[
 {
  "trial": "T116",
  "source": "fulltext",
  "arms": {
   "Esketamine group": {
    "randomized": "68",
    "analysed": "68"
   },
   "Normal saline group": {
    "randomized": "68",
    "analysed": "68"
   }
  },
  "depression": [
   {
    "measure": "EPDS",
    "day": 2,
    "form": "mean_sd",
    "location": "Table 2, Total scores",
    "values": {
     "Esketamine group": {
      "mean": "21.10",
      "sd": "2.02",
      "n": "68"
     },
     "Normal saline group": {
      "mean": "23.34",
      "sd": "2.01",
      "n": "68"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 3,
    "form": "count",
    "definition": "PPD as the paper reports it; criterion not stated (EPDS is the only depression scale the paper names)",
    "location": "Results, 'Comparison of postpartum depression (PPD) incidence' (text)",
    "values": {
     "Esketamine group": {
      "events": "4",
      "n": null
     },
     "Normal saline group": {
      "events": "15",
      "n": null
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 7,
    "form": "mean_sd",
    "location": "Table 3, Total scores",
    "values": {
     "Esketamine group": {
      "mean": "17.86",
      "sd": "2.17",
      "n": "68"
     },
     "Normal saline group": {
      "mean": "20.55",
      "sd": "2.21",
      "n": "68"
     }
    }
   }
  ],
  "pain": [],
  "adverse_events": [
   {
    "window": "intraoperative",
    "location": "Table 6 (rows without 'Postoperative'; text: intraoperative adverse reactions)",
    "values": {
     "Esketamine group": {
      "dizziness": "14",
      "hallucination": "1",
      "dissociation": "1",
      "agitation": "1",
      "visual": "2"
     },
     "Normal saline group": {
      "dizziness": "11",
      "hallucination": "2",
      "dissociation": "3",
      "agitation": "1",
      "visual": "1"
     }
    }
   },
   {
    "window": "postoperative",
    "location": "Table 6 ('Postoperative dizziness')",
    "values": {
     "Esketamine group": {
      "dizziness": "3"
     },
     "Normal saline group": {
      "dizziness": "4"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2024-08",
   "end": "2025-08"
  },
  "registration": {
   "number": "ChiCTR2400088992",
   "date": null
  },
  "note": "Single-blind (mothers only). The paper calls the Esketamine group 'study group' and the Normal saline group 'control group'; Tables 2 to 5 list the control group first. EPDS entries are the 'Total scores' rows, copied as printed (about 18 to 23, high beside the PPD rates). PPD incidence is given only in the text, with no criterion stated: day 3, 4 (5.88%) vs 15 (22.06%), no denominator printed (the percentages fit 68 per arm), entered under EPDS as a count without n; days 7 and 14 as percentages only (5.08% vs 22.41%; 5.08% vs 20.69%), which are not k/68, so fewer were assessed then; day 30 not significant, no numbers; Figure 2 has no printed values; none of these entered. Pain: VAS at rest and during movement (4, 12, 24 h) appear only in Figure 4, with no printed values, so nothing is entered. Table 4's PCIA pump presses are not a design measure and are not entered: within 24 h 2.57±0.74 vs 4.15±1.22, within 48 h 3.55±1.24 vs 4.75±1.33, time to first press 5.63±0.81 vs 5.79±0.72 h (esketamine vs saline). Adverse events (Table 6): rows without 'Postoperative' are intraoperative, as the text says; 'Illusion' coded as hallucination (the text calls them hallucinations), 'Restless and agitated' as agitation, 'Nystagmus' as visual; 'Disgusting' (nausea), vomiting, hypertension, tremble, hypertonia and cold sweat not coded; postoperative events were monitored for 24 h. Enrollment period is the trial period in Methods ('between August 2024 and August 2025'); the Results give none.",
  "reason": "The coders differed only in the name of the day-3 PPD count (4 vs 15, no denominator printed). Measures follow the design, whose only depression measure is EPDS, the only depression scale the paper names, so I kept coder B's 'EPDS' and said in the definition that the paper never states its PPD criterion. I also removed both coders' pain entries: Table 4's analgesic-pump presses are not a design measure (the design's VAS at rest and on movement are only in Figure 4 without printed values); their values are kept in the note."
