study9 fields
| study_design | RCTNon-randomized TrialProspective CohortRetrospective CohortCase-ControlCross-sectionalOther | Study design classification. RCT requires TRUE random allocation (computer-generated sequence, random-number table, sealed random envelopes). A controlled comparison where the investigator assigned the intervention by a systematic non-random rule — alternation, enrolment date/month, record number, odd/even — is a Non-randomized Trial, NOT a cohort. Do not classify RCT on the word 'randomized' alone; check the described allocation method. Cohort/Case-Control/Cross-sectional apply only to observational studies where exposure is not investigator-assigned; for those, forward data collection = Prospective Cohort, existing records = Retrospective Cohort. |
| country | text | Country of patient enrollment. MUST use ISO 3166-1 short names, except: always write 'UK' (not 'United Kingdom') and 'USA' (not 'United States of America' or 'United States'). Multiple countries comma-separated, alphabetical. Use country of enrollment, not author affiliation (e.g., 'France, Spain, UK, USA'). |
| center_type | singlemulti | Single-center or multicenter study. Multicenter requires patients enrolled at >=2 distinct sites. National registry studies = Multicenter. |
| enrollment_criteria | textharmonize | Key inclusion AND exclusion criteria as reported. Limit to 5-7 criteria: age, condition, procedure, severity, exclusions (prefix with 'no'). Use parentheses to group alternatives with 'or' (e.g., 'age >=18 & (hip or knee) arthroplasty & ASA I-III & no revision surgery'). |
| enrollment_period | textharmonize | Date range of patient enrollment. Format: 'YYYY-MM to YYYY-MM' or 'YYYY to YYYY' if months not reported. Use enrollment dates, not publication or data collection dates (e.g., '2015-01 to 2020-12'). |
| funding_source | IndustryNon-industryMixedDeclared none | Primary funding source AND/OR conflict-of-interest disclosure. Industry = any pharmaceutical/device/commercial company funded the work. Non-industry = government/academic/foundation/charity only. Mixed = both. Declared none = positive disclosure of no funding or no COI with no offsetting positive funding signal. When a positive funding signal is present, use that; only fall through to Declared none if no funding source is named. |
| sample_size_total | number | Total participants allocated/enrolled across the on-axis arms — the sum of the per-unit sample_size (the pre-attrition denominator), matching that field's stage. Not the screened, eligible, or source-population/registry denominator, and not the analyzed/complete-case total. If not explicitly stated, sum the per-unit sample_size values. |
| data_source | textharmonize | Primary data source for the analysis. Format as a short noun phrase that names the source type and, when specified, the named registry or database (e.g., 'institutional database', 'national registry', 'UNOS/OPTN registry', 'NHANES', 'claims database', 'prospective single-center cohort'). When the paper draws from multiple sources, comma-separate. Use the source named in Methods, not author affiliation. |
| km_curve_present | Yes | Whether the paper contains or references a Kaplan-Meier survival curve for any reported time-to-event outcome. Mark Yes if a KM figure appears, is referenced in figure captions, or is described in the survival analysis methodology. |
unit19 fields
| sample_size | number | Participants allocated/enrolled to this unit — the randomized or baseline-characteristics-table N, before attrition. Do NOT use the analyzed/complete-case N when they differ under dropout. Prefer the baseline Table 1 N; fall back to the CONSORT 'allocated' count. |
| age_years | average | Age at enrollment/baseline in years. |
| female_percent | number | Percentage female in this unit. Calculate the complement if only male is given (60% male = 40% female). If the cohort is sex-restricted by procedure or eligibility, infer accordingly (a female-only procedure → 100; a male-only procedure → 0). |
| withdrawals | number | Participants in this unit who withdrew consent or discontinued participation between randomization/enrollment and final analysis. Count only consent-withdrawal and active discontinuation — do not include participants who remained enrolled but were not reached for follow-up. |
| lost_to_follow_up | number | Participants in this unit who remained enrolled but could not be reached for the final outcome assessment. Count only contact-loss with retained consent. If the paper reports a single combined count without distinguishing consent-withdrawal from contact-loss, record the combined count here and note the combined nature in the comment. |
| donor_count | number | Number of actual liver donors contributing organs in this unit. Restrict to the liver donor subset when a multi-organ procurement series reports pooled all-organ donor counts; if only a pooled multi-organ donor N is given with no liver breakout, mark ambiguous. |
| donor_age_years | average | Donor age at donation in years. Prefer the liver-donor subset when multi-organ series report age only for the pooled donor cohort. |
| donor_male_percent | number | Percentage of donors who are male in this unit. Calculate complement if only female given (60% female = 40% male). Restrict to the liver-donor subset when multi-organ series pool sexes across organs. |
