: Ovid MEDLINE(R) <1996 to January Week 3 2009>
KEY QUESTIONS 1, 2, 3
Search Strategy:
1exp Tamoxifen/ae, po, to
2exp Raloxifene/ae, to, po
3exp Placebos/or placebo$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]
4exp Breast Neoplasms/
51 and 2
61 and 3
72 and 3
84 and 5
94 and 6
104 and 7
11random$.mp.
12exp Randomized Controlled Trials/
13randomized controlled trial.pt.
14rct$.mp.
1511 or 12 or 13 or 14
168 and 15
179 and 15
1810 and 15
1916 or 17 or 18
20exp Cardiovascular Diseases/ep, et [Epidemiology, Etiology]
21exp Endometrial Neoplasms/ep, et [Epidemiology, Etiology]
22exp tamoxifen/
23exp raloxifene/
2420 or 21
2522 and 23
263 and 22
273 and 23
2825 or 26 or 27
2924 and 28
3015 and 29
3119 or 30
32(200705$ or 200706$ or 200707$ or 200708$ or 200709$ or 20071$ or 2008$).ed. (634348)
3331 and 32
Database: Ovid MEDLINE(R) <1996 to January Week 3 2009>
KEY QUESTIONS 1, 2, 3
Search Strategy:
1exp Breast Neoplasms/pc [Prevention & Control]
2exp Ovarian Neoplasms/pc [Prevention & Control]
31 or 2
4(family adj5 histor$).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
5exp Genetic Predisposition to Disease/
6brca.mp.
7(brca1 or brca2).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
84 or 5 or 6 or 7
9exp Selective Estrogen Receptor Modulators/
10(serm or serms or tamoxifen or raloxifene).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
119 or 10
123 and 8 and 11
13exp Contraceptives, Oral/
143 and 8 and 13
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1exp Tamoxifen/
2exp Raloxifene/
31 or 2
4exp Tamoxifen/ae, po, to
5exp raloxifene/ae, po, to
64 or 5
7exp Genital Diseases, Female/ci, ep, et [Chemically Induced, Epidemiology, Etiology]
8exp Genital Diseases, Female/
98 and 6
103 and 7
1110 or 9
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1exp Tamoxifen/ae, po, to
2exp raloxifene/ae, po, to
31 or 2
4exp Uterine Diseases/
5exp uterus/
64 or 5
73 and 6
8exp Hysterectomy/
93 and 8
107 or 9
11limit 10 to (english language and humans)
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1(ovar$ adj5 (cancer$ or tumor$ or malignan$ or carcino$ or neoplas$)).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
2exp tamoxifen/
3exp raloxifene/
42 or 3
54 and 1
6limit 5 to humans
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1exp Tamoxifen/ae, po, ct, to [Adverse Effects, Poisoning, Contraindications, Toxicity]
2exp Raloxifene/ae, ct, to [Adverse Effects, Contraindications, Toxicity]
3Selective Estrogen Receptor Modulators/ae, co, to, po
41 or 2 or 3
5exp Cardiovascular Diseases/mo, ci, co, ep, et [Mortality, Chemically Induced, Complications, Epidemiology, Etiology]
6exp Stroke/mo, co, ci, ep, et
7exp Cardiovascular System/pp, de
85 or 6 or 7
94 and 8
10exp Cardiovascular System/
11exp Cardiovascular Diseases/
1210 or 11
13exp Tamoxifen/
14exp Raloxifene/
15Selective Estrogen Receptor Modulators/
1613 or 14 or 15
174 and 12
188 and 16
1917 or 18
20limit 9 to humans
21limit 19 to humans
2221 not 20
2312 and 16
24limit 23 to humans
2524 not 21
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1exp Tamoxifen/
2exp Raloxifene/
3Selective Estrogen Receptor Modulators/
41 or 2 or 3
5((heart$ or myocardi$ or cardi$ or atria$ or ventric$) adj5 (fibril$ or arrhythm$ or (abnormal$ adj2 rhythm$))).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
65 and 4
7(tamoxifen or raloxifene).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
85 and 7
98 or 6
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3
Search Strategy:
1exp biliary tract/
2exp biliary tract diseases/
31 or 2
4exp Tamoxifen/
5exp Raloxifene/
6Selective Estrogen Receptor Modulators/
74 or 5 or 6
83 and 7
9limit 8 to humans
10(gallstone$ or gall stone$ or gallbladder$ or gall bladder$ or bile duct$ or biliary tract$ or cholelith$ or CHOLECYST$ or CHOLEDOCHOLITH$).mp.
117 and 10
12limit 11 to humans
139 or 12
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTIONS 2, 3, 4
Search Strategy:
1tibolone.mp.
2exp Breast Neoplasms/
3exp Breast/
4or 2
54 and 1
Database: Ovid MEDLINE(R) <1950 to January Week 3 2009>
KEY QUESTION 5
Search Strategy:
1exp Breast Neoplasms/
2exp risk/
31 and 2
4exp risk assessment/
51 and 4
6limit 5 to humans
7exp breast neoplasms/ep, et
84 and 7
9exp Breast Neoplasms/pc, eh
10exp Breast Neoplasms/ge
114 and 9
124 and 10
13exp Disease Susceptibility/
147 and 13
159 and 13
168 or 11 or 14 or 15
17limit 16 to (english language and humans)
18(model$ or valid$).mp. [mp=title, original title, abstract, name of substance word, subject heading word]
1917 and 18
20seer.mp.
2117 and 20
2219 or 21
2317 not 22

