Table 1 REMARK profile—improving the Nottingham Prognostic Index (NPI), adapted from Winzer et al. [16]
From: Structured reporting to improve transparency of analyses in prognostic marker studies
Part a: Patients, treatments, and variables | ||||
 Study and marker | Remarks | |||
  Marker handled |  = NPI Continuous and categorical. Cutpoints as predefined in the literature. For details see Blamey et al. [27] in [16] | |||
  Further variables | v1 = Tumor size, v2 = no. of pos. Lymph nodes, v3 = tumor grade, v4 = age, v5 = histology, v6 = hormone receptor status, v7 = menopausal status, v8 = vessel invasion, v9 = lymphatic vessel invasion | |||
 Patients | n | Remarks | ||
  Assessed for eligibility | 2062 | Disease: primary breast cancer Patient source: Database Surgical clinic Charité, Berlin. All patients with surgery from 1st Jan. 1984 to 31st Dec. 1998. | ||
  Excluded | 502 | 63 metastasis, 73 previous carcinomas other than breast cancer, 86 primary breast cancer prior to the study, 134 breast cancer in situ, 8 pt0, 123 older than 80 years, 20 neo-adjuvant chemotherapy, 71 death within the first months of surgery, three or more standard prognostic factors missing. For some patients, more than one exclusion criterion applied | ||
  Included | 1560 | Previously untreated. Treatment: local therapy: BCT or mastectomy with or without radiotherapy, adjuvant therapy: chemo (y/n), hormone (y/n). For details see, Add file 1 and table 2 in Winzer et al. [28] in [16] | ||
  Outcome events | 221 | Overall survival: death from any cause | ||
Part b: Statistical analysesh | ||||
 Analysis | Patients | Events | Variables considered | Results/remarks |
  IDA 1a: imputation for missing values | 1560 | NRb | v1(94), v2 (68), v3(217), v6(490), v7(54) | Variables (number of patients) with imputed values |
  A1c: NPI (3) | 1560 | 221 | NPI | Prognostic value of NPI in 3 categories (Tables 2 and 3, Fig. 1) |
  A2: NPI (6) | 1560 | 221 | NPI | 6 categories (Fig. 1, Table 3) |
  C1d: check of PHe in NPI (3) and in NPI (6) | 1560 | 221 | NPI | Fig. 2, S4 and non-significant result of FPTf (see last paragraph 4.2) |
  A3: NPIcont | 1560 | 221 | NPI | More information from continuous data? (Table 3) |
  C2: NPIcont. has a linear effect | 1560 | 221 | NPI | FP2 function not significantly better, see 4.3.1 |
  C3: check of PHe in NPIcont | 1560 | 221 | NPI | Non-significant result of FPTf (see last paragraph 4.3.1) |
  A4: MFP7 of the three NPI variables (univ. and multivariable) | 1560 | 221 | v1, v2, v3 | Table 4 |
  A5: functional form for nodes | 1560 | 221 | v2 | Fig. 3 |
  A6: prognostic value and additional value of further variables (univ. and multiv.) | 1560 | 221 | NPI, v4, v5, v6, v7, v8, v9 | Table 5, Fig. 4 |
  A7: MFP using all available information | 1560 | 221 | v1, v2, v3, v4, v5, v6, v7, v8, v9 | Final MFP model in Table 6, see 4.5 |
  A8: measures of separation | 1560 | 221 | NPI, v1, v2, v3, v4, v5, v6, v7, v8, v9 | Table 7, see 4.6 |
  C4: check of PHe in MFP model | 1560 | 221 | v1, v2, v3, v6 | Non-significant result of FPTf (see end of 4.5) |