{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Evidence sheet: added ribociclib × invasive disease-free survival — NATALEE interim and final results",
  "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 preservation of the selected question, grade and note and the original parent judgment",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Separate preservation of the selected question, grade and note and the original parent judgment",
      "basis": "Improved invasive disease-free survival",
      "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": "What is the actual early-breast-cancer population and scope of baseline conditions?",
      "needed": "Original eligibility, HR/HER2, stage, sex, baseline characteristics and denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original eligibility, HR/HER2, stage, sex, baseline characteristics and denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original eligibility, baseline, previous-treatment and group-specific participant materials."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What is the actual comparison between added treatment and endocrine therapy alone?",
      "needed": "Original intervention and comparator, shared endocrine therapy, concomitant treatment and actual exposure",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original intervention and comparator, shared endocrine therapy, concomitant treatment and actual exposure",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original group-specific interventions, shared endocrine therapy, concomitant treatment and changes."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are the study dose and 3-year plan distinguished from actual treatment completion?",
      "needed": "Original study exposure, planned duration, actual adherence, reduction or discontinuation, and denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original study exposure, planned duration, actual adherence, reduction or discontinuation, and denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original plans, actual exposure, completion, discontinuation, dose reduction and denominators."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Is concomitant exposure in premenopausal women and men recorded separately?",
      "needed": "Population-specific concomitant treatment, original denominators, actual exposure and analyses",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Population-specific concomitant treatment, original denominators, actual exposure and analyses",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain population-specific shared or added exposure, denominators and prespecified-analysis materials."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What are the 5,101 randomized participants and outcome-specific denominators or risk sets?",
      "needed": "Randomization, original group counts, ITT, follow-up and outcome-specific denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Randomization, original group counts, ITT, follow-up and outcome-specific denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original participant flow, group allocation, ITT, risk sets, censoring and denominators."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are the original roles of open-label design, central allocation and objective events distinguished?",
      "needed": "Allocation, concealment, adjudicators, blinding and event ascertainment",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Allocation, concealment, adjudicators, blinding and event ascertainment",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original allocation, ascertainment, adjudication, analysis, censoring and bias materials."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are the composite iDFS events distinguished from overall survival?",
      "needed": "Original STEEP definition, components, people or events, all-cause death and duration",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original STEEP definition, components, people or events, all-cause death and duration",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original STEEP definitions, component-specific events, overall survival, durations and denominators separately."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Are the interim 3-year survival rates, HR, CI and two-sided P preserved as recorded?",
      "needed": "Original analysis timing, 3-year estimates, HR, CI, tests and denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original analysis timing, 3-year estimates, HR, CI, tests and denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original estimation methods, group risk sets, censoring, denominators, CI and models."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Are the prespecified one-sided boundary and two-sided P distinguished?",
      "needed": "Protocol, interim analysis, test direction, alpha spending, boundary and changes",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Protocol, interim analysis, test direction, alpha spending, boundary and changes",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original interim-analysis plans, boundaries, direction, alpha spending and change history."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are the final 33.3-month analysis and 226/283 events distinguished from interim values?",
      "needed": "Analysis cutoff date, follow-up statistics, events, original effects and denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Analysis cutoff date, follow-up statistics, events, original effects and denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original analysis cutoffs, follow-up distributions, risk sets, models and event mapping."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are interim and final reports kept from being added as new independent confirmation?",
      "needed": "The same trial and population, follow-up reports, individual outcomes and sibling-sheet relationships",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "The same trial and population, follow-up reports, individual outcomes and sibling-sheet relationships",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Connect additional reports through original registration, population, timing and overlap relationships."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in overall-survival event maturity, effects, CI, P and hierarchy?",
      "needed": "Original deaths, follow-up, OS effect of interest, denominators, plans and maturity",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original deaths, follow-up, OS effect of interest, denominators, plans and maturity",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original OS events, denominators, follow-up, prespecified hierarchy, boundaries, models and CI."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Is the original scope of iDFS improvement kept from extending to long-term survival or cure?",
      "needed": "Original composite endpoint, clinical components, duration and direct long-term outcomes",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original composite endpoint, clinical components, duration and direct long-term outcomes",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original component-specific outcomes, long-term iDFS, OS and functional outcomes separately."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Are actual exposure completion, survival follow-up and long-term persistence distinguished?",