Other Database Searches

Database: EBM Reviews - Cochrane Central Register of Controlled Trials <4th Quarter 2008>
KEY QUESTIONS 1, 2, 3
Search Strategy:
1tamoxifen.mp. [mp=title, original title, abstract, mesh headings, heading words, keyword]
2raloxifene.mp. [mp=title, original title, abstract, mesh headings, heading words, keyword]
3placebo$.mp. [mp=title, original title, abstract, mesh headings, heading words, keyword]
41 and 2
51 and 3
62 and 3
74 or 5 or 6
8((breast$ or mammar$) adj5 (cancer$ or tumor$ or carcino$ or adenocarcin$ or neoplas$ or malignan$)).mp.
97 and 8
Database: EBM Reviews - Cochrane Central Register of Controlled Trials <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1((tamoxifen or raloxifene) adj5 (endometri$ or uterine or uterus or hysterect$)).mp. [mp=title, original title, abstract, mesh headings, heading words, keyword]
Database: EBM Reviews - Cochrane Database of Systematic Reviews <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1((tamoxifen or raloxifene) adj5 (endometri$ or uterine or uterus or hysterect$)).mp. [mp=title, abstract, full text, keywords, caption text]
Database: EBM Reviews - Database of Abstracts of Reviews of Effects <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1((tamoxifen or raloxifene) adj5 (endometri$ or uterine or uterus or hysterect$)).mp. [mp=title, full text, keywords]
Database: EBM Reviews - Cochrane Central Register of Controlled Trials <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1tibolone.mp.
Database: EBM Reviews - Cochrane Database of Systematic Reviews <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1tibolone.mp.
Database: EBM Reviews - Database of Abstracts of Reviews of Effects <4th Quarter 2008>
KEY QUESTIONS 2, 3
Search Strategy:
1tibolone.mp.

Appendix A-2. Inclusion and Exclusion Criteria By Key Question

Key QuestionsIncludeExcludeDuration and size of studyOutcomes
1. Benefits*
3. Benefits among population subgroups
≥3 months

≥100 participants
Primary or secondary breast cancer outcomes; other benefits defined by key question 1.
2. Harms§
3. Harms among population subgroups
  • Randomized, double-blind, placebo controlled trials of tamoxifen, raloxifene, or tibolone.
  • Head-to-head trials that include direct comparisons between tamoxifen, raloxifene, or tibolone.
  • Observational studies that report results for women using tamoxifen, raloxifene, or tibolone and compares results to a nonuser group or compares results between these drug use groups.
  • Studies enroll women without pre-existing breast cancer and can include women of all ages, pre or postmenopausal status, hysterectomy or nonhysterectomy status, US and non US.
  • Health outcomes.
  • English language publications.
  • Women with pre-existing breast cancer, known precursor conditions, or known carriers of breast cancer susceptibility mutations (BRCA1 BRCA2, or others).
  • Drugs other than tamoxifen, raloxifene, or tibolone.
  • No harms results.
  • Intermediate outcomes rather than health outcomes.
  • Laboratory or animal studies.
  • Non-English language publications.
≥3 months

