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Table 4 REMARK profile for Huzell et al. (2015) [24]

From: Structured reporting to improve transparency of analyses in prognostic marker studies

Part a: Patients, treatment, and variables
 Patients: diagnosis of primary breast cancer 2002–2011 at Skåne University Hospital Lund, Sweden
  1045
  51
  994
Patients assessed
Patients excluded (treatment prior to surgery)
Patients included for descriptive analysis
  46 Patients additionally excluded (in situ carcinoma, 38; metastatic spread within 3 months, 8)
  948 Patients included for predictive analysis of the risk of an early breast cancer (BC) event
 Treatment and follow-up: standard care. Follow-up up to 9 years (until December 2012); median 3.03 years (IQR 1.93–5.23)
  Markers Oral contraceptive (OC) use:
M1 = ever OC use (yes/no)
M2 = se before age 20 (yes/no)
M3 = OC use before first child (yes/no)
M4 = OC start 1974 or later (proxy for dose) (yes/no)
M5 = duration of OC use (continuous)
  Outcomes (events) Breast cancer events (BCE) (100): distant metastasis (DM) (65)
  Variables v1 = age, v1_c50 = age ≥ 50 (proxy for menopause), v2 = tumor sizea, v3 = gradeb, v4 = nodal involvement, v5 = hormone receptor status, v6 = BMI9, v7 = endocrine treatment
  Missing data See Tables 1 and 2
Part b: Statistical analysis of survival outcomes
 Aim n Events Outcome Variables considered Results/remarks
  IDA1: data screening and definitions of categories 994 NA   M1, M2, M3 Stat. methods. Definition of markers (categorization of OC use)
  IDA2: descriptive 994 NA OC use categories (M1, M2, M3) v1–6, plus 12 descriptive-only variables Table 1 (patient characteristics), Table 2 (tumor characteristics)
  A1: multivariable 948 100 BCE M1, M2, M3, v1-v6 Reported only in the text (no data provided), p.508 first column
  A2: univariable/multivariable subgroup v1_c50 ≥ 50 760 70 BCE M1, M2, M3, v1–v6 For M2: Fig. 2a, Table 3. Kaplan-Meier, log-rank, and HR. M1 and M3 non-significant and reported only in the text, p.508 first column
  A3: univariable/multivariable subgroup v1_c50 < 50 188 30 BCE M1, M2, M3, v1–v6 For M2: Fig. 2b, Table 3. Kaplan-Meier, log-rank, and HR. M1 and M3 non-significant and reported only in the text, p.508 first column
  A4: multivariable subgroup v1_c50 ≥ 50 ? ? DM M2; v1–v6 Reported in the text, no data provided: p.508 second column
  A5: multivariable subgroup v1_c50 < 50 ? ? DM M2; v1–v6 Log-rank and HR in text, p.508 second column
  A6: multivariable 948 100 BCE M4; v1–v6 HR in text, p.508 second column
  A7: multivariable subgroup v1_c50 ≥ 50 760 70 BCE M4, M5; v1–v6 HR in text, p.508 second column
  A8: multivariable subgroup v1_c50 < 50 188 30 BCE M4, M5; v1–v6 HR in text, p.508 second column
  A9: multivariable subgroup v7 (TAM treatment), v1_c50 (age ≥ 50), v5 (ER+) 372 29 BCE M1; v1–v7 Fig. 3a. Kaplan-Meier, log-rank, and HR—adjusted for tumor and patient characteristics and aromatase inhibitor (AI) treatment
  A10: multivariable subgroup v7 (AI treatment), v1_c50 (age ≥ 50), v5 (ER+) 277 26 BCE M1; v1–v7 Fig. 3b. Kaplan-Meier, log-rank, and HR—adjusted for tumor and patient characteristics and tamoxifen (TAM) treatment
  1. Statistical software packages used: SPSS v.19
  2. BMI body mass index, BCE breast cancer event = local or regional recurrence, distant metastasis, or contralateral breast cancer
  3. aInvasive tumor size ≥ 21 or muscle or skin involvement (yes/no) in the multivariable model
  4. bGrades I–II vs grade III in the multivariable model
  5. 9BMI ≥ 25 kg/m2 (yes/no) in the multivariable model