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. |
| number_of_open_drf_cases | number | Count of analysed eligible open distal radius fractures managed operatively in this paper. Use the open-DRF operatively-treated subset, not the paper's headline all-distal-radius or mixed-site cohort, and not the screened/eligible-but-excluded denominator. When only a mixed cohort is reported, leave not_reported unless the open-DRF operative subset is stated or recoverable from per-patient listings. |
| open_fracture_classification_method | Gustilo-AndersonOther | Classification system used for open-fracture severity. Gustilo-Anderson = GA grade I–IIIc (any variant spelling). Other = OTA open-fracture classification, TSCHERNÉ, or any non-GA system named in Methods. A paper silent on classification is not_reported, not Other. |
unit27 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. |
| time_to_debridement_hours | average | Observed time in hours from time_zero to initial operative debridement/irrigation in this unit. Convert days to hours (×24). Use actual/observed times, not protocol targets. When only a range is given without a central value, leave unset and note the range in comment. Distinct from time_to_definitive_fixation_hours under staged care. |
| time_to_definitive_fixation_hours | average | Observed time in hours from time_zero to definitive fracture fixation in this unit. Convert days to hours (×24). Use actual/observed times. When debridement and fixation were the same procedure, this equals time_to_debridement_hours; when staged, use the later definitive-fixation time. Distinct from time_to_debridement_hours. |
| timing_event | debridementdefinitive_fixationany_surgery | Which operative event defines this study's early/late (or timed) grouping for this unit. debridement = split on time to initial irrigation/debridement; definitive_fixation = split on time to definitive fixation; any_surgery = paper uses undifferentiated 'time to surgery' without separating debridement from fixation. Infer from Methods' arm-definition wording; not_reported if the timed event is unstated. |
| timing_threshold | textharmonize | Study's exact operative-timing cutpoint verbatim as used to define arms (e.g., "≤6h vs >6h", "≤24h vs >24h", "24–72h vs >72h", ">2 days"). Capture the threshold string, not a normalized arm label. Same value may repeat across units within a study when both sides share one cut. |
| time_zero | injurypresentation | Anchor from which operative timing is measured. injury = from injury moment; presentation = from hospital/ED arrival or first presentation. A paper that does not state the anchor is not_reported — do not assume injury. Timing from injury is not comparable to timing from presentation. |
| reason_for_delay | text | Stated reasons delayed cases underwent later operative treatment, as reported for this unit (e.g., "transfer from outside facility", "operating-room availability", "polytrauma resuscitation"). Comma-separate multiple reasons. not_reported when the paper gives no delay rationale. |
| bmi | average | Body mass index in kg/m² at baseline in this unit. |
| diabetes_rate | rate | Participants in this unit with diabetes mellitus (any type) as reported at baseline. Prefer physician-diagnosed or charted diabetes; exclude isolated hyperglycemia without a diabetes label when the paper distinguishes them. |
| smoking_rate | rate | Participants in this unit who are current smokers at baseline as defined by the paper. Do not combine former smokers into the numerator unless the paper reports only a combined ever-smoked figure and states no current-only split — then use the combined figure and note combined definition in comment. |
| immunocompromised_rate | rate | Participants in this unit labelled immunocompromised or immunosuppressed at baseline (e.g., active chemotherapy, transplant immunosuppression, high-dose chronic steroids, advanced HIV). Use the paper's stated definition; do not infer from diabetes or smoking alone. |
| polytrauma_rate | rate | Participants in this unit with polytrauma or multiple-system injury concurrent with the open distal radius fracture, as defined by the paper (ISS threshold, additional long-bone/axial injuries, or explicit 'polytrauma' label). |
| gustilo_grade_distribution | text | Counts of open fractures by Gustilo-Anderson grade in this unit. Format: I=n, II=n, IIIa=n, IIIb=n, IIIc=n (omit grades not reported; keep III subdivided when the paper subdivides). When only pooled III is given, write III=n and note lack of ABC split in comment. Reconstruct from per-patient tables when arm-level totals are absent but grade and timing are row-wise. Not a timing arm — grade is a stratifier only. |
| wound_contamination | text | Wound contamination grade or description as reported for this unit (e.g., "clean", "contaminated", "farm/soil", "gross contamination n=3"). Prefer the paper's grading terms; comma-separate mixed descriptors. not_reported when contamination is unstated. |
| mechanism_of_injury | textharmonize | Injury mechanism distribution in this unit as a short noun-phrase list with counts when given (e.g., "fall from height n=12, MVC n=8, industrial n=3"). Harmonize common synonyms (RTA/MVC/MVA → MVC). not_reported when mechanism is unstated for this unit. |
