[
 {
  "trial": "T119",
  "source": "fulltext",
  "arms": {
   "ES group": {
    "randomized": "60",
    "analysed": "60"
   },
   "P group (saline)": {
    "randomized": "60",
    "analysed": "60"
   }
  },
  "depression": [
   {
    "measure": "PHQ-9",
    "day": -1,
    "form": "mean_sd",
    "location": "Table 2 (Baseline)",
    "values": {
     "ES group": {
      "mean": "5.3",
      "sd": "3.70",
      "n": "60"
     },
     "P group (saline)": {
      "mean": "5.2",
      "sd": "2.44",
      "n": "60"
     }
    }
   },
   {
    "measure": "PHQ-9",
    "day": 7,
    "form": "change_difference",
    "location": "Table 4 (linear mixed model, group * Timepoint, P * POD7); Results, Secondary outcome",
    "estimate": "1.25",
    "lower": "0.45",
    "upper": "2.05",
    "level": "0.95",
    "scale": "mean_difference",
    "direction": "P group (saline) minus ES group, change from baseline",
    "values": {
     "ES group": {
      "n": "60"
     },
     "P group (saline)": {
      "n": "60"
     }
    }
   },
   {
    "measure": "PHQ-9",
    "day": 30,
    "form": "mean_sd",
    "location": "Table 2 (POD30-PHQ9)",
    "values": {
     "ES group": {
      "mean": "2.2",
      "sd": "1.54",
      "n": "60"
     },
     "P group (saline)": {
      "mean": "3.1",
      "sd": "1.87",
      "n": "60"
     }
    }
   },
   {
    "measure": "PHQ-9",
    "day": 30,
    "form": "change_mean_sd",
    "location": "Table 2 (Change from Baseline, Mean (SD))",
    "values": {
     "ES group": {
      "mean": "-3.1",
      "sd": "3.33",
      "n": "60"
     },
     "P group (saline)": {
      "mean": "-2.1",
      "sd": "2.14",
      "n": "60"
     }
    }
   },
   {
    "measure": "PHQ-9",
    "day": 30,
    "form": "change_mean_ci",
    "location": "Table 2 (Change from Baseline, LS Mean (95% CI), ANCOVA adjusted for baseline)",
    "values": {
     "ES group": {
      "mean": "-3.07",
      "lower": "-3.46",
      "upper": "-2.68",
      "level": "0.95",
      "n": "60"
     },
     "P group (saline)": {
      "mean": "-2.11",
      "lower": "-2.50",
      "upper": "-1.72",
      "level": "0.95",
      "n": "60"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "NRS at rest",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 5 (Total NRS scores on POD1)",
    "values": {
     "ES group": {
      "median": "3",
      "q1": "2",
      "q3": "3",
      "n": "60"
     },
     "P group (saline)": {
      "median": "3",
      "q1": "2.8",
      "q3": "3",
      "n": "60"
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "postoperative",
    "values": {
     "ES group": {
      "psychiatric_any": "1"
     },
     "P group (saline)": {
      "psychiatric_any": "0"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": null,
  "registration": null,
  "note": "All 120 randomized (60 per arm) received the allocated intervention and completed follow-up, with no missing data, and were analysed by intention to treat (Results). PHQ-9 on POD7 has no arm summaries: only the linear mixed model's group-by-timepoint coefficient P * POD7 (Table 4: 1.25, 95% CI 0.45 to 2.05; ES is the reference, so it is P minus ES in change from baseline to POD7, positive favouring ES), coded as change_difference with each arm's n of 60 (Table 4 prints N 60 for P * POD7 and 120 for POD7). At POD30 Table 2 gives raw means, raw change from baseline, and the ANCOVA (baseline-adjusted) LS mean change with its 95% CI, the pre-specified primary analysis; each is coded in its own form. The between-arm results at POD30 are not coded because arm values exist: Table 2's difference in LS mean P - ES 0.96 (0.42, 1.51), Table 4's P * POD30 1.05 (0.25, 1.85), and Table 8's overall subgroup-model MD -1.13 (-1.74, -0.53) and SMD -0.81 (-1.18, -0.44). NRS at rest on POD1 from Table 5 (columns P before ES); baseline NRS 0[0,0] in both arms. Adverse events from Table 6 (within 24 h after surgery): 'Psychiatric symptoms' P 0, ES 1 (1.7%), coded psychiatric_any; nausea and vomiting and drowsiness are not listed categories. No enrollment dates or registration number in the text.",
  "reason": "Two differences. Coder B's change_mean_ci at POD30 is kept: Table 2 prints each arm's ANCOVA LS mean change from baseline with its 95% CI (ES -3.07 (-3.46, -2.68); P -2.11 (-2.50, -1.72)), a per-arm value in one of the codebook's change forms, and the code chooses among forms. For the POD7 change_difference the arm n's are 60 and 60, as coder A gave: each arm's 60 is printed and all 120 completed follow-up, while coder B left the ES n empty. The n's sit under each arm in values, with the estimate fields at the entry level, so values holds only arms."