| donor_cause_of_death | textharmonize | Primary cause(s) of donor death as reported for this unit. Format as a short noun phrase or comma-separated list when multiple causes are tabulated (e.g., "trauma", "anoxia, CVA"). Prefer cause distribution specific to liver donors over pooled multi-organ figures. |
| functional_warm_ischemia_time_minutes | average | Functional warm ischemia time in minutes for donors in this unit, from the paper's stated fWIT start (commonly systolic BP <50 mmHg or oxygen saturation threshold) to cold perfusion or NRP start. Convert from hours if needed. Do not substitute total warm ischemia, agonal-phase duration, or asystole-to-perfusion time when fWIT is not reported; those belong in the comment only. |
| donor_risk_index | average | Donor Risk Index (DRI) or liver-specific donor risk score as reported for this unit. Extract the named index value; if both DRI and a modified/UK DRI variant are given, prefer the score the paper uses in adjusted outcome models and name the instrument in the comment. |
| recipient_age_years | average | Liver transplant recipient age at transplantation in years for this unit. Restrict to liver recipients when multi-organ series report pooled recipient age. |
| recipient_male_percent | number | Percentage of liver transplant recipients who are male in this unit. Calculate complement if only female given (60% female = 40% male). Restrict to the liver-recipient subset in multi-organ series. |
| recipient_meld_score | average | Recipient MELD or MELD-Na score at transplant for this unit. Prefer laboratory MELD at allocation/transplant over exception or listing MELD when both are reported; name the variant in the comment. |
| nrp_type | TA-NRPA-NRPmixed | NRP configuration used for liver recovery in this unit. TA-NRP = thoracoabdominal NRP; A-NRP = abdominal-only NRP; mixed = unit pools both configurations. not_applicable on scs, mp, and dnc units. Do not infer type from cannula description or center habit when the paper is silent — use not_reported. When mixed, record per-type counts in the comment if given. |
| nrp_duration_minutes | average | Duration of in-situ NRP in minutes from NRP start to cessation/cross-clamp for livers in this unit. Convert from hours if needed. not_applicable on scs, mp, and dnc units that never received NRP. |
| nrp_temperature_celsius | average | Target or measured NRP perfusate temperature in degrees Celsius for this unit. not_applicable on scs, mp, and dnc units. If a range is given without a central value, record the midpoint and note the range in the comment. |
| heparin_timing | pre-mortempost-mortem | When systemic heparin was administered relative to circulatory death declaration during DCC recovery. pre-mortem = given before withdrawal of life-sustaining therapy or before death declaration; post-mortem = given only after death declaration or at NRP/cannulation start. not_applicable on dnc units and on units with no heparin policy stated as part of a non-DCC pathway. A study silent on timing is not_reported, not post-mortem. |
| preservation_adjunct | textharmonize | Ex-situ preservation method used after recovery (and after NRP when applicable) for livers in this unit. Format as a short noun phrase naming modality and any device (e.g., "static cold storage", "NMP (OrganOx Metra)", "HMP (Liver Assist)", "SCS then NMP"). Capture the post-recovery pathway only — do not restate the in-situ NRP step here. |
outcomes13 outcomes · 56 fields
| recipient_mortality8 | ||
| recipient_mortality_in_hospital_rate | rate | Rate of recipient_mortality within the index hospitalization (any stay duration) in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| recipient_mortality_30d_rate | rate | Rate of recipient_mortality within 30 days in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 30 days — mark not_reported. |
| recipient_mortality_1yr_rate | rate | Rate of recipient_mortality within 12 calendar months in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 12 calendar months — mark not_reported. |
| recipient_mortality_5yr_rate | rate | Rate of recipient_mortality within 60 calendar months in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 60 calendar months — mark not_reported. |
| recipient_mortality_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for recipient_mortality. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| recipient_mortality_effect_vs_scs | effect_estimate | Adjusted effect estimate for recipient_mortality, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'scs' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'scs' itself, which is not_applicable. If the paper reports no recipient_mortality effect for this arm vs 'scs', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| recipient_mortality_effect_vs_mp | effect_estimate | Adjusted effect estimate for recipient_mortality, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'mp' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'mp' itself, which is not_applicable. If the paper reports no recipient_mortality effect for this arm vs 'mp', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| recipient_mortality_effect_vs_dnc | effect_estimate | Adjusted effect estimate for recipient_mortality, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'dnc' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'dnc' itself, which is not_applicable. If the paper reports no recipient_mortality effect for this arm vs 'dnc', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| graft_failure8 | ||