 },
 {
  "trial": "T121",
  "source": "library",
  "arms": {
   "Esketamine group": {
    "randomized": "87",
    "analysed": "85"
   },
   "Control group (normal saline; PCIA without esketamine)": {
    "randomized": "87",
    "analysed": "84"
   }
  },
  "depression": [
   {
    "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)",
    "day": -1,
    "form": "median_iqr",
    "location": "Table 1 (Preoperative EPDS Score)",
    "values": {
     "Esketamine group": {
      "median": "12",
      "q1": "10",
      "q3": "13",
      "n": "85"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "median": "12",
      "q1": "10.8",
      "q3": "14",
      "n": "84"
     }
    }
   },
   {
    "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)",
    "day": 3,
    "form": "median_iqr",
    "location": "Table 2 (3 days postpartum, EPDS score)",
    "values": {
     "Esketamine group": {
      "median": "9.0",
      "q1": "7.0",
      "q3": "11.0",
      "n": "85"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "median": "10.0",
      "q1": "8.8",
      "q3": "13.0",
      "n": "84"
     }
    }
   },
   {
    "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)",
    "day": 3,
    "form": "count",
    "definition": "EPDS score ≥ 10",
    "location": "Table 2 (3 days postpartum, PPD risk)",
    "values": {
     "Esketamine group": {
      "events": "37",
      "n": "85"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "events": "53",
      "n": "84"
     }
    }
   },
   {
    "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)",
    "day": 42,
    "form": "median_iqr",
    "location": "Table 2 (6 weeks postpartum, EPDS score)",
    "values": {
     "Esketamine group": {
      "median": "6.0",
      "q1": "3.0",
      "q3": "9.0",
      "n": "85"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "median": "7.0",
      "q1": "4.0",
      "q3": "11.3",
      "n": "84"
     }
    }
   },
   {
    "measure": "EPDS (PPD = EPDS >=10; incidence at 6 weeks primary)",
    "day": 42,
    "form": "count",
    "definition": "EPDS score ≥ 10",
    "location": "Table 2 (Primary outcome, 6 weeks postpartum PPD risk)",
    "values": {
     "Esketamine group": {
      "events": "16",
      "n": "85"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "events": "33",
      "n": "84"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "NRS at rest (supine) at 24 and 48 h",
    "day": 1,
    "form": "median_iqr",
    "location": "Results 3.3, text (24 h; one value pair printed for 'NRS pain scores at rest and during coughing')",
    "values": {
     "Esketamine group": {
      "median": "3.0",
      "q1": "2.0",
      "q3": "4.0",
      "n": null
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "median": "4.0",
      "q1": "3.0",
      "q3": "5.0",
      "n": null
     }
    }
   },
   {
    "measure": "NRS during coughing at 24 and 48 h",
    "day": 1,
    "form": "median_iqr",
    "location": "Results 3.3, text (24 h; one value pair printed for 'NRS pain scores at rest and during coughing')",
    "values": {
     "Esketamine group": {
      "median": "3.0",
      "q1": "2.0",
      "q3": "4.0",
      "n": null
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "median": "4.0",
      "q1": "3.0",
      "q3": "5.0",
      "n": null
     }
    }
   },
   {
    "measure": "Cumulative sufentanil consumption (0-12, 12-24, 0-24, 24-48, 0-48 h)",
    "day": 1,
    "form": "mean_sd",
    "location": "Results 3.3, text (0–24 h)",
