{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "PEGPH20 add-on therapy × improved overall survival — evidence sheet for hyaluronan-high metastatic pancreatic ductal adenocarcinoma",
  "language": "en",
  "translation_date": "2026-10-11",
  "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; detailed original materials remain unverified. This does not certify 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": "Review of existing content incomplete",
    "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": "Were the original overall-survival subclaim verdict and parent context preserved separately?",
      "needed": "Separate records of the original claim, grade, note and parent values",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of the original claim, grade, note and parent values",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link additional materials separately to the selected survival question and parent context."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Who were the hyaluronan-high, untreated stage IV pancreatic ductal adenocarcinoma participants?",
      "needed": "Original tumor, expression, treatment-history, stage, eligibility and denominator materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original tumor, expression, treatment-history, stage, eligibility and denominator materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original eligibility, baseline characteristics, biomarker-assessment methods and denominators."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Were PEGPH20 add-on therapy and shared anticancer treatment distinguished?",
      "needed": "Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Records of study drug, placebo, shared regimen, actual exposure and concomitant-treatment management",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link original intervention, placebo, shared regimen, actual exposure and discontinuation materials."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "What were the shared research conditions for matching placebo and thrombosis prophylaxis?",
      "needed": "Original placebo, shared prophylaxis, co-exposure and adherence materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original placebo, shared prophylaxis, co-exposure and adherence materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original protocol materials on shared management, actual exposure, deviations and concomitant treatments."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Were 494 randomized participants, 492 ITT participants and 2:1 allocation distinguished?",
      "needed": "Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Group-specific allocation, ITT, exclusions and outcome-specific analysis denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original participant flow, group allocation, ITT exclusions and outcome-specific denominators."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What were the overall-survival definitions for start time, death ascertainment, follow-up and censoring?",
      "needed": "Original survival-time, start-point, death, censoring, follow-up and denominator materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original survival-time, start-point, death, censoring, follow-up and denominator materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original survival definitions, death ascertainment, censoring, follow-up and group-specific event tables."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Were median overall survival and HR, CI and P preserved as original values?",
      "needed": "Group-specific medians, between-group HR, CI, tests, models and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Group-specific medians, between-group HR, CI, tests, models and denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original survival curves, median CI, models, group-specific denominators and tests."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Were the null HR 1.00 result and remaining possible benefit distinguished?",
      "needed": "Original CI, prespecified success or importance thresholds and effect interpretation",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original CI, prespecified success or importance thresholds and effect interpretation",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original planned clinical-importance criteria, testing assumptions and effect CI."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Were the prespecified 2019 amendment and sole primary overall-survival endpoint preserved?",
      "needed": "Records of original registration, protocol, SAP, dates and decisions before and after amendment",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Records of original registration, protocol, SAP, dates and decisions before and after amendment",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original registration history, protocol, SAP and amendment events separately."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "What was the response-rate hierarchy in fixed-sequence testing?",
      "needed": "Original plans for OS, lower-order endpoints, testing sequence and multiplicity",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original plans for OS, lower-order endpoints, testing sequence and multiplicity",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original SAP materials on fixed sequence, outcome lists, changes and endpoint-specific tests."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Were objective response of 47% versus 36% and survival separated?",
      "needed": "Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of imaging-response definitions, denominators, ratio, CI and hierarchy",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original response definitions, assessments, denominators and hierarchy materials separately."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Were the definitions and effects of progression-free and overall survival distinguished?",
      "needed": "PFS and OS events, times, denominators, effects and CI",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "PFS and OS events, times, denominators, effects and CI",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original PFS definitions, models, denominators, plans and tests separately."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What was the scope of original allocation-concealment and blinding methods?",
      "needed": "Central allocation, concealment and participant, assessor or analyst procedures",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Central allocation, concealment and participant, assessor or analyst procedures",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original methods, allocation, blinding roles and unblinding procedures."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Were gaps in ITT, missing-data, censoring and subsequent-treatment handling retained?",
      "needed": "Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original analysis-population, model, censoring, deviation, subsequent-treatment and sensitivity materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original SAP, analysis-population, follow-up, censoring, subsequent-treatment and sensitivity materials."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Is there information on actual drug exposure, discontinuation and anticancer dose intensity?",
