[ { "trial": "T111", "source": "fulltext", "arms": { "Group E (esketamine)": { "randomized": "48", "analysed": "46" }, "Group C (saline)": { "randomized": "48", "analysed": "45" } }, "depression": [], "pain": [ { "measure": "VAS pain", "day": 1, "form": "median_iqr", "location": "Table 2 (VAS scores, 24 h)", "values": { "Group E (esketamine)": { "median": "2", "q1": "1", "q3": "2", "n": "46" }, "Group C (saline)": { "median": "2", "q1": "2", "q3": "2", "n": "45" } } }, { "measure": "VAS pain", "day": 2, "form": "median_iqr", "location": "Table 2 (VAS scores, 48 h)", "values": { "Group E (esketamine)": { "median": "1.5", "q1": "1", "q3": "2", "n": "46" }, "Group C (saline)": { "median": "2", "q1": "1", "q3": "2", "n": "45" } } } ], "adverse_events": [ { "window": "postoperative", "location": "Table 4 (Postoperative Adverse Reactions, within 48 h)", "values": { "Group E (esketamine)": { "nightmare": "0", "psychiatric_any": "1", "dizziness": "1" }, "Group C (saline)": { "nightmare": "0", "psychiatric_any": "0", "dizziness": "2" } } } ], "blinding_check": null, "enrollment": null, "registration": { "number": "NCT06920576", "date": null }, "note": "Three-arm trial; Group M (magnesium sulfate, role 'other') is not extracted. 48 randomized per group (Methods: '48 patients per group were enrolled'; CONSORT: each group 'with 48 patients receiving allocated interventions'). Analysed: Group C 45 (1 dropout for intractable hypertension, 2 declined callbacks), Group E 46 (2 dropouts for intractable hypertension); per-protocol, missing data 7/144. Depression: HADS-D and Zung SDS (PRE, POD1, POD2) appear only in Figures 2 (box plots) and 3 (bar graphs), whose descriptions give readings estimated from the charts ('~7' vs '~6', 'about 54' vs 'about 49'), not printed values, so nothing is entered; the text says Group E had lower HADS-D and SDS than Group C on POD1 (P < 0.01) and POD2 (P < 0.001). Pain: Table 2 VAS at 24 h is day 1 and at 48 h day 2, median (IQR) printed as 'median (q1, q3)'; 2, 4 and 8 h are day 0 and left out. Rescue ketorolac (Table 3: 2 (4.3%) Group E vs 9 (20%) Group C) was given in the PACU for VAS > 3, with no day 1 or day 2 time, so it is left out. Adverse events (Table 4, within 48 h postoperatively): the combined row 'Hallucinations or double vision' (Group E 1, Group C 0) is entered as psychiatric_any, since no separate hallucination or diplopia count is printed, so neither hallucination nor visual is entered. 'Dizziness or headache' (1 vs 2) is entered as dizziness although it includes headache. Nightmares are printed as 0 (0%) in both arms. Also reported (E vs C): PONV 1 vs 6, respiratory depression 0 vs 5, hypersomnia 1 vs 1, dry mouth 1 vs 0, flushing 0 vs 0, sweating 0 vs 0. No enrollment dates are given. Registered at ClinicalTrials.gov (NCT06920576) 'before patient enrollment', with no date.", "reason": "The coders differed only on Table 4's combined row 'Hallucinations or double vision' (Group E 1, Group C 0): A entered it as hallucination, B as psychiatric_any. The source prints no separate hallucination or diplopia count, so calling it a hallucination would claim an event that may have been double vision; the codebook's place for psychotomimetic events counted together is psychiatric_any, so B's coding is kept. Everything else (arms, VAS at 24 and 48 h, dizziness, nightmares 0, no depression values outside the figures) matches the source and both coders." }, { "trial": "T113", "source": "fulltext", "arms": { "ES1 group": { "randomized": "33", "analysed": "31" }, "ES2 group": { "randomized": "33", "analysed": "30" }, "C group": { "randomized": "33", "analysed": "30" } }, "depression": [ { "measure": "HAMD", "day": -1, "form": "mean_sd", "location": "Table 4 (Preop)", "values": { "ES1 group": { "mean": "8.0", "sd": "2.1" }, "ES2 group": { "mean": "8.0", "sd": "2.7" }, "C group": { "mean": "6.8", "sd": "2.7" } } }, { "measure": "HAMD", "day": 1, "form": "mean_sd", "location": "Table 4 (24 h postop)", "values": { "ES1 group": { "mean": "6.2", "sd": "2.2" }, "ES2 group": { "mean": "7.1", "sd": "2.6" }, "C group": { "mean": "9.9", "sd": "3.7" } } }, { "measure": "HAMD", "day": 3, "form": "mean_sd", "location": "Table 4 (72 h postop)", "values": { "ES1 group": { "mean": "5.2", "sd": "2.4" }, "ES2 group": { "mean": "5.6", "sd": "2.6" }, "C group": { "mean": "9.0", "sd": "3.5" } } } ], "pain": [ { "measure": "VAS at rest (24 h)", "day": 1, "form": "mean_sd", "location": "Table 5 (24 h postop)", "values": { "ES1 group": { "mean": "0.71", "sd": "0.82" }, "ES2 group": { "mean": "0.97", "sd": "1.00" }, "C group": { "mean": "0.62", "sd": "0.82" } } }, { "measure": "VAS on activity (24 h)", "day": 1, "form": "mean_sd", "location": "Table 6 (24 h postop)", "values": { "ES1 group": { "mean": "2.87", "sd": "1.34" }, "ES2 group": { "mean": "3.17", "sd": "1.39" }, "C group": { "mean": "2.93", "sd": "1.00" } } } ], "adverse_events": [ { "window": "postoperative", "time": "24 h", "location": "Table 7 (24 h AE, n (%))", "values": { "ES1 group": { "any_ae": "7" }, "ES2 group": { "any_ae": "5" }, "C group": { "any_ae": "8" } } }, { "window": "postoperative", "time": "48 h", "location": "Table 7 (48 h AE, n (%))", "values": { "ES1 group": { "any_ae": "1" }, "ES2 group": { "any_ae": "3" }, "C group": { "any_ae": "6" } } } ], "blinding_check": null, "enrollment": { "start": "2023-05-01", "end": "2024-01-01" }, "registration": { "number": "ChiCTR2300070763", "date": null }, "note": "99 randomized, 33 per group (Table 1). 8 were excluded before receiving the intervention (5 withdrew consent or family refused assessment at the preoperative evaluation, 3 intraoperative conversions); analysed per Table 3's headers: C 30, ES1 31, ES2 30. Tables 4-7 and the text print no n at any time point, so no n is entered in the outcome values; the arms' analysed counts apply. HAMD is HAMD-17 (Fig. 1), mean ± SD (Statistical analysis: 'Continuous data: Mean ± SD'), from Table 4: 'Preop' (administered 24 h before surgery) is day -1, '24 h postop' day 1, '72 h postop' day 3; the Results text repeats group C's values (6.8 ± 2.7, 9.9 ± 3.7, 9.0 ± 3.5), matching the table. The primary outcome (Table 2) is HAMA/HAMD score ≥ 8 at 24 h, but no counts by arm are printed. Pain: VAS at rest (Table 5) and on activity (Table 6) at 24 h are day 1, with the within-group superscript letters dropped; 2 h, 6 h and 72 h are outside the windows. 'PCA bolus demands' (Results: C 4.69 ± 4.38, ES1 4.16 ± 2.60, ES2 5.77 ± 6.59; Table 2 lists supplemental analgesia demands for 0-24 h postop) is not a pain measure the design lists, so it is not entered; the ES groups' PCA itself held esketamine (1 or 2 mg/kg), with sufentanil 2 µg/kg in all groups. Adverse events: Table 7 gives only the number with any adverse event at 24 h and at 48 h (one entry each; the two counts may include the same patients); Table 2 lists PONV, dizziness and nightmares (0-72 h) and nystagmus, pruritus and hallucinations as safety outcomes, but no counts by type are printed. Enrollment: the Results give no dates; the Methods' inclusion criteria name surgery between May 1, 2023 and January 1, 2024. Registration ChiCTR2300070763, no date given.", "reason": "The coders differed only on n: B gave every HAMD, VAS and PCA value an n (ES1 31, ES2 30, C 30) taken from Table 3's demographic headers, while A left n out. Tables 4-7 and the text