{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Twenty-four-hour antibiotic prophylaxis × Noninferior 90-day SSI — Evidence sheet distinguishing the prespecified margin and denominators",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Existing content review pending",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Are the original subclaim and grade distinguished from the parent judgment context?",
      "needed": "Separate records of the selected subclaim, grade and note, and the original parent verdict",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Separate records of the selected subclaim, grade and note, and the original parent verdict",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional materials separately to the relevant subclaim and parent context."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "What surgery, population and center were actually studied?",
      "needed": "Eligibility, surgery type, urinary diversion, baseline characteristics and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Eligibility, surgery type, urinary diversion, baseline characteristics and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original eligibility, baseline characteristics, surgery, center and denominator records."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What were the historical intervention and comparator exposure until catheter and stent removal?",
      "needed": "Original intervention, comparator, stopping criteria, actual exposure and accompanying care",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original intervention, comparator, stopping criteria, actual exposure and accompanying care",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original arm-specific tables of drugs, prophylactic and treatment exposure, actual duration and accompanying care."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are 196 randomized participants distinguished from 193 in the primary analysis and denominators 95/98?",
      "needed": "Arm-specific randomization, canceled surgery, analysis and follow-up flow",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Arm-specific randomization, canceled surgery, analysis and follow-up flow",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original participant flow, exclusion reasons, arm-specific allocation and analysis counts, and missing-data tables."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are the open-label design and infection adjudicators' roles distinguished?",
      "needed": "Allocation, concealment, measurement, adjudicator and analyst procedures",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Allocation, concealment, measurement, adjudicator and analyst procedures",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original allocation, adjudication, blinding and analysis procedures."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What is the actual access status of registration, protocol and analysis-plan materials?",
      "needed": "Original registration, protocol, SAP, outcome hierarchy and amendment history",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original registration, protocol, SAP, outcome hierarchy and amendment history",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original registration, plans, analysis populations, hierarchy, amendments and multiplicity information."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "What direct outcome is 90-day CDC-defined SSI?",
      "needed": "Infection definition, categories, ascertainment, time points and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Infection definition, categories, ascertainment, time points and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original CDC definitions, classification, ascertainment, results by time point and denominators."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are arm-specific SSI events 8/95 and 12/98 and original percentages preserved?",
      "needed": "Arm-specific events, people, denominators, original percentages and time window",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Arm-specific events, people, denominators, original percentages and time window",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original event tables, arm-specific denominators, repeated-infection records and analysis definitions."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Are the risk-difference direction and 90% CI preserved as originally recorded?",
      "needed": "Risk difference of interest, arm order, CI level and original model",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Risk difference of interest, arm order, CI level and original model",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original comparison direction, risk-difference model, CI calculation and denominators."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Are the prespecified 10%p noninferiority margin and scope of the original conclusion distinguished?",
      "needed": "Margin, direction, rationale, prespecification, CI and plans",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Margin, direction, rationale, prespecification, CI and plans",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the margin rationale, prespecification, testing and analysis plans, and original CI."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Has noninferiority been kept separate from superiority for reducing infection and exact equivalence?",
      "needed": "Original design, effect, interval, hypothesis and interpretation",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original design, effect, interval, hypothesis and interpretation",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link the original hypothesis, interval, margin and effect interpretation to the relevant question."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are the per-protocol primary analysis and gaps in ITT and sensitivity analyses distinguished?",
      "needed": "Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original PP/ITT definitions, exclusions, adherence, missing-data assumptions, sensitivity analyses and original CI."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What are the follow-up, missingness and ascertainment limits within the original infection period?",
      "needed": "90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original follow-up, infection ascertainment, missingness, denominators and handling of events outside the study center."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Is antibiotic duration the same outcome as SSI?",
      "needed": "Distinguishing exposure duration, endpoint, summary statistics and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Distinguishing exposure duration, endpoint, summary statistics and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Share the exposure outcome with the related question while linking it separately from the direct infection outcome."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Are clinical importance and original small-study limitations preserved without new assessment?",
      "needed": "Infection, margin, precision, sample size and original limitations",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Infection, margin, precision, sample size and original limitations",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original sample-size assumptions, clinical margin rationale and precision information."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Are the two subclaims from the same trial kept separate from independent replications?",
      "needed": "Relationships among report, trial, shared participants, outcomes and related questions",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Relationships among report, trial, shared participants, outcomes and related questions",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional reports while preserving original identifiers and population and time-point relationships."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "What is known about company and institutional funding, in-kind support, affiliations and analysis roles?",
      "needed": "Cash, products/in-kind support, author affiliations, external analysis and study roles",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Cash, products/in-kind support, author affiliations, external analysis and study roles",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original support, in-kind, affiliation, analysis, design and writing disclosures separately."
