{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Adjunctive intravenous immunoglobulin × death or major disability at age 2 in neonates — composite outcome evidence sheet",
  "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information is in the stored summary; detailed original material remains unverified. This does not certify 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": "Review of existing content incomplete",
    "Met": "Use only within the relevant condition's scope after user review; no automatic display 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": "Have the original subclaim verdict and the parent values and context been distinguished?",
      "needed": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional materials separately to the selected question and the parent context."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Who was the original population receiving antibiotics for suspected or confirmed sepsis?",
      "needed": "Original sepsis definition, eligibility, baseline, entry timing and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original sepsis definition, eligibility, baseline, entry timing and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original population, diagnosis, eligibility, baseline and entry-timing materials."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What was the actual comparison of added IVIG versus placebo with antibiotics common to both groups?",
      "needed": "Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original product, placebo, common treatment, concomitant treatment and changes."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Have the original administration exposure, actual completion and safety denominators been separated?",
      "needed": "Original study plan, actual administration, omissions, exposure and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original study plan, actual administration, omissions, exposure and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original tables of planned and actual administration, omissions, discontinuation and exposure."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Have the 113 hospitals, 3,493 participants and analysis by assigned group been preserved?",
      "needed": "Original allocation, group denominators, analysis population, sites and missing data",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, group denominators, analysis population, sites and missing data",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original participant flow, analysis population, group denominators, follow-up and missing-data handling."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What is the composite definition of death or major disability at age 2?",
      "needed": "Composite events, components, severity criteria, instruments, assessment timing and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Composite events, components, severity criteria, instruments, assessment timing and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original composite definition, severity criteria, instruments, assessed population, timing and denominators."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Have 686/1759, 677/1734 and the original 39.0% been preserved?",
      "needed": "Original group order, composite events, original denominators, people versus events and proportions",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original group order, composite events, original denominators, people versus events and proportions",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original composite event tables, denominators, components, overlap and missing data."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Have RR 1.00, 95% CI 0.92~1.08 and the absolute difference of 0.0%p been distinguished?",
      "needed": "Original RR, comparison direction, CI, absolute difference, model and test",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original RR, comparison direction, CI, absolute difference, model and test",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original effect of interest, model, test, denominators and interval."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Has a null result been distinguished from the CI tail that leaves a small benefit possible?",
      "needed": "Original interval, clinical importance, uncertainty and margin",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original interval, clinical importance, uncertainty and margin",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original clinical boundaries, precision, analysis assumptions and interval."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Have the death and major-disability components and survivor assessment been separated?",
      "needed": "Original events by component, people, survivor assessment, denominators and overlap",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original events by component, people, survivor assessment, denominators and overlap",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original events by component, survivors to be assessed, denominators, overlap and plans."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in follow-up at age 2, age definition, missing data, loss to follow-up and proxy assessment?",
      "needed": "Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original follow-up flow, age definition, omissions, assessment methods, handling and sensitivity analyses."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Have allocation concealment, double blinding and the original listed-defect judgment been distinguished?",
      "needed": "Original allocation, concealment, blinding, assessment, analysis and reporting",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, concealment, blinding, assessment, analysis and reporting",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original allocation, blinding, assessment, analysis, missing-data and reporting materials."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What has actually been accessed for registration, the prespecified composite endpoint, multiplicity and the analysis hierarchy?",
      "needed": "Original registration, protocol, SAP, hierarchy, changes and analysis",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original registration, protocol, SAP, hierarchy, changes and analysis",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original registration, plans, hierarchy, changes and analysis-population materials."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Have subgroups, other outcomes or mechanisms replaced the direct composite effect?",
      "needed": "Prespecified subgroups, interactions, original denominators and clinical outcomes",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Prespecified subgroups, interactions, original denominators and clinical outcomes",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original prespecified subgroups, interactions, denominators and direct outcomes."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Have public funding, product provision, affiliations and external-analysis information been separated?",
      "needed": "Cash, IVIG or placebo provision, company affiliations, external analysis and study roles",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Cash, IVIG or placebo provision, company affiliations, external analysis and study roles",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures separately for funding, products or placebo, affiliations, design, analysis and writing."
    },
    {
      "item_id": "N16",
      "question_type": "Supplementary harm evidence",
      "question": "Have 12 versus 10 adverse events and the included 2 versus 4 deaths been separated?",
      "needed": "Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original adverse-event counts and people, included deaths, denominators, relatedness, exposure and component mapping."
    },
    {
      "item_id": "N17",
      "question_type": "Supplementary harm evidence",
      "question": "Has the absence of a reported adverse-event significance test been turned into a safety difference?",
      "needed": "Original adverse-event plan, comparison, test, interval and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original adverse-event plan, comparison, test, interval and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original adverse-event plans, denominators, exposure, tests and intervals."
    },
    {
      "item_id": "N18",
      "question_type": "Supplementary harm evidence",
      "question": "Have exposure, discontinuation, rare or long-term harms and the age-2 outcome been separated?",
      "needed": "Harm collection, actual exposure, duration, denominators, relatedness and discontinuation",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Harm collection, actual exposure, duration, denominators, relatedness and discontinuation",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original safety-population, exposure, discontinuation, collection and long-term follow-up materials."
    },
    {
      "item_id": "N19",
      "question_type": "Supplementary harm evidence",
      "question": "Have prevention trials and other populations or products been distinguished from independent replication?",
      "needed": "Original question, timing, intervention, population and report or cohort relationships",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original question, timing, intervention, population and report or cohort relationships",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve direct outcomes for new populations, products or timing and the report or cohort relationships."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Do gaps remain for outcomes beyond age 2 and applications to other indications?",
      "needed": "Direct comparisons of long-term components, other populations, other products and exposure",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Direct comparisons of long-term components, other populations, other products and exposure",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effect and harm materials by duration, population, product and exposure."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Are the stored summary, original URLs, registration identifier and access to linked targets distinguished?",
      "needed": "Reports or cross-citations, URLs, identifiers and access by material",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Reports or cross-citations, URLs, identifiers and access by material",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link user-provided original materials to each material type and access status."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Have the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?",
      "needed": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "role": "Supplementary",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve user materials and decisions in full, then link them as separate events."
    }
  ]
}