 },
 {
  "trial": "T054",
  "source": "fulltext",
  "arms": {
   "Group S (esketamine + butorphanol)": {
    "randomized": "80",
    "analysed": "78"
   },
   "Group C (butorphanol)": {
    "randomized": "80",
    "analysed": "77"
   }
  },
  "depression": [
   {
    "measure": "EPDS",
    "day": -1,
    "form": "median_iqr",
    "location": "Table 1 (Preoperative EPDS score)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "median": "3",
      "q1": "2",
      "q3": "4",
      "n": null
     },
     "Group C (butorphanol)": {
      "median": "3",
      "q1": "2",
      "q3": "4",
      "n": null
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 0,
    "form": "difference",
    "location": "Results, 'EPDS scores at different time points' (postoperative 8 h); Fig. 2 has no printed values",
    "estimate": null,
    "lower": "1",
    "upper": "2",
    "level": "0.95",
    "scale": null,
    "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "n": "78"
     },
     "Group C (butorphanol)": {
      "n": "77"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 1,
    "form": "difference",
    "location": "Results, 'EPDS scores at different time points' (postoperative 24 h); Fig. 2 has no printed values",
    "estimate": null,
    "lower": "1",
    "upper": "2",
    "level": "0.95",
    "scale": null,
    "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "n": "78"
     },
     "Group C (butorphanol)": {
      "n": "77"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 4,
    "form": "difference",
    "location": "Results, 'EPDS scores at different time points' (postoperative 96 h); Fig. 2 has no printed values",
    "estimate": null,
    "lower": "1",
    "upper": "2",
    "level": "0.95",
    "scale": null,
    "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "n": "78"
     },
     "Group C (butorphanol)": {
      "n": "77"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 7,
    "form": "difference",
    "location": "Results, 'EPDS scores at different time points' (one week); Fig. 2 has no printed values",
    "estimate": null,
    "lower": "1",
    "upper": "2",
    "level": "0.95",
    "scale": null,
    "direction": "Group C (butorphanol) minus Group S (esketamine + butorphanol), inferred (see note)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "n": "78"
     },
     "Group C (butorphanol)": {
      "n": "77"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "PCIA presses in 24 h",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 2 (PCA compressions)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "median": "10",
      "q1": "5",
      "q3": "22",
      "n": null
     },
     "Group C (butorphanol)": {
      "median": "12",
      "q1": "6",
      "q3": "18",
      "n": null
     }
    }
   },
   {
    "measure": "VAS",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 2 (VAS scores, postoperative 24 h)",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "median": "2",
      "q1": "2",
      "q3": "3",
      "n": null
     },
     "Group C (butorphanol)": {
      "median": "3",
      "q1": "2",
      "q3": "3",
      "n": null
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "postoperative",
    "values": {
     "Group S (esketamine + butorphanol)": {
      "dizziness": "15",
      "nightmare": "2",
      "agitation": "2",
      "hallucination": "1",
      "visual": "0"
     },
     "Group C (butorphanol)": {
      "dizziness": "4",
      "nightmare": "1",
      "agitation": "2",
      "hallucination": "0",
      "visual": "1"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2022-01",
   "end": "2022-08"
  },
  "registration": {
   "number": "ChiCTR2100054435",
   "date": "2021-12-27"
  },