| graft_failure_in_hospital_rate | rate | Rate of graft_failure within the index hospitalization (any stay duration) in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| graft_failure_30d_rate | rate | Rate of graft_failure within 30 days in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 30 days — mark not_reported. |
| graft_failure_1yr_rate | rate | Rate of graft_failure within 12 calendar months in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 12 calendar months — mark not_reported. |
| graft_failure_5yr_rate | rate | Rate of graft_failure within 60 calendar months in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. Reject a cumulative count spanning a window wider than 60 calendar months — mark not_reported. |
| graft_failure_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for graft_failure. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| graft_failure_effect_vs_scs | effect_estimate | Adjusted effect estimate for graft_failure, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'scs' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'scs' itself, which is not_applicable. If the paper reports no graft_failure effect for this arm vs 'scs', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| graft_failure_effect_vs_mp | effect_estimate | Adjusted effect estimate for graft_failure, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'mp' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'mp' itself, which is not_applicable. If the paper reports no graft_failure effect for this arm vs 'mp', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| graft_failure_effect_vs_dnc | effect_estimate | Adjusted effect estimate for graft_failure, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'dnc' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'dnc' itself, which is not_applicable. If the paper reports no graft_failure effect for this arm vs 'dnc', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| ischemic_cholangiopathy6 | ||
| ischemic_cholangiopathy_rate | rate | Rate of ischemic_cholangiopathy in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| ischemic_cholangiopathy_timepoint | text | Time at which ischemic_cholangiopathy was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| ischemic_cholangiopathy_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for ischemic_cholangiopathy. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| ischemic_cholangiopathy_effect_vs_scs | effect_estimate | Adjusted effect estimate for ischemic_cholangiopathy, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'scs' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'scs' itself, which is not_applicable. If the paper reports no ischemic_cholangiopathy effect for this arm vs 'scs', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| ischemic_cholangiopathy_effect_vs_mp | effect_estimate | Adjusted effect estimate for ischemic_cholangiopathy, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'mp' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'mp' itself, which is not_applicable. If the paper reports no ischemic_cholangiopathy effect for this arm vs 'mp', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| ischemic_cholangiopathy_effect_vs_dnc | effect_estimate | Adjusted effect estimate for ischemic_cholangiopathy, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'dnc' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'dnc' itself, which is not_applicable. If the paper reports no ischemic_cholangiopathy effect for this arm vs 'dnc', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| early_allograft_dysfunction6 | ||
| early_allograft_dysfunction_rate | rate | Rate of early_allograft_dysfunction in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| early_allograft_dysfunction_timepoint | text | Time at which early_allograft_dysfunction was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| early_allograft_dysfunction_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for early_allograft_dysfunction. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| early_allograft_dysfunction_effect_vs_scs | effect_estimate | Adjusted effect estimate for early_allograft_dysfunction, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'scs' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'scs' itself, which is not_applicable. If the paper reports no early_allograft_dysfunction effect for this arm vs 'scs', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| early_allograft_dysfunction_effect_vs_mp | effect_estimate | Adjusted effect estimate for early_allograft_dysfunction, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'mp' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'mp' itself, which is not_applicable. If the paper reports no early_allograft_dysfunction effect for this arm vs 'mp', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| early_allograft_dysfunction_effect_vs_dnc | effect_estimate | Adjusted effect estimate for early_allograft_dysfunction, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'dnc' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'dnc' itself, which is not_applicable. If the paper reports no early_allograft_dysfunction effect for this arm vs 'dnc', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| primary_non_function6 | ||
