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 | |||||
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 |