  "note": "Tables list Group C before Group S. Randomized 80 per arm from the sample-size paragraph ('a total of 160 patients (80 patients per arm) were recruited'); Results: 160 randomized, 5 excluded (3 excessive blood loss, 2 switched to general anaesthesia), final analysis Group S n = 78, Group C n = 77. No table prints a per-column n, so n is null in the median_iqr entries (Table 1's ASA counts sum to 78 and 77, the analysed patients). Postoperative EPDS (8 h, 24 h, 96 h, one week; days 0, 1, 4, 7) is plotted only in Fig. 2, with no printed values; the text gives for each time only 'P < 0.001, 95 % CI (1−2)', with no point estimate, so these are difference entries with estimate null and the analysed arm n's. The CI is positive while group S scored lower, so it appears to be group C minus group S (the paper's relative risks are likewise C relative to S, e.g. dizziness RR 0.270 = (4/77)/(15/78)). The estimator is not named: non-normal data were analysed with the Mann-Whitney U test, and integer bounds (the VAS CIs include '(0−0)') suggest Hodges-Lehmann median differences, but the source does not say so, so scale is null. Table 2 does not label its form; median (IQR) from Table 1's footnote, the text ('[12 (6−18)]'), and the Methods. PCA presses: the text gives group S '10 (5–22.25)', Table 2 '10 (5−22)'; the table's value is used. VAS at 8 h and 96 h are outside the pain windows; VAS at 48 h was planned but not reported. Rescue (diclofenac) analgesia over an unstated postoperative period, C 19 % (15/77) vs S 23 % (18/78), not coded. Adverse events (Table 5, after surgery): restlessness coded as agitation, blurred vision as visual. Enrollment dates from Methods (patients recruited January 2022 to August 2022; Results give none).",
  "reason": "The postoperative EPDS entries print only a 95% CI, (1−2), at each time. Their arm n's are 78 and 77, as coder B gave: the difference form asks for the arm n's, and the Results print the final analysis as Group S n = 78 and Group C n = 77; coder A left them null. Scale is null, as coder A had it: the source names no estimator, and coder B's 'median_difference' is an inference and not one of the codebook's scales. A direction field records that the CI appears to be control minus esketamine."
 },
 {
  "trial": "T057",
  "source": "fulltext",
  "arms": {
   "Low-dose group": {
    "randomized": null,
    "analysed": "97"
   },
   "High-dose group": {
    "randomized": null,
    "analysed": "97"
   },
   "Control group": {
    "randomized": null,
    "analysed": "98"
   }
  },
  "depression": [
   {
    "measure": "EPDS",
    "day": -1,
    "form": "mean_sd",
    "location": "Table 3 (Prenatal 1 day)",
    "values": {
     "Low-dose group": {
      "mean": "7.5",
      "sd": "2.2",
      "n": "97"
     },
     "High-dose group": {
      "mean": "7.2",
      "sd": "2.3",
      "n": "97"
     },
     "Control group": {
      "mean": "7.3",
      "sd": "2.3",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 2,
    "form": "mean_sd",
    "location": "Table 3 (Postoperative 2 day)",
    "values": {
     "Low-dose group": {
      "mean": "7.2",
      "sd": "2.2",
      "n": "97"
     },
     "High-dose group": {
      "mean": "7.5",
      "sd": "2.6",
      "n": "97"
     },
     "Control group": {
      "mean": "8.8",
      "sd": "3.4",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 7,
    "form": "mean_sd",
    "location": "Table 3 (Postoperative 7 day)",
    "values": {
     "Low-dose group": {
      "mean": "7.3",
      "sd": "3.1",
      "n": "97"
     },
     "High-dose group": {
      "mean": "7.0",
      "sd": "2.9",
      "n": "97"
     },
     "Control group": {
      "mean": "9.1",
      "sd": "3.3",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "mean_sd",
    "location": "Table 3 (Postoperative 42 day)",
    "values": {
     "Low-dose group": {
      "mean": "8.3",
      "sd": "3.1",
      "n": "97"
     },
     "High-dose group": {
      "mean": "8.1",
      "sd": "3.0",
      "n": "97"
     },
     "Control group": {
      "mean": "8.8",
      "sd": "3.6",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 2,
    "form": "count",
    "definition": "postpartum depression, EPDS ≥ 13",
    "location": "Table 4 (Postoperative 2 day)",
    "values": {
     "Low-dose group": {
      "events": "5",
      "n": "97"
     },
     "High-dose group": {
      "events": "6",
      "n": "97"
     },
     "Control group": {
      "events": "14",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 7,
    "form": "count",
    "definition": "postpartum depression, EPDS ≥ 13",
    "location": "Table 4 (Postoperative 7 day)",
    "values": {
     "Low-dose group": {
      "events": "8",
      "n": "97"
     },