    "values": {
     "Esketamine group": {
      "mean": "33.5",
      "sd": "9.7",
      "n": null
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "mean": "48.2",
      "sd": "11.8",
      "n": null
     }
    }
   },
   {
    "measure": "Cumulative sufentanil consumption (0-12, 12-24, 0-24, 24-48, 0-48 h)",
    "day": 2,
    "form": "mean_sd",
    "location": "Results 3.3, text (total 48-h consumption, 0–48 h)",
    "values": {
     "Esketamine group": {
      "mean": "59.4",
      "sd": "11.6",
      "n": null
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "mean": "75.5",
      "sd": "14.1",
      "n": null
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "intraoperative",
    "location": "Table 3 (Adverse effects during the operation)",
    "values": {
     "Esketamine group": {
      "dizziness": "27",
      "hallucination": "5",
      "nightmare": "2"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "dizziness": "9",
      "hallucination": "0",
      "nightmare": "0"
     }
    }
   },
   {
    "window": "postoperative",
    "location": "Table 3 (Adverse effects after surgery)",
    "values": {
     "Esketamine group": {
      "dizziness": "9",
      "hallucination": "2",
      "nightmare": "2"
     },
     "Control group (normal saline; PCIA without esketamine)": {
      "dizziness": "2",
      "hallucination": "0",
      "nightmare": "0"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2023-10-20",
   "end": "2024-06-16"
  },
  "registration": {
   "number": "ChiCTR2300077191",
   "date": null
  },
  "note": "Women with prenatal EPDS >= 10; esketamine 0.25 mg/kg after cord clamping plus 1.25 mg/kg in the PCIA. Randomized 87 and 87; analysed 85 and 84 (2 and 3 withdrew or were lost), the tables' column N. Baseline EPDS is the preoperative-interview score, median (Q1, Q3). Counts use the paper's PPD criterion, EPDS >= 10. Table 2's exploratory counts at other cut-offs are not entered (esketamine vs control, of 85 and 84): EPDS >= 13, day 3 11 vs 22, 6 weeks 5 vs 15; EPDS >= 12, day 3 13 vs 30, 6 weeks 7 vs 21; EPDS >= 11, day 3 22 vs 39, 6 weeks 12 vs 24. NRS: the text prints one value pair per time for 'NRS pain scores at rest and during coughing' without separating them, so the same 24-h pair is entered under both design measures; it is one printed pair, not two measurements. The 6-h and 12-h pairs fall outside the day windows, 48 h is only 'comparable (P > 0.05)', and Fig. 2 (captioned mean ± SD) has no printed values. Sufentanil in μg: 0-24 h entered as day 1 and the 0-48 h total as day 2; also printed, esketamine vs control: 0-12 h 17.7 ± 6.0 vs 27.6 ± 6.4, 12-24 h 15.8 ± 4.7 vs 20.6 ± 7.0, 24-48 h 25.9 ± 3.3 vs 27.4 ± 4.4; no n printed for pain. Postoperative adverse events cover the first 48 h. Enrollment dates are the screening period stated in Results ('From 20 October 2023 to 16 June 2024'); last follow-up July 28, 2024.",
  "reason": "Two differences. Coder B also entered Table 2's exploratory counts at EPDS >= 11, >= 12 and >= 13; the codebook counts participants with depression by the source's definition, which is EPDS >= 10 (also the design's), so I kept coder A's single count per time and listed the others in the note. Both coders put the 24-h NRS pair under the source's wording, differing only in 'Postoperative'; measure names must follow the design, and the text gives one pair for 'at rest and during coughing', so I entered that same pair under both design NRS measures and said so in the note."