| primary_non_function_rate | rate | Rate of primary_non_function in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| primary_non_function_timepoint | text | Time at which primary_non_function was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| primary_non_function_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for primary_non_function. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| primary_non_function_effect_vs_scs | effect_estimate | Adjusted effect estimate for primary_non_function, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'scs' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'scs' itself, which is not_applicable. If the paper reports no primary_non_function effect for this arm vs 'scs', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| primary_non_function_effect_vs_mp | effect_estimate | Adjusted effect estimate for primary_non_function, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'mp' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'mp' itself, which is not_applicable. If the paper reports no primary_non_function effect for this arm vs 'mp', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| primary_non_function_effect_vs_dnc | effect_estimate | Adjusted effect estimate for primary_non_function, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'dnc' reference arm (see the '## Comparison axis' block), over the whole study follow-up — one estimate per outcome, NOT a per-timepoint value. Populate on any unit other than 'dnc' itself, which is not_applicable. If the paper reports no primary_non_function effect for this arm vs 'dnc', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| organ_utilization2 | ||
| organ_utilization_rate | rate | Livers transplanted divided by donor livers available/assessed/perfused in this unit (events = livers transplanted; evaluated = livers from actual donors made available or assessed for transplant). Do not backfill evaluated from recipient sample_size or from multi-organ all-organ donor counts; reject denominators that are potential donors, offers only, or pooled non-liver organs. Percent alone without an explicit liver-level denominator is not_reported rather than imputed. |
| organ_utilization_definition_as_reported | textharmonize | Paper's stated definition of liver utilization or acceptance numerator and denominator (e.g., "transplanted / NRP-initiated livers", "transplanted / livers offered"). Capture verbatim phrasing of both sides of the ratio; not_reported when utilization is given without defining the denominator. |
| icu_los3 | ||
| icu_los_days | average | Value of icu_los in this unit, in days. Record per the average field shape: mean+SD, median+IQR, or median+min/max — include whichever the paper reports. Convert units when the field name specifies one; record verbatim otherwise. |
| icu_los_timepoint | text | Time at which icu_los was measured in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., 'baseline', 'day 1', 'discharge'). When measured at multiple timepoints, use the protocol's primary or pre-specified one. |
| icu_los_definition_as_reported | textharmonize | Author's stated measurement method for icu_los. Use the canonical instrument/assay/scale name when applicable (the named measurement device, lab assay, or rating scale the paper cites); otherwise a concise paraphrase capturing what was measured and how ('measured by', 'assessed with', 'derived from'). Keep to a short noun phrase or single clause. |
| hospital_los3 | ||
| hospital_los_days | average | Value of hospital_los in this unit, in days. Record per the average field shape: mean+SD, median+IQR, or median+min/max — include whichever the paper reports. Convert units when the field name specifies one; record verbatim otherwise. |
| hospital_los_timepoint | text | Time at which hospital_los was measured in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., 'baseline', 'day 1', 'discharge'). When measured at multiple timepoints, use the protocol's primary or pre-specified one. |
| hospital_los_definition_as_reported | textharmonize | Author's stated measurement method for hospital_los. Use the canonical instrument/assay/scale name when applicable (the named measurement device, lab assay, or rating scale the paper cites); otherwise a concise paraphrase capturing what was measured and how ('measured by', 'assessed with', 'derived from'). Keep to a short noun phrase or single clause. |
| hepatic_artery_thrombosis3 | ||
| hepatic_artery_thrombosis_rate | rate | Rate of hepatic_artery_thrombosis in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| hepatic_artery_thrombosis_timepoint | text | Time at which hepatic_artery_thrombosis was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| hepatic_artery_thrombosis_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for hepatic_artery_thrombosis. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| other_biliary_complications3 | ||
| other_biliary_complications_rate | rate | Rate of other_biliary_complications in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| other_biliary_complications_timepoint | text | Time at which other_biliary_complications was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| other_biliary_complications_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for other_biliary_complications. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| retransplant4 | ||