      "needed": "Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Actual exposure, adherence and discontinuation for the added drug, shared regimen and prophylactic drug",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original exposure, discontinuation, group-specific concomitant-treatment and prespecified effect-of-interest materials."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Was survival not filled in from mechanisms, hyaluronan selection or imaging response?",
      "needed": "Relationships between biomarker, mechanism, imaging and direct survival",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Relationships between biomarker, mechanism, imaging and direct survival",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link original mechanism and biomarker analysis plans separately to direct survival materials."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Were gaps in prespecified subgroups, sensitivity and long-term survival retained?",
      "needed": "Original subgroup, interaction, follow-up, model, denominator and multiplicity materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original subgroup, interaction, follow-up, model, denominator and multiplicity materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original subgroup, interaction, long-term follow-up and sensitivity materials."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Were the same HALO report, two outcomes and sibling sheets not added as independent evidence?",
      "needed": "Links among original trial, report, shared population, endpoints and times",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Links among original trial, report, shared population, endpoints and times",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link additional reports to the same registration and trial identifiers and their relationships."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Were Halozyme funding, products, employee authors, management and writing roles separated?",
      "needed": "Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of cash support, drug or placebo supply, affiliations and external analysis or writing",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original disclosures separately for funding, supply, affiliations, data management, analysis and writing roles."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Were original independence, R1 and I0 axes distinguished from new certification?",
      "needed": "Preservation of original verdict, support, investigators and report relationships",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Preservation of original verdict, support, investigators and report relationships",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: If other materials are provided, separately link only study, funding, author and denominator relationships."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Were original grade 3 or worse fatigue, muscle-spasm and hyponatremia proportions retained?",
      "needed": "Original group-specific harm definitions, denominators, grades, relatedness and exposure tables",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original group-specific harm definitions, denominators, grades, relatedness and exposure tables",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety-population, group-specific event, denominator, grade and exposure tables."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Were descriptively more frequent harms and inferential-testing plans distinguished?",
      "needed": "Prespecified safety plans, tests, effects, intervals and relatedness",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Prespecified safety plans, tests, effects, intervals and relatedness",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original safety plans, descriptive tables, relatedness and follow-up materials separately."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Were thrombosis risk, shared enoxaparin and safety-applicability boundaries separated?",
      "needed": "Risk management, shared prophylaxis, actual exposure, events and denominators",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Risk management, shared prophylaxis, actual exposure, events and denominators",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain original thrombosis-event, prophylactic-exposure, deviation and group-specific denominator materials."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain in other, rare or long-term harms and discontinuation?",
      "needed": "Original serious-event, discontinuation, exposure, follow-up and direct-harm materials",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original serious-event, discontinuation, exposure, follow-up and direct-harm materials",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Obtain complete original safety tables, exposure, discontinuation, serious or rare-event and long-term materials."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Were effects or harms not generalized to other cancers, treatment lines or combinations?",
      "needed": "Direct comparative and safety materials by population, exposure and combination",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Direct comparative and safety materials by population, exposure and combination",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link direct materials on new populations or combinations to separate questions if provided."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative efficacy",
      "question": "Were actual access to the preserved summary, external papers, registration and plans distinguished?",
      "needed": "Original source links, registration identifiers and material-specific reading states",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Original source links, registration identifiers and material-specific reading states",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link materials acquired by the user to individual types and access states."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy",
      "question": "Were original dates, Korean and English drafts, false or missing values, empty values and verdict history preserved?",
      "needed": "Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history",
      "role": "Required",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of the complete preserved summary, subclaim verdict, parent values, corrections and history",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Link new materials or decisions to separate change events while preserving original text."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Were production completion, incomplete existing-content review and independence status distinguished?",
      "needed": "Existing candidate history and current production or review states",
      "role": "Supplementary",
      "role_reason": "Individual application conditions documenting the selected endpoint, original values, denominators, hierarchy and applicability boundaries",
      "application_exception": "Externally unread materials, other endpoints or out-of-scope results do not replace condition fulfillment, zero effect or safety.",
      "criterion": "Existing candidate history and current production or review states",
      "basis": "Improved overall survival",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Reflect only user-provided materials or decisions as separate events."
    }
  ]
}