| antibiotic_agents | textharmonize | Prophylactic antibiotic agent(s) used in this unit. Format: agent list with optional dose (e.g., "cefazolin", "ceftriaxone + gentamicin"). Harmonize brand to generic names. Capture prophylaxis regimen, not culture-directed treatment of established infection. |
| antibiotic_route | IVoralmixed | Route of prophylactic antibiotics in this unit. IV = parenteral only; oral = enteral only; mixed = both routes used in the prophylactic regimen. Refers to prophylaxis, not later treatment of infection. |
| antibiotic_duration_hours | average | Duration of prophylactic antibiotic administration in hours for this unit. Convert days to hours (×24). Use planned or protocol duration when only that is stated and note planned in comment; prefer actual duration when both appear. Distinct from time_to_first_antibiotic_dose_hours. |
| time_to_first_antibiotic_dose_hours | average | Time in hours from time_zero to first prophylactic antibiotic dose in this unit. Convert minutes to hours. Actual observed time, not a protocol target. Distinct from antibiotic_duration_hours and from operative timing fields. |
| fixation_type | volar_platedorsal_platebridge_plateext_fixatork_wiresnonoperativeother | Definitive fixation method predominant in this unit. volar_plate/dorsal_plate/bridge_plate = plate osteosynthesis by approach; ext_fixator = external fixation (spanning or non-spanning); k_wires = percutaneous wires alone; nonoperative = no fixation after debridement; other = fragment-specific, IM device, mixed methods without a majority, or unnamed. When multiple methods are used, pick the majority method or other if no majority; note the mix in comment. |
| staged_vs_immediate_fixation | stagedimmediate | Whether definitive fixation occurred in the same operative sitting as initial debridement. immediate = debridement and definitive fixation in one procedure; staged = temporary stabilization or debridement alone first, definitive fixation later. Classify from surgical-strategy description, not from timing-threshold labels alone. |
| number_of_debridements | average | Number of operative debridement procedures per patient in this unit, including the index debridement. Count operative trips for irrigation/debridement, not bedside dressing changes. |
| wound_closure_method | textharmonize | Method of wound management/closure in this unit (e.g., "primary closure", "delayed primary closure", "secondary intention", "STSG", "flap coverage"). Comma-separate mixed strategies with counts when given. Harmonize synonyms (split-thickness skin graft → STSG). |
outcomes12 outcomes · 43 fields
| deep_infection10 | ||
| deep_infection_rate | rate | Rate of deep_infection in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| deep_infection_timepoint | text | Time at which deep_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. |
| deep_infection_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for deep_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. |
| deep_infection_effect_vs_le_6h | effect_estimate | Adjusted effect estimate for deep_infection, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'le_6h' 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 'le_6h' itself, which is not_applicable. If the paper reports no deep_infection effect for this arm vs 'le_6h', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| deep_infection_effect_vs_le_24h | effect_estimate | Adjusted effect estimate for deep_infection, comparing the extraction unit (the arm named in the '## Extraction unit' block) against the 'le_24h' 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 'le_24h' itself, which is not_applicable. If the paper reports no deep_infection effect for this arm vs 'le_24h', mark not_reported. Give measure and adjustment per the effect_estimate shape; note the adjustment model/covariates and follow-up horizon in the comment. |
| osteomyelitis_rate | rate | Participants in this unit with osteomyelitis as diagnosed/reported. Component of the deep_infection composite — capture here for component detail; do not treat as a second independent infection outcome at synthesis. When osteomyelitis is only reported inside a pooled deep-infection total with no component split, leave not_reported rather than copying the composite count. |
| return_to_or_for_id_rate | rate | Participants in this unit who returned to the OR for operative irrigation and debridement of infection. Component of the deep_infection composite — capture for component detail; do not double-count as a separate infection outcome. Exclude index debridement and noninfectious reoperations. When I&D for infection is only inside a pooled deep-infection total without a component split, leave not_reported. |
| hardware_removal_for_infection_rate | rate | Participants in this unit who underwent hardware removal specifically for infection. Component of the deep_infection composite — capture for component detail; do not double-count. Exclude elective or prominence-related hardware removal without infection. When infection-related removal is only inside a pooled deep-infection total without a component split, leave not_reported. |