     "High-dose group": {
      "events": "5",
      "n": "97"
     },
     "Control group": {
      "events": "16",
      "n": "98"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "count",
    "definition": "postpartum depression, EPDS ≥ 13",
    "location": "Table 4 (Postoperative 42 day)",
    "values": {
     "Low-dose group": {
      "events": "11",
      "n": "97"
     },
     "High-dose group": {
      "events": "10",
      "n": "97"
     },
     "Control group": {
      "events": "17",
      "n": "98"
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "VAS pain",
    "day": 1,
    "form": "mean_sd",
    "location": "Table 2 (Postoperative 24 hours)",
    "values": {
     "Low-dose group": {
      "mean": "3.1",
      "sd": "1.0",
      "n": "97"
     },
     "High-dose group": {
      "mean": "2.7",
      "sd": "0.8",
      "n": "97"
     },
     "Control group": {
      "mean": "3.5",
      "sd": "1.2",
      "n": "98"
     }
    }
   },
   {
    "measure": "VAS pain",
    "day": 2,
    "form": "mean_sd",
    "location": "Table 2 (Postoperative 48 hours)",
    "values": {
     "Low-dose group": {
      "mean": "2.1",
      "sd": "0.6",
      "n": "97"
     },
     "High-dose group": {
      "mean": "2.1",
      "sd": "0.7",
      "n": "97"
     },
     "Control group": {
      "mean": "2.4",
      "sd": "1.1",
      "n": "98"
     }
    }
   },
   {
    "measure": "rescue acetaminophen",
    "day": 2,
    "form": "count",
    "definition": "rescue acetaminophen (given when VAS > 4) within the first 2 days postoperatively",
    "location": "Table 2 (Rescue rate, n (%)); Results, Comparison of postoperative analgesia",
    "values": {
     "Low-dose group": {
      "events": "15",
      "n": "97"
     },
     "High-dose group": {
      "events": "14",
      "n": "97"
     },
     "Control group": {
      "events": "27",
      "n": "98"
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "postoperative",
    "values": {
     "Low-dose group": {
      "hallucination": "2",
      "dizziness": "7",
      "visual": "2"
     },
     "High-dose group": {
      "hallucination": "9",
      "dizziness": "7",
      "visual": "9"
     },
     "Control group": {
      "hallucination": "0",
      "dizziness": "2",
      "visual": "0"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2021-01",
   "end": "2023-01"
  },
  "registration": null,
  "note": "The source calls the high-dose arm 'How-dose group' (a typo for High-dose). Per-arm randomized numbers are not printed: 315 were enrolled, with '8 lost to follow-up in Low-dose group and high-dose group, and 7 in control group', leaving 97, 97 and 98 analysed (315 - 292 = 23 suggests 8 lost in each dose group, so 105 per arm, but that is not printed and randomized is left null); the tables' column n's are used for every entry. EPDS 'Prenatal 1 day' (Methods: preoperative day 1) coded as day -1. Table 4 counts are postpartum depression, defined in Methods as EPDS ≥ 13, so they count participants with depression and sit under the design's 'EPDS' beside the Table 3 means, told apart by form. The rescue rate is 'the rate of rescue analgesia within the first 2 days postoperatively', coded as day 2. VAS at 6 h and 12 h not coded. Adverse events from Table 7, window '0-2 h' (Results: within 2 hours after the esketamine injection, which was given after delivery during caesarean; Methods: 0–2 hours postoperatively), coded postoperative; diplopia coded as visual. In Table 7 the low-dose percentages do not match the counts (hallucination '2 (7.2)', diplopia '2 (8)', drowsiness '6 (10.3)' with n = 97); counts copied as printed. Adverse events at 2.1–48 h are reported only as not significantly different. Enrollment dates from Methods (Results give none). No registration number given (only IRB protocol 20200060).",
  "reason": "The only difference is the measure name of Table 4's counts of postpartum depression (EPDS ≥ 13) on postoperative days 2, 7 and 42: they go under the design's 'EPDS', as coder A had them, with the threshold in definition; coder B's 'Postpartum depression incidence (EPDS ≥ 13)' is not a design name. The counts are of participants with depression, and every value matches Tables 2, 3, 4 and 7."
