study10 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. |
| comparison_type | DCD-NRP vs DCD-No-NRPDCD-NRP vs DBDOther | Structured classification of the study's between-arm comparison when any NRP recipients are present. DCD-NRP vs DCD-No-NRP = NRP compared with controlled DCD without NRP (SCS and/or ex-situ machine perfusion). DCD-NRP vs DBD = NRP compared with donation after neurological death. Use the matching category even when a DCD arm mixes NRP with non-NRP patients — note the mixed cohort in the comment. Reserve Other only for genuinely unstructured comparisons that fit neither category. |
unit18 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 heart donors contributing to this unit. Restrict to the heart subset when the paper reports multi-organ procurement; do not use pooled multi-organ donor N. When only pooled multi-organ donor counts are reported with no heart breakout, mark ambiguous and comment 'heart sub-cohort not separately reported'. |
| donor_age_years | average | Donor age at donation in years for hearts in this unit. Restrict to heart donors when multi-organ series report other organs alongside. |
| donor_male_percent | number | Percentage of heart donors in this unit who are male. Calculate complement if only female given (60% female = 40% male). Restrict to the heart-donor subset in multi-organ series. |
| donor_cause_of_death | textharmonize | Primary cause of donor death for hearts in this unit. Format as a short noun phrase (e.g., 'trauma', 'anoxia', 'CVA/stroke', 'mixed: trauma 40%, anoxia 35%, CVA 25%'). When only a distribution is given, summarise the leading causes with percentages; when a single cause defines the cohort, state that cause. |
| total_warm_ischemia_time_minutes | average | Total warm ischemia time in minutes for donated hearts in this unit (withdrawal of life-sustaining therapy to reperfusion or cold flush, as the paper defines total WIT). Convert from hours if needed. Distinct from functional warm ischemia time; when the paper reports only one WIT without labelling total vs functional, record it here and note the ambiguous label in the comment. |
| functional_warm_ischemia_time_minutes | average | Functional warm ischemia time in minutes for donated hearts in this unit (onset of functional ischemia — typically systolic BP <50 mmHg or SpO2 <70% — to reperfusion or cold flush, as defined by the paper). Convert from hours if needed. Distinct from total warm ischemia time; do not copy total WIT here unless the paper explicitly equates them. |
| recipient_age_years | average | Heart transplant recipient age at transplant in years for this unit. Restrict to heart recipients when multi-organ series report other organ recipients alongside. |
| recipient_male_percent | number | Percentage of heart transplant recipients in this unit who are male. Calculate complement if only female given (60% female = 40% male). Restrict to the heart-recipient subset in multi-organ series. |
| nrp_type | TA-NRPA-NRPmixed | Normothermic regional perfusion configuration used for heart recovery in this unit. TA-NRP = thoracoabdominal NRP; A-NRP = abdominal-only NRP; mixed = unit pools recipients of more than one NRP type (state per-type counts in the comment when reported). When the paper procures a heart and does not explicitly name the NRP type, infer TA-NRP. not_applicable on non-NRP units (scs, mp, dnc). |
| nrp_duration_minutes | average | Duration of in-situ NRP in minutes for hearts in this unit (start of regional perfusion to cessation/cross-clamp). Convert from hours if needed. not_applicable on non-NRP units. |
| nrp_temperature_celsius | average | Target or measured NRP perfusate temperature in degrees Celsius for hearts in this unit. not_applicable on non-NRP units. |
| heparin_timing | pre-mortempost-mortem | Timing of systemic heparin administration relative to circulatory death declaration for donors in this unit. pre-mortem = heparin given before withdrawal of life-sustaining therapy or before death declaration; post-mortem = heparin given only after death declaration. not_applicable when heparin use is not part of the recovery protocol and on arms where the paper never addresses heparin. |
| preservation_adjunct | text | Additional ex-situ or in-transit preservation steps applied after NRP or direct procurement for hearts in this unit, beyond the arm's defining modality. Format as a short noun phrase (e.g., 'OCS Heart after TA-NRP', 'static cold storage only', 'hypothermic machine perfusion'). State 'none' when no adjunct beyond the arm-defining technique is used. |
outcomes17 outcomes · 68 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_failure5 | ||
| 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. |
| primary_graft_dysfunction6 | ||
| primary_graft_dysfunction_rate | rate | Rate of primary_graft_dysfunction in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| primary_graft_dysfunction_timepoint | text | Time at which primary_graft_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. |
| primary_graft_dysfunction_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for primary_graft_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. |
| primary_graft_dysfunction_effect_vs_scs | effect_estimate | Adjusted effect estimate for primary_graft_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 primary_graft_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. |
| primary_graft_dysfunction_effect_vs_mp | effect_estimate | Adjusted effect estimate for primary_graft_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 primary_graft_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. |
| primary_graft_dysfunction_effect_vs_dnc | effect_estimate | Adjusted effect estimate for primary_graft_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 primary_graft_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. |
| 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_nonfunction6 | ||
| primary_nonfunction_rate | rate | Rate of primary_nonfunction in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| primary_nonfunction_timepoint | text | Time at which primary_nonfunction 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_nonfunction_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for primary_nonfunction. 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_nonfunction_effect_vs_scs | effect_estimate | Adjusted effect estimate for primary_nonfunction, 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_nonfunction 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_nonfunction_effect_vs_mp | effect_estimate | Adjusted effect estimate for primary_nonfunction, 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_nonfunction 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_nonfunction_effect_vs_dnc | effect_estimate | Adjusted effect estimate for primary_nonfunction, 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_nonfunction 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. |
