Table 3 REMARK profile for Xing et al. (2015)Â [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 | |