 },
 {
  "trial": "T063",
  "source": "fulltext",
  "arms": {
   "Esketamine group": {
    "randomized": "182",
    "analysed": "182"
   },
   "Placebo (saline) group": {
    "randomized": "182",
    "analysed": "182"
   }
  },
  "depression": [
   {
    "measure": "EPDS",
    "day": -1,
    "form": "median_iqr",
    "location": "Table 1 (Median (IQR) Edinburgh postnatal depression scale)",
    "values": {
     "Esketamine group": {
      "median": "10",
      "q1": "10",
      "q3": "12",
      "n": "182"
     },
     "Placebo (saline) group": {
      "median": "10",
      "q1": "10",
      "q3": "12",
      "n": "182"
     }
    }
   },
   {
    "measure": "MINI 6.0.0 depression module (major depressive episode)",
    "day": 42,
    "form": "count",
    "definition": "major depressive episode diagnosed with the MINI 6.0.0",
    "location": "Table 3 (primary endpoint); denominators from Results, Efficacy outcomes",
    "values": {
     "Esketamine group": {
      "events": "12",
      "n": "180"
     },
     "Placebo (saline) group": {
      "events": "46",
      "n": "181"
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 7,
    "form": "median_iqr",
    "location": "Table 3 (Median (IQR) EPDS score at 7 days)",
    "values": {
     "Esketamine group": {
      "median": "5",
      "q1": "2",
      "q3": "8",
      "n": null
     },
     "Placebo (saline) group": {
      "median": "9",
      "q1": "5",
      "q3": "11",
      "n": null
     }
    }
   },
   {
    "measure": "EPDS",
    "day": 42,
    "form": "median_iqr",
    "location": "Table 3 (Median (IQR) EPDS score at 42 days)",
    "values": {
     "Esketamine group": {
      "median": "5",
      "q1": "3",
      "q3": "8",
      "n": null
     },
     "Placebo (saline) group": {
      "median": "8",
      "q1": "5",
      "q3": "11",
      "n": null
     }
    }
   },
   {
    "measure": "HAMD-17",
    "day": 42,
    "form": "median_iqr",
    "location": "Table 3 (Median (IQR) Hamilton depression rating scale score at 42 days)",
    "values": {
     "Esketamine group": {
      "median": "5",
      "q1": "2",
      "q3": "8",
      "n": null
     },
     "Placebo (saline) group": {
      "median": "10",
      "q1": "5",
      "q3": "17",
      "n": null
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "NRS pain",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 3 (NRS for pain at 1 day, at rest)",
    "values": {
     "Esketamine group": {
      "median": "2",
      "q1": "1",
      "q3": "3",
      "n": "182"
     },
     "Placebo (saline) group": {
      "median": "2",
      "q1": "1",
      "q3": "3",
      "n": null
     }
    }
   },
   {
    "measure": "NRS pain",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 3 (NRS for pain at 1 day, with movement)",
    "values": {
     "Esketamine group": {
      "median": "3",
      "q1": "2",
      "q3": "5",
      "n": "182"
     },
     "Placebo (saline) group": {
      "median": "4",
      "q1": "3",
      "q3": "6",
      "n": null
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "intraoperative",
    "values": {
     "Esketamine group": {
      "dizziness": "48",
      "visual": "9",
      "hallucination": "6",
      "agitation": "6"
     },
     "Placebo (saline) group": {
      "dizziness": "17",
      "visual": "0",
      "hallucination": "0",
      "agitation": "5"
     }
    }
   },
   {
    "window": "postoperative",
    "values": {
     "Esketamine group": {
      "dizziness": "32",
      "visual": "4",
      "hallucination": "3"
     },
     "Placebo (saline) group": {
      "dizziness": "24",
      "visual": "0",
      "hallucination": "0"
     }
    }
   },
   {
    "window": "overall",
    "values": {
     "Esketamine group": {
      "psychiatric_any": "82"
     },
     "Placebo (saline) group": {
      "psychiatric_any": "40"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2020-06-19",
   "end": "2022-06-21"
  },
  "registration": null,