print no n at any time point, and the codebook takes n only where the source gives it for that time, so A's values are kept and the analysed counts stay in arms. I also removed the 'PCA bolus demands' entry both coders added: it is not a pain measure the design lists (and the ES arms' PCA contained esketamine); its numbers are kept in the note." }, { "trial": "T022", "source": "fulltext", "arms": { "C group": { "randomized": null, "analysed": "153" }, "S group (S-ketamine)": { "randomized": null, "analysed": "122" } }, "depression": [ { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": -1, "form": "mean_sd", "location": "Table 1", "values": { "C group": { "mean": "6.54", "sd": "2.35", "n": "153" }, "S group (S-ketamine)": { "mean": "6.72", "sd": "2.25", "n": "122" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 3, "form": "mean_sd", "location": "Results, Secondary outcome paragraph", "values": { "C group": { "mean": "7.65", "sd": "3.14" }, "S group (S-ketamine)": { "mean": "6.00", "sd": "2.47" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "mean_sd", "location": "Results, Secondary outcome paragraph", "values": { "C group": { "mean": "7.62", "sd": "3.14" }, "S group (S-ketamine)": { "mean": "6.38", "sd": "2.67" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 3, "form": "percent", "definition": "EPDS ≥ 10", "location": "Results, Primary outcome paragraph", "values": { "C group": { "percent": "24.2" }, "S group (S-ketamine)": { "percent": "17.6" } } }, { "measure": "Edinburgh Postnatal Depression Scale (EPDS)", "day": 14, "form": "percent", "definition": "EPDS ≥ 10", "location": "Results, Primary outcome paragraph", "values": { "C group": { "percent": "9.8" }, "S group (S-ketamine)": { "percent": "8.2" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "C group": { "dizziness": "14" }, "S group (S-ketamine)": { "dizziness": "15" } } } ], "blinding_check": null, "enrollment": { "start": "2019-09-01", "end": "2020-07-15" }, "registration": { "number": "ChiCTR2100050263", "date": "2021-08-24" }, "note": "Randomized per arm not printed (451 recruited; 71 vaginal delivery, 53 refused after cesarean delivery, 52 lost to follow-up; 275 analysed: Table 1 n = 153 C, 122 S). Baseline EPDS (day of surgery, before it): the Results text says 'similar between the S group and C group before delivery (6.54 ± 2.35 vs. 6.72 ± 2.25, P = 0.508)', naming S first, but Table 1 puts 6.54 ± 2.35 under C group and 6.72 ± 2.25 under S group (P 0.48); Table 1 taken. ARM AMBIGUITY: the day 3 and day 14 EPDS means are in the text only, without arm labels ('at 3 days (7.65 ± 3.14 vs. 6.00 ± 2.47)' and '14 days (7.62 ± 3.14 vs. 6.38 ± 2.67)'); assigned C first, S second, the order of the baseline pair in the same paragraph (which Table 1 shows is C then S), which also fits the S group's lower depression rate; please check. The depression rates (primary outcome, EPDS ≥ 10) are printed only as percentages, so they are entered in form 'percent' with no events or n; that sentence names the S group first ('lower in the S group ... (17.6 and 8.2% vs. 24.2 and 9.8%)'). n at days 3 and 14 is not printed; S's 17.6% at day 3 is not a whole number out of 122 (21/122 is 17.2%, 22/122 is 18.0%), so its denominator is not the analysed 122 or the figure is misprinted. Day 28 EPDS scores and rates appear only in Figs. 2 and 3 with no printed values. VAS appears only in Fig. 4a with no printed values, so no pain entries (RSS is sedation). AEs were recorded during the 48 h PCIA (Table 2); only 'Dizzy' maps to a codebook category (headache, nausea, drowsiness and vomiting are not coded). Registered retroactively on 2021-08-24, after enrollment ended (Results: recruited September 1, 2019 to July 15, 2020).", "reason": "The coders differed only on the form of the EPDS ≥ 10 rates at days 3 and 14, which the source prints only as percentages (S 17.6% and 8.2%, C 24.2% and 9.8%): A used form 'percent', B form 'count' holding percentages. The count form means events and n, neither of which is printed, and the codebook says to record values in the form printed and leave conversions to the code, so A's 'percent' entries are kept. The other values (Table 1 baseline over the text's arm order, day 3 and 14 means, dizziness 14 vs 15, dates, registration) match the source." }, { "trial": "T087", "source": "fulltext", "arms": { "Group K (study group)": { "randomized": "70", "analysed": "70" }, "Group C (control group)": { "randomized": "70", "analysed": "70" } }, "depression": [ { "measure": "POMS depression-dejection subscale (within total mood score)", "day": -1, "form": "median_iqr", "location": "Table 1 (POMS Questionnaire, Depression-dejection, before surgery)", "values": { "Group K (study group)": { "median": "9,5", "q1": "3,0", "q3": "18,5" }, "Group C (control group)": { "median": "9,0", "q1": "3,0", "q3": "16,3" } } }, { "measure": "POMS depression-dejection subscale (within total mood score)", "day": 0, "form": "median_iqr", "location": "Table 2 (depression-dejection, 120 min after surgery)", "values": { "Group K (study group)": { "median": "5,0", "q1": "2,0", "q3": "15,0" }, "Group C (control group)": { "median": "5,0", "q1": "2,0", "q3": "15,5" } } } ], "pain": [], "adverse_events": [ { "window": "overall", "values": { "Group K (study group)": { "visual": "2", "psychiatric_any": "0" }, "Group C (control group)": { "psychiatric_any": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2022-04-01", "end": "2022-09-01" }, "registration": null, "note": "Tables print decimal commas (e.g. '9,5' is 9.5); copied as printed. POMS was taken before surgery (Table 1, day -1) and 120 min after surgery (Table 2's lower-case subscale rows under 'Variables during and after surgery', day 0); the text confirms group C's depression subscale fell after surgery (p = 0,048). n is not printed in Tables 1-2; 70 randomized per group (Results) and 70 analysed per group (Table 3's regression headers, Group-K n = 70, Group-C n = 70). The only pain score is NRS at 120 min (Table 2: K 4.0 (0.8) vs C 4.6 (0.7), mean (SD)), day 0, so no pain entries; need for rescue analgesics (34 (48,6) vs 45 (64,3)) has no time beyond 'during and after surgery'. AEs from the Results text: 'Only two patients in group K (2/70 (3%)) suffered headaches and diplopia, while two patients in group C (2/70 (3%)) experienced a headache. Psychomimetic side effects were not reported by any patients.' Entered visual 2 for K (it is unclear whether both patients had both symptoms); no diplopia count for C (none implied, not stated); psychiatric_any 0 in both arms from 'not reported by any patients'. any_ae is not entered: the sentence counts patients with headache and diplopia (K) or headache (C), not patients with any adverse event, and the trial reports no other events (PONV is not mentioned). Window overall (perioperative and postoperative events). No registration number in the text.", "reason": "The coders differed only on any_ae: A entered 2 per arm, reading 'Only two patients in group K (2/70 (3%)) suffered headaches and diplopia, while two patients in group C (2/70 (3%)) experienced a headache' as the count of all adverse events; B left it out. That sentence counts patients with headache and diplopia, not patients with any adverse event, and the trial named only a few events to collect, so the source gives no any-AE count and B's coding is