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Table 3 REMARK profile for Xing et al. (2015) [23]

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

Part a: Patients, treatment, and variables
 Patients: consecutively selected patients treated for papillary thyroid cancer (PTC) at 16 medical centers in 8 countries (USA, Italy, Poland, Japan, Australia, Spain, Czech Rep, South Korea), over differing time periods spanning 1978-2011.
  ? Patients assessed
  ? Patients excluded
  2099 Patients included for analysis, subgroups by v8 (v8-S1: CPTC, n = 1448; v8-S2: FVPTC, n = 431), v9 (v9-S1: stage I, n = 1273; v9-S2: stage II, n = 234), and v4 (v4-S1: tumor size ≤ 1.0 cm, n = 534)
Missing data not mentioned—appears to have been none
 Treatment and follow-up: total thyroidectomy and neck dissection in all patients, postoperative hormone suppression, and radioiodine ablation (in all centers except the Japanese center). Median follow-up 36 months (IQR 14 to 75 months)
  Marker: M = BRAF V600E mutation (positive/negative)
  Outcome (events) Recurrence free survival (RFS, events overall: n = 338; in subgroups: v8-S1: n = 247, v8-S2: n = 43, v9-S1: n = 119, v9-S2: n = 32, v4-S1: n = 57). Expressed as both a proportion of recurrences, and as rate of recurrence per 1000 person-years of follow-up
  Further variables v1 = age, v2 = sex, v3 = medical center, v4 = tumor size, v5 = extrathyroidal invasion, v6 = lymph node metastasis, v7 = multifocality, v8 = PTC subtype, v9 = tumor stage
Adjustment model 2: v1–v3; model 3: v1–v8
Part b: Statistical analysis of survival outcomes
 Aim n Outcome (events) Variables considered Results/remarks
  Ch1: check of proportional hazards assumption after initially fitting models A2 and A3     Led to stratification by medical center (v3) and revision of these analyses
  IDA1: computation of rates of recurrence per 1000 person-years Total and all subgroups    Displayed in Tables 2 and 4 and A3
  A1: univariable unadjusted model 1 All 2099 RFS (338) M Poisson regression p-values and CI; Cox regression HR, CI: Table 2; Kaplan-Meier estimates of recurrence-free survival, p-values: Fig. 1
v8-S1 1448 RFS (247)
v8-S2 431 RFS (43)
  A2: multivariable model 2 All 2099 RFS (338) M, v1–v3 p-values, HR, CI, Table 2
v8-S1 1448 RFS (247)
v8-S2 431 RFS (43)
  A3: multivariable model 3 All 2099 RFS (338) M, v1–v8 p-values, HR, CI, Table 2
v8-S1 1448 RFS (247)
v8-S2 431 RFS (43)
  A4: sensitivity analysis, excluding patients with < 3 year follow-up, no recurrence ? RFS ? M Results p.44 text. Data not shown
  A5: interaction of M with conventional risk factors, univariable 2099 RFS (338) M, v1 (dichotomized), v5, v6 Kaplan-Meier estimates, p-values, Fig. 2, Synergy Index, CI, Table 3
  A6: low-risk patients, unadjusted model 1 v9-S1 1273 RFS (119) M Poisson regression p-values and CI; Cox regression HR, CI: Table 4
v9-S2 234 RFS (32)
v4-S1 534 RFS (57)
  A7: low-risk patients, multivariable model 2 v9-S1 1273 RFS (119) M, v1–v3 p-values, HR, CI, Table 4
v9-S2 234 RFS (32)
v4-S1 534 RFS (57)
  A8: low-risk patients, multivariable model 3 v9-S1 1273 RFS (119) M, v1–v8 p-values, HR, CI, Table 4
v9-S2 234 RFS (32)
v4-S1 534 RFS (57)
  A9: univariable model in v4 subgroups Varies by subgroup RFS (varies) M p-values, HR, CI, Tab. A2
  A10: univariable model for 35 subgroups by v1, v2, and v8 Varies by subgroup RFS (Varies) M HR, CI, Tab. A4
  1. Statistical software packages used: SAS v.9.3
  2. CPTC conventional PTC, FVPTC follicular-variant PTC