≥100 participants
Any health outcome defined by key question 2.
4. Treatment adherence, persistence, concordance, or treatment choice
  • Randomized, double-blind, placebo controlled trials of tamoxifen, raloxifene, or tibolone for breast cancer prevention.
  • Head-to-head trials that include direct comparisons between tamoxifen, raloxifene, or tibolone.
  • Observational and descriptive studies that report results for women using tamoxifen, raloxifene, or tibolone and compares results to a nonuser group or compares results between these drug use groups.
  • Trials enroll women without pre-existing breast cancer and can include women of all ages, pre or postmenopausal status, hysterectomy or nonhysterectomy status, US and non US.
  • Observational and descriptive studies of treatment choice.
  • Studies include data for treatment adherence, persistence, concordance, or treatment choice.
  • English language publications.
  • Women with pre-existing breast cancer, known precursor conditions, or known carriers of breast cancer susceptibility mutations (BRCA1, BRCA2, or others).
  • Drugs other than tamoxifen, raloxifene, or tibolone.
  • No adherence, persistence, concordance, or treatment choice data.
  • Laboratory or animal studies.
  • Non-English language publications.
RCTS: >3 months and >100 participantsAny measure of treatment adherence, persistence, or concordance; data on treatment choice.
5. Clinical risk assessment models
  • Studies of risk stratification models for women of any age.
  • Models used to identify women at higher than average risk for breast cancer.
  • Derivation or validation studies.
  • Study must include discriminatory accuracy of the model.
  • Models must be applicable to the primary care setting.
  • English language publications.
  • Family history/genetics models designed to determine risk for BRCA mutations.
  • Studies of individual risk factors.
  • Laboratory tests.
  • Non-English language publications.
Not specified.Evaluation of risk models for breast cancer that include more than 1 risk factor.
*

Benefit outcomes are defined by key question 1 and include:

Population subgroups are defined by key question 3 and include but are not limited to those based on:

Age, menopausal status (pre-, peri-, postmenopausal), hysterectomy status, use of exogenous estrogen, level of risk of breast cancer (based on family history, body mass index, parity [number of pregnancies], age at first live birth, age at menarche, personal history of breast abnormalities, prior breast biopsy, estradiol levels, breast density), ethnicity and race, metabolism status (CYP 2D6 mutation), and risk for thromboembolic events (obesity, and other risk factors).

Definitions of types of outcomes:

  • A primary outcome is the main outcome of a study that the study was designed and powered to demonstrate.
  • A secondary outcome is a major outcome of a study that the study was designed and powered to demonstrate, but is not the primary outcome of the study.
  • Health outcomes are signs, symptoms, conditions, or events that individuals experience, such as myocardial infarction, death, or hot flahes.
  • Intermediate outcomes are health measures that individuals do not personally experience, such as a laboratory test results or bone mineral density.

§

Harms outcomes are defined by key question 2 and may include but are not limited to:

Benefit outcomes are defined by key question 1 and include:

Population subgroups are defined by key question 3 and include but are not limited to those based on:

Age, menopausal status (pre-, peri-, postmenopausal), hysterectomy status, use of exogenous estrogen, level of risk of breast cancer (based on family history, body mass index, parity [number of pregnancies], age at first live birth, age at menarche, personal history of breast abnormalities, prior breast biopsy, estradiol levels, breast density), ethnicity and race, metabolism status (CYP 2D6 mutation), and risk for thromboembolic events (obesity, and other risk factors).

Definitions of types of outcomes:

  • A primary outcome is the main outcome of a study that the study was designed and powered to demonstrate.
  • A secondary outcome is a major outcome of a study that the study was designed and powered to demonstrate, but is not the primary outcome of the study.
  • Health outcomes are signs, symptoms, conditions, or events that individuals experience, such as myocardial infarction, death, or hot flahes.
  • Intermediate outcomes are health measures that individuals do not personally experience, such as a laboratory test results or bone mineral density.

Harms outcomes are defined by key question 2 and may include but are not limited to:

Cover of Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women
Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women [Internet].
AHRQ Comparative Effectiveness Reviews, No. 17.
Nelson HD, Fu R, Humphrey L, et al.

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