kept. The rest of both extractions matches the source." }, { "trial": "T105", "source": "fulltext", "arms": { "Esketamine group": { "randomized": "42", "analysed": "39" }, "Placebo group": { "randomized": "42", "analysed": "38" } }, "depression": [ { "measure": "HADS-D", "day": 1, "form": "median_iqr", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "median": "2", "q1": "1", "q3": "3" }, "Placebo group": { "median": "6", "q1": "5", "q3": "8" } } }, { "measure": "HADS-D", "day": 3, "form": "median_iqr", "location": "Results, Primary outcome paragraph", "values": { "Esketamine group": { "median": "1", "q1": "0", "q3": "2" }, "Placebo group": { "median": "5", "q1": "3", "q3": "6" } } }, { "measure": "HADS-D", "day": 1, "form": "percent", "definition": "HADS-D > 7", "location": "Results, Primary outcome paragraph (also abstract)", "values": { "Esketamine group": { "percent": "7.7" }, "Placebo group": { "percent": "31.6" } } }, { "measure": "HADS-D", "day": 3, "form": "percent", "definition": "HADS-D > 7", "location": "Results, Primary outcome paragraph (also abstract)", "values": { "Esketamine group": { "percent": "0.0" }, "Placebo group": { "percent": "15.8" } } } ], "pain": [], "adverse_events": [ { "window": "postoperative", "values": { "Esketamine group": { "visual": "0", "dizziness": "0", "nightmare": "0" }, "Placebo group": { "visual": "0", "dizziness": "0", "nightmare": "0" } } } ], "blinding_check": null, "enrollment": { "start": "2024-06-04", "end": "2025-08-26" }, "registration": { "number": "ChiCTR2400084537", "date": "2024-05-20" }, "note": "Tables 1-4 and Tables S1-S2 are not in the source (captions and 'Display Table' only), so all values come from the Results prose. Arms: 84 randomized, 42 per group; 77 analysed per protocol (abstract: 39 esketamine, 38 placebo). HADS-D, median [IQR], on POD1 (day 1) and POD3 (day 3); the placebo values print as '6 [ Citation 5–8]' and '5 [ Citation 3–6]' (the web page turned the bracketed ranges into citation links), read as median 6, IQR 5–8 and median 5, IQR 3–6. Median differences −4 (95% CI −5 to −3) on both days are not entered since arm values are given. Depression incidence (HADS-D > 7, the primary outcome) is printed only as percentages, entered in form 'percent' with no events or n (each fits a whole number of the analysed 39 or 38, but no counts are printed); relative risks 0.24 (95% CI 0.08–0.80) on POD1 and 0.00 (0.00–0.47) on POD3 are not entered since arm values are given. n per day not printed. No baseline HADS-D values printed. VAS at rest and with movement, intraoperative morphine equivalents, and rescue analgesia are reported only as not different (Table 3, Figure S1), so no pain entries; intraoperative sufentanil (30 [25–40] vs 35 [30–44] μg) is day 0. AE zeros come from 'None of the patients experienced diplopia, dizziness, nightmares, or loss of intraoperative awareness' (safety outcomes within 48 h). 'Postoperative delirium or scalp hydrops was observed in only one patient in the esketamine group' does not say which event, so agitation is not coded. PONV (4 (10.3%) vs 5 (13.2%)) is not a codebook category. Blinding not assessed: the authors say no allocation-guessing survey was given.", "reason": "Same difference as T022: the HADS-D > 7 incidence on POD1 and POD3 is printed only as percentages (7.7% vs 31.6%, 0.0% vs 15.8%); A used form 'percent', B form 'count' holding percentages. A's 'percent' entries are kept, since no events or n are printed and the codebook records values in the form printed. The medians and IQRs (placebo IQRs garbled into citation links, read as 5–8 and 3–6), AE zeros, arms, dates and registration match the source and both coders." } ]