| retransplant_rate | rate | Rate of retransplant in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| retransplant_timepoint | text | Time at which retransplant was assessed in this unit. Format: relative-to-baseline duration or named clinical milestone (e.g., '30 days post-randomization', '1 year', 'in-hospital', 'discharge'). When multiple timepoints are reported, use the protocol's primary or pre-specified one. |
| retransplant_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for retransplant. Use the canonical instrument name when applicable (the named scale, grading system, or clinical-criteria set the paper cites); otherwise a concise paraphrase capturing the paper's diagnostic criterion or definitional phrase ('was defined as', 'diagnosed by', 'graded using'). Keep to a short noun phrase or single clause. |
| retransplant_timing | EarlyLateTotal | Timing classification of re-transplantation events counted in retransplant_rate for this unit. Early = paper-defined early/urgent retransplant (typically ≤7–30 days or for PNF); Late = retransplant beyond the paper's early window; Total = paper reports only an undifferentiated all-time retransplant count. When both early and late are reported separately, prefer Total only if a combined figure is explicitly given; otherwise encode the stratum the rate row reflects and note split counts in the comment. |
| donor_conversion2 | ||
| donor_conversion_rate | rate | Actual donors divided by potential donors for this unit's pathway (events = actual donors proceeding to donation; evaluated = potential donors identified or approached). Do not backfill evaluated from sample_size, transplanted-liver counts, or referral-center catchment totals that are not the paper's stated potential-donor denominator. Percent alone without an explicit potential-donor N is not_reported rather than imputed. |
| donor_conversion_definition_as_reported | textharmonize | Paper's stated definition of potential versus actual donors used for conversion (e.g., "actual DCC donors / planned WLST referrals"). Capture both numerator and denominator definitions; not_reported when a conversion percentage is given without defining the potential-donor pool. |
| donor_family_satisfaction2 | ||
| donor_family_satisfaction | Yes | Whether the paper presents or references donor_family_satisfaction. Mark Yes when the paper measures, reports, or explicitly references this outcome — even when a numeric value is not provided. |
| donor_family_satisfaction_definition_as_reported | text | Author's stated scope of donor_family_satisfaction, when the paper delimits it. Concise paraphrase of the scope-limiting phrase ('including', 'limited to', 'covers'). Keep to a short noun phrase. |
rob14 fields
| rob2_randomization | LowSome concernsHigh | RoB 2 Domain 1: bias arising from the randomization process. LOW: random sequence (computer-generated, random number table) AND allocation adequately concealed (central randomization, sequentially numbered sealed opaque envelopes) AND baseline characteristics balanced. SOME CONCERNS: sequence generation or concealment not described, OR small baseline imbalances of uncertain origin. HIGH: predictable allocation (alternation, date of birth, day of week), OR substantial baseline imbalances suggesting failed randomization. |
| rob2_deviations | LowSome concernsHigh | RoB 2 Domain 2: bias due to deviations from intended interventions (effect of assignment). LOW: participants and personnel blinded OR no deviations from intended intervention arose OR appropriate ITT/mITT analysis estimating effect of assignment. SOME CONCERNS: minor deviations with unclear impact, OR analysis approach unclear. HIGH: substantial unbalanced deviations affecting the outcome, OR analysis was naive per-protocol/as-treated rather than ITT. |
| rob2_missing_data | LowSome concernsHigh | RoB 2 Domain 3: bias due to missing outcome data. LOW: outcome data available for nearly all participants OR appropriate methods handle missingness with sensitivity analyses showing the result is robust. SOME CONCERNS: missing data present but no positive evidence the result is biased. HIGH: missingness on the outcome plausibly depends on its true value AND missing fraction is comparable to event count (binary outcomes) or substantial (continuous outcomes); OR LOCF/single imputation used for substantial missingness. |
| rob2_measurement | LowSome concernsHigh | RoB 2 Domain 4: bias in measurement of the outcome. LOW: outcome is objective (all-cause mortality, automated lab values) AND ascertainment methods identical across groups, OR outcome assessors explicitly blinded to intervention. SOME CONCERNS: subjective outcome assessed by unblinded assessors in a neutral-belief context, OR blinding unclear for a judgment-dependent outcome. HIGH: subjective outcome (patient-reported, clinician-graded severity) assessed by unblinded assessors with strong prior beliefs about the intervention. |
| rob2_reporting | LowSome concernsHigh | RoB 2 Domain 5: bias in selection of the reported result. LOW: pre-registered protocol or SAP (dated before outcome unblinding) available AND reported numerical result matches the pre-specified primary analysis. SOME CONCERNS: no protocol available but no apparent selective outcome or analysis reporting. HIGH: evidence of selective outcome reporting, outcome switching, analysis switching, or selection of the most favorable of multiple analyses. |