    },
    {
      "item_id": "N18",
      "question_type": "Supplementary harm evidence",
      "question": "Are 90-day mortality counts, denominators and P distinguished from SSI?",
      "needed": "Mortality definition, duration, arm-specific denominators, original events and testing",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Mortality definition, duration, arm-specific denominators, original events and testing",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original mortality, relatedness, denominator, plan, CI and follow-up materials."
    },
    {
      "item_id": "N19",
      "question_type": "Supplementary harm evidence",
      "question": "What do the infection-resolution statement and treatment and safety collection cover?",
      "needed": "Infection types, treatment exposure, follow-up, recovery, relatedness and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Infection types, treatment exposure, follow-up, recovery, relatedness and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original infection, treatment-exposure, treatment-success definition, follow-up, relatedness and denominator records."
    },
    {
      "item_id": "N20",
      "question_type": "Supplementary harm evidence",
      "question": "Does shorter antibiotic exposure directly demonstrate reduced harms?",
      "needed": "Drug harms, collection, exposure, arm-specific events and denominators",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Drug harms, collection, exposure, arm-specific events and denominators",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original harm-collection records, arm-specific events/people, exposure, discontinuation, relatedness and duration."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Are resistance selection pressure, individual resistance, costs and other infections distinguished?",
      "needed": "Direct outcomes, definitions and denominators for resistance, costs and infection types",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Direct outcomes, definitions and denominators for resistance, costs and infection types",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain prespecified direct measurements, denominators, effects and follow-up for resistance, costs and other infections."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "What application gaps remain for populations, surgery, drugs and resistance environments outside the single center?",
      "needed": "Direct comparisons in new populations, surgeries, drug combinations and settings",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Direct comparisons in new populations, surgeries, drug combinations and settings",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effects/harms, denominators and follow-up for each new population, surgery, drug and setting."
    },
    {
      "item_id": "N23",
      "question_type": "Comparative efficacy",
      "question": "Do gaps remain in durability beyond 90 days and independent replication?",
      "needed": "Long-term follow-up, new trials, populations, centers and independence relationships",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Long-term follow-up, new trials, populations, centers and independence relationships",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain long-term direct outcomes, independent-report relationships and center-specific materials."
    },
    {
      "item_id": "N24",
      "question_type": "Comparative efficacy",
      "question": "Are the preserved summary and external abstract, full text, registration and plans distinguished?",
      "needed": "Bibliography, existing links, registration identifiers and material-specific access status",
      "role": "Required",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Bibliography, existing links, registration identifiers and material-specific access status",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link individual original materials supplied by the user separately from their actual access status."
    },
    {
      "item_id": "N25",
      "question_type": "Comparative efficacy",
      "question": "Are the reference date, Korean/English texts, corrections, empty values, candidate history and production state preserved?",
      "needed": "Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history",
      "role": "Supplementary",
      "role_reason": "Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits",
      "application_exception": "Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.",
      "criterion": "Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history",
      "basis": "Noninferior 90-day surgical-site infection",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve original texts before linking additional user materials or decisions as separate events."
    }
  ]
}