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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