  "note": "All 364 randomized (182 per arm) were in the intention-to-treat analysis; 2 esketamine and 1 placebo participants withdrew consent (per protocol 361). Table 3's columns are n = 182 and it prints, in parentheses marked ‡, the number of participants with missing data, not n: EPDS 7 d 1 and 1; EPDS 42 d 2 and 1; HAMD-17 42 d 33 and 28 (esketamine, placebo), so n is null there. NRS at 1 day, at rest and with movement, has no ‡ for esketamine (n is the column's 182) and (1)‡ for placebo (n null). Major depressive episode n from the text (6.7% (12/180) vs 25.4% (46/181)), RR 0.26 (0.14 to 0.48); with missing data imputed (worst case for esketamine) 14 (7.7) vs 46 (25.3) of 182, RR 0.30 (0.17 to 0.53), not coded. Table 3 median differences (esketamine minus placebo, Hodges-Lehmann): EPDS 7 d −3 (−4 to −2); EPDS 42 d −3 (−4 to −2); HAMD-17 −4 (−6 to −3); NRS at rest and with movement −1 (−1 to 0). Exploratory counts (EPDS ≤ 9 at 7 d 153 vs 103 and at 42 d 151 vs 106, EPDS reductions ≥ 4 and ≥ 50%, HAMD-17 ≤ 7 106 vs 60) count non-depressed or improved participants and are not coded. Pain at 1 day (interview 18 to 30 h after childbirth) has two NRS pain entries with the same measure, day and form, at rest first and then with movement, told apart by location. Adverse events (Table 4): window 1 is 'during and within 1 hour after study drug infusion' (a 40-minute infusion started after cord clamping, vaginal or caesarean birth), coded intraoperative; window 2 is 'at 2 hours after study drug infusion', coded postoperative; 'Hallucination or daymare' (merged by the authors) coded as hallucination, though the text says five mothers reported hallucinations during and within an hour after infusion; diplopia coded as visual; agitation is RASS ≥ 2. The combined neuropsychiatric rows of Table 4 (61 vs 20; 37 vs 24) are not coded because their parts are. The overall incidence of neuropsychiatric adverse events (text: 45.1% (82/182) vs 22.0% (40/182)) includes dizziness and is coded psychiatric_any with window overall; the text also says no neuropsychiatric symptoms were observed on postpartum day 1. Enrollment dates are the screening period in Results; the last participant was followed up on 3 August 2022. No registration number in the text.",
  "reason": "Two differences, both in the pain entries at 1 day. NRS with movement goes under the design's 'NRS pain', as coder A had it (coder B used the source's wording, which is not a design name); the at-rest and with-movement entries are told apart by location, at rest first. Esketamine n is 182 in both, as coder B gave: Table 3's column is n = 182 and those cells carry no ‡ missing-data count, while the placebo cells print (1)‡ missing, so placebo n stays null rather than computed. Exploratory counts of non-depressed or improved participants stay out, as both coders decided."
 },
 {
  "trial": "T085",
  "source": "fulltext",
  "arms": {
   "Study group (esketamine)": {
    "randomized": "70",
    "analysed": "70"
   },
   "Control group (normal saline)": {
    "randomized": "70",
    "analysed": "70"
   }
  },
  "depression": [
   {
    "measure": "PHQ-9 (>= 10 = depressive symptoms)",
    "day": -1,
    "form": "median_iqr",
    "location": "Table 1 (Preoperative PHQ-9 score)",
    "values": {
     "Study group (esketamine)": {
      "median": "2",
      "q1": "1",
      "q3": "4",
      "n": "70"
     },
     "Control group (normal saline)": {
      "median": "3",
      "q1": "1",
      "q3": "5",
      "n": "70"
     }
    }
   },
   {
    "measure": "PHQ-9 (>= 10 = depressive symptoms)",
    "day": -1,
    "form": "count",
    "definition": "preoperative depressive symptom, PHQ-9 ≥ 10",
    "location": "Table 1 (Preoperative depressive symptom)",
    "values": {
     "Study group (esketamine)": {
      "events": "6",
      "n": "70"
     },
     "Control group (normal saline)": {
      "events": "3",
      "n": "70"
     }
    }
   },
   {
    "measure": "PHQ-9 (>= 10 = depressive symptoms)",
    "day": 7,
    "form": "median_iqr",
    "location": "Table 3 (PHQ-9, on POD 7)",
    "values": {
     "Study group (esketamine)": {
      "median": "2",
      "q1": "1",
      "q3": "4",
      "n": null
     },
     "Control group (normal saline)": {
      "median": "3",
      "q1": "1",
      "q3": "6.5",
      "n": null
     }