 },
 {
  "trial": "T031",
  "source": "fulltext",
  "arms": {
   "Ketamine group": {
    "randomized": "33",
    "analysed": "32"
   },
   "Placebo group": {
    "randomized": "33",
    "analysed": "32"
   }
  },
  "depression": [
   {
    "measure": "EPDS",
    "day": -1,
    "form": "median_iqr",
    "location": "Table 1, 'Depression score (point)'",
    "values": {
     "Ketamine group": {
      "median": "12",
      "q1": "10",
      "q3": "13",
      "n": "32"
     },
     "Placebo group": {
      "median": "11",
      "q1": "10",
      "q3": "12",
      "n": "32"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 2,
    "form": "median_iqr",
    "location": "Table 3, 'Depression score at 48 h (point)'",
    "values": {
     "Ketamine group": {
      "median": "9",
      "q1": "6",
      "q3": "13",
      "n": "32"
     },
     "Placebo group": {
      "median": "8",
      "q1": "6",
      "q3": "10",
      "n": "32"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 2,
    "form": "change_median_iqr",
    "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 48 h'",
    "values": {
     "Ketamine group": {
      "median": "-4",
      "q1": "-5",
      "q3": "0",
      "n": "32"
     },
     "Placebo group": {
      "median": "-2",
      "q1": "-4",
      "q3": "-1",
      "n": "32"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "median_iqr",
    "location": "Table 3, 'Depression score at 42 days (point)'",
    "values": {
     "Ketamine group": {
      "median": "10",
      "q1": "7",
      "q3": "12",
      "n": "32"
     },
     "Placebo group": {
      "median": "9",
      "q1": "7",
      "q3": "11",
      "n": "32"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "count",
    "definition": "EPDS ≥ 10",
    "location": "Table 3, 'Depression score ≥10 at 42 days'",
    "values": {
     "Ketamine group": {
      "events": "18",
      "n": "32"
     },
     "Placebo group": {
      "events": "14",
      "n": "32"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "change_median_iqr",
    "location": "Table 3, exploratory analysis, 'Change from baseline depression score (point): At 42 days'",
    "values": {
     "Ketamine group": {
      "median": "-2",
      "q1": "-4",
      "q3": "0",
      "n": "32"
     },
     "Placebo group": {
      "median": "-2",
      "q1": "-5",
      "q3": "-1",
      "n": "32"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "NRS at rest",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 3, 'Numeric rating scale of pain at rest: At 24 h'",
    "values": {
     "Ketamine group": {
      "median": "4",
      "q1": "3",
      "q3": "5",
      "n": "32"
     },
     "Placebo group": {
      "median": "4",
      "q1": "3",
      "q3": "4",
      "n": "32"
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "intraoperative",
    "location": "Table 5, Intraoperative period",
    "values": {
     "Ketamine group": {
      "hallucination": "1",
      "dizziness": "5",
      "visual": "3"
     },
     "Placebo group": {
      "hallucination": "0",
      "dizziness": "3",
      "visual": "0"
     }
    }
   },
   {
    "window": "postoperative",
    "location": "Table 5, Postoperative period",
    "values": {
     "Ketamine group": {
      "nightmare": "0"
     },
     "Placebo group": {
      "nightmare": "0"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2017-11-23",
   "end": "2018-05-14"
  },
  "registration": {
   "number": "NCT03336541",
   "date": "08/11/2017"
  },
  "note": "66 randomized (33/33); one per arm withdrew consent, so efficacy analyses (ITT and per-protocol) have 32/32 and the safety analysis (Table 5) 33/33. EPDS baseline was taken the day before surgery (Table 1, median (IQR)). Table 3 footnote says 'mean ± SD, n (%) or median (interquartile range)'; the text confirms depression scores are median (IQR). Table 3 also prints Hodges-Lehmann median differences (48 h: 1 (-1, 3); 42 days: 1 (-1, 2)) and RR 1.29 (0.78, 2.12) for EPDS ≥10, not recorded since arm values are given; Table 4 gives regression results. Minus signs printed as U+2212 are recorded as '-'. Pain: NRS at rest at 4 h, 8 h and 42 days left out (outside the day 1/day 2 windows). Adverse events from Table 5: 'Diplopia' coded as visual. Table 5 also prints a composite 'Dissociative symptoms' 10 (30.3%) vs 3 (9.1%), which the text defines as hallucination, dizziness, diplopia and hypertonia, so it is not coded as dissociation; hypertonia 1 vs 0, somnolence 4 vs 0 and sedation 5 vs 0 not coded. Enrollment is the Results' eligibility-assessment window; last follow-up June 25, 2018. Registration date printed '08/11/2017' (format not stated; the ethics approval date is printed the same way).",
  "reason": "The coders differed only in how the minus signs of Table 3's change-from-baseline medians and quartiles were written: the source prints U+2212, coder B copied it and coder A wrote an ASCII hyphen-minus. The numbers, their precision, arms and days agree and match Table 3. I kept coder A's ASCII '-' so the values parse as numbers, and the note says so. I also added coder B's Table 5 locations to the adverse events."