| acute_rejection3 | ||
| acute_rejection_rate | rate | Rate of acute_rejection in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| acute_rejection_timepoint | text | Time at which acute_rejection 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. |
| acute_rejection_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for acute_rejection. 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. |
| antibody_mediated_rejection3 | ||
| antibody_mediated_rejection_rate | rate | Rate of antibody_mediated_rejection in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| antibody_mediated_rejection_timepoint | text | Time at which antibody_mediated_rejection 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. |
| antibody_mediated_rejection_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for antibody_mediated_rejection. 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. |
| cardiac_allograft_vasculopathy3 | ||
| cardiac_allograft_vasculopathy_rate | rate | Rate of cardiac_allograft_vasculopathy in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| cardiac_allograft_vasculopathy_timepoint | text | Time at which cardiac_allograft_vasculopathy 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. |
| cardiac_allograft_vasculopathy_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for cardiac_allograft_vasculopathy. 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. |
| mechanical_circulatory_support3 | ||
| mechanical_circulatory_support_rate | rate | Rate of mechanical_circulatory_support in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| mechanical_circulatory_support_timepoint | text | Time at which mechanical_circulatory_support 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. |
| mechanical_circulatory_support_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for mechanical_circulatory_support. 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. |
| hospital_length_of_stay3 | ||
| hospital_length_of_stay_days | average | Value of hospital_length_of_stay 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_length_of_stay_timepoint | text | Time at which hospital_length_of_stay 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_length_of_stay_definition_as_reported | textharmonize | Author's stated measurement method for hospital_length_of_stay. 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. |
| icu_length_of_stay3 | ||
| icu_length_of_stay_days | average | Value of icu_length_of_stay 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_length_of_stay_timepoint | text | Time at which icu_length_of_stay 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_length_of_stay_definition_as_reported | textharmonize | Author's stated measurement method for icu_length_of_stay. 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. |
| ventilation3 | ||
| ventilation_duration | average | Duration of ventilation in this unit. Record the value verbatim from the paper without unit conversion (the companion units field carries the reporting unit). Record per the average field shape: mean+SD, median+IQR, or median+min/max — whichever the paper reports. |
| ventilation_duration_units | text | Units for ventilation_duration as the paper reports them. Common values: 'hours', 'days', 'minutes'. Use the exact unit token the paper uses. |
| ventilation_definition_as_reported | text | Author's stated start and end points for the ventilation duration. Format as `start → end` naming the paper's two boundary events (e.g., `procedure start → procedure end`); otherwise a concise paraphrase of the paper's two endpoints. |
| retransplantation4 | ||
| retransplantation_rate | rate | Rate of retransplantation in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| retransplantation_timepoint | text | Time at which retransplantation 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. |
| retransplantation_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for retransplantation. 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. |
| retransplantation_timing | EarlyLateTotal | Timing classification of cardiac retransplantation events counted in retransplantation_rate for this unit. Early = retransplant during the index admission or within the paper's early window (typically ≤30d); Late = retransplant after that window; Total = paper reports only a combined early+late count without breakout. When early and late are both reported separately, prefer the category matching the events included in the paired rate cell and note the other count in the comment. |
| acute_kidney_injury3 | ||
| acute_kidney_injury_rate | rate | Rate of acute_kidney_injury in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| acute_kidney_injury_timepoint | text | Time at which acute_kidney_injury 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. |
| acute_kidney_injury_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for acute_kidney_injury. 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. |
| stroke3 | ||
| stroke_rate | rate | Rate of stroke in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| stroke_timepoint | text | Time at which stroke 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. |
| stroke_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for stroke. 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. |
| reexploration_for_bleeding3 | ||
| reexploration_for_bleeding_rate | rate | Rate of reexploration_for_bleeding in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| reexploration_for_bleeding_timepoint | text | Time at which reexploration_for_bleeding 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. |
| reexploration_for_bleeding_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for reexploration_for_bleeding. 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. |
| infection3 | ||
| infection_rate | rate | Rate of infection in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| infection_timepoint | text | Time at which infection 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. |
| infection_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for infection. 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. |
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. |