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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
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