| rob2_overall | LowSome concernsHigh | RoB 2 overall risk-of-bias judgment, derived from the five per-domain judgments per Cochrane Table 1. HIGH when any one domain is HIGH, OR when multiple domains are SOME CONCERNS and the combined concern substantially lowers confidence. SOME CONCERNS when at least one domain is SOME CONCERNS, no domain is HIGH, and the multi-domain escalation does not apply. LOW only when all five domains are LOW. |
| robins_confounding | LowModerateSeriousCritical | ROBINS-I Domain 1: bias from confounding in the intervention-vs-comparator effect estimate. LOW: design adds RCT-grade control (target-trial emulation with active comparator, negative-control falsification, or a quasi-experimental instrument) AND analysis covers important confounders. MODERATE: analysis adjusts for important measured confounders via propensity matching/weighting, regression, or stratification, but residual unmeasured confounding remains plausible. SERIOUS: the adjustment set omits a clinically-recognized driver of treatment choice or strong prognostic factor for the outcome, OR no quantitative adjustment was performed. CRITICAL: confounding renders the result uninterpretable. |
| robins_selection | LowModerateSeriousCritical | ROBINS-I Domain 2: bias from selection of participants into the analytic cohort. LOW: selection based on pre-intervention characteristics; analytic cohort defined at start of follow-up; no post-baseline exclusion correlated with intervention or outcome. MODERATE: some post-baseline exclusion or analytic-cohort filtering present but unlikely to depend on both intervention and outcome. SERIOUS: selection depends on both intervention and outcome (collider stratification, immortal-time bias, post-baseline cohort definition correlated with outcome). CRITICAL: selection virtually guarantees biased results. |
| robins_classification | LowModerateSeriousCritical | ROBINS-I Domain 3: bias from misclassification of intervention status. LOW: intervention status documented from the procedural record at the start of intervention. MODERATE: intervention status inferred from a proxy variable (administrative category, time-threshold cut-off, billing or ICD code) or from records recorded after intervention started; classification not influenced by outcome knowledge. SERIOUS: classification influenced by outcome knowledge (recall, retrospective recoding) or differential misclassification across groups. CRITICAL: classification errors invalidate the comparison. |
| robins_deviations | LowModerateSeriousCritical | ROBINS-I Domain 4: bias from deviations from intended interventions. LOW: no substantial deviations from intended intervention, OR the analysis appropriately estimates the targeted effect (ITT-style for assignment effect; g-methods for per-protocol effect). MODERATE: minor deviations not handled analytically. SERIOUS: substantial unbalanced deviations affecting the outcome, OR per-protocol analysis uses standard regression on time-varying confounders affected by prior intervention. CRITICAL: deviations render the comparison meaningless. |
| robins_missing | LowModerateSeriousCritical | ROBINS-I Domain 5: bias from missing data on intervention, outcome, or important confounders. LOW: complete data for at least 95% of participants with proportions similar across groups, OR appropriate multiple imputation, OR sensitivity analyses show results robust to missingness. MODERATE: some missing data with reasonable handling but incomplete documentation; missingness unlikely to depend on the true outcome value. SERIOUS: substantial missingness depending on the true outcome value or differing between groups, OR only LOCF / single imputation used for substantial missingness, OR no information on extent of missing data. CRITICAL: missing data so extensive and selective that the result cannot be interpreted. |
| robins_measurement | LowModerateSeriousCritical | ROBINS-I Domain 6: bias from outcome measurement (differential or non-differential measurement error). LOW: outcome is hard and objective (mortality, lab values, registry-linked death) AND ascertainment methods are identical across groups AND surveillance frequency does not differ by intervention. MODERATE: assessment methods comparable across groups; blinding not documented for a judgment-dependent outcome; minor ascertainment timing differences without documented detection differential. SERIOUS: differential ascertainment across groups (active vs passive surveillance, different diagnostic thresholds, different follow-up intensity), OR subjective outcome assessed by unblinded assessors with strong prior beliefs about the intervention. CRITICAL: measurement so unsuitable that the intervention-outcome relationship is uninterpretable. |
| robins_reporting | LowModerateSeriousCritical | ROBINS-I Domain 7: bias from selective reporting of the result. LOW: pre-registered protocol or statistical analysis plan available and results match the pre-specified analysis. MODERATE: no protocol available but no apparent selective outcome or analysis reporting. SERIOUS: evidence of selective outcome reporting, analysis switching, or subgroup-cherry-picking. CRITICAL: reporting selection virtually guarantees a biased result. |
| robins_overall | LowModerateSeriousCritical | ROBINS-I overall risk-of-bias judgment, computed as the worst per-domain judgment. LOW only when every domain is LOW (the result is comparable to a well-conducted RCT). MODERATE when at least one domain is MODERATE and no domain is SERIOUS or CRITICAL. SERIOUS when at least one domain is SERIOUS and no domain is CRITICAL. CRITICAL when at least one domain is CRITICAL. |