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Table 1 Characteristics of the included studies for estimating the calibration of the Gail model

From: Assessment of performance of the Gail model for predicting breast cancer risk: a systematic review and meta-analysis with trial sequential analysis

Reference

Author

Publication year

Geographic background

Gail model version

5/10-year risk

Sample size

Mean age (years)

Study population

Risk for breast cancera

Time period

Follow-up period

E/O (95% CI)

[9]

Bondy

1994

America

1

5

1981

30–75

American Cancer Society 1987 Texas Breast Screening Project (with family history of breast cancer)

High risk

1987–1992

5.0

1.31 (0.96–1.79)

[10]

Spiegelman

1994

America

1

5

115,172

29–61

Nurses’ Health Study (NHS)

General population

1976–1981

6.0

1.33 (1.28–1.39)

[12]

Costantino-1

1999

America

1

5

5969

> 35

Placebo group of Breast cancer prevention trial (BCPT)

General population

1992–1998

4.03 (0.1–5.83)

0.84 (0.73–0.97)

[12]

Costantino-2

1999

America

2

5

5969

> 35

Placebo group of Breast cancer prevention trial (BCPT)

General population

1992–1998

4.03 (0.1–5.83)

1.03 (0.88–1.21)

[11]

Rockhill

2001

America

2

5

82,109

45–71

Nurses’ Health Study (NHS)

General population

1992–1997

5.0

0.94 (0.89–0.99)

[30]

Amir

2003

United Kingdom

2

10

3150

44 (21–73)

Women attending the Family History Screening Programme in University Hospital of South Manchester

Not defined

1987–2001

5.27 (0.1–15)

0.69 (0.54–0.90)

[13]

Bernatsky

2004

America

1

5

871

41 ± 13

Systemic lupus erythematosus clinic cohorts at Canada, Northwestern and UK center

High risk

1984–2000

9.1

0.48 (0.29–0.80)

[14]

Olson

2004

America

1

5

674

31–90

Women with possible bilateral oophorectomy identified from the Mayo Clinic Surgical Index

Low risk

1994–2004

NA

1.37 (0.92–2.04)

[28]

Boyle

2004

Italy

2

5

5383

NA

Women participated in RCT of tamoxifen for breast cancer prevention in Italy

General population

1992–2001

5.0

1.16 (0.89–1.49)

[29]

Decarli

2006

Italy

2

5

10,031

35–64

Florence—European Prospective Investigation Into Cancer and Nutrition Cohort (EPIC)

General population

1993–2002

9.0

0.93 (0.81–1.07)

[31]

Chlebowski

2007

America

2

5

147,916

63 (50–79)

Women’s Health Initiative (WHI)

General population

1993–2005

5.0

0.79 (0.77–0.82)

[15]

Tice

2008

America

2

5

629,229

40–74

National Cancer Institute-funded Breast Cancer Surveillance Consortium (BCSC)

General population

since 1994

5.3

0.88 (0.86–0.90)

[16]

Schonfeld-1

2010

America

2

5

181,979

62.8

National Institutes of Health-American Association of Retired Persons (NIH-AARP)

General population

1995–2003

7.5

0.87 (0.85–0.89)

[16]

Schonfeld-2

2010

America

2

5

64,868

62.3

Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO)

General population

1993–2006

8.6

0.86 (0.82–0.90)

[17]

Tarabishy

2011

America

2

5

4726

18–85

Mayo Benign Breast Disease (BBD)

High risk

1991–1996

5.0

1.08 (0.88–1.33)

[38]

Chay-1

2012

Singapore

3

5

28,104

50–64

Singapore Breast Cancer Screening Project (SBCSP)

General population

1997–2007

5.0

2.51 (2.14–2.96)

[38]

Chay-2

2012

Singapore

3

10

28,104

50–64

Singapore Breast Cancer Screening Project (SBCSP)

General population

1997–2007

10.0

1.85 (1.68–2.04)

[52]

Maclnnis

2012

Australia

NA

NA

2000

NA

Female relatives of the breast cancer cases in Australia

High risk

NA

10.0

0.89 (0.73–1.09)

[32]

Pastor-Barriuso

2013

Spain

2

5

54,649

45–68

Population-based Navarre Breast Cancer Screening Program (NBCSP)

General population

1996–2005

7.7

1.46 (1.36–1.56)

[33]

Buron

2013

Spain

2

5

2200

49–64

Participants with a positive screening mammogram in “Parc de Salut Mar” breast cancer screening program

High risk

2003–2010

6.0

0.58 (0.54–0.63)

[41]

Min-1

2014

Korea

2

5

40,229

> 10

Women routinely screened in Women’s Healthcare Center of Cheil General Hospital

Not defined

1999–2004

5.0

2.46 (2.10–2.87)

[41]

Min-2

2014

Korea

3

5

40,229

> 10

Women routinely screened in Women’s Healthcare Center of Cheil General Hospital

Not defined

1999–2004

5.0

1.29 (1.11–1.51)

[18]

Powell

2014

America

2

5

12,843

NA

Marin Women’s Study with high rate of breast cancer, null parity and delayed childbirth

High risk

2003–2007

5.0

0.81 (0.71–0.93)

[19]

McCarthy

2015

America

2

5

464

48.7 ± 13.2

Women referred for biopsy with abnormal (Breast Imaging Reporting And Data System, BI-RADS 4) mammograms at the Hospital of the University of Pennsylvania

High risk

2003–2012

5.0

3.78 (2.78–5.13)

[34]

Dartois

2015

France

2

5

13,174

42–72

Women in French E3N prospective cohort to investigate the cancer risk factors

General population

1993–1998

5.0

0.97 (0.84–1.12)

[39]

Hu

2015

China

2

5

42,908

35–69

Women participated in the breast cancer screening in Zhejiang eastern coastal areas of China

General population

2008–2014

5.0

2.09 (1.73–2.52)

[20]

Schonberg-1

2015

America

2

5

71,293

70 ± 7.0

Nurses’ Health Study (NHS)

High risk

2004–2009

5.0

1.20 (1.13–1.26)

[20]

Schonberg-2

2015

America

2

5

79,611

71 ± 6.8

Women’s Health Initiative (WHI), extensive study

High risk

2005–2010

5.0

1.05 (1.00–1.10)

[35]

Brentnall

2015

United Kingdom

2

10

50,628

47–73

15 screening areas in Greater Manchester, UK

General population

2009–2014

3.2

2.67 (2.46–2.90)

  1. Note: Gail model type 1, original Gail model; Gail model type 2, modified Gail model for Caucasian-American; Gail model type 3, modified Gail model for Asian-American
  2. NA not available, E/O expected-to-observed ratio, CI confidence interval, RCT randomized controlled trial
  3. aCohort studies enrolled women with high risk for breast cancer (with higher average age (> 70 years), dense mammary image, postmenopausal state, breast cancer relatives or high rate of delayed childbirth) were defined as “High risk”; cohort studies that did not accurately depict the characteristics of the participants were defined as “Not defined”. Participants with protective factors for breast cancer were considered low risk