 },
 {
  "trial": "T040",
  "source": "fulltext",
  "arms": {
   "Ketamine group": {
    "randomized": "20",
    "analysed": "20"
   },
   "Placebo (saline) group": {
    "randomized": "20",
    "analysed": "20"
   }
  },
  "depression": [
   {
    "measure": "MADRS",
    "day": -1,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 0 (pre-infusion)'",
    "values": {
     "Ketamine group": {
      "mean": "25.1",
      "sd": "8.3",
      "n": "20"
     },
     "Placebo (saline) group": {
      "mean": "29.9",
      "sd": "7.0",
      "n": "19"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 1,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 1'",
    "values": {
     "Ketamine group": {
      "mean": "12.7",
      "sd": "7.6",
      "n": "20"
     },
     "Placebo (saline) group": {
      "mean": "16.4",
      "sd": "10.0",
      "n": "19"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 1,
    "form": "change_mean_sd",
    "location": "Results, Outcomes, second paragraph (change from day 0 to day 1)",
    "values": {
     "Ketamine group": {
      "mean": "-12.4",
      "sd": "9.2",
      "n": null
     },
     "Placebo (saline) group": {
      "mean": "-14.7",
      "sd": "9.0",
      "n": null
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 2,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 2'",
    "values": {
     "Ketamine group": {
      "mean": "15.1",
      "sd": "11.1",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "17.5",
      "sd": "11.5",
      "n": "20"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 3,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 3'",
    "values": {
     "Ketamine group": {
      "mean": "17.0",
      "sd": "10.5",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "17.2",
      "sd": "12.0",
      "n": "20"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 5,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 5'",
    "values": {
     "Ketamine group": {
      "mean": "16.9",
      "sd": "8.0",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "16.9",
      "sd": "10.1",
      "n": "18"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 7,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 7'",
    "values": {
     "Ketamine group": {
      "mean": "15.9",
      "sd": "9.2",
      "n": "18"
     },
     "Placebo (saline) group": {
      "mean": "18.5",
      "sd": "10.8",
      "n": "19"
     }
    }
   },
   {
    "measure": "MADRS",
    "day": 14,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'Day 14'",
    "values": {
     "Ketamine group": {
      "mean": "16.9",
      "sd": "10.0",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "16.2",
      "sd": "12.5",
      "n": "19"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": -1,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 0 (pre-infusion)'",
    "values": {
     "Ketamine group": {
      "mean": "22.9",
      "sd": "4.2",
      "n": "20"
     },
     "Placebo (saline) group": {
      "mean": "24.6",
      "sd": "5.6",
      "n": "19"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 1,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 1'",
    "values": {
     "Ketamine group": {
      "mean": "17.8",
      "sd": "6.6",
      "n": "20"
     },
     "Placebo (saline) group": {
      "mean": "19.9",
      "sd": "5.5",
      "n": "19"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 2,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 2'",
    "values": {
     "Ketamine group": {
      "mean": "18.8",
      "sd": "7.5",
      "n": "18"
     },
     "Placebo (saline) group": {
      "mean": "21.2",
      "sd": "5.9",
      "n": "20"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 3,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 3'",
    "values": {
     "Ketamine group": {
      "mean": "19.3",
      "sd": "6.3",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "20.8",
      "sd": "5.4",
      "n": "20"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 5,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 5'",
    "values": {
     "Ketamine group": {
      "mean": "18.3",
      "sd": "4.8",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "18.9",
      "sd": "7.3",
      "n": "19"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 7,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 7'",
    "values": {
     "Ketamine group": {
      "mean": "18.4",