      "needed": "Planned exposure, actual completion, follow-up duration and post-discontinuation outcomes",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Planned exposure, actual completion, follow-up duration and post-discontinuation outcomes",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original actual exposure, follow-up, censoring and long-term outcomes after discontinuation."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Do information gaps remain for subgroups, stage or sex application, and multiplicity?",
      "needed": "Prespecified subgroups, interactions, models, original denominators and effects",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Prespecified subgroups, interactions, models, original denominators and effects",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain prespecified subgroup, interaction, denominator, CI and multiplicity materials."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "What are the other drug, trial and level of wording in PALLAS?",
      "needed": "Palbociclib population, intervention, comparison, denominators, original effects and bibliography",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Palbociclib population, intervention, comparison, denominators, original effects and bibliography",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original PALLAS reports, population, comparison, effects, duration, denominators and bibliography separately."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are the repeated CI, drug and original comparison scope of PENELOPE-B preserved?",
      "needed": "Original drug, double blinding, placebo, effects, repeated CI and denominators",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original drug, double blinding, placebo, effects, repeated CI and denominators",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original repeated CI, plans, population, follow-up, denominators and effects."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Are monarchE's other drug and 4-year results distinguished from NATALEE?",
      "needed": "Original drug, population, duration, denominators, effects and independent relationships",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original drug, population, duration, denominators, effects and independent relationships",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original monarchE bibliography, eligibility, comparison, duration, effects and plans separately."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Are different within-class results kept from becoming a class-wide effect or new independent replication?",
      "needed": "Drug-specific questions, eligibility, comparators, durations and report or participant relationships",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Drug-specific questions, eligibility, comparators, durations and report or participant relationships",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain drug-specific direct questions, original eligibility, duration, comparators and overlap relationships."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Are Novartis, TRIO, unreported public support and company roles distinguished?",
      "needed": "Cash, drugs or in-kind support, affiliations, external analysis, supervision and writing roles",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Cash, drugs or in-kind support, affiliations, external analysis, supervision and writing roles",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures of funding, supply, affiliations, supervision, analysis and writing separately."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Are funding and independence information for other-drug trials kept within their original scope?",
      "needed": "Each trial's funding, in-kind support, authors, analysis and roles",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Each trial's funding, in-kind support, authors, analysis and roles",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain each trial's original support, products, affiliations, analysis and writing relationships."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "What collection gaps remain for neutropenia, liver-related adverse events and QT prolongation?",
      "needed": "Each harm's definition, grade, people or events, original denominators, exposure and relatedness",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Each harm's definition, grade, people or events, original denominators, exposure and relatedness",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original harm types, grades, collection, group denominators, exposure, relatedness and discontinuation."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Are harm-related discontinuation, dose reduction, actual exposure and ITT distinguished?",
      "needed": "Original discontinuation, dose reduction, adherence, exposure, harms and event mapping",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Original discontinuation, dose reduction, adherence, exposure, harms and event mapping",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original actual exposure, harm-related discontinuation, dose reduction, adherence, follow-up and event connections."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Are rare or long-term harms and replication of harms in other drugs kept from being newly established?",
      "needed": "Long-term harms, exposure, duration, denominators and direct drug-specific comparisons",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Long-term harms, exposure, duration, denominators and direct drug-specific comparisons",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain drug-specific direct harm, long-term exposure, collection, denominator and follow-up materials."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative efficacy",
      "question": "Are original registration, three bibliography URLs and two evidence records without bibliography distinguished?",
      "needed": "Each report, existing links, registration identifiers and access status",
      "role": "Required",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Each report, existing links, registration identifiers and access status",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Connect additional user-provided original materials by report type, bibliography and actual access status."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy",
      "question": "Are Korean and English articles, axes, reference dates, corrections, empty values and preparation status preserved?",
      "needed": "Distinguishing the entire parent, selected subclaim, original languages and history from the current preparation",
      "role": "Supplementary",
      "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries",
      "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.",
      "criterion": "Distinguishing the entire parent, selected subclaim, original languages and history from the current preparation",
      "basis": "Improved invasive disease-free survival",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve original texts before connecting additional user materials or decisions as separate events."
    }
  ]
}