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Table 5 REMARK profile for Thurner et al. (2015) [25]

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

Part a: Patients, treatment, and variables
 Patients: treated for primary prostate cancer at the Department of Therapeutic Radiology and Oncology, Medical University of Graz, Austria, 2003–2007
  > 700 Patients assessed
  > 439 Patients excluded (did not meet below criteria, as well as those with a follow-up of < 4 months)a
  261 Patients included for analysis (histologically confirmed primary prostate cancer + pre-treatment CRP levels taken)
 Treatment and follow-up: 3D radiation therapy in curative intent; median follow-up 80 months
  Markers M = pre-treatment CRP (continuous variable; analyses for dichotomized or categorical data, based on optimal cutpoints)
  Outcomes (events) CSS—primary outcome (24), OS (59), DFS (56)
  Further variables v1 = age at diagnosis, v2 = PSA at diagnosis, v3 = tumor stage, v4 = Gleason score, v5 = risk groupb, v6 = total duration of ADT
Part b: Statistical analysis of survival outcomes
 Aim n Outcome (events) Variables considered Results/remarks
  IDA1: correlations Variesc   M, v1–v5 Results p.613 first column
  IDA2: determination of optimal cutpoint for M 261 CSS (24) M CRP dichotomised into high (≥ 8.6 mg 1−1) and low (< 8.6 mg -−1)
  A1: univariable survival analysis 261 A1.1 CSS (24)
A1.2 OS (59)
A1.3 DFS (56)
M Kaplan-Meier estimates, Figs. 1, 2, and 3
  A2: univariable associations Varies A2.1 CSS (24)
A2.2 OS (59)
A2.3 DFS (56)
M, v1, v2, v3, v4, v6 HR, CI, p-values, Tables 2, 3, and 4
  A3: multivariable (including v. from A2.1, A2.2, and A2.3 with p<.05) ? CSS (?)
OS (?)
DFS (?)
M, v2, v3, v4, v6 HR, CI, p-values, Table 2 (CSS), Table 3 (OS), Table 4 (DFS)
  A4: univariable, high risk (v5) 144 A4.1 CSS (?)
A4.2 OS (?)
A4.3 DFS (?)
M HR, CI, p-value, Table  5
  A5: multivariable, high risk (v5) 144 A5.1 CSS (?)
A5.2 DFS (?)
M, v6 HR, CI, p-value, Table 5d
  A6: univariable, intermediate risk (v5) 66 A6.1 CSS (?)
A6.2 OS (?)
A6.3 DFS (?)
M p-values in text, p.615 first column (all n.s.)
  A7: univariable, low risk (v5) 51 A7.1 CSS (?)
A7.2 OS (?)
A7.3 DFS (?)
M p -values in text, p.615 first column (all n.s.)
  IDA3: cutpoint determination for M in subgroups of v5 261 CSS (24) M CRP categorized with cutoff values of 8.9, 8.4, and 13.4 for the v5 risk groups
  A8: univariable by v5 subgroups 144/66/51 A8.1 high-risk, CSS (?)
A8.2 intermediate-risk, CSS (?)
A8.3 low-risk, CSS (?)
M No data shown, p.615 first column (findings same as A4.1, A6.1, and A7.1)
  IDA4: cutpoint determination for M in subgroups of v6e 261 CSS (24) M CRP dichotomized with cutoff values of 6.7 and 8.9 for patients with and without ADT
  A9: univariable by v6 subgroups ?/? A9.1 CSS (?)
A9.2 OS (?)
A9.3 DFS (?)
M HR, CI, p-value, p.615 first and second columns
  1. Statistical software packages used: SPSS v.20
  2. CRP C-reactive protein, CSS cancer-specific survival: time from diagnosis to date of prostate cancer-related death, OS overall survival, DFS clinical disease-free survival, ADT androgen deprivation therapy
  3. aIt is not stated how many patients had a follow-up of < 4 months, nor whether these were excluded prior to the final 261 or were excluded from the 261 in subsequent analyses. We will assume the former
  4. bThree categories
  5. cDue to missing data. Numbers are available in Table 1
  6. dNo multivariable analysis was carried out for OS because v6 was not significant at A4
  7. eHere defined as with/without ADT