      "sd": "5.3",
      "n": "16"
     },
     "Placebo (saline) group": {
      "mean": "19.6",
      "sd": "8.1",
      "n": "19"
     }
    }
   },
   {
    "measure": "HADS score",
    "day": 14,
    "form": "mean_sd",
    "location": "Extended Data Table 1, 'HADS total score: Day 14'",
    "values": {
     "Ketamine group": {
      "mean": "16.4",
      "sd": "7.2",
      "n": "19"
     },
     "Placebo (saline) group": {
      "mean": "17.2",
      "sd": "8.5",
      "n": "19"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "cumulative and daily opioid use (MME)",
    "day": 1,
    "form": "mean_sd",
    "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 1'",
    "values": {
     "Ketamine group": {
      "mean": "81.6",
      "sd": "59.6",
      "n": "14"
     },
     "Placebo (saline) group": {
      "mean": "69.2",
      "sd": "62.2",
      "n": "16"
     }
    }
   },
   {
    "measure": "cumulative and daily opioid use (MME)",
    "day": 2,
    "form": "mean_sd",
    "location": "Extended Data Table 2, 'Average Daily Inpatient Opioid Use, in MME: Day 2'",
    "values": {
     "Ketamine group": {
      "mean": "83.3",
      "sd": "65.2",
      "n": "8"
     },
     "Placebo (saline) group": {
      "mean": "77.6",
      "sd": "71.3",
      "n": "13"
     }
    }
   }
  ],
  "adverse_events": [],
  "blinding_check": {
   "who": "participants",
   "day": 14,
   "values": null,
   "overall": {
    "correct": "36.8%",
    "kappa": "0.33",
    "n_per_arm": "19",
    "guessed_ketamine": "16",
    "guessed_placebo": "10",
    "dont_know": "12"
   },
   "location": "Results, Outcomes (text after the MADRS change scores); by-arm guesses only as percentages in Figure 2B (graph, n=19 per group, no printed values); Extended Data Figure 1 caption gives guess groups n=17/10/11"
  },
  "enrollment": {
   "start": "2020-02-19",
   "end": "2022-08-18"
  },
  "registration": null,
  "note": "40 randomized (20/20, after 5 open-label pilot patients not reported); ITT analysis of the primary outcome with n=20 per arm. Day -1 is the Day 0 pre-infusion assessment on the morning of surgery (Extended Data Table 1), the baseline nearest the procedure and the one the text's change scores start from. The screening visit, a mean of 5.1 days before surgery, is not entered as a second day -1 entry: Table 1, n=20 per arm, MADRS 27.7±7.8 vs 30.6±6.3, HADS total 24.6±6.0 vs 24.7±5.7. Post-infusion days equal postoperative days (infusion given during surgery). The day 1 change from day 0 (-12.4 SD 9.2 vs -14.7 SD 9.0) is from the text, no n given. Minus signs printed as U+2212 are recorded as '-'. Table 1's screening HADS depression subscore (12.0±3.2 vs 10.5±3.6) and PHQ-8 total (15.8±3.6 vs 15.8±3.8) are not design measures and are not entered; neither is the HADS anxiety subscore. Extended Data Table 1 also gives clinical response (>=50% MADRS reduction from screening) and remission (MADRS <=12) as n/N by day (e.g. remission day 1: 10/20 vs 7/20); not entered, since they count improved participants, not participants with depression, and the MADRS means are given at every time. Table 3 gives mixed-model estimates only. Pain: BPI-SF is reported only at screening and day 14 (average pain 4.8 SD 1.5 vs 3.7 SD 2.0), outside day 1/2. Opioid use day 1/2 is average daily inpatient MME among patients hospitalised the whole day; cumulative opioid consumption is only in Figure 2E (median, IQR graph). No psychotomimetic adverse events are reported; one death in the ketamine group 5 days post-infusion (cardiac arrest at home) and one placebo reoperation on day 3. Blinding: guesses by arm are only percentages in Figure 2B; the text gives 36.8% correct overall, kappa 0.33, and guess groups n=16 ketamine / 10 placebo / 12 don't know, while the Extended Data Figure 1 caption gives 17/10/11. No trial registration number appears in the text.",
  "reason": "The coders differed only in the minus signs of the text's day-1 MADRS change means (-12.4 and -14.7): the source prints U+2212, and I kept coder A's ASCII '-' so they parse as numbers; the values match the Results. I also removed baseline entries both coders added: Table 1's HADS depression subscore and PHQ-8 total, which are not design measures, and the screening-visit MADRS and HADS totals, which duplicated the day -1 key beside the Day 0 pre-infusion baseline nearest the procedure. Their values are in the note."