| causative_organism | textharmonize | Organism(s) cultured from deep infection in this unit (e.g., "MSSA", "MRSA", "Pseudomonas aeruginosa", "polymicrobial"). Comma-separate multiple organisms; harmonize common abbreviations. not_reported when infection is stated without microbiology. |
| time_to_infection_diagnosis_days | average | Time in days from injury or index surgery to diagnosis of deep infection in this unit, using the paper's stated anchor. Convert weeks to days (×7). Prefer time to deep-infection diagnosis over time to any wound issue. |
| superficial_ssi3 | ||
| superficial_ssi_rate | rate | Rate of superficial_ssi in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| superficial_ssi_timepoint | text | Time at which superficial_ssi 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. |
| superficial_ssi_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for superficial_ssi. 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. |
| reoperation_noninfectious3 | ||
| reoperation_noninfectious_rate | rate | Rate of reoperation_noninfectious in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| reoperation_noninfectious_timepoint | text | Time at which reoperation_noninfectious 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. |
| reoperation_noninfectious_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for reoperation_noninfectious. 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. |
| reoperation_total3 | ||
| reoperation_total_rate | rate | Rate of reoperation_total in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| reoperation_total_timepoint | text | Time at which reoperation_total 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. |
| reoperation_total_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for reoperation_total. 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. |
| crps3 | ||
| crps_rate | rate | Rate of crps in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| crps_timepoint | text | Time at which crps 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. |
| crps_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for crps. 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. |
| tendon_complications3 | ||
| tendon_complications_rate | rate | Rate of tendon_complications in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| tendon_complications_timepoint | text | Time at which tendon_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. |
| tendon_complications_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for tendon_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. |
| nerve_complications3 | ||
| nerve_complications_rate | rate | Rate of nerve_complications in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| nerve_complications_timepoint | text | Time at which nerve_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. |
| nerve_complications_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for nerve_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. |
| nonunion3 | ||
| nonunion_rate | rate | Rate of nonunion in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| nonunion_timepoint | text | Time at which nonunion 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. |
| nonunion_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for nonunion. 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. |
| malunion3 | ||
| malunion_rate | rate | Rate of malunion in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| malunion_timepoint | text | Time at which malunion 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. |
| malunion_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for malunion. 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. |
| time_to_union3 | ||
| time_to_union_duration | average | Duration of time_to_union 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. |
| time_to_union_duration_units | text | Units for time_to_union_duration as the paper reports them. Common values: 'hours', 'days', 'minutes'. Use the exact unit token the paper uses. |
| time_to_union_definition_as_reported | text | Author's stated start and end points for the time_to_union 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. |
| hardware_failure3 | ||
| hardware_failure_rate | rate | Rate of hardware_failure in this unit (events / evaluated / percent). Include only confirmed cases; exclude unconfirmed or suspected cases unless the paper explicitly counts them. |
| hardware_failure_timepoint | text | Time at which hardware_failure 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. |
| hardware_failure_definition_as_reported | textharmonize | Author's stated definition, grading criteria, threshold, or measurement modality for hardware_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. |
| patient_reported_function3 | ||
| patient_reported_function | average | Value of patient_reported_function in this unit, in the units the paper reports. 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. |
| patient_reported_function_timepoint | text | Time at which patient_reported_function 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. |
| patient_reported_function_definition_as_reported | textharmonize | Author's stated measurement method for patient_reported_function. 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. |
rob8 fields
| 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. |