    }
   },
   {
    "measure": "PHQ-9 (>= 10 = depressive symptoms)",
    "day": 7,
    "form": "count",
    "definition": "postoperative depressive symptom, PHQ-9 ≥ 10",
    "location": "Table 3 (Postoperative depressive symptom, on POD 7)",
    "values": {
     "Study group (esketamine)": {
      "events": "5",
      "n": null
     },
     "Control group (normal saline)": {
      "events": "6",
      "n": null
     }
    }
   }
  ],
  "pain": [
   {
    "measure": "NRS pain at designated time points",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 3 (NRS, at 24h)",
    "values": {
     "Study group (esketamine)": {
      "median": "1.3",
      "q1": "1",
      "q3": "3",
      "n": "70"
     },
     "Control group (normal saline)": {
      "median": "2",
      "q1": "1",
      "q3": "3",
      "n": "70"
     }
    }
   },
   {
    "measure": "NRS pain at designated time points",
    "day": 2,
    "form": "median_iqr",
    "location": "Table 3 (NRS, at 48h)",
    "values": {
     "Study group (esketamine)": {
      "median": "1",
      "q1": "1",
      "q3": "2",
      "n": "70"
     },
     "Control group (normal saline)": {
      "median": "1",
      "q1": "1",
      "q3": "2",
      "n": "70"
     }
    }
   },
   {
    "measure": "total morphine consumption (PACU rescue + PCA) in the first 24 h",
    "day": 1,
    "form": "median_iqr",
    "location": "Table 3 (Morphine, at 24h (mg))",
    "values": {
     "Study group (esketamine)": {
      "median": "4",
      "q1": "3",
      "q3": "8",
      "n": "70"
     },
     "Control group (normal saline)": {
      "median": "5.5",
      "q1": "3",
      "q3": "8",
      "n": "70"
     }
    }
   }
  ],
  "adverse_events": [
   {
    "window": "emergence",
    "values": {
     "Study group (esketamine)": {
      "hallucination": "2",
      "agitation": "4",
      "nightmare": "0",
      "dissociation": "0",
      "visual": "0"
     },
     "Control group (normal saline)": {
      "hallucination": "0",
      "agitation": "0",
      "nightmare": "0",
      "dissociation": "0",
      "visual": "0"
     }
    }
   }
  ],
  "blinding_check": null,
  "enrollment": {
   "start": "2022-09",
   "end": "2024-03"
  },
  "registration": {
   "number": "ChiCTR 2200061021",
   "date": "2022-06-15"
  },
  "note": "140 randomized, 70 per arm, all in the intention-to-treat analysis. PHQ-9 is reported both as scores (median, IQR) and as counts of PHQ-9 ≥ 10 at baseline and on POD 7; both go under the design's single PHQ-9 measure, so each of those times has two entries, one per form. Table 3's columns say n = 70, but the POD 7 percentages (5, 7.2%; 6, 8.7%) fit 69 assessed per arm, so n is left null for the POD 7 entries; the other Table 3 entries take the column n. Table 3 median differences (study minus control, Hodges-Lehmann): PHQ-9 POD 7 −1 (−2 to 0); NRS 24 h 0 (−1 to 0); NRS 48 h 0 (0 to 0); morphine 24 h −1 (−2 to 0). The control NRS at 24 h is printed '2 (1, 3)'. 'Morphine, at 24h' taken as the Methods' total morphine consumption (PACU rescue plus PCA within the first 24 h). NRS in PACU and at 2 h are outside the pain windows. Adverse events are for the PACU stay (Table 5), coded as window emergence: 'Delirium' 4 vs 0 (four study-group patients were confused and given dexmedetomidine) coded as agitation; the zeros for nightmare, dissociation and diplopia come from the text ('no cases of nightmares, dissociation, diplopia, or hypoxemia were recorded'); dizziness was planned but not reported; over sedation (18 vs 3) is not a listed category. Chronic pain (NRS ≥ 4) at 3 months, 1 (1.4%) vs 0 (Table 4, n = 67 and 69), is outside the coded days. Enrollment dates from Methods ('conducted ... between September 2022 and March 2024'); Results give none.",
  "reason": "The only difference is the measure name of the PHQ-9 median (IQR) entries at baseline and on POD 7: every PHQ-9 entry goes under the design's single measure 'PHQ-9 (>= 10 = depressive symptoms)', as coder A had them, told apart by form (median_iqr for scores, count for PHQ-9 ≥ 10); coder B's 'PHQ-9 score' is not a design name. All values match Tables 1, 3 and 5."
 }
]