 },
 {
  "trial": "T086",
  "source": "fulltext",
  "arms": {
   "Esketamine group": {
    "randomized": null,
    "analysed": "140"
   },
   "Control group": {
    "randomized": null,
    "analysed": "140"
   }
  },
  "depression": [
   {
    "measure": "EPDS (postpartum depression incidence, >= 10)",
    "day": -1,
    "form": "mean_sd",
    "location": "Table 1, Pre-operative EPDS score",
    "values": {
     "Esketamine group": {
      "mean": "8.9",
      "sd": "4.0",
      "n": "140"
     },
     "Control group": {
      "mean": "9.3",
      "sd": "4.0",
      "n": "140"
     }
    }
   },
   {
    "measure": "EPDS (postpartum depression incidence, >= 10)",
    "day": -1,
    "form": "count",
    "definition": "Prenatal depression (Table 1 label; criterion not stated; EPDS and SDS were both given the day before surgery)",
    "location": "Table 1, 'Prenatal depression, n (%)'",
    "values": {
     "Esketamine group": {
      "events": "57",
      "n": "140"
     },
     "Control group": {
      "events": "64",
      "n": "140"
     }
    }
   },
   {
    "measure": "EPDS (postpartum depression incidence, >= 10)",
    "day": null,
    "form": "count",
    "definition": "EPDS ≥10",
    "location": "Table 2, PPD (total)",
    "values": {
     "Esketamine group": {
      "events": "41",
      "n": "140"
     },
     "Control group": {
      "events": "50",
      "n": "140"
     }
    }
   }
  ],
  "pain": [],
  "adverse_events": [
   {
    "window": "intraoperative",
    "location": "Table 4, Intra-operative",
    "values": {
     "Esketamine group": {
      "dizziness": "4",
      "hallucination": "2",
      "nightmare": "5"
     },
     "Control group": {
      "dizziness": "0",
      "hallucination": "0",
      "nightmare": "0"
     }
    }
   },
   {
    "window": "postoperative",
    "location": "Table 4, Post-operative",
    "values": {
     "Esketamine group": {
      "dizziness": "1"
     },
     "Control group": {
      "dizziness": "4"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2022-01-15",
   "end": "2022-07-30"
  },
  "registration": {
   "number": "ChiCTR2100050976",
   "date": "09/09/2021"
  },
  "note": "Tables 1, 2 and 4 list the control group first. 290 recruited and randomized 1:1; 10 excluded after randomization (2 converted to general anaesthesia, 1 post-partum haemorrhage, 5 lost to follow-up, 2 EPQ L-scale >60), leaving 140 per group; per-arm randomized numbers are not printed (the Fig. 1 flow chart is not reproduced). Day -1 entries are from the assessment the day before surgery. 'Prenatal depression' (Table 1) has no stated criterion or instrument; it is entered under the design's EPDS measure with that said in its definition. Table 1's pre-operative SDS (45.8 ± 9.0 vs 45.7 ± 10.1, esketamine vs control) is not a design measure and is not entered. The time of the postpartum EPDS is not stated anywhere (the sample size cites a 28% PPD incidence 'on the 3rd day after a caesarean section' from another study; median hospital stay 4 days), so day is null for the PPD (total) count, PPD being EPDS >= 10. Table 2 also gives PPD by personality type (subgroups, not entered). Pain: NRS at rest and on movement (4-48 h) and severe-pain rates are only in Figs 2-3 (no printed values); indomethacin use is not reported. Adverse events from Table 4's intra-operative and post-operative rows; drowsiness, nausea/vomiting and RSS >3 not coded. Enrollment period is from Methods, Participants (the Results do not state it).",
  "reason": "Two naming differences. For Table 1's prenatal-depression count (57 vs 64 of 140), coder A used the source's label and coder B the design's EPDS measure; measure names must follow the design, whose only depression measure is EPDS, so I kept coder B's entry with a definition saying the criterion is not stated. The coders named the baseline SDS differently, but the SDS is not a design measure, so I removed it and kept its values in the note."
 }
]